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APPROVED

DRUG

PRODUCTS

WITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

39th 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

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF GENERIC DRUGS


OFFICE OF GENERIC DRUG POLICY

2019

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, 2018.

39th EDITION

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF GENERIC DRUGS

OFFICE OF GENERIC DRUG POLICY

2019

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

With

Therapeutic Equivalence Evaluations

CONTENTS
PAGE

PREFACE TO THIRTY-NINTH EDITION…...…….……………………………..…................iv

1.0 INTRODUCTION ........................................................................................................... vi

1.1 Content and Exclusion ................................................................................................... vi

1.2 Therapeutic Equivalence-Related Terms .......................................................................vii

1.3 Further Guidance on Bioequivalence ............................................................................. ix

1.4 Reference Listed Drug and Reference Standard............................................................ ix

1.5 General Policies and Legal Status .................................................................................. x

1.6 Practitioner/User Responsibilities .................................................................................. xi

1.7 Therapeutic Equivalence Evaluations Codes ................................................................xiii

1.8 Description of Certain Special Situations ......................................................................xxi

1.9 Therapeutic Equivalence Code Change for a Drug Entity ........................................... xxiii

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product ....................xxiv

1.11 Discontinued Section ...................................................................................................xxv

1.12 Changes to the Orange Book.......................................................................................xxv

1.13 Availability of the Edition .............................................................................................xxvi

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

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

2.2 Drug Product Illustration ……………………………………………..….…………….……..2-3

2.3 Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4

DRUG PRODUCT LISTS

Prescription Drug Product List ……………………………………….…………….………………...3-1

OTC Drug Product List ……………………………………………….…………….…………………4-1

Drug Products with Approval under Section 505 of the FD&C 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
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

APPROVED DRUG PRODUCTS

With

Therapeutic Equivalence Evaluations

PREFACE TO THIRTY-NINTH 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
FD&C Act). The main criterion for the inclusion of any product is that the
product is the subject of an application with an approval that has not been
withdrawn for safety or efficacy reasons. Inclusion of products in the
Orange Book is independent of any current regulatory action being taken
administratively or judicially against a drug product. In addition, the
Orange Book 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 FD&C 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 announcing 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 Orange Book was distributed as a proposal in January 1979. 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 FD&C Act and FDA
regulations at that time.

The therapeutic equivalence evaluations in the Orange Book reflect FDA's


application of specific criteria to the multisource prescription drug
products listed in the Orange Book and approved under Section 505 of the FD&C
Act. These evaluations are presented in the form of code letters that
indicate the basis for the evaluation made. An explanation of the codes
appears in the Introduction.

iv
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 on October 31, 1980 (45 FR 72582). The first publication of
the Orange Book in October 1980, concurrent with finalization of the rule,
incorporated appropriate corrections and additions. Each subsequent edition
has included 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 of 1984 (Hatch-Waxman
Amendments). The Hatch-Waxman Amendments require that FDA, among other
things, make publicly available a list of approved drug products with monthly
supplements. The Orange Book and its monthly Cumulative Supplements satisfy
this requirement. The Addendum to this publication identifies drugs that
qualify under the FD&C Act for periods of exclusivity and provides patent
information concerning the approved drug products in the Orange Book. The
Addendum also provides additional information that may be helpful to those
submitting an NDA or ANDA 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 Legal and Regulatory
Support, Office of Generic Drug Policy, Office of Generic Drugs, Center for
Drug Evaluation and Research, 7620 Standish Place, Rockville, MD 20855-2773.
Comments received are publicly available to the extent allowable under the
Freedom of Information Act and FDA regulations.

v
1.0 INTRODUCTION

1.1 Content and Exclusion

The Orange Book 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 FD&C 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 and
we have not determined that they were withdrawn from sale for safety or
effectiveness reasons, 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 name (proprietary name) or established name (if no trade name
exists) and by applicant name (holder of the approved application), which
have been abbreviated for this publication. Established names for active
ingredients generally conform to official compendial names or United States
Adopted Names (USAN) as described in 21 CFR 299.4(e). A list of uniform
terms is provided in Appendix C.

The Addendum contains patent and exclusivity information for the


Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products
with Approval under Section 505 of the FD&C 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 FD&C Act
administered by the Center for Biologics Evaluation and Research. The Hatch-
Waxman 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 FD&C Act, some drug products are given tentative approvals. The
Agency will not include drug products with tentative approvals in the Orange
Book because a drug product that is granted tentative approval is not an
approved drug product. Tentative approval lists by month are available on
FDA’s website Drugs@FDA. When the tentative approval becomes a final
approval through a subsequent action letter to the applicant, the Agency will
list the drug product and the date of approval in the appropriate approved
drug product list. In addition, we note that Section 505(x) of the FD&C Act
affects the date of approval for certain drug products subject to scheduling
under the Controlled Substances Act. The Agency will list the drug product in
the Orange Book and the date of approval as determined under Section 505(x).

The Orange Book identifies the application holder of a drug product and
does not identify distributors or repackagers.

1
Generally, newly approved products are added to the Active Section of the Orange Book (i.e.,
the Prescription Drug Product List or the Over-the-Counter Drug Product List), depending on the
dispensing requirements (prescription or OTC) or approval authority, unless the Orange Book staff
is otherwise notified before publication. See Section 1.12.

vi
1.2 Therapeutic Equivalence-Related Terms

Pharmaceutical Equivalents. Pharmaceutical equivalents are drug products


in identical dosage forms and route(s) of administration that contain
identical amounts of the identical active drug ingredient, i.e., the same
salt or ester of the same therapeutic moiety, or, in the case of modified-
release dosage forms that require a reservoir or overage or such forms as
prefilled syringes where the residual volume may vary, that deliver identical
amounts of the active drug ingredient over the identical dosing period; do
not necessarily contain the same inactive ingredients; and meet the identical
compendial or other applicable standard of identity, strength, quality, and
purity, including potency and, where applicable, content uniformity,
disintegration times, and/or dissolution rates. 2 They may differ in
characteristics such as shape, scoring configuration, release mechanisms,
packaging, excipients (including colors, flavors, preservatives), expiration
date/time, and, within certain limits, labeling.

Pharmaceutical Alternatives. Pharmaceutical alternatives are drug


products that contain the identical therapeutic moiety, or its precursor, but
not necessarily in the same amount or dosage form, or the same salt or ester
(e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline phosphate
complex, 250mg capsules; quinidine sulfate, 200mg tablets vs. quinidine
sulfate, 200mg capsules). 3 Each such drug product individually meets either
the identical or its own respective compendial or other applicable standard
of identity, strength, quality, and purity, including potency and, where
applicable, content uniformity, disintegration times, and/or dissolution
rates. 4 Different dosage forms and strengths within a product line by a
single manufacturer are pharmaceutical alternatives, as are extended-release
products when compared with immediate-release or standard-release
formulations of the same active ingredient.

Therapeutic Equivalents. Approved drug products are considered to be


therapeutic equivalents only if they are pharmaceutical equivalents for which
bioequivalence has been demonstrated, and they can be expected to have the
same clinical effect and safety profile when administered to patients under
the conditions specified in the labeling. 5

FDA classifies as therapeutically equivalent those drug 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 identical active drug ingredient in the identical 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; and
(5) they are manufactured in compliance with Current Good Manufacturing
Practice regulations. The concept of therapeutic equivalence applies only to
drug products containing the identical active ingredient(s) and does not
encompass a comparison of different therapeutic agents used for the same
condition (e.g., meperidine hydrochloride vs. morphine sulfate for the
treatment of pain). Any drug product in the Orange Book repackaged and/or
distributed by other than the applicant is considered to be therapeutically

2 21 CFR 314.3(b).
3 See 21 CFR 314.3(b).
4 21 CFR 314.3(b).
5 21 CFR 314.3(b).

vii
equivalent to the applicant’s drug product even if the applicant’s drug
product is single source or coded as non-equivalent (e.g., BN). Distributors
or repackagers of an applicant’s drug product are not identified in the
Orange Book.

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 certain 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 specific product 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 can be expected to have the
same clinical effect and safety profile as the prescribed product when
administered to patients under the conditions specified in the labeling.

Strength. Strength refers to the amount of drug substance contained in,


delivered, or deliverable from a drug product, which includes: (1)(a) the
total quantity of drug substance in mass or units of activity in a dosage
unit or container closure (e.g., weight/unit dose, weight/volume or
weight/weight in a container closure, or units/volume or units/weight in a
container closure); and/or, as applicable, (b) the concentration of the drug
substance in mass or units of activity per unit volume or mass (e.g., weight/
weight, weight/volume, or units/volume); or (2) such other criteria the
Agency establishes for determining the amount of drug substance contained in,
delivered, or deliverable from a drug product if the weights and measures
described in clause (1)(a) do not apply (e.g., certain drug-device
combination products for which the amount of drug substance is emitted per
use or unit time). 6 Note that if the criteria the Agency establishes for
determining and expressing the amount of drug substance in a product evolves
over time, the Agency generally does not intend to revise the expressions of
strength for drug products already included in the Orange Book, but rather
intends to apply the criteria prospectively to drug products added to the
Orange Book.

Although the strength of drug products in the Orange Book is generally


expressed in terms of the amount of drug substance (active ingredient) in the
drug product, it is sometimes expressed in terms of the amount of the active
moiety. For example, certain drug products included in the Orange Book
include a designation of “EQ” next to their expression of strength. This
“EQ” designation generally is used in connection with salt drug products to
indicate that the strength of such drug product is being expressed in terms
of the equivalent strength of the active moiety (e.g., “EQ 200MG BASE”),
rather than in terms of the strength of the active ingredient.

Bioavailability. Bioavailability is the rate and extent to which the


active ingredient or active moiety is absorbed from a drug product and
becomes available at the site of drug action. For drug products that are not
intended to be absorbed into the bloodstream, bioavailability may be assessed
by scientifically valid measurements intended to reflect the rate and extent
to which the active ingredient or active moiety becomes available at the site
of drug action. 7

6 See 21 CFR 314.3(b).


7 21 CFR 314.3(b).

viii
Bioequivalence. Bioequivalence is the absence of a significant difference
in the rate and extent to which the active ingredient or active moiety in
pharmaceutical equivalents or pharmaceutical alternatives becomes available
at the site of drug action when administered at the same molar dose under
similar conditions in an appropriately designed study. 8 Section 505(j)(8)(B)
of the FD&C Act describes certain conditions under which a test drug and
reference listed drug (see Section 1.4) shall be considered bioequivalent:

(i) 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] listed 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

(ii) the extent of absorption of the [test] drug does not show a
significant difference from the extent of absorption of the
[reference] listed 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] listed 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 scientifically
valid in vivo or in vitro test methods to demonstrate bioequivalence may be
appropriate.

For example, 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. 9

1.3 Further Guidance on Bioequivalence

FDA’s regulations and guidance documents provide additional information


regarding bioequivalence and bioavailability, including methodologies and
statistical criteria used to establish the bioequivalence of drug products. 10

1.4 Reference Listed Drug and Reference Standard

A reference listed drug is the listed drug identified by FDA as the drug
product upon which an applicant relies in seeking approval of its ANDA. 11
Generally, a reference listed drug is a drug product approved in a new drug
application under Section 505(c) of the FD&C Act based on full reports of

8 21 CFR 314.3(b).
9
21 CFR 320.24
10 We note that prior editions of the Preface to the Orange Book included a section entitled
“Statistical Criteria for Bioequivalence.” Please see FDA’s regulations and guidance documents
for additional information regarding bioequivalence and bioavailability. See generally 21 CFR
part 320. See FDA Drugs guidance Web page at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; FDA Drugs
guidance (Product-Specific Recommendations for Generic Drug Development) Web page at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm.
11 21 CFR 314.3(b).

ix
investigations of safety and effectiveness. For an ANDA based on an approved
suitability petition (a petitioned ANDA), the reference listed drug generally
is the listed drug referenced in the approved suitability petition. 12

A reference standard is the drug product selected by FDA that an applicant


seeking approval of an ANDA must use in conducting an in vivo bioequivalence
study required for approval. 13 FDA generally selects a single reference
standard that ANDA applicants must use in in vivo bioequivalence testing.
Ordinarily, FDA will select the reference listed drug as the reference
standard. However, in some instances, the reference listed drug and the
reference standard may be different. For example, where the reference listed
drug has been withdrawn from sale and FDA has determined it was not withdrawn
for reasons of safety or effectiveness, FDA may select an ANDA as the
reference standard.

FDA identifies reference listed drugs in the Prescription Drug Product,


OTC Drug Product, and Discontinued Drug Product Lists. Listed drugs
identified as reference listed drugs represent drug products upon which an
applicant can rely in seeking approval of an ANDA. FDA intends to update
periodically the reference listed drugs identified in the Prescription Drug
Product, OTC Drug Product, and Discontinued Drug Product Lists, as
appropriate.

In some instances when FDA has not designated a listed drug as a reference
listed drug, such listed drug may be shielded from generic competition. If
FDA has not designated a reference listed drug for a drug product the
applicant intends to duplicate, the potential applicant may submit a
controlled correspondence to the Office of Generic Drugs to ask FDA to
designate a reference listed drug for that drug product. Section 1.7,
Therapeutic Equivalence Evaluations Codes (products meeting necessary
bioequivalence requirements) explains the character coding system (e.g., AB,
AB1, AB2, AB3...) for multisource drug products listed under the same heading
with two or more reference listed drugs.

FDA also identifies reference standards in the Prescription Drug Product


and OTC Drug Product Lists. Listed drugs identified as reference standards
represent FDA’s best judgment at this time as to the appropriate comparator
for purposes of conducting any in vivo bioequivalence studies required for
approval.

A potential applicant should consult Agency guidance related to


referencing approved drug products in ANDA submissions for information on
submitting a request for selection of a reference standard. FDA may, on its
own initiative, select a new reference standard when doing so will help to
ensure that applications for generic drugs may be submitted and evaluated,
e.g., in the event that the listed drug currently selected as the reference
standard has been withdrawn from sale for other than safety and efficacy
reasons.

If an applicant has a question related to the appropriate reference


standard, it is recommended that an applicant planning to conduct an in vivo
bioequivalence study submit a controlled correspondence to the Office of
Generic Drugs.

1.5 General Policies and Legal Status

12 21 CFR 314.94(a)(3)(i).
13 21 CFR 314.3(b).

x
The Orange Book contains public information and advice. It does not
mandate the drug products that are purchased, prescribed, dispensed, or
substituted for one another, nor does it, conversely, mandate the products
that should be avoided. To the extent that the Orange Book 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 FD&C 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, e.g., reducing the cost of drugs to consumers. To the extent that
the Orange Book identifies drug products approved under Section 505 of the
FD&C 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 Orange Book does not necessarily mean
that the drug product is in violation of Section 505 of the FD&C Act, 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 may
be 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 Orange


Book. 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
the same clinical effect and safety profile when administered to patients
under the conditions specified in the labeling. However, these products may
differ in other characteristics that are not required by statute or
regulation to be the same, 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, e.g., 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 patient-specific
allergic reactions in rare cases due to a coloring or a preservative
ingredient.

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 practitioner's prescribing of that product may be
appropriate. Pharmacists must also be familiar with the different
characteristics of therapeutically equivalent products, e.g., expiration
dates/times and labeling directions for storage of the different products
(particularly for reconstituted products), so they can properly advise
patients when one product is substituted for another.

Multisource and single-source drug products. In the Orange Book, FDA has
evaluated for therapeutic equivalence only multisource prescription drug
products approved under Section 505 of the FD&C Act, which in most instances
means those pharmaceutical equivalents available from more than one
manufacturer. For such products, a therapeutic equivalence code is included
xi
and 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 in the Orange Book,
but no therapeutic equivalence code is included with such products. Any drug
product in the Orange Book repackaged and/or distributed by the applicant or
some other person authorized by the applicant (e.g., an authorized generic)
is considered to be therapeutically equivalent to the applicant’s drug
product even if the applicant’s drug product is single source or coded as
non-equivalent (e.g., BN). Distributors or repackagers of an applicant’s
drug product are not identified in the Orange Book. The details of
therapeutic equivalence codes and the policies underlying them are discussed
in Section 1.7, Therapeutic Equivalence Evaluations Codes.

Products in the Orange Book are identified by the names of the holders of
approved applications (applicants) who may not necessarily be the
manufacturer of the product. There are numerous entities other than the
applicant that may be involved in the development, manufacturing, and/or
marketing of a product. The applicant may or may not be the manufacturer and
may simply be distributing the product for which it has obtained approval.
In many 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 applicant or marketer.

Although the products in the Orange Book 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 in the Orange Book are, in most cases,
correct.

To relate firm name information on a product label to that in the


Orange Book, the following should be noted: the applicant's name always
appears in the Orange Book. This applies whether the applicant (firm name on
the Form FDA 356h in the application) is the manufacturer or 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 in the Orange Book
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 in the Orange
Book 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 in the Orange Book; 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 Orange
Book, 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 in the Orange Book, the following should be noted: if the applicant is
the marketer, the applicant’s name appears in the Orange Book 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 name of the active ingredient, if no trade name exists)
appears in the Orange Book. If a corporate relationship exists between an
applicant and a marketer and both firms are distributing the drug product,
xii
the FDA reserves the right to select the trade name of either the marketer or
the applicant to appear in the Orange Book. If there is no known corporate
relationship between the applicant and the marketer, the established drug
name (i.e., non-proprietary name) appears in the Orange Book.

Every product in the Orange Book 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 FD&C Act. In such circumstances, the Agency may
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 in the Orange Book. The
main criterion for inclusion of a product is that it has an application that
has been approved and that has not been withdrawn for safety or efficacy
reasons. FDA believes that retention of a violative product in the Orange
Book 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 Agency's assessment of whether a product meets the
criteria for therapeutic equivalence.

1.7 Therapeutic Equivalence Evaluations Codes

Generally, drug products that the Agency considers multisource have been
assigned a therapeutic equivalence code. The coding system for therapeutic
equivalence evaluations is designed to allow users to determine quickly
whether the Agency has evaluated a particular approved product (e.g., a
particular strength of an approved drug) 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 some exceptions (e.g., therapeutic equivalence evaluations for certain
505(b)(2) applications), 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 of the relevant therapeutic equivalence code 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*.

xiii
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 there are no known or suspected
bioequivalence problems or for which actual or potential bioequivalence
problems have been resolved with adequate in vivo and/or in vitro evidence
supporting bioequivalence. 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
either presumed and considered self-evident (based on other information
in the application for some dosage forms (e.g., solutions)), or satisfied
by a showing that an acceptable in vitro approach 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 Drug Efficacy Study Implementation (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 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 (e.g.,
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). FDA’s determination that such
products are therapeutically equivalent is applicable only when each product
is reconstituted, stored, and used under the conditions specified in its
labeling.

The Agency may 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 Certain Special
Situations.

xiv
For example, in certain 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
may 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, generally the Agency has considered products to
be pharmaceutically equivalent with labeled strengths of an ingredient that
do not vary by more than 1%.

Different salts, esters or other noncovalent derivatives (such as a


complex, chelate, or clathrate) of the same active moiety are regarded as
different active ingredients. For the purpose of this publication, products
containing such different active ingredients are considered pharmaceutical
alternatives and, thus, not therapeutically equivalent. Anhydrous and
hydrated entities, as well as different polymorphs, are considered to be the
same active ingredient and are expected to meet the same standards for
identity to be considered pharmaceutical equivalents and therapeutic
equivalents.

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 and other inactive ingredients may differ among some


therapeutically equivalent drug products. These differences 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

Multisource drug products coded as AA contain active ingredients and are


in dosage forms that are not regarded as presenting either actual or
xv
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, Strength) generally will be coded AB if data and information are
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
generally are assigned only in situations when more than one reference
listed drug of the same strength has been designated under the same
heading. If a study is submitted that demonstrates bioequivalence to a
reference 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 and Procardia XL®, extended-release tablets, are
listed under the active ingredient nifedipine. These drug products, listed
under the same heading, are not bioequivalent to each other. Adalat® CC
and Procardia XL® have been assigned ratings of AB1 and AB2, respectively.
Generic drug products deemed by FDA to be bioequivalent to Adalat® CC and
Procardia XL® have been approved. As a result, the generic drug products
bioequivalent to Adalat® CC have been assigned a rating of AB1 and those
bioequivalent to Procardia XL® have been assigned a rating of 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 Orange Book, they are considered
therapeutically equivalent to the applicant’s drug product if the
applicant’s drug product is rated either with an AB or three-character
code or is single source in the Orange Book. 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 general-use 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 and are otherwise
determined to be therapeutically equivalent. 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
xvi
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, historically 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 in glass


containers are not included in the Orange Book (e.g., dextrose injection
5%, dextrose injection 10%, sodium chloride injection 0.9%) since these
products are on the market without FDA approval and 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.

Consistent with the definition of strength included in Section 1.2,


Therapeutic Equivalence-Related Terms, the strength of parenteral drug
products generally is identified by both the total drug content and the
concentration of drug substance in a container approved by FDA. 14 In the
past, the strength of liquid parenteral drug products in the Orange Book
has not been fully displayed. Rather, the strength of liquid parenteral
drug products in the Orange Book has been displayed in terms of
concentration, expressed as xmg/mL. Generally, the amount of dry powder
or lyophilized powder in a container is identified as the strength,
expressed as xmg/vial.

After the enactment of the Medicare Prescription Drug, Improvement, and


Modernization Act of 2003 (MMA), which amended the FD&C Act, it became
evident that the format of the Orange Book with respect to parenteral

14 The strengths of certain parenteral drug products, including contrast agents, may be expressed
as a percentage.

xvii
solutions should be changed to reflect that each strength of a drug is
considered to be a separate listed drug. The Orange Book now displays 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. For example, if this application had a 20 mL and
60 mL container approved, we would now display two product strengths,
listing both total drug content and concentration of drug substance in the
relevant approved container, e.g. 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, or the
application contains adequate scientific evidence establishing through an
in vitro approach the bioequivalence of the product to a selected
reference product, 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 and for which a waiver of in vivo
bioequivalence has not been granted, including all post-1962 non-solution
topical drug products, are coded AB when supported by adequate in vivo
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 bioequivalence problems or a significant potential for
such problems and for which no adequate studies demonstrating
bioequivalence have been submitted to FDA; or

(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:

xviii
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 drug substance 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 applicants 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.

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,
xix
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 bioequivalence data are submitted, after which 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 bioequivalent only if in vivo evidence of
bioequivalence is available. In those cases where in vivo evidence is
available, the products are 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.

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,
gels, lotions, oils, ointments, pastes, solutions, 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.

xx
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 Certain Special Situations

Certain drugs listed in the Orange Book present special situations that
merit further discussion. The following are descriptions of certain examples
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 expected to have the same clinical effect and safety
profile when administered to patients under the conditions specified in the
labeling.

Gaviscon®. Gaviscon® is an OTC product that 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 that 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. Gaviscon®’s 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 that cite Gaviscon®
tablets as the reference 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


for 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 sodium tablet drug products.

Levothyroxine Sodium (Mylan ANDA 076187), Levoxyl (King Pharms NDA 021301),
Synthroid (Abbvie NDA 021402), and Levo-T (Cediprof Inc NDA 021342) tablets
have been determined to be therapeutically equivalent to corresponding
strengths of Unithroid (Jerome Stevens NDA 021210) tablets.

Levo-T (Cediprof Inc NDA 021342), Euthyrox (Provell Pharma LLC NDA 021292),
Levothyroxine Sodium (Mylan ANDA 076187), and Unithroid (Jerome Stevens NDA
021210) tablets have been determined to be therapeutically equivalent to
xxi
corresponding strengths of Synthroid (Abbvie NDA 021402) tablets.

Levo-T (Cediprof Inc NDA 021342), Unithroid (Jerome Stevens NDA 021210), and
Levothyroxine Sodium (Mylan ANDA 076187) tablets have been determined to be
therapeutically equivalent to corresponding strengths of Levoxyl (King Pharms
NDA 021301) tablets.

Levothyroxine Sodium (Mylan ANDA 076187) tablets have been determined to be


therapeutically equivalent to corresponding strengths of Thyro-Tabs (Lloyd
NDA 021116) tablets. 15

The chart outlines TE codes for all 0.025 mg products in the active section
of the Orange Book. 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.

TE Appl Product
Trade Name Applicant Strength
Code No No
UNITHROID STEVENS J 0.025MG AB1 021210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB1 076187 001
LEVOXYL KING PHARMS 0.025MG AB1 021301 001
SYNTHROID ABBVIE 0.025MG AB1 021402 001
LEVO-T CEDIPROF INC 0.025MG AB1 021342 001

SYNTHROID ABBVIE 0.025MG AB2 021402 001


LEVOTHYROXINE SODIUM MYLAN 0.025MG AB2 076187 001
LEVO-T CEDIPROF INC 0.025MG AB2 021342 001
UNITHROID STEVENS J 0.025MG AB2 021210 001
EUTHYROX PROVELL PHARM 0.025MG AB2 021292 001

LEVOXYL KING PHARMS 0.025MG AB3 021301 001


LEVO-T CEDIPROF INC 0.025MG AB3 021342 001
UNITHROID STEVENS J 0.025MG AB3 021210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB3 076187 001

THYRO-TABS LLOYD 0.025MG 16 021116 001


N/A
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB4 076187 001

15 Lloyd’s Thyro-Tabs tablets (NDA 021116) (previously known as Levothroid) is currently listed
in the Discontinued Drug Product List section of the Orange Book. It is the RLD for the AB4
category. Mylan’s levothyroxine product (ANDA 076187) has been selected as the reference standard
for ANDA applicants to use to establish bioequivalence to Thyro-Tabs. If an ANDA that uses
Mylan’s levothyroxine product as its reference standard is approved, the ANDA will receive an AB4
rating. The ANDA applicant also may obtain an AB rating for its product to the other reference
listed drugs (i.e., Unithroid, Synthroid, and Levoxyl) by submitting supplements that demonstrate
that the generic product is bioequivalent to these other reference listed drugs and satisfies all
other therapeutic equivalence criteria with respect to these reference listed drugs. See Letter
from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA to Teri
Nataline, Principal Consultant, Lachman Consultant Services, Inc., Docket No. FDA-2015-P-0403
(May 27, 2016).
16 Id. Thyro-Tabs is in the Discontinued Drug Product List and therefore no longer is assigned a
TE code.

xxii
Patent Certification(s) and Reference Standard for ANDAs Duplicating a
Drug Product Approved in a Petitioned ANDA. To submit an ANDA for a generic
drug that is not the same as its reference listed drug because it has one
different active ingredient in a fixed-combination drug product, or has a
different route of administration, dosage form, or strength than that of the
reference listed drug, an applicant first must obtain permission from FDA
through what is known as a suitability petition pursuant to Section
505(j)(2)(C) of the FD&C Act. A petitioned ANDA relies on the reference
listed drug described in the suitability petition. An ANDA seeking approval
of a drug that is the same as a drug product approved in a petitioned ANDA
should use as its reference listed drug, the reference listed drug that
served as the basis for the approved suitability petition, and use the drug
product approved in the petitioned ANDA as its reference standard for
conducting an in vivo bioequivalence study required for approval. However,
the reference listed drug for any such ANDA is generally the listed drug
referenced in the approved suitability petition. The ANDA must include
appropriate patent certification(s) and an exclusivity statement with respect
to the reference listed drug that served as the basis for the approved
suitability petition. 17 (This concept also generally applies to an ANDA
applicant that utilizes a reference standard that is not a reference listed
drug, as such an application must include appropriate patent certification(s)
and an exclusivity statement with respect to the reference listed drug.)

Waived exclusivity. If an NDA submitted under Section 505(b) of the FD&C


Act qualifies for exclusivity under the FD&C Act, the exclusivity is
generally listed in the Patent and Exclusivity Section of the Orange Book.
If a drug product has received this exclusivity, FDA will not accept for
review and/or will not approve a 505(b)(2) application or an ANDA under
Section 505(j) of the FD&C Act, as applicable, in accordance with the
relevant exclusivity. 18 If the listed drug is also protected by one or more
patents, the approval date for the ANDA or 505(b)(2) application will be
determined based on an analysis of the applicant’s patent certification(s) or
statement(s) for each relevant patent and the effect of relevant exclusivity
listed in the Orange Book. However, the holder of the NDA may waive its
exclusivity as to any or all ANDAs and 505(b)(2) applications that might
otherwise be blocked by such exclusivity. If an NDA sponsor waives its
exclusivity, qualified ANDAs or 505(b)(2) applications may be accepted for
review and/or approved, as applicable. An NDA for which the holder has
waived its exclusivity as to all ANDAs and 505(b)(2) applications will be
coded with a “W” in the Patent and Exclusivity Section of the Orange Book.
The applicant whose product might otherwise be blocked by this exclusivity
should indicate in the exclusivity statement in its application that the
holder of the listed drug has waived its exclusivity.

1.9 Therapeutic Equivalence Code Change for a Category of Multisource Drug Products

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 multisource 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

17 If after approval of a suitability petition and before approval of an ANDA submitted pursuant
to the approved petition, a drug product is approved in an NDA for the change described in the
petition, the suitability petition and the listed drug identified in the petition can no longer
be the basis of submission for such ANDA. Under these circumstances, an applicant seeking
approval for a drug product with the change approved in the suitability petition must submit a
new ANDA that identifies the drug product approved under such NDA as the RLD and comply with
applicable regulatory requirements. See 21 CFR 314.93(f)(2).
18
See Patent and Exclusivity Information Addendum in the Orange Book.

xxiii
multisource drug products in the Orange Book (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
active ingredient 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 an actual or potential 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 multisource drug products as described above, the Agency will
announce in the Introduction to the Cumulative Supplement that it is
considering the change and will invite comments. Comments, along with
scientific data, may be sent to the Director, Office of Bioequivalence, Food
and Drug Administration, Office of Generic Drugs,Central Document Room, 5901­
B Ammendale Rd., Beltsville, MD 20705-1266.

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 submitted to support comments is


an in vivo bioavailability/bioequivalence study conducted on batches of the
subject drug products. Comments including scientific data from an in vivo
bioavailability/bioequivalence study 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 submission of comments based on such
information is discouraged. However, when there is supporting published or
unpublished scientific literature, copies should be submitted with comments.

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product

The procedure described in Section 1.9 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
in the Cumulative Supplement. 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.

We recognize that certain drug products approved in 505(b)(2)


applications may not have therapeutic equivalence codes, and that FDA may
undertake therapeutic equivalence evaluations with respect to such drug
products. A person seeking to have a therapeutic equivalence rating for a
drug product approved in a 505(b)(2) application may petition the Agency
through the citizen petition procedure (see 21 CFR 10.25(a) and 21 CFR
10.30).

xxiv
1.11 Discontinued Section

Those drug products in the discontinued section of the Orange Book


(Discontinued Drug Product List) for which a determination has been made that
the products were not withdrawn for safety or effectiveness reasons have been
annotated with a footnote following the product strength: “**Federal Register
determination that product was not discontinued or withdrawn for safety or
efficacy reasons**”. The determinations listed in the Orange Book are only
reflective of determinations made since 1995 and published in the Federal
Register. The identification of these drug products in the Discontinued Drug
Product List should avoid the submission of multiple citizen petitions
requesting a determination for the same drug product.

Generally, approved products are added to the Discontinued Drug Product


List when the applicant notifies the Orange Book staff of the products’ not-
marketed status. Products may also be added to the Discontinued Drug Product
List if annual reports or other submissions to the Agency indicate the
product is not being marketed or as a result of other Agency administrative
actions. 19 Changes to the Orange Book are not affected by the drug
registration and listing requirements of Section 510 of the FD&C Act.

1.12 Changes to the Orange Book

Every effort is made to ensure the Annual Edition is current and


accurate. Applicants are requested to inform the FDA Orange Book Staff of
any changes or corrections, including any change in ownership or a product’s
marketing status that would result in the product being moved to the
Discontinued Drug Product List. FDA notes that under Section 506I(a) of the
FD&C Act, applicants must notify the Agency in writing 180 days prior to
withdrawing a drug product from sale, or if 180 days is not practicable, not
later than the date of withdrawal from sale. Furthermore, Section 506I(b) of
the FD&C Act requires that applicants notify the Agency in writing within 180
days of approval of a drug product if such drug product will not be available
for sale within 180 days of approval. A request to include a newly approved
product in the Discontinued Drug Product List, rather than parts 1, 2 or 3 of
the Orange Book (as discussed in Section 1.1), must be submitted to the
Orange Book staff 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.

In addition, the FDA Orange Book Staff generally will act on requests to
change a proprietary name for a listed drug only after approval of a
supplement for the relevant change in proprietary name. To the extent that
conventions for describing product identification information (i.e., active
ingredients, dosage forms, routes of administration, product names,
applicants, strengths) evolve over time, the Agency generally does not intend
to revise such information for drug products already included in the Orange
Book, but rather intends to apply the change prospectively to drug products
added to the Orange Book.

You can contact the Orange Book Staff by email at orangebook@fda.hhs.gov.

19 See, e.g., Section 506I(d) of the FD&C Act.

xxv
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 Orange Book home page 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 Publishing Office,
https://www.gpo.gov/.

xxvi
2.0 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, applicants, 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 Drug 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 and we have not
determined that they were withdrawn for safety or effectiveness reasons, 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 December Cumulative Supplement of the previous
Edition List have been added to the Discontinued Drug Product List appearing
in this 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 Drug Product List.

Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by trade name or established name of the active
ingredient, if no trade name exists. 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 25MG/ML N013111 001 AUG 22, 1983
REFERENCE LISTED DRUG* (+) AP +! 50MG/ML N013111 002 AUG 22, 1983
REFERENCE STANDARD * (!) AP +! 75MG/ML N013111 003 AUG 22, 1983
AP +! 100MG/ML N013111 004 JAN 04, 1989

MEPERIDINE HCL
AP GREENBERG PHARM25MG/ML A064890 001 FEB 29, 1987
THERAPEUTIC EQUIVALENCE (TE) AP 50MG/ML A064890 002 FEB 29, 1987
CODE FOR MULTISOURCE PRODUCT AP 75MG/ML A064890 003 FEB 29, 1987
AP 100MG/ML A064890 004 MAR 08, 1992

SINGLE SOURCE PRODUCT (NO TE CODE) ! TIMOKIM LLC 10MG/ML A099225 001 DEC 12, 1995
AP JOHNSON MED 25MG/ML A099226 001 NOV 27, 1993
! KENDRA PHARM 150MG/ML A079444 001 OCT 31, 1999

APPLICANT

AVAILABLE STRENGTH(S) OF A PRODUCT

APPLICATION NUMBER AND PRODUCT NUMBER


PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY

APPROVAL DATE

*NOTE: REFERENCE LISTED DRUG AND REFERENCE STANDARD ARE DISCUSSED IN THE PREFACE SECTION 1.4

MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION

ALPHABETICALLY SORTED BY
ACTIVE INGREDIENT HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL
PRODUCT INFORMATION HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL
REINWALD LABS 25MG;15MG;0.1MG A069808 001 JAN 18, 1982

THIS EXAMPLE IS FOR PURPOSE OF ILLUSTRATION ONLY. 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 500MG A042999 001

PRODUCTS CONSIDERED THERAPEUTICALLY SULAZINE

EQUIVALENT TO EACH OTHER AB URSA 500MG A042222 001

SULFASALAZINE

PRODUCTS CONSIDERED NOT THERAPEUTICALLY BP BROWN 500MG A041297 001

EQUIVALENT TO ANY OTHER PRODUCTS LISTED

SULFASALAZINE

TABLET; ORAL
FAZINE
AB PARKLAND 500MG A042999 001

PRODUCTS CONSIDERED NOT THERAPEUTICALLY SULFASALAZINE

EQUIVALENT TO EACH OTHER BP BROWN 500MG A041297 001

SOUTH 500MG A067627 001

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.
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-1(of 452)

ABACAVIR SULFATE

SOLUTION;ORAL

ABACAVIR SULFATE

AA AUROBINDO PHARMA EQ 20MG BASE/ML A077950 001 Mar 14, 2018

LTD

AA HETERO LABS LTD III EQ 20MG BASE/ML A201107 001 Sep 26, 2016

ZIAGEN

AA +! VIIV HLTHCARE EQ 20MG BASE/ML N020978 001 Dec 17, 1998

TABLET;ORAL

ABACAVIR SULFATE

AB APOTEX INC EQ 300MG BASE A201570 001 Dec 17, 2012

AB AUROBINDO PHARMA EQ 300MG BASE A077844 001 Dec 17, 2012

LTD

AB CIPLA EQ 300MG BASE A078119 001 Nov 21, 2017

AB HETERO LABS LTD III EQ 300MG BASE A091560 001 Sep 13, 2013

AB MYLAN PHARMS INC EQ 300MG BASE A091294 001 Jun 18, 2012

AB STRIDES PHARMA EQ 300MG BASE A091050 001 Oct 28, 2016

ZIAGEN

AB +! VIIV HLTHCARE EQ 300MG BASE N020977 001 Dec 17, 1998

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

TABLET;ORAL

TRIUMEQ

+! VIIV HLTHCARE EQ 600MG BASE;EQ 50MG BASE;300MG N205551 001 Aug 22, 2014

ABACAVIR SULFATE; LAMIVUDINE

TABLET;ORAL

ABACAVIR SULFATE AND LAMIVUDINE



AB AUROBINDO PHARMA EQ 600MG BASE;300MG A090159 001 Nov 15, 2018

LTD

AB EQ 600MG BASE;300MG A206151 001 Mar 28, 2017

AB CIPLA EQ 600MG BASE;300MG A091144 001 Mar 28, 2017

AB LUPIN LTD EQ 600MG BASE;300MG A204990 001 Mar 28, 2017

AB TEVA PHARMS USA EQ 600MG BASE;300MG A079246 001 Sep 29, 2016

AB ZYDUS PHARMS USA EQ 600MG BASE;300MG A208990 001 Nov 15, 2018

INC

EPZICOM

AB +! VIIV HLTHCARE EQ 600MG BASE;300MG N021652 001 Aug 02, 2004

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

AB LUPIN LTD EQ 300MG BASE;150MG;300MG A202912 001 Dec 05, 2013

TRIZIVIR

AB +! VIIV HLTHCARE EQ 300MG BASE;150MG;300MG N021205 001 Nov 14, 2000

ABALOPARATIDE

SOLUTION;SUBCUTANEOUS

TYMLOS

+! RADIUS HEALTH INC 3.12MG/1.56ML (2MG/ML) N208743 001 Apr 28, 2017

ABEMACICLIB

TABLET;ORAL

VERZENIO

+ ELI LILLY AND CO 50MG N208716 001 Sep 28, 2017

+ 100MG N208716 002 Sep 28, 2017

+ 150MG N208716 003 Sep 28, 2017

+! 200MG N208716 004 Sep 28, 2017



ABIRATERONE ACETATE

TABLET;ORAL

ABIRATERONE ACETATE

AB AMNEAL PHARMS 250MG A208327 001 Jan 07, 2019

AB APOTEX INC 250MG A208453 001 Oct 31, 2018

AB HIKMA PHARMS 250MG A208339 001 Oct 31, 2018

AB MYLAN PHARMS INC 250MG A208446 001 Oct 31, 2018

AB TEVA PHARMS USA 250MG A208432 001 Oct 31, 2018

ZYTIGA

AB + JANSSEN BIOTECH 250MG N202379 001 Apr 28, 2011

YONSA

+! SUN PHARMA GLOBAL 125MG N210308 001 May 22, 2018

ZYTIGA

+! JANSSEN BIOTECH 500MG N202379 002 Apr 14, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-2(of 452)

ACALABRUTINIB

CAPSULE;ORAL

CALQUENCE

+! ASTRAZENECA 100MG N210259 001 Oct 31, 2017

ACAMPROSATE CALCIUM

TABLET, DELAYED RELEASE;ORAL

ACAMPROSATE CALCIUM

AB BARR LABS DIV TEVA 333MG A200143 001 Nov 18, 2013

AB ! GLENMARK GENERICS 333MG A202229 001 Jul 16, 2013

AB MYLAN PHARMS INC 333MG A200142 001 Mar 11, 2014

AB ZYDUS PHARMS USA 333MG A205995 001 May 26, 2017

INC

ACARBOSE

TABLET;ORAL

ACARBOSE

AB EMCURE PHARMS LTD 25MG A202271 001 Feb 07, 2012

AB 50MG A202271 002 Feb 07, 2012

AB 100MG A202271 003 Feb 07, 2012

AB IMPAX LABS 25MG A078441 001 May 14, 2009

AB 50MG A078441 002 May 14, 2009

AB 100MG A078441 003 May 14, 2009

AB MYLAN 25MG A091053 001 Jan 06, 2011

AB 50MG A091053 002 Jan 06, 2011

AB 100MG A091053 003 Jan 06, 2011

AB STRIDES PHARMA 25MG A090912 001 Jul 27, 2011

AB 50MG A090912 002 Jul 27, 2011

AB 100MG A090912 003 Jul 27, 2011

AB VIRTUS PHARM 25MG A091343 001 Oct 17, 2013

AB 50MG A091343 002 Oct 17, 2013

AB 100MG A091343 003 Oct 17, 2013

AB WATSON LABS 25MG A077532 001 May 07, 2008

AB 50MG A077532 002 May 07, 2008

AB 100MG A077532 003 May 07, 2008

AB WEST-WARD PHARMS 25MG A078470 001 May 07, 2008

INT

AB 50MG A078470 002 May 07, 2008

AB 100MG A078470 003 May 07, 2008

PRECOSE

AB +! BAYER HLTHCARE 25MG N020482 004 May 29, 1997

AB + 50MG N020482 001 Sep 06, 1995

AB + 100MG N020482 002 Sep 06, 1995



ACEBUTOLOL HYDROCHLORIDE

CAPSULE;ORAL

ACEBUTOLOL HYDROCHLORIDE

AB ! AMNEAL PHARM EQ 200MG BASE A075047 001 Dec 30, 1999

AB ! EQ 400MG BASE A075047 002 Dec 30, 1999

AB MYLAN EQ 200MG BASE A074288 001 Apr 24, 1995

AB EQ 400MG BASE A074288 002 Apr 24, 1995



ACETAMINOPHEN

SOLUTION;INTRAVENOUS

ACETAMINOPHEN

AP CUSTOPHARM INC 1GM/100ML (10MG/ML) A202605 001 Jun 13, 2016

AP SANDOZ INC 1GM/100ML (10MG/ML) A204052 001 Mar 22, 2016

OFIRMEV

AP +! MALLINCKRODT HOSP 1GM/100ML (10MG/ML) N022450 001 Nov 02, 2010

ACETAMINOPHEN

FRESENIUS KABI USA 1GM/100ML (10MG/ML) N204767 001 Oct 28, 2015

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

TABLET;ORAL

APADAZ

+ KEMPHARM 325MG;EQ 6.12MG BASE N208653 001 Feb 23, 2018

ACETAMINOPHEN; BUTALBITAL

CAPSULE;ORAL

BUTALBITAL AND ACETAMINOPHEN

! MAYNE PHARMA INC 300MG;50MG A207313 001 Dec 27, 2017

TABLET;ORAL

BUTALBITAL AND ACETAMINOPHEN



AA CNTY LINE PHARMS 300MG;50MG A207635 001 Jun 05, 2017

AA 325MG;50MG A205120 001 Oct 30, 2015

AA LARKEN LABS INC 325MG;50MG A203484 002 Dec 04, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-3(of 452)

ACETAMINOPHEN; BUTALBITAL

TABLET;ORAL

BUTALBITAL AND ACETAMINOPHEN



AA MIKART 300MG;50MG A207386 001 Nov 15, 2016

AA ! NEXGEN PHARMA 300MG;50MG A090956 001 Aug 23, 2011

BUTAPAP

AA ! MIKART 325MG;50MG A089987 001 Oct 26, 1992

ALLZITAL

LARKEN LABS INC 325MG;25MG A203484 001 Dec 04, 2015

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

AA AUROLIFE PHARMA LLC 325MG;50MG;40MG A204733 001 Sep 26, 2018

AA ! MAYNE PHARMA INC 325MG;50MG;40MG A089007 001 Mar 17, 1986

AA ! NEXGEN PHARMA 300MG;50MG;40MG A040885 001 Nov 16, 2009

AA NUVO PHARMS INC 300MG;50MG;40MG A207118 001 Oct 28, 2016

AA WRASER PHARMS LLC 300MG;50MG;40MG A206615 001 Aug 04, 2017

SOLUTION;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

! MIKART 325MG/15ML;50MG/15ML;40MG/15ML A040387 001 Jan 31, 2003

TABLET;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

AA ABHAI LLC 325MG;50MG;40MG A211106 001 Sep 26, 2018

AA ACTAVIS LABS UT INC 325MG;50MG;40MG A088616 001 Nov 09, 1984

AA CNTY LINE PHARMS 325MG;50MG;40MG A204984 001 Jan 10, 2017

AA HIKMA PHARMS 325MG;50MG;40MG A089718 001 Jun 12, 1995

AA LANNETT CO INC 325MG;50MG;40MG A200243 001 Sep 13, 2012

AA MIKART 325MG;50MG;40MG A089175 001 Jan 21, 1987

AA NEXGEN PHARMA INC 325MG;50MG;40MG A209587 001 Oct 31, 2018

AA SPECGX LLC 325MG;50MG;40MG A087804 001 Jan 24, 1985

AA ! VINTAGE PHARMS 325MG;50MG;40MG A040511 001 Aug 27, 2003



ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A076560 001 Jun 10, 2004

AB VINTAGE PHARMS 325MG;50MG;40MG;30MG A075929 001 Apr 22, 2002

FIORICET W/ CODEINE

AB +! ACTAVIS LABS UT INC 325MG;50MG;40MG;30MG N020232 001 Jul 30, 1992



BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

NEXGEN PHARMA INC 300MG;50MG;40MG;30MG A076560 002 Jul 19, 2012

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE;ORAL

TREZIX

WRASER PHARMS LLC 320.5MG;30MG;16MG A204785 001 Nov 26, 2014

TABLET;ORAL

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

LARKEN LABS INC 325MG;30MG;16MG A204209 001 Sep 30, 2016

ACETAMINOPHEN; CODEINE PHOSPHATE

SOLUTION;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE



AA HI TECH PHARMA 120MG/5ML;12MG/5ML A040119 001 Apr 26, 1996

AA LANNETT CO INC 120MG/5ML;12MG/5ML A091238 001 Nov 10, 2011

AA MIKART 120MG/5ML;12MG/5ML A089450 001 Oct 27, 1992

AA ! PHARM ASSOC 120MG/5ML;12MG/5ML A087508 001



AA WOCKHARDT BIO AG 120MG/5ML;12MG/5ML A087006 001

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE



AA AMNEAL PHARMS NY 300MG;30MG A040779 001 May 29, 2008

AA AUROLIFE PHARMA LLC 300MG;15MG A202800 001 Apr 15, 2013

AA 300MG;30MG A202800 002 Apr 15, 2013

AA 300MG;60MG A202800 003 Apr 15, 2013

AA ! SPECGX LLC 300MG;15MG A040419 001 May 31, 2001

AA 300MG;30MG A040419 002 May 31, 2001

AA 300MG;60MG A040419 003 May 31, 2001

AA SUN PHARM INDS LTD 300MG;30MG A085868 001



AA 300MG;60MG A087083 001

AA TEVA 300MG;15MG A088627 001 Mar 06, 1985

AA 300MG;30MG A088628 001 Mar 06, 1985

AA ! 300MG;60MG A088629 001 Mar 06, 1985

AA VINTAGE 300MG;15MG A089990 001 Sep 30, 1988



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-4(of 452)

ACETAMINOPHEN; CODEINE PHOSPHATE



TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE



AA 300MG;30MG A089805 001 Sep 30, 1988

AA VINTAGE PHARMS 300MG;60MG A089828 001 Sep 30, 1988

TYLENOL W/ CODEINE NO. 3

AA ! JANSSEN PHARMS 300MG;30MG A085055 003



TYLENOL W/ CODEINE NO. 4

AA JANSSEN PHARMS 300MG;60MG A085055 004



ACETAMINOPHEN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN



AA GENUS LIFESCIENCES 325MG/15ML;7.5MG/15ML A040894 001 Jul 19, 2011

AA ! MIKART 325MG/15ML;7.5MG/15ML A040482 001 Sep 25, 2003

AA PHARM ASSOC 325MG/15ML;7.5MG/15ML A040838 001 May 10, 2013

AA VISTAPHARM 325MG/15ML;7.5MG/15ML A200343 001 Jan 25, 2012



! MIKART 300MG/15ML;10MG/15ML A040881 001 Feb 25, 2010

! PHARM ASSOC 325MG/15ML;10MG/15ML A040834 001 Apr 18, 2008

TABLET;ORAL

ANEXSIA 5/325

AA SPECGX LLC 325MG;5MG A040409 001 Oct 20, 2000

ANEXSIA 7.5/325

AA SPECGX LLC 325MG;7.5MG A040405 001 Sep 08, 2000

HYDROCODONE BITARTRATE AND ACETAMINOPHEN



AA ABHAI LLC 300MG;5MG A209036 001 Jun 21, 2017

AA 300MG;7.5MG A209036 002 Jun 21, 2017

AA 300MG;10MG A209036 003 Jun 21, 2017

AA 325MG;5MG A209037 001 Jun 21, 2017

AA 325MG;7.5MG A209037 002 Jun 21, 2017

AA 325MG;10MG A209037 003 Jun 21, 2017

AA ACTAVIS LABS FL INC 300MG;5MG A206470 001 Jun 02, 2016

AA 300MG;7.5MG A206470 002 Jun 02, 2016

AA 300MG;10MG A206470 003 Jun 02, 2016

AA ALVOGEN PINE BROOK 300MG;5MG A208540 001 Nov 08, 2018

AA 300MG;7.5MG A208540 002 Nov 08, 2018

AA 300MG;10MG A208540 003 Nov 08, 2018

AA 325MG;2.5MG A209958 001 Oct 24, 2018

AA 325MG;5MG A209958 002 Oct 24, 2018

AA 325MG;7.5MG A209958 003 Oct 24, 2018

AA 325MG;10MG A209958 004 Oct 24, 2018

AA AMNEAL PHARMS 300MG;10MG A207137 001 Nov 29, 2016

AA AMNEAL PHARMS NY 300MG;5MG A206869 001 Jun 23, 2017

AA 325MG;5MG A040736 001 Aug 25, 2006

AA 325MG;7.5MG A040746 002 May 10, 2016

AA 325MG;10MG A040746 001 Aug 25, 2006

AA ASCENT PHARMS INC 325MG;2.5MG A211487 001 Nov 07, 2018

AA 325MG;5MG A211487 002 Nov 07, 2018

AA 325MG;7.5MG A211487 003 Nov 07, 2018

AA 325MG;10MG A211487 004 Nov 07, 2018

AA AUROLIFE PHARMA LLC 300MG;5MG A207709 001 Sep 13, 2018

AA 300MG;7.5MG A207709 002 Sep 13, 2018

AA 300MG;10MG A207709 003 Sep 13, 2018

AA 325MG;5MG A201013 001 Apr 11, 2012

AA 325MG;7.5MG A201013 002 Apr 11, 2012

AA 325MG;10MG A201013 003 Apr 11, 2012

AA ELITE LABS INC 325MG;2.5MG A209924 001 Nov 16, 2018

AA 325MG;5MG A209924 002 Nov 16, 2018

AA 325MG;7.5MG A209924 003 Nov 16, 2018

AA 325MG;10MG A209924 004 Nov 16, 2018

AA EPIC PHARMA LLC 325MG;5MG A203863 001 Mar 30, 2018

AA 325MG;7.5MG A203863 002 Mar 30, 2018

AA 325MG;10MG A203863 003 Mar 30, 2018

AA LANNETT CO INC 300MG;5MG A207171 001 Jun 20, 2017

AA 300MG;7.5MG A207171 002 Jun 20, 2017

AA 300MG;10MG A207171 003 Jun 20, 2017

AA 325MG;5MG A207172 001 Jun 22, 2017

AA 325MG;7.5MG A207172 002 Jun 22, 2017

AA 325MG;10MG A207172 003 Jun 22, 2017

AA ! MIKART 300MG;5MG A040658 001 Jan 19, 2006

AA ! 300MG;7.5MG A040658 002 Mar 24, 2006

AA ! 300MG;10MG A040658 003 Jun 23, 2004

AA ! 325MG;2.5MG A040846 001 Jun 09, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-5(of 452)

ACETAMINOPHEN; HYDROCODONE BITARTRATE



TABLET;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN



AA
325MG;7.5MG
A040432 001 Jan 22, 2003

AA NOVEL LABS INC


300MG;5MG
A206142 001 Nov 14, 2016

AA
300MG;7.5MG
A206142 002 Nov 14, 2016

AA
300MG;10MG
A206142 003 Nov 14, 2016

AA
325MG;5MG
A206245 001 Dec 01, 2016

AA
325MG;7.5MG
A206245 002 Dec 01, 2016

AA
325MG;10MG
A206245 003 Dec 01, 2016

AA PAR PHARM
300MG;5MG
A205001 001 Jul 05, 2016

AA
300MG;7.5MG
A205001 002 Jul 05, 2016

AA
300MG;10MG
A205001 003 Jul 05, 2016

AA
325MG;5MG
A202935 002 Jun 15, 2016

AA
325MG;7.5MG
A202935 003 Jun 15, 2016

AA
325MG;10MG
A202935 004 Jun 15, 2016

AA RHODES PHARMS
300MG;5MG
A207808 001 Mar 30, 2018

AA
300MG;7.5MG
A207808 002 Mar 30, 2018

AA
300MG;10MG
A207808 003 Mar 30, 2018

AA
325MG;5MG
A202991 001 Apr 12, 2016

AA
325MG;7.5MG
A202991 002 Apr 12, 2016

AA
325MG;10MG
A202991 003 Apr 12, 2016

AA SPECGX LLC
300MG;5MG
A206718 001 Mar 31, 2017

AA
300MG;7.5MG
A206718 002 Mar 31, 2017

AA
300MG;10MG
A206718 003 Mar 31, 2017

AA
325MG;10MG
A040400 001 Jul 26, 2000

AA SUN PHARM INDS INC


325MG;5MG
A090118 001 Dec 23, 2008

AA
325MG;7.5MG
A090118 002 Dec 23, 2008

AA
325MG;10MG
A090118 003 Dec 23, 2008

AA TRIS PHARMA INC


300MG;5MG
A202214 004 Mar 15, 2016

AA
300MG;7.5MG
A202214 005 Mar 15, 2016

AA
300MG;10MG
A202214 006 Mar 15, 2016

AA
325MG;5MG
A202214 001 Mar 27, 2013

AA
325MG;7.5MG
A202214 002 Mar 27, 2013

AA
325MG;10MG
A202214 003 Mar 27, 2013

AA UPSHER SMITH LABS


325MG;5MG
A206484 001 Mar 24, 2017

AA
325MG;7.5MG
A206484 002 Mar 24, 2017

AA
325MG;10MG
A206484 003 Mar 24, 2017

AA VINTAGE PHARMS
300MG;5MG
A090415 001 Jan 24, 2011

AA
300MG;7.5MG
A090415 002 Jan 24, 2011

AA
300MG;10MG
A090415 003 Jan 24, 2011

AA
325MG;5MG
A040655 001 Jan 19, 2006

AA
325MG;7.5MG
A040656 001 Jan 19, 2006

AA
325MG;10MG
A040355 001 May 31, 2000

AA WES PHARMA INC


300MG;5MG
A207509 001 Oct 29, 2018

AA
300MG;7.5MG
A207509 002 Oct 29, 2018

AA
300MG;10MG
A207509 003 Oct 29, 2018

AA
325MG;5MG
A210211 001 Oct 30, 2017

AA
325MG;7.5MG
A210211 002 Oct 30, 2017

AA
325MG;10MG
A210211 003 Oct 30, 2017

NORCO

AA APIL
325MG;2.5MG
A040148 004 Jul 07, 2014

AA !
325MG;5MG
A040099 001 Jun 25, 1997

AA
325MG;5MG
A040148 005 Jul 07, 2014

AA !
325MG;7.5MG
A040148 003 Sep 12, 2000

AA !
325MG;10MG
A040148 001 Feb 14, 1997

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL

OXYCODONE AND ACETAMINOPHEN

! ABHAI LLC
325MG/5ML;5MG/5ML
A211499 001 Dec 31, 2018

MIKART INC
300MG/5ML;10MG/5ML
A202142 001 Nov 27, 2018

TABLET;ORAL

OXYCET

AA SPECGX LLC
325MG;5MG
A087463 001 Dec 07, 1983

OXYCODONE AND ACETAMINOPHEN

AA ABHAI LLC
325MG;2.5MG
A210644 001 Feb 09, 2018

AA
325MG;5MG
A210644 002 Feb 09, 2018

AA
325MG;7.5MG
A210644 003 Feb 09, 2018

AA
325MG;10MG
A210644 004 Feb 09, 2018

AA ACTAVIS ELIZABETH
325MG;2.5MG
A201447 001 Apr 12, 2013

AA
325MG;5MG
A201447 002 Apr 12, 2013

AA
325MG;7.5MG
A201447 003 Apr 12, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-6(of 452)

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE



TABLET;ORAL

OXYCODONE AND ACETAMINOPHEN



AA 325MG;10MG A201447 004 Apr 12, 2013

AA ALVOGEN MALTA 325MG;5MG A202677 003 Mar 08, 2016

AA 325MG;7.5MG A202677 001 Jul 26, 2012

AA 325MG;10MG A202677 002 Jul 26, 2012

AA AMNEAL PHARMS 325MG;5MG A040777 001 Nov 27, 2007

AA AMNEAL PHARMS NY 325MG;7.5MG A040778 002 Jun 27, 2014

AA 325MG;10MG A040778 001 Nov 27, 2007

AA ASCENT PHARMS INC 325MG;2.5MG A207419 001 Mar 22, 2017

AA 325MG;5MG A207419 002 Mar 22, 2017

AA 325MG;7.5MG A207419 003 Mar 22, 2017

AA 325MG;10MG A207419 004 Mar 22, 2017

AA AUROLIFE PHARMA LLC 325MG;2.5MG A201972 001 Jul 15, 2013

AA 325MG;5MG A201972 002 Jul 15, 2013

AA 325MG;7.5MG A201972 003 Jul 15, 2013

AA 325MG;10MG A201972 004 Jul 15, 2013

AA CHEMO RESEARCH SL 325MG;5MG A207574 001 Dec 13, 2016

AA ELITE LABS INC 325MG;5MG A209385 001 Jul 02, 2018

AA 325MG;7.5MG A209385 002 Jul 02, 2018

AA 325MG;10MG A209385 003 Jul 02, 2018

AA EPIC PHARMA LLC 325MG;5MG A203864 001 Jul 02, 2018

AA 325MG;7.5MG A203864 002 Jul 02, 2018

AA 325MG;10MG A203864 003 Jul 02, 2018

AA LANNETT CO INC 325MG;5MG A207333 001 Sep 25, 2017

AA 325MG;10MG A207333 002 Sep 25, 2017

AA MAYNE PHARMA INC 325MG;2.5MG A090177 001 Oct 20, 2008

AA 325MG;5MG A090177 002 Oct 20, 2008

AA 325MG;7.5MG A090177 003 Oct 20, 2008

AA 325MG;10MG A090177 004 Oct 20, 2008

AA NESHER PHARMS 325MG;2.5MG A210079 001 Dec 28, 2017

AA 325MG;5MG A210079 002 Dec 28, 2017

AA 325MG;7.5MG A210079 003 Dec 28, 2017

AA 325MG;10MG A210079 004 Dec 28, 2017

AA NOVEL LABS INC 325MG;2.5MG A204407 001 Feb 24, 2017

AA 325MG;5MG A204407 002 Feb 24, 2017

AA 325MG;7.5MG A204407 003 Feb 24, 2017

AA 325MG;10MG A204407 004 Feb 24, 2017

AA RHODES PHARMS 325MG;5MG A201278 001 Aug 28, 2014

AA 325MG;7.5MG A201278 002 Aug 28, 2014

AA 325MG;10MG A201278 003 Aug 28, 2014

AA SPECGX LLC 325MG;7.5MG A040545 001 Jun 30, 2004

AA 325MG;10MG A040545 002 Jun 30, 2004

AA SUN PHARM INDS INC 325MG;2.5MG A090535 001 Dec 26, 2013

AA 325MG;5MG A090535 002 Dec 26, 2013

AA 325MG;7.5MG A090535 003 Dec 26, 2013

AA 325MG;10MG A090535 004 Dec 26, 2013

AA VINTAGE PHARMS 325MG;2.5MG A090733 001 Jul 11, 2013

AA 325MG;5MG A040105 001 Jul 30, 1996

AA 325MG;7.5MG A090734 001 Jul 11, 2013

AA 325MG;10MG A090734 002 Jul 11, 2013

AA WATSON LABS 325MG;5MG A040171 001 Oct 30, 1997

AA 325MG;7.5MG A040535 001 Sep 05, 2003

AA 325MG;10MG A040535 002 Sep 05, 2003

AA WES PHARMA INC 325MG;5MG A207510 001 Mar 21, 2018

AA 325MG;7.5MG A207510 002 Mar 21, 2018

AA 325MG;10MG A207510 003 Mar 21, 2018

PERCOCET

AA ! VINTAGE PHARMS LLC 325MG;2.5MG A040330 001 Jun 25, 1999

AA ! 325MG;5MG A040330 002 Jun 25, 1999

AA ! 325MG;7.5MG A040330 003 Nov 23, 2001

AA ! 325MG;10MG A040330 004 Nov 23, 2001

ROXICET

AA WEST-WARD PHARMS 325MG;5MG A087003 001

INT

OXYCODONE AND ACETAMINOPHEN

! MIKART 300MG;2.5MG A040608 001 Dec 30, 2005

! 300MG;5MG A040608 002 Dec 30, 2005

! 300MG;7.5MG A040608 003 Dec 30, 2005

! 300MG;10MG A040608 004 Dec 30, 2005

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-7(of 452)

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE



TABLET;ORAL

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN



AB ALKEM LABS LTD 325MG;37.5MG A202076 001 Mar 30, 2012

AB AMNEAL PHARMS 325MG;37.5MG A090485 001 Dec 09, 2009

AB APOTEX INC 325MG;37.5MG A078778 001 Apr 07, 2014

AB AUROBINDO PHARMA 325MG;37.5MG A207152 001 Mar 22, 2017

LTD

AB MACLEODS PHARMS LTD 325MG;37.5MG A206885 001 May 02, 2017

AB MICRO LABS LTD 325MG;37.5MG A201952 001 Dec 14, 2012

INDIA

AB MYLAN 325MG;37.5MG A077858 001 Sep 26, 2008

AB PAR PHARM 325MG;37.5MG A076475 001 Apr 21, 2005

AB SUN PHARM INDS INC 325MG;37.5MG A077184 001 Dec 16, 2005

AB ZYDUS PHARMS USA 325MG;37.5MG A090460 001 Sep 06, 2012

INC

ULTRACET

AB +! JANSSEN PHARMS 325MG;37.5MG N021123 001 Aug 15, 2001

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL

ACETAZOLAMIDE

AB ACCORD HLTHCARE 500MG A207659 001 Oct 18, 2018

AB HERITAGE PHARMS INC 500MG A090779 001 Jul 14, 2011

AB NOSTRUM LABS INC 500MG A204691 001 Mar 29, 2016

AB NOVAST LABS 500MG A203434 001 Sep 30, 2016

AB XYLOPIA 500MG A205301 001 Jan 16, 2019

AB ZYDUS PHARMS USA 500MG A040904 001 Dec 10, 2008

INC

DIAMOX

AB +! TEVA BRANDED PHARM 500MG N012945 001

TABLET;ORAL

ACETAZOLAMIDE

AB HERITAGE PHARMA 125MG A205530 001 Oct 27, 2016

AB 250MG A205530 002 Oct 27, 2016

AB LANNETT 250MG A084840 001



AB STRIDES PHARMA 125MG A209734 001 Nov 20, 2017

AB 250MG A209734 002 Nov 20, 2017

AB SUN PHARM 125MG A089753 002 Jun 22, 1988

INDUSTRIES

AB TARO 125MG A040195 001 May 28, 1997

AB ! 250MG A040195 002 May 28, 1997



ACETAZOLAMIDE SODIUM

INJECTABLE;INJECTION

ACETAZOLAMIDE SODIUM

AP EMCURE PHARMS LTD EQ 500MG BASE/VIAL A202693 001 Dec 19, 2014

AP MYLAN ASI EQ 500MG BASE/VIAL A200880 001 May 09, 2012

AP PAR STERILE EQ 500MG BASE/VIAL A205358 001 Jun 20, 2017

PRODUCTS

AP WEST-WARD PHARMS EQ 500MG BASE/VIAL A040089 001 Feb 28, 1995

INT

AP ! X GEN PHARMS EQ 500MG BASE/VIAL A040784 001 Dec 10, 2008

ACETIC ACID, GLACIAL

SOLUTION;IRRIGATION, URETHRAL

ACETIC ACID 0.25% IN PLASTIC CONTAINER



AT B BRAUN 250MG/100ML N018161 001

AT BAXTER HLTHCARE 250MG/100ML N018523 001 Feb 19, 1982

AT +! ICU MEDICAL INC 250MG/100ML N017656 001



SOLUTION/DROPS;OTIC

ACETIC ACID

AT LANNETT CO INC 2% A040607 001 Feb 24, 2005

AT RISING PHARMS 2% A207280 001 Mar 09, 2018

AT TARO 2% A088638 001 Sep 06, 1984

AT ! WOCKHARDT BIO AG 2% A040166 001 Jul 26, 1996

VOSOL

AT HI TECH PHARMA 2% N012179 001

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS;OTIC

ACETASOL HC

AT ACTAVIS MID 2%;1% A087143 001 Jan 13, 1982

ATLANTIC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-8(of 452)

ACETIC ACID, GLACIAL; HYDROCORTISONE



SOLUTION/DROPS;OTIC

HYDROCORTISONE AND ACETIC ACID



AT TARO PHARM INDS LTD 2%;1% A088759 001 Mar 04, 1985

AT VINTAGE 2%;1% A040609 001 Feb 06, 2006

VOSOL HC

AT +! HI TECH PHARMA 2%;1% N012770 001

ACETOHYDROXAMIC ACID

TABLET;ORAL

LITHOSTAT

+! MISSION PHARMA 250MG N018749 001 May 31, 1983

ACETYLCHOLINE CHLORIDE

FOR SOLUTION;OPHTHALMIC

MIOCHOL-E

+! BAUSCH AND LOMB 20MG/VIAL N020213 001 Sep 22, 1993

ACETYLCYSTEINE

INJECTABLE;INTRAVENOUS

ACETADOTE

AP +! CUMBERLAND PHARMS 6GM/30ML (200MG/ML) N021539 001 Jan 23, 2004

ACETYLCYSTEINE

AP AKORN INC 6GM/30ML (200MG/ML) A203173 001 Mar 24, 2015

AP AUROBINDO PHARMA 6GM/30ML (200MG/ML) A207358 001 Feb 29, 2016

LTD

AP FRESENIUS KABI USA 6GM/30ML (200MG/ML) A200644 001 Nov 07, 2012

AP MYLAN INSTITUTIONAL 6GM/30ML (200MG/ML) A203624 001 Jun 19, 2015

AP SAGENT PHARMS 6GM/30ML (200MG/ML) A091684 001 Oct 31, 2017

AP ZYDUS PHARMS USA 6GM/30ML (200MG/ML) A208166 001 Jul 20, 2018

INC

SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

AN ALVOGEN INC 10% A204674 001 Feb 11, 2014

AN 20% A203853 001 Jun 21, 2012

AN HOSPIRA 10% A073664 001 Aug 30, 1994

AN 20% A074037 001 Aug 30, 1994

AN ! LUITPOLD 10% A072489 001 Jul 28, 1995

AN ! 20% A072547 001 Jul 28, 1995



TABLET, EFFERVESCENT;ORAL

CETYLEV

+ ARBOR PHARMS LLC 500MG N207916 001 Jan 29, 2016

+! 2.5GM N207916 002 Jan 29, 2016

ACITRETIN

CAPSULE;ORAL

ACITRETIN

AB BARR LABS INC 10MG A091455 001 Apr 04, 2013

AB 25MG A091455 002 Apr 04, 2013

AB IMPAX LABS INC 10MG A202552 001 Dec 23, 2015

AB 17.5MG A202552 002 Dec 23, 2015

AB 22.5MG A202552 003 Dec 23, 2015

AB 25MG A202552 004 Dec 23, 2015

AB MYLAN PHARMS INC 10MG A202148 001 Sep 10, 2015

AB 25MG A202148 002 Sep 10, 2015

AB SIGMAPHARM LABS LLC 10MG A204633 001 May 22, 2015

AB 17.5MG A204633 002 May 22, 2015

AB 22.5MG A204633 003 May 22, 2015

AB 25MG A204633 004 May 22, 2015

AB TEVA PHARMS USA 17.5MG A202897 001 Apr 04, 2013

AB 22.5MG A202897 002 Apr 04, 2013

SORIATANE

AB + STIEFEL LABS INC 10MG N019821 001 Oct 28, 1996

AB + 17.5MG N019821 003 Aug 06, 2009

AB + 22.5MG N019821 004 Aug 06, 2009

AB +! 25MG N019821 002 Oct 28, 1996



ACLIDINIUM BROMIDE

POWDER, METERED;INHALATION

TUDORZA PRESSAIR

+! ASTRAZENECA PHARMS 0.4MG/INH N202450 001 Jul 23, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-9(of 452)

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE



CAPSULE;ORAL

SEMPREX-D

+! AUXILIUM PHARMS LLC 8MG;60MG N019806 001 Mar 25, 1994

ACYCLOVIR

CAPSULE;ORAL

ACYCLOVIR

AB ! APOTEX INC 200MG A075677 001 Sep 28, 2005

AB BOSCOGEN 200MG A075090 001 Jan 26, 1999

AB CADILA PHARMS LTD 200MG A201445 001 Mar 06, 2014

AB CARLSBAD TECHNOLOGY 200MG A206261 001 Aug 16, 2017

AB DAVA PHARMS INC 200MG A074833 001 Apr 22, 1997

AB HERITAGE PHARMS INC 200MG A074889 001 Oct 31, 1997

AB TEVA 200MG A074578 001 Apr 22, 1997

AB ZYDUS PHARMS USA 200MG A204313 001 Mar 25, 2016

INC

ZOVIRAX

AB + MYLAN PHARMS INC 200MG N018828 001 Jan 25, 1985

CREAM;TOPICAL

ZOVIRAX

+! VIB 5% N021478 001 Dec 30, 2002

OINTMENT;TOPICAL

ACYCLOVIR

AB ALEMBIC PHARMS LTD 5% A209000 001 Apr 06, 2018

AB AMNEAL PHARMS 5% A204605 001 Jun 18, 2014

AB FOUGERA PHARMS INC 5% A206633 001 May 11, 2016

AB G AND W LABS INC 5% A205591 001 Nov 13, 2017

AB GLENMARK PHARMS LTD 5% A205510 001 Jul 31, 2017

AB MYLAN PHARMS INC 5% A202459 001 Apr 03, 2013

AB TARO 5% A205469 001 Dec 21, 2016

AB TOLMAR 5% A206437 001 Jul 31, 2017

AB TORRENT PHARMS LTD 5% A209971 001 Jan 11, 2019

ZOVIRAX

AB +! VALEANT BERMUDA 5% N018604 001 Mar 29, 1982

SUSPENSION;ORAL

ACYCLOVIR

AB ACTAVIS MID 200MG/5ML A074738 001 Apr 28, 1997

ATLANTIC

AB HI TECH PHARMA 200MG/5ML A077026 001 Jun 07, 2005

ZOVIRAX

AB +! MYLAN PHARMS INC 200MG/5ML N019909 001 Dec 22, 1989

TABLET;BUCCAL

SITAVIG

+! EPI HLTH 50MG N203791 001 Apr 12, 2013

TABLET;ORAL

ACYCLOVIR

AB APOTEX INC 400MG A077309 001 Sep 29, 2005

AB 800MG A077309 002 Sep 29, 2005

AB CADILA PHARMS LTD 400MG A202168 001 Nov 15, 2013

AB 800MG A202168 002 Nov 15, 2013

AB CARLSBAD 400MG A075382 001 Apr 30, 1999

AB 800MG A075382 002 Apr 30, 1999

AB DAVA PHARMS INC 400MG A074946 001 Nov 19, 1997

AB 800MG A074946 002 Nov 19, 1997

AB HERITAGE PHARMS INC 400MG A074891 001 Oct 31, 1997

AB 800MG A074891 002 Oct 31, 1997

AB HETERO LABS LTD V 400MG A203834 001 Oct 29, 2013

AB 800MG A203834 002 Oct 29, 2013

AB TEVA 400MG A074556 002 Apr 22, 1997

AB 800MG A074556 003 Apr 22, 1997

AB YILING PHARM LTD 400MG A210401 001 Mar 07, 2018

AB 800MG A210401 002 Mar 07, 2018

AB ZYDUS PHARMS USA 400MG A204314 001 Aug 19, 2014

INC

AB 800MG A204314 002 Aug 19, 2014

ZOVIRAX

AB + MYLAN PHARMS INC 400MG N020089 001 Apr 30, 1991

AB +! 800MG N020089 002 Apr 30, 1991



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-10(of 452)

ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ACYCLOVIR SODIUM

AP AUROBINDO PHARMA EQ 50MG BASE/ML
A203701 001 Oct 11, 2013

LTD
AP ! FRESENIUS KABI USA EQ 50MG BASE/ML
A074930 001 May 13, 1998

ZYDUS PHARMS USA EQ 500MG BASE/VIAL


A206535 001 Aug 31, 2018

INC
EQ 1GM BASE/VIAL
A206535 002 Aug 31, 2018

ACYCLOVIR; HYDROCORTISONE

CREAM;TOPICAL

XERESE

+! VALEANT BERMUDA
5%;1%
N022436 001 Jul 31, 2009

ADAPALENE

CREAM;TOPICAL

ADAPALENE

AB FOUGERA PHARMS
0.1%
A090824 001 Jun 30, 2010

DIFFERIN

AB +! GALDERMA LABS LP
0.1%
N020748 001 May 26, 2000

GEL;TOPICAL

ADAPALENE

AB ACTAVIS MID
0.3%
A201000 001 Oct 27, 2014

ATLANTIC

AB GLENMARK GENERICS
0.1%
A091314 001 Jul 01, 2010

AB PLIVA HRVATSKA DOO


0.1%
A090962 001 Jun 02, 2010

AB TARO
0.3%
A208322 001 Jun 23, 2016

AB TOLMAR
0.3%
A200298 001 Jun 14, 2012

DIFFERIN

AB +! GALDERMA LABS LP
0.3%
N021753 001 Jun 19, 2007

LOTION;TOPICAL

DIFFERIN

+! GALDERMA LABS LP
0.1%
N022502 001 Mar 17, 2010

SOLUTION;TOPICAL

ADAPALENE

AB CALL INC
0.1%
A203981 001 Sep 23, 2016

AB
0.1%
A204593 001 Jan 05, 2016

ADAPALENE; BENZOYL PEROXIDE

GEL;TOPICAL

ADAPALENE AND BENZOYL PEROXIDE



AB ACTAVIS MID
0.1%;2.5%
A203790 001 Sep 30, 2015

ATLANTIC

AB PERRIGO ISRAEL
0.1%;2.5%
A205033 001 Jan 23, 2018

AB TARO
0.1%;2.5%
A206959 001 Jan 24, 2018

AB
0.3%;2.5%
A209148 001 Oct 17, 2018

AB TOLMAR
0.1%;2.5%
A206164 001 May 23, 2018

EPIDUO

AB +! GALDERMA LABS LP
0.1%;2.5%
N022320 001 Dec 08, 2008

EPIDUO FORTE

AB +! GALDERMA LABS
0.3%;2.5%
N207917 001 Jul 15, 2015

ADEFOVIR DIPIVOXIL

TABLET;ORAL

ADEFOVIR DIPIVOXIL

AB APOTEX INC
10MG
A205459 001 Jul 06, 2018

AB SIGMAPHARM LABS LLC


10MG
A202051 001 Aug 29, 2013

HEPSERA

AB +! GILEAD
10MG
N021449 001 Sep 20, 2002

ADENOSINE

INJECTABLE;INJECTION

ADENOSINE

AP ! AKORN 3MG/ML
A078076 001 Oct 31, 2008

AP FRESENIUS KABI USA 3MG/ML


A077133 001 Apr 27, 2005

AP 3MG/ML
A205568 001 Apr 16, 2018

AP GLAND PHARMA LTD 3MG/ML


A077283 001 Jun 14, 2007

AP 3MG/ML
A206778 001 Feb 16, 2018

AP LUITPOLD 3MG/ML
A090010 001 Apr 28, 2009

AP MYLAN LABS LTD 3MG/ML


A078640 001 Mar 21, 2014

AP 3MG/ML
A078686 001 May 13, 2009

AP WEST-WARD PHARMS 3MG/ML


A076404 001 Jun 16, 2004

INT
AP 3MG/ML
A076500 001 Jun 16, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-11(of 452)

ADENOSINE

SOLUTION;INTRAVENOUS

ADENOSINE

AP AKORN 60MG/20ML (3MG/ML) A090450 001 Oct 02, 2014

AP 90MG/30ML (3MG/ML) A090450 002 Oct 02, 2014

AP AUROBINDO PHARMA 60MG/20ML (3MG/ML) A205331 001 Nov 02, 2017

LTD

AP 90MG/30ML (3MG/ML) A205331 002 Nov 02, 2017

AP EMCURE PHARMS LTD 60MG/20ML (3MG/ML) A202313 001 Sep 15, 2014

AP 90MG/30ML (3MG/ML) A202313 002 Sep 15, 2014

AP FRESENIUS KABI USA 60MG/20ML (3MG/ML) A077897 001 Nov 27, 2017

AP 90MG/30ML (3MG/ML) A077897 002 Nov 27, 2017

AP HOSPIRA INC 60MG/20ML (3MG/ML) A203883 001 Mar 24, 2014

AP 90MG/30ML (3MG/ML) A203883 002 Mar 24, 2014

AP MYLAN ASI 60MG/20ML (3MG/ML) A090212 001 Mar 28, 2014

AP 90MG/30ML (3MG/ML) A090212 002 Mar 28, 2014

AP ! TEVA PHARMS USA 60MG/20ML (3MG/ML) A077425 001 Aug 29, 2013

AP ! 90MG/30ML (3MG/ML) A077425 002 Aug 29, 2013



AFATINIB DIMALEATE

TABLET;ORAL

GILOTRIF

+ BOEHRINGER EQ 20MG BASE N201292 001 Jul 12, 2013

INGELHEIM

+ EQ 30MG BASE N201292 002 Jul 12, 2013

+! EQ 40MG BASE N201292 003 Jul 12, 2013

ALBENDAZOLE

TABLET;ORAL

ALBENDAZOLE

AB CIPLA LTD 200MG A210434 001 Sep 21, 2018

AB STRIDES VIVIMED 200MG A210011 001 Dec 07, 2018

AB ZYDUS PHARMS USA 200MG A208979 001 Dec 14, 2018

INC

ALBENZA

AB +! IMPAX LABS INC 200MG N020666 001 Jun 11, 1996

ALBUMIN HUMAN

INJECTABLE;INJECTION

OPTISON

+! GE HEALTHCARE 10MG/ML N020899 001 Dec 31, 1997

ALBUMIN IODINATED I-125 SERUM

INJECTABLE;INJECTION

JEANATOPE

+ ISO TEX 100uCi/10ML (10uCi/ML) N017836 003 Jun 08, 2004

+ 500uCi/0.5ML N017836 001

+! 1,000uCi/ML N017836 002

ALBUMIN IODINATED I-131 SERUM

INJECTABLE;INJECTION

MEGATOPE

+! ISO TEX 0.5mCi/VIAL N017837 001

+! 1mCi/VIAL N017837 002

ALBUTEROL SULFATE

AEROSOL, METERED;INHALATION

PROAIR HFA

BX +! TEVA BRANDED PHARM EQ 0.09MG BASE/INH N021457 001 Oct 29, 2004

PROVENTIL-HFA

BX +! 3M DRUG DELIVERY EQ 0.09MG BASE/INH N020503 001 Aug 15, 1996

VENTOLIN HFA

BX +! GLAXOSMITHKLINE EQ 0.09MG BASE/INH N020983 001 Apr 19, 2001

POWDER, METERED;INHALATION

PROAIR RESPICLICK

+! TEVA BRANDED PHARM EQ 0.090MG BASE/INH N205636 001 Mar 31, 2015

SOLUTION;INHALATION

ACCUNEB

AN +! MYLAN SPECIALITY LP EQ 0.021% BASE N020949 002 Apr 30, 2001

AN +! EQ 0.042% BASE N020949 001 Apr 30, 2001

ALBUTEROL SULFATE

AN AUROBINDO PHARMA EQ 0.083% BASE A206224 001 Oct 17, 2017

LTD

AN ! BAUSCH AND LOMB EQ 0.5% BASE A075050 001 Jun 18, 1998

AN HI TECH PHARMA EQ 0.5% BASE A074543 001 Jan 15, 1998

AN NEPHRON EQ 0.021% BASE A076355 002 Mar 31, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-12(of 452)

ALBUTEROL SULFATE

SOLUTION;INHALATION

ALBUTEROL SULFATE

AN EQ 0.042% BASE A076355 001 Jun 28, 2004

AN ! EQ 0.083% BASE A074880 001 Sep 17, 1997

AN EQ 0.5% BASE A075664 001 Jun 26, 2001

AN RITEDOSE CORP EQ 0.083% BASE A077839 001 Dec 16, 2008

AN SUN PHARMA GLOBAL EQ 0.083% BASE A207857 001 Jul 21, 2017

AN WATSON LABS EQ 0.021% BASE A077772 001 Sep 25, 2007

AN EQ 0.042% BASE A077772 002 Sep 25, 2007

SYRUP;ORAL

ALBUTEROL SULFATE

AA AMNEAL PHARMS EQ 2MG BASE/5ML A079241 001 May 12, 2010

AA G AND W LABS INC EQ 2MG BASE/5ML A074454 001 Sep 25, 1995

AA HI TECH PHARMA EQ 2MG BASE/5ML A074749 001 Jan 30, 1998

AA LANNETT CO INC EQ 2MG BASE/5ML A078105 001 Dec 27, 2006

AA ! TEVA EQ 2MG BASE/5ML A073419 001 Mar 30, 1992

AA VISTAPHARM EQ 2MG BASE/5ML A077788 001 Jun 26, 2007



TABLET;ORAL

ALBUTEROL SULFATE

AB AMNEAL PHARMS CO EQ 2MG BASE A208804 001 May 21, 2018

AB EQ 4MG BASE A208804 002 May 21, 2018

AB MYLAN EQ 2MG BASE A072894 002 Jan 17, 1991

AB ! EQ 4MG BASE A072894 001 Jan 17, 1991

AB RISING PHARMS EQ 2MG BASE A207046 001 Jun 29, 2018

AB EQ 4MG BASE A207046 002 Jun 29, 2018

AB SUN PHARM EQ 2MG BASE A072637 002 Dec 05, 1989

INDUSTRIES

AB EQ 4MG BASE A072637 001 Dec 05, 1989

AB VIRTUS PHARM EQ 2MG BASE A211397 001 Oct 26, 2018

AB EQ 4MG BASE A211397 002 Oct 26, 2018



TABLET, EXTENDED RELEASE;ORAL

ALBUTEROL SULFATE

AB MYLAN EQ 4MG BASE A078092 002 Jan 29, 2007

VOSPIRE ER

AB DAVA PHARMS INC EQ 4MG BASE A076130 002 Sep 26, 2002

ALBUTEROL SULFATE

! MYLAN EQ 8MG BASE A078092 001 Jan 29, 2007

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

SOLUTION;INHALATION

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE



AN CIPLA EQ 0.083% BASE;0.017% A077559 001 Dec 31, 2007

AN NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007

AN RITEDOSE CORP EQ 0.083% BASE;0.017% A202496 001 Oct 01, 2012

AN SUN PHARMA GLOBAL EQ 0.083% BASE;0.017% A207875 001 Aug 07, 2017

AN WATSON LABS TEVA EQ 0.083% BASE;0.017% A077063 001 Dec 31, 2007

SPRAY, METERED;INHALATION

COMBIVENT RESPIMAT

+! BOEHRINGER EQ 0.1MG BASE/INH;0.02MG/INH N021747 001 Oct 07, 2011

INGELHEIM

ALCAFTADINE

SOLUTION/DROPS;OPHTHALMIC

LASTACAFT

+! ALLERGAN 0.25% N022134 001 Jul 28, 2010

ALCLOMETASONE DIPROPIONATE

CREAM;TOPICAL

ALCLOMETASONE DIPROPIONATE

AB ! FOUGERA PHARMS 0.05% A076973 001 Jul 12, 2005

AB GLENMARK GENERICS 0.05% A079061 001 Jun 23, 2009

AB TARO 0.05% A076587 001 Sep 15, 2005

OINTMENT;TOPICAL

ALCLOMETASONE DIPROPIONATE

AB ! FOUGERA PHARMS 0.05% A076884 001 Jul 18, 2005

AB GLENMARK GENERICS 0.05% A079227 001 Jul 30, 2009

AB TARO 0.05% A076730 001 Jul 29, 2004



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-13(of 452)

ALCOHOL

SOLUTION;INTRA-ARTERIAL

ABLYSINOL

+ BELCHER PHARMS LLC 99% (1ML) N207987 001 Jun 21, 2018

+! 99% (5ML) N207987 002 Jun 21, 2018

ALECTINIB HYDROCHLORIDE

CAPSULE;ORAL

ALECENSA

+! HOFFMANN-LA ROCHE EQ 150MG BASE N208434 001 Dec 11, 2015

ALENDRONATE SODIUM

SOLUTION;ORAL

ALENDRONATE SODIUM

! WEST-WARD PHARMS EQ 70MG BASE/75ML A090520 001 Feb 25, 2013

INT

TABLET;ORAL

ALENDRONATE SODIUM

AB APOTEX EQ 5MG BASE A077982 001 Aug 04, 2008

AB EQ 10MG BASE A077982 002 Aug 04, 2008

AB EQ 35MG BASE A077982 003 Aug 04, 2008

AB EQ 70MG BASE A077982 004 Aug 04, 2008

AB AUROBINDO PHARMA EQ 10MG BASE A090124 001 Aug 04, 2008

AB EQ 35MG BASE A090124 002 Aug 04, 2008

AB EQ 70MG BASE A090124 003 Aug 04, 2008

AB CIPLA EQ 5MG BASE A076768 001 Aug 04, 2008

AB EQ 10MG BASE A076768 002 Aug 04, 2008

AB EQ 35MG BASE A076768 003 Aug 04, 2008

AB EQ 40MG BASE A076768 004 Aug 04, 2008

AB EQ 70MG BASE A076768 005 Aug 04, 2008

AB HANGZHOU BINJIANG EQ 5MG BASE A090258 001 Sep 24, 2009

AB EQ 10MG BASE A090258 002 Sep 24, 2009

AB EQ 35MG BASE A090258 003 Sep 24, 2009

AB EQ 70MG BASE A090258 004 Sep 24, 2009

AB IMPAX LABS INC EQ 5MG BASE A075710 001 Feb 06, 2008

AB EQ 10MG BASE A075710 002 Feb 06, 2008

AB EQ 35MG BASE A075710 003 Feb 06, 2008

AB EQ 40MG BASE A075710 004 Feb 06, 2008

AB EQ 70MG BASE A075710 005 Feb 06, 2008

AB JUBILANT CADISTA EQ 5MG BASE A090557 001 Feb 18, 2010

AB EQ 10MG BASE A090557 002 Feb 18, 2010

AB EQ 35MG BASE A090557 003 Feb 18, 2010

AB EQ 70MG BASE A090557 004 Feb 18, 2010

AB MYLAN EQ 5MG BASE A076584 001 Aug 04, 2008

AB EQ 10MG BASE A076584 002 Aug 04, 2008

AB NEOPHARMA EQ 5MG BASE A079049 003 Aug 04, 2008

AB EQ 10MG BASE A079049 004 Aug 04, 2008

AB EQ 35MG BASE A079049 001 Aug 04, 2008

AB EQ 70MG BASE A079049 002 Aug 04, 2008

AB SUN PHARMA GLOBAL EQ 5MG BASE A090022 001 Sep 10, 2008

AB EQ 10MG BASE A090022 002 Sep 10, 2008

AB EQ 35MG BASE A090022 003 Sep 10, 2008

AB EQ 70MG BASE A090022 004 Sep 10, 2008

AB WATSON LABS EQ 35MG BASE A076984 001 Aug 04, 2008

AB EQ 40MG BASE A076984 002 Aug 04, 2008

AB EQ 70MG BASE A076984 003 Aug 04, 2008

FOSAMAX

AB +! MERCK AND CO INC EQ 70MG BASE N020560 005 Oct 20, 2000

TABLET, EFFERVESCENT;ORAL

BINOSTO

+! MISSION PHARMA EQ 70MG BASE N202344 001 Mar 12, 2012

ALENDRONATE SODIUM; CHOLECALCIFEROL

TABLET;ORAL

FOSAMAX PLUS D

+ MERCK EQ 70MG BASE;2,800 IU N021762 001 Apr 07, 2005

+! EQ 70MG BASE;5,600 IU N021762 002 Apr 26, 2007



ALFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION

ALFENTA

AP +! AKORN EQ 0.5MG BASE/ML N019353 001 Dec 29, 1986

ALFENTANIL

AP HOSPIRA EQ 0.5MG BASE/ML A075221 001 Oct 28, 1999

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-14(of 452)

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALFUZOSIN HYDROCHLORIDE

AB APOTEX INC 10MG A079013 001 Jul 18, 2011

AB AUROBINDO PHARMA 10MG A079060 001 Aug 30, 2012

LTD

AB INVAGEN PHARMS 10MG A090284 001 Jan 17, 2012

AB MYLAN 10MG A079014 001 Jul 18, 2011

AB SUN PHARMA GLOBAL 10MG A079057 001 Jul 18, 2011

AB TEVA PHARMS 10MG A079056 001 Jul 18, 2011

AB TORRENT PHARMS 10MG A079054 001 Jul 18, 2011

AB UNICHEM LABS LTD 10MG A203192 001 Jan 28, 2016

UROXATRAL

AB +! CONCORDIA PHARMS 10MG N021287 001 Jun 12, 2003

INC

ALISKIREN HEMIFUMARATE

TABLET;ORAL

TEKTURNA

+ NODEN PHARMA EQ 150MG BASE N021985 001 Mar 05, 2007

+! EQ 300MG BASE N021985 002 Mar 05, 2007

ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

TEKTURNA HCT

+ NODEN PHARMA EQ 150MG BASE;12.5MG N022107 001 Jan 18, 2008

+ EQ 150MG BASE;25MG N022107 002 Jan 18, 2008

+! EQ 300MG BASE;12.5MG N022107 003 Jan 18, 2008

+! EQ 300MG BASE;25MG N022107 004 Jan 18, 2008

ALITRETINOIN

GEL;TOPICAL

PANRETIN

+! EISAI INC EQ 0.1% BASE N020886 001 Feb 02, 1999

ALLOPURINOL

TABLET;ORAL

ALLOPURINOL

AB ACCORD HLTHCARE 100MG A203154 001 May 06, 2013

AB 300MG A203154 002 May 06, 2013

AB APOTEX INC 100MG A077353 001 Sep 08, 2005

AB 300MG A077353 002 Sep 08, 2005

AB INDOCO REMEDIES 100MG A204467 001 Jul 28, 2016

AB 300MG A204467 002 Jul 28, 2016

AB IPCA LABS LTD 100MG A090637 001 Mar 16, 2011

AB 300MG A090637 002 Mar 16, 2011

AB MYLAN 100MG A018659 001 Oct 24, 1986

AB 300MG A018659 002 Oct 24, 1986

AB NORTHSTAR HLTHCARE 100MG A078253 001 Sep 11, 2007

AB 300MG A078253 002 Sep 11, 2007

AB SUN PHARM INDS INC 100MG A078390 001 Aug 30, 2007

AB 300MG A078390 002 Aug 30, 2007

AB SUN PHARM 100MG A071450 002 Jan 09, 1987

INDUSTRIES

AB 300MG A071450 001 Jan 09, 1987

AB VINTAGE PHARMS 100MG A075798 001 Jun 27, 2003

AB 300MG A075798 002 Jun 27, 2003

AB WATSON LABS 100MG N018832 002 Sep 28, 1984

AB 300MG N018877 001 Sep 28, 1984

AB ZYDUS PHARMS USA 100MG A210117 001 Oct 12, 2017

INC

AB 300MG A210117 002 Oct 12, 2017

LOPURIN

AB DR REDDYS LA 100MG A071586 001 Apr 02, 1987

AB 300MG A071587 001 Apr 02, 1987

ZYLOPRIM

AB + CASPER PHARMA LLC 100MG N016084 001

AB +! 300MG N016084 002

ALLOPURINOL SODIUM

INJECTABLE;INJECTION

ALLOPURINOL SODIUM

AP WEST-WARD PHARMS EQ 500MG BASE/VIAL A076870 001 Aug 26, 2004

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-15(of 452)

ALLOPURINOL SODIUM

INJECTABLE;INJECTION

ALOPRIM

AP +! MYLAN INSTITUTIONAL EQ 500MG BASE/VIAL N020298 001 May 17, 1996

ALLOPURINOL; LESINURAD

TABLET;ORAL

DUZALLO

+ IRONWOOD PHARMS INC 200MG;200MG N209203 001 Aug 18, 2017

+! 300MG;200MG N209203 002 Aug 18, 2017



ALMOTRIPTAN MALATE

TABLET;ORAL

ALMOTRIPTAN MALATE

AB AJANTA PHARMA LTD EQ 6.25MG BASE A205523 001 Mar 03, 2016
AB EQ 12.5MG BASE A205523 002 Mar 03, 2016
AB MYLAN PHARMS INC EQ 6.25MG BASE A205171 001 Nov 09, 2015
AB EQ 12.5MG BASE A205171 002 Nov 09, 2015
AB TEVA PHARMS USA EQ 6.25MG BASE A078027 001 Jul 07, 2015
AB EQ 12.5MG BASE A078027 002 Jul 07, 2015
AXERT
AB + JANSSEN PHARMS EQ 6.25MG BASE N021001 001 May 07, 2001
AB +! EQ 12.5MG BASE N021001 002 May 07, 2001
ALOGLIPTIN BENZOATE

TABLET;ORAL

NESINA

+ TAKEDA PHARMS USA EQ 6.25MG BASE N022271 001 Jan 25, 2013

+ EQ 12.5MG BASE N022271 002 Jan 25, 2013

+! EQ 25MG BASE N022271 003 Jan 25, 2013

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

KAZANO

+ TAKEDA PHARMS USA EQ 12.5MG BASE;500MG N203414 001 Jan 25, 2013

+! EQ 12.5MG BASE;1GM N203414 002 Jan 25, 2013

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

OSENI

+ TAKEDA PHARMS USA EQ 12.5MG BASE;EQ 15MG BASE N022426 004 Jan 25, 2013

+ EQ 12.5MG BASE;EQ 30MG BASE N022426 005 Jan 25, 2013

+ EQ 12.5MG BASE;EQ 45MG BASE N022426 006 Jan 25, 2013

+ EQ 25MG BASE;EQ 15MG BASE N022426 001 Jan 25, 2013

+ EQ 25MG BASE;EQ 30MG BASE N022426 002 Jan 25, 2013

+! EQ 25MG BASE;EQ 45MG BASE N022426 003 Jan 25, 2013

ALOSETRON HYDROCHLORIDE

TABLET;ORAL

ALOSETRON HYDROCHLORIDE

AB AMNEAL PHARMS EQ 0.5MG BASE A206647 001 Dec 22, 2016

AB EQ 1MG BASE A206647 002 Dec 22, 2016

AB CIPLA EQ 0.5MG BASE A209180 001 Jan 14, 2019

AB EQ 1MG BASE A209180 002 Jan 14, 2019

AB PAR PHARM INC EQ 0.5MG BASE A206113 001 Feb 23, 2018

AB EQ 1MG BASE A206113 002 Feb 23, 2018

AB WEST-WARD PHARMS EQ 0.5MG BASE A200652 001 May 04, 2015

INT

AB EQ 1MG BASE A200652 002 May 04, 2015

LOTRONEX

AB + SEBELA IRELAND LTD EQ 0.5MG BASE N021107 002 Dec 23, 2003

AB +! EQ 1MG BASE N021107 001 Feb 09, 2000



ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL;

FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE

HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K



SOLUTION;INTRAVENOUS

INFUVITE ADULT

+! SANDOZ INC 2 IU/ML;40MG/ML;12MCG/ML;40 N021163 001 May 18, 2000

IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1

.2MG/ML;0.72MG/ML;1.2MG/ML;660

IU/ML;0.03MG/ML

+! 2 IU/ML;40MG/ML;12MCG/ML;40 N021559 001 Jun 16, 2003

IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1

.2MG/ML;0.72MG/ML;1.2MG/ML;660

IU/ML;30MCG/ML

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-16(of 452)

ALPRAZOLAM

CONCENTRATE;ORAL

ALPRAZOLAM

! WEST-WARD PHARMS 1MG/ML A074312 001 Oct 31, 1993

INT

TABLET;ORAL

ALPRAZOLAM

AB ACTAVIS ELIZABETH 0.25MG A074342 001 Oct 31, 1993

AB 0.5MG A074342 002 Oct 31, 1993

AB 1MG A074342 003 Oct 31, 1993

AB 2MG A074342 004 Oct 31, 1993

AB APOTEX INC 0.25MG A077741 001 Jan 19, 2007

AB 0.5MG A077741 002 Jan 19, 2007

AB 1MG A077741 003 Jan 19, 2007

AB 2MG A077741 004 Jan 19, 2007

AB AUROBINDO PHARMA 0.25MG A203346 001 Jul 31, 2015

LTD

AB 0.5MG A203346 002 Jul 31, 2015

AB 1MG A203346 003 Jul 31, 2015

AB 2MG A203346 004 Jul 31, 2015

AB BRECKENRIDGE PHARM 0.25MG A207507 001 Jul 09, 2018

AB 0.5MG A207507 002 Jul 09, 2018

AB 1MG A207507 003 Jul 09, 2018

AB 2MG A207507 004 Jul 09, 2018

AB DAVA INTL INC 0.25MG A074174 001 Oct 19, 1993

AB 0.5MG A074174 002 Oct 19, 1993

AB 1MG A074174 003 Oct 19, 1993

AB 2MG A074174 004 Oct 19, 1993

AB MYLAN 0.25MG A074215 001 Jan 27, 1994

AB 0.5MG A074215 002 Jan 27, 1994

AB 1MG A074215 003 Jan 27, 1994

AB 2MG A074215 004 Jan 27, 1994

AB NATCO PHARMA LTD 0.25MG A200739 001 Apr 15, 2015

AB 0.5MG A200739 002 Apr 15, 2015

AB 1MG A200739 003 Apr 15, 2015

AB 2MG A200739 004 Apr 15, 2015

AB OXFORD PHARMS 0.25MG A078491 001 Sep 25, 2008

AB 0.5MG A078491 002 Sep 25, 2008

AB 1MG A078491 003 Sep 25, 2008

AB 2MG A078491 004 Dec 12, 2008

AB SANDOZ 0.25MG A074112 001 Dec 29, 1995

AB 0.5MG A074112 002 Dec 29, 1995

AB 1MG A074112 003 Dec 29, 1995

AB 2MG A074909 001 Mar 25, 1998

AB SUN PHARMA GLOBAL 0.25MG A090082 001 Jun 17, 2010

AB 0.5MG A090082 002 Jun 17, 2010

AB 1MG A090082 003 Jun 17, 2010

AB 2MG A090082 004 Jun 17, 2010

AB VINTAGE PHARMS 0.25MG A090248 001 Sep 17, 2010

AB 0.5MG A090248 002 Sep 17, 2010

AB 1MG A090248 003 Sep 17, 2010

AB 2MG A090248 004 Sep 17, 2010

XANAX

AB + PHARMACIA AND 0.25MG N018276 001

UPJOHN

AB + 0.5MG N018276 002

AB +! 1MG N018276 003

AB + 2MG N018276 004 Nov 27, 1985

TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM

AB ACTAVIS ELIZABETH 0.5MG A078056 001 Feb 13, 2007

AB 1MG A078056 002 Feb 13, 2007

AB 2MG A078056 003 Feb 13, 2007

AB 3MG A078056 004 Feb 13, 2007

AB AMNEAL PHARMS NY 0.5MG A078387 001 May 30, 2008

AB 1MG A078387 002 May 30, 2008

AB 2MG A078387 003 May 30, 2008

AB 3MG A078387 004 May 30, 2008

AB ANCHEN PHARMS 0.5MG A078469 001 Sep 29, 2011

AB 1MG A078469 002 Sep 29, 2011

AB 2MG A078469 003 Sep 29, 2011

AB 3MG A078469 004 Sep 29, 2011

AB ANI PHARMS INC 0.5MG A077725 001 Jul 31, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-17(of 452)

ALPRAZOLAM

TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM

AB 1MG A077725 002 Jul 31, 2006

AB 2MG A077725 004 Jul 31, 2006

AB 3MG A077725 003 Jul 31, 2006

AB APOTEX INC 0.5MG A078449 001 Nov 12, 2008

AB 1MG A078449 004 Dec 23, 2015

AB 2MG A078449 002 Nov 12, 2008

AB 3MG A078449 003 Nov 12, 2008

AB AUROBINDO PHARMA 0.5MG A090871 001 Jun 07, 2011

LTD

AB 1MG A090871 002 Jun 07, 2011

AB 2MG A090871 003 Jun 07, 2011

AB 3MG A090871 004 Jun 07, 2011

AB HERITAGE PHARMS INC 0.5MG A078489 001 Oct 17, 2008

AB 1MG A078489 002 Oct 17, 2008

AB 2MG A078489 003 Oct 17, 2008

AB 3MG A078489 004 Oct 17, 2008

XANAX XR

AB + PHARMACIA AND 0.5MG N021434 001 Jan 17, 2003

UPJOHN

AB + 1MG N021434 002 Jan 17, 2003

AB + 2MG N021434 003 Jan 17, 2003

AB +! 3MG N021434 004 Jan 17, 2003



TABLET, ORALLY DISINTEGRATING;ORAL

ALPRAZOLAM

AB ACTAVIS ELIZABETH 0.25MG A078561 001 Mar 16, 2010

AB 0.5MG A078561 002 Mar 16, 2010

AB 1MG A078561 003 Mar 16, 2010

AB 2MG A078561 004 Mar 16, 2010

AB PAR PHARM 0.25MG A078088 001 Jan 09, 2009

AB 0.5MG A078088 002 Jan 09, 2009

AB ! 1MG A078088 003 Jan 09, 2009

AB 2MG A078088 004 Jan 09, 2009



ALPROSTADIL

INJECTABLE;INJECTION

ALPROSTADIL

AP TEVA PHARMS USA 0.5MG/ML A075196 001 Apr 30, 1999

AP WEST-WARD PHARMS 0.5MG/ML A074815 001 Jan 20, 1998

INT

CAVERJECT

AP + PHARMACIA AND 0.01MG/VIAL N020379 001 Jul 06, 1995

UPJOHN

AP +! 0.02MG/VIAL N020379 002 Jul 06, 1995

AP +! 0.04MG/VIAL N020379 004 May 19, 1997

EDEX

AP + AUXILIUM PHARMS LLC 0.01MG/VIAL N020649 002 Jun 12, 1997

AP + 0.02MG/VIAL N020649 003 Jun 12, 1997

AP +! 0.04MG/VIAL N020649 004 Jun 12, 1997

PROSTIN VR PEDIATRIC

AP +! PHARMACIA AND 0.5MG/ML N018484 001

UPJOHN

CAVERJECT IMPULSE

PHARMACIA AND 0.01MG/VIAL N021212 001 Jun 11, 2002

UPJOHN

0.02MG/VIAL N021212 002 Jun 11, 2002

EDEX

+! AUXILIUM PHARMS LLC 0.01MG/VIAL N020649 005 Jul 30, 1998

+! 0.02MG/VIAL N020649 006 Jul 30, 1998

+! 0.04MG/VIAL N020649 007 Jul 30, 1998

SUPPOSITORY;URETHRAL

MUSE

+! MYLAN SPECIALITY LP 0.125MG N020700 001 Nov 19, 1996

+! 0.25MG N020700 002 Nov 19, 1996

+! 0.5MG N020700 003 Nov 19, 1996

+! 1MG N020700 004 Nov 19, 1996

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-18(of 452)

ALTRETAMINE

CAPSULE;ORAL

HEXALEN

+! EISAI INC 50MG N019926 001 Dec 26, 1990

ALVIMOPAN

CAPSULE;ORAL

ENTEREG

+! CUBIST PHARMS 12MG N021775 001 May 20, 2008

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL

AMANTADINE HYDROCHLORIDE

AB ALEMBIC PHARMS LTD 100MG A208966 001 Jun 21, 2017

AB BIONPHARMA INC 100MG A078720 001 May 29, 2008

AB GRAVITI PHARMS 100MG A207570 001 Sep 30, 2016

AB HERITAGE PHARMA 100MG A209171 001 Jun 12, 2017

AB ! SANDOZ 100MG A071293 001 Feb 18, 1987

AB STRIDES PHARMA 100MG A209047 001 Jun 07, 2017

AB USL PHARMA 100MG A070589 001 Aug 05, 1986

AB WATSON LABS INC 100MG A208107 001 Dec 06, 2016

AB ZYDUS PHARMS USA 100MG A208278 001 May 31, 2016

INC

CAPSULE, EXTENDED RELEASE;ORAL

GOCOVRI

+ ADAMAS PHARMA EQ 68.5MG BASE N208944 001 Aug 24, 2017

+! EQ 137MG BASE N208944 002 Aug 24, 2017

SYRUP;ORAL

AMANTADINE HYDROCHLORIDE

AA ! CMP PHARMA INC 50MG/5ML A075819 001 Sep 11, 2002

AA ! HI TECH PHARMA 50MG/5ML A074170 001 Oct 28, 1994

AA ! MIKART 50MG/5ML A074028 001 Jun 28, 1993

AA ! PHARM ASSOC 50MG/5ML A074509 001 Jul 17, 1995

AA ! WOCKHARDT BIO AG 50MG/5ML A075060 001 Dec 24, 1998



TABLET;ORAL

AMANTADINE HYDROCHLORIDE

AB GRAVITI PHARMS 100MG A207571 001 Jan 31, 2017

AB JUBILANT GENERICS 100MG A210403 001 Feb 07, 2018

AB STRIDES PHARMA 100MG A209035 001 Jun 09, 2017

AB ! USL PHARMA 100MG A076186 001 Dec 16, 2002

AB WATSON LABS INC 100MG A208096 001 Dec 15, 2016



TABLET, EXTENDED RELEASE;ORAL

OSMOLEX ER

+ OSMOTICA PHARM EQ 129MG BASE N209410 001 Feb 16, 2018

+ EQ 193MG BASE N209410 002 Feb 16, 2018

+! EQ 258MG BASE N209410 003 Feb 16, 2018

AMBRISENTAN

TABLET;ORAL

LETAIRIS

+ GILEAD 5MG N022081 001 Jun 15, 2007

+! 10MG N022081 002 Jun 15, 2007

AMCINONIDE

CREAM;TOPICAL

AMCINONIDE

AB ! FOUGERA PHARMS 0.1% A076065 001 May 15, 2003

AB TARO PHARM INDS 0.1% A076229 001 May 31, 2002

LOTION;TOPICAL

AMCINONIDE

! FOUGERA PHARMS 0.1% A076329 001 Nov 06, 2002

OINTMENT;TOPICAL

AMCINONIDE

AB ! FOUGERA PHARMS 0.1% A076096 001 Nov 19, 2002

AB TARO PHARM INDS 0.1% A076367 001 Mar 19, 2003



AMIFAMPRIDINE PHOSPHATE

TABLET;ORAL

FIRDAPSE

+! CATALYST PHARMS EQ 10MG BASE N208078 001 Nov 28, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-19(of 452)

AMIFOSTINE

INJECTABLE;INJECTION

AMIFOSTINE

AP MYLAN LABS LTD 500MG/VIAL A204363 001 Jul 17, 2017

AP SUN PHARMA GLOBAL 500MG/VIAL A077126 001 Mar 14, 2008

ETHYOL

AP +! CLINIGEN HLTHCARE 500MG/VIAL N020221 001 Dec 08, 1995

AMIKACIN SULFATE

INJECTABLE;INJECTION

AMIKACIN SULFATE

AP ! EMCURE PHARMS LTD EQ 250MG BASE/ML A204040 001 Dec 12, 2013

AP FRESENIUS KABI USA EQ 50MG BASE/ML A205605 001 Dec 09, 2015

AP EQ 250MG BASE/ML A205604 001 Dec 09, 2015

AP SAGENT PHARMS EQ 250MG BASE/ML A203323 001 May 12, 2016

AP TEVA PHARMS USA EQ 250MG BASE/ML A064045 002 Sep 28, 1993

AP ! WEST-WARD PHARMS EQ 50MG BASE/ML A063313 001 Apr 11, 1994

INT

AP EQ 250MG BASE/ML A063315 001 Apr 11, 1994

SUSPENSION, LIPOSOMAL;INHALATION

ARIKAYCE KIT

+! INSMED INC EQ 590MG BASE/8.4ML N207356 001 Sep 28, 2018

AMILORIDE HYDROCHLORIDE

TABLET;ORAL

AMILORIDE HYDROCHLORIDE

AB ! PAR PHARM 5MG A070346 001 Jan 22, 1986

AB SIGMAPHARM LABS LLC 5MG A079133 001 Jan 30, 2009

AB USPHARMA WINDLAS 5MG A204180 001 Aug 07, 2015

MIDAMOR

AB + PADDOCK LLC 5MG N018200 001

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE



AB BARR EQ 5MG ANHYDROUS;50MG A071111 001 May 10, 1988

AB ! MYLAN EQ 5MG ANHYDROUS;50MG A073209 001 Oct 31, 1991



AMINO ACIDS

INJECTABLE;INJECTION

AMINO ACIDS

B BRAUN 15%(150GM/1000ML) A091112 001 Apr 13, 2012

15%(300GM/2000ML) A091112 002 Apr 13, 2012

AMINOSYN 10%

ICU MEDICAL INC 10% (10GM/100ML) N017673 003

AMINOSYN 8.5%

ICU MEDICAL INC 8.5% (8.5GM/100ML) N017673 004

AMINOSYN II 10% IN PLASTIC CONTAINER

ICU MEDICAL INC 10% (10GM/100ML) N020015 001 Dec 19, 1991

AMINOSYN II 15% IN PLASTIC CONTAINER

ICU MEDICAL INC 15% (15GM/100ML) N020041 001 Dec 19, 1991

AMINOSYN-PF 10%

ICU MEDICAL INC 10% (10GM/100ML) N019492 002 Oct 17, 1986

AMINOSYN-PF 7%

ICU MEDICAL INC 7% (7GM/100ML) N019398 001 Sep 06, 1985

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER



BAXTER HLTHCARE 15% (15GM/100ML) A020512 001 Aug 30, 1996

FREAMINE HBC 6.9%



B BRAUN 6.9% (6.9GM/100ML) N016822 006 May 17, 1983

FREAMINE III 10%



B BRAUN 10% (10GM/100ML) N016822 005

FREAMINE III 8.5%

B BRAUN 8.5% (8.5GM/100ML) N016822 004

HEPATAMINE 8%

B BRAUN 8% (8GM/100ML) N018676 001 Aug 03, 1982

NEPHRAMINE 5.4%

B BRAUN 5.4% (5.4GM/100ML) N017766 001

PREMASOL 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 10% (10GM/100ML) A075880 002 Jun 19, 2003

PREMASOL 6% IN PLASTIC CONTAINER

BAXTER HLTHCARE 6% (6GM/100ML) A075880 001 Jun 19, 2003

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 20% (20GM/100ML) N020849 001 Aug 26, 1998

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-20(of 452)

AMINO ACIDS

INJECTABLE;INJECTION

TRAVASOL 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 10% (10MG/100ML) N018931 003 Aug 23, 1984

TRAVASOL 5.5% IN PLASTIC CONTAINER



BAXTER HLTHCARE 5.5% (5.5GM/100ML) N018931 001 Aug 23, 1984

TRAVASOL 8.5% IN PLASTIC CONTAINER



BAXTER HLTHCARE 8.5% (8.5GM/100ML) N018931 002 Aug 23, 1984

TROPHAMINE

+! B BRAUN 6% (6GM/100ML) N019018 001 Jul 20, 1984

TROPHAMINE 10%

+! B BRAUN 10% (10GM/100ML) N019018 003 Sep 07, 1988

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE;

SODIUM ACETATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

PROCALAMINE

B BRAUN 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG N018582 001 May 08, 1982

/100ML;150MG/100ML;200MG/100ML;120MG/10

0ML

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

ACETATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2.75%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 002 Mar 26, 1997

261MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2.75%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 005 Mar 26, 1997

261MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 001 Mar 26, 1997

61MG/100ML;217MG/100ML;112MG/100ML

CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 4.25%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 009 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 4.25%;33MG/100ML;20GM/100ML;51MG/100ML; N020678 011 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 4.25%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 012 Mar 26, 1997

261MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 008 Mar 26, 1997

61MG/100ML;297MG/100ML;77MG/100ML

CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5%;33MG/100ML;10GM/100ML;51MG/100ML;261 N020678 016 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5%;33MG/100ML;15GM/100ML;51MG/100ML;261 N020678 017 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5%;33MG/100ML;20GM/100ML;51MG/100ML;261 N020678 018 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5%;33MG/100ML;25GM/100ML;51MG/100ML;261 N020678 019 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5%;33MG/100ML;35GM/100ML;51MG/100ML;261 N020678 021 Mar 26, 1997

MG/100ML;340MG/100ML;59MG/100ML

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL



EMULSION;INTRAVENOUS

KABIVEN IN PLASTIC CONTAINER

+ FRESENIUS KABI USA 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 004 Aug 25, 2014

174MG/100ML;239MG/100ML

;147MG/100ML;3.9GM/100ML (1026ML)

+ 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 005 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (1540ML)

+ 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 006 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (2053ML)

+! 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 007 Aug 25, 2014

174MG/100ML;239MG/100ML;147MG/100ML;3.9

GM/100ML (2566ML)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-21(of 452)

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE;

SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL



EMULSION;INTRAVENOUS

PERIKABIVEN IN PLASTIC CONTAINER

+ FRESENIUS KABI USA 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 001 Aug 25, 2014

124MG/100ML;170MG/100ML;105MG/100ML;3.5

GM/100ML (1440ML)

+ 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 002 Aug 25, 2014

124MG/100ML;170MG/100ML;105MG/100ML;3.5

GM/100ML (1920ML)

+ 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;
N200656 003 Aug 25, 2014

124MG/100ML;170MG/100ML

;105MG/100ML;3.5GM/100ML (2400ML)

AMINO ACIDS; DEXTROSE

INJECTABLE;INJECTION

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;10GM/100ML


N020734 002 Sep 29, 1997

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;25GM/100ML


N020734 005 Sep 29, 1997

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;5GM/100ML


N020734 001 Sep 29, 1997

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;10GM/100ML


N020734 008 Sep 29, 1997

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;20GM/100ML


N020734 010 Sep 29, 1997

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;25GM/100ML


N020734 011 Sep 29, 1997

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;5GM/100ML


N020734 007 Sep 29, 1997

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5%;10GM/100ML


N020734 014 Sep 29, 1997

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5%;15GM/100ML


N020734 015 Sep 29, 1997

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5%;20GM/100ML


N020734 016 Sep 29, 1997

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5%;25GM/100ML


N020734 017 Sep 29, 1997

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5%;35GM/100ML


N020734 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 N016822 007 Jul 01, 1988

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

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

INJECTABLE;INJECTION

AMINOSYN 3.5% M

ICU MEDICAL INC 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N017789 003

234MG/100ML

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

CHLORIDE

INJECTABLE;INJECTION

FREAMINE III 3% W/ ELECTROLYTES

B BRAUN 3%;54MG/100ML;40MG/100ML;150MG/100ML;20 N016822 003



0MG/100ML;120MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC

INJECTABLE;INJECTION

AMINOSYN 8.5% W/ELECTROLYTES

ICU MEDICAL INC


8.5%;102MG/100ML;487MG/100ML;28MG/100ML N017673 009 Oct 25, 2002

;425MG/100ML

AMINOCAPROIC ACID

INJECTABLE;INJECTION

AMINOCAPROIC ACID

AP LUITPOLD
250MG/ML A071192 001 Dec 01, 1987

AMINOCAPROIC ACID IN PLASTIC CONTAINER



AP ! HOSPIRA 250MG/ML A070010 001 Mar 09, 1987

SYRUP;ORAL

AMICAR

+! CLOVER PHARMS 1.25GM/5ML N015230 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-22(of 452)

AMINOCAPROIC ACID

TABLET;ORAL

AMICAR

AB + CLOVER PHARMS 500MG N015197 001

AB +! 1GM N015197 002 Jun 24, 2004

AMINOCAPROIC ACID

AB SUNNY PHARMTECH INC 500MG A209060 001 Nov 27, 2018

AB 1GM A209060 002 Nov 27, 2018



AMINOLEVULINIC ACID HYDROCHLORIDE

FOR SOLUTION;ORAL

GLEOLAN

+! NXDC 1.5GM/VIAL N208630 001 Jun 06, 2017

GEL;TOPICAL

AMELUZ

+! BIOFRONTERA 10% N208081 001 May 10, 2016

SOLUTION;TOPICAL

LEVULAN

+! DUSA 20% N020965 001 Dec 03, 1999

AMINOPHYLLINE

INJECTABLE;INJECTION

AMINOPHYLLINE

AP ! HOSPIRA 25MG/ML A087242 001 Oct 26, 1983

AP LUITPOLD 25MG/ML A087600 001



AMINOSALICYLIC ACID

GRANULE, DELAYED RELEASE;ORAL

PASER

! JACOBUS 4GM/PACKET A074346 001 Jun 30, 1994

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION

AMIODARONE HYDROCHLORIDE

AP AUROBINDO PHARMA 50MG/ML A204550 001 Oct 25, 2017

LTD

AP ! FRESENIUS KABI USA 50MG/ML A075761 001 Oct 15, 2002

AP ! GLAND PHARMA LTD 50MG/ML A077161 001 Apr 20, 2005

AP HIKMA FARMACEUTICA 50MG/ML A077234 001 Feb 25, 2008

AP ! HOSPIRA 50MG/ML A075955 001 Oct 18, 2002

AP HOSPIRA INC 50MG/ML A203884 001 Nov 25, 2013

AP 50MG/ML A203885 001 Nov 25, 2013

AP ! MYLAN INSTITUTIONAL 50MG/ML A076217 001 Oct 15, 2002

AP WOCKHARDT 50MG/ML A077610 001 Oct 30, 2008

AP 50MG/ML A077834 001 Oct 30, 2008



NEXTERONE

+! BAXTER HLTHCARE 150MG/100ML (1.5MG/ML) N022325 002 Nov 16, 2010

+! 360MG/200ML (1.8MG/ML) N022325 003 Nov 16, 2010

TABLET;ORAL

AMIODARONE HYDROCHLORIDE

AB APOTEX INC 200MG A078578 001 Nov 06, 2008

AB AUROBINDO PHARMA 200MG A204742 001 Jun 03, 2016

LTD

AB MAYNE PHARMA INC 100MG A075389 002 Dec 28, 2017

AB 200MG A075389 001 Jan 25, 2001

AB 400MG A075389 003 Dec 28, 2017

AB MURTY PHARMS 100MG A077069 003 Oct 04, 2016

AB 200MG A077069 001 Apr 08, 2005

AB 400MG A077069 002 Apr 08, 2005

AB ! SANDOZ 200MG A075315 001 Dec 23, 1998

AB 400MG A075315 002 Jun 30, 2000

AB TARO PHARM 100MG A075424 002 Dec 18, 2002

AB 200MG A075424 001 Mar 30, 2001

AB 400MG A076362 001 Nov 29, 2002

AB TEVA PHARMS 200MG A074739 001 Nov 30, 1998

AB ZYDUS PHARMS USA 200MG A079029 001 Sep 16, 2008

INC

PACERONE

AB UPSHER SMITH LABS 100MG A075135 002 Apr 12, 2005

AB 200MG A075135 001 Apr 30, 1998

AMIODARONE HYDROCHLORIDE

TARO PHARM 300MG A076362 002 Dec 02, 2003

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-23(of 452)

AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

AB ACCORD HLTHCARE 10MG A202446 001 Jun 04, 2014

AB 25MG A202446 002 Jun 04, 2014

AB 50MG A202446 003 Jun 04, 2014

AB 75MG A202446 004 Jun 04, 2014

AB 100MG A202446 005 Jun 04, 2014

AB 150MG A202446 006 Jun 04, 2014

AB MYLAN 10MG A086009 002



AB 25MG A086009 003

AB 50MG A086009 001

AB 75MG A086009 004

AB 100MG A086009 005

AB 150MG A086009 006

AB SANDOZ 10MG A085969 001

AB ! 25MG A085966 001

AB 50MG A085968 001

AB 75MG A085971 001

AB 100MG A085967 001

AB 150MG A085970 001

AB SUN PHARM INDS INC 10MG A089399 002 Jul 14, 1987

AB 25MG A089399 001 Jul 14, 1987

AB 50MG A089399 003 Jul 14, 1987

AB 75MG A089399 004 Jul 14, 1987

AB 100MG A089399 005 Jul 14, 1987

AB 150MG A089399 006 Jul 14, 1987

AB VINTAGE PHARMS 10MG A040218 001 Sep 11, 1997

AB 25MG A040218 002 Sep 11, 1997

AB 50MG A040218 003 Sep 11, 1997

AB 75MG A040218 004 Sep 11, 1997

AB 100MG A040218 005 Sep 11, 1997

AB 150MG A040218 006 Sep 11, 1997

AB ZYDUS PHARMS USA 10MG A210086 001 Oct 06, 2017

INC

AB 25MG A210086 002 Oct 06, 2017

AB 50MG A210086 003 Oct 06, 2017

AB 75MG A210086 004 Oct 06, 2017

AB 100MG A210086 005 Oct 06, 2017

AB 150MG A210086 006 Oct 06, 2017



AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

MYLAN PHARMS INC EQ 12.5MG BASE;5MG A071297 002 Dec 10, 1986

! EQ 25MG BASE;10MG A071297 001 Dec 10, 1986

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET;ORAL

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

MYLAN 10MG;2MG A071443 002 Nov 10, 1988

10MG;4MG A071443 003 Nov 10, 1988

! 25MG;2MG A071443 004 Nov 10, 1988

! 25MG;4MG A071443 005 Nov 10, 1988

! 50MG;4MG A071443 001 Nov 10, 1988

AMLODIPINE BESYLATE

TABLET;ORAL

AMLODIPINE BESYLATE

AB ACCORD HLTHCARE EQ 2.5MG BASE A202553 001 Apr 29, 2013

AB EQ 5MG BASE A202553 002 Apr 29, 2013

AB EQ 10MG BASE A202553 003 Apr 29, 2013

AB ALKEM EQ 2.5MG BASE A078925 001 May 04, 2009

AB EQ 5MG BASE A078925 002 May 04, 2009

AB EQ 10MG BASE A078925 003 May 04, 2009

AB APOTEX EQ 2.5MG BASE A076719 001 May 23, 2007

AB EQ 5MG BASE A076719 002 May 23, 2007

AB EQ 10MG BASE A076719 003 May 23, 2007

AB AUROBINDO PHARMA EQ 2.5MG BASE A078021 001 Jul 17, 2007

AB EQ 5MG BASE A078021 002 Jul 17, 2007

AB EQ 10MG BASE A078021 003 Jul 17, 2007

AB CHINA RESOURCES EQ 2.5MG BASE A090752 003 May 16, 2016

AB EQ 5MG BASE A090752 001 Apr 15, 2011

AB EQ 10MG BASE A090752 002 Apr 15, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-24(of 452)

AMLODIPINE BESYLATE

TABLET;ORAL

AMLODIPINE BESYLATE

AB CIPLA EQ 2.5MG BASE A077073 001 Sep 26, 2007

AB EQ 5MG BASE A077073 002 Sep 26, 2007

AB EQ 10MG BASE A077073 003 Sep 26, 2007

AB EPIC PHARMA LLC EQ 2.5MG BASE A078552 001 Apr 08, 2009

AB EQ 5MG BASE A078552 002 Apr 08, 2009

AB EQ 10MG BASE A078552 003 Apr 08, 2009

AB HEBEI CHANGSHAN EQ 2.5MG BASE A076692 001 Jul 20, 2007

AB EQ 5MG BASE A076692 002 Jul 20, 2007

AB EQ 10MG BASE A076692 003 Jul 20, 2007

AB HIKMA PHARMS EQ 2.5MG BASE A077771 001 Apr 12, 2011

AB EQ 5MG BASE A077771 002 Apr 12, 2011

AB EQ 10MG BASE A077771 003 Apr 12, 2011

AB INVAGEN PHARMS EQ 2.5MG BASE A077955 001 Aug 28, 2007

AB EQ 2.5MG BASE A206367 001 Dec 10, 2015

AB EQ 5MG BASE A077955 002 Aug 28, 2007

AB EQ 5MG BASE A206367 002 Dec 10, 2015

AB EQ 10MG BASE A077955 003 Aug 28, 2007

AB EQ 10MG BASE A206367 003 Dec 10, 2015

AB LUPIN EQ 2.5MG BASE A078043 001 Jul 12, 2007

AB EQ 5MG BASE A078043 002 Jul 12, 2007

AB EQ 10MG BASE A078043 003 Jul 12, 2007

AB MACLEODS PHARMS LTD EQ 5MG BASE A201380 001 Apr 13, 2012

AB EQ 10MG BASE A201380 002 Apr 13, 2012

AB MYLAN PHARMS INC EQ 2.5MG BASE A076418 001 Oct 03, 2005

AB EQ 5MG BASE A076418 002 Oct 03, 2005

AB EQ 10MG BASE A076418 003 Oct 03, 2005

AB ORCHID HLTHCARE EQ 2.5MG BASE A078453 001 Jul 02, 2009

AB EQ 5MG BASE A078453 002 Jul 02, 2009

AB EQ 10MG BASE A078453 003 Jul 02, 2009

AB OXFORD PHARMS EQ 2.5MG BASE A078414 001 Apr 07, 2010

AB EQ 5MG BASE A078414 002 Apr 07, 2010

AB EQ 10MG BASE A078414 003 Apr 07, 2010

AB POLYGEN PHARMS EQ 2.5MG BASE A207821 001 Jul 11, 2016

AB EQ 5MG BASE A207821 002 Jul 11, 2016

AB EQ 10MG BASE A207821 003 Jul 11, 2016

AB STRIDES VIVIMED EQ 2.5MG BASE A077516 001 Jul 11, 2007

AB EQ 5MG BASE A077516 002 Jul 11, 2007

AB EQ 10MG BASE A077516 003 Jul 11, 2007

AB SUN PHARM INDS INC EQ 2.5MG BASE A078231 001 Nov 30, 2007

AB EQ 5MG BASE A078231 002 Nov 30, 2007

AB EQ 10MG BASE A078231 003 Nov 30, 2007

AB SUN PHARM INDS LTD EQ 2.5MG BASE A077974 001 Jul 09, 2007

AB EQ 5MG BASE A077974 002 Jul 09, 2007

AB EQ 10MG BASE A077974 003 Jul 09, 2007

AB TEVA EQ 2.5MG BASE A076846 001 Jun 28, 2007

AB EQ 5MG BASE A076846 002 Jun 28, 2007

AB EQ 10MG BASE A076846 003 Jun 28, 2007

AB TORRENT PHARMS EQ 2.5MG BASE A078573 001 Sep 22, 2008

AB EQ 5MG BASE A078573 002 Sep 22, 2008

AB EQ 10MG BASE A078573 003 Sep 22, 2008

AB UNICHEM LABS LTD EQ 2.5MG BASE A203245 001 Oct 21, 2013

AB EQ 5MG BASE A203245 002 Oct 21, 2013

AB EQ 10MG BASE A203245 003 Oct 21, 2013

AB UPSHER SMITH LABS EQ 2.5MG BASE A077759 001 Jul 09, 2007

AB EQ 5MG BASE A077759 002 Jul 09, 2007

AB EQ 10MG BASE A077759 003 Jul 09, 2007

AB WATSON LABS EQ 2.5MG BASE A077671 001 Jul 19, 2007

AB EQ 5MG BASE A077671 002 Jul 19, 2007

AB EQ 10MG BASE A077671 003 Jul 19, 2007

AB WEST-WARD PHARMS EQ 2.5MG BASE A077262 001 Jul 09, 2007

INT

AB EQ 5MG BASE A077262 002 Jul 09, 2007

AB EQ 10MG BASE A077262 003 Jul 09, 2007

AB WOCKHARDT EQ 2.5MG BASE A078500 001 Sep 06, 2007

AB EQ 5MG BASE A078500 002 Sep 06, 2007

AB EQ 10MG BASE A078500 003 Sep 06, 2007

AB ZYDUS PHARMS USA EQ 2.5MG BASE A078226 001 Jul 09, 2007

AB EQ 5MG BASE A078226 002 Jul 09, 2007

AB EQ 10MG BASE A078226 003 Jul 09, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-25(of 452)

AMLODIPINE BESYLATE

TABLET;ORAL

NORVASC

AB + PFIZER EQ 2.5MG BASE
N019787 001 Jul 31, 1992

AB + EQ 5MG BASE
N019787 002 Jul 31, 1992

AB +! EQ 10MG BASE
N019787 003 Jul 31, 1992

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

TABLET;ORAL

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM



AB DR REDDYS LABS LTD EQ 2.5MG BASE;EQ 10MG BASE
A203874 001 Mar 07, 2014

AB
EQ 2.5MG BASE;EQ 20MG BASE
A203874 002 Mar 07, 2014

AB
EQ 2.5MG BASE;EQ 40MG BASE
A203874 003 Mar 07, 2014

AB
EQ 5MG BASE;EQ 10MG BASE
A203874 004 Mar 07, 2014

AB
EQ 5MG BASE;EQ 20MG BASE
A203874 005 Mar 07, 2014

AB
EQ 5MG BASE;EQ 40MG BASE
A203874 006 Mar 07, 2014

AB
EQ 5MG BASE;EQ 80MG BASE
A203874 007 Mar 07, 2014

AB
EQ 10MG BASE;EQ 10MG BASE
A203874 008 Mar 07, 2014

AB
EQ 10MG BASE;EQ 20MG BASE
A203874 009 Mar 07, 2014

AB
EQ 10MG BASE;EQ 40MG BASE
A203874 010 Mar 07, 2014

AB
EQ 10MG BASE;EQ 80MG BASE
A203874 011 Mar 07, 2014

AB MYLAN PHARMS INC


EQ 2.5MG BASE;EQ 10MG BASE
A200465 001 Nov 29, 2013

AB
EQ 2.5MG BASE;EQ 20MG BASE
A200465 002 Nov 29, 2013

AB
EQ 2.5MG BASE;EQ 40MG BASE
A200465 003 Nov 29, 2013

AB
EQ 5MG BASE;EQ 10MG BASE
A200465 004 Nov 29, 2013

AB
EQ 5MG BASE;EQ 20MG BASE
A200465 005 Nov 29, 2013

AB
EQ 5MG BASE;EQ 40MG BASE
A200465 006 Nov 29, 2013

AB
EQ 5MG BASE;EQ 80MG BASE
A200465 007 Nov 29, 2013

AB
EQ 10MG BASE;EQ 10MG BASE
A200465 008 Nov 29, 2013

AB
EQ 10MG BASE;EQ 20MG BASE
A200465 009 Nov 29, 2013

AB
EQ 10MG BASE;EQ 40MG BASE
A200465 010 Nov 29, 2013

AB
EQ 10MG BASE;EQ 80MG BASE
A200465 011 Nov 29, 2013

AB ZYDUS PHARMS USA


EQ 2.5MG BASE;EQ 10MG BASE
A207762 001 Jan 11, 2019

INC

AB
EQ 2.5MG BASE;EQ 20MG BASE
A207762 002 Jan 11, 2019

AB
EQ 2.5MG BASE;EQ 40MG BASE
A207762 003 Jan 11, 2019

AB
EQ 5MG BASE;EQ 10MG BASE
A207762 004 Jan 11, 2019

AB
EQ 5MG BASE;EQ 20MG BASE
A207762 005 Jan 11, 2019

AB
EQ 5MG BASE;EQ 40MG BASE
A207762 006 Jan 11, 2019

AB
EQ 5MG BASE;EQ 80MG BASE
A207762 007 Jan 11, 2019

AB
EQ 10MG BASE;EQ 10MG BASE
A207762 008 Jan 11, 2019

AB
EQ 10MG BASE;EQ 20MG BASE
A207762 009 Jan 11, 2019

AB
EQ 10MG BASE;EQ 40MG BASE
A207762 010 Jan 11, 2019

AB
EQ 10MG BASE;EQ 80MG BASE
A207762 011 Jan 11, 2019

CADUET

AB + PFIZER
EQ 2.5MG BASE;EQ 10MG BASE
N021540 009 Jul 29, 2004

AB +
EQ 2.5MG BASE;EQ 20MG BASE
N021540 010 Jul 29, 2004

AB +
EQ 2.5MG BASE;EQ 40MG BASE
N021540 011 Jul 29, 2004

AB +
EQ 5MG BASE;EQ 10MG BASE
N021540 001 Jan 30, 2004

AB +
EQ 5MG BASE;EQ 20MG BASE
N021540 002 Jan 30, 2004

AB +
EQ 5MG BASE;EQ 40MG BASE
N021540 003 Jan 30, 2004

AB +
EQ 5MG BASE;EQ 80MG BASE
N021540 004 Jan 30, 2004

AB +
EQ 10MG BASE;EQ 10MG BASE
N021540 005 Jan 30, 2004

AB +
EQ 10MG BASE;EQ 20MG BASE
N021540 006 Jan 30, 2004

AB +
EQ 10MG BASE;EQ 40MG BASE
N021540 007 Jan 30, 2004

AB +!
EQ 10MG BASE;EQ 80MG BASE
N021540 008 Jan 30, 2004

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE



AB APOTEX INC
EQ 2.5MG BASE;10MG
A091431 001 Dec 30, 2013

AB
EQ 5MG BASE;10MG
A091431 002 Dec 30, 2013

AB
EQ 5MG BASE;20MG
A091431 003 Dec 30, 2013

AB
EQ 5MG BASE;40MG
A091431 004 Dec 30, 2013

AB
EQ 10MG BASE;20MG
A091431 005 Dec 30, 2013

AB
EQ 10MG BASE;40MG
A091431 006 Dec 30, 2013

AB AUROBINDO PHARMA
EQ 2.5MG BASE;10MG
A202239 001 Sep 05, 2012

LTD

AB
EQ 5MG BASE;10MG
A202239 002 Sep 05, 2012

AB
EQ 5MG BASE;20MG
A202239 003 Sep 05, 2012

AB
EQ 5MG BASE;40MG
A202239 004 Sep 05, 2012

AB
EQ 10MG BASE;20MG
A202239 005 Sep 05, 2012

AB
EQ 10MG BASE;40MG
A202239 006 Sep 05, 2012

AB CIPLA
EQ 2.5MG BASE;10MG
A077215 001 Dec 07, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-26(of 452)

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE



CAPSULE;ORAL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE



AB EQ 5MG BASE;10MG
A077215 002 Dec 07, 2018

AB EQ 5MG BASE;20MG
A077215 003 Dec 07, 2018

AB EQ 10MG BASE;20MG
A077215 004 Dec 07, 2018

AB DR REDDYS LABS INC EQ 2.5MG BASE;10MG


A077183 001 Apr 15, 2010

AB EQ 5MG BASE;10MG
A077183 002 Apr 15, 2010

AB EQ 5MG BASE;20MG
A077183 003 Apr 15, 2010

AB EQ 5MG BASE;40MG
A090149 001 Jul 05, 2011

AB EQ 10MG BASE;20MG
A077183 004 Apr 15, 2010

AB EQ 10MG BASE;40MG
A090149 002 Jul 05, 2011

AB LUPIN PHARMS EQ 2.5MG BASE;10MG


A078466 001 Feb 05, 2010

AB EQ 5MG BASE;10MG
A078466 002 Feb 05, 2010

AB EQ 5MG BASE;20MG
A078466 003 Feb 05, 2010

AB EQ 5MG BASE;40MG
A078466 005 Jul 05, 2011

AB EQ 10MG BASE;20MG
A078466 004 Feb 05, 2010

AB EQ 10MG BASE;40MG
A078466 006 Jul 05, 2011

AB MYLAN EQ 2.5MG BASE;10MG


A077375 001 May 21, 2010

AB EQ 5MG BASE;10MG
A077375 002 May 21, 2010

AB EQ 5MG BASE;20MG
A077375 003 May 21, 2010

AB EQ 5MG BASE;40MG
A079047 001 Jul 05, 2011

AB EQ 10MG BASE;20MG
A077375 004 May 21, 2010

AB EQ 10MG BASE;40MG
A079047 002 Jul 05, 2011

AB PAR PHARM EQ 2.5MG BASE;10MG


A078381 001 Jul 29, 2010

AB EQ 5MG BASE;10MG
A078381 002 Jul 29, 2010

AB EQ 5MG BASE;20MG
A078381 003 Jul 29, 2010

AB EQ 5MG BASE;40MG
A078381 005 Jul 29, 2010

AB EQ 10MG BASE;20MG
A078381 004 Jul 29, 2010

AB EQ 10MG BASE;40MG
A078381 006 Jul 29, 2010

AB TEVA PHARMS EQ 2.5MG BASE;10MG


A077179 001 May 18, 2007

AB EQ 5MG BASE;10MG
A077179 002 May 18, 2007

AB EQ 5MG BASE;20MG
A077179 003 May 18, 2007

AB EQ 5MG BASE;40MG
A077179 005 Jul 05, 2011

AB EQ 10MG BASE;20MG
A077179 004 May 18, 2007

AB EQ 10MG BASE;40MG
A077179 006 Jul 05, 2011

AB WATSON LABS EQ 2.5MG BASE;10MG


A077890 001 Oct 14, 2010

AB EQ 5MG BASE;10MG
A077890 002 Oct 14, 2010

AB EQ 5MG BASE;20MG
A077890 003 Oct 14, 2010

AB EQ 10MG BASE;20MG
A077890 004 Oct 14, 2010

AB WATSON LABS INC EQ 5MG BASE;40MG


A090364 001 Jul 05, 2011

AB EQ 10MG BASE;40MG
A090364 002 Jul 05, 2011

LOTREL
AB + NOVARTIS EQ 2.5MG BASE;10MG
N020364 002 Mar 03, 1995

AB + EQ 5MG BASE;10MG
N020364 003 Mar 03, 1995

AB + EQ 5MG BASE;20MG
N020364 004 Mar 03, 1995

AB + EQ 5MG BASE;40MG
N020364 007 Apr 11, 2006

AB + EQ 10MG BASE;20MG
N020364 005 Jun 20, 2002

AB +! EQ 10MG BASE;40MG
N020364 006 Apr 11, 2006

AMLODIPINE BESYLATE; CELECOXIB

TABLET;ORAL

CONSENSI

+ KITOV PHARMS LTD
EQ 2.5MG BASE;200MG
N210045 001 May 31, 2018

+
EQ 5MG BASE;200MG
N210045 002 May 31, 2018

+!
EQ 10MG BASE;200MG
N210045 003 May 31, 2018

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

AB PAR PHARM INC


EQ 5MG BASE;12.5MG;20MG
A206137 001 Oct 26, 2016

AB
EQ 5MG BASE;12.5MG;40MG
A206137 002 Oct 26, 2016

AB
EQ 5MG BASE;25MG;40MG
A206137 003 Oct 26, 2016

AB
EQ 10MG BASE;12.5MG;40MG
A206137 004 Oct 26, 2016

AB
EQ 10MG BASE;25MG;40MG
A206137 005 Oct 26, 2016

AB TEVA PHARMS USA


EQ 5MG BASE;12.5MG;20MG
A202491 001 Nov 03, 2016

AB
EQ 5MG BASE;12.5MG;40MG
A202491 002 Nov 03, 2016

AB
EQ 5MG BASE;25MG;40MG
A202491 003 Nov 03, 2016

AB
EQ 10MG BASE;12.5MG;40MG
A202491 004 Nov 03, 2016

AB
EQ 10MG BASE;25MG;40MG
A202491 005 Nov 03, 2016

AB TORRENT PHARMS LTD


EQ 5MG BASE;12.5MG;20MG
A203580 001 Oct 26, 2016

AB
EQ 5MG BASE;12.5MG;40MG
A203580 002 Oct 26, 2016

AB
EQ 5MG BASE;25MG;40MG
A203580 003 Oct 26, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-27(of 452)

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL



TABLET;ORAL

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

AB EQ 10MG BASE;12.5MG;40MG A203580 004 Oct 26, 2016

AB EQ 10MG BASE;25MG;40MG A203580 005 Oct 26, 2016

TRIBENZOR

AB + DAIICHI SANKYO EQ 5MG BASE;12.5MG;20MG N200175 001 Jul 23, 2010

AB + EQ 5MG BASE;12.5MG;40MG N200175 002 Jul 23, 2010

AB + EQ 5MG BASE;25MG;40MG N200175 003 Jul 23, 2010

AB + EQ 10MG BASE;12.5MG;40MG N200175 004 Jul 23, 2010

AB +! EQ 10MG BASE;25MG;40MG N200175 005 Jul 23, 2010



AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE

AB AUROBINDO PHARMA 5MG;12.5MG;160MG A206180 001 Dec 19, 2017

LTD

AB 5MG;25MG;160MG A206180 002 Dec 19, 2017

AB 10MG;12.5MG;160MG A206180 003 Dec 19, 2017

AB 10MG;25MG;160MG A206180 004 Dec 19, 2017

AB 10MG;25MG;320MG A206180 005 Dec 19, 2017

AB LUPIN LTD 5MG;12.5MG;160MG A200797 001 Jun 03, 2015

AB 5MG;25MG;160MG A200797 002 Jun 03, 2015

AB 10MG;12.5MG;160MG A200797 003 Jun 03, 2015

AB 10MG;25MG;160MG A200797 004 Jun 03, 2015

AB 10MG;25MG;320MG A200797 005 Jun 03, 2015

AB PAR PHARM 5MG;12.5MG;160MG A201087 001 Jun 01, 2015

AB 5MG;25MG;160MG A201087 002 Jun 01, 2015

AB 10MG;12.5MG;160MG A201087 003 Jun 01, 2015

AB 10MG;25MG;160MG A201087 004 Jun 01, 2015

AB 10MG;25MG;320MG A201087 005 Jun 01, 2015

AB TEVA PHARMS 5MG;12.5MG;160MG A200435 001 Sep 25, 2012

AB 5MG;25MG;160MG A200435 002 Sep 25, 2012

AB 10MG;12.5MG;160MG A200435 005 Sep 25, 2012

AB 10MG;25MG;160MG A200435 003 Sep 25, 2012

AB 10MG;25MG;320MG A200435 004 Sep 25, 2012

AB TORRENT PHARMS LTD 5MG;12.5MG;160MG A201593 001 Jun 03, 2015

AB 5MG;25MG;160MG A201593 002 Jun 03, 2015

AB 10MG;12.5MG;160MG A201593 003 Jun 03, 2015

AB 10MG;25MG;160MG A201593 004 Jun 03, 2015

AB 10MG;25MG;320MG A201593 005 Jun 03, 2015

EXFORGE HCT

AB + NOVARTIS 5MG;12.5MG;160MG N022314 001 Apr 30, 2009

AB + 5MG;25MG;160MG N022314 002 Apr 30, 2009

AB + 10MG;12.5MG;160MG N022314 003 Apr 30, 2009

AB + 10MG;25MG;160MG N022314 004 Apr 30, 2009

AB +! 10MG;25MG;320MG N022314 005 Apr 30, 2009



AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

AMLODIPINE AND OLMESARTAN MEDOXOMIL



AB ACCORD HLTHCARE INC EQ 5MG BASE;20MG A209600 001 Aug 30, 2018

AB EQ 5MG BASE;40MG A209600 003 Aug 30, 2018

AB EQ 10MG BASE;20MG A209600 002 Aug 30, 2018

AB EQ 10MG BASE;40MG A209600 004 Aug 30, 2018

AB AJANTA PHARMA LTD EQ 5MG BASE;20MG A207216 001 Oct 28, 2016

AB EQ 5MG BASE;40MG A207216 002 Oct 28, 2016

AB EQ 10MG BASE;20MG A207216 003 Oct 28, 2016

AB EQ 10MG BASE;40MG A207216 004 Oct 28, 2016

AB ALEMBIC PHARMS LTD EQ 5MG BASE;20MG A207073 001 Jul 17, 2017

AB EQ 5MG BASE;40MG A207073 002 Jul 17, 2017

AB EQ 10MG BASE;20MG A207073 003 Jul 17, 2017

AB EQ 10MG BASE;40MG A207073 004 Jul 17, 2017

AB ALKEM LABS LTD EQ 5MG BASE;20MG A209042 001 Aug 14, 2017

AB EQ 5MG BASE;40MG A209042 002 Aug 14, 2017

AB EQ 10MG BASE;20MG A209042 003 Aug 14, 2017

AB EQ 10MG BASE;40MG A209042 004 Aug 14, 2017

AB AUROBINDO PHARMA EQ 5MG BASE;20MG A206906 001 May 15, 2017

LTD

AB EQ 5MG BASE;40MG A206906 002 May 15, 2017

AB EQ 10MG BASE;20MG A206906 003 May 15, 2017

AB EQ 10MG BASE;40MG A206906 004 May 15, 2017

AB GLENMARK PHARMS LTD EQ 5MG BASE;20MG A207807 001 Jul 05, 2017

AB EQ 5MG BASE;40MG A207807 002 Jul 05, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-28(of 452)

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL



TABLET;ORAL

AMLODIPINE AND OLMESARTAN MEDOXOMIL



AB EQ 10MG BASE;20MG A207807 003 Jul 05, 2017

AB EQ 10MG BASE;40MG A207807 004 Jul 05, 2017

AB JUBILANT GENERICS EQ 5MG BASE;20MG A207450 001 May 15, 2017

AB EQ 5MG BASE;40MG A207450 002 May 15, 2017

AB EQ 10MG BASE;20MG A207450 003 May 15, 2017

AB EQ 10MG BASE;40MG A207450 004 May 15, 2017

AB MACLEODS PHARMS LTD EQ 5MG BASE;20MG A206884 001 Oct 26, 2016

AB EQ 5MG BASE;40MG A206884 003 Oct 26, 2016

AB EQ 10MG BASE;20MG A206884 002 Oct 26, 2016

AB EQ 10MG BASE;40MG A206884 004 Oct 26, 2016

AB MICRO LABS EQ 5MG BASE;20MG A207435 001 Nov 02, 2017

AB EQ 5MG BASE;40MG A207435 002 Nov 02, 2017

AB EQ 10MG BASE;20MG A207435 003 Nov 02, 2017

AB EQ 10MG BASE;40MG A207435 004 Nov 02, 2017

AB SCIEGEN PHARMS INC EQ 5MG BASE;20MG A209010 001 Dec 03, 2018

AB EQ 5MG BASE;40MG A209010 002 Dec 03, 2018

AB EQ 10MG BASE;20MG A209010 003 Dec 03, 2018

AB EQ 10MG BASE;40MG A209010 004 Dec 03, 2018

AB TEVA PHARMS USA EQ 5MG BASE;20MG A091154 001 Oct 26, 2016

AB EQ 5MG BASE;40MG A091154 002 Oct 26, 2016

AB EQ 10MG BASE;20MG A091154 003 Oct 26, 2016

AB EQ 10MG BASE;40MG A091154 004 Oct 26, 2016

AB TORRENT PHARMS LTD EQ 5MG BASE;20MG A202933 001 Nov 25, 2016

AB EQ 5MG BASE;40MG A202933 002 Nov 25, 2016

AB EQ 10MG BASE;20MG A202933 003 Nov 25, 2016

AB EQ 10MG BASE;40MG A202933 004 Nov 25, 2016

AB ZYDUS PHARMS USA EQ 5MG BASE;20MG A207771 001 Sep 22, 2017

INC

AB EQ 5MG BASE;40MG A207771 002 Sep 22, 2017

AB EQ 10MG BASE;20MG A207771 003 Sep 22, 2017

AB EQ 10MG BASE;40MG A207771 004 Sep 22, 2017

AZOR

AB + DAIICHI SANKYO EQ 5MG BASE;20MG N022100 001 Sep 26, 2007

AB + EQ 5MG BASE;40MG N022100 002 Sep 26, 2007

AB + EQ 10MG BASE;20MG N022100 003 Sep 26, 2007

AB +! EQ 10MG BASE;40MG N022100 004 Sep 26, 2007



AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

TABLET;ORAL

PRESTALIA

+ MARINA BIOTECH EQ 2.5MG BASE;3.5MG N205003 001 Jan 21, 2015

+ EQ 5MG BASE;7MG N205003 002 Jan 21, 2015

+! EQ 10MG BASE;14MG N205003 003 Jan 21, 2015

AMLODIPINE BESYLATE; TELMISARTAN

TABLET;ORAL

TELMISARTAN AND AMLODIPINE



AB ALEMBIC PHARMS LTD EQ 5MG BASE;40MG A205234 001 Nov 17, 2016

AB EQ 5MG BASE;80MG A205234 003 Nov 17, 2016

AB EQ 10MG BASE;40MG A205234 002 Nov 17, 2016

AB EQ 10MG BASE;80MG A205234 004 Nov 17, 2016

AB LUPIN LTD EQ 5MG BASE;40MG A201586 001 Jan 08, 2014

AB EQ 5MG BASE;80MG A201586 003 Jan 08, 2014

AB EQ 10MG BASE;40MG A201586 002 Jan 08, 2014

AB EQ 10MG BASE;80MG A201586 004 Jan 08, 2014

AB MYLAN PHARMS INC EQ 5MG BASE;40MG A202516 001 Aug 26, 2014

AB EQ 5MG BASE;80MG A202516 003 Aug 26, 2014

AB EQ 10MG BASE;40MG A202516 002 Aug 26, 2014

AB EQ 10MG BASE;80MG A202516 004 Aug 26, 2014

AB TORRENT PHARMS LTD EQ 5MG BASE;40MG A202517 001 Jan 08, 2014

AB EQ 5MG BASE;80MG A202517 003 Jan 08, 2014

AB EQ 10MG BASE;40MG A202517 002 Jan 08, 2014

AB EQ 10MG BASE;80MG A202517 004 Jan 08, 2014

TWYNSTA

AB + BOEHRINGER EQ 5MG BASE;40MG N022401 001 Oct 16, 2009

INGELHEIM

AB + EQ 5MG BASE;80MG N022401 003 Oct 16, 2009

AB + EQ 10MG BASE;40MG N022401 002 Oct 16, 2009

AB +! EQ 10MG BASE;80MG N022401 004 Oct 16, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-29(of 452)

AMLODIPINE BESYLATE; VALSARTAN



TABLET;ORAL

AMLODIPINE BESYLATE AND VALSARTAN



AB ALEMBIC PHARMS LTD
EQ 5MG BASE;160MG
A202713 001 Apr 03, 2015

AB
EQ 5MG BASE;320MG
A202713 003 Apr 03, 2015

AB
EQ 10MG BASE;160MG
A202713 002 Apr 03, 2015

AB
EQ 10MG BASE;320MG
A202713 004 Apr 03, 2015

AB AUROBINDO PHARMA
EQ 5MG BASE;160MG
A206512 001 Apr 22, 2016

LTD

AB
EQ 5MG BASE;320MG
A206512 002 Apr 22, 2016

AB
EQ 10MG BASE;160MG
A206512 003 Apr 22, 2016

AB
EQ 10MG BASE;320MG
A206512 004 Apr 22, 2016

AB INVAGEN PHARMS
EQ 5MG BASE;160MG
A205137 001 Sep 16, 2016

AB
EQ 5MG BASE;320MG
A205137 003 Sep 16, 2016

AB
EQ 10MG BASE;160MG
A205137 002 Sep 16, 2016

AB
EQ 10MG BASE;320MG
A205137 004 Sep 16, 2016

AB LUPIN
EQ 5MG BASE;160MG
A090245 001 Mar 30, 2015

AB
EQ 5MG BASE;320MG
A090245 003 Mar 30, 2015

AB
EQ 10MG BASE;160MG
A090245 002 Mar 30, 2015

AB
EQ 10MG BASE;320MG
A090245 004 Mar 30, 2015

AB MYLAN PHARMS INC


EQ 5MG BASE;160MG
A090483 001 Mar 30, 2015

AB
EQ 5MG BASE;320MG
A090483 003 Mar 30, 2015

AB
EQ 10MG BASE;160MG
A090483 002 Mar 30, 2015

AB
EQ 10MG BASE;320MG
A090483 004 Mar 30, 2015

AB NOVEL LABS INC


EQ 5MG BASE;160MG
A202829 001 Mar 30, 2015

AB
EQ 5MG BASE;320MG
A202829 003 Mar 30, 2015

AB
EQ 10MG BASE;160MG
A202829 002 Mar 30, 2015

AB
EQ 10MG BASE;320MG
A202829 004 Mar 30, 2015

AB PAR PHARM INC


EQ 5MG BASE;160MG
A090011 001 Mar 28, 2013

AB
EQ 5MG BASE;320MG
A090011 003 Mar 28, 2013

AB
EQ 10MG BASE;160MG
A090011 002 Mar 28, 2013

AB
EQ 10MG BASE;320MG
A090011 004 Mar 28, 2013

AB TEVA PHARMS USA


EQ 5MG BASE;160MG
A091235 001 Mar 30, 2015

AB
EQ 5MG BASE;320MG
A091235 003 Mar 30, 2015

AB
EQ 10MG BASE;160MG
A091235 002 Mar 30, 2015

AB
EQ 10MG BASE;320MG
A091235 004 Mar 30, 2015

AB TORRENT PHARMS LTD


EQ 5MG BASE;160MG
A202377 001 Mar 30, 2015

AB
EQ 5MG BASE;320MG
A202377 002 Mar 30, 2015

AB
EQ 10MG BASE;160MG
A202377 003 Mar 30, 2015

AB
EQ 10MG BASE;320MG
A202377 004 Mar 30, 2015

EXFORGE

AB + NOVARTIS
EQ 5MG BASE;160MG
N021990 002 Jun 20, 2007

AB +
EQ 5MG BASE;320MG
N021990 004 Jun 20, 2007

AB +!
EQ 10MG BASE;160MG
N021990 003 Jun 20, 2007

AB +!
EQ 10MG BASE;320MG
N021990 005 Jun 20, 2007

AMMONIA N-13

INJECTABLE;INTRAVENOUS

AMMONIA N 13

AP 3D IMAGING DRUG
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203779 001 Oct 19, 2015

AP BIOMEDCL RES FDN


48.75mCi-487.5mCi/13ML (3.75- A204352 001 May 01, 2015

37.5mCi/ML)

AP BRIGHAM WOMENS HOSP


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203783 001 Oct 30, 2014

AP CARDINAL HEALTH 414


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203700 001 Feb 25, 2013

AP +! FEINSTEIN
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
N022119 001 Aug 23, 2007

AP GEN HOSP
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A207025 001 Feb 03, 2016

AP GLOBAL ISOTOPES LLC


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204465 001 Oct 23, 2014

AP IONETIX
22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)
A210524 001 Dec 21, 2018

AP JOHNS HOPKINS UNIV


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204514 001 Aug 19, 2014

AP KREITCHMAN PET CTR


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203938 001 Dec 09, 2013

AP MCPRF
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203321 001 Feb 25, 2013

AP MIDWEST MEDCL
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204457 001 Nov 18, 2015

AP MIPS CRF
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204535 001 Nov 20, 2014

AP PETNET
30mCi-300mCi (3.75-37.5mCi/ML)
A204510 001 Nov 02, 2015

AP SOFIE
18.8mCi-188mCi/5ML (3.75-37.5mCi/ML)
A204667 001 Apr 22, 2015

AP SPECTRON MRC LLC


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204455 001 Apr 23, 2015

AP UCLA BIOMEDICAL
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A203812 001 Jun 27, 2013

AP UCSF RODIOPHARM
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204496 001 Mar 28, 2014

AP WA UNIV SCH MED


30mCi-300mCi/8ML (3.75-37.5mCi/ML)
A204506 001 Feb 07, 2014

ESSENTIAL ISOTOPES
3.75-260mCi/ML
A205687 001 Dec 17, 2015

HOUSTON CYCLOTRON
3.75-260mCi/ML
A203543 001 Dec 14, 2012

NCM USA BRONX LLC
3.75-260mCi/mL
A204515 001 Feb 04, 2015

PRECISION NUCLEAR
3.75-260mCi/ML
A204547 001 Aug 14, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-30(of 452)

AMMONIA N-13

INJECTABLE;INTRAVENOUS

AMMONIA N 13

SHERTECH LABS LLC 3.75-260mCi/ML
A204366 001 Sep 19, 2014

WI MEDCL CYCLOTRON 3.75-260mCi/ML


A204356 001 Dec 18, 2014

AMMONIUM CHLORIDE

INJECTABLE;INJECTION

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

! HOSPIRA 5MEQ/ML
A088366 001 Jun 13, 1984

AMMONIUM LACTATE

CREAM;TOPICAL

AMMONIUM LACTATE

AB ! PERRIGO NEW YORK EQ 12% BASE
A075774 001 May 01, 2002

AB TARO EQ 12% BASE


A075883 001 Apr 10, 2003

AB WATSON LABS INC EQ 12% BASE


A076829 001 Feb 07, 2006

LOTION;TOPICAL

AMMONIUM LACTATE

AB ! PERRIGO NEW YORK EQ 12% BASE
A075570 001 Jun 23, 2004

AB TARO EQ 12% BASE


A076216 001 May 28, 2004

AB WATSON LABS INC EQ 12% BASE


A075575 001 Jun 11, 2002

AMOXAPINE

TABLET;ORAL

AMOXAPINE

WATSON LABS 25MG
A072691 002 Aug 28, 1992

50MG
A072691 003 Aug 28, 1992

100MG
A072691 004 Aug 28, 1992

! 150MG
A072691 001 Aug 28, 1992

AMOXICILLIN

CAPSULE;ORAL

AMOXICILLIN

AB AM ANTIBIOTICS 250MG
A062058 001

AB 500MG
A062058 002

AB AUROBINDO 250MG
A065271 001 Nov 09, 2005

AB 500MG
A065271 002 Nov 09, 2005

AB DAVA PHARMS INC 250MG


A062884 001 Feb 25, 1988

AB 500MG
A062881 001 Feb 25, 1988

AB HIKMA PHARMS 250MG


A065291 001 Feb 05, 2007

AB 500MG
A065291 002 Feb 05, 2007

AB SANDOZ 250MG
A064076 001 Sep 30, 1994

AB 500MG
A064076 002 Sep 30, 1994

AB TEVA 250MG
A061926 001

AB ! 500MG
A061926 003

AMOXIL

AB NEOPHARMA 250MG
A062216 001

AB 500MG
A062216 004

FOR SUSPENSION;ORAL

AMOXICILLIN

AB AUROBINDO 200MG/5ML
A065334 001 Dec 28, 2006

AB 400MG/5ML
A065334 002 Dec 28, 2006

AB AUROBINDO PHARMA 125MG/5ML


A204030 001 Sep 15, 2014

LTD

AB 250MG/5ML
A204030 002 Sep 15, 2014

AB DAVA PHARMS INC 125MG/5ML


A062927 001 Nov 25, 1988

AB 250MG/5ML
A062927 002 Nov 25, 1988

AB HIKMA 125MG/5ML
A065322 002 Jun 19, 2006

AB 200MG/5ML
A065325 002 Jun 19, 2006

AB 250MG/5ML
A065322 001 Jun 19, 2006

AB 400MG/5ML
A065325 001 Jun 19, 2006

AB SANDOZ 125MG/5ML
A065387 001 Mar 26, 2007

AB 200MG/5ML
A065378 001 Mar 26, 2007

AB 250MG/5ML
A065387 002 Mar 26, 2007

AB 400MG/5ML
A065378 002 Mar 26, 2007

AB TEVA 125MG/5ML
A061931 001

AB 200MG/5ML
A065119 001 Dec 04, 2002

AB ! 250MG/5ML
A061931 002

AB ! 400MG/5ML
A065119 002 Dec 04, 2002

AB WOCKHARDT BIO AG 400MG/5ML


A065319 002 Jun 18, 2007

AMOXICILLIN PEDIATRIC

AB TEVA 50MG/ML
A061931 003 Dec 01, 1982

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-31(of 452)

AMOXICILLIN

FOR SUSPENSION;ORAL

AMOXIL

AB NEOPHARMA 50MG/ML A062226 005

AB 125MG/5ML A062226 001

AB 250MG/5ML A062226 002

LAROTID

AB NEOPHARMA 125MG/5ML A062226 003

AB 250MG/5ML A062226 004

TABLET;ORAL

AMOXICILLIN

AB AUROBINDO 500MG A065256 001 Nov 09, 2005

AB 875MG A065256 002 Nov 09, 2005

AB HIKMA 875MG A065255 001 Mar 29, 2006

AB SANDOZ 500MG A065228 001 Jul 13, 2005

AB 875MG A065228 002 Jul 13, 2005

AB TEVA 500MG A065056 001 Sep 18, 2000

AB ! 875MG A065056 002 Sep 18, 2000

TABLET, CHEWABLE;ORAL

AMOXICILLIN

TEVA 125MG A064013 002 Sep 11, 1995

! 250MG A064013 001 Dec 22, 1992



AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

AB ! RISING PHARMS 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A206006 001 Oct 07, 2016

G

AB SANDOZ INC 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A202588 001 Mar 04, 2014

G

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN

+! CUMBERLAND PHARMS 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M N050824 001 Feb 08, 2011

G

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM



AB AUROBINDO PHARMA 200MG/5ML;EQ 28.5MG BASE/5ML A201090 001 Dec 20, 2011

LTD

AB 400MG/5ML;EQ 57MG BASE/5ML A201090 002 Dec 20, 2011

AB 600MG/5ML;EQ 42.9MG BASE/5ML A201091 001 Dec 20, 2011

AB HIKMA PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML A065191 002 Jan 25, 2005

AB 400MG/5ML;EQ 57MG BASE/5ML A065191 001 Jan 25, 2005

AB 600MG/5ML;EQ 42.9MG BASE/5ML A065373 001 Nov 09, 2007

AB SANDOZ 200MG/5ML;EQ 28.5MG BASE/5ML A065066 001 Jun 05, 2002

AB 400MG/5ML;EQ 57MG BASE/5ML A065066 002 Jun 05, 2002

AB SANDOZ INC 200MG/5ML;EQ 28.5MG BASE/5ML A065098 001 Dec 16, 2002

AB 400MG/5ML;EQ 57MG BASE/5ML A065098 002 Dec 16, 2002

AB 600MG/5ML;EQ 42.9MG BASE/5ML A065358 001 Aug 13, 2007

AB TEVA 200MG/5ML;EQ 28.5MG BASE/5ML A065089 001 May 25, 2004

AB ! 400MG/5ML;EQ 57MG BASE/5ML A065089 002 May 25, 2004

AB ! 600MG/5ML;EQ 42.9MG BASE/5ML A065162 001 Mar 12, 2004

AB WOCKHARDT BIO AG 250MG/5ML;EQ 62.5MG BASE/5ML A065431 001 Nov 25, 2008

AB 600MG/5ML;EQ 42.9MG BASE/5ML A065420 001 Dec 02, 2013

AUGMENTIN '250'

AB +! NEOPHARMA 250MG/5ML;EQ 62.5MG BASE/5ML N050575 002 Aug 06, 1984

AUGMENTIN '125'

+ NEOPHARMA 125MG/5ML;EQ 31.25MG BASE/5ML N050575 001 Aug 06, 1984

TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM



AB AUROBINDO PHARMA 250MG;EQ 125MG BASE A091569 001 Jan 20, 2012

LTD

AB 500MG;EQ 125MG BASE A091569 002 Jan 20, 2012

AB 875MG;EQ 125MG BASE A091568 001 Jan 20, 2012

AB HIKMA PHARMS 875MG;EQ 125MG BASE A203824 001 Aug 23, 2016

AB MICRO LABS LTD 250MG;EQ 125MG BASE A205707 001 Dec 30, 2016

INDIA

AB 500MG;EQ 125MG BASE A205707 002 Dec 30, 2016

AB 875MG;EQ 125MG BASE A204755 003 Dec 30, 2016

AB ! SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005

AB 500MG;EQ 125MG BASE A065064 001 Mar 15, 2002

AB ! 875MG;EQ 125MG BASE A065063 001 Mar 14, 2002



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-32(of 452)

AMOXICILLIN; CLAVULANATE POTASSIUM



TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM



AB ! SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002

AB 875MG;EQ 125MG BASE A065093 001 Nov 21, 2002

AB TEVA 500MG;EQ 125MG BASE A065101 001 Oct 30, 2002

AB TEVA PHARMS USA 875MG;EQ 125MG BASE A065096 001 Oct 29, 2002

AUGMENTIN '875'

AB + DR REDDYS LABS INC 875MG;EQ 125MG BASE N050720 001 Feb 13, 1996

TABLET, CHEWABLE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

TEVA 200MG;EQ 28.5MG BASE A065205 001 Feb 09, 2005

! 400MG;EQ 57MG BASE A065205 002 Feb 09, 2005

TABLET, EXTENDED RELEASE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM



AB SANDOZ 1GM;EQ 62.5MG BASE A090227 001 Apr 21, 2010

AUGMENTIN XR

AB +! NEOPHARMA 1GM;EQ 62.5MG BASE N050785 001 Sep 25, 2002

AMPHETAMINE

SUSPENSION, EXTENDED RELEASE;ORAL

ADZENYS ER

+! NEOS THERAPS INC EQ 1.25MG BASE/ML N204325 001 Sep 15, 2017

DYANAVEL XR

+! TRIS PHARMA INC EQ 2.5MG BASE/ML N208147 001 Oct 19, 2015

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

ADZENYS XR-ODT

+ NEOS THERAPS EQ 3.1MG BASE N204326 001 Jan 27, 2016

+ EQ 6.3MG BASE N204326 002 Jan 27, 2016

+ EQ 9.4MG BASE N204326 003 Jan 27, 2016

+ EQ 12.5MG BASE N204326 004 Jan 27, 2016

+ EQ 15.7MG BASE N204326 005 Jan 27, 2016

+! EQ 18.8MG BASE N204326 006 Jan 27, 2016

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

ADDERALL XR 10

AB + SHIRE 2.5MG;2.5MG;2.5MG;2.5MG N021303 001 Oct 11, 2001

ADDERALL XR 15

AB + SHIRE 3.75MG;3.75MG;3.75MG;3.75MG N021303 006 May 22, 2002

ADDERALL XR 20

AB + SHIRE 5MG;5MG;5MG;5MG N021303 002 Oct 11, 2001

ADDERALL XR 25

AB + SHIRE 6.25MG;6.25MG;6.25MG;6.25MG N021303 004 May 22, 2002

ADDERALL XR 30

AB +! SHIRE 7.5MG;7.5MG;7.5MG;7.5MG N021303 003 Oct 11, 2001

ADDERALL XR 5

AB + SHIRE 1.25MG;1.25MG;1.25MG;1.25MG N021303 005 May 22, 2002

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG A077302 001 Jun 22, 2012

AB 2.5MG;2.5MG;2.5MG;2.5MG A077302 002 Jun 22, 2012

AB 3.75MG;3.75MG;3.75MG;3.75MG A077302 003 Jun 22, 2012

AB 5MG;5MG;5MG;5MG A077302 004 Jun 22, 2012

AB 6.25MG;6.25MG;6.25MG;6.25MG A077302 005 Jun 22, 2012

AB 7.5MG;7.5MG;7.5MG;7.5MG A077302 006 Jun 22, 2012

AB IMPAX LABS 1.25MG;1.25MG;1.25MG;1.25MG A076852 001 Feb 16, 2016

AB 2.5MG;2.5MG;2.5MG;2.5MG A076852 002 Feb 16, 2016

AB 3.75MG;3.75MG;3.75MG;3.75MG A076852 003 Feb 16, 2016

AB 5MG;5MG;5MG;5MG A076852 004 Feb 16, 2016

AB 6.25MG;6.25MG;6.25MG;6.25MG A076852 005 Feb 16, 2016

AB 7.5MG;7.5MG;7.5MG;7.5MG A076852 006 Feb 16, 2016

AB TEVA 1.25MG;1.25MG;1.25MG;1.25MG A077488 001 Apr 29, 2013

AB 2.5MG;2.5MG;2.5MG;2.5MG A077488 002 Apr 29, 2013

AB 3.75MG;3.75MG;3.75MG;3.75MG A077488 003 Apr 29, 2013

AB 5MG;5MG;5MG;5MG A077488 004 Apr 29, 2013

AB 6.25MG;6.25MG;6.25MG;6.25MG A077488 005 Apr 29, 2013

AB 7.5MG;7.5MG;7.5MG;7.5MG A077488 006 Apr 29, 2013

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE

AB BARR LABS INC 1.25MG;1.25MG;1.25MG;1.25MG A076536 001 Feb 12, 2013

AB 2.5MG;2.5MG;2.5MG;2.5MG A076536 002 Feb 12, 2013

AB 3.75MG;3.75MG;3.75MG;3.75MG A076536 003 Feb 12, 2013

AB 5MG;5MG;5MG;5MG A076536 004 Feb 12, 2013

AB 6.25MG;6.25MG;6.25MG;6.25MG A076536 005 Feb 12, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-33(of 452)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE

AB 7.5MG;7.5MG;7.5MG;7.5MG A076536 006 Feb 12, 2013



MYDAYIS

+ SHIRE DEV LLC 3.125MG;3.125MG;3.125MG;3.125MG N022063 001 Jun 20, 2017

+ 6.25MG;6.25MG;6.25MG;6.25MG N022063 002 Jun 20, 2017

+ 9.375MG;9.375MG;9.375MG;9.375MG N022063 003 Jun 20, 2017

+! 12.5MG;12.5MG;12.5MG;12.5MG N022063 004 Jun 20, 2017

TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB ACTAVIS ELIZABETH
1.25MG;1.25MG;1.25MG;1.25MG
A206340 001 Feb 05, 2016

AB
1.875MG;1.875MG;1.875MG;1.875MG
A206340 002 Feb 05, 2016

AB
2.5MG;2.5MG;2.5MG;2.5MG
A206340 003 Feb 05, 2016

AB
3.125MG;3.125MG;3.125MG;3.125MG
A206340 004 Feb 05, 2016

AB
3.75MG;3.75MG;3.75MG;3.75MG
A206340 005 Feb 05, 2016

AB
5MG;5MG;5MG;5MG
A206340 006 Feb 05, 2016

AB
7.5MG;7.5MG;7.5MG;7.5MG
A206340 007 Feb 05, 2016

AB ALVOGEN MALTA
1.25MG;1.25MG;1.25MG;1.25MG
A207388 001 Jul 28, 2017

AB
1.875MG;1.875MG;1.875MG;1.875MG
A207388 002 Jul 28, 2017

AB
2.5MG;2.5MG;2.5MG;2.5MG
A207388 003 Jul 28, 2017

AB
3.125MG;3.125MG;3.125MG;3.125MG
A207388 004 Jul 28, 2017

AB
3.75MG;3.75MG;3.75MG;3.75MG
A207388 005 Jul 28, 2017

AB
5MG;5MG;5MG;5MG
A207388 006 Jul 28, 2017

AB
7.5MG;7.5MG;7.5MG;7.5MG
A207388 007 Jul 28, 2017

AB AUROLIFE PHARMA LLC


1.25MG;1.25MG;1.25MG;1.25MG
A202424 001 Nov 27, 2013

AB
1.875MG;1.875MG;1.875MG;1.875MG
A202424 002 Nov 27, 2013

AB
2.5MG;2.5MG;2.5MG;2.5MG
A202424 003 Nov 27, 2013

AB
3.125MG;3.125MG;3.125MG;3.125MG
A202424 004 Nov 27, 2013

AB
3.75MG;3.75MG;3.75MG;3.75MG
A202424 005 Nov 27, 2013

AB
5MG;5MG;5MG;5MG
A202424 006 Nov 27, 2013

AB
7.5MG;7.5MG;7.5MG;7.5MG
A202424 007 Nov 27, 2013

AB BARR
1.25MG;1.25MG;1.25MG;1.25MG
A040422 001 Feb 11, 2002

AB
1.875MG;1.875MG;1.875MG;1.875MG
A040422 005 Mar 19, 2003

AB
2.5MG;2.5MG;2.5MG;2.5MG
A040422 002 Feb 11, 2002

AB
3.125MG;3.125MG;3.125MG;3.125MG
A040422 006 Mar 19, 2003

AB
3.75MG;3.75MG;3.75MG;3.75MG
A040422 007 Mar 19, 2003

AB
5MG;5MG;5MG;5MG
A040422 003 Feb 11, 2002

AB !
7.5MG;7.5MG;7.5MG;7.5MG
A040422 004 Feb 11, 2002

AB EPIC PHARMA LLC


1.25MG;1.25MG;1.25MG;1.25MG
A040444 001 Jun 19, 2002

AB
1.875MG;1.875MG;1.875MG;1.875MG
A040444 005 Nov 03, 2014

AB
2.5MG;2.5MG;2.5MG;2.5MG
A040444 002 Jun 19, 2002

AB
3.125MG;3.125MG;3.125MG;3.125MG
A040444 006 Nov 03, 2014

AB
3.75MG;3.75MG;3.75MG;3.75MG
A040444 007 Nov 03, 2014

AB
5MG;5MG;5MG;5MG
A040444 003 Jun 19, 2002

AB
7.5MG;7.5MG;7.5MG;7.5MG
A040444 004 Jun 19, 2002

AB MYLAN PHARMS INC


1.25MG;1.25MG;1.25MG;1.25MG
A206721 001 Nov 10, 2015

AB
1.875MG;1.875MG;1.875MG;1.875MG
A206721 002 Nov 10, 2015

AB
2.5MG;2.5MG;2.5MG;2.5MG
A206721 003 Nov 10, 2015

AB
3.125MG;3.125MG;3.125MG;3.125MG
A206721 004 Nov 10, 2015

AB
3.75MG;3.75MG;3.75MG;3.75MG
A206721 005 Nov 10, 2015

AB
5MG;5MG;5MG;5MG
A206721 006 Nov 10, 2015

AB
7.5MG;7.5MG;7.5MG;7.5MG
A206721 007 Nov 10, 2015

AB NESHER PHARMS
1.25MG;1.25MG;1.25MG;1.25MG
A207340 001 Oct 31, 2017

AB
1.875MG;1.875MG;1.875MG;1.875MG
A207340 002 Oct 31, 2017

AB
2.5MG;2.5MG;2.5MG;2.5MG
A207340 003 Oct 31, 2017

AB
3.125MG;3.125MG;3.125MG;3.125MG
A207340 004 Oct 31, 2017

AB
3.75MG;3.75MG;3.75MG;3.75MG
A207340 005 Oct 31, 2017

AB
5MG;5MG;5MG;5MG
A207340 006 Oct 31, 2017

AB
7.5MG;7.5MG;7.5MG;7.5MG
A207340 007 Oct 31, 2017

AB NUVO PHARM
1.25MG;1.25MG;1.25MG;1.25MG
A209799 001 Dec 28, 2017

AB
1.875MG;1.875MG;1.875MG;1.875MG
A209799 002 Dec 28, 2017

AB
2.5MG;2.5MG;2.5MG;2.5MG
A209799 003 Dec 28, 2017

AB
3.125MG;3.125MG;3.125MG;3.125MG
A209799 004 Dec 28, 2017

AB
3.75MG;3.75MG;3.75MG;3.75MG
A209799 005 Dec 28, 2017

AB
5MG;5MG;5MG;5MG
A209799 006 Dec 28, 2017

AB
7.5MG;7.5MG;7.5MG;7.5MG
A209799 007 Dec 28, 2017

AB SANDOZ
1.25MG;1.25MG;1.25MG;1.25MG
A040439 004 Sep 27, 2002

AB
2.5MG;2.5MG;2.5MG;2.5MG
A040439 001 Jun 14, 2002

AB
5MG;5MG;5MG;5MG
A040439 002 Jun 14, 2002

AB
7.5MG;7.5MG;7.5MG;7.5MG
A040439 003 Jun 14, 2002

AB SPECGX LLC
1.25MG;1.25MG;1.25MG;1.25MG
A040440 001 Oct 07, 2003

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-34(of 452)

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB 1.875MG;1.875MG;1.875MG;1.875MG
A040440 002 Oct 07, 2003

AB 2.5MG;2.5MG;2.5MG;2.5MG
A040440 003 Oct 07, 2003

AB 3.125MG;3.125MG;3.125MG;3.125MG
A040440 004 Oct 07, 2003

AB 3.75MG;3.75MG;3.75MG;3.75MG
A040440 005 Oct 07, 2003

AB 5MG;5MG;5MG;5MG
A040440 006 Oct 07, 2003

AB 7.5MG;7.5MG;7.5MG;7.5MG
A040440 007 Oct 07, 2003

AB SUN PHARM 1.25MG;1.25MG;1.25MG;1.25MG


A040480 001 Sep 09, 2003

INDUSTRIES
AB 1.875MG;1.875MG;1.875MG;1.875MG
A040480 002 Sep 09, 2003

AB 2.5MG;2.5MG;2.5MG;2.5MG
A040480 003 Sep 09, 2003

AB 3.125MG;3.125MG;3.125MG;3.125MG
A040480 004 Sep 09, 2003

AB 3.75MG;3.75MG;3.75MG;3.75MG
A040480 005 Sep 09, 2003

AB 5MG;5MG;5MG;5MG
A040480 006 Sep 09, 2003

AB 7.5MG;7.5MG;7.5MG;7.5MG
A040480 007 Sep 09, 2003

AB SUNGEN PHARMA 1.25MG;1.25MG;1.25MG;1.25MG


A211352 001 Dec 07, 2018

AB 1.875MG;1.875MG;1.875MG;1.875MG
A211352 002 Dec 07, 2018

AB 2.5MG;2.5MG;2.5MG;2.5MG
A211352 003 Dec 07, 2018

AB 3.125MG;3.125MG;3.125MG;3.125MG
A211352 004 Dec 07, 2018

AB 3.75MG;3.75MG;3.75MG;3.75MG
A211352 005 Dec 07, 2018

AB 5MG;5MG;5MG;5MG
A211352 006 Dec 07, 2018

AB 7.5MG;7.5MG;7.5MG;7.5MG
A211352 007 Dec 07, 2018

AMPHETAMINE SULFATE

TABLET;ORAL

AMPHETAMINE SULFATE

AA AMNEAL PHARMS
5MG
A211139 001 Sep 26, 2018

AA
10MG
A211139 002 Sep 26, 2018

EVEKEO

AA ARBOR PHARMS LLC
5MG
A200166 001 Aug 09, 2012

AA !
10MG
A200166 002 Aug 09, 2012

AMPHOTERICIN B

INJECTABLE;INJECTION

AMPHOTERICIN B

! X GEN PHARMS
50MG/VIAL
A063206 001 Apr 29, 1992

INJECTABLE, LIPID COMPLEX;INJECTION

ABELCET

+! LEADIANT BIOSCI INC 5MG/ML
N050724 001 Nov 20, 1995

INJECTABLE, LIPOSOMAL;INJECTION

AMBISOME

+! ASTELLAS
50MG/VIAL
N050740 001 Aug 11, 1997

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM
AP ACS DOBFAR SPA EQ 10GM BASE/VIAL
A090889 001 Apr 03, 2013

AP ANTIBIOTICE EQ 250MG BASE/VIAL


A090354 001 Dec 28, 2009

AP EQ 500MG BASE/VIAL
A090354 002 Dec 28, 2009

AP EQ 1GM BASE/VIAL
A090354 003 Dec 28, 2009

AP EQ 2GM BASE/VIAL
A090354 004 Dec 28, 2009

AP AUROBINDO PHARMA EQ 250MG BASE/VIAL


A065499 002 Aug 17, 2010

AP EQ 500MG BASE/VIAL
A065499 003 Aug 17, 2010

AP EQ 1GM BASE/VIAL
A065499 004 Aug 17, 2010

AP EQ 2GM BASE/VIAL
A065499 005 Aug 17, 2010

AP EQ 10GM BASE/VIAL
A065493 001 Aug 17, 2010

AP HANFORD GC EQ 250MG BASE/VIAL


A062772 006 Apr 15, 1993

AP EQ 500MG BASE/VIAL
A062772 007 Apr 15, 1993

AP EQ 1GM BASE/VIAL
A062772 001 Apr 15, 1993

AP EQ 2GM BASE/VIAL
A062772 003 Apr 15, 1993

AP EQ 10GM BASE/VIAL
A063142 001 Apr 15, 1993

AP HOSPIRA INC EQ 250MG BASE/VIAL


A202864 001 Sep 04, 2015

AP EQ 500MG BASE/VIAL
A202864 002 Sep 04, 2015

AP EQ 1GM BASE/VIAL
A202864 003 Sep 04, 2015

AP EQ 2GM BASE/VIAL
A202864 004 Sep 04, 2015

AP EQ 10GM BASE/VIAL
A202865 001 Sep 04, 2015

AP ISTITUTO BIO ITA EQ 10GM BASE/VIAL


A201404 001 Dec 20, 2013

SPA
AP EQ 250MG BASE/VIAL
A062719 001 May 12, 1987

AP EQ 500MG BASE/VIAL
A062719 003 May 12, 1987

AP EQ 1GM BASE/VIAL
A062719 002 May 12, 1987

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-35(of 452)

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

AP
EQ 2GM BASE/VIAL
A062797 002 Jul 12, 1993

AP MYLAN LABS LTD


EQ 250MG BASE/VIAL
A201025 001 Apr 09, 2014

AP
EQ 500MG BASE/VIAL
A201025 002 Apr 09, 2014

AP
EQ 1GM BASE/VIAL
A201025 003 Apr 09, 2014

AP
EQ 2GM BASE/VIAL
A201025 004 Apr 09, 2014

AP
EQ 10GM BASE/VIAL
A202198 001 Apr 07, 2014

AP SAGENT PHARMS
EQ 125MG BASE/VIAL
A090583 001 Nov 27, 2015

AP
EQ 250MG BASE/VIAL
A090583 002 Nov 27, 2015

AP
EQ 500MG BASE/VIAL
A090583 003 Nov 27, 2015

AP
EQ 1GM BASE/VIAL
A090583 004 Nov 27, 2015

AP
EQ 2GM BASE/VIAL
A090583 005 Nov 27, 2015

AP
EQ 10GM BASE/VIAL
A090581 001 Oct 20, 2015

AP ! SANDOZ
EQ 125MG BASE/VIAL
A061395 001

AP !
EQ 250MG BASE/VIAL
A061395 002

AP !
EQ 500MG BASE/VIAL
A061395 003

AP !
EQ 1GM BASE/VIAL
A061395 004

AP !
EQ 2GM BASE/VIAL
A061395 005

AP !
EQ 10GM BASE/VIAL
A061395 006

POWDER;INTRAVENOUS

AMPICILLIN SODIUM

AP ! SANDOZ
EQ 1GM BASE/VIAL
A062738 001 Feb 19, 1987

AP !
EQ 2GM BASE/VIAL
A062738 002 Feb 19, 1987

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

AMPICILLIN AND SULBACTAM



AP ACS DOBFAR EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
A065406 001 Dec 22, 2009

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A065406 002 Dec 22, 2009

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A065403 001 Dec 23, 2009

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


A201406 001 Dec 07, 2015

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A201406 002 Dec 07, 2015

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


A090579 001 Jan 08, 2016

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A090579 002 Jan 08, 2016

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A090578 001 Jan 11, 2016

AP AUROBINDO PHARMA EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A090340 001 Sep 20, 2010

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


A090349 001 Sep 20, 2010

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A090340 002 Sep 20, 2010

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A090349 002 Sep 20, 2010

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A090339 001 Sep 20, 2010

AP HANFORD GC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A065176 001 Nov 30, 2005

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A065176 002 Nov 30, 2005

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A065188 001 Nov 25, 2005

AP HOSPIRA INC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A090375 001 Dec 21, 2011

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


A090653 001 Dec 21, 2011

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A090375 002 Dec 21, 2011

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A090653 002 Dec 21, 2011

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A090646 001 Dec 21, 2011

AP ISTITUTO BIO ITA EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A065222 001 Nov 29, 2005

SPA
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
A065222 002 Nov 29, 2005

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A065314 001 Nov 27, 2006

AP MUSTAFA NEVZAT ILAC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A065316 001 Jun 29, 2007

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A065316 002 Jun 29, 2007

AP MYLAN LABS LTD EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A201024 001 Apr 07, 2014

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A201024 002 Apr 07, 2014

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A202197 001 Apr 07, 2014

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


A065241 001 Jul 25, 2006

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


A065310 001 Jul 25, 2006

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A065241 002 Jul 25, 2006

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


A065310 002 Jul 25, 2006

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A065240 001 Jul 25, 2006

AP WEST-WARD PHARMS EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


A065074 001 Mar 19, 2002

INT
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
A065074 002 Mar 19, 2002

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL


A065076 001 Mar 19, 2002

UNASYN
AP ! PFIZER EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
A062901 002 Feb 27, 1992

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


A062901 001 Nov 23, 1988

AP +! EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL


N050608 002 Dec 31, 1986

AP +! EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL


N050608 001 Dec 31, 1986

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-36(of 452)

AMPICILLIN SODIUM; SULBACTAM SODIUM



INJECTABLE;INJECTION

UNASYN

AP +! EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL N050608 005 Dec 10, 1993

AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMPICILLIN TRIHYDRATE

AB DAVA PHARMS INC EQ 250MG BASE A062883 001 Feb 25, 1988

AB ! EQ 500MG BASE A062882 001 Feb 25, 1988

AB SANDOZ EQ 250MG BASE A064082 001 Aug 29, 1995

AB EQ 500MG BASE A064082 002 Aug 29, 1995

FOR SUSPENSION;ORAL

AMPICILLIN TRIHYDRATE

DAVA PHARMS INC EQ 125MG BASE/5ML A062982 001 Feb 10, 1989

! EQ 250MG BASE/5ML A062982 002 Feb 10, 1989

ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL

AGRYLIN

AB SHIRE LLC EQ 0.5MG BASE N020333 001 Mar 14, 1997

ANAGRELIDE HYDROCHLORIDE

AB BARR EQ 0.5MG BASE A076530 001 Apr 18, 2005

AB EQ 1MG BASE A076530 002 Apr 18, 2005

AB IMPAX LABS EQ 0.5MG BASE A076910 001 Apr 18, 2005

AB EQ 1MG BASE A076910 002 Apr 18, 2005

AB IVAX SUB TEVA EQ 0.5MG BASE A076468 001 Apr 18, 2005

PHARMS

AB ! EQ 1MG BASE A076468 002 Apr 18, 2005

AB TORRENT PHARMS LTD EQ 0.5MG BASE A209151 001 Jun 30, 2017

AB EQ 1MG BASE A209151 002 Jun 30, 2017



ANASTROZOLE

TABLET;ORAL

ANASTROZOLE

AB ACCORD HLTHCARE 1MG A090568 001 Jun 28, 2010

AB APOTEX INC 1MG A200654 001 May 11, 2012

AB BEIJING YILING 1MG A206037 001 Nov 09, 2018

AB BOSCOGEN 1MG A078944 001 Jun 28, 2010

AB CIPLA 1MG A091164 001 Jun 28, 2010

AB FRESENIUS KABI 1MG A090088 001 Jun 28, 2010

ONCOL

AB MYLAN 1MG A091051 001 Jun 28, 2010

AB NATCO PHARMA LTD 1MG A079220 001 Jun 28, 2010

AB NEOPHARMA 1MG A090732 001 Jun 28, 2010

AB TEVA PHARMS 1MG A078058 001 Jun 28, 2010

AB WEST-WARD PHARMS 1MG A078485 001 Jun 28, 2010

INT

AB ZYDUS PHARMS USA 1MG A078921 001 Jun 28, 2010

INC

ARIMIDEX

AB +! ANI PHARMS INC 1MG N020541 001 Dec 27, 1995

ANGIOTENSIN II ACETATE

SOLUTION;INTRAVENOUS

GIAPREZA

+! LA JOLLA PHARMA EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) N209360 001 Dec 21, 2017

ANIDULAFUNGIN

POWDER;INTRAVENOUS

ERAXIS

+! VICURON 50MG/VIAL N021632 001 Feb 17, 2006

+! 100MG/VIAL N021632 002 Nov 14, 2006

APALUTAMIDE

TABLET;ORAL

ERLEADA

+! JANSSEN BIOTECH 60MG N210951 001 Feb 14, 2018

APIXABAN

TABLET;ORAL

ELIQUIS

+ BRISTOL MYERS 2.5MG N202155 001 Dec 28, 2012

SQUIBB

+! 5MG N202155 002 Dec 28, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-37(of 452)

APOMORPHINE HYDROCHLORIDE

INJECTABLE;SUBCUTANEOUS

APOKYN

+! US WORLDMEDS 30MG/3ML (10MG/ML) N021264 002 Apr 20, 2004

APRACLONIDINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

APRACLONIDINE HYDROCHLORIDE

AT AKORN INC EQ 0.5% BASE A077764 001 Mar 12, 2009

IOPIDINE

AT +! NOVARTIS PHARMS EQ 0.5% BASE N020258 001 Jul 30, 1993

CORP

+! EQ 1% BASE N019779 001 Dec 31, 1987

APREMILAST

TABLET;ORAL

OTEZLA

+ CELGENE CORP 10MG N205437 001 Mar 21, 2014

+ 20MG N205437 002 Mar 21, 2014

+! 30MG N205437 003 Mar 21, 2014

APREPITANT

CAPSULE;ORAL

APREPITANT

AB GLENMARK PHARMS SA 40MG A207777 001 Oct 12, 2017

AB 80MG A207777 002 Oct 12, 2017

AB 125MG A207777 003 Oct 12, 2017

AB SANDOZ 40MG A090999 001 Sep 24, 2012

AB 80MG A090999 002 Sep 24, 2012

AB 125MG A090999 003 Sep 24, 2012

EMEND

AB + MERCK 40MG N021549 003 Jun 30, 2006

AB + 80MG N021549 001 Mar 26, 2003

AB +! 125MG N021549 002 Mar 26, 2003



EMULSION;INTRAVENOUS

CINVANTI

+! HERON THERAPS INC 130MG/18ML (7.2MG/ML) N209296 001 Nov 09, 2017

FOR SUSPENSION;ORAL

EMEND

+! MSD MERCK CO 125MG/KIT N207865 001 Dec 17, 2015

ARFORMOTEROL TARTRATE

SOLUTION;INHALATION

BROVANA

+! SUNOVION EQ 0.015MG BASE/2ML N021912 001 Oct 06, 2006

ARGATROBAN

INJECTABLE;INJECTION

ARGATROBAN

AP AMNEAL PHARMS CO 250MG/2.5ML (100MG/ML) A206698 001 Jan 26, 2018

AP FRESENIUS KABI USA 250MG/2.5ML (100MG/ML) N201811 001 Mar 23, 2015

AP HIKMA PHARM CO LTD 250MG/2.5ML (100MG/ML) N203049 001 Jan 05, 2012

AP HOSPIRA INC 250MG/2.5ML (100MG/ML) A204120 001 Sep 21, 2016

AP MYLAN INSTITUTIONAL 250MG/2.5ML (100MG/ML) A202626 001 Jun 30, 2014

AP +! NOVARTIS PHARMS 250MG/2.5ML (100MG/ML) N020883 001 Jun 30, 2000

CORP

AP PAR STERILE 250MG/2.5ML (100MG/ML) A091665 001 Jun 30, 2014

PRODUCTS

+! HIKMA PHARM CO LTD 50MG/50ML (1MG/ML) N203049 002 Sep 30, 2016

INJECTABLE;INTRAVENOUS

ARGATROBAN IN SODIUM CHLORIDE



AP GLAND PHARMA LTD 125MG/125ML (1MG/ML) A205570 001 May 22, 2017

AP +! SANDOZ 125MG/125ML (1MG/ML) N022485 001 May 09, 2011

ARGATROBAN IN 0.9% SODIUM CHLORIDE



TEVA PHARMS USA 250MG/250ML (1MG/ML) N206769 001 Dec 15, 2014

ARGATROBAN IN SODIUM CHLORIDE

+! EAGLE PHARMS 50MG/50ML (1MG/ML) N022434 001 Jun 29, 2011

SOLUTION;INTRAVENOUS

ARGATROBAN IN SODIUM CHLORIDE

AUROBINDO PHARMA 50MG/50ML (1MG/ML) N209552 001 Nov 27, 2018

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-38(of 452)

ARGININE HYDROCHLORIDE

INJECTABLE;INJECTION

R-GENE 10

+! PHARMACIA AND 10GM/100ML N016931 001

UPJOHN

ARIPIPRAZOLE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ABILIFY MAINTENA KIT

+ OTSUKA PHARM CO LTD 300MG/VIAL N202971 001 Feb 28, 2013

+ 300MG N202971 003 Sep 29, 2014

+! 400MG/VIAL N202971 002 Feb 28, 2013



+ 400MG N202971 004 Sep 29, 2014

SOLUTION;ORAL

ARIPIPRAZOLE

AA ! AMNEAL PHARMS 1MG/ML A203906 001 Aug 14, 2015

AA APOTEX INC 1MG/ML A204094 001 Sep 30, 2015

AA LANNETT CO INC 1MG/ML A204171 001 Aug 14, 2015

TABLET;ORAL

ABILIFY

AB + OTSUKA 2MG N021436 006 Nov 15, 2002

AB +! 5MG N021436 005 Nov 15, 2002

AB +! 10MG N021436 001 Nov 15, 2002

AB + 15MG N021436 002 Nov 15, 2002

AB + 20MG N021436 003 Nov 15, 2002

AB + 30MG N021436 004 Nov 15, 2002

ARIPIPRAZOLE

AB ACCORD HLTHCARE 2MG A206251 001 Dec 07, 2016

AB 5MG A206251 002 Dec 07, 2016

AB 10MG A206251 003 Dec 07, 2016

AB 15MG A206251 004 Dec 07, 2016

AB 20MG A206251 005 Dec 07, 2016

AB 30MG A206251 006 Dec 07, 2016

AB AJANTA PHARMA LTD 2MG A206174 001 Sep 12, 2016

AB 5MG A206174 002 Sep 12, 2016

AB 10MG A206174 003 Sep 12, 2016

AB 15MG A206174 004 Sep 12, 2016

AB 20MG A206174 005 Sep 12, 2016

AB 30MG A206174 006 Sep 12, 2016

AB ALEMBIC PHARMS LTD 2MG A202101 001 Apr 28, 2015

AB 5MG A202101 002 Apr 28, 2015

AB 10MG A202101 003 Apr 28, 2015

AB 15MG A202101 004 Apr 28, 2015

AB 20MG A202101 005 Apr 28, 2015

AB 30MG A202101 006 Apr 28, 2015

AB AMNEAL PHARMS 2MG A204838 001 Jun 17, 2016

AB 5MG A204838 002 Jun 17, 2016

AB 10MG A204838 003 Jun 17, 2016

AB 15MG A204838 004 Jun 17, 2016

AB 20MG A204838 005 Jun 17, 2016

AB 30MG A204838 006 Jun 17, 2016

AB APOTEX INC 2MG A078583 001 Jul 24, 2015

AB 5MG A078583 002 Jul 24, 2015

AB 10MG A078583 003 Jul 24, 2015

AB 15MG A078583 004 Jul 24, 2015

AB 20MG A078583 005 Jul 24, 2015

AB 30MG A078583 006 Jul 24, 2015

AB AUROBINDO PHARMA 2MG A203908 001 Oct 08, 2015

LTD

AB 5MG A203908 002 Oct 08, 2015

AB 10MG A203908 003 Oct 08, 2015

AB 15MG A203908 004 Oct 08, 2015

AB 20MG A203908 005 Oct 08, 2015

AB 30MG A203908 006 Oct 08, 2015

AB BOSCOGEN 2MG A091279 001 Jan 09, 2017

AB 5MG A091279 002 Jan 09, 2017

AB 10MG A091279 003 Jan 09, 2017

AB 15MG A091279 004 Jan 09, 2017

AB 20MG A091279 005 Jan 09, 2017

AB 30MG A091279 006 Jan 09, 2017

AB HETERO LABS LTD V 2MG A205064 001 Apr 28, 2015

AB 5MG A205064 002 Apr 28, 2015

AB 10MG A205064 003 Apr 28, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-39(of 452)

ARIPIPRAZOLE

TABLET;ORAL

ARIPIPRAZOLE

AB 15MG A205064 004 Apr 28, 2015

AB 20MG A205064 005 Apr 28, 2015

AB 30MG A205064 006 Apr 28, 2015

AB MACLEODS PHARMS LTD 2MG A204111 001 Oct 07, 2016

AB 5MG A204111 002 Oct 07, 2016

AB 10MG A204111 003 Oct 07, 2016

AB 15MG A204111 004 Oct 07, 2016

AB 20MG A204111 005 Oct 07, 2016

AB 30MG A204111 006 Oct 07, 2016

AB ORCHID HLTHCARE 2MG A202683 001 May 23, 2017

AB 5MG A202683 002 May 23, 2017

AB 10MG A202683 003 May 23, 2017

AB 15MG A202683 004 May 23, 2017

AB 20MG A202683 005 May 23, 2017

AB 30MG A202683 006 May 23, 2017

AB PRINSTON INC 2MG A205363 001 Dec 04, 2017

AB 5MG A205363 002 Dec 04, 2017

AB 10MG A205363 003 Dec 04, 2017

AB 15MG A205363 004 Dec 04, 2017

AB 20MG A205363 005 Dec 04, 2017

AB 30MG A205363 006 Dec 04, 2017

AB SCIEGEN PHARMS INC 2MG A206383 001 Sep 29, 2016

AB 5MG A206383 002 Sep 29, 2016

AB 10MG A206383 003 Sep 29, 2016

AB 15MG A206383 004 Sep 29, 2016

AB 20MG A206383 005 Sep 29, 2016

AB 30MG A206383 006 Sep 29, 2016

AB TEVA PHARMS USA 2MG A078607 001 Apr 28, 2015

AB 5MG A078607 002 Apr 28, 2015

AB 10MG A078608 001 Apr 28, 2015

AB 15MG A078708 001 Apr 28, 2015

AB 20MG A078708 002 Apr 28, 2015

AB 30MG A078708 003 Apr 28, 2015

AB TORRENT PHARMS LTD 2MG A201519 001 Apr 28, 2015

AB 10MG A201519 003 Apr 28, 2015

AB 5MG A201519 002 Apr 28, 2015

AB 15MG A201519 004 Apr 28, 2015

AB 20MG A201519 005 Apr 28, 2015

AB 30MG A201519 006 Apr 28, 2015

AB ZYDUS PHARMS USA 2MG A090472 001 Jan 07, 2019

INC

AB 5MG A090472 002 Jan 07, 2019

AB 10MG A090472 003 Jan 07, 2019

AB 15MG A090472 004 Jan 07, 2019

AB 20MG A090472 005 Jan 07, 2019

AB 30MG A090472 006 Jan 07, 2019



ABILIFY MYCITE KIT

+ OTSUKA PHARM CO LTD 2MG N207202 001 Nov 13, 2017

+! 5MG N207202 002 Nov 13, 2017

+ 10MG N207202 003 Nov 13, 2017

+ 15MG N207202 004 Nov 13, 2017

+ 20MG N207202 005 Nov 13, 2017

+ 30MG N207202 006 Nov 13, 2017

TABLET, ORALLY DISINTEGRATING;ORAL

ARIPIPRAZOLE

AB ! ALEMBIC PHARMS LTD 10MG A202102 001 Apr 28, 2015

AB 15MG A202102 002 Apr 28, 2015

AB ORCHID HLTHCARE 10MG A202547 001 Dec 11, 2017

AB 15MG A202547 002 Dec 11, 2017

AB SCIEGEN PHARMS INC 10MG A207240 001 Apr 18, 2018

AB 15MG A207240 002 Apr 18, 2018

AB ZYDUS PHARMS USA 10MG A090165 001 Aug 28, 2018

INC

AB 15MG A090165 002 Aug 28, 2018

20MG A090165 003 Aug 28, 2018

30MG A090165 004 Aug 28, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-40(of 452)

ARIPIPRAZOLE LAUROXIL

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ARISTADA

+ ALKERMES INC 441MG/1.6ML (275.63MG/ML) N207533 001 Oct 05, 2015

+ 662MG/2.4ML (275.83MG/ML) N207533 002 Oct 05, 2015

+! 882MG/3.2ML (275.63MG/ML) N207533 003 Oct 05, 2015

+ 1064MG/3.9ML (272.82MG/ML) N207533 004 Jun 05, 2017

ARISTADA INITIO KIT

+ ALKERMES INC 675MG/2.4ML N209830 001 Jun 29, 2018

ARMODAFINIL

TABLET;ORAL

ARMODAFINIL

AB AUROBINDO PHARMA 50MG A206069 001 Mar 06, 2018

LTD

AB 150MG A206069 002 Mar 06, 2018

AB 250MG A206069 003 Mar 06, 2018

AB LUPIN LTD 50MG A200751 001 Nov 28, 2016

AB 150MG A200751 003 Nov 28, 2016

AB 200MG A200751 004 Nov 28, 2016

AB 250MG A200751 005 Nov 28, 2016

AB MYLAN PHARMS INC 50MG A200043 001 Jun 01, 2012

AB 150MG A200043 002 Jun 01, 2012

AB 250MG A200043 003 Jun 01, 2012

AB NATCO PHARMA LTD 50MG A202768 001 Nov 28, 2016

AB 150MG A202768 002 Nov 28, 2016

AB 200MG A202768 005 Sep 28, 2017

AB 250MG A202768 003 Nov 28, 2016

NUVIGIL

AB + CEPHALON 50MG N021875 001 Jun 15, 2007

AB + 150MG N021875 003 Jun 15, 2007

AB + 200MG N021875 005 Mar 26, 2009

AB +! 250MG N021875 004 Jun 15, 2007



ARMODAFINIL

NATCO PHARMA LTD 100MG A202768 004 Sep 28, 2017

ARSENIC TRIOXIDE

INJECTABLE;INJECTION

ARSENIC TRIOXIDE

AP AMRING PHARMS 1MG/ML A210802 001 Nov 13, 2018

AP FRESENIUS KABI USA 1MG/ML A208231 001 Aug 31, 2018

AP INGENUS PHARMS LLC 1MG/ML A209315 001 Nov 15, 2018

AP NEXUS PHARMS 1MG/ML A209780 001 Nov 15, 2018

AP ZYDUS PHARMS USA 1MG/ML A206228 001 Nov 13, 2018

INC

TRISENOX

+! CEPHALON 2MG/ML N021248 002 Oct 13, 2017

ARTEMETHER; LUMEFANTRINE

TABLET;ORAL

COARTEM

+! NOVARTIS 20MG;120MG N022268 001 Apr 07, 2009

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE



AP HOSPIRA 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG A079138 001 Jun 18, 2010

BASE/ML)

SEPTOCAINE

AP +! DEPROCO 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ N022010 001 Mar 30, 2006

0.005MG BASE/ML)

AP +! 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG N020971 001 Apr 03, 2000

BASE/ML)

ULTACAN

AP HANSAMED INC 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ A201751 001 Jul 11, 2017

0.005MG BASE/ML)

ULTACAN FORTE

AP HANSAMED INC 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG A201750 001 Jul 11, 2017

BASE/ML)

ORABLOC

+ PIERREL 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG N022466 001 Feb 26, 2010

BASE/ML)

+! 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG N022466 002 Feb 26, 2010

BASE/ML)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-41(of 452)

ASCORBIC ACID

SOLUTION;INTRAVENOUS

ASCOR

+! MCGUFF 25,000MG/50ML (500MG/ML) N209112 001 Oct 02, 2017

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K



INJECTABLE;INTRAVENOUS

INFUVITE PEDIATRIC

+! SANDOZ INC 80MG/VIAL;0.02MG/VIAL;400 N021265 001 Feb 21, 2001

IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI

AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/

VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

+! SANDOZ INC 80MG/VIAL;0.02MG/VIAL;400 N021646 001 Jan 29, 2004

IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI

AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/

VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL



ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;

VITAMIN A; VITAMIN E

FOR SOLUTION;INTRAVENOUS

M.V.I. PEDIATRIC

+! HOSPIRA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/ N018920 001 Sep 21, 2000

VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;

0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG

BASE/VIAL;0.7MG/VIAL;7MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E; VITAMIN K

INJECTABLE;INTRAVENOUS

M.V.I. ADULT

+! HOSPIRA 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N021625 001 Jan 30, 2004

G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA

L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL

;10MG/VIAL;0.15MG/VIAL

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

+! HOSPIRA 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5 N021643 001 Feb 18, 2004

ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5

ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0

.15MG/5ML

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

SODIUM SULFATE

FOR SOLUTION;ORAL

MOVIPREP

+! SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM N021881 001 Aug 02, 2006

PLENVU

+! SALIX PHARMS INC 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM N209381 001 May 04, 2018

ASENAPINE MALEATE

TABLET;SUBLINGUAL

ASENAPINE MALEATE

AB SIGMAPHARM LABS LLC EQ 5MG BASE A206107 001 Jul 17, 2018

AB EQ 10MG BASE A206107 002 Jul 17, 2018

SAPHRIS

AB + FOREST LABS LLC EQ 5MG BASE N022117 001 Aug 13, 2009

AB +! EQ 10MG BASE N022117 002 Aug 13, 2009

+ EQ 2.5 BASE N022117 003 Mar 12, 2015



ASPIRIN

CAPSULE, EXTENDED RELEASE;ORAL

DURLAZA

+! ESPERO 162.5MG N200671 001 Sep 04, 2015

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

FIORINAL

AA +! ALLERGAN SALES LLC 325MG;50MG;40MG N017534 005 Apr 16, 1986

LANORINAL

AA LANNETT 325MG;50MG;40MG A086996 002 Oct 11, 1985

TABLET;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

AA ! HIKMA INTL PHARMS 325MG;50MG;40MG A086162 002 Feb 16, 1984

AA PII 325MG;50MG;40MG A204195 001 Sep 22, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-42(of 452)

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE



CAPSULE;ORAL

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

AB MAYNE PHARMA INC 325MG;50MG;40MG;30MG A203335 001 Oct 30, 2015

AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A075231 001 Nov 30, 2001

AB STEVENS J 325MG;50MG;40MG;30MG A074951 001 Aug 31, 1998

FIORINAL W/CODEINE

AB +! ALLERGAN SALES LLC 325MG;50MG;40MG;30MG N019429 003 Oct 26, 1990



ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET;ORAL

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

SANDOZ 385MG;30MG;25MG A074654 001 Dec 31, 1996

! 770MG;60MG;50MG A074654 002 Dec 31, 1996

ASPIRIN; CARISOPRODOL

TABLET;ORAL

CARISOPRODOL AND ASPIRIN



AB ! HERITAGE PHARMS INC 325MG;200MG A089594 001 Mar 31, 1989

AB NOVAST LABS 325MG;200MG A040832 001 Jan 07, 2010

AB SANDOZ 325MG;200MG A040116 001 Apr 25, 1996



ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

TABLET;ORAL

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

AB INGENUS PHARMS NJ 325MG;200MG;16MG A040860 001 Jan 07, 2010

AB ! SANDOZ 325MG;200MG;16MG A040118 001 Apr 16, 1996



ASPIRIN; DIPYRIDAMOLE

CAPSULE, EXTENDED RELEASE;ORAL

AGGRENOX

AB +! BOEHRINGER 25MG;200MG N020884 001 Nov 22, 1999

INGELHEIM

ASPIRIN AND DIPYRIDAMOLE

AB AMNEAL PHARMS 25MG;200MG A206392 001 Mar 08, 2016

AB ANI PHARMS INC 25MG;200MG A206964 001 Jan 18, 2017

AB BARR 25MG;200MG A078804 001 Aug 14, 2009

AB DR REDDYS LABS LTD 25MG;200MG A209048 001 Oct 10, 2018

AB PAR PHARM INC 25MG;200MG A207944 001 Jan 18, 2017

AB SANDOZ INC 25MG;200MG A206739 001 Jan 18, 2017

AB SUN PHARMA GLOBAL 25MG;200MG A208572 001 Aug 21, 2018

AB ZYDUS PHARMS USA 25MG;200MG A206753 001 Aug 29, 2017

INC

ASPIRIN; METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL AND ASPIRIN

! STEVENS J 325MG;400MG A081145 001 Jan 31, 1995

ASPIRIN; OMEPRAZOLE

TABLET, DELAYED RELEASE;ORAL

YOSPRALA

+ GENUS LIFESCIENCES 81MG;40MG N205103 001 Sep 14, 2016

+! 325MG;40MG N205103 002 Sep 14, 2016



ASPIRIN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE AND ASPIRIN



AA ACTAVIS LABS FL INC 325MG;4.8355MG A090084 001 Mar 22, 2011

AA MAYNE PHARMA INC 325MG;4.8355MG A091670 001 Mar 16, 2011

PERCODAN

AA +! ENDO PHARMS 325MG;4.8355MG N007337 007 Aug 05, 2005

ATAZANAVIR SULFATE

CAPSULE;ORAL

ATAZANAVIR SULFATE

AB AUROBINDO PHARMA EQ 100MG BASE A204806 001 Jun 25, 2018

LTD

AB EQ 150MG BASE A204806 002 Jun 25, 2018

AB EQ 200MG BASE A204806 003 Jun 25, 2018

AB EQ 300MG BASE A204806 004 Jun 25, 2018

AB CIPLA EQ 100MG BASE A200626 001 Aug 09, 2018

AB EQ 150MG BASE A200626 002 Aug 09, 2018

AB EQ 200MG BASE A200626 003 Aug 09, 2018

AB EQ 300MG BASE A200626 004 Aug 09, 2018

AB MYLAN PHARMS INC EQ 150MG BASE A208177 001 Sep 24, 2018

AB EQ 200MG BASE A208177 002 Sep 24, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-43(of 452)

ATAZANAVIR SULFATE

CAPSULE;ORAL

ATAZANAVIR SULFATE

AB EQ 300MG BASE A208177 003 Sep 24, 2018

AB TEVA PHARMS USA EQ 100MG BASE A091673 001 Apr 22, 2014

AB EQ 150MG BASE A091673 002 Apr 22, 2014

AB EQ 200MG BASE A091673 003 Apr 22, 2014

AB EQ 300MG BASE A091673 004 Apr 22, 2014

REYATAZ

AB + BRISTOL MYERS EQ 150MG BASE N021567 002 Jun 20, 2003

SQUIBB

AB + EQ 200MG BASE N021567 003 Jun 20, 2003

AB +! EQ 300MG BASE N021567 004 Oct 16, 2006



POWDER;ORAL

REYATAZ

+! BRISTOL MYERS EQ 50MG BASE/PACKET N206352 001 Jun 02, 2014

SQUIBB

ATAZANAVIR SULFATE; COBICISTAT

TABLET;ORAL

EVOTAZ

+! BRISTOL-MYERS EQ 300MG BASE;150MG N206353 001 Jan 29, 2015

SQUIBB

ATENOLOL

TABLET;ORAL

ATENOLOL

AB ALVOGEN MALTA 25MG A072304 002 Jul 31, 1992

AB 50MG A072304 003 Jul 18, 1988

AB 100MG A072304 001 Jul 15, 1988

AB AUROBINDO PHARMA 25MG A078512 001 Oct 31, 2007

AB 50MG A078512 002 Oct 31, 2007

AB 100MG A078512 003 Oct 31, 2007

AB DAVA PHARMS INC 50MG A073542 001 Dec 19, 1991

AB 100MG A073543 001 Dec 19, 1991

AB IPCA LABS LTD 25MG A077877 001 Dec 27, 2006

AB 50MG A077877 002 Dec 27, 2006

AB 100MG A077877 003 Dec 27, 2006

AB MYLAN 25MG A073457 002 Apr 26, 1999

AB 50MG A073457 003 Jan 24, 1992

AB 100MG A073457 001 Jan 24, 1992

AB SANDOZ 25MG A074052 001 May 01, 1992

AB 50MG A073025 001 Sep 17, 1991

AB 100MG A073026 001 Sep 17, 1991

AB SUN PHARM INDS INC 25MG A078210 001 Jul 10, 2007

AB 50MG A078210 002 Jul 10, 2007

AB 100MG A078210 003 Jul 10, 2007

AB SUN PHARM 25MG A074499 001 Jul 30, 1997

INDUSTRIES

AB 50MG A073475 001 Mar 30, 1993

AB 100MG A073476 001 Mar 30, 1993

AB TEVA 25MG A074056 003 Jul 19, 2004

AB 50MG A074056 001 Jan 18, 1995

AB 100MG A074056 002 Jan 18, 1995

AB UNIQUE PHARM LABS 25MG A077443 001 Sep 13, 2006

AB 50MG A077443 002 Sep 13, 2006

AB 100MG A077443 003 Sep 13, 2006

AB ZYDUS PHARMS USA 25MG A076900 001 Jan 28, 2005

AB 50MG A076900 002 Jan 28, 2005

AB 100MG A076900 003 Jan 28, 2005

TENORMIN

AB + ALVOGEN MALTA 25MG N018240 004 Apr 09, 1990

AB + 50MG N018240 001



AB +! 100MG N018240 002

ATENOLOL; CHLORTHALIDONE

TABLET;ORAL

ATENOLOL AND CHLORTHALIDONE



AB ALVOGEN MALTA 50MG;25MG A072302 002 May 31, 1990

AB 100MG;25MG A072302 001 May 31, 1990

AB MYLAN 50MG;25MG A074203 001 Oct 31, 1993

AB 100MG;25MG A074203 002 Oct 31, 1993

AB SUN PHARM 50MG;25MG A073582 002 Apr 29, 1993

INDUSTRIES

AB 100MG;25MG A073582 001 Apr 29, 1993

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-44(of 452)

ATENOLOL; CHLORTHALIDONE

TABLET;ORAL

ATENOLOL AND CHLORTHALIDONE



AB WATSON LABS 50MG;25MG A073665 001 Jul 02, 1992

AB 100MG;25MG A073665 002 Jul 02, 1992

TENORETIC 100

AB +! ALVOGEN MALTA 100MG;25MG N018760 001 Jun 08, 1984

TENORETIC 50

AB + ALVOGEN MALTA 50MG;25MG N018760 002 Jun 08, 1984

ATOMOXETINE HYDROCHLORIDE

CAPSULE;ORAL

ATOMOXETINE HYDROCHLORIDE

AB APOTEX INC 10MG A078983 001 May 30, 2017

AB 18MG A078983 002 May 30, 2017

AB 25MG A078983 003 May 30, 2017

AB 40MG A078983 004 May 30, 2017

AB 60MG A078983 005 May 30, 2017

AB 80MG A078983 006 May 30, 2017

AB 100MG A078983 007 May 30, 2017

AB AUROBINDO PHARMA 10MG A079016 001 May 30, 2017

LTD

AB 18MG A079016 002 May 30, 2017

AB 25MG A079016 003 May 30, 2017

AB 40MG A079016 004 May 30, 2017

AB 60MG A079016 005 May 30, 2017

AB 80MG A079016 006 May 30, 2017

AB 100MG A079016 007 May 30, 2017

AB DR REDDYS LABS LTD 10MG A090609 001 Feb 23, 2018

AB 18MG A090609 002 Feb 23, 2018

AB 25MG A090609 003 Feb 23, 2018

AB 40MG A090609 004 Feb 23, 2018

AB 60MG A090609 005 Feb 23, 2018

AB 80MG A090609 006 Feb 23, 2018

AB 100MG A090609 007 Feb 23, 2018

AB GLENMARK PHARMS LTD 10MG A079019 001 May 30, 2017

AB 18MG A079019 002 May 30, 2017

AB 25MG A079019 003 May 30, 2017

AB 40MG A079019 004 May 30, 2017

AB 60MG A079019 005 May 30, 2017

AB 80MG A079019 006 May 30, 2017

AB 100MG A079019 007 May 30, 2017

AB TEVA PHARMS USA 10MG A079022 001 May 30, 2017

AB 18MG A079022 002 May 30, 2017

AB 25MG A079022 003 May 30, 2017

AB 40MG A079022 004 May 30, 2017

AB 60MG A079022 005 May 30, 2017

AB 80MG A079022 006 May 30, 2017

AB 100MG A079022 007 May 30, 2017

STRATTERA

AB + LILLY 10MG N021411 002 Nov 26, 2002

AB + 18MG N021411 003 Nov 26, 2002

AB + 25MG N021411 004 Nov 26, 2002

AB + 40MG N021411 005 Nov 26, 2002

AB +! 60MG N021411 006 Nov 26, 2002

AB + 80MG N021411 007 Feb 14, 2005

AB + 100MG N021411 008 Feb 14, 2005



ATORVASTATIN CALCIUM

TABLET;ORAL

ATORVASTATIN CALCIUM

AB ACCORD HLTHCARE EQ 10MG BASE A207687 001 Mar 30, 2018

AB EQ 20MG BASE A207687 002 Mar 30, 2018

AB EQ 40MG BASE A207687 003 Mar 30, 2018

AB EQ 80MG BASE A207687 004 Mar 30, 2018

AB APOTEX INC EQ 10MG BASE A090548 001 May 29, 2012

AB EQ 20MG BASE A090548 002 May 29, 2012

AB EQ 40MG BASE A090548 003 May 29, 2012

AB EQ 80MG BASE A090548 004 May 29, 2012

AB DR REDDYS LABS LTD EQ 10MG BASE A091650 001 Jul 17, 2012

AB EQ 20MG BASE A091650 002 Jul 17, 2012

AB EQ 40MG BASE A091650 003 Jul 17, 2012

AB EQ 80MG BASE A202357 001 Jul 17, 2012

AB GRAVITI PHARMS EQ 10MG BASE A209912 001 Jun 18, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-45(of 452)

ATORVASTATIN CALCIUM

TABLET;ORAL

ATORVASTATIN CALCIUM

AB
EQ 20MG BASE
A209912 002 Jun 18, 2018

AB
EQ 40MG BASE
A209912 003 Jun 18, 2018

AB
EQ 80MG BASE
A209912 004 Jun 18, 2018

AB INVAGEN PHARMS
EQ 10MG BASE
A204846 001 Jan 09, 2017

AB
EQ 20MG BASE
A204846 002 Jan 09, 2017

AB
EQ 40MG BASE
A204846 003 Jan 09, 2017

AB
EQ 80MG BASE
A204846 004 Jan 09, 2017

AB LANNETT CO INC
EQ 10MG BASE
A091624 001 Apr 05, 2013

AB
EQ 20MG BASE
A091624 002 Apr 05, 2013

AB
EQ 40MG BASE
A091624 003 Apr 05, 2013

AB
EQ 80MG BASE
A091624 004 Apr 05, 2013

AB MYLAN PHARMS INC


EQ 10MG BASE
A091226 001 May 29, 2012

AB
EQ 20MG BASE
A091226 002 May 29, 2012

AB
EQ 40MG BASE
A091226 003 May 29, 2012

AB
EQ 80MG BASE
A091226 004 May 29, 2012

AB SANDOZ INC
EQ 10MG BASE
A077575 001 May 29, 2012

AB
EQ 20MG BASE
A077575 002 May 29, 2012

AB
EQ 40MG BASE
A077575 003 May 29, 2012

AB
EQ 80MG BASE
A077575 004 May 29, 2012

AB SCIEGEN PHARMS INC


EQ 10MG BASE
A205519 001 May 19, 2016

AB
EQ 20MG BASE
A205519 002 May 19, 2016

AB
EQ 40MG BASE
A205519 003 May 19, 2016

AB
EQ 80MG BASE
A205519 004 May 19, 2016

AB SUN PHARM INDS LTD


EQ 10MG BASE
A076477 001 Nov 30, 2011

AB
EQ 20MG BASE
A076477 002 Nov 30, 2011

AB
EQ 40MG BASE
A076477 003 Nov 30, 2011

AB
EQ 80MG BASE
A076477 004 Nov 30, 2011

AB TEVA PHARMS USA


EQ 10MG BASE
A205300 001 Mar 27, 2017

AB
EQ 20MG BASE
A205300 002 Mar 27, 2017

AB
EQ 40MG BASE
A205300 003 Mar 27, 2017

AB
EQ 80MG BASE
A205300 004 Mar 27, 2017

AB THEPHARMANETWORK
EQ 10MG BASE
A209288 001 Dec 21, 2018

LLC

AB
EQ 20MG BASE
A209288 002 Dec 21, 2018

AB
EQ 40MG BASE
A209288 003 Dec 21, 2018

AB
EQ 80MG BASE
A209288 004 Dec 21, 2018

AB ZYDUS PHARMS USA


EQ 10MG BASE
A206536 001 Nov 20, 2018

INC

AB
EQ 20MG BASE
A206536 002 Nov 20, 2018

AB
EQ 40MG BASE
A206536 003 Nov 20, 2018

AB
EQ 80MG BASE
A206536 004 Nov 20, 2018

LIPITOR

AB + PFIZER
EQ 10MG BASE
N020702 001 Dec 17, 1996

AB +
EQ 20MG BASE
N020702 002 Dec 17, 1996

AB +
EQ 40MG BASE
N020702 003 Dec 17, 1996

AB +!
EQ 80MG BASE
N020702 004 Apr 07, 2000

ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL

EZETIMIBE AND ATORVASTATIN CALCIUM

WATSON LABS TEVA
EQ 10MG BASE;10MG
A206084 001 Apr 26, 2017

EQ 20MG BASE;10MG
A206084 002 Apr 26, 2017

EQ 40MG BASE;10MG
A206084 003 Apr 26, 2017

!
EQ 80MG BASE;10MG
A206084 004 Apr 26, 2017

ATOVAQUONE

SUSPENSION;ORAL

ATOVAQUONE

AB AMNEAL PHARMS 750MG/5ML


A202960 001 Mar 18, 2014

AB APOTEX INC 750MG/5ML


A209750 001 Oct 11, 2017

AB GLENMARK PHARMS 750MG/5ML


A209685 001 Nov 21, 2018

AB HETERO LABS LTD III 750MG/5ML


A210692 001 Oct 11, 2018

AB LUPIN LTD 750MG/5ML


A209105 001 Sep 11, 2018

AB PADDOCK LLC 750MG/5ML


A207833 001 Apr 28, 2017

MEPRON
AB +! GLAXOSMITHKLINE LLC 750MG/5ML
N020500 001 Feb 08, 1995

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-46(of 452)

ATOVAQUONE; PROGUANIL HYDROCHLORIDE



TABLET;ORAL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

AB GLENMARK GENERICS 62.5MG;25MG A091211 002 Apr 06, 2015

AB 250MG;100MG A091211 001 Jan 12, 2011

AB MYLAN PHARMS INC 62.5MG;25MG A202362 001 May 27, 2014

AB 250MG;100MG A202362 002 May 27, 2014

MALARONE

AB +! GLAXOSMITHKLINE 250MG;100MG N021078 001 Jul 14, 2000

MALARONE PEDIATRIC

AB + GLAXOSMITHKLINE 62.5MG;25MG N021078 002 Jul 14, 2000

ATRACURIUM BESYLATE

INJECTABLE;INJECTION

ATRACURIUM BESYLATE

AP AUROBINDO PHARMA 10MG/ML A206011 001 Apr 08, 2015
LTD
AP HOSPIRA INC 10MG/ML A090761 001 Oct 18, 2012
AP MYLAN LABS LTD 10MG/ML A206096 001 Jun 22, 2017
AP NANJING KING-FRIEND 10MG/ML A091489 001 Feb 17, 2012
AP ! WEST-WARD PHARMS 10MG/ML A074901 001 Jul 18, 1997
INT
ATRACURIUM BESYLATE PRESERVATIVE FREE
AP AUROBINDO PHARMA 10MG/ML A206010 001 Apr 08, 2015
LTD
AP HOSPIRA INC 10MG/ML A090782 001 Oct 18, 2012
AP MYLAN LABS LTD 10MG/ML A206001 001 Apr 07, 2017
AP NANJING KING-FRIEND 10MG/ML A091488 001 Feb 17, 2012
AP ! WEST-WARD PHARMS 10MG/ML A074900 001 Jul 18, 1997
INT
ATROPINE SULFATE

SOLUTION;INTRAMUSCULAR

ATROPEN

+! MERIDIAN MEDCL 0.25MG/0.3ML N017106 004 Sep 17, 2004

TECHN

+! 0.5MG/0.7ML N017106 003 Jun 19, 2003

+! 1MG/0.7ML N017106 002 Jun 19, 2003

+! 2MG/0.7ML N017106 001

SOLUTION;INTRAVENOUS

ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE

+! HOSPIRA 0.5MG/5ML (0.1MG/ML) N021146 004 Aug 17, 2017

+! 1MG/10ML (0.1MG/ML) N021146 005 Aug 17, 2017

SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL



ATROPINE SULFATE ANSYR PLASTIC SYRINGE

+! HOSPIRA 0.25MG/5ML (0.05MG/ML) N021146 002 Jul 09, 2001

+! 1MG/10ML (0.1MG/ML) N021146 003 Jul 09, 2001

SOLUTION;IV (INFUSION), INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL

ATROPINE SULFATE

+! FRESENIUS KABI USA 8MG/20ML (0.4MG/ML) N209260 001 Jan 26, 2018

SOLUTION/DROPS;OPHTHALMIC

ATROPINE SULFATE

+! AKORN 1% N206289 001 Jul 18, 2014

ISOPTO ATROPINE

ALCON LABS INC 1% N208151 001 Dec 01, 2016

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

TABLET;ORAL

MOTOFEN

+! SEBELA IRELAND LTD 0.025MG;1MG N017744 002

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

SOLUTION;ORAL

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

! WEST-WARD PHARMS 0.025MG/5ML;2.5MG/5ML A087708 001 May 03, 1982

INT

TABLET;ORAL

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE



AA ANI PHARMS INC 0.025MG;2.5MG A086727 001

AA BAYSHORE PHARMS LLC 0.025MG;2.5MG A210819 001 Nov 13, 2018

AA LANNETT 0.025MG;2.5MG A085372 001



AA MYLAN 0.025MG;2.5MG A085762 001

AA PAR PHARM 0.025MG;2.5MG A040357 001 May 02, 2000

AA UPSHER SMITH LABS 0.025MG;2.5MG A210571 001 Aug 31, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-47(of 452)

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE



TABLET;ORAL

LOMOTIL

AA +! GD SEARLE LLC 0.025MG;2.5MG N012462 001

ATROPINE; PRALIDOXIME CHLORIDE

INJECTABLE;INTRAMUSCULAR

DUODOTE

+! MERIDIAN MEDCL 2.1MG/0.7ML;600MG/2ML N021983 001 Sep 28, 2006

AURANOFIN

CAPSULE;ORAL

RIDAURA

+! SEBELA IRELAND LTD 3MG N018689 001 May 24, 1985

AVANAFIL

TABLET;ORAL

STENDRA

+ METUCHEN PHARMS 50MG N202276 001 Apr 27, 2012

+ 100MG N202276 002 Apr 27, 2012

+! 200MG N202276 003 Apr 27, 2012



AVATROMBOPAG MALEATE

TABLET;ORAL

DOPTELET

+! AKARX INC EQ 20MG BASE N210238 001 May 21, 2018

AVIBACTAM SODIUM; CEFTAZIDIME

POWDER;IV (INFUSION)

AVYCAZ

+! ALLERGAN SALES LLC EQ 0.5GM BASE;2GM/VIAL N206494 001 Feb 25, 2015

AXITINIB

TABLET;ORAL

INLYTA

+ PF PRISM CV 1MG N202324 001 Jan 27, 2012

+! 5MG N202324 002 Jan 27, 2012

AZACITIDINE

POWDER;INTRAVENOUS, SUBCUTANEOUS

AZACITIDINE

AP ACCORD HLTHCARE 100MG/VIAL A207475 001 Jul 02, 2018

AP ACTAVIS LLC 100MG/VIAL N208216 001 Apr 29, 2016

AP CIPLA 100MG/VIAL A209540 001 May 04, 2018

AP DR REDDYS LABS LTD 100MG/VIAL A201537 001 Sep 16, 2013

AP MYLAN INSTITUTIONAL 100MG/VIAL A204949 001 Apr 28, 2016

AP NATCO PHARMA LTD 100MG/VIAL A207234 001 Jun 23, 2017

AP SHILPA MEDICARE 100MG/VIAL A207518 001 Sep 29, 2016

VIDAZA

AP +! CELGENE 100MG/VIAL N050794 001 May 19, 2004

AZATHIOPRINE

TABLET;ORAL

AZASAN

AB AAIPHARMA LLC 25MG A075252 002 Feb 03, 2003

AB 50MG A075252 001 Jun 07, 1999

AB 75MG A075252 003 Feb 03, 2003

AB 100MG A075252 004 Feb 03, 2003

AZATHIOPRINE

AB AMNEAL PHARMS LLC 50MG A074069 001 Feb 16, 1996

AB MYLAN 50MG A075568 001 Dec 13, 1999

AB ZYDUS PHARMS USA 25MG A077621 002 Sep 05, 2008

AB 50MG A077621 001 Mar 15, 2007

AB 75MG A077621 003 Sep 05, 2008

AB 100MG A077621 004 Sep 05, 2008

IMURAN

AB +! SEBELA IRELAND LTD 50MG N016324 001

AZATHIOPRINE SODIUM

INJECTABLE;INJECTION

AZATHIOPRINE SODIUM

! WEST-WARD PHARMS EQ 100MG BASE/VIAL A074419 001 Mar 31, 1995

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-48(of 452)

AZELAIC ACID

AEROSOL, FOAM;TOPICAL

FINACEA

+! LEO PHARMA AS 15% N207071 001 Jul 29, 2015

CREAM;TOPICAL

AZELEX

+! AQUA PHARMS LLC 20% N020428 001 Sep 13, 1995

GEL;TOPICAL

AZELAIC ACID

AB ACTAVIS LABS UT INC 15% A208011 001 Nov 19, 2018

AB GLENMARK PHARMS 15% A204637 001 Nov 19, 2018

AB TOLMAR 15% A208724 001 Nov 19, 2018

FINACEA

AB +! LEO PHARMA AS 15% N021470 001 Dec 24, 2002

AZELASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AZELASTINE HYDROCHLORIDE

AT AKORN 0.05% A203660 001 Nov 08, 2016

AT APOTEX INC 0.05% A078621 001 Aug 03, 2009

AT ! SANDOZ INC 0.05% A202305 001 May 31, 2012

AT SUN PHARMA GLOBAL 0.05% A078738 001 Jun 21, 2010



SPRAY, METERED;NASAL

ASTELIN

AB +! MYLAN SPECIALITY LP EQ 0.125MG BASE/SPRAY N020114 001 Nov 01, 1996

ASTEPRO

AB +! MYLAN SPECIALITY LP EQ 0.1876MG BASE/SPRAY N022203 002 Aug 31, 2009

AZELASTINE HYDROCHLORIDE

AB ALKEM LABS LTD EQ 0.125MG BASE/SPRAY A208156 001 Aug 18, 2017

AB AMNEAL PHARMS LLC EQ 0.125MG BASE/SPRAY A204660 001 Aug 28, 2017

AB EQ 0.1876MG BASE/SPRAY A208199 001 Dec 15, 2017

AB APOTEX INC EQ 0.125MG BASE/SPRAY A077954 001 Apr 30, 2009

AB EQ 0.1876MG BASE/SPRAY A201846 001 Aug 31, 2012

AB BRECKENRIDGE PHARM EQ 0.125MG BASE/SPRAY A090176 001 Jul 28, 2015

AB PERRIGO ISRAEL EQ 0.1876MG BASE/SPRAY A202743 001 May 08, 2014

AB SUN PHARMA GLOBAL EQ 0.125MG BASE/SPRAY A090423 001 May 23, 2012

AB UPSHER SMITH LABS EQ 0.125MG BASE/SPRAY A202609 001 Mar 17, 2017

AB WEST-WARD PHARMS EQ 0.125MG BASE/SPRAY A091444 001 Oct 24, 2014

INT

AB EQ 0.1876MG BASE/SPRAY A207243 001 Sep 22, 2017

AB ZYDUS PHARMS USA EQ 0.125MG BASE/SPRAY A091409 001 Aug 14, 2017

INC

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

DYMISTA

+! MYLAN SPECIALITY LP EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY N202236 001 May 01, 2012

AZILSARTAN KAMEDOXOMIL

TABLET;ORAL

EDARBI

+ ARBOR PHARMS LLC EQ 40MG MEDOXOMIL N200796 001 Feb 25, 2011

+! EQ 80MG MEDOXOMIL N200796 002 Feb 25, 2011

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

TABLET;ORAL

EDARBYCLOR

+ ARBOR PHARMS LLC EQ 40MG MEDOXOMIL;12.5MG N202331 001 Dec 20, 2011

+! EQ 40MG MEDOXOMIL;25MG N202331 002 Dec 20, 2011

AZITHROMYCIN

FOR SUSPENSION;ORAL

AZITHROMYCIN

AB AMNEAL PHARMS LLC EQ 100MG BASE/5ML A205666 001 Jul 19, 2018

AB EQ 200MG BASE/5ML A205666 002 Jul 19, 2018

AB AUROBINDO PHARMA EQ 100MG BASE/5ML A209201 001 Oct 09, 2018

LTD

AB EQ 200MG BASE/5ML A209201 002 Oct 09, 2018

AB EPIC PHARMA LLC EQ 100MG BASE/5ML A207531 001 Apr 09, 2018

AB EQ 200MG BASE/5ML A207531 002 Apr 09, 2018

AB LUPIN LTD EQ 100MG BASE/5ML A065488 001 May 15, 2015

AB EQ 200MG BASE/5ML A065488 002 May 15, 2015

AB PLIVA EQ 100MG BASE/5ML A065246 002 Jul 05, 2006

AB EQ 200MG BASE/5ML A065246 001 Jul 05, 2006

AB TEVA PHARMS EQ 100MG BASE/5ML A065419 001 Jun 24, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-49(of 452)

AZITHROMYCIN

FOR SUSPENSION;ORAL

AZITHROMYCIN

AB EQ 200MG BASE/5ML A065419 002 Jun 24, 2008

AB ZYDUS WORLDWIDE EQ 100MG BASE/5ML A211147 001 Jul 31, 2018

AB EQ 200MG BASE/5ML A211147 002 Jul 31, 2018

ZITHROMAX

AB + PFIZER EQ 100MG BASE/5ML N050710 001 Oct 19, 1995

AB +! EQ 200MG BASE/5ML N050710 002 Oct 19, 1995



+! EQ 1GM BASE/PACKET N050693 001 Sep 28, 1994

INJECTABLE;INJECTION

AZITHROMYCIN

AP AUROBINDO PHARMA EQ 500MG BASE/VIAL A203294 001 Jun 19, 2015

LTD

AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A065179 001 Dec 13, 2005

AP GLAND PHARMA LTD EQ 500MG BASE/VIAL A065501 001 Nov 09, 2009

AP HAINAN POLY PHARM EQ 500MG BASE/VIAL A203412 001 Oct 09, 2018

AP HOSPIRA EQ 500MG BASE/VIAL A065500 001 Jun 26, 2009

AP EQ 500MG BASE/VIAL A065511 001 Jun 26, 2009

AP MYLAN ASI EQ 500MG BASE/VIAL A065506 001 Mar 24, 2009

AP MYLAN LABS LTD EQ 500MG BASE/VIAL A204732 001 Jan 26, 2017

AP SUN PHARM INDS LTD EQ 500MG BASE/VIAL A090923 001 Apr 02, 2013

ZITHROMAX

AP +! PFIZER EQ 500MG BASE/VIAL N050733 001 Jan 30, 1997

SOLUTION/DROPS;OPHTHALMIC

AZASITE

+! OAK PHARMS INC 1% N050810 001 Apr 27, 2007

TABLET;ORAL

AZITHROMYCIN

AB AUROBINDO PHARMA EQ 250MG BASE A207370 001 Jul 05, 2018

LTD

AB EQ 500MG BASE A207398 001 Jul 05, 2018

AB BIONPHARMA INC EQ 600MG BASE A209999 001 Dec 26, 2018

AB CSPC OUYI PHARM CO EQ 500MG BASE A208249 001 Oct 25, 2018

AB EQ 600MG BASE A207566 001 Sep 24, 2018

AB LUPIN LTD EQ 250MG BASE A065398 001 May 15, 2015

AB EQ 500MG BASE A065399 001 May 15, 2015

AB EQ 600MG BASE A065400 001 May 15, 2015

AB MYLAN EQ 600MG BASE A065360 001 Jan 08, 2007

AB PLIVA EQ 250MG BASE A065225 001 Nov 14, 2005

AB EQ 500MG BASE A065223 001 Nov 14, 2005

AB EQ 600MG BASE A065218 001 Nov 14, 2005

AB SANDOZ EQ 250MG BASE A065211 001 Nov 14, 2005

AB EQ 500MG BASE A065212 001 Nov 14, 2005

AB EQ 600MG BASE A065209 001 Nov 14, 2005

AB SUNSHINE LAKE EQ 250MG BASE A209045 001 Dec 07, 2018

AB EQ 500MG BASE A209044 001 Dec 07, 2018

AB EQ 600MG BASE A209043 001 Dec 06, 2018

AB TEVA EQ 250MG BASE A065153 001 Nov 14, 2005

AB EQ 500MG BASE A065193 001 Nov 14, 2005

AB EQ 600MG BASE A065150 001 Nov 14, 2005

AB WOCKHARDT EQ 250MG BASE A065404 001 Feb 11, 2008

AB EQ 500MG BASE A065405 001 Feb 11, 2008

AB EQ 600MG BASE A065302 003 Feb 11, 2008

ZITHROMAX

AB + PFIZER EQ 250MG BASE N050711 001 Jul 18, 1996

AB + EQ 500MG BASE N050784 001 May 24, 2002

AB +! EQ 600MG BASE N050730 001 Jun 12, 1996



AZTREONAM

FOR SOLUTION;INHALATION

CAYSTON

+! GILEAD 75MG/VIAL N050814 001 Feb 22, 2010

INJECTABLE;INJECTION

AZACTAM

AP +! BRISTOL MYERS 1GM/VIAL N050580 002 Dec 31, 1986

SQUIBB

AP +! 2GM/VIAL N050580 003 Dec 31, 1986

AZTREONAM

AP FRESENIUS KABI USA 1GM/VIAL A065439 002 Jun 18, 2010

AP 2GM/VIAL A065439 003 Jun 18, 2010



AZACTAM IN PLASTIC CONTAINER

+! BRISTOL MYERS 20MG/ML N050632 002 May 24, 1989

SQUIBB

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-50(of 452)

AZTREONAM

INJECTABLE;INJECTION

AZACTAM IN PLASTIC CONTAINER

+!
40MG/ML N050632 001 May 24, 1989
AZTREONAM

FRESENIUS KABI USA
500MG/VIAL A065439 001 Jun 18, 2010
BACITRACIN

INJECTABLE;INJECTION

BACIIM

AP X GEN PHARMS
50,000 UNITS/VIAL A064153 001 May 09, 1997
BACITRACIN

AP AKORN 50,000 UNITS/VIAL A206719 001 Oct 20, 2017
AP FRESENIUS KABI USA 50,000 UNITS/VIAL A065116 001 Dec 03, 2002
AP ! PHARMACIA AND 50,000 UNITS/VIAL A060733 002
UPJOHN
AP XELLIA PHARMS APS 50,000 UNITS/VIAL A203177 001 Aug 25, 2014
OINTMENT;OPHTHALMIC

BACITRACIN

! PERRIGO CO
500 UNITS/GM A061212 001
TENNESSEE

BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

! PERRIGO CO 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000


A062166 002

TENNESSEE UNITS/GM

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

AT AKORN 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000


A065213 001 Jul 25, 2012

UNITS/GM

AT ! BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000


A064068 001 Oct 30, 1995

UNITS/GM

OINTMENT;TOPICAL

CORTISPORIN

+! MONARCH PHARMS 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000
N050168 002 May 04, 1984

UNITS/GM

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC



AT AKORN 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A065088 001 Feb 06, 2004

UNITS/GM

AT ! BAUSCH AND LOMB 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000


A064064 001 Oct 30, 1995

UNITS/GM

AT PERRIGO CO 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000


A060764 002

TENNESSEE UNITS/GM

NEOSPORIN

AT + CASPER PHARMA LLC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
N050417 001

UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN ZINC AND POLYMYXIN B SULFATE



AT AKORN 500 UNITS/GM;10,000 UNITS/GM
A064028 001 Jan 30, 1995

AT ! BAUSCH AND LOMB 500 UNITS/GM;10,000 UNITS/GM


A064046 001 Jan 26, 1995

AT PERRIGO CO 500 UNITS/GM;10,000 UNITS/GM


A065022 001 Feb 27, 2002

TENNESSEE
BACLOFEN

INJECTABLE;INTRATHECAL

BACLOFEN

AP EMERALD INTL LTD
0.05MG/ML
A091193 001 May 03, 2016

AP
0.5MG/ML
A091193 002 May 03, 2016

AP
2MG/ML
A091193 003 May 03, 2016

AP MYLAN LABS LTD


0.5MG/ML
A209592 001 Mar 21, 2018

AP
1MG/ML
A209594 001 Mar 06, 2018

AP
2MG/ML
A209592 002 Mar 21, 2018

GABLOFEN

AP PIRAMAL CRITICAL
0.05MG/ML
N022462 001 Nov 19, 2010

AP
0.5MG/ML
N022462 002 Nov 19, 2010

AP +!
1MG/ML
N022462 004 Jun 22, 2012

AP
2MG/ML
N022462 003 Nov 19, 2010

LIORESAL

AP +! SAOL THERAPS RES
0.05MG/ML
N020075 003 Nov 07, 1996

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-51(of 452)

BACLOFEN

INJECTABLE;INTRATHECAL

LIORESAL

AP +! 0.5MG/ML N020075 001 Jun 17, 1992

AP +! 2MG/ML N020075 002 Jun 17, 1992



TABLET;ORAL

BACLOFEN

AB IMPAX LABS 10MG A077971 001 Oct 26, 2007

AB 20MG A077971 002 Oct 26, 2007

AB IVAX SUB TEVA 10MG A072234 001 Jul 21, 1988

PHARMS

AB ! 20MG A072235 001 Jul 21, 1988

AB LANNETT CO INC 10MG A077241 002 Jul 06, 2007

AB 20MG A077241 001 Dec 20, 2005

AB MYLAN 20MG A077121 002 Jul 29, 2005

AB MYLAN PHARMS INC 10MG A090334 001 Feb 18, 2010

AB 20MG A090334 002 Feb 18, 2010

AB NORTHSTAR HLTHCARE 10MG A078401 002 Sep 18, 2009

AB 20MG A078401 001 Sep 18, 2009

AB OXFORD PHARMS 10MG A077088 002 Oct 31, 2007

AB 20MG A077088 001 Oct 31, 2007

AB RUBICON RES PVT LTD 10MG A209102 002 Nov 28, 2017

AB 20MG A209102 003 Nov 28, 2017

AB SUN PHARM INDS INC 10MG A077862 001 Aug 14, 2006

AB 20MG A077862 002 Aug 14, 2006

AB USL PHARMA 10MG A074584 001 Aug 19, 1996

AB 20MG A074584 002 Aug 19, 1996

AB VINTAGE PHARMS 10MG A077068 002 Aug 30, 2005

AB 20MG A077068 001 Aug 30, 2005

AB ZYDUS WORLDWIDE 10MG A211659 001 Nov 23, 2018

AB 20MG A211659 002 Nov 23, 2018



RUBICON RES PVT LTD 5MG A209102 001 Nov 28, 2017

BALOXAVIR MARBOXIL

TABLET;ORAL

XOFLUZA

+ GENENTECH INC 20MG N210854 001 Oct 24, 2018

+! 40MG N210854 002 Oct 24, 2018

BALSALAZIDE DISODIUM

CAPSULE;ORAL

BALSALAZIDE DISODIUM

AB APOTEX INC 750MG A077883 001 Dec 28, 2007

AB MYLAN 750MG A077807 001 Dec 28, 2007

AB WEST-WARD PHARMS 750MG A077806 001 Dec 28, 2007

INT

COLAZAL

AB +! VALEANT PHARMS INTL 750MG N020610 001 Jul 18, 2000

TABLET;ORAL

BALSALAZIDE DISODIUM

AB PAR PHARM INC 1.1GM A206336 001 Sep 08, 2015

GIAZO

AB +! VALEANT PHARMS INTL 1.1GM N022205 001 Feb 03, 2012

BARICITINIB

TABLET;ORAL

OLUMIANT

+! ELI LILLY AND CO 2MG N207924 001 May 31, 2018

BARIUM SULFATE

FOR SUSPENSION;ORAL

E-Z-HD

+! BRACCO 98% (334GM/BOT) N208036 001 Jan 11, 2016

E-Z-PAQUE

+! BRACCO 96% (169GM/BOT) N208036 002 Apr 07, 2017

PASTE;ORAL

VARIBAR PUDDING

BRACCO 40% N208844 001 Oct 14, 2016

SUSPENSION;ORAL

LIQUID E-Z-PAQUE

+! BRACCO 60% (213GM/BOT) N208143 003 Mar 01, 2017

READI-CAT 2

+! BRACCO 2% (9GM/BOT) N208143 001 Jan 15, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-52(of 452)

BARIUM SULFATE

SUSPENSION;ORAL

READI-CAT 2 SMOOTHIES

+! BRACCO 2% (9GM/BOT) N208143 002 Jan 15, 2016

TAGITOL V

+! BRACCO 40% (8GM/BOT) N208143 005 Aug 04, 2017

VARIBAR HONEY

+! BRACCO 40% (100GM/250ML) N208143 007 Mar 26, 2018

VARIBAR NECTAR

+! BRACCO 40% (96GM/240ML) N208143 004 Jul 07, 2017

VARIBAR THIN HONEY

+! BRACCO 40% (100GM/250ML) N208143 006 Jan 23, 2018

BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED

TABLET;ORAL

DUAVEE

+! WYETH PHARMS EQ 20MG BASE;0.45MG N022247 001 Oct 03, 2013

BECLOMETHASONE DIPROPIONATE

AEROSOL, METERED;INHALATION

QVAR REDIHALER

+ NORTON WATERFORD 0.04MG/INH N207921 001 Aug 03, 2017

+ 0.08MG/INH N207921 002 Aug 03, 2017

AEROSOL, METERED;NASAL

QNASL

+ TEVA BRANDED PHARM 0.04MG/ACTUATION N202813 002 Dec 17, 2014

+! 0.08MG/ACTUATION N202813 001 Mar 23, 2012

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED;NASAL

BECONASE AQ

+! GLAXOSMITHKLINE EQ 0.042MG DIPROP/SPRAY N019389 001 Jul 27, 1987

BEDAQUILINE FUMARATE

TABLET;ORAL

SIRTURO

+! JANSSEN THERAP EQ 100MG BASE N204384 001 Dec 28, 2012

BELINOSTAT

POWDER;INTRAVENOUS

BELEODAQ

+! SPECTRUM PHARMS 500MG/VIAL N206256 001 Jul 03, 2014

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE

AB AMNEAL PHARMS 5MG A076820 001 Feb 03, 2006

AB 10MG A076820 002 Feb 03, 2006

AB 20MG A076820 003 Feb 03, 2006

AB 40MG A076820 004 Feb 03, 2006

AB APOTEX INC 5MG A077128 001 Mar 08, 2006

AB 10MG A077128 002 Mar 08, 2006

AB 20MG A077128 003 Mar 08, 2006

AB 40MG A077128 004 Mar 08, 2006

AB AUROBINDO PHARMA 10MG A078212 001 May 22, 2008

AB 20MG A078212 002 May 22, 2008

AB 40MG A078212 003 May 22, 2008

AB CASI PHARMS INC 5MG A076402 001 Feb 11, 2004

AB 10MG A076402 002 Feb 11, 2004

AB 20MG A076402 003 Feb 11, 2004

AB 40MG A076402 004 Feb 11, 2004

AB IVAX SUB TEVA 5MG A076333 001 Feb 11, 2004

PHARMS

AB 10MG A076333 002 Feb 11, 2004

AB 20MG A076333 003 Feb 11, 2004

AB 40MG A076333 004 Feb 11, 2004

AB MYLAN 5MG A076430 001 Feb 11, 2004

AB 10MG A076430 002 Feb 11, 2004

AB 20MG A076430 003 Feb 11, 2004

AB 40MG A076430 004 Feb 11, 2004

AB PRINSTON INC 5MG A076118 001 Feb 11, 2004

AB 10MG A076118 002 Feb 11, 2004

AB 20MG A076118 003 Feb 11, 2004

AB 40MG A076118 004 Feb 11, 2004

AB SUN PHARM INDS LTD 5MG A076344 001 Feb 11, 2004

AB 10MG A076344 002 Feb 11, 2004



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-53(of 452)

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE

AB 20MG A076344 003 Feb 11, 2004

AB 40MG A076344 004 Feb 11, 2004

AB TEVA 5MG A076211 001 Feb 11, 2004

AB 10MG A076211 002 Feb 11, 2004

AB 20MG A076211 003 Feb 11, 2004

AB 40MG A076211 004 Feb 11, 2004

AB ZYDUS PHARMS USA 5MG A078848 001 May 23, 2008

AB 10MG A078848 002 May 23, 2008

AB 20MG A078848 003 May 23, 2008

AB 40MG A078848 004 May 23, 2008

LOTENSIN

AB + US PHARMS HOLDINGS 5MG N019851 001 Jun 25, 1991

I

AB + 10MG N019851 002 Jun 25, 1991

AB + 20MG N019851 003 Jun 25, 1991

AB +! 40MG N019851 004 Jun 25, 1991



BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE



AB APOTEX INC 5MG;6.25MG A078794 001 Aug 21, 2014

AB 10MG;12.5MG A078794 002 Aug 21, 2014

AB 20MG;12.5MG A078794 003 Aug 21, 2014

AB 20MG;25MG A078794 004 Aug 21, 2014

AB MYLAN 5MG;6.25MG A076688 001 Feb 11, 2004

AB 10MG;12.5MG A076688 002 Feb 11, 2004

AB 20MG;12.5MG A076688 003 Feb 11, 2004

AB 20MG;25MG A076688 004 Feb 11, 2004

AB SANDOZ 5MG;6.25MG A076631 001 Feb 11, 2004

AB 10MG;12.5MG A076631 002 Feb 11, 2004

AB 20MG;12.5MG A076631 003 Feb 11, 2004

AB 20MG;25MG A076631 004 Feb 11, 2004

LOTENSIN HCT

AB + US PHARMS HOLDINGS 10MG;12.5MG N020033 002 May 19, 1992

I

AB + 20MG;12.5MG N020033 004 May 19, 1992

AB +! 20MG;25MG N020033 003 May 19, 1992



BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION)

BENDAMUSTINE HYDROCHLORIDE

AP ACCORD HLTHCARE 25MG/VIAL A205574 001 May 19, 2016

AP 100MG/VIAL A205574 002 May 19, 2016

AP BRECKENRIDGE PHARM 25MG/VIAL A205447 001 Dec 29, 2016

AP 100MG/VIAL A205447 002 Dec 29, 2016

AP GLENMARK PHARMS LTD 25MG/VIAL A204771 001 Mar 24, 2016

AP 100MG/VIAL A204771 002 Mar 24, 2016

AP MYLAN LABS LTD 25MG/VIAL A204104 001 Apr 26, 2018

AP 100MG/VIAL A204104 002 Apr 26, 2018

TREANDA

AP +! CEPHALON 25MG/VIAL N022249 002 May 01, 2009

AP +! 100MG/VIAL N022249 001 Mar 20, 2008



SOLUTION;IV (INFUSION)

BELRAPZO

+! EAGLE PHARMS 100MG/4ML (25MG/ML) N205580 001 May 15, 2018

BENDEKA

+! EAGLE PHARMS 100MG/4ML (25MG/ML) N208194 001 Dec 07, 2015

BENDROFLUMETHIAZIDE; NADOLOL

TABLET;ORAL

CORZIDE

AB + KING PHARMS LLC 5MG;40MG N018647 001 May 25, 1983

AB +! 5MG;80MG N018647 002 May 25, 1983

NADOLOL AND BENDROFLUMETHIAZIDE



AB IMPAX LABS 5MG;40MG A077833 001 Mar 30, 2007

AB 5MG;80MG A077833 002 Mar 30, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-54(of 452)

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM



SOLUTION/DROPS;OPHTHALMIC

ALTAFLUOR BENOX

+! ALTAIRE PHARMS INC 0.4%;0.25% N208582 001 Dec 14, 2017

BENZNIDAZOLE

TABLET;ORAL

BENZNIDAZOLE

+ CHEMO RESEARCH SL 12.5MG N209570 001 Aug 29, 2017

+! 100MG N209570 002 Aug 29, 2017



BENZONATATE

CAPSULE;ORAL

BENZONATATE

AA AIPING PHARM INC 100MG A210562 001 Nov 09, 2018

AA 150MG A210562 002 Nov 09, 2018

AA 200MG A210562 003 Nov 09, 2018

AA APOTEX INC 100MG A091310 001 Jan 16, 2015

AA 200MG A091310 002 Jan 16, 2015

AA BIONPHARMA INC 100MG A081297 001 Jan 29, 1993

AA 200MG A081297 002 Oct 30, 2007

AA CSPC NBP PHARM CO 100MG A202765 002 Aug 25, 2017

AA 200MG A202765 001 Jul 31, 2015

AA MIKART 100MG A040851 001 Nov 09, 2009

AA 150MG A040851 002 Nov 09, 2009

AA 200MG A040851 003 Nov 09, 2009

AA ORIT LABS LLC 100MG A040682 001 Jul 30, 2007

AA 200MG A040682 002 Jul 30, 2007

AA PURACAP PHARM LLC 100MG A206948 001 Dec 19, 2018

AA 200MG A206948 002 Dec 19, 2018

AA STRIDES PHARMA 100MG A091133 001 Jul 30, 2015

AA 200MG A091133 002 Jul 30, 2015

AA SUN PHARM INDS INC 100MG A040587 001 Mar 19, 2008

AA 200MG A040587 002 Mar 19, 2008

AA ! THEPHARMANETWORK 100MG A040627 001 Mar 30, 2007

LLC

AA ! 150MG A201209 001 Sep 24, 2014

AA ! 200MG A040749 001 Jul 25, 2007

AA ZYDUS PHARMS USA 100MG A040597 001 Jun 08, 2007

AA 200MG A040597 002 Jun 08, 2007

TESSALON

AA + PFIZER 100MG N011210 001

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

ACANYA

AB +! DOW PHARM 2.5%;EQ 1.2% BASE N050819 001 Oct 23, 2008

BENZACLIN

AB +! VALEANT BERMUDA 5%;EQ 1% BASE N050756 001 Dec 21, 2000

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE



AB ACTAVIS LABS UT INC 2.5%;EQ 1.2% BASE A205128 001 Jun 19, 2015

AB MYLAN PHARMS INC 5%;EQ 1% BASE A065443 001 Aug 11, 2009

AB PERRIGO ISRAEL 5%;EQ 1% BASE A202440 001 Sep 21, 2015

AB 5%;1.2% A090979 001 Jun 26, 2012

AB TARO 3.75%;EQ 1.2% BASE A208683 001 Jun 05, 2018

AB 5%;EQ 1% BASE A208776 001 May 25, 2018

AB TARO PHARMS 5%;1.2% A206218 001 Dec 15, 2017

AB TOLMAR 5%;EQ 1% BASE A204087 001 Jun 27, 2017

AB 5%;1.2% A203688 001 Aug 25, 2016

AB ZYDUS PHARMS USA 5%;1.2% A210794 001 Dec 28, 2018

INC

DUAC

AB +! STIEFEL 5%;1.2% N050741 001 Aug 26, 2002

ONEXTON

AB +! DOW PHARM 3.75%;EQ 1.2% BASE N050819 002 Nov 24, 2014

BENZOYL PEROXIDE; ERYTHROMYCIN

GEL;TOPICAL

BENZAMYCIN

AB +! VALEANT INTL 5%;3% N050557 001 Oct 26, 1984

ERYTHROMYCIN AND BENZOYL PEROXIDE



AB LYNE 5%;3% A065385 001 Sep 18, 2015

AB TOLMAR 5%;3% A065112 001 Mar 29, 2004



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-55(of 452)

BENZOYL PEROXIDE; ERYTHROMYCIN



GEL;TOPICAL

AKTIPAK

+! CUTANEA 5%;3% N050769 001 Nov 27, 2000

BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL

BENZPHETAMINE HYDROCHLORIDE

AA EMCURE PHARMS LTD 50MG A202061 001 Jan 27, 2012

AA EPIC PHARMA LLC 50MG A090346 001 Dec 15, 2015

AA ! KVK TECH 50MG A090968 001 Jul 20, 2010

AA MIKART 50MG A090473 002 Sep 15, 2010

AA SPECGX LLC 50MG A040773 001 Apr 25, 2007

AA TWI PHARMS 50MG A040578 001 Apr 17, 2006

MIKART 25MG A090473 001 Sep 15, 2010



BENZTROPINE MESYLATE

INJECTABLE;INJECTION

BENZTROPINE MESYLATE

AP FRESENIUS KABI USA 1MG/ML A090233 001 Jul 28, 2009

AP HIKMA FARMACEUTICA 1MG/ML A090287 001 Aug 31, 2009

AP LUITPOLD 1MG/ML A091152 001 Mar 29, 2010

AP NAVINTA LLC 1MG/ML A091525 001 Feb 05, 2013

COGENTIN

AP +! OAK PHARMS AKORN 1MG/ML N012015 001

TABLET;ORAL

BENZTROPINE MESYLATE

AA ASPEN GLOBAL INC 0.5MG A204713 001 Apr 14, 2015

AA 1MG A204713 002 Apr 14, 2015

AA 2MG A204713 003 Apr 14, 2015

AA EPIC PHARMA LLC 0.5MG A072264 001 Feb 27, 1989

AA 1MG A072265 001 Feb 27, 1989

AA 2MG A072266 001 Feb 27, 1989

AA INVAGEN PHARMS 0.5MG A090294 001 Mar 29, 2010

AA 1MG A090294 002 Mar 29, 2010

AA 2MG A090294 003 Mar 29, 2010

AA LEADING PHARMA LLC 0.5MG A090168 001 Nov 28, 2012

AA 1MG A090168 002 Nov 28, 2012

AA 2MG A090168 003 Nov 28, 2012

AA PLIVA 0.5MG A089058 001 Aug 10, 1988

AA 1MG A089059 001 Aug 10, 1988

AA 2MG A089060 001 Aug 10, 1988

AA ! USL PHARMA 0.5MG A040103 001 Dec 12, 1996

AA ! 1MG A040103 002 Dec 12, 1996

AA ! 2MG A040103 003 Dec 12, 1996

AA VINTAGE 0.5MG A040715 001 Aug 27, 2007

AA 1MG A040715 002 Aug 27, 2007

AA 2MG A040715 003 Aug 27, 2007

OXFORD PHARMS 0.5MG A040706 002 Feb 14, 2008



1MG A040706 003 Feb 14, 2008

BENZYL ALCOHOL

LOTION;TOPICAL

ULESFIA

+! SHIONOGI INC 5% N022129 001 Apr 09, 2009

BENZYLPENICILLOYL POLYLYSINE

INJECTABLE;INJECTION

PRE-PEN

+! ALLERQUEST 60UMOLAR N050114 001

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC

BEPREVE

+! BAUSCH AND LOMB INC 1.5% N022288 001 Sep 08, 2009

BERACTANT

SUSPENSION;INTRATRACHEAL

SURVANTA

+! ABBVIE 25MG/ML N020032 001 Jul 01, 1991

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-56(of 452)

BESIFLOXACIN HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

BESIVANCE

+! BAUSCH AND LOMB EQ 0.6% BASE N022308 001 May 28, 2009

BETAINE

FOR SOLUTION;ORAL

CYSTADANE

+! ORPHAN EUROPE 1GM/SCOOPFUL N020576 001 Oct 25, 1996

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE



AB LUITPOLD 3MG/ML;EQ 3MG BASE/ML A090747 001 Jul 31, 2009

CELESTONE SOLUSPAN

AB +! MERCK SHARP DOHME 3MG/ML;EQ 3MG BASE/ML N014602 001

BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ACTAVIS MID EQ 0.05% BASE A070885 001 Feb 03, 1987

ATLANTIC

AB +! FOUGERA PHARMS EQ 0.05% BASE N019137 001 Jun 26, 1984

AB G AND W LABS INC EQ 0.05% BASE A210217 001 Oct 12, 2018

AB TARO EQ 0.05% BASE A073552 001 Apr 30, 1992

AB ZYDUS PHARMS USA EQ 0.05% BASE A208885 001 Jan 11, 2019

INC

CREAM, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ANDA REPOSITORY EQ 0.05% BASE A076603 001 Jan 23, 2004

AB FOUGERA PHARMS EQ 0.05% BASE A076215 001 Dec 09, 2003

AB GLENMARK GENERICS EQ 0.05% BASE A078930 001 Sep 23, 2008

AB PERRIGO NEW YORK EQ 0.05% BASE A076592 001 Dec 09, 2003

AB TARO EQ 0.05% BASE A076543 001 Dec 09, 2003

DIPROLENE AF

AB +! MERCK SHARP DOHME EQ 0.05% BASE N019555 001 Apr 27, 1987

GEL, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ! FOUGERA PHARMS EQ 0.05% BASE A075276 001 May 13, 2003

AB TARO EQ 0.05% BASE A076508 001 Dec 02, 2003



LOTION;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ACTAVIS MID EQ 0.05% BASE A070281 001 Jul 31, 1985

ATLANTIC

AB ! FOUGERA PHARMS INC EQ 0.05% BASE A070275 001 Aug 12, 1985

AB G AND W LABS INC EQ 0.05% BASE A071467 001 Aug 10, 1987

AB HI-TECH PHARMACAL EQ 0.05% BASE A209896 001 Feb 06, 2018

AB PERRIGO NEW YORK EQ 0.05% BASE A072538 001 Jan 31, 1990

LOTION, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB FOUGERA PHARMS EQ 0.05% BASE A077111 001 May 21, 2007

AB ! TARO EQ 0.05% BASE A077477 001 May 21, 2007

AB TELIGENT PHARMA INC EQ 0.05% BASE A206389 001 Feb 13, 2018

OINTMENT;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ACTAVIS MID EQ 0.05% BASE A071012 001 Feb 03, 1987

ATLANTIC

AB +! FOUGERA PHARMS INC EQ 0.05% BASE N019141 001 Sep 04, 1984

AB TARO EQ 0.05% BASE A074271 001 Sep 15, 1994

OINTMENT, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

AB ACTAVIS MID EQ 0.05% BASE A074304 001 Aug 31, 1995

ATLANTIC

AB FOUGERA PHARMS EQ 0.05% BASE A075373 001 Jun 22, 1999

AB TARO EQ 0.05% BASE A076753 001 Oct 12, 2004

AB TELIGENT PHARMA INC EQ 0.05% BASE A206118 001 Nov 09, 2017

DIPROLENE

AB +! MERCK SHARP DOHME EQ 0.05% BASE N018741 001 Jul 27, 1983

SPRAY;TOPICAL

SERNIVO

+! PROMIUS PHARMA LLC EQ 0.05% BASE/SPRAY N208079 001 Feb 05, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-57(of 452)

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE



AEROSOL, FOAM;TOPICAL

ENSTILAR

+! LEO PHARMA AS 0.064%;0.005% N207589 001 Oct 16, 2015

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE

OINTMENT;TOPICAL

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE



AB PERRIGO ISRAEL 0.064%;0.005% A200174 001 Dec 12, 2014

AB TOLMAR 0.064%;0.005% A201615 001 Jan 14, 2013

TACLONEX

AB +! LEO PHARMA AS 0.064%;0.005% N021852 001 Jan 09, 2006

SUSPENSION;TOPICAL

TACLONEX

+! LEO PHARMA AS 0.064%;0.005% N022185 001 May 09, 2008

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM;TOPICAL

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE



AB ACTAVIS MID EQ 0.05% BASE;1% A076002 001 Aug 02, 2002

ATLANTIC

AB FOUGERA PHARMS EQ 0.05% BASE;1% A075502 001 Jun 05, 2001

AB GLENMARK PHARMS EQ 0.05% BASE;1% A202894 001 Oct 30, 2015

AB TARO EQ 0.05% BASE;1% A075673 001 May 29, 2001

LOTRISONE

AB +! MERCK SHARP DOHME EQ 0.05% BASE;1% N018827 001 Jul 10, 1984

LOTION;TOPICAL

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE



AB FOUGERA PHARMS EQ 0.05% BASE;1% A076516 001 Jun 16, 2005

AB TARO EQ 0.05% BASE;1% A076493 001 Jul 28, 2004

LOTRISONE

AB +! MERCK SHARP DOHME EQ 0.05% BASE;1% N020010 001 Dec 08, 2000

BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL

BETAMETHASONE VALERATE

AB PERRIGO UK FINCO 0.12% A078337 001 Nov 26, 2012

AB RICONPHARMA LLC 0.12% A207144 001 May 24, 2017

AB TARO PHARM 0.12% A208204 001 May 24, 2017

LUXIQ

AB +! MYLAN PHARMS INC 0.12% N020934 001 Feb 28, 1999



CREAM;TOPICAL

BETA-VAL

AB G AND W LABS INC EQ 0.1% BASE N018642 001 Mar 24, 1983

BETAMETHASONE VALERATE

AB +! FOUGERA PHARMS INC EQ 0.1% BASE N018861 001 Aug 31, 1983

DERMABET

AB TARO EQ 0.1% BASE A072041 001 Jan 06, 1988

VALNAC

AB ACTAVIS MID EQ 0.1% BASE A070050 001 Oct 10, 1984

ATLANTIC

LOTION;TOPICAL

BETAMETHASONE VALERATE

AB +! FOUGERA PHARMS INC EQ 0.1% BASE N018866 001 Aug 31, 1983

AB STI PHARMA LLC EQ 0.1% BASE A070052 001 Jul 31, 1985

OINTMENT;TOPICAL

BETA-VAL

AB G AND W LABS INC EQ 0.1% BASE A070069 001 Dec 19, 1985

BETAMETHASONE VALERATE

AB ACTAVIS MID EQ 0.1% BASE A070051 001 Oct 10, 1984

ATLANTIC

AB +! FOUGERA PHARMS INC EQ 0.1% BASE N018865 001 Aug 31, 1983

BETAXOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

BETAXOLOL HYDROCHLORIDE

AT AKORN EQ 0.5% BASE A075386 001 Jun 30, 2000

AT MEDIMETRIKS PHARMS EQ 0.5% BASE A075630 001 Apr 12, 2001

AT WOCKHARDT EQ 0.5% BASE A078694 001 Nov 16, 2009

BETOPTIC

AT +! SANDOZ INC EQ 0.5% BASE N019270 001 Aug 30, 1985

SUSPENSION/DROPS;OPHTHALMIC

BETOPTIC S

+! NOVARTIS PHARMS EQ 0.25% BASE N019845 001 Dec 29, 1989

CORP

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-58(of 452)

BETAXOLOL HYDROCHLORIDE

TABLET;ORAL

BETAXOLOL HYDROCHLORIDE

AB EPIC PHARMA 10MG A075541 001 Oct 22, 1999

AB ! 20MG A075541 002 Oct 22, 1999

AB KVK TECH 10MG A078962 001 Jun 27, 2008

AB 20MG A078962 002 Jun 27, 2008



BETHANECHOL CHLORIDE

TABLET;ORAL

BETHANECHOL CHLORIDE

AA AMNEAL PHARM 5MG A040855 001 Nov 21, 2007

AA 10MG A040855 002 Nov 21, 2007

AA 25MG A040855 003 Nov 21, 2007

AA 50MG A040855 004 Nov 21, 2007

AA ECI PHARMS LLC 5MG A040725 001 Oct 26, 2007

AA 10MG A040726 001 Oct 26, 2007

AA 25MG A040727 001 Oct 26, 2007

AA 50MG A040728 001 Oct 26, 2007

AA HERITAGE PHARMA 5MG A091256 001 May 04, 2010

AA 10MG A091256 002 May 04, 2010

AA 25MG A091256 003 May 04, 2010

AA 50MG A091256 004 May 04, 2010

AA LANNETT CO INC 5MG A040677 002 Mar 27, 2008

AA 10MG A040677 003 Mar 27, 2008

AA 25MG A040677 004 Mar 27, 2008

AA 50MG A040677 001 Mar 27, 2008

AA UPSHER SMITH LABS 5MG A040633 001 Jun 01, 2005

AA 10MG A040634 001 Jun 01, 2005

AA 25MG A040635 001 Jun 01, 2005

AA 50MG A040636 001 Jun 01, 2005

AA WOCKHARDT 5MG A040532 001 Sep 29, 2003

AA 10MG A040533 001 Sep 29, 2003

AA 25MG A040534 001 Sep 29, 2003

AA 50MG A040518 001 Sep 29, 2003

DUVOID

AA BI-COASTAL PHARMA 10MG A086262 001

AA 25MG A086263 001

AA 50MG A085882 003

URECHOLINE

AA ! ODYSSEY PHARMS 5MG A089095 001 Dec 19, 1985

AA ! 10MG A088440 001 May 29, 1984

AA ! 25MG A088441 001 May 29, 1984

AA ! 50MG A089096 001 Dec 19, 1985



BETRIXABAN

CAPSULE;ORAL

BEVYXXA

+ PORTOLA PHARMS INC 40MG N208383 001 Jun 23, 2017

+! 80MG N208383 002 Jun 23, 2017

BEXAROTENE

CAPSULE;ORAL

BEXAROTENE

AB AMERIGEN PHARMS LTD 75MG A209861 001 May 08, 2018

AB AMNEAL PHARMS NY 75MG A210105 001 Sep 04, 2018

AB BIONPHARMA INC 75MG A203174 001 Aug 12, 2014

AB UPSHER SMITH LABS 75MG A209886 001 Jul 25, 2018

TARGRETIN

AB +! VALEANT LUXEMBOURG 75MG N021055 001 Dec 29, 1999

GEL;TOPICAL

TARGRETIN

+! VALEANT LUXEMBOURG 1% N021056 001 Jun 28, 2000

BICALUTAMIDE

TABLET;ORAL

BICALUTAMIDE

AB ACCORD HLTHCARE 50MG A078917 001 Jul 06, 2009

AB APOTEX INC 50MG A200274 001 May 21, 2015

AB BOSCOGEN 50MG A091011 001 Jun 10, 2015

AB FRESENIUS KABI 50MG A079045 001 May 13, 2010

ONCOL

AB MYLAN 50MG A079185 001 Jul 06, 2009

AB SANDOZ 50MG A078575 001 Jul 06, 2009

AB SUN PHARMA GLOBAL 50MG A079110 001 Jul 06, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-59(of 452)

BICALUTAMIDE

TABLET;ORAL

BICALUTAMIDE

AB TEVA 50MG A076932 001 Jul 06, 2009

AB WATSON LABS TEVA 50MG A078634 001 Aug 28, 2009

AB ZYDUS PHARMS USA 50MG A079089 001 Jul 06, 2009

INC

CASODEX

AB +! ANI PHARMS INC 50MG N020498 001 Oct 04, 1995

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

BIKTARVY

+! GILEAD SCIENCES INC EQ 50MG BASE;200MG;EQ 25MG BASE N210251 001 Feb 07, 2018

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC

BIMATOPROST

AT APOTEX INC 0.03% A090449 001 Jul 20, 2015

AT HI-TECH PHARMA CO 0.03% A203299 001 Nov 08, 2018

AT ! LUPIN LTD 0.03% A203991 001 Feb 20, 2015

AT SANDOZ INC 0.03% A202565 001 May 05, 2015

LUMIGAN

+! ALLERGAN 0.01% N022184 001 Aug 31, 2010

SOLUTION/DROPS;TOPICAL

BIMATOPROST

AT APOTEX INC 0.03% A201894 001 Dec 01, 2014

AT HI-TECH PHARMACAL 0.03% A203051 001 Oct 09, 2018

AT SANDOZ INC 0.03% A202719 001 Apr 19, 2016

LATISSE

AT +! ALLERGAN 0.03% N022369 001 Dec 24, 2008

BINIMETINIB

TABLET;ORAL

MEKTOVI

+! ARRAY BIOPHARMA INC 15MG N210498 001 Jun 27, 2018

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE

CAPSULE;ORAL

PYLERA

+! ALLERGAN SALES LLC 140MG;125MG;125MG N050786 001 Sep 28, 2006

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

! AILEX PHARMS LLC 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, A202584 001 Nov 30, 2018

N/A, 500MG

BISOPROLOL FUMARATE

TABLET;ORAL

BISOPROLOL FUMARATE

AB AUROBINDO PHARMA 5MG A077910 001 Dec 27, 2006

AB 10MG A077910 002 Dec 27, 2006

AB CASI PHARMS INC 5MG A075643 001 Nov 16, 2000

AB 10MG A075643 002 Nov 16, 2000

AB MYLAN 5MG A075831 001 Dec 14, 2005

AB ! 10MG A075831 002 Dec 14, 2005

AB ORIT LABS LLC 5MG A204891 001 Jan 11, 2017

AB 10MG A204891 002 Jan 11, 2017

AB TEVA PHARMS 5MG A075644 001 Jun 26, 2001

AB 10MG A075644 002 Jun 26, 2001

AB UNICHEM PHARMS 5MG A078635 001 Aug 18, 2009

(USA)

AB 10MG A078635 002 Aug 18, 2009



BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE



AB MYLAN 2.5MG;6.25MG A075768 001 Sep 25, 2000

AB 5MG;6.25MG A075768 002 Sep 25, 2000

AB 10MG;6.25MG A075768 003 Sep 25, 2000

AB SANDOZ 2.5MG;6.25MG A075579 001 Sep 25, 2000

AB 5MG;6.25MG A075579 002 Sep 25, 2000

AB 10MG;6.25MG A075579 003 Sep 25, 2000

AB UNICHEM 2.5MG;6.25MG A079106 001 Jul 28, 2010

AB 5MG;6.25MG A079106 002 Jul 28, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-60(of 452)

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE



TABLET;ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE



AB 10MG;6.25MG A079106 003 Jul 28, 2010

ZIAC

AB + TEVA BRANDED PHARM 2.5MG;6.25MG N020186 003 Mar 26, 1993

AB + 5MG;6.25MG N020186 001 Mar 26, 1993

AB +! 10MG;6.25MG N020186 002 Mar 26, 1993



BIVALIRUDIN

INJECTABLE;INTRAVENOUS

ANGIOMAX

AP +! SANDOZ INC 250MG/VIAL N020873 001 Dec 15, 2000

BIVALIRUDIN

AP ACCORD HLTHCARE 250MG/VIAL A206551 001 Nov 22, 2017

AP APOTEX INC 250MG/VIAL A204876 001 Jul 06, 2017

AP AUROBINDO PHARMA 250MG/VIAL A205962 001 Jul 27, 2018

LTD

AP CIPLA 250MG/VIAL A091602 001 Jul 16, 2018

AP DR REDDYS LABS LTD 250MG/VIAL A201577 001 May 26, 2017

AP FRESENIUS KABI USA 250MG/VIAL A090189 001 Oct 28, 2016

AP HOSPIRA INC 250MG/VIAL A090811 001 Jul 14, 2015

AP 250MG/VIAL A090816 001 Jul 14, 2015

AP MYLAN INSTITUTIONAL 250MG/VIAL A202471 001 Jun 01, 2018



SOLUTION;INTRAVENOUS

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

+! BAXTER HLTHCARE 250MG/50ML (5MG/ML) N208374 001 Dec 21, 2017

CORP

+! 500MG/100ML (5MG/ML) N208374 002 Dec 21, 2017

BLEOMYCIN SULFATE

INJECTABLE;INJECTION

BLEOMYCIN SULFATE

AP ! FRESENIUS KABI USA EQ 15 UNITS BASE/VIAL A065185 001 Jan 28, 2008

AP ! EQ 30 UNITS BASE/VIAL A065185 002 Jan 28, 2008

AP HONG KONG EQ 15 UNITS BASE/VIAL A205030 001 Apr 20, 2018

AP EQ 30 UNITS BASE/VIAL A205030 002 Apr 20, 2018

AP HOSPIRA EQ 15 UNITS BASE/VIAL A065031 001 Mar 10, 2000

AP EQ 30 UNITS BASE/VIAL A065031 002 Mar 10, 2000

AP TEVA PHARMS USA EQ 15 UNITS BASE/VIAL A065033 001 Jun 27, 2000

AP EQ 30 UNITS BASE/VIAL A065033 002 Jun 27, 2000

AP WEST-WARD PHARMS EQ 15 UNITS BASE/VIAL A065042 002 Oct 17, 2001

INT

AP EQ 30 UNITS BASE/VIAL A065042 001 Oct 17, 2001

BORTEZOMIB

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

VELCADE

+! MILLENNIUM PHARMS 3.5MG/VIAL N021602 001 May 13, 2003

POWDER;INTRAVENOUS

BORTEZOMIB

FRESENIUS KABI USA 3.5MG/VIAL N205004 001 Nov 06, 2017

POWDER;INTRAVENOUS, SUBCUTANEOUS

BORTEZOMIB

+ HOSPIRA INC 1MG/VIAL N209191 002 Dec 28, 2018

BOSENTAN

TABLET;ORAL

TRACLEER

+ ACTELION PHARMS LTD 62.5MG N021290 001 Nov 20, 2001

+! 125MG N021290 002 Nov 20, 2001

TABLET, FOR SUSPENSION;ORAL

TRACLEER

+! ACTELION PHARMS 32MG N209279 001 Sep 05, 2017

BOSUTINIB MONOHYDRATE

TABLET;ORAL

BOSULIF

+! PF PRISM CV EQ 100MG BASE N203341 001 Sep 04, 2012

+ EQ 400MG BASE N203341 003 Oct 27, 2017



+ EQ 500MG BASE N203341 002 Sep 04, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-61(of 452)

BRETYLIUM TOSYLATE

INJECTABLE;INJECTION

BRETYLIUM TOSYLATE

! ACADEMIC PHARMS INC 50MG/ML A204386 001 Dec 21, 2018

BREXPIPRAZOLE

TABLET;ORAL

REXULTI

+ OTSUKA PHARM CO LTD 0.25MG N205422 001 Jul 10, 2015

+ 0.5MG N205422 002 Jul 10, 2015

+ 1MG N205422 003 Jul 10, 2015

+! 2MG N205422 004 Jul 10, 2015

+ 3MG N205422 005 Jul 10, 2015

+ 4MG N205422 006 Jul 10, 2015

BRIGATINIB

TABLET;ORAL

ALUNBRIG

+ ARIAD 30MG N208772 001 Apr 28, 2017

+ 90MG N208772 002 Apr 28, 2017

+! 180MG N208772 003 Oct 02, 2017



BRIMONIDINE TARTRATE

GEL;TOPICAL

MIRVASO

+! GALDERMA LABS LP EQ 0.33% BASE N204708 001 Aug 23, 2013

SOLUTION/DROPS;OPHTHALMIC

ALPHAGAN P

AT +! ALLERGAN 0.15% N021262 001 Mar 16, 2001

BRIMONIDINE TARTRATE

AT AKORN 0.2% A076439 001 Mar 14, 2006

AT ! BAUSCH AND LOMB 0.2% A076260 001 May 28, 2003

AT INDOCO REMEDIES 0.2% A091691 001 Nov 18, 2014

AT SANDOZ INC 0.2% A076254 001 Sep 16, 2003

AT 0.2% A078075 001 Jan 30, 2008

QOLIANA

AT SANDOZ INC 0.15% N021764 001 May 22, 2006

ALPHAGAN P

+! ALLERGAN 0.1% N021770 001 Aug 19, 2005

BRIMONIDINE TARTRATE; BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC

SIMBRINZA

+! NOVARTIS PHARMS 0.2%;1% N204251 001 Apr 19, 2013

CORP

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

COMBIGAN

+! ALLERGAN 0.2%;EQ 0.5% BASE N021398 001 Oct 30, 2007

BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC

AZOPT

+! NOVARTIS PHARMS 1% N020816 001 Apr 01, 1998

CORP

BRIVARACETAM

SOLUTION;INTRAVENOUS

BRIVIACT

+! UCB INC 50MG/5ML (10MG/ML) N205837 001 May 12, 2016

SOLUTION;ORAL

BRIVIACT

+! UCB INC 10MG/ML N205838 001 May 12, 2016

TABLET;ORAL

BRIVIACT

+ UCB INC 10MG N205836 001 May 12, 2016

+ 25MG N205836 002 May 12, 2016

+ 50MG N205836 003 May 12, 2016

+ 75MG N205836 004 May 12, 2016

+! 100MG N205836 005 May 12, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-62(of 452)

BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC

BROMFENAC SODIUM

! HI-TECH PHARMACAL EQ 0.09% ACID A203395 001 Jan 22, 2014

BROMSITE

+! SUN PHARMA GLOBAL EQ 0.075% ACID N206911 001 Apr 08, 2016

PROLENSA

+! BAUSCH AND LOMB EQ 0.07% ACID N203168 001 Apr 05, 2013

BROMOCRIPTINE MESYLATE

CAPSULE;ORAL

BROMOCRIPTINE MESYLATE

AB ! MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005
AB ZYDUS PHARMS USA EQ 5MG BASE A078899 001 Jul 30, 2008
INC
PARLODEL
AB + US PHARMS HOLDINGS EQ 5MG BASE N017962 002 Mar 01, 1982
I
TABLET;ORAL
BROMOCRIPTINE MESYLATE
AB MYLAN EQ 2.5MG BASE A076962 001 Sep 24, 2004
AB ! PADDOCK LLC EQ 2.5MG BASE A077646 001 Oct 01, 2008
AB SANDOZ INC EQ 2.5MG BASE A074631 001 Jan 13, 1998
PARLODEL
AB + US PHARMS HOLDINGS EQ 2.5MG BASE N017962 001
I
CYCLOSET
+! VEROSCIENCE EQ 0.8MG BASE N020866 001 May 05, 2009
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMFED-DM

AA ! WOCKHARDT BIO AG 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

AA ACELLA PHARMS LLC 2MG/5ML;10MG/5ML;30MG/5ML A203375 001 Sep 20, 2016

AA MAYNE PHARMA INC 2MG/5ML;10MG/5ML;30MG/5ML A207676 001 Dec 04, 2018

AA PADDOCK LLC 2MG/5ML;10MG/5ML;30MG/5ML A205292 001 Jul 15, 2014

AA TARO PHARM 2MG/5ML;10MG/5ML;30MG/5ML A205112 001 Feb 27, 2017

AA VINTAGE PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A202940 001 Jul 21, 2014



BUDESONIDE

AEROSOL, FOAM;RECTAL

UCERIS

+! VALEANT PHARMS INTL 2MG/ACTUATION N205613 001 Oct 07, 2014

CAPSULE;ORAL

BUDESONIDE

AB ALVOGEN MALTA 3MG A206724 001 Nov 23, 2016

AB AMNEAL PHARMS 3MG A206200 001 Jul 31, 2017

AB BARR LABS DIV TEVA 3MG A090379 001 Apr 02, 2014

AB MAYNE PHARMA 3MG A206623 001 Apr 08, 2016

AB MYLAN 3MG A090410 001 May 16, 2011

AB RISING PHARMS 3MG A207367 001 Apr 07, 2017

AB SCIECURE PHARMA INC 3MG A209041 001 Sep 28, 2017

AB ZYDUS PHARMS USA 3MG A206134 001 May 04, 2017

INC

ENTOCORT EC

AB +! PERRIGO PHARMA INTL 3MG N021324 001 Oct 02, 2001

POWDER, METERED;INHALATION

PULMICORT FLEXHALER

+ ASTRAZENECA 0.08MG/INH N021949 001 Jul 12, 2006

+! 0.16MG/INH N021949 002 Jul 12, 2006

SUSPENSION;INHALATION

BUDESONIDE

AN APOTEX INC 0.25MG/2ML A078202 001 Mar 30, 2009

AN 0.5MG/2ML A078202 002 Mar 30, 2009

AN CIPLA 0.25MG/2ML A205710 001 Nov 16, 2017

AN 0.5MG/2ML A205710 002 Nov 16, 2017

AN 1MG/2ML A205710 003 Nov 16, 2017

AN IMPAX LABS INC 0.25MG/2ML A078404 001 Jul 31, 2012

AN 0.5MG/2ML A078404 002 Jul 31, 2012

AN LUPIN ATLANTIS 0.5MG/2ML A210897 001 Nov 09, 2018

AN SANDOZ INC 0.25MG/2ML A201966 003 Sep 27, 2013

AN 0.5MG/2ML A201966 002 Sep 27, 2013

AN 1MG/2ML A201966 001 Sep 27, 2013

AN TEVA PHARMS 0.25MG/2ML A077519 001 Nov 18, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-63(of 452)

BUDESONIDE

SUSPENSION;INHALATION

BUDESONIDE

AN 0.5MG/2ML A077519 002 Nov 18, 2008

AN TEVA PHARMS USA 1MG/2ML A204548 001 Mar 08, 2016

PULMICORT RESPULES

AN + ASTRAZENECA PHARMS 0.25MG/2ML N020929 001 Aug 08, 2000

AN + 0.5MG/2ML N020929 002 Aug 08, 2000

AN +! 1MG/2ML N020929 003 Aug 08, 2000

TABLET, EXTENDED RELEASE;ORAL

BUDESONIDE

AB ACTAVIS LABS FL INC 9MG A205457 001 Jul 03, 2018

UCERIS

AB +! VALEANT PHARMS INTL 9MG N203634 001 Jan 14, 2013

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

AEROSOL, METERED;INHALATION

SYMBICORT

+! ASTRAZENECA 0.08MG/INH;0.0045MG/INH N021929 001 Jul 21, 2006

+! 0.16MG/INH;0.0045MG/INH N021929 002 Jul 21, 2006

BUMETANIDE

INJECTABLE;INJECTION

BUMETANIDE

AP HOSPIRA 0.25MG/ML A074332 001 Oct 31, 1994

AP ! WEST-WARD PHARMS 0.25MG/ML A079196 001 Apr 30, 2008

INT

TABLET;ORAL

BUMETANIDE

AB AMNEAL PHARMS CO 0.5MG A209724 001 Oct 18, 2017

AB 1MG A209724 002 Oct 18, 2017

AB 2MG A209724 003 Oct 18, 2017

AB IVAX SUB TEVA 0.5MG A074225 001 Apr 24, 1995

PHARMS

AB 1MG A074225 002 Apr 24, 1995

AB 2MG A074225 003 Apr 24, 1995

AB SANDOZ 0.5MG A074700 001 Nov 21, 1996

AB 1MG A074700 002 Nov 21, 1996

AB ! 2MG A074700 003 Nov 21, 1996

AB UPSHER SMITH LABS 0.5MG A209916 001 Jan 23, 2018

AB 1MG A209916 002 Jan 23, 2018

AB 2MG A209916 003 Jan 23, 2018

AB ZYDUS PHARMS USA 0.5MG A202900 001 Apr 30, 2018

INC

AB 1MG A202900 002 Apr 30, 2018

AB 2MG A202900 003 Apr 30, 2018

BUMEX

AB + VALIDUS PHARMS 0.5MG N018225 002 Feb 28, 1983

AB + 1MG N018225 001 Feb 28, 1983

AB + 2MG N018225 003 Jun 14, 1985



BUPIVACAINE

INJECTABLE, LIPOSOMAL;INJECTION

EXPAREL

+! PACIRA PHARMS INC 133MG/10ML (13.3MG/ML) N022496 001 Oct 28, 2011

+! 266MG/20ML (13.3MG/ML) N022496 002 Oct 28, 2011

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE

AP AUROBINDO PHARMA 0.25% A207183 001 May 13, 2016

LTD

AP 0.5% A207183 002 May 13, 2016

AP HOSPIRA 0.25% A070583 001 Feb 17, 1987

AP 0.25% A070586 001 Mar 03, 1987

AP 0.25% A070590 001 Feb 17, 1987

AP 0.25% N018053 002



AP 0.5% A070584 001 Feb 17, 1986

AP 0.5% A070597 001 Mar 03, 1987

AP 0.5% A070609 001 Mar 03, 1987

AP 0.5% N018053 001



AP 0.75% A070585 001 Mar 03, 1987

AP 0.75% N018053 003



AP MYLAN ASI 0.25% A091503 001 Oct 18, 2011

AP 0.5% A091503 002 Oct 18, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-64(of 452)

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE



AP AUROBINDO PHARMA 0.25% A203895 001 Nov 05, 2013

LTD

AP 0.5% A203895 002 Nov 05, 2013

AP 0.75% A203895 003 Nov 05, 2013

AP MYLAN ASI 0.25% A091487 002 Oct 18, 2011

AP 0.5% A091487 001 Oct 18, 2011

AP 0.75% A091487 003 Oct 18, 2011

MARCAINE HYDROCHLORIDE

AP +! HOSPIRA 0.25% N016964 001

AP +! 0.5% N016964 006

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

AP +! HOSPIRA 0.25% N016964 012
AP +! 0.5% N016964 005
AP +! 0.75% N016964 009
SENSORCAINE
AP FRESENIUS KABI USA 0.25% A070552 001 May 21, 1986
AP 0.25% N018304 001
AP 0.5% A070553 001 May 21, 1986
AP 0.5% N018304 002
AP 0.75% A070554 001 May 21, 1986
AP 0.75% N018304 003
INJECTABLE;SPINAL
BUPIVACAINE HYDROCHLORIDE
AP BAXTER HLTHCARE 0.75% A207266 001 Jul 25, 2016
CORP
AP HOSPIRA 0.75% A071810 001 Dec 11, 1987
MARCAINE
AP +! HOSPIRA 0.75% N018692 001 May 04, 1984
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE



AP ! HOSPIRA 0.5%;0.005MG/ML A071168 001 Jun 16, 1988

AP 0.5%;0.005MG/ML A071170 001 Jun 16, 1988



! 0.25%;0.005MG/ML A071165 001 Jun 16, 1988

0.25%;0.005MG/ML A071167 001 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE



AP SEPTODONT 0.5%;0.0091MG/ML A077250 001 Sep 27, 2006

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE

AP +! HOSPIRA 0.5%;0.0091MG/ML N022046 001 Jul 13, 1983

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

AP +! HOSPIRA 0.25%;0.0091MG/ML N016964 004



AP +! 0.5%;0.0091MG/ML N016964 008

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

AP +! HOSPIRA 0.25%;0.0091MG/ML N016964 013



AP +! 0.5%;0.0091MG/ML N016964 007

AP +! 0.75%;0.0091MG/ML N016964 010

SENSORCAINE

AP FRESENIUS KABI USA 0.25%;0.0091MG/ML A070966 001 Oct 13, 1987

AP 0.25%;0.0091MG/ML A070967 001 Oct 13, 1987

AP 0.5%;0.0091MG/ML A070968 001 Oct 13, 1987

AP 0.5%;0.0091MG/ML N018304 004 Sep 02, 1983

AP 0.75%;0.0091MG/ML N018304 005 Sep 02, 1983



BUPRENORPHINE

FILM, EXTENDED RELEASE;TRANSDERMAL

BUPRENORPHINE

AB WATSON LABS TEVA 5MCG/HR A204937 001 Nov 20, 2018

AB 10MCG/HR A204937 002 Nov 20, 2018

AB 15MCG/HR A204937 003 Nov 20, 2018

AB 20MCG/HR A204937 004 Nov 20, 2018

BUTRANS

AB + PURDUE PHARMA LP 5MCG/HR N021306 001 Jun 30, 2010

AB + 10MCG/HR N021306 002 Jun 30, 2010

AB + 15MCG/HR N021306 004 Jul 25, 2013

AB +! 20MCG/HR N021306 003 Jun 30, 2010



+ 7.5MCG/HR N021306 005 Jun 30, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-65(of 452)

BUPRENORPHINE

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS

SUBLOCADE

+ INDIVIOR INC 100MG/0.5ML (100MG/0.5ML) N209819 001 Nov 30, 2017

+! 300MG/1.5ML (200MG/ML) N209819 002 Nov 30, 2017

BUPRENORPHINE HYDROCHLORIDE

FILM;BUCCAL

BELBUCA

+ BDSI EQ 0.075MG BASE N207932 001 Oct 23, 2015
+ EQ 0.15MG BASE N207932 002 Oct 23, 2015
+ EQ 0.3MG BASE N207932 003 Oct 23, 2015
+ EQ 0.45MG BASE N207932 004 Oct 23, 2015
+ EQ 0.6MG BASE N207932 005 Oct 23, 2015
+ EQ 0.75MG BASE N207932 006 Oct 23, 2015
+! EQ 0.9MG BASE N207932 007 Oct 23, 2015
IMPLANT;IMPLANTATION
PROBUPHINE
+! TITAN PHARMS EQ 80MG BASE/IMPLANT N204442 001 May 26, 2016
INJECTABLE;INJECTION
BUPRENEX
AP +! INDIVIOR INC EQ 0.3MG BASE/ML N018401 001
BUPRENORPHINE HYDROCHLORIDE
AP HOSPIRA EQ 0.3MG BASE/ML A074137 001 Jun 03, 1996
AP LUITPOLD EQ 0.3MG BASE/ML A078331 001 Mar 27, 2007
AP PAR STERILE EQ 0.3MG BASE/ML A206586 001 Jul 28, 2015
PRODUCTS
AP WEST-WARD PHARMS EQ 0.3MG BASE/ML A076931 001 Mar 02, 2005
INT
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 2MG BASE A090819 001 Feb 19, 2015
AB EQ 8MG BASE A090819 002 Feb 19, 2015
AB BARR EQ 2MG BASE A090360 001 May 07, 2010
AB EQ 8MG BASE A090360 002 May 07, 2010
AB CASI PHARMS INC EQ 2MG BASE A090279 001 Jun 10, 2015
AB EQ 8MG BASE A090279 002 Jun 10, 2015
AB ETHYPHARM EQ 2MG BASE A090622 001 Sep 24, 2010
AB EQ 8MG BASE A090622 002 Sep 24, 2010
AB MYLAN PHARMS INC EQ 2MG BASE A201066 001 Mar 06, 2015
AB EQ 8MG BASE A201066 002 Mar 06, 2015
AB RHODES PHARMS EQ 2MG BASE A207276 001 Mar 27, 2017
AB EQ 8MG BASE A207276 002 Mar 27, 2017
AB SUN PHARM INDS LTD EQ 2MG BASE A201760 001 Jan 29, 2016
AB EQ 8MG BASE A201760 002 Jan 29, 2016
AB WEST-WARD PHARMS EQ 2MG BASE A078633 001 Oct 08, 2009
INT
AB ! EQ 8MG BASE A078633 002 Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

FILM;BUCCAL

BUNAVAIL

+ BDSI EQ 2.1MG BASE;EQ 0.3MG BASE N205637 001 Jun 06, 2014

+ EQ 4.2MG BASE;EQ 0.7MG BASE N205637 002 Jun 06, 2014

+! EQ 6.3MG BASE;EQ 1MG BASE N205637 003 Jun 06, 2014

FILM;BUCCAL, SUBLINGUAL

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE



AB DR REDDYS LABS SA EQ 2MG BASE;EQ 0.5MG BASE A205299 001 Jun 14, 2018

AB EQ 4MG BASE;EQ 1MG BASE A205806 001 Jun 14, 2018

AB EQ 8MG BASE;EQ 2MG BASE A205299 002 Jun 14, 2018

AB EQ 12MG BASE;EQ 3MG BASE A205806 002 Jun 14, 2018

AB MYLAN TECHNOLOGIES EQ 8MG BASE;EQ 2MG BASE A207607 001 Jun 14, 2018

AB EQ 12MG BASE;EQ 3MG BASE A207607 002 Jun 14, 2018

SUBOXONE

AB + INDIVIOR INC EQ 2MG BASE;EQ 0.5MG BASE N022410 001 Aug 30, 2010

AB + EQ 4MG BASE;EQ 1MG BASE N022410 003 Aug 10, 2012

AB + EQ 8MG BASE;EQ 2MG BASE N022410 002 Aug 30, 2010

AB +! EQ 12MG BASE;EQ 3MG BASE N022410 004 Aug 10, 2012

FILM;SUBLINGUAL

CASSIPA

+! TEVA PHARMS USA EQ 16MG BASE;EQ 4MG BASE N208042 001 Sep 07, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-66(of 452)

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE



TABLET;SUBLINGUAL

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE



AB ACTAVIS ELIZABETH EQ 2MG BASE;EQ 0.5MG BASE A091422 001 Feb 22, 2013

AB ! EQ 8MG BASE;EQ 2MG BASE A091422 002 Feb 22, 2013

AB AMNEAL PHARMS EQ 2MG BASE;EQ 0.5MG BASE A203136 001 Feb 22, 2013

AB EQ 8MG BASE;EQ 2MG BASE A203136 002 Feb 22, 2013

AB ETHYPHARM USA CORP EQ 2MG BASE;EQ 0.5MG BASE A204431 001 Oct 16, 2015

AB EQ 8MG BASE;EQ 2MG BASE A204431 002 Oct 16, 2015

AB LANNETT CO INC EQ 2MG BASE;EQ 0.5MG BASE A205022 001 Sep 19, 2016

AB EQ 8MG BASE;EQ 2MG BASE A205022 002 Sep 19, 2016

AB SPECGX LLC EQ 2MG BASE;EQ 0.5MG BASE A207000 001 Dec 13, 2017

AB EQ 8MG BASE;EQ 2MG BASE A207000 002 Dec 13, 2017

AB SUN PHARM INDS LTD EQ 2MG BASE;EQ 0.5MG BASE A201633 001 Aug 05, 2016

AB EQ 8MG BASE;EQ 2MG BASE A201633 002 Aug 05, 2016

AB TEVA PHARMS USA EQ 2MG BASE;EQ 0.5MG BASE A091149 001 Sep 08, 2014

AB EQ 8MG BASE;EQ 2MG BASE A091149 002 Sep 08, 2014

AB WEST-WARD PHARMS EQ 2MG BASE;EQ 0.5MG BASE A203326 001 Jun 27, 2014

INT

AB EQ 8MG BASE;EQ 2MG BASE A203326 002 Jun 27, 2014

ZUBSOLV

+ OREXO US INC EQ 0.7MG BASE;EQ 0.18MG BASE N204242 006 Oct 04, 2016

+ EQ 1.4MG BASE;EQ 0.36MG BASE N204242 001 Jul 03, 2013

+ EQ 2.9MG BASE;EQ 0.71MG BASE N204242 005 Jun 04, 2015

+ EQ 5.7MG BASE;EQ 1.4MG BASE N204242 002 Jul 03, 2013

+ EQ 8.6MG BASE;EQ 2.1MG BASE N204242 003 Dec 11, 2014

+! EQ 11.4MG BASE;EQ 2.9MG BASE N204242 004 Dec 11, 2014

BUPROPION HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

APLENZIN

+ VALEANT PHARMS 174MG N022108 001 Apr 23, 2008

NORTH

+ 348MG N022108 002 Apr 23, 2008

+! 522MG N022108 003 Apr 23, 2008



BUPROPION HYDROCHLORIDE

TABLET;ORAL

BUPROPION HYDROCHLORIDE

AB ALEMBIC PHARMS LTD 75MG A203013 001 Jun 08, 2018

AB 100MG A203013 002 Jun 08, 2018

AB APOTEX INC 75MG A076143 001 Jan 17, 2006

AB ! 100MG A076143 002 Jan 17, 2006

AB HERITAGE PHARMA 75MG A206975 001 Aug 19, 2016

AB 100MG A206975 002 Aug 19, 2016

AB INVAGEN PHARMS 75MG A207389 001 Sep 18, 2017

AB 100MG A207389 002 Sep 18, 2017

AB MYLAN 75MG A075491 001 Apr 17, 2000

AB 100MG A075491 002 Apr 17, 2000

AB SANDOZ 75MG A075584 001 Feb 07, 2000

AB 100MG A075584 002 Feb 07, 2000



TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

AB1 ACTAVIS LABS FL INC 100MG A079095 001 Mar 24, 2009

AB1 150MG A079095 002 Mar 24, 2009

AB1 200MG A079095 003 Mar 24, 2009

AB1 ANCHEN PHARMS 100MG A091459 001 Jun 09, 2011

AB1 150MG A091459 002 Jun 09, 2011

AB1 200MG A091459 003 Jun 09, 2011

AB1 IMPAX LABS 100MG A075913 001 Jan 28, 2004

AB1 150MG A075913 002 Mar 22, 2004

AB1 200MG A076711 001 Dec 03, 2004

AB1 INVAGEN PHARMS 100MG A206674 001 Feb 09, 2016

AB1 150MG A206674 002 Feb 09, 2016

AB1 200MG A206674 003 Feb 09, 2016

AB1 JUBILANT GENERICS 100MG A202774 001 Oct 11, 2013

AB1 150MG A202774 002 Oct 11, 2013

AB1 200MG A202774 003 Oct 11, 2013

AB1 MYLAN 100MG A090325 001 Apr 08, 2010

AB1 150MG A090325 002 Apr 08, 2010

AB1 200MG A090325 003 Apr 08, 2010

AB1 PRINSTON INC 100MG A202304 001 May 26, 2015

AB1 150MG A202304 002 May 26, 2015

AB1 200MG A202304 003 May 26, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-67(of 452)

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

AB1 SANDOZ 100MG A075932 001 Nov 25, 2003

AB1 150MG A075932 002 Mar 22, 2004

AB1 200MG A075932 003 Jun 22, 2005

AB1 SCIEGEN PHARMS INC 100MG A205794 001 Mar 01, 2016

AB1 150MG A205794 002 Mar 01, 2016

AB1 200MG A205794 003 Mar 01, 2016

AB1 SUN PHARMA GLOBAL 100MG A078866 001 Apr 06, 2010

AB1 150MG A078866 002 Apr 06, 2010

AB1 200MG A078866 003 Apr 06, 2010

AB1 TORRENT PHARMS LTD 100MG A203969 001 Oct 31, 2014

AB1 150MG A203969 002 Oct 31, 2014

AB1 200MG A203969 003 Oct 31, 2014

AB1 WATSON LABS INC 100MG A077455 001 Jul 19, 2010

AB1 150MG A077455 002 Mar 12, 2008

AB1 200MG A077455 003 Jul 19, 2010

AB1 YICHANG HUMANWELL 100MG A211347 001 Oct 16, 2018

AB1 150MG A211347 002 Oct 16, 2018

AB1 200MG A211347 003 Oct 16, 2018

WELLBUTRIN SR

AB1 + GLAXOSMITHKLINE 100MG N020358 002 Oct 04, 1996

AB1 + 150MG N020358 003 Oct 04, 1996

AB1 +! 200MG N020358 004 Jun 14, 2002

BUPROPION HYDROCHLORIDE

AB2 ACTAVIS LABS FL INC 150MG A079094 001 Mar 24, 2009

AB2 ANCHEN PHARMS 150MG A091520 001 Jun 09, 2011

AB2 IMPAX LABS 150MG A075914 001 May 27, 2004

AB2 JUBILANT GENERICS 150MG A202775 001 Oct 11, 2013

AB2 MYLAN 150MG A090941 001 May 03, 2010

AB2 SANDOZ INC 150MG A077475 001 Mar 12, 2008

AB2 SCIEGEN PHARMS INC 150MG A206122 001 Aug 17, 2016

ZYBAN

AB2 +! GLAXOSMITHKLINE 150MG N020711 003 May 14, 1997

BUPROPION HYDROCHLORIDE

AB3 ACCORD HLTHCARE 150MG A210497 001 Oct 31, 2018

AB3 300MG A210497 002 Oct 31, 2018

AB3 ACTAVIS LABS FL INC 150MG A077715 001 Nov 26, 2008

AB3 ANBISON LAB 150MG A207224 001 Jun 30, 2017

AB3 300MG A207224 002 Jun 30, 2017

AB3 ANCHEN PHARMS 150MG A077284 001 Dec 14, 2006

AB3 300MG A077284 002 Dec 14, 2006

AB3 IMPAX LABS 150MG A077415 001 Nov 26, 2008

AB3 INVAGEN PHARMS 150MG A206556 001 Aug 26, 2016

AB3 300MG A206556 002 Aug 26, 2016

AB3 JUBILANT GENERICS 150MG A207459 001 Jun 30, 2017

AB3 300MG A207459 002 Jun 30, 2017

AB3 LUPIN LTD 150MG A090693 001 Apr 06, 2017

AB3 300MG A090693 002 Apr 06, 2017

AB3 MYLAN 150MG A090942 001 Jul 14, 2010

AB3 300MG A090942 002 Jul 14, 2010

AB3 SCIEGEN PHARMS INC 150MG A207479 001 Apr 12, 2017

AB3 300MG A207479 002 Apr 12, 2017

AB3 SINOTHERAPEUTICS 150MG A208652 001 Aug 21, 2017

INC

AB3 300MG A208652 002 Aug 21, 2017

AB3 SUN PHARMA GLOBAL 150MG A200695 001 Dec 18, 2014

AB3 TWI PHARMS 150MG A210081 001 Nov 03, 2017

AB3 300MG A210081 002 Nov 03, 2017

AB3 WATSON LABS INC 150MG A077285 001 Nov 26, 2008

AB3 300MG A077285 002 Aug 15, 2008

AB3 WOCKHARDT LTD 150MG A202189 001 Nov 21, 2012

AB3 YICHANG HUMANWELL 150MG A210015 001 Jun 14, 2018

AB3 300MG A210015 002 Jun 14, 2018

AB3 ZYDUS PHARMS USA 150MG A201567 002 Jul 23, 2018

INC

AB3 300MG A201567 001 Jan 17, 2014

WELLBUTRIN XL

AB3 + VALEANT INTL 150MG N021515 001 Aug 28, 2003

AB3 +! 300MG N021515 002 Aug 28, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-68(of 452)

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

FORFIVO XL

+! ALVOGEN 450MG N022497 001 Nov 10, 2011

BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CONTRAVE

+! NALPROPION 90MG;8MG N200063 001 Sep 10, 2014

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL

BUSPIRONE HYDROCHLORIDE

AB ACCORD HLTHCARE 5MG A202557 001 Dec 30, 2014

AB 7.5MG A202557 002 Dec 30, 2014

AB 10MG A202557 003 Dec 30, 2014

AB 15MG A202557 004 Dec 30, 2014

AB 30MG A202557 005 Dec 30, 2014

AB AMNEAL PHARMS CO 5MG A208829 001 May 24, 2017

AB 7.5MG A208829 002 May 24, 2017

AB 10MG A208829 003 May 24, 2017

AB 15MG A208829 004 May 24, 2017

AB 30MG A208829 005 May 24, 2017

AB AUROBINDO PHARMA 5MG A078246 001 Feb 27, 2009

LTD

AB 10MG A078246 002 Feb 27, 2009

AB 15MG A078246 003 Feb 27, 2009

AB 30MG A078246 004 Feb 27, 2009

AB HERITAGE PHARMA 5MG A204582 001 Sep 18, 2015

AB 10MG A204582 002 Sep 18, 2015

AB 15MG A204582 003 Sep 18, 2015

AB 30MG A204582 004 Sep 18, 2015

AB IMPAX LABS INC 5MG A074253 001 Mar 28, 2001

AB 10MG A074253 002 Mar 28, 2001

AB 15MG A074253 003 Mar 13, 2002

AB INVENTIA HLTHCARE 5MG A209696 001 May 03, 2018

AB 7.5MG A209696 002 May 03, 2018

AB 10MG A209696 003 May 03, 2018

AB 15MG A209696 004 May 03, 2018

AB 30MG A209696 005 May 03, 2018

AB MYLAN 5MG A076008 003 Mar 01, 2002

AB 7.5MG A075467 002 Mar 28, 2001

AB 7.5MG A076008 002 Jul 08, 2013

AB 10MG A076008 004 Mar 01, 2002

AB 15MG A076008 005 Mar 28, 2001

AB 30MG A076008 001 Jun 28, 2001

AB OXFORD PHARMS 30MG A078302 001 Dec 17, 2007

AB STRIDES PHARMA 5MG A202330 001 Aug 25, 2014

AB 7.5MG A202330 005 Feb 17, 2017

AB 10MG A202330 002 Aug 25, 2014

AB 15MG A202330 003 Aug 25, 2014

AB 30MG A202330 004 Aug 25, 2014

AB TEVA 5MG A075022 001 Feb 28, 2002

AB 10MG A075022 002 Feb 28, 2002

AB ! 15MG A075022 003 Feb 28, 2002

AB 30MG A075022 004 Mar 25, 2004

AB YILING PHARM LTD 5MG A202087 001 Dec 16, 2015

AB 10MG A202087 002 Dec 16, 2015

AB 15MG A202087 003 Dec 16, 2015

AB 30MG A202087 004 Dec 16, 2015

AB ZYDUS PHARMS USA 5MG A078888 001 Feb 07, 2014

INC

AB 10MG A078888 002 Feb 07, 2014

AB 15MG A078888 003 Feb 07, 2014

AB 30MG A078888 004 Feb 07, 2014



BUSULFAN

INJECTABLE;INJECTION

BUSULFAN

AP ACTAVIS LLC 6MG/ML A205139 001 Dec 08, 2017

AP AMNEAL PHARMS CO 6MG/ML A209580 001 Dec 18, 2017

AP HOSPIRA INC 6MG/ML A205672 001 Jul 31, 2018

AP LUITPOLD 6MG/ML A202259 001 Dec 22, 2015

AP MYLAN LABS LTD 6MG/ML A205184 001 Jul 13, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-69(of 452)

BUSULFAN

INJECTABLE;INJECTION

BUSULFAN

AP NEXUS PHARMS 6MG/ML A207794 001 Jan 14, 2019

AP PHARMASCIENCE INC 6MG/ML A207050 001 Mar 24, 2017

AP SANDOZ INC 6MG/ML A205106 001 Sep 21, 2018

BUSULFEX

AP +! OTSUKA PHARM 6MG/ML N020954 001 Feb 04, 1999

MYLERAN

AP ASPEN GLOBAL INC 6MG/ML A208536 001 Nov 20, 2017

TABLET;ORAL

MYLERAN

+! ASPEN GLOBAL 2MG N009386 001

BUTABARBITAL SODIUM

TABLET;ORAL

BUTISOL SODIUM

+! MYLAN SPECIALITY LP 30MG N000793 004

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

MENTAX

+! MYLAN 1% N020524 001 Oct 18, 1996

BUTOCONAZOLE NITRATE

CREAM;VAGINAL

GYNAZOLE-1

! PERRIGO ISRAEL 2% A200923 001 May 18, 2012

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION

BUTORPHANOL TARTRATE

AP HIKMA FARMACEUTICA 1MG/ML A078400 001 May 01, 2009

AP 2MG/ML A078400 002 May 01, 2009

AP WEST-WARD PHARMS 2MG/ML A075046 001 Aug 12, 1998

INT

BUTORPHANOL TARTRATE PRESERVATIVE FREE

AP ! HOSPIRA 1MG/ML A074626 001 Jan 23, 1997

AP ! 2MG/ML A074626 002 Jan 23, 1997

AP WEST-WARD PHARMS 1MG/ML A075045 001 Aug 12, 1998

INT

AP 2MG/ML A075045 002 Aug 12, 1998

SPRAY, METERED;NASAL

BUTORPHANOL TARTRATE

AB APOTEX INC 1MG/SPRAY A075499 001 Dec 04, 2002

AB ! MYLAN 1MG/SPRAY A075759 001 Aug 08, 2001

AB WEST-WARD PHARMS 1MG/SPRAY A075824 001 Mar 12, 2002

INT

CABAZITAXEL

SOLUTION;INTRAVENOUS

JEVTANA KIT

+! SANOFI AVENTIS US 60MG/1.5ML (40MG/ML) N201023 001 Jun 17, 2010

CABERGOLINE

TABLET;ORAL

CABERGOLINE

AB ACTAVIS LABS FL INC 0.5MG A078035 001 Apr 21, 2008

AB INGENUS PHARMS LLC 0.5MG A204735 001 Aug 01, 2018

AB IVAX SUB TEVA 0.5MG A077750 001 Mar 07, 2007

PHARMS

AB MYLAN PHARMS INC 0.5MG A202947 001 Dec 02, 2013

AB ! PAR PHARM 0.5MG A076310 001 Dec 29, 2005



CABOZANTINIB S-MALATE

CAPSULE;ORAL

COMETRIQ

+! EXELIXIS EQ 20MG BASE N203756 001 Nov 29, 2012

+ EQ 80MG BASE N203756 002 Nov 29, 2012

TABLET;ORAL

CABOMETYX

+ EXELIXIS INC EQ 20MG BASE N208692 001 Apr 25, 2016

+ EQ 40MG BASE N208692 002 Apr 25, 2016

+! EQ 60MG BASE N208692 003 Apr 25, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-70(of 452)

CAFFEINE CITRATE

SOLUTION;INTRAVENOUS

CAFCIT

AP +! WEST-WARD PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 001 Sep 21, 1999

INT

CAFFEINE CITRATE

AP AUROBINDO PHARMA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A205013 001 Sep 22, 2015

LTD

AP EXELA PHARMA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077233 001 Sep 21, 2006

SCIENCE

AP FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077997 001 Jul 20, 2007

AP LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077906 001 May 15, 2007

AP MICRO LABS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A207400 001 Dec 14, 2017

AP SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090827 001 Aug 29, 2012

AP SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090077 001 Sep 30, 2009

SOLUTION;ORAL

CAFCIT

AA +! WEST-WARD PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 002 Apr 12, 2000

INT

CAFFEINE CITRATE

AA EXELA PHARMA SCS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077304 001 Sep 21, 2006

LLC

AA FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A078002 001 Jan 31, 2008

AA LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090064 001 Nov 20, 2009

AA SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A091102 001 Aug 29, 2012

AA SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090357 001 Sep 30, 2009

CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY;RECTAL

MIGERGOT

! HZNP 100MG;2MG A086557 001 Oct 04, 1983

TABLET;ORAL

CAFERGOT

AA ! SANDOZ 100MG;1MG A084294 001

ERGOTAMINE TARTRATE AND CAFFEINE

AA HIKMA INTL PHARMS 100MG;1MG A040510 001 Sep 17, 2004

AA MIKART 100MG;1MG A040590 001 Sep 16, 2005



CALCIFEDIOL

CAPSULE, EXTENDED RELEASE;ORAL

RAYALDEE

+! OPKO IRELAND GLOBAL 0.03MG N208010 001 Jun 17, 2016

CALCIPOTRIENE

AEROSOL, FOAM;TOPICAL

SORILUX

+! MAYNE PHARMA 0.005% N022563 001 Oct 06, 2010

CREAM;TOPICAL

CALCIPOTRIENE

AB GLENMARK PHARMS 0.005% A205772 001 Jun 09, 2015

AB TOLMAR 0.005% A200935 001 May 30, 2012

DOVONEX

AB +! LEO PHARMA AS 0.005% N020554 001 Jul 22, 1996

OINTMENT;TOPICAL

CALCIPOTRIENE

! GLENMARK PHARMS INC 0.005% A090633 001 Mar 24, 2010

SOLUTION;TOPICAL

CALCIPOTRIENE

AT FOUGERA PHARMS 0.005% A078305 001 May 06, 2008

AT G AND W LABS INC 0.005% A078468 001 Mar 24, 2011

AT HI TECH PHARMA 0.005% A077579 001 Nov 19, 2009

AT NOVEL LABS INC 0.005% A207163 001 Dec 26, 2017

AT ! TOLMAR 0.005% A077029 001 Nov 20, 2009



CALCITONIN SALMON

INJECTABLE;INJECTION

MIACALCIN

+! MYLAN IRELAND LTD 200 IU/ML N017808 002 Mar 29, 1991

SPRAY, METERED;NASAL

CALCITONIN-SALMON

AB ! APOTEX INC 200 IU/SPRAY A076396 001 Nov 17, 2008

AB PAR PHARM 200 IU/SPRAY A076979 001 Jun 08, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-71(of 452)

CALCITRIOL

CAPSULE;ORAL

CALCITRIOL

AB AMNEAL PHARMS 0.25MCG A203289 002 Jun 14, 2017

AB 0.5MCG A203289 001 Jun 14, 2017

AB BIONPHARMA INC 0.25MCG A091174 001 May 24, 2013

AB 0.5MCG A091174 002 May 24, 2013

AB STRIDES PHARMA 0.25MCG A091356 001 Dec 12, 2014

AB 0.5MCG A091356 002 Dec 12, 2014

AB TEVA 0.25MCG A075765 001 Oct 12, 2001

AB 0.5MCG A075765 002 Oct 12, 2001

AB WEST-WARD PHARMS 0.25MCG A076917 001 Mar 27, 2006

INT

ROCALTROL

AB + VALIDUS PHARMS 0.25MCG N018044 001

AB +! 0.5MCG N018044 002

INJECTABLE;INJECTION

CALCITRIOL

! AKORN 0.001MG/ML A078066 001 Jan 29, 2008

OINTMENT;TOPICAL

VECTICAL

+! GALDERMA LABS LP 3MCG/GM N022087 001 Jan 23, 2009

SOLUTION;ORAL

CALCITRIOL

AA INVATECH PHARMA 1MCG/ML A209798 001 Nov 21, 2018

AA WEST-WARD PHARMS 1MCG/ML A076242 001 Jul 18, 2003

INT

ROCALTROL

AA +! VALIDUS PHARMS 1MCG/ML N021068 001 Nov 20, 1998

CALCIUM ACETATE

CAPSULE;ORAL

CALCIUM ACETATE

AB AMNEAL PHARMS 667MG A201658 001 Oct 06, 2014

AB CHARTWELL RX 667MG A091312 001 Jun 01, 2012

AB HERITAGE PHARMS INC 667MG A202315 001 Jun 29, 2015

AB INVAGEN PHARMS 667MG A203135 001 Feb 07, 2013

AB LOTUS PHARM CO LTD 667MG A203298 001 Jul 26, 2016

AB LUPIN LTD 667MG A202127 001 Jul 09, 2015

AB NOSTRUM LABS INC 667MG A203179 001 Oct 26, 2015

AB WEST-WARD PHARMS 667MG A077728 001 Feb 26, 2008

INT

PHOSLO GELCAPS

AB +! FRESENIUS MEDCL 667MG N021160 003 Apr 02, 2001

SOLUTION;ORAL

PHOSLYRA

+! FRESENIUS MEDCL 667MG/5ML N022581 001 Apr 18, 2011

TABLET;ORAL

CALCIUM ACETATE

AB HERITAGE PHARMS INC 667MG A202885 001 Jan 22, 2015

AB INVAGEN PHARMS 667MG A202420 001 Feb 05, 2013

AB ! PADDOCK LLC 667MG A091561 001 Apr 13, 2011



CALCIUM CHLORIDE

INJECTABLE;INJECTION

CALCIUM CHLORIDE 10%



AP INTL MEDICATION SYS 100MG/ML A203477 001 May 09, 2018

AP LUITPOLD 100MG/ML A209088 001 Jul 27, 2017

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER



AP +! HOSPIRA 100MG/ML N021117 001 Jan 28, 2000

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

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE



SOLUTION;IRRIGATION

BSS PLUS

+! ALCON 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N018469 001

L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M

L

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-72(of 452)

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

BICARBONATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0 N021703 011 Oct 10, 2008

CORP 5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML

;7.07GM/1000ML (5000ML)

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 006 Oct 25, 2006

CORP 3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;

6.46GM/1000ML (5000ML)

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0 N021703 002 Oct 25, 2006

CORP 3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 003 Oct 25, 2006

CORP 2.03GM/1000ML;0.157GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4 N021703 015 Oct 10, 2008

CORP 4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML; N021703 004 Oct 25, 2006

CORP 3.05GM/1000ML;0.314GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44 N021703 014 Oct 10, 2008

CORP GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46

GM/1000ML (5000ML)

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

SOLUTION;INTRAPERITONEAL

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5 N018883 001 Nov 30, 1984

67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N018883 004 Nov 30, 1984

38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020171 001 Aug 19, 1992

38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5 N018883 002 Nov 30, 1984

67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N018883 005 Nov 30, 1984

38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020171 002 Aug 19, 1992

38MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML; N018883 003 Nov 30, 1984

567MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N018883 006 Nov 30, 1984

538MG/100ML;448MG/100ML

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER

AT FRESENIUS MEDCL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML; N020171 003 Aug 19, 1992

538MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020183 001 Dec 04, 1992

38MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N017512 004



38MG/100ML;448MG/100ML

AT 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5 N020163 001 Dec 04, 1992

38MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N017512 005



38MG/100ML;448MG/100ML

AT 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020163 002 Dec 04, 1992

38MG/100ML;448MG/100ML

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N017512 006



538MG/100ML;448MG/100ML

AT 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML; N020163 003 Dec 04, 1992



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-73(of 452)

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



SOLUTION;INTRAPERITONEAL

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

538MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5 N020183 002 Dec 04, 1992

38MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5 N020183 003 Dec 04, 1992

38MG/100ML;448MG/100ML

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML; N020183 004 Dec 04, 1992

538MG/100ML;448MG/100ML

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

CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE



INJECTABLE;INTRATHECAL

ELLIOTTS B SOLUTION

+! LUKARE MEDICAL LLC 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9 N020577 001 Sep 27, 1996

MG/ML;7.3MG/ML;0.2MG/ML

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

INJECTABLE;INJECTION

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



AP + ICU MEDICAL INC 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001

00ML;310MG/100ML

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER



AP B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003 Feb 24, 1988

00ML;310MG/100ML

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER



AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N016679 001

00ML;310MG/100ML

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006 Apr 05, 1985

100ML;310MG/100ML

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004 Apr 05, 1985

100ML;310MG/100ML

AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005 Apr 05, 1985

100ML;310MG/100ML

AP + ICU MEDICAL INC 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002 Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007 Apr 05, 1985

100ML;310MG/100ML

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008 Apr 05, 1985

100ML;310MG/100ML

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER



B BRAUN 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG N019634 001 Feb 24, 1988

/100ML;160MG/100ML

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 002 Apr 05, 1985

100ML;310MG/100ML

20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003 Apr 05, 1985

100ML;310MG/100ML

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 001 Apr 05, 1985

100ML;310MG/100ML

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

INJECTABLE;INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

+! HOSPIRA 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N018895 001 Jul 20, 1984

16.1MG/ML

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

CITRATE

SOLUTION;IRRIGATION

BALANCED SALT

AT AKORN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A075503 001 Sep 27, 2006

.4MG/ML;1.7MG/ML

AT B BRAUN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A091387 001 Feb 03, 2010

.4MG/ML;1.7MG/ML

BSS

AT +! ALCON 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 N020742 001 Dec 10, 1997

.4MG/ML;1.7MG/ML

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-74(of 452)

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE;

SODIUM PHOSPHATE

INJECTABLE;INJECTION

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML N207026 002 Jan 13, 2015

CORP ;2.21GM/1000ML;6.95GM/1000ML;0.187GM/10

00ML (5000ML)

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 3.68GM/1000ML;3.05GM/1000ML;0.314GM/100 N207026 001 Jan 13, 2015

CORP 0ML

;3.09GM/1000ML;6.34GM/1000ML;0.187GM/10

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

SOLUTION;PERFUSION, CARDIAC

CARDIOPLEGIC IN PLASTIC CONTAINER



AT BAXTER HLTHCARE 17.6MG/100ML;325.3MG/100ML;119.3MG/100M A075323 001 Apr 21, 2000

L;643MG/100ML

PLEGISOL IN PLASTIC CONTAINER



AT +! HOSPIRA 17.6MG/100ML;325.3MG/100ML;119.3MG/100M N018608 001 Feb 26, 1982

L;643MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

RINGER'S IN PLASTIC CONTAINER



AP B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N020002 001 Apr 17, 1992

AP BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N016693 001



AP ICU MEDICAL INC 33MG/100ML;30MG/100ML;860MG/100ML N018251 001

SOLUTION;IRRIGATION

RINGER'S IN PLASTIC CONTAINER



AT B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N018156 001

AT BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N018495 001 Feb 19, 1982

AT ICU MEDICAL INC 33MG/100ML;30MG/100ML;860MG/100ML N017635 001



CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

LACTATED RINGER'S IN PLASTIC CONTAINER



AP B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019632 001 Feb 29, 1988

/100ML

AP +! BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N016682 001



/100ML

AP ICU MEDICAL INC 20MG/100ML;30MG/100ML;600MG/100ML;310MG N017641 001



/100ML

SOLUTION;IRRIGATION

LACTATED RINGER'S IN PLASTIC CONTAINER



AT +! B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018681 001 Dec 27, 1982

/100ML

AT BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018494 001 Feb 19, 1982

/100ML

AT +! 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018921 001 Apr 03, 1984

/100ML

AT +! ICU MEDICAL INC 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019416 001 Jan 17, 1986

/100ML

CALCIUM GLUCONATE

SOLUTION;INTRAVENOUS

CALCIUM GLUCONATE

+! FRESENIUS KABI USA 1GM/10ML (100MG/ML) N208418 001 Jun 15, 2017

+! 5GM/50ML (100MG/ML) N208418 002 Jun 15, 2017

+! 10GM/100ML (100MG/ML) N208418 003 Jun 15, 2017

CALCIUM GLUCONATE IN SODIUM CHLORIDE

+! HQ SPCLT PHARMA 1GM/50ML (20MG/ML) N210906 001 Oct 29, 2018

+! 2GM/100ML (20MG/ML) N210906 002 Oct 29, 2018

CALFACTANT

SUSPENSION;INTRATRACHEAL

INFASURF PRESERVATIVE FREE

+! ONY 35MG/ML N020521 001 Jul 01, 1998

CANAGLIFLOZIN

TABLET;ORAL

INVOKANA

+ JANSSEN PHARMS 100MG N204042 001 Mar 29, 2013

+! 300MG N204042 002 Mar 29, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-75(of 452)

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE



TABLET;ORAL

INVOKAMET

+ JANSSEN PHARMS 50MG;500MG N204353 001 Aug 08, 2014

+ 50MG;1GM N204353 002 Aug 08, 2014

+ 150MG;500MG N204353 003 Aug 08, 2014

+! 150MG;1GM N204353 004 Aug 08, 2014

TABLET, EXTENDED RELEASE;ORAL



INVOKAMET XR

+ JANSSEN PHARMS 50MG;500MG N205879 001 Sep 20, 2016

+ 50MG;1GM N205879 002 Sep 20, 2016

+ 150MG;500MG N205879 003 Sep 20, 2016

+! 150MG;1GM N205879 004 Sep 20, 2016



CANDESARTAN CILEXETIL

TABLET;ORAL

ATACAND

AB + ANI PHARMS INC 4MG N020838 001 Jun 04, 1998

AB + 8MG N020838 002 Jun 04, 1998

AB + 16MG N020838 003 Jun 04, 1998

AB +! 32MG N020838 004 Jun 04, 1998

CANDESARTAN CILEXETIL

AB ALEMBIC PHARMS LTD 4MG A210302 001 Dec 04, 2018

AB 8MG A210302 002 Dec 04, 2018

AB 16MG A210302 003 Dec 04, 2018

AB 32MG A209119 001 Jun 20, 2017

AB MACLEODS PHARMS LTD 4MG A203813 001 Dec 05, 2016

AB 8MG A203813 002 Dec 05, 2016

AB 16MG A203813 003 Dec 05, 2016

AB 32MG A203813 004 Dec 05, 2016

AB MYLAN PHARMS INC 4MG A078702 001 May 03, 2013

AB 8MG A078702 002 May 03, 2013

AB 16MG A078702 003 May 03, 2013

AB 32MG A078702 004 May 03, 2013

AB ZYDUS PHARMS USA 4MG A091390 001 Aug 23, 2017

INC

AB 8MG A091390 002 Aug 23, 2017

AB 16MG A091390 003 Aug 23, 2017

AB 32MG A091390 004 Aug 23, 2017



CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ATACAND HCT

AB + ANI PHARMS INC 16MG;12.5MG N021093 001 Sep 05, 2000

AB + 32MG;12.5MG N021093 002 Sep 05, 2000

AB +! 32MG;25MG N021093 003 May 16, 2008

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE



AB DR REDDYS LABS LTD 16MG;12.5MG A202965 001 Jun 03, 2013

AB 32MG;12.5MG A202965 002 Jun 03, 2013

AB 32MG;25MG A202965 003 Jun 03, 2013

AB MACLEODS PHARMS LTD 16MG;12.5MG A204100 001 Feb 27, 2015

AB 32MG;12.5MG A204100 002 Feb 27, 2015

AB 32MG;25MG A204100 003 Feb 27, 2015

AB MYLAN PHARMS INC 16MG;12.5MG A090704 001 Dec 04, 2012

AB 32MG;12.5MG A090704 002 Dec 04, 2012

AB 32MG;25MG A090704 003 Dec 04, 2012

AB PRINSTON INC 16MG;12.5MG A207455 001 Apr 11, 2018

AB 32MG;12.5MG A207455 002 Apr 11, 2018

AB 32MG;25MG A207455 003 Apr 11, 2018

AB ZYDUS PHARMS USA 16MG;12.5MG A203466 001 Nov 27, 2017

INC

AB 32MG;12.5MG A203466 002 Nov 27, 2017

AB 32MG;25MG A203466 003 Nov 27, 2017



CANGRELOR

POWDER;INTRAVENOUS

KENGREAL

+! CHIESI USA INC 50MG/VIAL N204958 001 Jun 22, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-76(of 452)

CANNABIDIOL

SOLUTION;ORAL

EPIDIOLEX

+! GW RES LTD 100MG/ML N210365 001 Sep 28, 2018

CAPECITABINE

TABLET;ORAL

CAPECITABINE

AB ACCORD HLTHCARE 150MG A202593 001 Apr 23, 2015

AB 500MG A202593 002 Apr 23, 2015

AB ALKEM LABS LTD 150MG A207652 001 Nov 24, 2017

AB 500MG A207652 002 Nov 24, 2017

AB AMNEAL PHARMS 150MG A204741 001 Feb 28, 2017

AB 500MG A204741 002 Feb 28, 2017

AB EUGIA PHARMA 150MG A210604 001 Apr 17, 2018

AB 500MG A210604 002 Apr 17, 2018

AB MSN LABS PVT LTD 150MG A209365 001 Jul 02, 2018

AB 500MG A209365 002 Jul 02, 2018

AB MYLAN PHARMS INC 150MG A090943 001 Aug 08, 2014

AB 500MG A090943 002 Aug 08, 2014

AB SHILPA MEDICARE LTD 150MG A207456 001 Dec 12, 2016

AB 500MG A207456 002 Dec 12, 2016

AB TEVA PHARMS USA 150MG A091649 001 Sep 16, 2013

AB 500MG A091649 002 Sep 16, 2013

AB WEST-WARD PHARMS 150MG A200483 001 Jul 14, 2016

INT

AB 500MG A200483 002 Jul 14, 2016

XELODA

AB + HOFFMANN LA ROCHE 150MG N020896 001 Apr 30, 1998

AB +! 500MG N020896 002 Apr 30, 1998



CAPREOMYCIN SULFATE

INJECTABLE;INJECTION

CAPASTAT SULFATE

AP +! AKORN EQ 1GM BASE/VIAL N050095 001

CAPREOMYCIN SULFATE

AP HISUN PHARM EQ 1GM BASE/VIAL A204796 001 Oct 18, 2018

HANGZHOU

AP MYLAN LABS LTD EQ 1GM BASE/VIAL A202634 001 Nov 27, 2017

CAPSAICIN

PATCH;TOPICAL

QUTENZA

+! AVERITAS 8% N022395 001 Nov 16, 2009

CAPTOPRIL

TABLET;ORAL

CAPTOPRIL

AB HIKMA INTL PHARMS 12.5MG A074505 001 Feb 13, 1996

AB 25MG A074505 002 Feb 13, 1996

AB 50MG A074505 003 Feb 13, 1996

AB 100MG A074505 004 Feb 13, 1996

AB MYLAN PHARMS INC 12.5MG A074434 001 Feb 13, 1996

AB 25MG A074434 002 Feb 13, 1996

AB 50MG A074434 003 Feb 13, 1996

AB ! 100MG A074434 004 Feb 13, 1996

AB PRINSTON INC 12.5MG A074477 001 Feb 13, 1996

AB 25MG A074477 002 Feb 13, 1996

AB 50MG A074477 003 Feb 13, 1996

AB 100MG A074477 004 Feb 13, 1996

AB TEVA 12.5MG A074322 001 Feb 13, 1996

AB 25MG A074322 002 Feb 13, 1996

AB 50MG A074322 003 Feb 13, 1996

AB 100MG A074322 004 Feb 13, 1996

AB WATSON LABS 12.5MG A074386 001 May 23, 1996

AB 25MG A074386 002 May 23, 1996

AB 50MG A074386 003 May 23, 1996

AB 100MG A074386 004 May 23, 1996

AB WOCKHARDT LTD 12.5MG A074532 001 Mar 28, 1997

AB 25MG A074532 002 Mar 28, 1997

AB 50MG A074532 003 Mar 28, 1997

AB 100MG A074532 004 Mar 28, 1997



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-77(of 452)

CAPTOPRIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

MYLAN 25MG;15MG A074896 001 Dec 29, 1997

! 25MG;25MG A074896 002 Dec 29, 1997

! 50MG;15MG A074896 004 Dec 29, 1997

50MG;25MG A074896 003 Dec 29, 1997

CARBACHOL

SOLUTION;INTRAOCULAR

MIOSTAT

+! ALCON 0.01% N016968 001

CARBAMAZEPINE

CAPSULE, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

AB APOTEX INC 100MG A078986 001 Nov 25, 2011

AB 200MG A078986 002 Nov 25, 2011

AB 300MG A078986 003 Nov 25, 2011

AB MYLAN IRELAND LTD 100MG A076697 001 May 20, 2011

AB 200MG A076697 002 May 20, 2011

AB 300MG A076697 003 May 20, 2011

AB TARO 100MG A201106 001 Jun 21, 2013

AB 200MG A201106 002 Jun 21, 2013

AB 300MG A201106 003 Jun 21, 2013

AB TEVA PHARMS 100MG A078592 001 Sep 20, 2012

AB 200MG A078592 002 Sep 20, 2012

AB 300MG A078592 003 Sep 20, 2012

CARBATROL

AB + SHIRE 100MG N020712 003 Sep 30, 1997

AB + 200MG N020712 001 Sep 30, 1997

AB +! 300MG N020712 002 Sep 30, 1997

EQUETRO

+ VALIDUS PHARMS 100MG N021710 001 Dec 10, 2004

+ 200MG N021710 002 Dec 10, 2004

+! 300MG N021710 003 Dec 10, 2004

SUSPENSION;ORAL

CARBAMAZEPINE

AB WOCKHARDT BIO AG 100MG/5ML A075714 001 Jun 05, 2002

TEGRETOL

AB +! NOVARTIS 100MG/5ML N018927 001 Dec 18, 1987

TERIL

AB TARO PHARM 100MG/5ML A076729 001 Sep 20, 2004

TABLET;ORAL

CARBAMAZEPINE

AB APOTEX INC 200MG A075948 001 Feb 27, 2002

AB TARO 200MG A074649 001 Oct 03, 1996

AB TORRENT PHARMS 200MG A077272 002 Dec 07, 2005

EPITOL

AB TEVA 200MG A070541 001 Sep 17, 1986

TEGRETOL

AB +! NOVARTIS 200MG N016608 001

CARBAMAZEPINE

TORRENT PHARMS 100MG A077272 001 Dec 07, 2005

300MG A077272 003 Dec 07, 2005

400MG A077272 004 Dec 07, 2005

TABLET, CHEWABLE;ORAL

CARBAMAZEPINE

AB TARO PHARM INDS 100MG A075687 001 Oct 24, 2000

AB TORRENT PHARMS 100MG A075712 001 Jul 05, 2001

EPITOL

AB TEVA 100MG A073524 001 Jul 29, 1992

TEGRETOL

AB +! NOVARTIS 100MG N018281 001

CARBAMAZEPINE

! TARO PHARM INDS 200MG A075687 002 Jul 29, 2002

TABLET, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

AB TARO 100MG A078115 001 Mar 31, 2009

AB 200MG A078115 002 Mar 31, 2009

AB 400MG A078115 003 Mar 31, 2009

TEGRETOL-XR

AB + NOVARTIS 100MG N020234 001 Mar 25, 1996

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-78(of 452)

CARBAMAZEPINE

TABLET, EXTENDED RELEASE;ORAL

TEGRETOL-XR

AB + 200MG N020234 002 Mar 25, 1996

AB +! 400MG N020234 003 Mar 25, 1996



CARBIDOPA

TABLET;ORAL

CARBIDOPA

AB ALVOGEN MALTA 25MG A204291 001 Jan 08, 2016

AB AMERIGEN PHARMS LTD 25MG A203261 001 Mar 10, 2014

AB EDENBRIDGE PHARMS 25MG A205304 001 Feb 17, 2016

AB NOVEL LABS INC 25MG A204763 001 Oct 20, 2017

AB ZYDUS PHARMS USA 25MG A209910 001 May 07, 2018

INC

LODOSYN

AB +! ATON 25MG N017830 001

CARBIDOPA; ENTACAPONE; LEVODOPA

TABLET;ORAL

CARBIDOPA, LEVODOPA AND ENTACAPONE

AB SUN PHARMA GLOBAL 25MG;200MG;100MG A079085 001 May 10, 2012

AB 37.5MG;200MG;150MG A079085 002 May 10, 2012

AB WOCKHARDT LTD 12.5MG;200MG;50MG A090786 001 Nov 20, 2012

AB 18.75MG;200MG;75MG A090833 001 Nov 20, 2012

AB 25MG;200MG;100MG A090833 002 Nov 20, 2012

AB 31.25MG;200MG;125MG A090833 003 Nov 20, 2012

AB 37.5MG;200MG;150MG A090833 004 Nov 20, 2012

AB 50MG;200MG;200MG A090833 005 Nov 20, 2012

STALEVO 100

AB + ORION PHARMA 25MG;200MG;100MG N021485 002 Jun 11, 2003

STALEVO 125

AB + ORION PHARMA 31.25MG;200MG;125MG N021485 006 Aug 29, 2008

STALEVO 150

AB + ORION PHARMA 37.5MG;200MG;150MG N021485 003 Jun 11, 2003

STALEVO 200

AB +! ORION PHARMA 50MG;200MG;200MG N021485 004 Aug 02, 2007

STALEVO 50

AB +! ORION PHARMA 12.5MG;200MG;50MG N021485 001 Jun 11, 2003

STALEVO 75

AB + ORION PHARMA 18.75MG;200MG;75MG N021485 005 Aug 29, 2008

CARBIDOPA; LEVODOPA

CAPSULE, EXTENDED RELEASE;ORAL

RYTARY

+ IMPAX LABS INC 23.75MG;95MG N203312 001 Jan 07, 2015

+ 36.25MG;145MG N203312 002 Jan 07, 2015

+ 48.75MG;195MG N203312 003 Jan 07, 2015

+! 61.25MG;245MG N203312 004 Jan 07, 2015

SUSPENSION;ENTERAL

DUOPA

+! ABBVIE INC 4.63MG/ML;20MG/ML N203952 001 Jan 09, 2015

TABLET;ORAL

CARBIDOPA AND LEVODOPA



AB ACTAVIS ELIZABETH 10MG;100MG A074260 001 Sep 03, 1993

AB 25MG;100MG A074260 002 Sep 03, 1993

AB 25MG;250MG A074260 003 Sep 03, 1993

AB APOTEX INC 10MG;100MG A077120 001 Jun 02, 2008

AB 25MG;100MG A077120 002 Jun 02, 2008

AB 25MG;250MG A077120 003 Jun 02, 2008

AB MAYNE PHARMA 10MG;100MG A073618 001 Aug 28, 1992

AB 25MG;100MG A073589 001 Aug 28, 1992

AB 25MG;250MG A073607 001 Aug 28, 1992

AB MYLAN 10MG;100MG A090324 001 Sep 28, 2009

AB 25MG;100MG A090324 002 Sep 28, 2009

AB 25MG;250MG A090324 003 Sep 28, 2009

AB SUN PHARM INDS 10MG;100MG A078536 001 Oct 28, 2008

AB 25MG;100MG A078536 002 Oct 28, 2008

AB 25MG;250MG A078536 003 Oct 28, 2008

SINEMET

AB + MERCK SHARP DOHME 10MG;100MG N017555 001

AB + 25MG;100MG N017555 003

AB +! 25MG;250MG N017555 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-79(of 452)

CARBIDOPA; LEVODOPA

TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA



AB ACCORD HLTHCARE 25MG;100MG A202323 001 Feb 08, 2013

AB 50MG;200MG A202323 002 Feb 08, 2013

AB APOTEX 25MG;100MG A076212 001 Jun 16, 2004

AB 50MG;200MG A076212 002 Jun 16, 2004

AB IMPAX LABS 25MG;100MG A076521 001 May 14, 2004

AB 50MG;200MG A076521 002 May 14, 2004

AB MYLAN 25MG;100MG A075091 002 Apr 21, 2000

AB 50MG;200MG A075091 001 Sep 30, 1999

AB SUN PHARM INDS 25MG;100MG A077828 001 Aug 23, 2007

AB 50MG;200MG A077828 002 Aug 23, 2007

SINEMET CR

AB + MERCK SHARP DOHME 25MG;100MG N019856 002 Dec 24, 1992

AB +! 50MG;200MG N019856 001 May 30, 1991

TABLET, ORALLY DISINTEGRATING;ORAL

CARBIDOPA AND LEVODOPA



AB MYLAN 10MG;100MG A078893 001 Sep 18, 2008

AB 25MG;100MG A078893 002 Sep 18, 2008

AB ! 25MG;250MG A078893 003 Sep 18, 2008

AB SUN PHARMA GLOBAL 10MG;100MG A078690 001 Jul 31, 2009

AB 25MG;100MG A078690 002 Jul 31, 2009

AB 25MG;250MG A078690 003 Jul 31, 2009



CARBINOXAMINE MALEATE

SOLUTION;ORAL

CARBINOXAMINE MALEATE

AA ! MIKART 4MG/5ML A040458 001 Apr 25, 2003

AA VINTAGE PHARMS 4MG/5ML A040814 001 Feb 26, 2008



SUSPENSION, EXTENDED RELEASE;ORAL

KARBINAL ER

+! TRIS PHARMA INC 4MG/5ML N022556 001 Mar 28, 2013

TABLET;ORAL

CARBINOXAMINE MALEATE

AA INVAGEN PHARMS 4MG A090435 001 Apr 15, 2010

AA ! MIKART 4MG A040442 001 Mar 19, 2003

AA MISSION PHARMACAL 4MG A090756 001 May 27, 2011

CO

AA VINTAGE PHARMS 4MG A040639 002 May 30, 2008

MIKART 6MG A207484 001 May 31, 2016



CARBOPLATIN

INJECTABLE;IV (INFUSION)

CARBOPLATIN

AP ACCORD HLTHCARE 50MG/5ML (10MG/ML) A206775 001 Feb 09, 2017

AP 150MG/15ML (10MG/ML) A206775 002 Feb 09, 2017

AP 450MG/45ML (10MG/ML) A206775 003 Feb 09, 2017

AP 600MG/60ML (10MG/ML) A206775 004 Feb 09, 2017

AP AKORN 50MG/5ML (10MG/ML) A090475 001 Jul 29, 2009

AP 150MG/15ML (10MG/ML) A090475 002 Jul 29, 2009

AP 450MG/45ML (10MG/ML) A090475 003 Jul 29, 2009

AP 600MG/60ML (10MG/ML) A091268 002 Jul 28, 2010

AP CIPLA LTD 50MG/5ML (10MG/ML) A077861 001 Jan 18, 2007

AP 150MG/15ML (10MG/ML) A077861 002 Jan 18, 2007

AP 450MG/45ML (10MG/ML) A077861 003 Jan 18, 2007

AP 600MG/60ML (10MG/ML) A077861 004 Jan 18, 2007

AP EUGIA PHARMA 50MG/5ML (10MG/ML) A205487 001 Mar 28, 2016

AP 150MG/15ML (10MG/ML) A205487 002 Mar 28, 2016

AP 450MG/45ML (10MG/ML) A205487 003 Mar 28, 2016

AP FRESENIUS KABI USA 50MG/5ML (10MG/ML) A077432 001 Sep 29, 2006

AP 150MG/15ML (10MG/ML) A077432 002 Sep 29, 2006

AP 450MG/45ML (10MG/ML) A077432 003 Sep 29, 2006

AP 450MG/45ML (10MG/ML) A077247 003 Oct 21, 2004

AP 450MG/45ML (10MG/ML) A077266 003 Feb 15, 2006

AP 600MG/60ML (10MG/ML) A077266 004 Feb 15, 2006

AP GLAND PHARMA LTD 50MG/5ML (10MG/ML) A207324 001 Feb 15, 2017

AP 150MG/15ML (10MG/ML) A207324 002 Feb 15, 2017

AP 450MG/45ML (10MG/ML) A207324 003 Feb 15, 2017

AP 600MG/60ML (10MG/ML) A207324 004 Feb 15, 2017

AP HOSPIRA 50MG/5ML (10MG/ML) A076517 001 Oct 14, 2004

AP 150MG/15ML (10MG/ML) A076517 002 Oct 14, 2004

AP 450MG/45ML (10MG/ML) A076517 003 Oct 14, 2004

AP 600MG/60ML (10MG/ML) A077059 001 Nov 23, 2004



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-80(of 452)

CARBOPLATIN

INJECTABLE;IV (INFUSION)

CARBOPLATIN

AP INGENUS PHARMS LLC 50MG/5ML (10MG/ML) A208487 001 Apr 26, 2017

AP 150MG/15ML (10MG/ML) A208487 002 Apr 26, 2017

AP 450MG/45ML (10MG/ML) A208487 003 Apr 26, 2017

AP 600MG/60ML (10MG/ML) A208487 004 Apr 26, 2017

AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A077998 001 Apr 24, 2007

AP 150MG/15ML (10MG/ML) A077998 002 Apr 24, 2007

AP 450MG/45ML (10MG/ML) A077998 003 Apr 24, 2007

AP MYLAN LABS LTD 50MG/5ML (10MG/ML) A091063 001 Nov 09, 2011

AP 150MG/15ML (10MG/ML) A091063 002 Nov 09, 2011

AP 450MG/45ML (10MG/ML) A091063 003 Nov 09, 2011

AP 600MG/60ML (10MG/ML) A091063 004 Nov 09, 2011

AP NANJING KING-FRIEND 50MG/5ML (10MG/ML) A077096 001 Jun 14, 2005

AP 150MG/15ML (10MG/ML) A077096 002 Jun 14, 2005

AP 450MG/45ML (10MG/ML) A077096 003 Jun 14, 2005

AP 600MG/60ML (10MG/ML) A077096 004 Jun 03, 2013

AP ! PHARMACHEMIE BV 50MG/5ML (10MG/ML) A077269 001 Oct 14, 2004

AP ! 150MG/15ML (10MG/ML) A077269 002 Oct 14, 2004

AP ! 450MG/45ML (10MG/ML) A077269 003 Oct 14, 2004

AP ! 600MG/60ML (10MG/ML) A077269 004 Dec 28, 2007

AP PLIVA LACHEMA 50MG/5ML (10MG/ML) A078631 001 Dec 02, 2008

AP 150MG/15ML (10MG/ML) A078631 002 Dec 02, 2008

AP 450MG/45ML (10MG/ML) A078631 003 Dec 02, 2008

AP 600MG/60ML (10MG/ML) A078631 004 Dec 02, 2008

AP SANDOZ INC 50MG/5ML (10MG/ML) A078280 001 May 08, 2008

AP 150MG/15ML (10MG/ML) A078280 002 May 08, 2008

AP 450MG/45ML (10MG/ML) A078280 003 May 08, 2008

AP SUN PHARMA GLOBAL 50MG/5ML (10MG/ML) A077926 001 Sep 19, 2008

AP 150MG/15ML (10MG/ML) A077926 002 Sep 19, 2008

AP 450MG/45ML (10MG/ML) A077926 003 Sep 19, 2008

AP ! TEVA PHARMS USA 50MG/5ML (10MG/ML) A077139 001 Sep 21, 2005

AP ! 150MG/15ML (10MG/ML) A077139 002 Sep 21, 2005

AP ! 450MG/45ML (10MG/ML) A077139 003 Sep 21, 2005

AP ! 600MG/60ML (10MG/ML) A077139 004 Sep 21, 2005

AP WEST-WARD PHARMS 50MG/5ML (10MG/ML) A077244 001 Oct 15, 2004

INT

AP 150MG/15ML (10MG/ML) A077244 002 Oct 15, 2004

AP 450MG/45ML (10MG/ML) A077244 003 Oct 15, 2004

AP 600MG/60ML (10MG/ML) A077244 004 Jan 20, 2006



CARBOPROST TROMETHAMINE

INJECTABLE;INJECTION

HEMABATE

+! PHARMACIA AND EQ 0.25MG BASE/ML N017989 001

UPJOHN

CARFILZOMIB

POWDER;INTRAVENOUS

KYPROLIS

+ ONYX THERAP 10MG/VIAL N202714 003 Jun 07, 2018

+ 30MG/VIAL N202714 002 Jun 03, 2016

+! 60MG/VIAL N202714 001 Jul 20, 2012

CARGLUMIC ACID

TABLET;ORAL

CARBAGLU

+! ORPHAN EUROPE 200MG N022562 001 Mar 18, 2010

CARIPRAZINE HYDROCHLORIDE

CAPSULE;ORAL

VRAYLAR

+ ALLERGAN SALES LLC EQ 1.5MG BASE N204370 001 Sep 17, 2015

+ EQ 3MG BASE N204370 002 Sep 17, 2015

+ EQ 4.5MG BASE N204370 003 Sep 17, 2015

+! EQ 6MG BASE N204370 004 Sep 17, 2015



CARISOPRODOL

TABLET;ORAL

CARISOPRODOL

AA ACCELRX LABS 350MG A040576 001 Jun 07, 2005

AA AUROBINDO PHARMA 350MG A040792 001 Aug 06, 2009

AA HIKMA INTL PHARMS 350MG A040124 001 Jan 24, 1996

AA NATCO PHARMA LTD 350MG A090988 001 Oct 28, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-81(of 452)

CARISOPRODOL

TABLET;ORAL

CARISOPRODOL

AA NOVAST LABS 350MG A040823 001 Oct 22, 2008

AA ORIENT PHARMA CO 350MG A205085 001 Oct 28, 2014

LTD

AA SCIEGEN PHARMS INC 350MG A203374 001 Jan 27, 2014

AA STRIDES PHARMA 350MG A205513 002 Nov 12, 2015

AA SUN PHARM 350MG A089346 001 Oct 17, 1991

INDUSTRIES

AA VINTAGE PHARMS 350MG A040245 001 Sep 08, 1997

AA WATSON LABS 350MG A087499 001 Apr 20, 1982

AA WILSHIRE PHARMS INC 350MG A205126 002 Jul 08, 2015

SOMA

AA + MYLAN SPECIALITY LP 350MG N011792 001

CARISOPRODOL

AB AUROBINDO PHARMA 250MG A040792 002 Nov 08, 2016

AB NOSTRUM LABS INC 250MG A207237 001 May 11, 2017

AB STRIDES PHARMA 250MG A205513 001 Nov 12, 2015

AB WILSHIRE PHARMS INC 250MG A205126 001 Jul 08, 2015

SOMA

AB +! MYLAN SPECIALITY LP 250MG N011792 004 Sep 13, 2007

CARMUSTINE

IMPLANT;INTRACRANIAL

GLIADEL

+! ARBOR PHARMS LLC 7.7MG N020637 001 Sep 23, 1996

INJECTABLE;INJECTION

BICNU

AP +! EMCURE PHARMS LTD 100MG/VIAL N017422 001

CARMUSTINE

AP AMNEAL PHARMS CO 100MG/VIAL A211229 001 Oct 16, 2018

AP NAVINTA LLC 100MG/VIAL A210179 001 Sep 11, 2018



CARTEOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CARTEOLOL HYDROCHLORIDE

AT BAUSCH AND LOMB 1% A075546 001 Jan 20, 2000

AT ! SANDOZ INC 1% A075476 001 Jan 03, 2000



CARVEDILOL

TABLET;ORAL

CARVEDILOL

AB APOTEX INC 3.125MG A078165 001 Sep 05, 2007

AB 6.25MG A078165 002 Sep 05, 2007

AB 12.5MG A078165 003 Sep 05, 2007

AB 25MG A078165 004 Sep 05, 2007

AB AUROBINDO PHARMA 3.125MG A078332 001 Sep 05, 2007

AB 6.25MG A078332 002 Sep 05, 2007

AB 12.5MG A078332 003 Sep 05, 2007

AB 25MG A078332 004 Sep 05, 2007

AB BEXIMCO USA 3.125MG A078384 001 Sep 05, 2007

AB 6.25MG A078384 002 Sep 05, 2007

AB 12.5MG A078384 003 Sep 05, 2007

AB 25MG A078384 004 Sep 05, 2007

AB CHARTWELL MOLECULAR 3.125MG A077474 001 Sep 05, 2007

AB 6.25MG A077474 002 Sep 05, 2007

AB 12.5MG A077474 003 Sep 05, 2007

AB 25MG A077474 004 Sep 05, 2007

AB DR REDDYS LABS LTD 3.125MG A076649 001 Sep 05, 2007

AB 6.25MG A076649 002 Sep 05, 2007

AB 12.5MG A076649 003 Sep 05, 2007

AB 25MG A076649 004 Sep 05, 2007

AB GLENMARK GENERICS 3.125MG A078251 001 Sep 05, 2007

AB 6.25MG A078251 002 Sep 05, 2007

AB 12.5MG A078251 003 Sep 05, 2007

AB 25MG A078251 004 Sep 05, 2007

AB LUPIN 3.125MG A078217 001 Sep 05, 2007

AB 6.25MG A078217 002 Sep 05, 2007

AB 12.5MG A078217 003 Sep 05, 2007

AB 25MG A078217 004 Sep 05, 2007

AB MYLAN 3.125MG A077316 001 Sep 05, 2007

AB 6.25MG A077316 002 Sep 05, 2007

AB 12.5MG A077316 003 Sep 05, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-82(of 452)

CARVEDILOL

TABLET;ORAL

CARVEDILOL

AB 25MG A077316 004 Sep 05, 2007

AB SANDOZ 3.125MG A078227 001 Sep 05, 2007

AB 6.25MG A078227 002 Sep 05, 2007

AB 12.5MG A078227 003 Sep 05, 2007

AB 25MG A078227 004 Sep 05, 2007

AB SUN PHARM INDS INC 3.125MG A077346 004 Sep 05, 2007

AB 6.25MG A077346 001 Sep 05, 2007

AB 12.5MG A077346 002 Sep 05, 2007

AB 25MG A077346 003 Sep 05, 2007

AB SUN PHARM INDS LTD 3.125MG A076989 001 Sep 05, 2007

AB 6.25MG A076989 002 Sep 05, 2007

AB 12.5MG A076989 003 Sep 05, 2007

AB 25MG A076989 004 Sep 05, 2007

AB TARO 3.125MG A077780 001 Sep 05, 2007

AB 6.25MG A077780 002 Sep 05, 2007

AB 12.5MG A077780 003 Sep 05, 2007

AB 25MG A077780 004 Sep 05, 2007

AB TEVA 3.125MG A076373 001 Sep 05, 2007

AB 6.25MG A076373 002 Sep 05, 2007

AB 12.5MG A076373 003 Sep 05, 2007

AB 25MG A076373 004 Sep 05, 2007

AB ZYDUS PHARMS USA 3.125MG A077614 004 Sep 05, 2007

INC

AB 6.25MG A077614 001 Sep 05, 2007

AB 12.5MG A077614 002 Sep 05, 2007

AB 25MG A077614 003 Sep 05, 2007

COREG

AB + SMITHKLINE BEECHAM 3.125MG N020297 004 May 29, 1997

AB + 6.25MG N020297 003 Sep 14, 1995

AB +! 12.5MG N020297 002 Sep 14, 1995

AB + 25MG N020297 001 Sep 14, 1995



CARVEDILOL PHOSPHATE

CAPSULE, EXTENDED RELEASE;ORAL

CARVEDILOL PHOSPHATE

AB IMPAX LABS INC 10MG A204717 001 May 07, 2018

AB 20MG A204717 002 May 07, 2018

AB 40MG A204717 003 May 07, 2018

AB 80MG A204717 004 May 07, 2018

AB SUN PHARM 10MG A090132 001 Oct 25, 2017

INDUSTRIES

AB 20MG A090132 002 Oct 25, 2017

AB 40MG A090132 003 Oct 25, 2017

AB 80MG A090132 004 Oct 25, 2017

COREG CR

AB + SMITHKLINE BEECHAM 10MG N022012 001 Oct 20, 2006

AB + 20MG N022012 002 Oct 20, 2006

AB +! 40MG N022012 003 Oct 20, 2006

AB + 80MG N022012 004 Oct 20, 2006



CASPOFUNGIN ACETATE

POWDER;INTRAVENOUS

CANCIDAS

AP +! MERCK 50MG/VIAL N021227 001 Jan 26, 2001

AP +! 70MG/VIAL N021227 002 Jan 26, 2001

CASPOFUNGIN ACETATE

AP CIPLA 50MG/VIAL A209489 001 Jul 12, 2018

AP 70MG/VIAL A209489 002 Jul 12, 2018

AP FRESENIUS KABI USA 50MG/VIAL N206110 001 Dec 30, 2016

AP 70MG/VIAL N206110 002 Dec 30, 2016

AP GLAND PHARMA LTD 50MG/VIAL A207092 001 Sep 29, 2017

AP 70MG/VIAL A207092 002 Sep 29, 2017

AP MYLAN LABS LTD 50MG/VIAL A207650 001 Sep 29, 2017

AP 70MG/VIAL A207650 002 Sep 29, 2017

AP SANDOZ INC 50MG/VIAL A200833 001 Jun 28, 2018

AP 70MG/VIAL A200833 002 Jun 28, 2018

AP XELLIA PHARMS APS 50MG/VIAL A205923 001 Jul 02, 2018

AP 70MG/VIAL A205923 002 Jul 02, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-83(of 452)

CEFACLOR

CAPSULE;ORAL

CEFACLOR

AB HIKMA EQ 250MG BASE A065350 001 Apr 03, 2007

AB ! EQ 500MG BASE A065350 002 Apr 03, 2007

AB YUNG SHIN PHARM EQ 250MG BASE A065146 001 Jan 22, 2004

AB EQ 500MG BASE A065146 002 Jan 22, 2004



FOR SUSPENSION;ORAL

CEFACLOR

YUNG SHIN PHARM EQ 125MG BASE/5ML A065412 001 Feb 17, 2012

EQ 187MG BASE/5ML A065412 002 Feb 17, 2012

EQ 250MG BASE/5ML A065412 003 Feb 17, 2012

! EQ 375MG BASE/5ML A065412 004 Feb 17, 2012

TABLET, EXTENDED RELEASE;ORAL

CEFACLOR

TEVA EQ 375MG BASE A065058 001 Sep 04, 2002

! EQ 500MG BASE A065058 002 Sep 04, 2002



CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

CEFADROXIL

AB AUROBINDO PHARMA EQ 500MG BASE A065352 001 Jan 25, 2007

AB HIKMA EQ 500MG BASE A065311 001 Feb 07, 2006

AB LUPIN EQ 500MG BASE A065392 001 May 29, 2007

AB ORCHID HLTHCARE EQ 500MG BASE A065309 001 Sep 18, 2006

AB ! TEVA PHARMS EQ 500MG BASE A065282 001 Jan 20, 2006



FOR SUSPENSION;ORAL

CEFADROXIL

AB AUROBINDO EQ 250MG BASE/5ML A065349 001 Apr 25, 2013

AB EQ 500MG BASE/5ML A065349 002 Apr 25, 2013

AB HIKMA PHARMS EQ 250MG BASE/5ML A091036 001 Nov 28, 2012

AB EQ 500MG BASE/5ML A091036 002 Nov 28, 2012

AB LUPIN EQ 250MG BASE/5ML A065396 001 Feb 21, 2008

AB ! EQ 500MG BASE/5ML A065396 002 Feb 21, 2008

AB ORCHID HLTHCARE EQ 250MG BASE/5ML A065307 002 Oct 16, 2006

AB EQ 500MG BASE/5ML A065307 003 Oct 16, 2006



TABLET;ORAL

CEFADROXIL

AB HIKMA EQ 1GM BASE A065260 001 Mar 30, 2006

AB ORCHID HLTHCARE EQ 1GM BASE A065301 001 Sep 18, 2006

! TEVA PHARMS EQ 1GM BASE A062774 001 Apr 08, 1987



CEFAZOLIN SODIUM

INJECTABLE;INJECTION

CEFAZOLIN SODIUM

AP ACS DOBFAR EQ 500MG BASE/VIAL A065303 001 Oct 22, 2008

AP EQ 1GM BASE/VIAL A065303 002 Oct 22, 2008

AP EQ 10GM BASE/VIAL A065306 001 Oct 22, 2008

AP HIKMA FARMACEUTICA EQ 500MG BASE/VIAL A065047 001 Sep 18, 2001

AP EQ 1GM BASE/VIAL A065047 002 Sep 18, 2001

AP EQ 10GM BASE/VIAL A065143 001 Oct 18, 2004

AP ! HOSPIRA INC EQ 500MG BASE/VIAL A065226 001 Apr 21, 2005

AP ! EQ 1GM BASE/VIAL A065226 002 Apr 21, 2005

AP ! EQ 1GM BASE/VIAL A065244 001 Aug 12, 2005

AP EQ 1GM BASE/VIAL A201654 001 Feb 03, 2016

AP ! EQ 10GM BASE/VIAL A065247 001 Aug 12, 2005

AP QILU PHARM CO LTD EQ 1GM BASE/VIAL A203661 001 Dec 28, 2015

AP EQ 10GM BASE/VIAL A209217 001 Oct 17, 2018

AP SANDOZ EQ 500MG BASE/VIAL A062831 001 Dec 09, 1988

AP EQ 1GM BASE/VIAL A062831 002 Dec 09, 1988

AP EQ 1GM BASE/VIAL A065345 001 May 09, 2007

AP EQ 10GM BASE/VIAL A062831 003 Sep 25, 1992

ANCEF IN PLASTIC CONTAINER



! BAXTER HLTHCARE EQ 20MG BASE/ML A063002 002 Mar 28, 1991

CEFAZOLIN AND DEXTROSE

+! B BRAUN EQ 1GM BASE/VIAL N050779 002 Jul 27, 2000

+ EQ 2GM BASE/VIAL N050779 003 Jan 13, 2012

CEFAZOLIN SODIUM

! ACS DOBFAR EQ 20GM BASE/VIAL A065306 002 Aug 18, 2014

! SAMSON MEDCL EQ 100GM BASE/VIAL A065141 001 Nov 29, 2006



! EQ 300GM BASE/VIAL A065141 002 Nov 29, 2006

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-84(of 452)

CEFAZOLIN SODIUM

SOLUTION;INTRAVENOUS

CEFAZOLIN IN PLASTIC CONTAINER

BAXTER HLTHCARE EQ 2GM BASE/100ML (EQ 20MG BASE/ML) N207131 001 Aug 07, 2015

CORP

CEFDINIR

CAPSULE;ORAL

CEFDINIR

AB AUROBINDO PHARMA 300MG A065434 001 Jan 07, 2008

AB LUPIN 300MG A065264 001 May 19, 2006

AB ORCHID HLTHCARE 300MG A065418 001 Jul 18, 2007

AB ! SANDOZ 300MG A065330 001 Apr 06, 2007

AB TEVA PHARMS 300MG A065368 001 May 09, 2007

FOR SUSPENSION;ORAL

CEFDINIR

AB AUROBINDO PHARMA 125MG/5ML A065473 001 Dec 14, 2007

AB 250MG/5ML A065473 002 Dec 14, 2007

AB LUPIN 125MG/5ML A065259 001 May 31, 2006

AB 250MG/5ML A065259 002 May 07, 2007

AB ORCHID HLTHCARE 125MG/5ML A065429 001 Jul 18, 2007

AB 250MG/5ML A065429 002 Jul 18, 2007

AB SANDOZ 125MG/5ML A065337 001 Apr 06, 2007

AB ! 250MG/5ML A065337 002 Apr 06, 2007

AB TEVA PHARMS 125MG/5ML A065332 001 May 04, 2007

AB 250MG/5ML A065332 002 May 04, 2007



CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

AP ACS DOBFAR EQ 1GM BASE/VIAL A065441 001 Mar 20, 2008

AP EQ 2GM BASE/VIAL A065441 002 Mar 20, 2008

AP HOSPIRA INC EQ 500MG BASE/VIAL A065369 001 Jun 18, 2007

AP EQ 1GM BASE/VIAL A065369 002 Jun 18, 2007

AP EQ 1GM BASE/VIAL A202268 001 Jul 30, 2012

AP EQ 2GM BASE/VIAL A065369 003 Jun 18, 2007

AP EQ 2GM BASE/VIAL A202268 002 Jul 30, 2012

AP QILU PHARM CO LTD EQ 500MG BASE/VIAL A203704 001 Feb 01, 2016

AP EQ 1GM BASE/VIAL A203704 002 Feb 01, 2016

AP EQ 2GM BASE/VIAL A203704 003 Feb 01, 2016

AP SAGENT PHARMS EQ 1GM BASE/VIAL A091048 001 Jan 04, 2017

AP EQ 2GM BASE/VIAL A091048 002 Jan 04, 2017

MAXIPIME

AP +! HOSPIRA INC EQ 500MG BASE/VIAL N050679 001 Jan 18, 1996

AP +! EQ 1GM BASE/VIAL N050679 002 Jan 18, 1996

AP +! EQ 2GM BASE/VIAL N050679 003 Jan 18, 1996



CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER

B BRAUN EQ 1GM BASE/VIAL N050821 001 May 06, 2010

EQ 2GM BASE/VIAL N050821 002 May 06, 2010

CEFEPIME IN PLASTIC CONTAINER



+! BAXTER HLTHCARE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) N050817 001 Aug 05, 2008

+! EQ 2GM BASE/100ML (EQ 20MG BASE/ML) N050817 002 Aug 05, 2008

POWDER;INTRAVENOUS

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER

SAMSON MEDCL EQ 100GM BASE A209408 001 Aug 21, 2018

CEFIXIME

CAPSULE;ORAL

CEFIXIME

AB ALKEM LABS LTD 400MG A210574 001 Oct 09, 2018

SUPRAX

AB +! LUPIN LTD 400MG N203195 001 Jun 01, 2012

FOR SUSPENSION;ORAL

CEFIXIME

AB AUROBINDO PHARMA 100MG/5ML A204835 001 Apr 14, 2015

LTD

AB 200MG/5ML A204835 002 Apr 14, 2015

AB BELCHER PHARMS LLC 100MG/5ML A206938 001 Feb 06, 2017

AB 200MG/5ML A206938 002 Feb 06, 2017

AB 500MG/5ML A206939 001 Feb 06, 2017

AB SANDOZ INC 100MG/5ML A206144 001 Nov 17, 2017

AB 200MG/5ML A206144 002 Nov 17, 2017

SUPRAX

AB +! LUPIN LTD 500MG/5ML N202091 001 Feb 20, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-85(of 452)

CEFIXIME

FOR SUSPENSION;ORAL

SUPRAX

AB LUPIN PHARMS 100MG/5ML A065129 001 Feb 23, 2004

AB 200MG/5ML A065355 001 Apr 10, 2007

TABLET;ORAL

SUPRAX

! LUPIN PHARMS 400MG A065130 001 Feb 12, 2004

TABLET, CHEWABLE;ORAL

SUPRAX

LUPIN LTD 100MG A065380 001 Oct 25, 2010

150MG A065380 002 Oct 25, 2010

! 200MG A065380 003 Oct 25, 2010

CEFOTAXIME SODIUM

INJECTABLE;INJECTION

CEFOTAXIME

AP ! HIKMA EQ 500MG BASE/VIAL A065072 001 Nov 20, 2002

AP ! EQ 1GM BASE/VIAL A065072 002 Nov 20, 2002

AP ! EQ 2GM BASE/VIAL A065072 003 Nov 20, 2002

AP ! EQ 10GM BASE/VIAL A065071 001 Nov 20, 2002

AP WOCKHARDT EQ 1GM BASE/VIAL A065197 001 Aug 29, 2006

CEFOTAXIME SODIUM

AP HOSPIRA INC EQ 500MG BASE/VIAL A065290 001 Aug 11, 2006

AP EQ 1GM BASE/VIAL A065290 002 Aug 11, 2006

AP EQ 1GM BASE/VIAL A065293 001 Aug 10, 2006

AP EQ 1GM BASE/VIAL A203132 001 Feb 19, 2016

AP EQ 2GM BASE/VIAL A065290 003 Aug 11, 2006

AP EQ 2GM BASE/VIAL A065293 002 Aug 10, 2006

AP EQ 2GM BASE/VIAL A203132 002 Feb 19, 2016

AP EQ 10GM BASE/VIAL A065292 001 Aug 10, 2006

AP WOCKHARDT EQ 500MG BASE/VIAL A065197 002 Jun 20, 2008

AP EQ 2GM BASE/VIAL A065197 003 Jun 20, 2008



CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTAN

AP + TELIGENT EQ 1GM BASE/VIAL N050588 001 Dec 27, 1985

AP + EQ 2GM BASE/VIAL N050588 002 Dec 27, 1985

CEFOTETAN

AP ! FRESENIUS KABI USA EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007

AP ! EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007

AP ! EQ 10GM BASE/VIAL A065375 001 Aug 09, 2007

AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A091031 001 Oct 26, 2011

AP EQ 2GM BASE/VIAL A091031 002 Oct 26, 2011

AP WEST-WARD PHARM EQ 10GM BASE/VIAL A091030 001 Oct 26, 2011

CORP

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER

+! B BRAUN EQ 1GM BASE/VIAL N065430 001 Aug 09, 2007

+! EQ 2GM BASE/VIAL N065430 002 Aug 09, 2007



CEFOXITIN SODIUM

INJECTABLE;INJECTION

CEFOXITIN

AP ! ACS DOBFAR EQ 1GM BASE/VIAL A065414 001 Jun 12, 2009

AP ! EQ 2GM BASE/VIAL A065414 002 Jun 12, 2009

AP ! EQ 10GM BASE/VIAL A065415 001 May 19, 2010

AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065238 001 Mar 12, 2010

AP EQ 2GM BASE/VIAL A065238 002 Mar 12, 2010

AP EQ 10GM BASE/VIAL A065239 001 Mar 02, 2010

AP HOSPIRA INC EQ 1GM BASE/VIAL A065313 001 Jan 23, 2006

AP EQ 2GM BASE/VIAL A065313 002 Jan 23, 2006

AP EQ 10GM BASE/VIAL A065312 001 Feb 13, 2006

AP WEST-WARD PHARMS EQ 1GM BASE/VIAL A065051 001 Sep 11, 2000

INT

AP EQ 2GM BASE/VIAL A065051 002 Sep 11, 2000

AP EQ 10GM BASE/VIAL A065050 001 Sep 11, 2000

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER



AP +! B BRAUN EQ 1GM BASE/VIAL N065214 001 Mar 10, 2006

AP +! EQ 2GM BASE/VIAL N065214 002 Mar 10, 2006



MEFOXIN IN PLASTIC CONTAINER

! MYLAN INSTITUTIONAL EQ 20MG BASE/ML A063182 001 Jan 25, 1993

! EQ 40MG BASE/ML A063182 002 Jan 25, 1993

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-86(of 452)

CEFOXITIN SODIUM

POWDER;INTRAVENOUS

CEFOXITIN IN PLASTIC CONTAINER

SAMSON MEDCL EQ 100GM BASE A200938 001 Nov 16, 2015

CEFPODOXIME PROXETIL

FOR SUSPENSION;ORAL

CEFPODOXIME PROXETIL

AB AUROBINDO PHARMA EQ 50MG BASE/5ML A065409 001 Jun 08, 2007

LTD

AB EQ 100MG BASE/5ML A065409 002 Jun 08, 2007

AB SANDOZ EQ 50MG BASE/5ML A090031 001 Jan 14, 2009

AB ! EQ 100MG BASE/5ML A090031 002 Jan 14, 2009



TABLET;ORAL

CEFPODOXIME PROXETIL

AB AUROBINDO PHARMA EQ 100MG BASE A065370 001 Jun 11, 2007

AB EQ 200MG BASE A065370 002 Jun 11, 2007

AB ORCHID HLTHCARE EQ 100MG BASE A065388 001 Nov 14, 2007

AB EQ 200MG BASE A065388 002 Nov 14, 2007

AB SANDOZ EQ 100MG BASE A065462 001 May 28, 2008

AB ! EQ 200MG BASE A065462 002 May 28, 2008



CEFPROZIL

FOR SUSPENSION;ORAL

CEFPROZIL

AB APOTEX INC 125MG/5ML A065351 001 Feb 29, 2012

AB 250MG/5ML A065351 002 Feb 29, 2012

AB AUROBINDO PHARMA 125MG/5ML A065381 001 Jan 30, 2007

AB 250MG/5ML A065381 002 Jan 30, 2007

AB LUPIN 125MG/5ML A065261 001 Dec 19, 2005

AB ! 250MG/5ML A065261 002 Dec 19, 2005

AB ORCHID HLTHCARE 125MG/5ML A065284 002 Dec 30, 2005

AB 250MG/5ML A065284 001 Dec 30, 2005

AB SANDOZ 125MG/5ML A065257 001 Dec 08, 2005

AB 250MG/5ML A065257 002 Dec 08, 2005

AB TEVA PHARMS 125MG/5ML A065236 001 Dec 08, 2005

AB 250MG/5ML A065236 002 Dec 08, 2005



TABLET;ORAL

CEFPROZIL

AB APOTEX INC 250MG A065327 001 Mar 26, 2008

AB 500MG A065327 002 Mar 26, 2008

AB AUROBINDO PHARMA 250MG A065340 001 May 24, 2007

LTD

AB 500MG A065340 002 May 24, 2007

AB CASI PHARMS INC 250MG A065235 001 Nov 14, 2005

AB 500MG A065235 002 Nov 14, 2005

AB LUPIN 250MG A065276 001 Dec 08, 2005

AB ! 500MG A065276 002 Dec 08, 2005

AB ORCHID HLTHCARE 250MG A065267 001 Dec 19, 2005

AB 500MG A065267 002 Dec 19, 2005

AB TEVA 250MG A065208 001 Dec 06, 2005

AB 500MG A065208 002 Dec 06, 2005

AB WOCKHARDT 250MG A065428 001 Jun 14, 2007

AB 500MG A065428 002 Jun 14, 2007



CEFTAROLINE FOSAMIL

POWDER;INTRAVENOUS

TEFLARO

+ ALLERGAN SALES LLC 400MG/VIAL N200327 001 Oct 29, 2010

+! 600MG/VIAL N200327 002 Oct 29, 2010

CEFTAZIDIME

INJECTABLE;INJECTION

CEFTAZIDIME

AP ACS DOBFAR 1GM/VIAL A062640 002 Nov 20, 1985

AP 2GM/VIAL A062640 003 Nov 20, 1985

AP 6GM/VIAL A062640 004 Feb 03, 1992

AP WOCKHARDT 1GM/VIAL A065196 001 Oct 15, 2008

FORTAZ

AP +! TELIGENT 500MG/VIAL N050578 001 Jul 19, 1985

AP +! 1GM/VIAL N050578 002 Jul 19, 1985

AP +! 2GM/VIAL N050578 003 Jul 19, 1985

AP +! 6GM/VIAL N050578 004 Jul 19, 1985



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-87(of 452)

CEFTAZIDIME

INJECTABLE;INJECTION

TAZICEF

AP HOSPIRA 500MG/VIAL A062662 001 Mar 06, 1986

AP 1GM/VIAL A062662 002 Mar 06, 1986

AP 1GM/VIAL A064032 001 Oct 31, 1993

AP 2GM/VIAL A062662 003 Mar 06, 1986

AP 2GM/VIAL A064032 002 Oct 31, 1993

AP 6GM/VIAL A062662 004 Mar 06, 1986



CEFTAZIDIME IN DEXTROSE CONTAINER

+ B BRAUN EQ 1GM BASE N050823 001 Jun 13, 2011

+! EQ 2GM BASE N050823 002 Jun 13, 2011

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

POWDER;INTRAVENOUS

ZERBAXA

+! CUBIST PHARMS LLC EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL N206829 001 Dec 19, 2014

CEFTRIAXONE SODIUM

INJECTABLE;INJECTION

CEFTRIAXONE

AP ACS DOBFAR EQ 500MG BASE/VIAL A065329 001 Jul 24, 2008

AP EQ 1GM BASE/VIAL A065329 002 Jul 24, 2008

AP EQ 2GM BASE/VIAL A065329 003 Jul 24, 2008

AP EQ 10GM BASE/VIAL A065328 001 Jul 24, 2008

AP HOSPIRA INC EQ 10GM BASE/VIAL A065232 001 Aug 02, 2005

AP QILU PHARM CO LTD EQ 10GM BASE/VIAL A209218 001 Oct 17, 2018

AP ! SANDOZ EQ 10GM BASE/VIAL A065168 001 May 17, 2005

AP ! SANDOZ INC EQ 1GM BASE/VIAL A065204 001 May 03, 2005

AP ! EQ 2GM BASE/VIAL A065204 002 May 03, 2005

AP WOCKHARDT EQ 1GM BASE/VIAL A065180 001 May 12, 2006

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER



AP +! B BRAUN EQ 1GM BASE/VIAL N050796 001 Apr 20, 2005

AP +! EQ 2GM BASE/VIAL N050796 002 Apr 20, 2005

CEFTRIAXONE SODIUM

AP ASTRAL EQ 10GM BASE/VIAL A091117 001 Jan 20, 2017

AP HIKMA FARMACEUTICA EQ 10GM BASE/VIAL A090701 001 Oct 04, 2017



CEFTRIAXONE

SAMSON MEDCL EQ 100GM BASE/VIAL A090057 001 Apr 25, 2014

CEFTRIAXONE IN PLASTIC CONTAINER



! BAXTER HLTHCARE EQ 20MG BASE/ML A065224 001 Aug 23, 2005

! EQ 40MG BASE/ML A065224 002 Aug 23, 2005

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFTRIAXONE

AP AKORN INC EQ 250MG BASE/VIAL A065305 001 Jan 11, 2008

AP EQ 500MG BASE/VIAL A065305 002 Jan 11, 2008

AP EQ 1GM BASE/VIAL A065305 003 Jan 11, 2008

AP EQ 2GM BASE/VIAL A065305 004 Jan 11, 2008

AP ASTRAL EQ 250MG BASE/VIAL A091049 001 Jun 11, 2018

AP EQ 500MG BASE/VIAL A091049 002 Jun 11, 2018

AP EQ 1GM BASE/VIAL A091049 003 Jun 11, 2018

AP EQ 2GM BASE/VIAL A091049 004 Jun 11, 2018

AP HIKMA FARMACEUTICA EQ 250MG BASE/VIAL A065342 001 Jan 10, 2008

AP EQ 500MG BASE/VIAL A065342 002 Jan 10, 2008

AP EQ 1GM BASE/VIAL A065342 003 Jan 10, 2008

AP EQ 2GM BASE/VIAL A065342 004 Jan 10, 2008

AP HOSPIRA INC EQ 250MG BASE/VIAL A065230 001 Aug 02, 2005

AP EQ 500MG BASE/VIAL A065230 002 Aug 02, 2005

AP EQ 1GM BASE/VIAL A065230 003 Aug 02, 2005

AP EQ 2GM BASE/VIAL A065230 004 Aug 02, 2005

AP LUPIN EQ 250MG BASE/VIAL A065125 001 Sep 30, 2003

AP EQ 500MG BASE/VIAL A065125 002 Sep 30, 2003

AP EQ 1GM BASE/VIAL A065125 003 Sep 30, 2003

AP EQ 2GM BASE/VIAL A065125 004 Sep 30, 2003

AP QILU PHARM CO LTD EQ 250MG BASE/VIAL A203702 001 Jun 29, 2016

AP EQ 500MG BASE/VIAL A203702 002 Jun 29, 2016

AP EQ 1GM BASE/VIAL A203702 003 Jun 29, 2016

AP EQ 2GM BASE/VIAL A203702 004 Jun 29, 2016

AP ! SANDOZ EQ 250MG BASE/VIAL A065169 001 May 09, 2005

AP ! EQ 500MG BASE/VIAL A065169 002 May 09, 2005

AP ! EQ 1GM BASE/VIAL A065169 003 May 09, 2005

AP ! EQ 2GM BASE/VIAL A065169 004 May 09, 2005

AP WOCKHARDT EQ 250MG BASE/VIAL A065391 001 Apr 12, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-88(of 452)

CEFTRIAXONE SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFTRIAXONE

AP EQ 500MG BASE/VIAL A065391 002 Apr 12, 2007

AP EQ 2GM BASE/VIAL A065391 003 Apr 12, 2007



CEFUROXIME AXETIL

TABLET;ORAL

CEFUROXIME AXETIL

AB ALKEM LABS LTD EQ 250MG BASE A065496 001 Jun 07, 2010

AB EQ 500MG BASE A065496 002 Jun 07, 2010

AB ANI PHARMS INC EQ 250MG BASE A065190 001 Oct 18, 2004

AB EQ 500MG BASE A065190 002 Oct 18, 2004

AB APOTEX EQ 250MG BASE A065069 001 Oct 02, 2002

AB EQ 500MG BASE A065069 002 Oct 02, 2002

AB AUROBINDO PHARMA EQ 125MG BASE A065308 001 Mar 29, 2006

LTD

AB EQ 250MG BASE A065308 002 Mar 29, 2006

AB EQ 500MG BASE A065308 003 Mar 29, 2006

AB LUPIN EQ 250MG BASE A065135 001 Jul 25, 2003

AB ! EQ 500MG BASE A065135 002 Jul 25, 2003

AB ORCHID HLTHCARE EQ 125MG BASE A065359 001 Feb 15, 2008

AB EQ 250MG BASE A065359 002 Feb 15, 2008

AB EQ 500MG BASE A065359 003 Feb 15, 2008

AB WOCKHARDT EQ 125MG BASE A065166 001 Jul 29, 2005

AB EQ 250MG BASE A065166 002 Jul 29, 2005

AB EQ 500MG BASE A065166 003 Jul 29, 2005



CEFUROXIME SODIUM

INJECTABLE;INJECTION

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER



AP +! B BRAUN EQ 750MG BASE/VIAL N050780 001 Feb 21, 2001

AP +! EQ 1.5GM BASE/VIAL N050780 002 Feb 21, 2001

CEFUROXIME SODIUM

AP ACS DOBFAR SPA EQ 1.5GM BASE/VIAL A064125 002 May 30, 1997

AP EQ 7.5GM BASE/VIAL A064124 001 May 30, 1997

AP HIKMA FARMACEUTICA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004

AP EQ 7.5GM BASE/VIAL A065046 001 Jan 09, 2004

AP HOSPIRA INC EQ 1.5GM BASE/VIAL A065483 002 Oct 15, 2008

AP EQ 1.5GM BASE/VIAL A065503 001 Oct 15, 2008

AP EQ 7.5GM BASE/VIAL A065484 001 Oct 15, 2008

ZINACEF

AP +! TELIGENT EQ 1.5GM BASE/VIAL N050558 003 Oct 19, 1983

AP +! EQ 7.5GM BASE/VIAL N050558 004 Oct 23, 1986



INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFUROXIME SODIUM

AB ACS DOBFAR SPA EQ 750MG BASE/VIAL A064125 001 May 30, 1997

AB HIKMA FARMACEUTICA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004

ZINACEF

AB +! TELIGENT EQ 750MG BASE/VIAL N050558 002 Oct 19, 1983

CEFUROXIME SODIUM

AP HOSPIRA INC EQ 750MG BASE/VIAL A065483 001 Oct 15, 2008

CELECOXIB

CAPSULE;ORAL

CELEBREX

AB + GD SEARLE 50MG N020998 004 Dec 15, 2006

AB + 100MG N020998 001 Dec 31, 1998

AB + 200MG N020998 002 Dec 31, 1998

AB +! 400MG N020998 003 Aug 29, 2002

CELECOXIB

AB ALEMBIC PHARMS LTD 50MG A204519 001 Aug 21, 2015

AB 100MG A204519 002 Aug 21, 2015

AB 200MG A204519 003 Aug 21, 2015

AB 400MG A204519 004 Aug 21, 2015

AB AMNEAL PHARMS 50MG A208833 001 May 31, 2018

AB 100MG A208833 002 May 31, 2018

AB 200MG A208833 003 May 31, 2018

AB 400MG A208833 004 May 31, 2018

AB APOTEX INC 50MG A204197 001 Jun 02, 2015

AB 100MG A204197 002 Jun 02, 2015

AB 200MG A204197 003 Jun 02, 2015

AB AUROBINDO PHARMA 50MG A206827 001 Feb 01, 2016

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-89(of 452)

CELECOXIB

CAPSULE;ORAL

CELECOXIB

AB
100MG
A206827 002 Feb 01, 2016

AB
200MG
A206827 003 Feb 01, 2016

AB
400MG
A206827 004 Feb 01, 2016

AB CIPLA
50MG
A207446 001 Sep 23, 2015

AB
100MG
A207446 002 Sep 23, 2015

AB
200MG
A207446 003 Sep 23, 2015

AB
400MG
A207446 004 Sep 23, 2015

AB CSPC OUYI PHARM CO


50MG
A210071 001 Jan 23, 2018

AB
100MG
A210071 002 Jan 23, 2018

AB
200MG
A210071 003 Jan 23, 2018

AB JUBILANT GENERICS
50MG
A207061 001 Apr 04, 2017

AB
100MG
A207061 002 Apr 04, 2017

AB
200MG
A207061 003 Apr 04, 2017

AB
400MG
A207061 004 Apr 04, 2017

AB LUPIN LTD
50MG
A202240 001 Oct 29, 2014

AB
100MG
A202240 002 Jun 09, 2015

AB
200MG
A202240 003 Jun 09, 2015

AB
400MG
A202240 004 Jun 09, 2015

AB MACLEODS PHARMS LTD


50MG
A204590 001 Mar 16, 2016

AB
100MG
A204590 002 Mar 16, 2016

AB
200MG
A204590 003 Mar 16, 2016

AB
400MG
A204590 004 Mar 16, 2016

AB MICRO LABS
50MG
A204776 001 Apr 30, 2018

AB
100MG
A204776 002 Apr 30, 2018

AB
200MG
A204776 003 Apr 30, 2018

AB
400MG
A204776 004 Apr 30, 2018

AB MYLAN PHARMS INC


50MG
A078857 001 May 30, 2014

AB
100MG
A078857 002 Feb 11, 2015

AB
200MG
A078857 003 Feb 11, 2015

AB
400MG
A078857 004 Feb 11, 2015

AB TEVA
50MG
A076898 001 May 30, 2014

AB
100MG
A076898 002 May 30, 2014

AB
200MG
A076898 003 May 30, 2014

AB
400MG
A076898 004 May 30, 2014

AB TORRENT PHARMS LTD


50MG
A207677 001 Dec 23, 2015

AB
100MG
A207677 002 Dec 23, 2015

AB
200MG
A207677 003 Dec 23, 2015

AB
400MG
A207677 004 Dec 23, 2015

AB WATSON LABS INC


50MG
A200562 001 Feb 11, 2015

AB
100MG
A200562 002 Feb 11, 2015

AB
200MG
A200562 003 Feb 11, 2015

AB
400MG
A200562 004 Feb 11, 2015

CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

AB ALKEM LABS LTD EQ 250MG BASE
A090836 001 Dec 20, 2010

AB EQ 500MG BASE
A090836 002 Dec 20, 2010

AB EQ 750MG BASE
A090836 004 Mar 29, 2013

AB AUROBINDO PHARMA EQ 250MG BASE


A065253 001 Nov 16, 2005

LTD
AB EQ 500MG BASE
A065253 002 Nov 16, 2005

AB BELCHER PHARMS EQ 250MG BASE


A062713 001 Jul 15, 1988

AB EQ 500MG BASE
A062713 002 Jul 15, 1988

AB HIKMA EQ 250MG BASE


A065215 001 Jan 24, 2006

AB EQ 500MG BASE
A065215 002 Jan 24, 2006

AB LUPIN EQ 250MG BASE


A065229 001 Nov 25, 2005

AB EQ 500MG BASE
A065229 002 Nov 25, 2005

AB ORCHID HLTHCARE EQ 250MG BASE


A065248 001 Jun 28, 2005

AB EQ 500MG BASE
A065248 002 Jun 28, 2005

AB SUN PHARM INDS (IN) EQ 250MG BASE


A062791 001 Jun 11, 1987

AB EQ 500MG BASE
A062791 002 Jun 11, 1987

AB TEVA EQ 250MG BASE


A062702 001 Feb 13, 1987

AB EQ 500MG BASE
A062702 002 Feb 13, 1987

AB YUNG SHIN PHARM EQ 250MG BASE


A065152 001 Feb 24, 2005

AB EQ 500MG BASE
A065152 002 Feb 24, 2005

KEFLEX
AB + PRAGMA EQ 250MG BASE
N050405 002

AB + EQ 500MG BASE
N050405 003

AB +! EQ 750MG BASE
N050405 005 May 12, 2006

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-90(of 452)

CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

ALKEM LABS LTD EQ 333MG BASE A090836 003 Mar 29, 2013

FOR SUSPENSION;ORAL

CEPHALEXIN

AB LUPIN EQ 125MG BASE/5ML A065234 001 Aug 17, 2005

AB EQ 250MG BASE/5ML A065234 002 Aug 17, 2005

AB ORCHID HLTHCARE EQ 125MG BASE/5ML A065326 001 Jul 10, 2006

AB EQ 250MG BASE/5ML A065326 002 Jul 10, 2006

AB TEVA EQ 125MG BASE/5ML A062703 001 Feb 13, 1987

AB ! EQ 250MG BASE/5ML A062703 002 Feb 13, 1987

AB YUNG SHIN PHARM EQ 125MG BASE/5ML A065336 001 Jul 25, 2007

AB EQ 250MG BASE/5ML A065336 002 Jul 25, 2007



TABLET;ORAL

CEPHALEXIN

TEVA EQ 250MG BASE A063023 001 Jan 12, 1989

! EQ 500MG BASE A063024 001 Jan 12, 1989

CERITINIB

CAPSULE;ORAL

ZYKADIA

+! NOVARTIS PHARMS 150MG N205755 001 Apr 29, 2014

CORP

CETIRIZINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ZERVIATE

+! EYEVANCE PHARMS EQ 0.24% BASE N208694 001 May 30, 2017

SYRUP;ORAL

CETIRIZINE HYDROCHLORIDE

AA AMNEAL PHARMS 5MG/5ML A090766 001 Oct 07, 2009

AA ANDA REPOSITORY 5MG/5ML A090191 001 Nov 12, 2009

AA BIO PHARM INC 5MG/5ML A078870 001 Apr 27, 2009

AA BRECKENRIDGE PHARM 5MG/5ML A078488 001 Oct 06, 2008

AA LANNETT CO INC 5MG/5ML A078496 001 Sep 25, 2009

AA 5MG/5ML A078876 001 May 11, 2012

AA ! PERRIGO R AND D 5MG/5ML A078398 001 Jun 17, 2008

AA TARO 5MG/5ML A076601 001 Jun 20, 2008

AA TEVA PHARMS 5MG/5ML A077279 001 May 27, 2008



CETRORELIX

INJECTABLE;INJECTION

CETROTIDE

+! EMD SERONO INC EQ 0.25MG BASE/ML N021197 001 Aug 11, 2000

CEVIMELINE HYDROCHLORIDE

CAPSULE;ORAL

CEVIMELINE HYDROCHLORIDE

AB NOVEL LABS INC 30MG A204746 001 Dec 30, 2016

AB RISING PHARMS 30MG A203775 001 Jun 04, 2014

AB WEST-WARD PHARMS 30MG A091591 001 Jul 08, 2013

INT

EVOXAC

AB +! DAIICHI SANKYO INC 30MG N020989 002 Jan 11, 2000

CHENODIOL

TABLET;ORAL

CHENODIOL

! NEXGEN PHARMA 250MG A091019 001 Oct 22, 2009

CHLORAMBUCIL

TABLET;ORAL

LEUKERAN

+! ASPEN GLOBAL INC 2MG N010669 002

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE;INJECTION

CHLORAMPHENICOL SODIUM SUCCINATE

! FRESENIUS KABI USA EQ 1GM BASE/VIAL A062365 001 Aug 25, 1982

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-91(of 452)

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

CHLORDIAZEPOXIDE HYDROCHLORIDE

AB BARR 5MG A084768 001

AB 10MG A083116 001

AB 25MG A084769 001

LIBRIUM

AB VALEANT PHARM INTL 5MG A085461 001

AB 10MG A085472 001

AB ! 25MG A085475 001

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

CAPSULE;ORAL

LIBRAX

+! VALEANT PHARMS 5MG;2.5MG N012750 001

CHLORHEXIDINE GLUCONATE

SOLUTION;DENTAL

CHLORHEXIDINE GLUCONATE

AT HI TECH PHARMA 0.12% A074356 001 May 07, 1996

AT LYNE 0.12% A074291 001 Dec 28, 1995

AT TEVA 0.12% A074522 001 Dec 15, 1995

AT WOCKHARDT BIO AG 0.12% A075006 001 Mar 03, 2004

AT XTTRIUM 0.12% A077789 001 Jun 18, 2009

PAROEX

AT SUNSTAR AMERICAS 0.12% A076434 001 Nov 29, 2005

PERIDEX

AT +! 3M 0.12% N019028 001 Aug 13, 1986

PERIOGARD

AT COLGATE PALMOLIVE 0.12% A073695 001 Jan 14, 1994

CO

AT COLGATE-PALMOLIVE 0.12% A203212 001 Jan 28, 2016

CO

TABLET;DENTAL

PERIOCHIP

+! DEXCEL PHARMA 2.5MG N020774 001 May 15, 1998

CHLOROPROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHLOROPROCAINE HYDROCHLORIDE

AP HOSPIRA 2% A087447 001 Apr 16, 1982

AP 3% A087446 001 Apr 16, 1982

AP WEST-WARD PHARMS 2% A040273 001 Sep 09, 1998

INT

AP 3% A040273 002 Sep 09, 1998

NESACAINE

AP + FRESENIUS KABI USA 2% N009435 002

NESACAINE-MPF

AP +! FRESENIUS KABI USA 2% N009435 006 May 02, 1996

AP +! 3% N009435 007 May 02, 1996

NESACAINE

+! FRESENIUS KABI USA 1% N009435 001

SOLUTION;INTRATHECAL

CLOROTEKAL

+ B BRAUN MEDICAL INC 50MG/5ML (10MG/ML) N208791 001 Sep 26, 2017

CHLOROQUINE PHOSPHATE

TABLET;ORAL

CHLOROQUINE PHOSPHATE

AA ! HIKMA PHARMS EQ 150MG BASE A083082 001



AA EQ 300MG BASE A083082 002 Sep 17, 1999

AA IPCA LABS LTD EQ 150MG BASE A090610 001 Dec 03, 2009

AA EQ 300MG BASE A090249 001 Dec 03, 2009

AA NATCO PHARMA LTD EQ 150MG BASE A091621 001 Jan 21, 2011

AA ! EQ 300MG BASE A090612 001 Jan 21, 2011



CHLOROTHIAZIDE

SUSPENSION;ORAL

DIURIL

+! SALIX PHARMS 250MG/5ML N011870 001

TABLET;ORAL

CHLOROTHIAZIDE

! MYLAN 250MG A084217 002

500MG A084217 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-92(of 452)

CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION

CHLOROTHIAZIDE SODIUM

AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A090896 001 Oct 16, 2009

AP LUITPOLD EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013

AP MYLAN INSTITUTIONAL EQ 500MG BASE/VIAL A202493 001 Jun 18, 2014

AP SAGENT PHARMS EQ 500MG BASE/VIAL A202462 001 May 29, 2015

AP SUN PHARMA GLOBAL EQ 500MG BASE/VIAL A091546 001 Jul 26, 2011

DIURIL

AP +! OAK PHARMS AKORN EQ 500MG BASE/VIAL N011145 005

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

TABLET, EXTENDED RELEASE;ORAL

TUXARIN ER

MAINPOINTE 8MG;54.3MG N206323 001 Jun 22, 2015

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE



AA ACELLA PHARMS LLC 4MG/5ML;5MG/5ML A206891 001 Jun 09, 2017

VITUZ

AA +! CYPRESS PHARM 4MG/5ML;5MG/5ML N204307 001 Feb 20, 2013

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AA MAYNE PHARMA INC 4MG/5ML;5MG/5ML;60MG/5ML A205657 001 Aug 03, 2015

AA PADDOCK LLC 4MG/5ML;5MG/5ML;60MG/5ML A204627 001 Apr 29, 2014

ZUTRIPRO

AA +! CYPRESS PHARM 4MG/5ML;5MG/5ML;60MG/5ML N022439 001 Jun 08, 2011

CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

TUZISTRA XR

+! AYTU EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML N207768 001 Apr 30, 2015

CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

CAPSULE, EXTENDED RELEASE;ORAL

TUSSICAPS

ECR PHARMA EQ 4MG MALEATE;EQ 5MG BITARTRATE A077273 002 Sep 24, 2007

! EQ 8MG MALEATE;EQ 10MG BITARTRATE A077273 001 Sep 24, 2007

SUSPENSION, EXTENDED RELEASE;ORAL

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX



AB TRIS PHARMA INC EQ 8MG MALEATE/5ML;EQ 10MG A091632 001 Oct 01, 2010

BITARTRATE/5ML

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX



AB ! NEOS THERAP INC EQ 8MG MALEATE/5ML;EQ 10MG A091671 001 Jun 29, 2012

BITARTRATE/5ML

CHLORPROMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHLORPROMAZINE HYDROCHLORIDE

! WEST-WARD PHARMS 25MG/ML A083329 001

INT

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

AB AMNEAL PHARMS CO 10MG A209755 001 Sep 10, 2018

AB 25MG A209755 002 Sep 10, 2018

AB 50MG A209755 003 Sep 10, 2018

AB 100MG A209755 004 Sep 10, 2018

AB 200MG A209755 005 Sep 10, 2018

AB USL PHARMA 10MG A083386 001



AB ! 25MG A084112 001

AB 50MG A084113 001

AB ! 100MG A084114 001

AB 200MG A084115 001

CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

MYLAN 100MG A088549 002 Jun 01, 1984

! 250MG A088549 001 Jun 01, 1984

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-93(of 452)

CHLORTHALIDONE

TABLET;ORAL

CHLORTHALIDONE

AB APPCO PHARMA LLC 25MG A210742 001 Oct 12, 2018

AB 50MG A210742 002 Oct 12, 2018

AB MYLAN 25MG A086831 002



AB ! 50MG A086831 001

AB RICONPHARMA LLC 25MG A206904 001 Mar 30, 2017

AB 50MG A206904 002 Mar 30, 2017

AB SUN PHARM 25MG A089286 002 Jul 21, 1986

INDUSTRIES

AB 50MG A089286 001 Jul 21, 1986

AB UMEDICA LABS PVT 25MG A207222 001 May 24, 2018

LTD

AB 50MG A207222 002 May 24, 2018

CHLORZOXAZONE

TABLET;ORAL

CHLORZOXAZONE

! MIKART 250MG A207483 001 Jun 24, 2016

375MG A040861 001 Jun 01, 2010

! 750MG A040861 002 Jun 01, 2010

! WATSON LABS 500MG A089859 001 May 04, 1988

CHOLESTYRAMINE

POWDER;ORAL

CHOLESTYRAMINE

AB ANI PHARMS INC EQ 4GM RESIN/PACKET A074554 001 Oct 02, 1996

AB EQ 4GM RESIN/SCOOPFUL A074554 002 Oct 02, 1996

AB PAR PHARM EQ 4GM RESIN/PACKET A077204 001 Aug 26, 2005

AB EQ 4GM RESIN/SCOOPFUL A077204 002 Aug 26, 2005

AB ! SANDOZ EQ 4GM RESIN/PACKET A074557 001 Aug 15, 1996

AB EQ 4GM RESIN/SCOOPFUL A074557 002 Aug 15, 1996

AB ZYDUS PHARMS USA EQ 4GM RESIN/SCOOPFUL A202901 001 Jul 02, 2018

INC

CHOLESTYRAMINE LIGHT

AB PAR PHARM EQ 4GM RESIN/PACKET A077203 001 Aug 26, 2005

AB EQ 4GM RESIN/SCOOPFUL A077203 002 Aug 26, 2005

AB ! SANDOZ EQ 4GM RESIN/PACKET A074558 001 Aug 15, 1996

AB EQ 4GM RESIN/SCOOPFUL A074558 002 Aug 15, 1996

AB ZYDUS PHARMS USA EQ 4GM RESIN/SCOOPFUL A202902 001 Apr 25, 2017

INC

PREVALITE

AB UPSHER SMITH LABS EQ 4GM RESIN/PACKET A073263 001 Feb 22, 1996

AB EQ 4GM RESIN/SCOOPFUL A073263 002 Oct 30, 1997



CHOLIC ACID

CAPSULE;ORAL

CHOLBAM

+ RTRX 50MG N205750 001 Mar 17, 2015

+! 250MG N205750 002 Mar 17, 2015

CHOLINE C-11

INJECTABLE;INTRAVENOUS

CHOLINE C-11

AP GLOBAL ISOTOPES LLC 4-33.1mCi/ML A206319 001 Nov 13, 2015

AP +! MCPRF 4-33.1mCi/ML N203155 001 Sep 12, 2012

AP UCSF RODIOPHARM 4-33.1mCi/ML A208444 001 Nov 20, 2017

AP WA UNIV SCH MED 4-33.1mCi/ML A208413 001 Jan 10, 2017



UNIV TX MD ANDERSON 4-100mCi/ML A205690 001 Oct 29, 2015

CHOLINE FENOFIBRATE

CAPSULE, DELAYED RELEASE;ORAL

FENOFIBRIC ACID

AB ACTAVIS ELIZABETH EQ 45MG FENOFIBRIC ACID A200920 001 Oct 07, 2015

AB EQ 135MG FENOFIBRIC ACID A200920 002 Oct 07, 2015

AB ALEMBIC PHARMS LTD EQ 45MG FENOFIBRIC ACID A208705 001 May 12, 2017

AB EQ 135MG FENOFIBRIC ACID A208705 002 May 12, 2017

AB ANCHEN PHARMS EQ 45MG FENOFIBRIC ACID A201573 002 Jul 18, 2013

AB EQ 135MG FENOFIBRIC ACID A201573 001 Jul 18, 2013

AB IMPAX LABS INC EQ 45MG FENOFIBRIC ACID A200264 001 Sep 07, 2016

AB EQ 135MG FENOFIBRIC ACID A200264 002 Sep 07, 2016

AB LUPIN LTD EQ 45MG FENOFIBRIC ACID A200750 001 Dec 04, 2013

AB EQ 135MG FENOFIBRIC ACID A200750 002 Dec 04, 2013

AB MYLAN PHARMS INC EQ 45MG FENOFIBRIC ACID A200913 001 Mar 25, 2013

AB EQ 135MG FENOFIBRIC ACID A200913 002 Mar 25, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-94(of 452)

CHOLINE FENOFIBRATE

CAPSULE, DELAYED RELEASE;ORAL

TRILIPIX

AB + ABBVIE EQ 45MG FENOFIBRIC ACID N022224 001 Dec 15, 2008

AB +! EQ 135MG FENOFIBRIC ACID N022224 002 Dec 15, 2008



CHORIOGONADOTROPIN ALFA

INJECTABLE;SUBCUTANEOUS

OVIDREL

+! EMD SERONO EQ 0.25MG /0.5ML N021149 002 Oct 06, 2003

CHROMIC CHLORIDE

INJECTABLE;INJECTION

CHROMIC CHLORIDE IN PLASTIC CONTAINER

+! HOSPIRA EQ 0.004MG CHROMIUM/ML N018961 001 Jun 26, 1986

CICLESONIDE

AEROSOL, METERED;INHALATION

ALVESCO

+! ASTRAZENECA PHARMS 0.08MG/INH N021658 002 Jan 10, 2008

+! 0.16MG/INH N021658 003 Jan 10, 2008

AEROSOL, METERED;NASAL

ZETONNA

+! ASTRAZENECA PHARMS 0.037MG/INH N202129 001 Jan 20, 2012

SPRAY, METERED;NASAL

OMNARIS

+! ASTRAZENECA PHARMS 0.05MG/INH N022004 001 Oct 20, 2006

CICLOPIROX

CREAM;TOPICAL

CICLOPIROX

AB FOUGERA PHARMS 0.77% A076435 001 Dec 29, 2004

AB G AND W LABS INC 0.77% A078463 001 Dec 20, 2010

AB GLENMARK PHARMS 0.77% A090273 001 Nov 10, 2009

AB PERRIGO NEW YORK 0.77% A077364 001 Mar 03, 2006

AB TARO 0.77% A076790 001 Apr 12, 2005

LOPROX

AB +! MEDIMETRIKS PHARMS 0.77% N018748 001 Dec 30, 1982

GEL;TOPICAL

CICLOPIROX

AB +! CNTY LINE PHARMS 0.77% N020519 001 Jul 21, 1997

AB FOUGERA PHARMS 0.77% A077896 001 Jun 10, 2008

AB GLENMARK GENERICS 0.77% A091595 001 Feb 29, 2012

AB PADDOCK LLC 0.77% A078266 001 Jan 07, 2009



SHAMPOO;TOPICAL

CICLOPIROX

AT ACTAVIS MID 1% A090490 001 Nov 24, 2009

ATLANTIC

AT FOUGERA PHARMS 1% A090146 001 May 25, 2010

AT PERRIGO CO 1% A078594 001 Feb 16, 2010

AT TARO 1% A090269 001 Feb 23, 2011

AT TELIGENT PHARMA INC 1% A209975 001 Apr 05, 2018

LOPROX

AT +! MEDICIS 1% N021159 001 Feb 28, 2003

SOLUTION;TOPICAL

CICLOPIROX

AT ACTAVIS MID 8% A078046 001 Sep 18, 2007

ATLANTIC

AT AKORN 8% A078975 001 Feb 17, 2010

AT APOTEX INC 8% A078172 001 Sep 18, 2007

AT G AND W LABS 8% A078233 001 Sep 18, 2007

AT HI TECH PHARMA 8% A078270 001 Sep 18, 2007

AT INGENUS PHARMS LLC 8% A078124 001 Sep 18, 2007

AT PERRIGO NEW YORK 8% A077623 001 Sep 18, 2007

AT TARO PHARM INDS 8% A078144 001 Sep 18, 2007

AT TOLMAR 8% A077687 001 Sep 18, 2007

PENLAC

AT +! VALEANT BERMUDA 8% N021022 001 Dec 17, 1999

SUSPENSION;TOPICAL

CICLOPIROX

AB FOUGERA PHARMS 0.77% A076422 001 Aug 06, 2004

AB PERRIGO NEW YORK 0.77% A077676 001 Dec 15, 2006

AB TARO 0.77% A077092 001 Aug 10, 2005



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-95(of 452)

CICLOPIROX

SUSPENSION;TOPICAL

LOPROX

AB +! MEDIMETRIKS PHARMS 0.77% N019824 001 Dec 30, 1988

CIDOFOVIR

INJECTABLE;INJECTION

CIDOFOVIR

AP EMCURE PHARMS LTD EQ 75MG BASE/ML A202501 001 Jul 26, 2012

AP ! MYLAN INSTITUTIONAL EQ 75MG BASE/ML A201276 001 Jun 27, 2012



CILASTATIN SODIUM; IMIPENEM

POWDER;INTRAVENOUS

IMIPENEM AND CILASTATIN



AP ACS DOBFAR EQ 500MG BASE/VIAL;500MG/VIAL A090577 002 Dec 21, 2011

AP HOSPIRA INC EQ 500MG BASE/VIAL;500MG/VIAL A090825 002 Nov 16, 2011

AP EQ 500MG BASE/VIAL;500MG/VIAL A091007 001 Nov 16, 2011

PRIMAXIN

AP +! MERCK EQ 500MG BASE/VIAL;500MG/VIAL N050587 002 Nov 26, 1985

IMIPENEM AND CILASTATIN

! ACS DOBFAR EQ 250MG BASE/VIAL;250MG/VIAL A090577 001 Dec 21, 2011

CILOSTAZOL

TABLET;ORAL

CILOSTAZOL

AB APOTEX INC 50MG A077030 001 Dec 10, 2004

AB 100MG A077030 002 Dec 10, 2004

AB BRECKENRIDGE PHARM 50MG A077708 001 Sep 28, 2009

AB 100MG A077708 002 Sep 28, 2009

AB CASI PHARMS INC 50MG A077310 001 Nov 08, 2005

AB 100MG A077021 001 Nov 23, 2004

AB CHARTWELL RX 50MG A077722 001 Sep 24, 2012

AB 100MG A077831 001 Sep 24, 2012

AB FRONTIDA BIOPHARM 50MG A077208 002 Mar 29, 2006

AB 100MG A077208 001 Mar 29, 2006

AB ! TEVA 50MG A077027 001 Nov 24, 2004

AB ! 100MG A077027 002 Nov 24, 2004

AB WEST-WARD PHARMS 50MG A077024 001 May 17, 2005

INT

AB 100MG A077024 002 May 17, 2005

CIMETIDINE

TABLET;ORAL

CIMETIDINE

AB APOTEX 200MG A074890 001 Dec 18, 1998

AB 300MG A074890 002 Dec 18, 1998

AB 400MG A074890 003 Dec 18, 1998

AB 800MG A074890 004 Dec 18, 1998

AB MYLAN 200MG A074246 001 May 17, 1994

AB 300MG A074246 002 May 17, 1994

AB 400MG A074246 003 May 17, 1994

AB ! 800MG A074246 004 May 17, 1994

AB PLIVA 800MG A074566 001 Feb 27, 1997

AB TEVA 200MG A074151 001 May 17, 1994

AB 300MG A074151 002 May 17, 1994

AB 400MG A074151 003 May 17, 1994

AB 800MG A074463 001 May 17, 1994



CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CIMETIDINE HYDROCHLORIDE

DAVA PHARMS INC EQ 300MG BASE/2ML A074428 001 Apr 25, 1996

SOLUTION;ORAL

CIMETIDINE HYDROCHLORIDE

AA ANI PHARMS INC EQ 300MG BASE/5ML A074610 001 Sep 26, 1996

AA ! HI TECH PHARMA EQ 300MG BASE/5ML A074664 001 Oct 28, 1997

AA PHARM ASSOC EQ 300MG BASE/5ML A074553 001 Jan 27, 1997

AA WOCKHARDT BIO AG EQ 300MG BASE/5ML A074757 001 Oct 17, 1997



CINACALCET HYDROCHLORIDE

TABLET;ORAL

CINACALCET HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 30MG BASE A206125 001 Mar 08, 2018

LTD

AB EQ 60MG BASE A206125 002 Mar 08, 2018

AB EQ 90MG BASE A206125 003 Mar 08, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-96(of 452)

CINACALCET HYDROCHLORIDE

TABLET;ORAL

CINACALCET HYDROCHLORIDE

AB CIPLA EQ 30MG BASE A208915 001 Mar 08, 2018

AB EQ 60MG BASE A208915 002 Mar 08, 2018

AB EQ 90MG BASE A208915 003 Mar 08, 2018

AB MYLAN PHARMS INC EQ 30MG BASE A203422 001 Oct 16, 2018

AB EQ 60MG BASE A203422 002 Oct 16, 2018

AB EQ 90MG BASE A203422 003 Oct 16, 2018

AB PIRAMAL HLTHCARE UK EQ 30MG BASE A210207 001 Aug 01, 2018

AB EQ 60MG BASE A210207 002 Aug 01, 2018

AB EQ 90MG BASE A210207 003 Aug 01, 2018

AB STRIDES PHARMA EQ 30MG BASE A209226 001 Apr 30, 2018

AB EQ 60MG BASE A209226 002 Apr 30, 2018

AB EQ 90MG BASE A209226 003 Apr 30, 2018

AB SUN PHARMA GLOBAL EQ 30MG BASE A207008 001 Oct 11, 2018

AB EQ 60MG BASE A207008 002 Oct 11, 2018

AB EQ 90MG BASE A207008 003 Oct 11, 2018

AB WATSON LABS TEVA EQ 30MG BASE A204377 001 Dec 27, 2018

AB EQ 60MG BASE A204377 002 Dec 27, 2018

AB EQ 90MG BASE A204377 003 Dec 27, 2018

SENSIPAR

AB + AMGEN EQ 30MG BASE N021688 001 Mar 08, 2004

AB + EQ 60MG BASE N021688 002 Mar 08, 2004

AB +! EQ 90MG BASE N021688 003 Mar 08, 2004



CIPROFLOXACIN

FOR SUSPENSION;ORAL

CIPRO

AB + BAYER HLTHCARE 250MG/5ML N020780 001 Sep 26, 1997

AB +! 500MG/5ML N020780 002 Sep 26, 1997

CIPROFLOXACIN

AB LUPIN LTD 250MG/5ML A200563 001 Mar 05, 2014

AB 500MG/5ML A200563 002 Mar 05, 2014



INJECTABLE;INJECTION

CIPROFLOXACIN

AP ! BAXTER HLTHCARE 200MG/20ML (10MG/ML) A078062 001 Apr 29, 2008

CORP

AP ! 400MG/40ML (10MG/ML) A078062 002 Apr 29, 2008

AP HIKMA FARMACEUTICA 200MG/20ML (10MG/ML) A076717 001 Dec 22, 2009

AP 400MG/40ML (10MG/ML) A076717 002 Dec 22, 2009

AP HOSPIRA 200MG/20ML (10MG/ML) A077245 001 Aug 28, 2006

AP 400MG/40ML (10MG/ML) A077245 002 Aug 28, 2006

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER



AP BAXTER HLTHCARE 200MG/100ML A078024 001 Mar 18, 2008

CORP

AP 400MG/200ML A078024 002 Mar 18, 2008

AP HIKMA FARMACEUTICA 400MG/200ML A078431 001 Nov 18, 2009

AP ! HOSPIRA 200MG/100ML A077753 001 Mar 18, 2008

AP ! 400MG/200ML A077753 002 Mar 18, 2008

AP INFORLIFE 200MG/100ML A078252 001 Mar 18, 2008

AP 400MG/200ML A078252 002 Mar 18, 2008



INJECTABLE, SUSPENSION;OTIC

OTIPRIO

+! OTONOMY INC 6% (60MG/ML) N207986 001 Dec 10, 2015

CIPROFLOXACIN HYDROCHLORIDE

OINTMENT;OPHTHALMIC

CILOXAN

+! NOVARTIS PHARMS EQ 0.3% BASE N020369 001 Mar 30, 1998

CORP

SOLUTION/DROPS;OPHTHALMIC

CILOXAN

AT +! NOVARTIS PHARMS EQ 0.3% BASE N019992 001 Dec 31, 1990

CORP

CIPROFLOXACIN HYDROCHLORIDE

AT AKORN INC EQ 0.3% BASE A076555 001 Dec 11, 2008

AT ALTAIRE PHARMS INC EQ 0.3% BASE A204613 001 May 03, 2018

AT FDC LTD EQ 0.3% BASE A077568 001 Jun 30, 2008

AT RISING PHARMS EQ 0.3% BASE A077689 001 Dec 13, 2006

AT TELIGENT EQ 0.3% BASE A076754 001 Jun 09, 2004

AT WATSON LABS INC EQ 0.3% BASE A076673 001 Jan 21, 2005

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-97(of 452)

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OTIC

CETRAXAL

+! WRASER PHARMS EQ 0.2% BASE N021918 001 May 01, 2009

TABLET;ORAL

CIPRO

AB + BAYER HLTHCARE EQ 250MG BASE N019537 002 Oct 22, 1987

AB +! EQ 500MG BASE N019537 003 Oct 22, 1987

CIPROFLOXACIN HYDROCHLORIDE

AB APOTEX EQ 250MG BASE A076896 001 Nov 04, 2004

AB EQ 500MG BASE A076896 002 Nov 04, 2004

AB EQ 750MG BASE A076896 003 Nov 04, 2004

AB AUROBINDO PHARMA EQ 250MG BASE A077859 001 Apr 26, 2007

AB EQ 500MG BASE A077859 002 Apr 26, 2007

AB EQ 750MG BASE A077859 003 Apr 26, 2007

AB CARLSBAD EQ 250MG BASE A076126 002 Jun 09, 2004

AB EQ 500MG BASE A076126 003 Jun 09, 2004

AB EQ 750MG BASE A076126 004 Jun 09, 2004

AB DR REDDYS LABS LTD EQ 100MG BASE A075593 002 Jun 09, 2004

AB EQ 250MG BASE A075593 003 Jun 09, 2004

AB EQ 500MG BASE A075593 004 Jun 09, 2004

AB EQ 750MG BASE A075593 001 Jun 09, 2004

AB HIKMA EQ 250MG BASE A076558 002 Jun 09, 2004

AB EQ 500MG BASE A076558 003 Jun 09, 2004

AB EQ 750MG BASE A076558 004 Jun 09, 2004

AB IVAX SUB TEVA EQ 250MG BASE A076089 002 Jun 09, 2004

PHARMS

AB EQ 500MG BASE A076089 003 Jun 09, 2004

AB EQ 750MG BASE A076089 004 Jun 09, 2004

AB MYLAN EQ 500MG BASE A075817 003 Jun 09, 2004

AB TARO PHARM EQ 100MG BASE A076912 001 Feb 18, 2005

AB EQ 250MG BASE A076912 002 Oct 06, 2004

AB EQ 500MG BASE A076912 003 Oct 06, 2004

AB EQ 750MG BASE A076912 004 Oct 06, 2004

AB UNIQUE PHARM LABS EQ 250MG BASE A076639 001 Sep 10, 2004

AB EQ 500MG BASE A076639 002 Sep 10, 2004

AB EQ 750MG BASE A076639 003 Sep 10, 2004

AB WATSON LABS EQ 100MG BASE A076794 001 Feb 10, 2005

AB EQ 250MG BASE A076794 002 Jun 09, 2004

AB EQ 500MG BASE A076794 003 Jun 09, 2004

AB EQ 750MG BASE A076794 004 Jun 09, 2004

AB YILING PHARM LTD EQ 250MG BASE A208921 001 Jun 22, 2018

AB EQ 500MG BASE A208921 002 Jun 22, 2018



CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

SOLUTION/DROPS;OTIC

OTOVEL

+! LABORATORIOS SALVAT EQ 0.3% BASE;0.025% N208251 001 Apr 29, 2016

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

SUSPENSION/DROPS;OTIC

CIPRO HC

+! NOVARTIS PHARMS EQ 0.2% BASE;1% N020805 001 Feb 10, 1998

CORP

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CIPROFLOXACIN EXTENDED RELEASE



AB ANCHEN PHARMS 212.6MG;EQ 287.5MG BASE A078166 002 Nov 27, 2007

AB 425.2MG;EQ 574.9MG BASE A078166 001 Nov 27, 2007

AB DR REDDYS LABS LTD 425.2MG;EQ 574.9MG BASE A077701 001 Mar 26, 2007

AB ! MYLAN PHARMS INC 212.6MG;EQ 287.5MG BASE A078183 001 Mar 22, 2007

AB ! 425.2MG;EQ 574.9MG BASE A078183 002 Mar 22, 2007



CIPROFLOXACIN; DEXAMETHASONE

SUSPENSION/DROPS;OTIC

CIPRODEX

+! NOVARTIS PHARMS 0.3%;0.1% N021537 001 Jul 18, 2003

CORP

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-98(of 452)

CISATRACURIUM BESYLATE

INJECTABLE;INJECTION

CISATRACURIUM BESYLATE

AP ACCORD HLTHCARE EQ 2MG BASE/ML
A205873 001 Jun 16, 2017

AP FRESENIUS KABI USA EQ 2MG BASE/ML


A203183 001 Feb 26, 2015

AP JIANGSU HENGRUI MED EQ 2MG BASE/ML


A209334 001 Aug 30, 2017

AP SANDOZ INC EQ 2MG BASE/ML


A200159 001 Feb 03, 2012

CISATRACURIUM BESYLATE PRESERVATIVE FREE

AP ACCORD HLTHCARE
EQ 2MG BASE/ML
A205872 001 Jun 16, 2017

AP
EQ 10MG BASE/ML
A205872 002 Jun 16, 2017

AP FRESENIUS KABI USA


EQ 2MG BASE/ML
A203182 001 Feb 26, 2015

AP
EQ 10MG BASE/ML
A203182 002 Feb 26, 2015

AP JIANGSU HENGRUI MED


EQ 2MG BASE/ML
A204960 001 Jan 27, 2017

AP
EQ 10MG BASE/ML
A204960 002 Sep 19, 2017

AP SANDOZ INC
EQ 2MG BASE/ML
A200154 001 Feb 03, 2012

AP
EQ 10MG BASE/ML
A200154 002 Feb 03, 2012

NIMBEX

AP +! ABBVIE
EQ 2MG BASE/ML
N020551 001 Dec 15, 1995

NIMBEX PRESERVATIVE FREE

AP +! ABBVIE
EQ 2MG BASE/ML
N020551 003 Dec 15, 1995

+!
EQ 10MG BASE/ML
N020551 002 Dec 15, 1995

CISPLATIN

INJECTABLE;INJECTION

CISPLATIN

AP ACCORD HLTHCARE 1MG/ML
A206774 001 Aug 18, 2015

AP ! FRESENIUS KABI USA 1MG/ML


A074735 001 Jul 16, 1999

AP GLAND PHARMA LTD 1MG/ML


A207323 001 Mar 17, 2017

AP + HQ SPCLT PHARMA 1MG/ML


N018057 004 Nov 08, 1988

AP MYLAN LABS LTD 1MG/ML


A091062 001 Apr 18, 2012

AP PHARMACHEMIE BV 1MG/ML
A074656 001 May 16, 2000

AP WEST-WARD PHARMS 1MG/ML


A075036 001 Nov 07, 2000

INT
CITALOPRAM HYDROBROMIDE

SOLUTION;ORAL

CITALOPRAM HYDROBROMIDE

AA AUROBINDO PHARMA
EQ 10MG BASE/5ML
A077812 001 Aug 28, 2006

LTD

AA HETERO LABS LTD III
EQ 10MG BASE/5ML
A201450 001 Dec 15, 2015

AA LANNETT CO INC
EQ 10MG BASE/5ML
A077629 001 Jun 15, 2006

AA ! WEST-WARD PHARMS
EQ 10MG BASE/5ML
A077043 001 Dec 13, 2004

INT

TABLET;ORAL

CELEXA

AB + ALLERGAN SALES LLC
EQ 10MG BASE
N020822 001 Apr 27, 2000

AB +
EQ 20MG BASE
N020822 002 Jul 17, 1998

AB +!
EQ 40MG BASE
N020822 003 Jul 17, 1998

CITALOPRAM HYDROBROMIDE

AB AMNEAL PHARMS NY
EQ 10MG BASE
A077289 001 Nov 30, 2006

AB
EQ 20MG BASE
A077289 002 Nov 30, 2006

AB
EQ 40MG BASE
A077289 003 Nov 30, 2006

AB APOTEX INC
EQ 10MG BASE
A077046 001 Nov 24, 2004

AB AUROBINDO
EQ 10MG BASE
A077031 001 Oct 28, 2004

AB
EQ 20MG BASE
A077031 002 Oct 28, 2004

AB
EQ 40MG BASE
A077031 003 Oct 28, 2004

AB CHARTWELL MOLECULAR
EQ 10MG BASE
A077044 001 Nov 05, 2004

AB
EQ 20MG BASE
A077044 002 Nov 05, 2004

AB
EQ 40MG BASE
A077044 003 Nov 05, 2004

AB DR REDDYS LABS LTD


EQ 10MG BASE
A077038 001 Oct 28, 2004

AB
EQ 20MG BASE
A077038 002 Oct 28, 2004

AB
EQ 40MG BASE
A077038 003 Oct 28, 2004

AB EPIC PHARMA
EQ 10MG BASE
A077045 003 Apr 29, 2005

AB
EQ 20MG BASE
A077045 002 Apr 29, 2005

AB
EQ 40MG BASE
A077045 001 Apr 29, 2005

AB G AND W LABS INC


EQ 10MG BASE
A077048 001 Nov 16, 2004

AB
EQ 20MG BASE
A077048 002 Nov 16, 2004

AB
EQ 40MG BASE
A077048 003 Nov 16, 2004

AB GLENMARK GENERICS
EQ 10MG BASE
A077654 001 Feb 27, 2009

AB
EQ 20MG BASE
A077654 002 Feb 27, 2009

AB
EQ 40MG BASE
A077654 003 Feb 27, 2009

AB INVAGEN PHARMS
EQ 10MG BASE
A077534 001 Oct 03, 2006

AB
EQ 20MG BASE
A077534 002 Oct 03, 2006

AB
EQ 40MG BASE
A077534 003 Oct 03, 2006

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-99(of 452)

CITALOPRAM HYDROBROMIDE

TABLET;ORAL

CITALOPRAM HYDROBROMIDE

AB JUBILANT GENERICS EQ 10MG BASE A205407 001 Dec 23, 2015

AB EQ 20MG BASE A205407 002 Dec 23, 2015

AB EQ 40MG BASE A205407 003 Dec 23, 2015

AB MYLAN EQ 10MG BASE A077042 001 Nov 05, 2004

AB EQ 20MG BASE A077042 002 Nov 05, 2004

AB EQ 40MG BASE A077042 003 Nov 05, 2004

AB PLIVA EQ 10MG BASE A077232 001 Oct 31, 2005

AB EQ 20MG BASE A077232 002 Oct 31, 2005

AB EQ 40MG BASE A077232 003 Oct 31, 2005

AB SUN PHARM INDS INC EQ 10MG BASE A077032 001 Nov 12, 2004

AB EQ 20MG BASE A077032 002 Nov 12, 2004

AB EQ 40MG BASE A077032 003 Nov 12, 2004

AB TORPHARM EQ 20MG BASE A077046 002 Nov 24, 2004

AB EQ 40MG BASE A077046 003 Nov 24, 2004

AB TORRENT PHARMS EQ 10MG BASE A078216 001 Mar 27, 2007

AB EQ 20MG BASE A078216 002 Mar 27, 2007

AB EQ 40MG BASE A078216 003 Mar 27, 2007



CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

SOLUTION;IRRIGATION

RENACIDIN

+! UNITED GUARDIAN 6.602GM/100ML;198MG/100ML;3.177GM/100ML N019481 001 Oct 02, 1990

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FOR SOLUTION;ORAL

PREPOPIK

+! FERRING PHARMS INC 12GM/PACKET;3.5GM/PACKET;10MG/PACKET N202535 001 Jul 16, 2012

SOLUTION;ORAL

CLENPIQ

+! FERRING PHARMS INC 12GM/BOT;3.5GM/BOT;10MG/BOT N209589 001 Nov 28, 2017

CITRIC ACID; UREA C-13

FOR SOLUTION, TABLET, FOR SOLUTION;ORAL

IDKIT:HP

+! EXALENZ BIOSCIENCE N/A,4GM;75MG,N/A N021314 001 Dec 17, 2002

CLADRIBINE

INJECTABLE;INJECTION

CLADRIBINE

AP ! FRESENIUS KABI USA 1MG/ML A076571 001 Apr 22, 2004

AP MYLAN LABS LTD 1MG/ML A200510 001 Oct 06, 2011

AP WEST-WARD PHARMS 1MG/ML A075405 001 Feb 28, 2000

INT

CLARITHROMYCIN

FOR SUSPENSION;ORAL

CLARITHROMYCIN

AB SANDOZ 125MG/5ML A065283 002 Sep 04, 2007

AB ! 250MG/5ML A065283 003 Sep 04, 2007

TABLET;ORAL

CLARITHROMYCIN

AB ALLIED PHARMA INC 250MG A202710 001 Jun 10, 2013

AB 500MG A202710 002 Jun 10, 2013

AB APOTEX CORP 250MG A065384 001 Aug 20, 2007

AB 500MG A065384 002 Aug 20, 2007

AB ! AUROBINDO 250MG A065489 001 Jul 25, 2012

AB ! 500MG A065489 002 Jul 25, 2012

AB HEC PHARM 250MG A203584 001 Sep 28, 2015

AB 500MG A203584 002 Sep 28, 2015

AB SANDOZ 250MG A065144 001 Oct 18, 2005

AB 500MG A065136 001 Aug 25, 2005

AB TEVA 250MG A065155 001 May 31, 2005

AB 500MG A065155 002 May 31, 2005

AB WEST-WARD PHARMS 250MG A065178 002 May 25, 2004

INT

AB 500MG A065178 001 May 25, 2004

AB WOCKHARDT 250MG A065266 001 May 31, 2006

AB 500MG A065266 002 May 31, 2006

TABLET, EXTENDED RELEASE;ORAL

CLARITHROMYCIN

AB ACTAVIS LABS FL INC 500MG A065145 001 Jun 24, 2004

AB ALLIED 500MG A203243 001 Feb 29, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-100(of 452)

CLARITHROMYCIN

TABLET, EXTENDED RELEASE;ORAL

CLARITHROMYCIN

AB LUPIN LTD 500MG A202532 001 Sep 15, 2015

AB ! MAYNE PHARMA 500MG A065154 001 May 18, 2005

AB SUNSHINE LAKE 500MG A208987 001 Jul 09, 2018



CLEMASTINE FUMARATE

SYRUP;ORAL

CLEMASTINE FUMARATE

! TEVA EQ 0.5MG BASE/5ML A073399 001 Jun 30, 1994

TABLET;ORAL

CLEMASTINE FUMARATE

! TEVA 2.68MG A073283 001 Jan 31, 1992

CLEVIDIPINE

EMULSION;INTRAVENOUS

CLEVIPREX

+! CHIESI USA INC 25MG/50ML (0.5MG/ML) N022156 001 Aug 01, 2008

+! 50MG/100ML (0.5MG/ML) N022156 002 Aug 01, 2008



CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL

CLEOCIN HYDROCHLORIDE

AB + PHARMACIA AND EQ 75MG BASE N050162 001

UPJOHN

AB + EQ 150MG BASE N050162 002

AB +! EQ 300MG BASE N050162 003 Apr 14, 1988

CLINDAMYCIN HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 150MG BASE A065442 001 Aug 26, 2009

AB EQ 300MG BASE A065442 002 Aug 26, 2009

AB EPIC PHARMA LLC EQ 150MG BASE A065194 001 Mar 22, 2004

AB EQ 300MG BASE A065194 002 Mar 22, 2004

AB G AND W LABS INC EQ 150MG BASE A063029 001 Sep 20, 1989

AB EQ 300MG BASE A063029 002 Aug 05, 2005

AB LANNETT CO INC EQ 75MG BASE A065243 002 Aug 12, 2005

AB EQ 150MG BASE A065243 003 Aug 12, 2005

AB EQ 300MG BASE A065243 001 Aug 12, 2005

AB MICRO LABS EQ 75MG BASE A207402 001 Nov 05, 2018

AB EQ 150MG BASE A207402 002 Nov 05, 2018

AB EQ 300MG BASE A207402 003 Nov 05, 2018

AB SUN PHARM INDS LTD EQ 150MG BASE A065061 001 Feb 02, 2001

AB EQ 300MG BASE A065061 002 Feb 02, 2001

AB WATSON LABS EQ 150MG BASE A063083 001 Jul 31, 1991

AB EQ 300MG BASE A063083 002 Mar 18, 2003

AB ZYDUS PHARMS USA EQ 75MG BASE A065217 001 Jan 31, 2005

AB EQ 150MG BASE A065217 002 Jan 31, 2005

AB EQ 300MG BASE A065217 003 Jan 31, 2005



CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION;ORAL

CLEOCIN

AA ! PHARMACIA AND EQ 75MG BASE/5ML A062644 001 Apr 07, 1986

UPJOHN

CLINDAMYCIN PALMITATE HYDROCHLORIDE

AA AMNEAL PHARMS EQ 75MG BASE/5ML A203513 001 Mar 13, 2014

AA AUROBINDO PHARMA EQ 75MG BASE/5ML A202409 001 Apr 30, 2013

LTD

AA HERITAGE PHARMS INC EQ 75MG BASE/5ML A207047 001 May 11, 2018

AA LYNE EQ 75MG BASE/5ML A201821 001 Aug 28, 2012

AA MYLAN PHARMS INC EQ 75MG BASE/5ML A203063 001 May 25, 2016

AA ORIT LABS LLC EQ 75MG BASE/5ML A206958 001 May 05, 2017

AA PADDOCK LLC EQ 75MG BASE/5ML A090902 001 Jul 07, 2010



CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL

CLINDAMYCIN PHOSPHATE

AT PERRIGO UK FINCO 1% A090785 001 Mar 31, 2010

EVOCLIN

AT +! MYLAN PHARMS INC 1% N050801 001 Oct 22, 2004

CREAM;VAGINAL

CLEOCIN

AB +! PHARMACIA AND EQ 2% BASE N050680 002 Mar 02, 1998

UPJOHN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-101(of 452)

CLINDAMYCIN PHOSPHATE

CREAM;VAGINAL

CLINDAMYCIN PHOSPHATE

AB FOUGERA PHARMS EQ 2% BASE A065139 001 Dec 27, 2004

CLINDESSE

+! PERRIGO PHARMA INTL EQ 2% BASE N050793 001 Nov 30, 2004

GEL;TOPICAL

CLEOCIN T

AB +! PHARMACIA AND EQ 1% BASE N050615 001 Jan 07, 1987

UPJOHN

CLINDAMYCIN PHOSPHATE

AB FOUGERA PHARMS EQ 1% BASE A064160 001 Jan 28, 2000

CLINDAGEL

BT +! PRECISION DERMAT EQ 1% BASE N050782 001 Nov 27, 2000

INJECTABLE;INJECTION

CLEOCIN PHOSPHATE

AP PHARMACIA AND EQ 150MG BASE/ML A062803 001 Oct 16, 1987

UPJOHN

AP +! EQ 150MG BASE/ML N050441 001

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP +! PHARMACIA AND EQ 6MG BASE/ML N050639 001 Aug 30, 1989
UPJOHN
AP +! EQ 12MG BASE/ML N050639 002 Aug 30, 1989
AP +! EQ 18MG BASE/ML N050639 003 Apr 10, 1991
CLINDAMYCIN PHOSPHATE
AP ALVOGEN INC EQ 150MG BASE/ML A062800 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062801 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062943 001 Sep 29, 1988
AP FRESENIUS KABI USA EQ 150MG BASE/ML A065346 001 Mar 29, 2007
AP EQ 150MG BASE/ML A065347 001 May 09, 2007
AP MYLAN LABS LTD EQ 150MG BASE/ML A204748 001 Oct 10, 2017
AP EQ 150MG BASE/ML A204749 001 Oct 10, 2017
AP SAGENT PHARMS EQ 150MG BASE/ML A090108 001 Sep 30, 2011
AP EQ 150MG BASE/ML A090109 001 Sep 30, 2011
AP WEST-WARD PHARMS EQ 150MG BASE/ML A062889 001 Apr 25, 1988
INT
AP EQ 150MG BASE/ML A065206 001 Sep 24, 2004
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
AP AKORN INC EQ 6MG BASE/ML A203048 001 Apr 04, 2013

AP EQ 12MG BASE/ML A203048 002 Apr 04, 2013

AP EQ 18MG BASE/ML A203048 003 Apr 04, 2013

AP BAXTER HLTHCARE EQ 6MG BASE/ML A208084 001 Jun 28, 2017

CORP

AP EQ 12MG BASE/ML A208084 002 Jun 28, 2017

AP EQ 18MG BASE/ML A208084 003 Jun 28, 2017

AP SANDOZ INC EQ 6MG BASE/ML A201692 001 May 31, 2012

AP EQ 12MG BASE/ML A201692 002 May 31, 2012

AP EQ 18MG BASE/ML A201692 003 May 31, 2012

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%



+! ABRAXIS PHARM EQ 900MG BASE/100ML N050635 001 Dec 22, 1989

LOTION;TOPICAL

CLEOCIN T

AB +! PHARMACIA AND EQ 1% BASE N050600 001 May 31, 1989

UPJOHN

CLINDAMYCIN PHOSPHATE

AB FOUGERA PHARMS EQ 1% BASE A065067 001 Jan 31, 2002

SOLUTION;INTRAVENOUS

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE

+! BAXTER HLTHCARE EQ 300MG BASE/50ML (EQ 6MG BASE/ML) N208083 001 Apr 20, 2017

CORP

+! EQ 600MG BASE/50ML (EQ 12MG BASE/ML) N208083 002 Apr 20, 2017

+! EQ 900MG BASE/50ML (EQ 18MG BASE/ML) N208083 003 Apr 20, 2017

SOLUTION;TOPICAL

CLEOCIN T

AT +! PHARMACIA AND EQ 1% BASE N050537 001

UPJOHN

CLINDA-DERM

AT PADDOCK LLC EQ 1% BASE A063329 001 Sep 30, 1992

CLINDAMYCIN PHOSPHATE

AT FOUGERA PHARMS EQ 1% BASE A065254 001 Feb 14, 2006

AT FOUGERA PHARMS INC EQ 1% BASE A064159 001 Jun 05, 1997

AT G AND W LABS INC EQ 1% BASE A062811 001 Sep 01, 1988

AT GLASSHOUSE PHARMS EQ 1% BASE A209846 001 Feb 08, 2018

AT PERRIGO NEW YORK EQ 1% BASE A064050 001 Nov 30, 1995



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-102(of 452)

CLINDAMYCIN PHOSPHATE

SOLUTION;TOPICAL

CLINDAMYCIN PHOSPHATE

AT TARO PHARM INDS EQ 1% BASE A065184 001 Mar 31, 2004

AT TELIGENT PHARMA INC EQ 1% BASE A206945 001 Dec 30, 2016

AT VINTAGE PHARMS EQ 1% BASE A203343 001 May 29, 2015

AT ZYDUS PHARMS USA EQ 1% BASE A208767 001 Jul 16, 2018

INC

SUPPOSITORY;VAGINAL

CLEOCIN

+! PHARMACIA AND 100MG N050767 001 Aug 13, 1999

UPJOHN

SWAB;TOPICAL

CLEOCIN

AT + PHARMACIA AND EQ 1% BASE N050537 002 Feb 22, 1994

UPJOHN

CLINDAMYCIN PHOSPHATE

AT AKORN EQ 1% BASE A065513 001 Jun 17, 2010

AT PERRIGO NEW YORK EQ 1% BASE A065049 001 May 25, 2000

CLINDETS

AT PERRIGO CO EQ 1% BASE A064136 001 Sep 30, 1996

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL;TOPICAL

CLINDAMYCIN PHOSPHATE AND TRETINOIN



AB ACTAVIS MID 1.2%;0.025% A202564 001 Jun 12, 2015

ATLANTIC

ZIANA

AB +! MEDICIS 1.2%;0.025% N050802 001 Nov 07, 2006

VELTIN

BX +! AQUA PHARMS LLC 1.2%;0.025% N050803 001 Jul 16, 2010

CLOBAZAM

FILM;ORAL

SYMPAZAN

+ AQUESTIVE THERAP 5MG N210833 001 Nov 01, 2018

+ 10MG N210833 002 Nov 01, 2018

+! 20MG N210833 003 Nov 01, 2018

SUSPENSION;ORAL

CLOBAZAM

AB AMNEAL PHARMS LLC 2.5MG/ML A210039 001 Oct 22, 2018

AB BIONPHARMA INC 2.5MG/ML A208819 001 Oct 22, 2018

AB LUPIN LTD 2.5MG/ML A210546 001 Dec 28, 2018

AB MYLAN PHARMS INC 2.5MG/ML A211259 001 Oct 22, 2018

AB UPSHER SMITH LABS 2.5MG/ML A210569 001 Oct 22, 2018

AB WEST-WARD PHARMS 2.5MG/ML A209715 001 Oct 22, 2018

INT

ONFI

AB +! LUNDBECK PHARMS LLC 2.5MG/ML N203993 001 Dec 14, 2012

TABLET;ORAL

CLOBAZAM

AB AMNEAL PHARMS CO 10MG A209718 001 Oct 22, 2018

AB 20MG A209718 002 Oct 22, 2018

AB BIONPHARMA INC 10MG A208825 001 Oct 22, 2018

AB 20MG A208825 002 Oct 22, 2018

AB BRECKENRIDGE PHARM 10MG A209308 001 Oct 22, 2018

AB 20MG A209308 002 Oct 22, 2018

AB HETERO LABS LTD III 10MG A209795 001 Oct 22, 2018

AB 20MG A209795 002 Oct 22, 2018

AB LUPIN LTD 10MG A210545 001 Dec 14, 2018

AB 20MG A210545 002 Dec 14, 2018

AB PIRAMAL HLTHCARE UK 10MG A209808 001 Oct 22, 2018

AB 20MG A209808 002 Oct 22, 2018

AB TARO PHARM 10MG A209440 001 Oct 22, 2018

AB 20MG A209440 002 Oct 22, 2018

AB UPSHER SMITH LABS 10MG A209687 001 Oct 22, 2018

AB 20MG A209687 002 Oct 22, 2018

AB WEST-WARD PHARMS 10MG A208785 001 Oct 22, 2018

INT

AB 20MG A208785 002 Oct 22, 2018
AB ZYDUS PHARMS USA 10MG A211449 001 Oct 22, 2018
INC
AB 20MG A211449 002 Oct 22, 2018
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-103(of 452)

CLOBAZAM

TABLET;ORAL

ONFI

AB + LUNDBECK PHARMS LLC 10MG N202067 002 Oct 21, 2011

AB +! 20MG N202067 003 Oct 21, 2011



CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

CLOBETASOL PROPIONATE

AB1 INGENUS PHARMS LLC 0.05% A206805 001 Jul 31, 2017

AB1 PERRIGO ISRAEL 0.05% A077763 001 Mar 10, 2008

AB1 TARO PHARM 0.05% A208779 001 Oct 04, 2018

OLUX

AB1 +! MYLAN PHARMS INC 0.05% N021142 001 May 26, 2000

CLOBETASOL PROPIONATE

AB2 PERRIGO ISRAEL 0.05% A201402 001 Aug 14, 2012

OLUX E

AB2 +! MYLAN PHARMS INC 0.05% N022013 001 Jan 12, 2007

CREAM;TOPICAL

CLOBETASOL PROPIONATE

AB1 AMNEAL PHARMS LLC 0.05% A211256 001 Dec 26, 2018

AB1 CHEMO RESEARCH SL 0.05% A210034 001 Jun 15, 2018

AB1 FOUGERA PHARMS INC 0.05% A074392 001 Sep 30, 1996

AB1 G AND W LABS INC 0.05% A074139 001 Aug 03, 1994

AB1 GLENMARK PHARMS 0.05% A209095 001 May 10, 2018

AB1 LUPIN LTD 0.05% A210208 001 Jan 30, 2018

AB1 MYLAN PHARMS INC 0.05% A075338 001 Feb 09, 2001

AB1 SOLARIS PHARMA CORP 0.05% A211401 001 Jan 11, 2019

AB1 TARO 0.05% A074249 001 Jul 08, 1996

AB1 TELIGENT PHARMA INC 0.05% A209974 001 Apr 17, 2018

AB1 ZYDUS PHARMS USA 0.05% A211074 001 Oct 15, 2018

INC

CORMAX

AB1 ! HI TECH PHARMA 0.05% A074220 001 May 16, 1997

CLOBETASOL PROPIONATE (EMOLLIENT)

AB2 ! FOUGERA PHARMS 0.05% A075430 001 May 26, 1999

AB2 TARO 0.05% A075633 001 May 17, 2000

AB2 TELIGENT PHARMA INC 0.05% A209411 001 Aug 21, 2017

EMBELINE E

AB2 HI TECH PHARMA 0.05% A075325 001 Dec 24, 1998

IMPOYZ

+! ENCORE DERMAT 0.025% N209483 001 Nov 28, 2017

GEL;TOPICAL

CLOBETASOL PROPIONATE

AB ! FOUGERA PHARMS 0.05% A075368 001 Feb 15, 2000

AB PERRIGO CO 0.05% A075027 001 Oct 31, 1997

AB TARO 0.05% A075279 001 May 28, 1999

AB TELIGENT PHARMA INC 0.05% A208881 001 Mar 06, 2017

EMBELINE

AB HI TECH PHARMA 0.05% A076141 001 Apr 12, 2002

LOTION;TOPICAL

CLOBETASOL PROPIONATE

AB ACTAVIS MID 0.05% A078223 001 Dec 04, 2008

ATLANTIC

AB HI-TECH PHARMACAL 0.05% A211348 001 Oct 26, 2018

AB LUPIN LTD 0.05% A209147 001 Sep 22, 2017

AB TARO 0.05% A200302 001 Jul 02, 2012

AB TELIGENT PHARMA INC 0.05% A208667 001 Nov 29, 2016

CLOBEX

AB +! GALDERMA LABS LP 0.05% N021535 001 Jul 24, 2003

OINTMENT;TOPICAL

CLOBETASOL PROPIONATE

AB AMNEAL PHARMS LLC 0.05% A210551 001 Aug 21, 2018

AB CHEMO RESEARCH SL 0.05% A209701 001 Apr 17, 2018

AB ! FOUGERA PHARMS 0.05% A074407 001 Feb 23, 1996

AB G AND W LABS INC 0.05% A074089 001 Feb 16, 1994

AB GLENMARK PHARMS 0.05% A208933 001 Mar 20, 2017

AB MYLAN PHARMS INC 0.05% A075057 001 Aug 12, 1998

AB NOVEL LABS INC 0.05% A208841 001 May 04, 2018

AB TARO 0.05% A074248 001 Jul 12, 1996

AB ZYDUS PHARMS USA 0.05% A210199 001 Oct 27, 2017

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-104(of 452)

CLOBETASOL PROPIONATE

OINTMENT;TOPICAL

EMBELINE

AB HI TECH PHARMA 0.05% A074221 001 Mar 31, 1995

SHAMPOO;TOPICAL

CLOBETASOL PROPIONATE

AB ACTAVIS MID 0.05% A078854 001 Jun 07, 2011

ATLANTIC

AB HI-TECH PHARMACAL 0.05% A209871 001 Oct 27, 2017

AB PERRIGO ISRAEL 0.05% A090974 001 Aug 09, 2012

CLOBEX

AB +! GALDERMA LABS 0.05% N021644 001 Feb 05, 2004

SOLUTION;TOPICAL

CLOBETASOL PROPIONATE

AT FOUGERA PHARMS 0.05% A075391 001 Feb 08, 1999

AT G AND W LABS INC 0.05% A074331 001 Dec 15, 1995

AT GLENMARK PHARMS LTD 0.05% A210190 001 Apr 18, 2018

AT MACLEODS PHARMS LTD 0.05% A209361 001 Oct 25, 2017

AT NOVEL LABS INC 0.05% A206075 001 Nov 23, 2015

AT TARO 0.05% A075224 001 Nov 16, 1998

AT 0.05% A075363 001 Dec 29, 2000

AT TOLMAR 0.05% A076977 001 Aug 05, 2005

AT WOCKHARDT BIO AG 0.05% A075205 001 Nov 13, 1998

EMBELINE

AT ! HI TECH PHARMA 0.05% A074222 001 Dec 06, 1995

SPRAY;TOPICAL

CLOBETASOL PROPIONATE

AT AKORN 0.05% A207218 001 Apr 28, 2017

AT GLENMARK PHARMS 0.05% A209004 001 Mar 26, 2018

AT LUPIN LTD 0.05% A208125 001 Mar 26, 2018

AT PADDOCK LLC 0.05% A090898 001 Jun 16, 2011

AT TARO 0.05% A208842 001 Mar 26, 2018

AT ZYDUS PHARMS USA 0.05% A206378 001 Feb 16, 2017

INC

CLOBEX

AT +! GALDERMA LABS LP 0.05% N021835 001 Oct 27, 2005

CLOCORTOLONE PIVALATE

CREAM;TOPICAL

CLODERM

+! EPI HLTH 0.1% N017765 001

CLOFARABINE

SOLUTION;INTRAVENOUS

CLOFARABINE

AP ABON PHARMS LLC 20MG/20ML (1MG/ML) A204029 001 May 09, 2017

AP AMNEAL PHARMS CO 20MG/20ML (1MG/ML) A208857 001 Nov 06, 2017

AP DR REDDYS LABS LTD 20MG/20ML (1MG/ML) A205375 001 Nov 06, 2017

AP GLAND PHARMA LTD 20MG/20ML (1MG/ML) A207831 001 Oct 31, 2018

AP HOSPIRA INC 20MG/20ML (1MG/ML) A210283 001 Dec 27, 2018

AP INGENUS PHARMS LLC 20MG/20ML (1MG/ML) A210270 001 Sep 14, 2018

AP MSN LABS PVT LTD 20MG/20ML (1MG/ML) A209775 001 Dec 06, 2017

AP MYLAN LABS LTD 20MG/20ML (1MG/ML) A208860 001 Nov 06, 2017

CLOLAR

AP +! GENZYME 20MG/20ML (1MG/ML) N021673 001 Dec 28, 2004

CLOMIPHENE CITRATE

TABLET;ORAL

CLOMIPHENE CITRATE

! PAR PHARM 50MG A075528 001 Aug 30, 1999

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

ANAFRANIL

AB +! SPECGX LLC 25MG N019906 001 Dec 29, 1989

AB + 50MG N019906 002 Dec 29, 1989

AB + 75MG N019906 003 Dec 29, 1989

CLOMIPRAMINE HYDROCHLORIDE

AB AMNEAL PHARMS CO 25MG A208632 001 Oct 31, 2018

AB 50MG A208632 002 Oct 31, 2018

AB 75MG A208632 003 Oct 31, 2018

AB LUPIN LTD 25MG A209294 001 Nov 21, 2018

AB 50MG A209294 002 Nov 21, 2018

AB 75MG A209294 003 Nov 21, 2018

AB MYLAN 25MG A074947 001 Apr 30, 1998



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-105(of 452)

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

AB 50MG A074947 002 Apr 30, 1998

AB 75MG A074947 003 Apr 30, 1998

AB SANDOZ 25MG A074364 001 Mar 29, 1996

AB 25MG A074953 001 Jun 25, 1997

AB 50MG A074364 002 Mar 29, 1996

AB 50MG A074953 002 Jun 25, 1997

AB 75MG A074364 003 Mar 29, 1996

AB 75MG A074953 003 Jun 25, 1997

AB TARO 25MG A074694 001 Dec 31, 1996

AB 50MG A074694 002 Dec 31, 1996

AB 75MG A074694 003 Dec 31, 1996

AB TEVA 25MG A074958 001 Aug 26, 1997

AB 50MG A074958 002 Aug 26, 1997

AB 75MG A074958 003 Aug 26, 1997

AB ZYDUS PHARMS USA 25MG A208961 001 Dec 27, 2017

INC

AB 50MG A208961 002 Dec 27, 2017

AB 75MG A208961 003 Dec 27, 2017



CLONAZEPAM

TABLET;ORAL

CLONAZEPAM

AB ACCORD HLTHCARE 0.5MG A077147 001 May 02, 2005

AB 1MG A077147 002 May 02, 2005

AB 2MG A077147 003 May 02, 2005

AB ACTAVIS ELIZABETH 0.5MG A074869 001 Oct 31, 1996

AB 1MG A074869 002 Oct 31, 1996

AB 2MG A074869 003 Oct 31, 1996

AB MYLAN 0.5MG A075150 001 Oct 05, 1998

AB 1MG A075150 002 Oct 05, 1998

AB 2MG A075150 003 Oct 05, 1998

AB PRINSTON INC 0.5MG A077856 001 Jun 28, 2006

AB 1MG A077856 002 Jun 28, 2006

AB 2MG A077856 003 Jun 28, 2006

AB SANDOZ 0.5MG A074979 001 Aug 29, 1997

AB 1MG A074979 002 Aug 29, 1997

AB 2MG A074979 003 Aug 29, 1997

AB SUN PHARM INDS INC 0.5MG A075423 001 Apr 27, 2001

AB 1MG A075423 002 Apr 27, 2001

AB 2MG A075423 003 Apr 27, 2001

AB TEVA 0.5MG A074569 001 Sep 10, 1996

AB 1MG A074569 002 Sep 10, 1996

AB 2MG A074569 003 Sep 10, 1996

AB WATSON LABS 0.5MG A074964 001 Dec 30, 1997

AB 1MG A074964 002 Dec 30, 1997

AB 2MG A074964 003 Dec 30, 1997

KLONOPIN

AB + ROCHE 0.5MG N017533 001

AB +! 1MG N017533 002

AB + 2MG N017533 003

TABLET, ORALLY DISINTEGRATING;ORAL

CLONAZEPAM

AB BARR 0.125MG A077194 001 Aug 10, 2005

AB 0.25MG A077194 002 Aug 10, 2005

AB 0.5MG A077194 003 Aug 10, 2005

AB 1MG A077194 004 Aug 10, 2005

AB 2MG A077194 005 Aug 10, 2005

AB PAR PHARM 0.125MG A077171 001 Aug 03, 2005

AB 0.25MG A077171 002 Aug 03, 2005

AB 0.5MG A077171 003 Aug 03, 2005

AB ! 1MG A077171 004 Aug 03, 2005

AB 2MG A077171 005 Aug 03, 2005

AB SUN PHARM INDS INC 0.125MG A078654 001 Aug 27, 2014

AB 0.25MG A078654 002 Aug 27, 2014

AB 0.5MG A078654 003 Aug 27, 2014

AB 1MG A078654 004 Aug 27, 2014

AB 2MG A078654 005 Aug 27, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-106(of 452)

CLONIDINE

FILM, EXTENDED RELEASE;TRANSDERMAL

CATAPRES-TTS-1

AB + BOEHRINGER 0.1MG/24HR N018891 001 Oct 10, 1984

INGELHEIM

CATAPRES-TTS-2

AB + BOEHRINGER 0.2MG/24HR N018891 002 Oct 10, 1984

INGELHEIM

CATAPRES-TTS-3

AB +! BOEHRINGER 0.3MG/24HR N018891 003 Oct 10, 1984

INGELHEIM

CLONIDINE

AB ACTAVIS LABS UT INC 0.1MG/24HR A090873 001 May 06, 2014

AB 0.2MG/24HR A090873 002 May 06, 2014

AB 0.3MG/24HR A090873 003 May 06, 2014

AB AVEVA 0.1MG/24HR A076157 001 Aug 18, 2009

AB 0.2MG/24HR A076157 002 Aug 18, 2009

AB 0.3MG/24HR A076157 003 Aug 18, 2009

AB MAYNE PHARMA 0.1MG/24HR A079090 001 Aug 20, 2010

AB 0.2MG/24HR A079090 002 Aug 20, 2010

AB 0.3MG/24HR A079090 003 Aug 20, 2010

AB MYLAN TECHNOLOGIES 0.1MG/24HR A076166 001 Jul 16, 2010

AB 0.2MG/24HR A076166 002 Jul 16, 2010

AB 0.3MG/24HR A076166 003 Jul 16, 2010



CLONIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CLONIDINE HYDROCHLORIDE

AP FRESENIUS KABI USA 1MG/10ML (0.1MG/ML) A200673 001 Jul 08, 2011

AP 5MG/10ML (0.5MG/ML) A200673 002 Jul 08, 2011

AP HIKMA FARMACEUTICA 1MG/10ML (0.1MG/ML) A200300 001 Jan 26, 2011

AP 5MG/10ML (0.5MG/ML) A200300 002 Jan 26, 2011

AP LUITPOLD 1MG/10ML (0.1MG/ML) A091104 001 Oct 08, 2009

AP 5MG/10ML (0.5MG/ML) A091104 002 Oct 08, 2009

AP X-GEN PHARMS INC 1MG/10ML (0.1MG/ML) A203167 001 Oct 29, 2013

AP 5MG/10ML (0.5MG/ML) A203167 002 Oct 29, 2013

AP ZYDUS PHARMS USA 1MG/10ML (0.1MG/ML) A202601 001 Feb 20, 2014

INC

AP 5MG/10ML (0.5MG/ML) A202601 002 Feb 20, 2014

DURACLON

AP + MYLAN INSTITUTIONAL 1MG/10ML (0.1MG/ML) N020615 001 Oct 02, 1996

AP +! 5MG/10ML (0.5MG/ML) N020615 002 Apr 27, 1999

TABLET;ORAL

CATAPRES

AB + BOEHRINGER 0.1MG N017407 001

INGELHEIM

AB + 0.2MG N017407 002

AB +! 0.3MG N017407 003

CLONIDINE HYDROCHLORIDE

AB ACTAVIS ELIZABETH 0.1MG A070974 001 Dec 16, 1986

AB 0.2MG A070975 001 Dec 16, 1986

AB 0.3MG A070976 001 Dec 16, 1986

AB ALEMBIC PHARMS LTD 0.1MG A091368 001 Dec 06, 2011

AB 0.2MG A091368 002 Dec 06, 2011

AB 0.3MG A091368 003 Dec 06, 2011

AB FRONTIDA BIOPHARM 0.1MG A070925 001 Sep 04, 1987

AB 0.2MG A070924 001 Sep 04, 1987

AB 0.3MG A070923 001 Sep 04, 1987

AB IMPAX LABS 0.1MG A078099 001 Aug 27, 2009

AB 0.2MG A078099 002 Aug 27, 2009

AB 0.3MG A078099 003 Aug 27, 2009

AB MYLAN 0.1MG A070317 002 Jul 09, 1987

AB 0.2MG A070317 003 Jun 09, 1987

AB 0.3MG A070317 001 Jun 09, 1987

AB PRINSTON INC 0.1MG A077901 001 Mar 09, 2007

AB 0.2MG A077901 002 Mar 09, 2007

AB 0.3MG A077901 003 Mar 09, 2007

AB SUN PHARM INDS INC 0.1MG A090329 001 Jul 03, 2014

AB 0.2MG A090329 002 Jul 03, 2014

AB 0.3MG A090329 003 Jul 03, 2014

AB UNICHEM 0.1MG A078895 001 Aug 26, 2009

AB 0.2MG A078895 002 Aug 26, 2009

AB 0.3MG A078895 003 Aug 26, 2009

AB YUNG SHIN PHARM 0.1MG A202297 001 Jun 13, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-107(of 452)

CLONIDINE HYDROCHLORIDE

TABLET;ORAL

CLONIDINE HYDROCHLORIDE

AB 0.2MG A202297 002 Jun 13, 2013

AB 0.3MG A202297 003 Jun 13, 2013



TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE

AB1 ACTAVIS ELIZABETH 0.1MG A203320 001 May 15, 2015

AB1 AJANTA PHARMA LTD 0.1MG A209686 001 Nov 20, 2017

AB1 AMNEAL PHARMS NY 0.1MG A210052 001 Nov 20, 2017

AB1 ANCHEN PHARMS 0.1MG A202984 001 Sep 30, 2013

AB1 JUBILANT GENERICS 0.1MG A210338 001 Jan 29, 2018

AB1 LUPIN LTD 0.1MG A209285 001 Oct 23, 2017

AB1 MAYNE PHARMA INC 0.1MG A210680 001 Apr 30, 2018

AB1 UPSHER SMITH LABS 0.1MG A211433 001 Oct 12, 2018

AB1 XIAMEN LP PHARM CO 0.1MG A209757 001 Nov 20, 2017

KAPVAY

AB1 +! CONCORDIA PHARMS 0.1MG N022331 003 Sep 28, 2010

INC

CLONIDINE HYDROCHLORIDE

AB2 ACTAVIS ELIZABETH 0.1MG A202792 001 May 15, 2015

CLOPIDOGREL BISULFATE

TABLET;ORAL

CLOPIDOGREL BISULFATE

AB ACCORD HLTHCARE EQ 75MG BASE A202925 001 Mar 27, 2013

AB EQ 300MG BASE A202925 002 Mar 27, 2013

AB ACME LABS EQ 75MG BASE A078004 001 May 17, 2012

AB AMNEAL PHARMS EQ 75MG BASE A203751 001 Apr 11, 2014

AB APOTEX INC EQ 75MG BASE A076274 001 May 17, 2012

AB EQ 300MG BASE A076274 002 Mar 04, 2014

AB AUROBINDO PHARMA EQ 75MG BASE A090540 001 May 17, 2012

LTD

AB CSPC OUYI PHARM CO EQ 75MG BASE A204359 001 Feb 02, 2017

AB DR REDDYS LABS INC EQ 75MG BASE A076273 001 Jan 14, 2008

AB DR REDDYS LABS LTD EQ 300MG BASE A091023 001 May 17, 2012

AB GATE PHARMS EQ 300MG BASE A091216 001 May 17, 2012

AB MACLEODS PHARMS LTD EQ 75MG BASE A202928 001 Feb 10, 2014

AB MYLAN PHARMS INC EQ 75MG BASE A077665 001 May 17, 2012

AB EQ 300MG BASE A077665 002 May 17, 2012

AB PRINSTON INC EQ 75MG BASE A206376 001 May 07, 2018

AB EQ 300MG BASE A206376 002 May 07, 2018

AB SCIEGEN PHARMS INC EQ 75MG BASE A204165 001 Sep 15, 2014

AB EQ 300MG BASE A204165 002 Sep 15, 2014

AB SUN PHARM EQ 75MG BASE A078133 001 Jun 10, 2013

INDUSTRIES

AB SUN PHARMA GLOBAL EQ 75MG BASE A090494 001 May 17, 2012

AB TEVA EQ 75MG BASE A076999 001 May 17, 2012

AB TEVA PHARMS EQ 300MG BASE A090625 001 May 17, 2012

AB TORRENT PHARMS LTD EQ 75MG BASE A090844 001 May 17, 2012

AB WOCKHARDT LTD EQ 75MG BASE A202266 001 Aug 14, 2012

AB EQ 300MG BASE A202266 002 Nov 20, 2012

AB ZYDUS PHARMS USA EQ 75MG BASE A201686 001 Oct 10, 2012

INC

PLAVIX

AB + SANOFI AVENTIS US EQ 75MG BASE N020839 001 Nov 17, 1997

AB +! EQ 300MG BASE N020839 002 Sep 20, 2007



CLORAZEPATE DIPOTASSIUM

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

AB MYLAN 3.75MG A071858 002 Jul 17, 1987

AB 7.5MG A071858 003 Jul 17, 1987

AB ! 15MG A071858 001 Jul 17, 1987

AB TARO PHARM 3.75MG A075731 003 Apr 27, 2000

AB 7.5MG A075731 002 Apr 27, 2000

AB 15MG A075731 001 Apr 27, 2000

GEN-XENE

AB ALRA 3.75MG A071787 001 Apr 26, 1988

AB 7.5MG A071788 001 Apr 26, 1988

AB 15MG A071789 001 Apr 26, 1988

TRANXENE

AB + RECORDATI RARE 7.5MG N017105 007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-108(of 452)

CLOTRIMAZOLE

CREAM;TOPICAL

CLOTRIMAZOLE

AB FOUGERA PHARMS 1% A078338 001 Sep 02, 2008

AB GLENMARK PHARMS 1% A090219 001 Aug 03, 2010

AB ! TARO 1% A072640 001 Aug 31, 1993

SOLUTION;TOPICAL

CLOTRIMAZOLE

AT ! TARO 1% A074580 001 Jul 29, 1996

AT TEVA 1% A073306 001 Feb 28, 1995



TROCHE/LOZENGE;ORAL

CLOTRIMAZOLE

AB PADDOCK LLC 10MG A076763 001 Oct 28, 2005

AB ! WEST-WARD PHARMS 10MG A076387 001 Jul 29, 2004

INT

CLOZAPINE

SUSPENSION;ORAL

VERSACLOZ

+! TASMAN PHARMA 50MG/ML N203479 001 Feb 06, 2013

TABLET;ORAL

CLOZAPINE

AB ACCORD HLTHCARE 25MG A202873 001 Nov 25, 2015

AB 100MG A202873 002 Nov 25, 2015

AB AUROBINDO PHARMA 25MG A206433 001 Nov 29, 2016

LTD

AB 50MG A206433 002 Nov 29, 2016

AB 100MG A206433 003 Nov 29, 2016

AB 200MG A206433 004 Nov 29, 2016

AB IVAX SUB TEVA 25MG A074949 001 Nov 26, 1997

PHARMS

AB 50MG A074949 004 Apr 25, 2005

AB 50MG A076809 003 Dec 16, 2005

AB 100MG A074949 002 Nov 26, 1997

AB 100MG A076809 002 Dec 16, 2005

AB 200MG A076809 001 Dec 16, 2005

AB MAYNE PHARMA 25MG A203807 001 Sep 17, 2015

AB 50MG A203807 003 Aug 22, 2017

AB 100MG A203807 002 Sep 17, 2015

AB 200MG A203807 004 Aug 22, 2017

AB MYLAN 25MG A075417 001 May 27, 1999

AB 50MG A075417 004 Apr 15, 2010

AB 100MG A075417 002 May 27, 1999

AB 200MG A075417 005 Apr 15, 2010

AB SUN PHARM INDS INC 25MG A075713 001 Nov 15, 2002

AB 50MG A075713 003 Aug 19, 2005

AB 100MG A075713 002 Nov 15, 2002

AB 200MG A075713 004 Nov 07, 2017

CLOZARIL

AB + HERITAGE LIFE 25MG N019758 001 Sep 26, 1989

AB +! 100MG N019758 002 Sep 26, 1989

CLOZAPINE

IVAX SUB TEVA 12.5MG A074949 003 Jul 31, 2003

PHARMS

TABLET, ORALLY DISINTEGRATING;ORAL

CLOZAPINE

AB BARR LABS INC 12.5MG A090308 003 Apr 09, 2018

AB 25MG A090308 001 Nov 25, 2015

AB 100MG A090308 002 Nov 25, 2015

AB MYLAN PHARMS INC 25MG A201824 002 Sep 15, 2015

AB 100MG A201824 003 Sep 15, 2015

AB TEVA PHARMS USA 150MG A203039 001 Nov 25, 2015

AB 200MG A203039 002 Nov 25, 2015

FAZACLO ODT

AB + JAZZ PHARMS III 12.5MG N021590 004 May 30, 2007

AB + 25MG N021590 001 Feb 10, 2004

AB +! 100MG N021590 002 Feb 10, 2004

AB + 150MG N021590 005 Jul 09, 2010

AB + 200MG N021590 006 Jul 09, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-109(of 452)

COBICISTAT

TABLET;ORAL

TYBOST

+! GILEAD SCIENCES INC 150MG N203094 001 Sep 24, 2014

COBICISTAT; DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZCOBIX

+! JANSSEN PRODS 150MG;EQ 800MG BASE N205395 001 Jan 29, 2015

COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

SYMTUZA

+! JANSSEN PRODS 150MG;EQ 800MG BASE;200MG;EQ 10MG BASE N210455 001 Jul 17, 2018

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

GENVOYA

+! GILEAD SCIENCES INC 150MG;150MG;200MG;EQ 10MG BASE N207561 001 Nov 05, 2015

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

STRIBILD

+! GILEAD SCIENCES INC 150MG;150MG;200MG;300MG N203100 001 Aug 27, 2012

COBIMETINIB FUMARATE

TABLET;ORAL

COTELLIC

+! GENENTECH INC EQ 20MG BASE N206192 001 Nov 10, 2015

COCAINE HYDROCHLORIDE

SOLUTION;NASAL

GOPRELTO

+! GENUS LIFESCIENCES 4% N209963 001 Dec 14, 2017

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA VINTAGE 10MG/5ML;5MG/5ML;6.25MG/5ML A040660 001 Dec 07, 2006

PROMETH VC W/ CODEINE

AA ! ACTAVIS MID 10MG/5ML;5MG/5ML;6.25MG/5ML A088764 001 Oct 31, 1984

ATLANTIC

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA HI-TECH PHARMA CO 10MG/5ML;5MG/5ML;6.25MG/5ML A040674 001 Dec 23, 2014

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

AA AMNEAL PHARMS 10MG/5ML;5MG/5ML;6.25MG/5ML A200963 001 Aug 26, 2015



CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE



AA ! ACTAVIS MID 10MG/5ML;6.25MG/5ML A088763 001 Oct 31, 1984

ATLANTIC

AA AMNEAL PHARMS 10MG/5ML;6.25MG/5ML A200894 001 Apr 24, 2013

AA HI TECH PHARMA 10MG/5ML;6.25MG/5ML A040151 001 Aug 26, 1997

AA NOSTRUM LABS INC 10MG/5ML;6.25MG/5ML A090180 001 Mar 17, 2010

AA TRIS PHARMA INC 10MG/5ML;6.25MG/5ML A200386 001 Jun 29, 2012

AA WOCKHARDT BIO AG 10MG/5ML;6.25MG/5ML A088875 001 Dec 17, 1984

PROMETHAZINE WITH CODEINE



AA VINTAGE 10MG/5ML;6.25MG/5ML A040650 001 Jan 31, 2006

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

TRIACIN-C

! STI PHARMA LLC 10MG/5ML;30MG/5ML;1.25MG/5ML A088704 001 Mar 22, 1985

CODEINE SULFATE

TABLET;ORAL

CODEINE SULFATE

AB LANNETT CO INC 15MG A203046 001 Jun 13, 2014

AB 30MG A203046 002 Jun 13, 2014

AB 60MG A203046 003 Jun 13, 2014

AB + WEST-WARD PHARMS 15MG N022402 001 Jul 16, 2009

INT

AB + 30MG N022402 002 Jul 16, 2009

AB +! 60MG N022402 003 Jul 16, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-110(of 452)

COLCHICINE

CAPSULE;ORAL

COLCHICINE
AB PAR PHARM INC 0.6MG A208678 001 Nov 29, 2018
MITIGARE
AB +! HIKMA INTL PHARMS 0.6MG N204820 001 Sep 26, 2014
TABLET;ORAL
COLCRYS
+! TAKEDA PHARMS USA 0.6MG N022352 001 Jul 29, 2009
COLCHICINE; PROBENECID
TABLET;ORAL
COL-PROBENECID
AB ! WATSON LABS 0.5MG;500MG A084279 001
PROBENECID AND COLCHICINE
AB NOVAST LABS 0.5MG;500MG A040618 001 May 13, 2008
COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION;ORAL
COLESEVELAM HYDROCHLORIDE
AB GLENMARK PHARMS LTD 1.875GM/PACKET A202190 001 Jul 16, 2018
AB 3.75GM/PACKET A202190 002 Jul 16, 2018
WELCHOL
AB + DAIICHI SANKYO 1.875GM/PACKET N022362 001 Oct 02, 2009
AB +! 3.75GM/PACKET N022362 002 Oct 02, 2009
TABLET;ORAL
COLESEVELAM HYDROCHLORIDE
AB ALKEM LABS LTD 625MG A209038 001 Oct 05, 2018
AB DR REDDYS LABS LTD 625MG A210889 001 Oct 05, 2018
AB GLENMARK PHARMS LTD 625MG A203480 001 May 18, 2018
AB IMPAX LABS INC 625MG A091600 001 May 16, 2018
WELCHOL
AB +! DAIICHI SANKYO 625MG N021176 001 May 26, 2000
COLESTIPOL HYDROCHLORIDE
GRANULE;ORAL
COLESTID
AB + PHARMACIA UPJOHN 5GM/SCOOPFUL N017563 003 Sep 22, 1995
AB +! 5GM/PACKET N017563 004 Sep 22, 1995
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS 5GM/SCOOPFUL A077277 001 May 02, 2006
AB 5GM/PACKET A077277 002 May 02, 2006
FLAVORED COLESTID
+ PHARMACIA UPJOHN 5GM/PACKET N017563 001
+ 5GM/SCOOPFUL N017563 002
TABLET;ORAL
COLESTID
AB +! PHARMACIA UPJOHN 1GM N020222 001 Jul 19, 1994
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS 1GM A077510 001 Oct 24, 2006
COLISTIMETHATE SODIUM
INJECTABLE;INJECTION
COLISTIMETHATE SODIUM
AP EMCURE PHARMS LTD EQ 150MG BASE/VIAL A202359 001 Sep 28, 2012
AP FRESENIUS KABI USA EQ 150MG BASE/VIAL A065364 001 Apr 17, 2008
AP NEXUS PHARMS EQ 150MG BASE/VIAL A065177 001 Mar 19, 2004
AP SAGENT PHARMS EQ 150MG BASE/VIAL A201365 001 Feb 19, 2014
AP X GEN PHARMS EQ 150MG BASE/VIAL A064216 001 Feb 26, 1999
AP XELLIA PHARMS APS EQ 150MG BASE/VIAL A205356 001 May 29, 2015
COLY-MYCIN M
AP +! PAR STERILE EQ 150MG BASE/VIAL N050108 002
PRODUCTS
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

SUSPENSION/DROPS;OTIC

COLY-MYCIN S

+! ENDO PHARMS INC EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG N050356 001

BASE/ML;0.5MG/ML

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-111(of 452)

CONIVAPTAN HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER

+! CUMBERLAND PHARMS 20MG/100ML (0.2MG/ML) N021697 002 Oct 08, 2008

COPANLISIB DIHYDROCHLORIDE

POWDER;INTRAVENOUS

ALIQOPA

+! BAYER HEALTHCARE 60MG/VIAL N209936 001 Sep 14, 2017

COPPER

INTRAUTERINE DEVICE;INTRAUTERINE

PARAGARD T 380A

+! COOPERSURGICAL 309MG/COPPER N018680 001 Nov 15, 1984

CORTICORELIN OVINE TRIFLUTATE

INJECTABLE;INJECTION

ACTHREL

+! FERRING EQ 0.1MG BASE/VIAL N020162 001 May 23, 1996

CORTICOTROPIN

INJECTABLE;INJECTION

H.P. ACTHAR GEL

+! MALLINCKRODT ARD 80 UNITS/ML N008372 008

CORTISONE ACETATE

TABLET;ORAL

CORTISONE ACETATE

! HIKMA INTL PHARMS 25MG A080776 002

COSYNTROPIN

INJECTABLE;INJECTION

CORTROSYN

AP +! AMPHASTAR PHARMS 0.25MG/VIAL N016750 001

INC

COSYNTROPIN

AP MYLAN INSTITUTIONAL 0.25MG/VIAL A090574 001 Dec 17, 2009

AP SANDOZ 0.25MG/VIAL A202147 001 Jun 29, 2012



CRISABOROLE

OINTMENT;TOPICAL

EUCRISA

+! ANACOR PHARMS INC 2% N207695 001 Dec 14, 2016

CRIZOTINIB

CAPSULE;ORAL

XALKORI

+ PF PRISM CV 200MG N202570 001 Aug 26, 2011

+! 250MG N202570 002 Aug 26, 2011



CROFELEMER

TABLET, DELAYED RELEASE;ORAL

MYTESI

+! NAPO PHARMS INC 125MG N202292 001 Dec 31, 2012

CROMOLYN SODIUM

CONCENTRATE;ORAL

CROMOLYN SODIUM

AA AILEX PHARMS LLC 100MG/5ML A209264 001 Oct 16, 2017

AA MICRO LABS LTD 100MG/5ML A202745 001 Apr 04, 2013

INDIA

AA RISING PHARMS 100MG/5ML A202583 001 Oct 27, 2011

GASTROCROM

AA +! MYLAN SPECIALITY LP 100MG/5ML N020479 001 Feb 29, 1996

SOLUTION;INHALATION

CROMOLYN SODIUM

AN AILEX PHARMS LLC 10MG/ML A209453 001 Oct 16, 2017
AN MYLAN SPECIALITY LP 10MG/ML A074209 001 Apr 26, 1994
AN ! TEVA PHARMS 10MG/ML A075271 001 Jan 18, 2000
AN WOCKHARDT BIO AG 10MG/ML A075346 001 Oct 25, 1999
SOLUTION/DROPS;OPHTHALMIC
CROMOLYN SODIUM
AT ! AKORN 4% A074706 001 Apr 29, 1998
AT SANDOZ INC 4% A075282 001 Jun 16, 1999
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-112(of 452)

CROTAMITON

CREAM;TOPICAL

EURAX

+! SUN PHARM INDS INC 10% N006927 001

LOTION;TOPICAL

CROTAN

AT MARNEL PHARMS 10% A087204 001

EURAX

AT +! SUN PHARM INDS INC 10% N009112 003

CUPRIC CHLORIDE

INJECTABLE;INJECTION

CUPRIC CHLORIDE IN PLASTIC CONTAINER

+! HOSPIRA EQ 0.4MG COPPER/ML N018960 001 Jun 26, 1986

CYANOCOBALAMIN

INJECTABLE;INJECTION

CYANOCOBALAMIN

AP +! LUITPOLD 1MG/ML A080737 001

AP MYLAN LABS LTD 1MG/ML A204829 001 Jun 05, 2017

AP SOMERSET THERAPS 1MG/ML A206503 001 Dec 11, 2015

LLC

AP 1MG/ML A209429 001 Dec 18, 2018

AP VITRUVIAS THERAP 1MG/ML A209255 001 Dec 18, 2018

AP WEST-WARD PHARMS 1MG/ML A080515 002



INT

VIBISONE

AP ! FRESENIUS KABI USA 1MG/ML A080557 003

SPRAY, METERED;NASAL

NASCOBAL

+! ENDO PHARMS INC 0.5MG/SPRAY N021642 001 Jan 31, 2005

CYCLOBENZAPRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

AMRIX

AB + TEVA PHARMS INTL 15MG N021777 001 Feb 01, 2007

AB +! 30MG N021777 002 Feb 01, 2007

CYCLOBENZAPRINE HYDROCHLORIDE

AB APOTEX INC 15MG A206703 001 Jul 24, 2018

AB 30MG A206703 002 Jul 24, 2018



TABLET;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

AB ACTAVIS LABS FL INC 5MG A071611 002 Feb 03, 2006

AB 7.5MG A071611 003 Feb 03, 2006

AB 10MG A071611 001 May 03, 1989

AB AUROBINDO PHARMA 5MG A078643 001 Sep 26, 2008

AB 10MG A078643 002 Sep 26, 2008

AB FRONTIDA BIOPHARM 5MG A073541 002 Apr 06, 2006

AB 10MG A073541 001 May 23, 1995

AB INVAGEN PHARMS 5MG A090478 001 Jul 23, 2010

AB 10MG A090478 002 Jul 23, 2010

AB JUBILANT CADISTA 5MG A077563 001 Apr 19, 2006

AB 7.5MG A077563 003 Aug 25, 2017

AB 10MG A077563 002 Apr 19, 2006

AB KVK TECH 5MG A078048 001 Feb 28, 2011

AB 10MG A078048 002 Feb 28, 2011

AB MYLAN PHARMS INC 5MG A073144 002 Feb 03, 2006

AB 7.5MG A073144 003 Mar 25, 2013

AB ! 10MG A073144 001 May 30, 1991

AB ORIT LABS LLC 5MG A078218 002 Jun 19, 2015

AB 10MG A078218 001 Apr 18, 2008

AB OXFORD PHARMS 5MG A077209 002 Feb 03, 2006

AB 10MG A077209 001 Oct 04, 2005

AB PLIVA 10MG A074421 001 Sep 29, 1995

AB PRINSTON INC 5MG A077797 001 Feb 28, 2007

AB 10MG A077797 002 Feb 28, 2007

AB RUBICON RES PVT LTD 5MG A208170 001 May 31, 2017

AB 7.5MG A208170 002 May 31, 2017

AB 10MG A208170 003 May 31, 2017

AB SUN PHARM INDS LTD 5MG A078722 001 May 12, 2008

AB 7.5MG A078722 002 May 12, 2008

AB 10MG A078722 003 May 12, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-113(of 452)

CYCLOPENTOLATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKPENTOLATE

AT AKORN 1% A040164 001 Jan 13, 1997

CYCLOGYL

AT ! ALCON LABS INC 0.5% A084109 001

AT ! 1% A084110 001

CYCLOPENTOLATE HYDROCHLORIDE

AT AKORN INC 0.5% A205937 001 Dec 09, 2015

PENTOLAIR

AT BAUSCH AND LOMB 1% A040075 001 Apr 29, 1994

CYCLOGYL

! ALCON LABS INC 2% A084108 001

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYCLOMYDRIL

! ALCON LABS INC 0.2%;1% A084300 001

CYCLOPHOSPHAMIDE

CAPSULE;ORAL

CYCLOPHOSPHAMIDE

AB AMERIGEN PHARMS LTD 25MG A207014 001 Mar 19, 2018

AB 50MG A207014 002 Mar 19, 2018

AB STI PHARMA LLC 25MG A209872 001 May 07, 2018

AB 50MG A209872 002 May 07, 2018

AB + WEST-WARD PHARMS 25MG N203856 001 Sep 16, 2013

INT

AB +! 50MG N203856 002 Sep 16, 2013

INJECTABLE;INJECTION

CYCLOPHOSPHAMIDE

AP AMNEAL PHARMS CO 500MG/VIAL A210046 001 May 25, 2018

AP 1GM/VIAL A210046 002 May 25, 2018

AP 2GM/VIAL A210046 003 May 25, 2018

AP ! BAXTER HLTHCARE 500MG/VIAL A040745 001 May 21, 2008

AP ! 1GM/VIAL A040745 002 May 21, 2008

AP ! 2GM/VIAL A040745 003 May 21, 2008

AP JIANGSU HENGRUI MED 500MG/VIAL A204555 001 Oct 31, 2014

AP 1GM/VIAL A204555 002 Oct 31, 2014

AP 2GM/VIAL A204555 003 Oct 31, 2014



CYCLOSERINE

CAPSULE;ORAL

SEROMYCIN

! PURDUE GMP 250MG A060593 001

CYCLOSPORINE

CAPSULE;ORAL

CYCLOSPORINE

AB1 IVAX SUB TEVA 25MG A065110 003 Mar 29, 2005

PHARMS

AB1 100MG A065110 002 Mar 29, 2005

AB1 MAYNE PHARMA 25MG A065044 002 Dec 20, 2000

AB1 100MG A065044 001 Dec 20, 2000

AB1 SANDOZ 25MG A065017 002 Jan 13, 2000

AB1 100MG A065017 001 Jan 13, 2000

GENGRAF

AB1 ABBVIE 25MG A065003 001 May 12, 2000

AB1 100MG A065003 003 May 12, 2000

NEORAL

AB1 + NOVARTIS 25MG N050715 001 Jul 14, 1995

AB1 +! 100MG N050715 002 Jul 14, 1995

CYCLOSPORINE

AB2 APOTEX 25MG A065040 001 May 09, 2002

AB2 100MG A065040 002 May 09, 2002

SANDIMMUNE

AB2 + NOVARTIS 25MG N050625 001 Mar 02, 1990

AB2 +! 100MG N050625 002 Mar 02, 1990



BX + 50MG N050625 003 Nov 23, 1992

CYCLOSPORINE

IVAX SUB TEVA 50MG A065110 001 Mar 29, 2005

PHARMS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-114(of 452)

CYCLOSPORINE

EMULSION;OPHTHALMIC

RESTASIS

+! ALLERGAN 0.05% N050790 001 Dec 23, 2002

RESTASIS MULTIDOSE

+! ALLERGAN 0.05% N050790 002 Oct 27, 2016

INJECTABLE;INJECTION

CYCLOSPORINE

AP LUITPOLD 50MG/ML A065151 001 Oct 07, 2003

AP WEST-WARD PHARMS 50MG/ML A065004 001 Oct 29, 1999

INT

SANDIMMUNE

AP +! NOVARTIS 50MG/ML N050573 001 Nov 14, 1983

SOLUTION;OPHTHALMIC

CEQUA

+! SUN PHARMA GLOBAL 0.09% N210913 001 Aug 14, 2018

SOLUTION;ORAL

CYCLOSPORINE

AB1 ABBVIE 100MG/ML A065025 001 Mar 03, 2000

AB1 IVAX SUB TEVA 100MG/ML A065078 001 Mar 25, 2005

PHARMS

AB1 MAYNE PHARMA 100MG/ML A065054 001 Dec 18, 2001

NEORAL

AB1 +! NOVARTIS 100MG/ML N050716 001 Jul 14, 1995

CYCLOSPORINE

AB2 WOCKHARDT BIO AG 100MG/ML A065133 001 Sep 17, 2004

SANDIMMUNE

AB2 +! NOVARTIS 100MG/ML N050574 001 Nov 14, 1983

CYPROHEPTADINE HYDROCHLORIDE

SYRUP;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AA BIO-PHARM INC 2MG/5ML A204823 001 Dec 27, 2016

AA INVATECH PHARMA 2MG/5ML A209108 001 Oct 16, 2018

AA LANNETT CO INC 2MG/5ML A203191 001 Jul 13, 2017

AA ! LYNE 2MG/5ML A040668 001 Jun 28, 2006

AA PHARM ASSOC 2MG/5ML A091295 001 Mar 28, 2013



TABLET;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AA APEX PHARMS INC 4MG A207783 001 Dec 29, 2016

AA APNAR PHARMA LP 4MG A207555 001 Jan 31, 2017

AA BOSCOGEN 4MG A040644 001 May 30, 2006

AA ! IVAX SUB TEVA 4MG A087056 001



PHARMS

AA MOUNTAIN 4MG A040537 001 Sep 30, 2003

AA NOVAST LABS 4MG A205087 001 Sep 23, 2015

AA PAR PHARM 4MG A087129 001



AA STRIDES PHARMA 4MG A209172 001 Apr 11, 2018

AA TWI PHARMS 4MG A206553 001 Nov 29, 2016

AA ZYDUS PHARMS USA 4MG A208938 001 May 19, 2017

INC

CYSTEAMINE BITARTRATE

CAPSULE;ORAL

CYSTAGON

+ MYLAN EQ 50MG BASE N020392 001 Aug 15, 1994

+! EQ 150MG BASE N020392 002 Aug 15, 1994

CAPSULE, DELAYED RELEASE;ORAL



PROCYSBI

+ HORIZON PHARMA USA EQ 25MG BASE N203389 001 Apr 30, 2013

+! EQ 75MG BASE N203389 002 Apr 30, 2013



CYSTEAMINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYSTARAN

+! LEADIANT BIOSCI INC EQ 0.44% BASE N200740 001 Oct 02, 2012

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

AP ! FRESENIUS KABI USA 100MG/ML A076512 001 Jan 15, 2004

AP HONG KONG 20MG/ML A206190 001 Nov 09, 2017

AP 100MG/ML A205696 001 Jul 17, 2018

AP ! HOSPIRA 20MG/ML A071868 001 Jun 04, 1990

AP ! 20MG/ML A072168 001 Aug 31, 1990



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-115(of 452)

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

AP ! 20MG/ML A072945 001 Feb 28, 1994

AP 100MG/ML A075383 001 Nov 22, 1999

AP MYLAN LABS LTD 20MG/ML A200914 001 Dec 13, 2011

AP 20MG/ML A200915 001 Dec 13, 2011

AP 20MG/ML A200916 001 Dec 13, 2011

AP 100MG/ML A201784 001 Jan 30, 2012



WEST-WARD PHARMS 100MG/VIAL A071471 001 Aug 02, 1989

INT

! 500MG/VIAL A071472 001 Aug 02, 1989

! 1GM/VIAL A074245 001 Aug 31, 1994

! 2GM/VIAL A074245 002 Aug 31, 1994



CYTARABINE; DAUNORUBICIN

POWDER;INTRAVENOUS

VYXEOS

+! CELATOR PHARMS 100MG;44MG N209401 001 Aug 03, 2017

DABIGATRAN ETEXILATE MESYLATE

CAPSULE;ORAL

PRADAXA

+ BOEHRINGER EQ 75MG BASE N022512 001 Oct 19, 2010

INGELHEIM

+ EQ 110MG BASE N022512 003 Nov 20, 2015

+! EQ 150MG BASE N022512 002 Oct 19, 2010

DABRAFENIB MESYLATE

CAPSULE;ORAL

TAFINLAR

+ NOVARTIS PHARMS EQ 50MG BASE N202806 001 May 29, 2013

CORP

+! EQ 75MG BASE N202806 002 May 29, 2013

DACARBAZINE

INJECTABLE;INJECTION

DACARBAZINE

AP ! FRESENIUS KABI USA 200MG/VIAL A075371 002 Aug 27, 1999

AP HOSPIRA 200MG/VIAL A075940 001 Oct 18, 2001

AP TEVA PHARMS USA 200MG/VIAL A075259 002 Aug 27, 1998

AP ! 500MG/VIAL A075259 001 Sep 22, 2000

AP WEST-WARD PHARMS 200MG/VIAL A075812 001 Jun 15, 2001

INT

AP 500MG/VIAL A075812 002 Oct 31, 2002

! FRESENIUS KABI USA 100MG/VIAL A075371 001 Aug 27, 1999

DACLATASVIR DIHYDROCHLORIDE

TABLET;ORAL

DAKLINZA

+ BRISTOL-MYERS EQ 30MG BASE N206843 001 Jul 24, 2015

SQUIBB

+ EQ 60MG BASE N206843 002 Jul 24, 2015

+! EQ 90MG BASE N206843 003 Apr 13, 2016

DACOMITINIB

TABLET;ORAL

VIZIMPRO

+ PFIZER INC 15MG N211288 001 Sep 27, 2018

+ 30MG N211288 002 Sep 27, 2018

+! 45MG N211288 003 Sep 27, 2018



DACTINOMYCIN

INJECTABLE;INJECTION

COSMEGEN

AP +! RECORDATI RARE 0.5MG/VIAL N050682 001

DACTINOMYCIN

AP LUITPOLD 0.5MG/VIAL A202562 001 Aug 23, 2013

AP MYLAN LABS LTD 0.5MG/VIAL A203385 001 Nov 09, 2017



DALBAVANCIN HYDROCHLORIDE

POWDER;INTRAVENOUS

DALVANCE

+! ALLERGAN SALES LLC EQ 500MG BASE/VIAL N021883 001 May 23, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-116(of 452)

DALFAMPRIDINE

TABLET, EXTENDED RELEASE;ORAL

AMPYRA

AB +! ACORDA 10MG N022250 001 Jan 22, 2010

DALFAMPRIDINE

AB ACCORD HLTHCARE 10MG A206863 001 Jul 11, 2018

AB ACTAVIS LABS FL INC 10MG A206836 001 Jan 23, 2017

AB ALKEM LABS LTD 10MG A206765 001 Jul 30, 2018

AB AUROBINDO PHARMA 10MG A206811 001 Jan 23, 2017

LTD

AB WEST-WARD PHARMS 10MG A206646 001 Oct 24, 2018

INT

DALFOPRISTIN; QUINUPRISTIN

INJECTABLE;INTRAVENOUS

SYNERCID

+! KING PHARMS 350MG/VIAL;150MG/VIAL N050748 001 Sep 21, 1999

DALTEPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

FRAGMIN

+ PFIZER INC 2,500IU/0.2ML (12,500IU/ML) N020287 001 Dec 22, 1994

+ 5,000IU/0.2ML (25,000IU/ML) N020287 003 Mar 18, 1996

+ 7,500IU/0.3ML (25,000IU/ML) N020287 005 Apr 04, 2002

+ 10,000IU/ML (10,000IU/ML) N020287 004 Jan 30, 1998



+ 12,500IU/0.5ML (25,000IU/ML) N020287 009 May 01, 2007

+ 15,000IU/0.6ML (25,000IU/ML) N020287 010 May 01, 2007

+ 18,000IU/0.72ML (25,000IU/ML) N020287 011 May 01, 2007

+! 95,000IU/3.8ML (25,000IU/ML) N020287 006 Apr 04, 2002



DANAZOL

CAPSULE;ORAL

DANAZOL

AB BARR 50MG A074582 003 May 29, 1998

AB 100MG A074582 002 May 29, 1998

AB ! 200MG A074582 001 Aug 09, 1996

AB LANNETT CO INC 50MG A077246 002 Apr 19, 2007

AB 100MG A077246 003 Apr 19, 2007

AB 200MG A077246 001 Sep 28, 2005



DANTROLENE SODIUM

CAPSULE;ORAL

DANTRIUM

AB + PAR STERILE 25MG N017443 001

PRODUCTS

AB + 50MG N017443 003

AB +! 100MG N017443 002

DANTROLENE SODIUM

AB ELITE LABS INC 25MG A076686 001 Oct 24, 2005

AB 50MG A076686 002 Oct 24, 2005

AB 100MG A076686 003 Oct 24, 2005

AB IMPAX LABS 25MG A076856 001 Mar 01, 2005

AB 50MG A076856 002 Mar 01, 2005

AB 100MG A076856 003 Mar 01, 2005



FOR SUSPENSION;INTRAVENOUS

RYANODEX

+! EAGLE PHARMS 250MG/VIAL N205579 001 Jul 22, 2014

INJECTABLE;INJECTION

DANTRIUM

AP +! PAR STERILE 20MG/VIAL N018264 001

PRODUCTS

DANTROLENE SODIUM

AP HIKMA PHARMS 20MG/VIAL A204762 001 Jun 19, 2017

AP MYLAN INSTITUTIONAL 20MG/VIAL A205239 001 Feb 18, 2016

REVONTO

AP US WORLDMEDS 20MG/VIAL A078378 001 Jul 24, 2007

DAPAGLIFLOZIN

TABLET;ORAL

FARXIGA

+ ASTRAZENECA AB 5MG N202293 001 Jan 08, 2014

+! 10MG N202293 002 Jan 08, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-117(of 452)

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE



TABLET, EXTENDED RELEASE;ORAL

XIGDUO XR

+ ASTRAZENECA AB
2.5MG;1GM
N205649 005 Jul 28, 2017

+
5MG;500MG
N205649 001 Oct 29, 2014

+
5MG;1GM
N205649 002 Oct 29, 2014

+
10MG;500MG
N205649 003 Oct 29, 2014

+!
10MG;1GM
N205649 004 Oct 29, 2014

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL

QTERN

+! ASTRAZENECA AB
10MG;EQ 5MG BASE
N209091 001 Feb 27, 2017

DAPSONE

GEL;TOPICAL

ACZONE

AB +! ALLERGAN
5%
N021794 001 Jul 07, 2005

DAPSONE

AB TARO
5%
A209506 001 Oct 16, 2017

ACZONE

+! AQUA PHARMS LLC
7.5%
N207154 001 Feb 24, 2016

TABLET;ORAL

DAPSONE

AB ACTAVIS LLC 25MG
A204380 001 Mar 23, 2017

AB 100MG
A204380 002 Mar 23, 2017

AB ALVOGEN 25MG
A205429 001 Jan 07, 2016

AB 100MG
A205429 002 Jan 07, 2016

AB JACOBUS 25MG
A086841 001

AB ! 100MG
A086842 001

AB NOSTRUM LABS INC 25MG
A203887 001 May 06, 2016

AB 100MG
A203887 002 May 06, 2016

AB NOVITIUM PHARMA 25MG


A206505 001 Dec 01, 2016

AB 100MG
A206505 002 Dec 01, 2016

AB VIRTUS PHARMS 25MG


A204074 001 May 10, 2016

AB 100MG
A204074 002 May 10, 2016

DAPTOMYCIN

POWDER;INTRAVENOUS

CUBICIN

AP +! CUBIST PHARMS LLC
500MG/VIAL
N021572 002 Sep 12, 2003

DAPTOMYCIN

AP CRANE PHARMS LLC
500MG/VIAL
A206005 001 Jun 15, 2016

AP FRESENIUS KABI USA


500MG/VIAL
A206077 001 Apr 11, 2018

AP HOSPIRA INC
500MG/VIAL
A202857 001 Sep 12, 2014

AP MYLAN LABS LTD


500MG/VIAL
A205037 001 Jun 05, 2018

AP TEVA PHARMS USA


500MG/VIAL
A091039 001 Mar 25, 2016

CUBICIN RF

+! CUBIST PHARMS LLC
500MG/VIAL
N021572 003 Jul 06, 2016

POWDER;IV (INFUSION)

DAPTOMYCIN

+! SAGENT PHARMS
350MG/VIAL
N208385 001 Sep 12, 2017

+! XELLIA PHARMS APS


350MG/VIAL
N209949 001 Oct 20, 2017

DARIFENACIN HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

DARIFENACIN

AB MACLEODS PHARMS LTD
EQ 7.5MG BASE
A207302 001 Jul 28, 2017

AB
EQ 15MG BASE
A207302 002 Jul 28, 2017

DARIFENACIN HYDROBROMIDE

AB ALEMBIC PHARMS LTD
EQ 7.5MG BASE
A207681 001 Dec 08, 2017

AB
EQ 15MG BASE
A207681 002 Dec 08, 2017

AB ANCHEN PHARMS
EQ 7.5MG BASE
A091190 001 Mar 13, 2015

AB
EQ 15MG BASE
A091190 002 Mar 13, 2015

AB AUROBINDO PHARMA
EQ 7.5MG BASE
A206743 001 Sep 19, 2016

LTD

AB
EQ 15MG BASE
A206743 002 Sep 19, 2016

AB CIPLA
EQ 7.5MG BASE
A207664 001 Sep 01, 2016

AB
EQ 15MG BASE
A207664 002 Sep 01, 2016

AB JUBILANT GENERICS
EQ 7.5MG BASE
A205550 001 Oct 12, 2016

AB
EQ 15MG BASE
A205550 002 Oct 12, 2016

AB TORRENT PHARMS LTD


EQ 7.5MG BASE
A205209 001 Nov 17, 2016

AB
EQ 15MG BASE
A205209 002 Nov 17, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-118(of 452)

DARIFENACIN HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

ENABLEX

AB + APIL EQ 7.5MG BASE N021513 001 Dec 22, 2004

AB +! EQ 15MG BASE N021513 002 Dec 22, 2004



DARUNAVIR ETHANOLATE

SUSPENSION;ORAL

PREZISTA

+! JANSSEN PRODS EQ 100MG BASE/ML N202895 001 Dec 16, 2011

TABLET;ORAL

DARUNAVIR ETHANOLATE

AB TEVA PHARMS USA EQ 600MG BASE A202118 001 Nov 21, 2017

PREZISTA

AB + JANSSEN PRODS EQ 600MG BASE N021976 002 Feb 25, 2008

+ EQ 75MG BASE N021976 004 Dec 18, 2008

+ EQ 150MG BASE N021976 005 Dec 18, 2008

+! EQ 800MG BASE N021976 006 Nov 09, 2012

DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR

TABLET, TABLET;ORAL

VIEKIRA PAK (COPACKAGED)

+! ABBVIE INC EQ 250MG BASE,N/A,N/A,N/A; N206619 001 Dec 19, 2014

N/A,12.5MG,75MG,50MG

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

TABLET, EXTENDED RELEASE;ORAL

VIEKIRA XR

+! ABBVIE INC EQ 200MG BASE;8.33MG;50MG;33.33MG N208624 001 Jul 22, 2016

DASATINIB

TABLET;ORAL

SPRYCEL

+ BRISTOL MYERS 20MG N021986 001 Jun 28, 2006

SQUIBB

+ 50MG N021986 002 Jun 28, 2006

+ 70MG N021986 003 Jun 28, 2006

+ 80MG N021986 005 Oct 28, 2010

+! 100MG N021986 004 May 30, 2008

+ 140MG N021986 006 Oct 28, 2010



DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

CERUBIDINE

AP ! WEST-WARD PHARMS EQ 20MG BASE/VIAL A064103 001 Feb 03, 1995

INT

DAUNORUBICIN HYDROCHLORIDE

AP FRESENIUS KABI USA EQ 20MG BASE/VIAL A065000 001 May 25, 1999

AP TEVA PHARMS USA EQ 5MG BASE/ML A065035 001 Jan 24, 2000

AP +! WEST-WARD PHARMS EQ 5MG BASE/ML N050731 001 Jan 30, 1998

INT

FRESENIUS KABI USA EQ 5MG BASE/VIAL A065034 001 Nov 20, 2001

DECITABINE

INJECTABLE;INTRAVENOUS

DACOGEN

AP +! OTSUKA PHARM CO LTD 50MG/VIAL N021790 001 May 02, 2006

DECITABINE

AP ACCORD HLTHCARE 50MG/VIAL A203475 001 Feb 27, 2017

AP CHEMI SPA 50MG/VIAL A206033 001 Sep 22, 2017

AP CIPLA 50MG/VIAL A208601 001 Nov 16, 2017

AP DR REDDYS LABS LTD 50MG/VIAL A203131 001 Jul 11, 2013

AP LUPIN LTD 50MG/VIAL A210756 001 Nov 09, 2018

AP PHARMASCIENCE INC 50MG/VIAL A204607 001 May 31, 2017

AP SAGENT PHARMS 50MG/VIAL A207100 001 Mar 16, 2018

AP SANDOZ INC 50MG/VIAL A202969 001 Aug 28, 2014

POWDER;INTRAVENOUS

DECITABINE

+! SUN PHARMA GLOBAL 50MG/VIAL N205582 001 Jan 28, 2014

DEFERASIROX

GRANULE;ORAL

JADENU SPRINKLE

+ NOVARTIS PHARMS 90MG N207968 001 May 18, 2017

CORP

+ 180MG N207968 002 May 18, 2017

+! 360MG N207968 003 May 18, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-119(of 452)

DEFERASIROX

TABLET;ORAL

JADENU
+ NOVARTIS PHARMS 90MG N206910 001 Mar 30, 2015
CORP
+ 180MG N206910 002 Mar 30, 2015
+! 360MG N206910 003 Mar 30, 2015
TABLET, FOR SUSPENSION;ORAL
DEFERASIROX
AB ACTAVIS ELIZABETH 125MG A203560 001 Jan 26, 2016
AB 250MG A203560 002 Jan 26, 2016
AB 500MG A203560 003 Jan 26, 2016
EXJADE
AB + NOVARTIS 125MG N021882 001 Nov 02, 2005
AB + 250MG N021882 002 Nov 02, 2005
AB +! 500MG N021882 003 Nov 02, 2005
DEFERIPRONE
SOLUTION;ORAL
FERRIPROX
+ APOPHARMA INC 80MG/ML N208030 002 Apr 20, 2018
+! 100MG/ML N208030 001 Sep 09, 2015
TABLET;ORAL
FERRIPROX
+! APOPHARMA INC 500MG N021825 001 Oct 14, 2011
DEFEROXAMINE MESYLATE
INJECTABLE;INJECTION
DEFEROXAMINE MESYLATE
AP FRESENIUS KABI USA 500MG/VIAL A078718 001 Sep 15, 2009
AP 2GM/VIAL A078718 002 Sep 15, 2009
AP GLAND PHARMA LTD 500MG/VIAL A207384 001 Sep 29, 2017
AP 2GM/VIAL A207384 002 Sep 29, 2017
AP HOSPIRA 500MG/VIAL A076019 001 Mar 17, 2004
AP 2GM/VIAL A076019 002 Mar 17, 2004
AP WEST-WARD PHARMS 500MG/VIAL A078086 001 May 30, 2007
INT
AP 2GM/VIAL A078086 002 May 30, 2007
DESFERAL
AP +! NOVARTIS 500MG/VIAL N016267 001
AP +! 2GM/VIAL N016267 002 May 25, 2000
DEFIBROTIDE SODIUM
SOLUTION;INTRAVENOUS
DEFITELIO
+! JAZZ PHARMS INC 200MG/2.5ML (80MG/ML) N208114 001 Mar 30, 2016
DEFLAZACORT
SUSPENSION;ORAL
EMFLAZA
+! PTC THERAP 22.75MG/ML N208685 001 Feb 09, 2017
TABLET;ORAL
EMFLAZA
+ PTC THERAP 6MG N208684 001 Feb 09, 2017
+ 18MG N208684 002 Feb 09, 2017
+ 30MG N208684 003 Feb 09, 2017
+! 36MG N208684 004 Feb 09, 2017
DEGARELIX ACETATE
POWDER;SUBCUTANEOUS
FIRMAGON
+ FERRING EQ 80MG BASE/VIAL N022201 001 Dec 24, 2008
+! EQ 120MG BASE/VIAL N022201 002 Dec 24, 2008
DELAFLOXACIN MEGLUMINE
POWDER;INTRAVENOUS
BAXDELA
+! MELINTA EQ 300MG BASE/VIAL N208611 001 Jun 19, 2017
TABLET;ORAL
BAXDELA
+! MELINTA EQ 450MG BASE N208610 001 Jun 19, 2017
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-120(of 452)

DELAVIRDINE MESYLATE

TABLET;ORAL

RESCRIPTOR

+ VIIV HLTHCARE 100MG N020705 001 Apr 04, 1997

+! 200MG N020705 002 Jul 14, 1999



DEMECLOCYCLINE HYDROCHLORIDE

TABLET;ORAL

DEMECLOCYCLINE HYDROCHLORIDE

AB AKORN 150MG A065389 001 Dec 01, 2008

AB 300MG A065389 002 Dec 01, 2008

AB AMNEAL PHARM 150MG A065425 001 Feb 27, 2008

AB ! 300MG A065425 002 Feb 27, 2008

AB BARR 150MG A065171 001 Dec 13, 2004

AB 300MG A065171 002 Dec 13, 2004

AB EPIC PHARMA LLC 150MG A065447 001 Aug 18, 2015

AB 300MG A065447 002 Aug 18, 2015



DEOXYCHOLIC ACID

SOLUTION;SUBCUTANEOUS

KYBELLA

+! KYTHERA BIOPHARMS 20MG/2ML (10MG/ML) N206333 001 Apr 29, 2015

DESFLURANE

LIQUID;INHALATION

DESFLURANE

AN SHANGHAI HENGRUI 100% A208234 001 Feb 26, 2018

SUPRANE

AN +! BAXTER HLTHCARE 100% N020118 001 Sep 18, 1992

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL

DESIPRAMINE HYDROCHLORIDE

AB ACTAVIS TOTOWA 10MG A074430 001 Feb 09, 1996

AB 25MG A071601 001 Jun 05, 1987

AB 50MG A071588 001 Jun 05, 1987

AB 75MG A071602 001 Oct 05, 1987

AB 100MG A071766 001 Oct 05, 1987

AB 150MG A074430 002 Feb 09, 1996

AB AMNEAL PHARMS CO 10MG A208105 001 Mar 17, 2016

AB 25MG A208105 002 Mar 17, 2016

AB 50MG A208105 003 Mar 17, 2016

AB 75MG A208105 004 Mar 17, 2016

AB 100MG A208105 005 Mar 17, 2016

AB 150MG A208105 006 Mar 17, 2016

AB ANI PHARMS INC 10MG A205153 001 Oct 28, 2016

AB 25MG A205153 002 Oct 28, 2016

AB 50MG A205153 003 Oct 28, 2016

AB 75MG A205153 004 Oct 28, 2016

AB 100MG A205153 005 Oct 28, 2016

AB 150MG A205153 006 Oct 28, 2016

AB HERITAGE PHARMS INC 10MG A207433 001 May 05, 2016

AB 25MG A207433 002 May 05, 2016

AB 50MG A207433 003 May 05, 2016

AB 75MG A207433 004 May 05, 2016

AB 100MG A207433 005 May 05, 2016

AB 150MG A207433 006 May 05, 2016

AB INGENUS PHARMS LLC 10MG A204963 001 Dec 26, 2017

AB 25MG A204963 002 Dec 26, 2017

AB 50MG A204963 003 Dec 26, 2017

AB 75MG A204963 004 Dec 26, 2017

AB 100MG A204963 005 Dec 26, 2017

AB 150MG A204963 006 Dec 26, 2017

AB SANDOZ 10MG A072099 001 May 24, 1988

AB 25MG A072100 001 May 24, 1988

AB 50MG A072101 001 May 24, 1988

AB 75MG A072102 001 Jun 20, 1988

AB 100MG A072103 001 Jun 20, 1988

AB 150MG A072104 001 Jun 20, 1988

NORPRAMIN

AB + US PHARM HOLDINGS 10MG N014399 007 Feb 11, 1982

AB + 25MG N014399 001



AB + 50MG N014399 003

AB + 75MG N014399 004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-121(of 452)

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL

NORPRAMIN

AB +! 100MG N014399 005

AB + 150MG N014399 006

DESLORATADINE

SOLUTION;ORAL

CLARINEX

AA +! MERCK SHARP DOHME 0.5MG/ML N021300 001 Sep 01, 2004

DESLORATADINE

AA TARO PHARM 0.5MG/ML A202936 001 May 26, 2016

AA TARO PHARM INDS LTD 0.5MG/ML A202592 001 Jun 30, 2015

TABLET;ORAL

CLARINEX

AB +! MERCK SHARP DOHME 5MG N021165 001 Dec 21, 2001

DESLORATADINE

AB BELCHER PHARMS 5MG A078355 001 Apr 19, 2012

AB DR REDDYS LABS LTD 5MG A078365 001 Mar 08, 2011

AB LUPIN PHARMS 5MG A078352 001 Oct 25, 2010

AB MYLAN PHARMS INC 5MG A078351 001 Feb 10, 2012

AB ORCHID HLTHCARE 5MG A078357 001 Feb 19, 2010

AB PERRIGO R AND D 5MG A078361 001 Dec 22, 2011

AB SANDOZ 5MG A078364 001 Dec 03, 2010

AB SUN PHARM INDS 5MG A078359 001 Nov 16, 2010



TABLET, ORALLY DISINTEGRATING;ORAL

CLARINEX

AB + MERCK SHARP DOHME 2.5MG N021312 002 Jul 14, 2005

AB +! 5MG N021312 001 Jun 26, 2002

DESLORATADINE

AB REDDYS 2.5MG A078367 001 Jul 12, 2010

AB 5MG A078367 002 Jul 12, 2010



DESLORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CLARINEX D 24 HOUR

AB +! MERCK SHARP DOHME 5MG;240MG N021605 001 Mar 03, 2005

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR



AB DR REDDYS LABS LTD 5MG;240MG A078366 001 Apr 26, 2011

CLARINEX-D 12 HOUR

+! MERCK SHARP DOHME 2.5MG;120MG N021313 001 Feb 01, 2006

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION

DDAVP

AP +! FERRING PHARMS INC 0.004MG/ML N018938 001 Mar 30, 1984

DESMOPRESSIN ACETATE

AP SAGENT PHARMS 0.004MG/ML A204695 001 Aug 22, 2017

AP 0.004MG/ML A204751 001 Aug 22, 2017

AP SUN PHARM INDS LTD 0.004MG/ML A091280 001 Jan 25, 2013

SOLUTION;NASAL

DDAVP

AB +! FERRING PHARMS INC 0.01% N017922 001

DESMOPRESSIN ACETATE

AB SUN PHARM INDS 0.01% A077212 001 Apr 12, 2012

SPRAY, METERED;NASAL

DDAVP (NEEDS NO REFRIGERATION)

AB +! FERRING PHARMS INC 0.01MG/SPRAY N017922 003 Aug 07, 1996

DESMOPRESSIN ACETATE

AB ! BAUSCH AND LOMB 0.01MG/SPRAY A074830 001 Jan 25, 1999

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

AB APOTEX INC 0.01MG/SPRAY A076703 001 Jan 27, 2005

AB SUN PHARMA GLOBAL 0.01MG/SPRAY A078271 001 Dec 23, 2013

AB ZYDUS PHARMS USA 0.01MG/SPRAY A091345 001 Oct 03, 2017

INC

MINIRIN

AB +! FERRING 0.01MG/SPRAY N021333 001 Sep 16, 2002

NOCTIVA

+ AVADEL SPECLT 0.00083MG/SPRAY N201656 001 Mar 03, 2017

+! 0.00166MG/SPRAY N201656 002 Mar 03, 2017

STIMATE (NEEDS NO REFRIGERATION)

+! FERRING PHARMS INC 0.15MG/SPRAY N020355 002 Oct 24, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-122(of 452)

DESMOPRESSIN ACETATE

TABLET;ORAL

DDAVP

AB + FERRING PHARMS INC 0.1MG N019955 001 Sep 06, 1995

AB +! 0.2MG N019955 002 Sep 06, 1995

DESMOPRESSIN ACETATE

AB ACTAVIS LABS FL INC 0.1MG A076470 001 Jul 01, 2005

AB 0.2MG A076470 002 Jul 01, 2005

AB APOTEX INC 0.1MG A077414 001 Mar 07, 2006

AB 0.2MG A077414 002 Mar 07, 2006

AB GLENMARK PHARMS LTD 0.1MG A201831 001 May 28, 2015

AB 0.2MG A201831 002 May 28, 2015

AB HERITAGE PHARMA 0.1MG A207880 001 May 26, 2017

AB 0.2MG A207880 002 May 26, 2017

AB IMPAX LABS INC 0.1MG A077122 001 Jan 25, 2006

AB 0.2MG A077122 002 Jan 25, 2006

AB MYLAN PHARMS INC 0.1MG A200653 001 Jun 27, 2014

AB 0.2MG A200653 002 Jun 27, 2014



TABLET;SUBLINGUAL

NOCDURNA

+ FERRING PHARMS INC 0.0277MG N022517 001 Jun 21, 2018

+! 0.0553MG N022517 002 Jun 21, 2018

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-28

BEKYREE

AB LUPIN LTD 0.15MG,N/A;0.02MG,0.01MG A202226 001 Aug 12, 2015

CYCLESSA

AB +! ASPEN GLOBAL INC 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. N021090 001 Dec 20, 2000

025MG

DESOGEN

AB ORGANON USA INC 0.15MG;0.03MG N020071 002 Dec 10, 1992

DESOGESTREL AND ETHINYL ESTRADIOL



AB ACCORD HLTHCARE 0.15MG,N/A;0.02MG,0.01MG A209170 001 Jun 05, 2017

AB 0.15MG;0.03MG A207067 001 Sep 13, 2018

AB AUROBINDO PHARMA 0.15MG,N/A;0.02MG,0.01MG A206853 001 Mar 22, 2017

LTD

AB ! DURAMED PHARMS BARR 0.15MG;0.03MG A075256 002 Aug 12, 1999

AB MAYNE PHARMA 0.15MG,N/A;0.02MG,0.01MG A076916 001 Dec 29, 2008

AB 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. A077182 001 Jan 24, 2006

025MG

AB MYLAN LABS LTD 0.15MG,N/A;0.02MG,0.01MG A202296 001 Aug 30, 2013

AB 0.15MG;0.03MG A202085 001 May 20, 2015

AB NOVAST LABS 0.15MG;0.03MG A091234 001 Jul 12, 2013

AB WATSON LABS 0.15MG;0.03MG A076915 001 Jul 29, 2005

EMOQUETTE

AB VINTAGE PHARMS LLC 0.15MG;0.03MG A076675 001 Feb 25, 2011

ENSKYCE

AB LUPIN LTD 0.15MG;0.03MG A201887 001 Mar 07, 2013

ISIBLOOM

AB LABS LEON FARMA 0.15MG;0.03MG A202789 001 Aug 12, 2015

KALLIGA

AB AUROBINDO PHARMA 0.15MG;0.03MG A207081 001 May 17, 2017

LTD

KARIVA

AB ! BARR 0.15MG,N/A;0.02MG,0.01MG A075863 001 Apr 05, 2002

KIMIDESS

AB VINTAGE PHARMS 0.15MG,N/A;0.02MG,0.01MG A076681 001 Apr 30, 2015

PIMTREA

AB NOVAST LABS 0.15MG,N/A;0.02MG,0.01MG A091247 001 Aug 01, 2013

VELIVET

AB DURAMED PHARMS BARR 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. A076455 001 Feb 24, 2004

025MG

VIORELE

AB GLENMARK GENERICS 0.15MG,N/A;0.02MG,0.01MG A091346 001 Apr 02, 2012

VOLNEA

AB LABS LEON FARMA 0.15MG,N/A;0.02MG,0.01MG A202689 001 Sep 09, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-123(of 452)

DESONIDE

AEROSOL, FOAM;TOPICAL

VERDESO

+! AQUA PHARMS 0.05% N021978 001 Sep 19, 2006

CREAM;TOPICAL

DESONIDE

AB G AND W LABS INC 0.05% A074027 001 Sep 28, 1992

AB GLENMARK PHARMS 0.05% A209729 001 Jul 24, 2017

AB +! PERRIGO NEW YORK 0.05% N017010 001



AB TARO 0.05% A073548 001 Jun 30, 1992

DESOWEN

AB GALDERMA LABS LP 0.05% N019048 001 Dec 14, 1984

GEL;TOPICAL

DESONATE

+! LEO PHARMA AS 0.05% N021844 001 Oct 20, 2006

LOTION;TOPICAL

DESONIDE

AB FOUGERA PHARMS 0.05% A075860 001 Mar 19, 2002

AB GLENMARK PHARMS 0.05% A209494 001 Sep 26, 2017

AB TARO PHARM 0.05% A202161 001 Oct 31, 2014

AB TELIGENT PHARMA INC 0.05% A207855 001 Sep 28, 2017

DESOWEN

AB ! GALDERMA LABS LP 0.05% A072354 001 Jan 24, 1992

OINTMENT;TOPICAL

DESONIDE

AB FOUGERA PHARMS 0.05% A075751 001 Mar 12, 2001

AB GLENMARK PHARMS LTD 0.05% A209996 001 Sep 15, 2017

AB HI-TECH PHARMACAL 0.05% A208836 001 Mar 27, 2017

AB +! PERRIGO NEW YORK 0.05% N017426 001



AB TARO 0.05% A074254 001 Aug 03, 1994

DESOWEN

AB GALDERMA LABS LP 0.05% A071425 001 Jun 15, 1988

DESOXIMETASONE

CREAM;TOPICAL

DESOXIMETASONE

AB ACTAVIS MID 0.25% A205082 001 Sep 04, 2015

ATLANTIC

AB AKORN 0.05% A203787 001 Jan 06, 2017

AB 0.25% A203234 001 Jun 12, 2015

AB FOUGERA PHARMS 0.25% A078369 001 Jun 29, 2010

AB LUPIN ATLANTIS 0.05% A208163 001 Jan 10, 2017

AB 0.25% A208164 001 Jan 09, 2017

AB PERRIGO NEW YORK 0.25% A076510 001 Jul 01, 2003

AB RICONPHARMA LLC 0.05% A210980 001 Dec 21, 2018

AB RISING PHARMS 0.25% A205594 001 Jul 02, 2018

AB ZYDUS PHARMS USA 0.25% A205620 001 Sep 28, 2018

INC

TOPICORT

AB ! TARO PHARM INDS LTD 0.05% A073210 001 Nov 30, 1990

AB ! 0.25% A073193 001 Nov 30, 1990



GEL;TOPICAL

DESOXIMETASONE

AB AKORN 0.05% A090727 001 Mar 10, 2011

AB PERRIGO NEW YORK 0.05% A077552 001 Jan 09, 2006

AB RISING PHARMS 0.05% A204675 001 Aug 12, 2016

TOPICORT

AB ! TARO PHARM INDS LTD 0.05% A074904 001 Jul 14, 1998

OINTMENT;TOPICAL

DESOXIMETASONE

AB ACTAVIS MID 0.25% A204965 001 Nov 07, 2016

ATLANTIC

AB AKORN 0.25% A201005 001 Apr 24, 2014

AB FOUGERA PHARMS 0.25% A078657 001 Sep 28, 2012

AB G AND W LABS INC 0.25% A206740 001 Dec 23, 2016

AB GLENMARK GENERICS 0.25% A202838 001 Sep 20, 2013

AB LUPIN ATLANTIS 0.05% A208044 001 Dec 12, 2016

AB 0.25% A208104 001 Dec 01, 2016

AB NOVEL LABS INC 0.25% A206792 001 May 10, 2016

AB PERRIGO ISRAEL 0.25% A077770 001 Apr 20, 2015

AB RISING PHARMS 0.25% A204272 001 Nov 30, 2016

AB TELIGENT PHARMA INC 0.05% A209973 001 Oct 23, 2018

AB 0.25% A208101 001 Feb 25, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-124(of 452)

DESOXIMETASONE

OINTMENT;TOPICAL

DESOXIMETASONE

AB ZYDUS PHARMS USA 0.25% A205206 001 Sep 19, 2017

INC

TOPICORT

AB +! TARO PHARM INDS LTD 0.05% N018594 001 Jan 17, 1985

AB ! 0.25% A074286 001 Jun 07, 1996



SPRAY;TOPICAL

DESOXIMETASONE

AT LUPIN ATLANTIS 0.25% A208124 001 Mar 16, 2018

AT PERRIGO ISRAEL 0.25% A206441 001 Jan 20, 2017

TOPICORT

AT +! TARO PHARMS 0.25% N204141 001 Apr 11, 2013

DESVENLAFAXINE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE

BC +! ALEMBIC PHARMS LTD 50MG N204150 001 Mar 04, 2013

BC +! 100MG N204150 002 Mar 04, 2013

KHEDEZLA

BC OSMOTICA PHARM CORP 50MG N204683 001 Jul 10, 2013

BC 100MG N204683 002 Jul 10, 2013

DESVENLAFAXINE SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE SUCCINATE

AB ACTAVIS LABS FL EQ 25MG BASE A204065 001 Jul 29, 2016

AB EQ 50MG BASE A204065 002 Jul 29, 2016

AB EQ 100MG BASE A204065 003 Jul 29, 2016

AB ALEMBIC PHARMS LTD EQ 25MG BASE A204003 003 Sep 14, 2018

AB EQ 50MG BASE A204003 001 Jun 29, 2015

AB EQ 100MG BASE A204003 002 Jun 29, 2015

AB CASI PHARMS INC EQ 50MG BASE A204028 001 Jun 29, 2015

AB EQ 100MG BASE A204028 002 Jun 29, 2015

AB LUPIN LTD EQ 50MG BASE A204172 001 Jun 29, 2015

AB EQ 100MG BASE A204172 002 Jun 29, 2015

AB MYLAN PHARMS INC EQ 50MG BASE A204095 001 Jun 29, 2015

AB EQ 100MG BASE A204095 002 Jun 29, 2015

AB WEST-WARD PHARMS EQ 25MG BASE A204082 002 Aug 28, 2017

INT

AB EQ 50MG BASE A204082 001 Feb 16, 2016

AB EQ 100MG BASE A204083 001 Feb 16, 2016

AB YICHANG HUMANWELL EQ 50MG BASE A210014 001 Oct 01, 2018

AB EQ 100MG BASE A210014 002 Oct 01, 2018

AB ZYDUS PHARMS USA EQ 50MG BASE A204020 001 Oct 11, 2017

INC

AB EQ 100MG BASE A204020 002 Oct 11, 2017

PRISTIQ

AB + PF PRISM CV EQ 25MG BASE N021992 003 Aug 20, 2014

AB +! EQ 50MG BASE N021992 001 Feb 29, 2008

AB +! EQ 100MG BASE N021992 002 Feb 29, 2008



DEUTETRABENAZINE

TABLET;ORAL

AUSTEDO

+ TEVA BRANDED PHARM 6MG N208082 001 Apr 03, 2017

+ 9MG N208082 002 Apr 03, 2017

+! 12MG N208082 003 Apr 03, 2017



DEXAMETHASONE

CONCENTRATE;ORAL

DEXAMETHASONE INTENSOL

! WEST-WARD PHARMS 1MG/ML A088252 001 Sep 01, 1983

INT

ELIXIR;ORAL

DEXAMETHASONE

AA LANNETT CO INC 0.5MG/5ML A091188 001 May 11, 2011

AA LYNE 0.5MG/5ML A090891 001 Jul 12, 2011

AA ! STI PHARMA LLC 0.5MG/5ML A084754 001



AA WOCKHARDT BIO AG 0.5MG/5ML A088254 001 Jul 27, 1983

IMPLANT;INTRAVITREAL

OZURDEX

+! ALLERGAN 0.7MG N022315 001 Jun 17, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-125(of 452)

DEXAMETHASONE

INSERT;OPHTHALMIC

DEXTENZA

+! OCULAR THERAPEUTIX 0.4MG N208742 001 Nov 30, 2018

SOLUTION;ORAL

DEXAMETHASONE

! WEST-WARD PHARMS 0.5MG/5ML A088248 001 Sep 01, 1983

INT

SUSPENSION;INTRAOCULAR

DEXYCU KIT

+! EYEPOINT PHARMS 9% N208912 001 Feb 09, 2018

SUSPENSION/DROPS;OPHTHALMIC

MAXIDEX

+! NOVARTIS PHARMS 0.1% N013422 001

CORP

TABLET;ORAL

DEXAMETHASONE

AB ECR 1.5MG A040700 001 Aug 15, 2008

AB LARKEN LABS INC 1.5MG A201270 001 Jul 17, 2017

AB WEST-WARD PHARMS 1.5MG A084610 001



INT

BP FERA PHARMS LLC 0.5MG A088481 002 Apr 28, 1983

BP 0.75MG A088481 003 Apr 28, 1983

BP 4MG A088481 004 Apr 28, 1983

BP 6MG A088481 001 Nov 28, 1983



BP WEST-WARD PHARMS 0.5MG A084611 001

INT

BP 0.75MG A084613 001

BP 1MG A088306 001 Sep 15, 1983

BP 2MG A087916 001 Aug 26, 1982

BP 4MG A084612 001



BP ! 6MG A088316 001 Sep 15, 1983

BP XSPIRE PHARMA 1.5MG A088237 001 Apr 28, 1983



DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

DEXAMETHASONE SODIUM PHOSPHATE



AP AMNEAL PHARMS CO EQ 4MG PHOSPHATE/ML A208689 001 Aug 22, 2018

AP AUROBINDO PHARMA EQ 4MG PHOSPHATE/ML A206781 001 Dec 01, 2015

LTD

AP FRESENIUS KABI USA EQ 4MG PHOSPHATE/ML A084916 001

AP EQ 4MG PHOSPHATE/ML A203129 001 Sep 30, 2015

AP ! EQ 10MG PHOSPHATE/ML A040572 001 Apr 22, 2005

AP EQ 10MG PHOSPHATE/ML A209192 001 Jul 06, 2018

AP ! LUITPOLD EQ 4MG PHOSPHATE/ML A087440 001 Jul 21, 1982

AP MYLAN LABS LTD EQ 4MG PHOSPHATE/ML A040803 001 Aug 29, 2008

AP EQ 10MG PHOSPHATE/ML A040802 001 Aug 29, 2008

AP SOMERSET THERAPS EQ 4MG PHOSPHATE/ML A207521 001 Jun 08, 2018

LLC

AP WEST-WARD PHARMS EQ 4MG PHOSPHATE/ML A084282 001

INT

AP ! EQ 10MG PHOSPHATE/ML A087702 001 Sep 07, 1982

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE



AP AMNEAL PHARMS CO EQ 10MG PHOSPHATE/ML A208690 001 Aug 22, 2018

AP ! FRESENIUS KABI USA EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003

AP SOMERSET THERAPS EQ 10MG PHOSPHATE/ML A207442 001 Apr 19, 2018

LLC

SOLUTION/DROPS;OPHTHALMIC, OTIC

DEXAMETHASONE SODIUM PHOSPHATE



AT BAUSCH AND LOMB EQ 0.1% PHOSPHATE A040069 001 Jul 26, 1996

AT ! SANDOZ INC EQ 0.1% PHOSPHATE A088771 001 Jan 16, 1985



DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

MAXITROL

AT +! NOVARTIS PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050065 002

CORP

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A064063 001 Jul 25, 1994

AT PERRIGO CO 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062938 001 Jul 31, 1989

TENNESSEE

SUSPENSION/DROPS;OPHTHALMIC

DEXASPORIN

AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064135 001 Sep 13, 1995

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-126(of 452)

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE



SUSPENSION/DROPS;OPHTHALMIC

MAXITROL

AT +! NOVARTIS PHARMS 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050023 002

CORP

AT SANDOZ INC 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062341 001 May 22, 1984

DEXAMETHASONE; TOBRAMYCIN

OINTMENT;OPHTHALMIC

TOBRADEX

+! NOVARTIS PHARMS 0.1%;0.3% N050616 001 Sep 28, 1988

CORP

SUSPENSION/DROPS;OPHTHALMIC

TOBRADEX

AB +! NOVARTIS PHARMS 0.1%;0.3% N050592 001 Aug 18, 1988

CORP

TOBRAMYCIN AND DEXAMETHASONE

AB BAUSCH AND LOMB 0.1%;0.3% A064134 001 Oct 27, 1999

TOBRADEX ST

+! NOVARTIS PHARMS 0.05%;0.3% N050818 001 Feb 13, 2009

CORP

DEXCHLORPHENIRAMINE MALEATE

SYRUP;ORAL

DEXCHLORPHENIRAMINE MALEATE

AA ! WOCKHARDT BIO AG 2MG/5ML A088251 001 Mar 23, 1984

POLMON

AA CAPELLON PHARMS LLC 2MG/5ML A202520 001 Jul 16, 2018

DEXLANSOPRAZOLE

CAPSULE, DELAYED RELEASE;ORAL

DEXILANT

AB +! TAKEDA PHARMS USA 60MG N022287 002 Jan 30, 2009

DEXLANSOPRAZOLE

AB PAR PHARM INC 60MG A202294 001 Apr 19, 2017

DEXILANT

+ TAKEDA PHARMS USA 30MG N022287 001 Jan 30, 2009

DEXMEDETOMIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXMEDETOMIDINE HYDROCHLORIDE

AP ACCORD HLTHCARE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A204023 001 Feb 09, 2016

AP ACTAVIS INC EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A204686 001 Oct 17, 2016

AP AKORN INC EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A202585 001 Nov 24, 2014

AP AUROBINDO PHARMA EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A205867 001 Mar 17, 2016

LTD

AP BAXTER HLTHCARE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) A208532 001 Aug 21, 2018

CORP

AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) A208532 002 Aug 21, 2018

AP FRESENIUS KABI USA EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) A208129 001 Nov 29, 2018

AP EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A201072 001 Sep 18, 2015

AP EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) A208129 002 Nov 29, 2018

AP EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) A208129 003 Nov 29, 2018

AP JIANGSU HENGRUI MED EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A209065 001 Sep 19, 2017

AP LUITPOLD EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A203773 001 May 12, 2017

AP MYLAN INSTITUTIONAL EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A202881 001 Aug 18, 2014

AP PAR STERILE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A203972 001 Aug 18, 2014

PRODUCTS

AP SANDOZ INC EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A091465 001 Jun 14, 2016

AP SUN PHARM INDS INC EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A202126 001 Aug 20, 2015

AP TEVA PHARMS USA EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A205272 001 Nov 28, 2017

AP WEST-WARD PHARMS EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A205046 001 Apr 26, 2017

INT

AP ZYDUS PHARMS USA EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A206798 001 Feb 27, 2018

INC

PRECEDEX

AP +! HOSPIRA EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) N021038 004 Nov 14, 2014

AP +! EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) N021038 001 Dec 17, 1999

AP +! EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) N021038 002 Mar 13, 2013

AP +! EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) N021038 003 Mar 13, 2013

SOLUTION;INTRAVENOUS

DEXMEDETOMIDINE HYDROCHLORIDE

+! HQ SPCLT PHARMA EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) N206628 002 Oct 21, 2015

+ EQ 200MG BASE/50ML (EQ 4MCG BASE/ML) N206628 003 Jun 22, 2018

+ EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) N206628 001 Oct 21, 2015

+ EQ 400MG BASE/100ML (EQ 4MCG BASE/ML) N206628 004 Jun 22, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-127(of 452)

DEXMETHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

AB ADARE PHARMS INC 5MG A210279 001 Oct 09, 2018

AB 10MG A210279 002 Oct 09, 2018

AB 15MG A210279 003 Oct 09, 2018

AB 20MG A210279 004 Oct 09, 2018

AB 25MG A210279 005 Oct 09, 2018

AB 30MG A210279 006 Oct 09, 2018

AB 35MG A210279 007 Oct 09, 2018

AB 40MG A210279 008 Oct 09, 2018

AB IMPAX LABS INC 5MG A079108 001 Aug 05, 2015

AB 10MG A079108 002 Aug 05, 2015

AB 15MG A079108 003 May 19, 2014

AB 20MG A079108 004 Dec 21, 2015

AB 25MG A203614 001 Jul 05, 2017

AB 30MG A079108 005 Nov 21, 2013

AB 35MG A203614 002 Jul 05, 2017

AB INTELLIPHARMACEUTIC 15MG A078992 003 Nov 18, 2013

S

AB 30MG A078992 004 Nov 18, 2013

AB MYLAN PHARMS INC 5MG A204266 001 Aug 25, 2015

AB 10MG A204266 002 Aug 25, 2015

AB 15MG A204266 003 Aug 25, 2015

AB 20MG A204266 004 Dec 21, 2015

AB 30MG A202580 001 Aug 28, 2013

AB 40MG A204266 007 Aug 25, 2015

AB PAR PHARM INC 5MG A202842 001 Nov 30, 2016

AB 10MG A202842 002 Nov 30, 2016

AB 15MG A202842 003 Nov 30, 2016

AB 20MG A202842 004 Nov 30, 2016

AB 25MG A202842 005 Nov 30, 2016

AB 30MG A202842 006 Nov 30, 2016

AB 35MG A202842 007 Nov 30, 2016

AB 40MG A202842 008 Nov 30, 2016

AB TEVA PHARMS USA 5MG A078908 001 Nov 19, 2013

AB 10MG A078908 002 Nov 19, 2013

AB 15MG A078908 004 May 19, 2014

AB 20MG A078908 003 Nov 19, 2013

AB 25MG A202731 001 Jul 05, 2017

AB 30MG A202731 003 May 19, 2014

AB 35MG A202731 004 Jul 05, 2017

AB 40MG A202731 002 Nov 19, 2013

FOCALIN XR

AB + NOVARTIS 5MG N021802 001 May 26, 2005

AB + 10MG N021802 002 May 26, 2005

AB + 15MG N021802 004 Aug 01, 2006

AB + 20MG N021802 003 May 26, 2005

AB + 25MG N021802 008 Apr 21, 2011

AB + 30MG N021802 005 Oct 23, 2009

AB + 35MG N021802 007 Apr 21, 2011

AB +! 40MG N021802 006 Aug 11, 2010

TABLET;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

AB ABHAI INC 2.5MG A206931 001 Dec 04, 2015

AB 5MG A206931 002 Dec 04, 2015

AB 10MG A206931 003 Dec 04, 2015

AB CEDIPROF INC 5MG A209211 001 Sep 19, 2018

AB 10MG A209211 002 Sep 19, 2018

AB LANNETT CO INC 2.5MG A209468 001 Sep 25, 2017

AB 5MG A209468 002 Sep 25, 2017

AB 10MG A209468 003 Sep 25, 2017

AB NOVEL LABS INC 2.5MG A204534 001 Dec 04, 2015

AB 5MG A204534 002 Dec 04, 2015

AB 10MG A204534 003 Dec 04, 2015

AB RHODES PHARMS 2.5MG A208756 001 Nov 20, 2017

AB 5MG A208756 002 Nov 20, 2017

AB 10MG A208756 003 Nov 20, 2017

AB SUN PHARM 2.5MG A201231 001 Sep 24, 2015

INDUSTRIES

AB 5MG A201231 002 Sep 24, 2015

AB 10MG A201231 003 Sep 24, 2015

AB TEVA PHARMS 2.5MG A077107 003 Jan 29, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-128(of 452)

DEXMETHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL

DEXMETHYLPHENIDATE HYDROCHLORIDE

AB
5MG
A077107 001 Jan 29, 2007

AB
10MG
A077107 002 Jan 29, 2007

AB TRIS PHARMA INC


2.5MG
A207901 001 Aug 26, 2016

AB
5MG
A207901 002 Aug 26, 2016

AB
10MG
A207901 003 Aug 26, 2016

FOCALIN

AB + NOVARTIS
2.5MG
N021278 001 Nov 13, 2001

AB +
5MG
N021278 002 Nov 13, 2001

AB +!
10MG
N021278 003 Nov 13, 2001

DEXRAZOXANE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXRAZOXANE HYDROCHLORIDE

AP GLAND PHARMA LTD
EQ 500MG BASE/VIAL
A207321 001 Nov 28, 2016

AP MYLAN INSTITUTIONAL
EQ 250MG BASE/VIAL
A200752 001 Oct 19, 2011

AP
EQ 500MG BASE/VIAL
A200752 002 Oct 19, 2011

AP WEST-WARD PHARMS
EQ 250MG BASE/VIAL
A076068 001 Sep 28, 2004

INT

AP
EQ 500MG BASE/VIAL
A076068 002 Sep 28, 2004

ZINECARD

AP +! PHARMACIA AND
EQ 250MG BASE/VIAL
N020212 001 May 26, 1995

UPJOHN

AP +!
EQ 500MG BASE/VIAL
N020212 002 May 26, 1995

TOTECT

+! CLINIGEN HLTHCARE
EQ 500MG BASE/VIAL
N022025 001 Sep 06, 2007

DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

DEXEDRINE

AB + IMPAX LABS INC
5MG
N017078 001

AB +
10MG
N017078 002

AB +!
15MG
N017078 003

DEXTROAMPHETAMINE SULFATE

AB ACTAVIS ELIZABETH
5MG
A203901 001 Nov 30, 2012

AB
10MG
A203901 002 Nov 30, 2012

AB
15MG
A203901 003 Nov 30, 2012

AB MAYNE PHARMA
5MG
A076137 001 Jan 18, 2002

AB
10MG
A076137 002 Jan 18, 2002

AB
15MG
A076137 003 Jan 18, 2002

AB MYLAN PHARMS INC


5MG
A206735 001 Jan 27, 2016

AB
10MG
A206735 002 Jan 27, 2016

AB
15MG
A206735 003 Jan 27, 2016

AB NESHER PHARMS
5MG
A209111 001 Jun 27, 2017

AB
10MG
A209111 002 Jun 27, 2017

AB
15MG
A209111 003 Jun 27, 2017

AB SPECGX LLC
5MG
A076353 001 May 06, 2003

AB
10MG
A076353 002 May 06, 2003

AB
15MG
A076353 003 May 06, 2003

AB VINTAGE PHARMS
5MG
A205673 001 Oct 31, 2017

AB
10MG
A205673 002 Oct 31, 2017

AB
15MG
A205673 003 Oct 31, 2017

SOLUTION;ORAL

DEXTROAMPHETAMINE SULFATE

AA ! OUTLOOK PHARMS
5MG/5ML
A040776 001 Jan 29, 2008

AA TRIS PHARMA INC


5MG/5ML
A203644 001 May 29, 2013

TABLET;ORAL

DEXTROAMPHETAMINE SULFATE

AA ARBOR PHARMS LLC
5MG
A090533 002 Oct 25, 2011

AA
10MG
A090533 004 Oct 25, 2011

AA AUROLIFE PHARMA LLC


5MG
A202893 001 Jul 31, 2013

AA
10MG
A202893 002 Jul 31, 2013

AA AVANTHI INC
5MG
A203548 001 Nov 23, 2015

AA
10MG
A203548 002 Nov 23, 2015

AA BARR
5MG
A040361 001 Jan 31, 2001

AA !
10MG
A040361 002 Jan 31, 2001

AA NESHER PHARMS
5MG
A206588 001 Mar 28, 2016

AA
10MG
A206588 002 Mar 28, 2016

AA NOVEL LABS INC


5MG
A204330 001 Mar 16, 2016

AA
10MG
A204330 002 Mar 16, 2016

AA NUVO PHARM
5MG
A210059 001 Oct 18, 2017

AA
10MG
A210059 002 Oct 18, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-129(of 452)

DEXTROAMPHETAMINE SULFATE

TABLET;ORAL

DEXTROAMPHETAMINE SULFATE

AA SPECGX LLC 5MG A040436 001 Jan 29, 2002

AA 10MG A040436 002 Jan 29, 2002



ARBOR PHARMS LLC 2.5MG A090533 001 Oct 25, 2011

7.5MG A090533 003 Oct 25, 2011

15MG A090533 005 Oct 25, 2011

20MG A090533 006 Oct 25, 2011

30MG A090533 007 Oct 25, 2011

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE DM

AA ! VINTAGE 15MG/5ML;6.25MG/5ML A040649 001 Feb 14, 2006

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE



AA HI TECH PHARMA 15MG/5ML;6.25MG/5ML A040027 001 Jul 31, 1996

PROMETHAZINE W/ DEXTROMETHORPHAN

AA WOCKHARDT BIO AG 15MG/5ML;6.25MG/5ML A088864 001 Jan 04, 1985



DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

CAPSULE;ORAL

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

AB ACTAVIS ELIZABETH 20MG;10MG A202934 001 Oct 10, 2017

NUEDEXTA

AB +! AVANIR PHARMS 20MG;10MG N021879 001 Oct 29, 2010

DEXTROSE

INJECTABLE;INJECTION

DEXTROSE 10% IN PLASTIC CONTAINER



AP +! B BRAUN 10GM/100ML N019626 004 Feb 02, 1988

AP +! BAXTER HLTHCARE 10GM/100ML N016694 001



AP FRESENIUS KABI USA 10GM/100ML A209448 001 Jul 16, 2018

AP +! ICU MEDICAL INC 10GM/100ML N018080 001



DEXTROSE 5% IN PLASTIC CONTAINER

AP +! B BRAUN 50MG/ML N016730 002

AP +! 5GM/100ML N016730 001

AP +! 5GM/100ML N019626 002 Feb 02, 1988

AP +! BAXTER HLTHCARE 50MG/ML N016673 003 Oct 30, 1985

AP +! 50MG/ML N020179 002 Dec 07, 1992

AP +! 5GM/100ML N016673 001



AP +! 5GM/100ML N020179 001 Dec 07, 1992

AP FRESENIUS KABI USA 50MG/ML A207449 001 Oct 21, 2016

AP +! HOSPIRA 5GM/100ML N019466 001 Jul 15, 1985

AP +! 5GM/100ML N019479 001 Sep 17, 1985

AP +! ICU MEDICAL INC 50MG/ML N016367 002



DEXTROSE 50% IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 50GM/100ML N020047 001 Jul 02, 1991

AP +! ICU MEDICAL INC 50GM/100ML N018563 001 Mar 23, 1982

DEXTROSE 70% IN PLASTIC CONTAINER



AP +! B BRAUN 70GM/100ML N019626 005 Feb 18, 2015

AP +! BAXTER HLTHCARE 70GM/100ML N017521 006 Mar 26, 1982

AP +! 70GM/100ML N020047 003 Jul 02, 1991

AP +! ICU MEDICAL INC 70GM/100ML N018561 001 Mar 23, 1982

AP +! 70GM/100ML N019893 001 Dec 26, 1989



DEXTROSE 20% IN PLASTIC CONTAINER

+! ICU MEDICAL INC 20GM/100ML N018564 001 Mar 23, 1982

DEXTROSE 25%

+! HOSPIRA 250MG/ML N019445 002 Nov 23, 1998

DEXTROSE 30% IN PLASTIC CONTAINER

+! ICU MEDICAL INC 30GM/100ML N019345 001 Jan 26, 1985

DEXTROSE 40% IN PLASTIC CONTAINER

+! ICU MEDICAL INC 40GM/100ML N018562 001 Mar 23, 1982

DEXTROSE 50%

+ HOSPIRA 500MG/ML N019445 003 Sep 03, 2014

DEXTROSE 50% IN PLASTIC CONTAINER



+ HOSPIRA 500MG/ML N019445 001 Jun 03, 1986

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-130(of 452)

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;21MG/100ML;128MG/100ML;234MG/ N017610 001

100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

INJECTABLE;INJECTION

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019873 001 Jun 10, 1993

00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;

SODIUM LACTATE

INJECTABLE;INJECTION

DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;31MG/100ML;141MG/100ML;20MG/1 N017484 001

00ML;12MG/100ML;260MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE;

SODIUM PHOSPHATE, MONOBASIC ANHYDROUS



INJECTABLE;INJECTION

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;30MG/100ML;141MG/100ML;15MG/1 N019513 001 May 08, 1986

00ML;260MG/100ML;25MG/100ML

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

GLUCONATE

INJECTABLE;INJECTION

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;30MG/100ML;37MG/100ML;222MG/1 N017609 001
00ML;526MG/100ML;502MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 5GM/100ML;150MG/100ML N017634 001
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 5GM/100ML;224MG/100ML N017634 003
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 5GM/100ML;300MG/100ML N017634 002
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML N019699 004 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML N019699 006 Sep 29, 1989
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
AP ICU MEDICAL INC 5GM/100ML;224MG/100ML N018371 003
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5GM/100ML;75MG/100ML N017634 004
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
ICU MEDICAL INC 5GM/100ML;149MG/100ML N018371 001
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
ICU MEDICAL INC 5GM/100ML;298MG/100ML N018371 002
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ

AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 006 Apr 13, 1982

AP 5GM/100ML;150MG/100ML;200MG/100ML N018037 007 Apr 13, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)

AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 004



DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ

AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 008 Apr 13, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)

AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 001



DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ

AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 005 Apr 13, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ

AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 009 Apr 13, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ

AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 002



DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)

AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 003



DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 005 Mar 23, 1982

AP 5GM/100ML;150MG/100ML;330MG/100ML N018629 002 Mar 23, 1982



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-131(of 452)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE



INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 003 Mar 23, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;330MG/100ML N018629 004 Mar 23, 1982

AP 5GM/100ML;300MG/100ML;330MG/100ML N018629 006 Mar 23, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 007 Mar 23, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;330MG/100ML N018629 008 Mar 23, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 001 Mar 23, 1982

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 010



POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

AP B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N019630 008 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N019630 014 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N019630 020 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;900MG/100ML N019630 026 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N019630 010 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N019630 016 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N019630 022 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;900MG/100ML N019630 028 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N019630 012 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N019630 018 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N019630 024 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;900MG/100ML N019630 030 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 005 Apr 28, 1982
AP 5GM/100ML;150MG/100ML;450MG/100ML N018008 006 Apr 28, 1982
AP +! ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 009 Jul 05, 1983
AP +! 5GM/100ML;149MG/100ML;450MG/100ML N018362 005 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 007 Apr 28, 1982
AP +! ICU MEDICAL INC 5GM/100ML;149MG/100ML;450MG/100ML N018362 010 Jul 05, 1983
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 005 Apr 05, 1985
AP +! ICU MEDICAL INC 5GM/100ML;149MG/100ML;900MG/100ML N019691 005 Mar 24, 1988
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 008 Apr 28, 1982
AP +! ICU MEDICAL INC 5GM/100ML;224MG/100ML;450MG/100ML N018362 002
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 009 Apr 28, 1982
AP +! ICU MEDICAL INC 5GM/100ML;298MG/100ML;450MG/100ML N018362 003
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;900MG/100ML N019308 007 Apr 05, 1985
AP +! ICU MEDICAL INC 5GM/100ML;298MG/100ML;900MG/100ML N019691 009 Mar 24, 1988
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
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-132(of 452)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE



INJECTABLE;INJECTION

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

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;75MG/100ML;300MG/100ML N019630 049 May 07, 1992

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;75MG/100ML;110MG/100ML N019630 002 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;110MG/100ML;200MG/100ML N019630 033 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;110MG/100ML;450MG/100ML N019630 039 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;110MG/100ML;900MG/100ML N019630 045 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;110MG/100ML;300MG/100ML N019630 050 May 07, 1992

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML;110MG/100ML N019630 003 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML;200MG/100ML N019630 009 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML;330MG/100ML N019630 015 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML;450MG/100ML N019630 021 Feb 17, 1988

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML;900MG/100ML N019630 027 Feb 17, 1988

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;150MG/100ML;200MG/100ML N019630 034 Feb 17, 1988

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;150MG/100ML;450MG/100ML N019630 040 Feb 17, 1988

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;150MG/100ML;900MG/100ML N019630 046 Feb 17, 1988

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;150MG/100ML;300MG/100ML N019630 051 May 07, 1992

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;110MG/100ML N019630 004 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;220MG/100ML;200MG/100ML N019630 035 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;220MG/100ML;450MG/100ML N019630 041 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;220MG/100ML;900MG/100ML N019630 047 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;220MG/100ML;300MG/100ML N019630 052 May 07, 1992

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;110MG/100ML N019630 005 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N019630 011 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N019630 017 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N019630 023 Feb 17, 1988

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;900MG/100ML N019630 029 Feb 17, 1988

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;300MG/100ML;200MG/100ML N019630 036 Feb 17, 1988

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;300MG/100ML;450MG/100ML N019630 042 Feb 17, 1988

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;300MG/100ML;900MG/100ML N019630 048 Feb 17, 1988

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;300MG/100ML;300MG/100ML N019630 053 May 07, 1992

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;300MG/100ML;110MG/100ML N019630 006 Feb 17, 1988

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-133(of 452)

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE



INJECTABLE;INJECTION

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 002 Jul 05, 1983

+ 5GM/100ML;149MG/100ML;225MG/100ML N018365 006 Mar 28, 1988

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 001 Jan 17, 1986

5GM/100ML;149MG/100ML;300MG/100ML N018876 006 Mar 28, 1988

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;75MG/100ML;900MG/100ML N019308 004 Apr 05, 1985

5GM/100ML;150MG/100ML;900MG/100ML N019308 002 Apr 05, 1985

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;224MG/100ML;225MG/100ML N018365 008 Mar 28, 1988

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;224MG/100ML;300MG/100ML N018876 007 Mar 28, 1988

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;149MG/100ML;225MG/100ML N018365 001

+ 5GM/100ML;298MG/100ML;225MG/100ML N018365 009 Mar 28, 1988

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;298MG/100ML;300MG/100ML N018876 008 Mar 28, 1988

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;300MG/100ML;900MG/100ML N019308 003 Apr 05, 1985

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER



ICU MEDICAL INC 5GM/100ML;149MG/100ML;300MG/100ML N018876 002 Jan 17, 1986

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;224MG/100ML;225MG/100ML N018365 003 Jul 05, 1983

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;224MG/100ML;300MG/100ML N018876 003 Jan 17, 1986

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;224MG/100ML;900MG/100ML N019308 006 Apr 05, 1985

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;298MG/100ML;225MG/100ML N018365 004 Jul 05, 1983

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;298MG/100ML;300MG/100ML N018876 004 Mar 28, 1988

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 005 Mar 28, 1988

5GM/100ML;149MG/100ML;225MG/100ML N018365 007 Mar 28, 1988

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 005 Mar 28, 1988

5GM/100ML;149MG/100ML;300MG/100ML N018876 009 Mar 28, 1988

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 004

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 001 Apr 05, 1985
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 2.5GM/100ML;450MG/100ML N019631 004 Feb 24, 1988
AP +! BAXTER HLTHCARE 2.5GM/100ML;450MG/100ML N016697 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;200MG/100ML N019631 007 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;330MG/100ML N019631 008 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;450MG/100ML N019631 009 Feb 24, 1988
AP + ICU MEDICAL INC 5GM/100ML;450MG/100ML N017607 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;900MG/100ML N019631 010 Feb 24, 1988
AP +! ICU MEDICAL INC 5GM/100ML;900MG/100ML N017585 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;200MG/100ML N016689 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;330MG/100ML N016687 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;450MG/100ML N016683 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;900MG/100ML N016678 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML N019631 011 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML N019631 012 Feb 24, 1988
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-134(of 452)

DEXTROSE; SODIUM CHLORIDE



INJECTABLE;INJECTION

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;330MG/100ML N019631 013 Feb 24, 1988

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;450MG/100ML N019631 014 Feb 24, 1988

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML;900MG/100ML N019631 015 Feb 24, 1988

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 2.5GM/100ML;110MG/100ML N019631 001 Feb 24, 1988

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

B BRAUN 2.5GM/100ML;200MG/100ML N019631 002 Feb 24, 1988

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN 2.5GM/100ML;330MG/100ML N019631 003 Feb 24, 1988

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 2.5GM/100ML;900MG/100ML N019631 005 Feb 24, 1988

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML;300MG/100ML N019631 016 Jan 19, 1990

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML N019631 006 Feb 24, 1988

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

+! ICU MEDICAL INC 5GM/100ML;225MG/100ML N017606 001

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

+! ICU MEDICAL INC 5GM/100ML;300MG/100ML N017799 001

DIATRIZOATE MEGLUMINE

SOLUTION;URETHRAL

CYSTOGRAFIN

+ BRACCO 30% N010040 018

CYSTOGRAFIN DILUTE

+ BRACCO 18% N010040 022 Nov 09, 1982

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

SOLUTION;ORAL, RECTAL

GASTROGRAFIN

AA +! BRACCO 66%;10% N011245 003

MD-GASTROVIEW

AA LIEBEL-FLARSHEIM 66%;10% A087388 001

DIAZEPAM

CONCENTRATE;ORAL

DIAZEPAM

AA LANNETT CO INC 5MG/ML A204433 001 Apr 14, 2014

DIAZEPAM INTENSOL

AA ! WEST-WARD PHARMS 5MG/ML A071415 001 Apr 03, 1987

INT

GEL;RECTAL

DIASTAT

+ VALEANT PHARMS 2.5MG/0.5ML (5MG/ML) N020648 001 Jul 29, 1997

NORTH

DIASTAT ACUDIAL

+ VALEANT PHARMS 10MG/2ML (5MG/ML) N020648 007 Sep 15, 2005
NORTH
+! 20MG/4ML (5MG/ML) N020648 006 Sep 15, 2005
INJECTABLE;INJECTION
DIAZEPAM
! HOSPIRA 10MG/2ML (5MG/ML) A072079 001 Dec 20, 1988
! 50MG/10ML (5MG/ML) A071583 001 Oct 13, 1987
SOLUTION;ORAL
DIAZEPAM
AA LANNETT CO INC 5MG/5ML A206477 001 Jun 24, 2016
AA ! WEST-WARD PHARMS 5MG/5ML A070928 001 Apr 03, 1987
INT
TABLET;ORAL
DIAZEPAM
AB BARR 2MG A070152 001 Nov 01, 1985
AB 10MG A070154 001 Nov 01, 1985
AB IVAX SUB TEVA 2MG A071307 001 Dec 10, 1986
PHARMS
AB 5MG A071321 001 Dec 10, 1986
AB 10MG A071322 001 Dec 10, 1986
AB MAYNE PHARMA 2MG A071134 001 Feb 03, 1987
AB 5MG A071135 001 Feb 03, 1987
AB 10MG A071136 001 Feb 03, 1987
AB MYLAN 2MG A070325 002 Sep 04, 1985
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-135(of 452)

DIAZEPAM

TABLET;ORAL

DIAZEPAM

AB 5MG A070325 003 Sep 04, 1985

AB 10MG A070325 001 Sep 04, 1985

AB VINTAGE PHARMS 2MG A077749 001 Mar 31, 2006

AB 5MG A077749 002 Mar 31, 2006

AB 10MG A077749 003 Mar 31, 2006

VALIUM

AB + ROCHE 2MG N013263 002

AB + 5MG N013263 004

AB +! 10MG N013263 006

DIAZOXIDE

SUSPENSION;ORAL

PROGLYCEM

+! TEVA BRANDED PHARM 50MG/ML N017453 001

DICHLORPHENAMIDE

TABLET;ORAL

KEVEYIS

+! STRONGBRIDGE US 50MG N011366 002 Aug 07, 2015

DICLOFENAC

CAPSULE;ORAL

ZORVOLEX

+ IROKO PHARMS LLC 18MG N204592 001 Oct 18, 2013

+! 35MG N204592 002 Oct 18, 2013

DICLOFENAC EPOLAMINE

PATCH;TOPICAL

FLECTOR

+! INST BIOCHEM 1.3% N021234 001 Jan 31, 2007

SYSTEM;TOPICAL

LICART

+! IBSA INST BIO 1.3% N206976 001 Dec 19, 2018

DICLOFENAC POTASSIUM

CAPSULE;ORAL

DICLOFENAC POTASSIUM

AB BIONPHARMA INC 25MG A204648 001 Feb 23, 2016

ZIPSOR

AB +! ASSERTIO 25MG N022202 001 Jun 16, 2009

FOR SOLUTION;ORAL

CAMBIA

AB +! ASSERTIO 50MG N022165 001 Jun 17, 2009

DICLOFENAC POTASSIUM

AB PAR FORM 50MG A202964 001 May 02, 2016

TABLET;ORAL

DICLOFENAC POTASSIUM

AB APOTEX 50MG A076561 001 Mar 18, 2004

AB CASI PHARMS INC 50MG A075229 001 Nov 20, 1998

AB ! MYLAN 50MG A075463 001 Jul 26, 1999

AB TEVA 50MG A075219 001 Aug 06, 1998



DICLOFENAC SODIUM

GEL;TOPICAL

DICLOFENAC SODIUM

AB ACTAVIS MID 3% A206493 001 Dec 02, 2015

ATLANTIC

AB AMNEAL PHARMS 1% A208077 001 Mar 18, 2016

AB CIPLA 1% A209903 001 Aug 03, 2018

AB GLENMARK PHARMS LTD 3% A208301 001 Sep 13, 2016

AB HI-TECH PHARMACAL 1% A209484 001 Nov 21, 2018

AB PERRIGO UK FINCO 3% A210893 001 Jul 27, 2018

AB TARO 3% A206298 001 Apr 28, 2016

AB TOLMAR 3% A200936 001 Oct 28, 2013

SOLARAZE

AB +! FOUGERA PHARMS 3% N021005 001 Oct 16, 2000

VOLTAREN

AB +! GLAXOSMITHKLINE 1% N022122 001 Oct 17, 2007

CONS

SOLUTION;TOPICAL

DICLOFENAC SODIUM

AT AMNEAL PHARMS 1.5% A206116 001 Sep 02, 2016

AT ! APOTEX INC 1.5% A202027 001 May 27, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-136(of 452)

DICLOFENAC SODIUM

SOLUTION;TOPICAL

DICLOFENAC SODIUM

AT LUPIN LTD 1.5% A204132 001 Aug 20, 2015

AT NOVEL LABS INC 1.5% A205878 001 Dec 09, 2015

AT RICONPHARMA LLC 1.5% A206715 001 Aug 07, 2017

AT TARO 1.5% A203818 001 Nov 26, 2014

AT TELIGENT PHARMA INC 1.5% A202769 001 Jul 08, 2015

AT TWI PHARMS 1.5% A202393 001 Nov 24, 2014

AT WATSON LABS INC 1.5% A202852 001 Nov 24, 2014

AT ZYDUS PHARMS USA 1.5% A206411 001 Apr 17, 2018

INC

PENNSAID

+! HZNP 2% N204623 001 Jan 16, 2014

SOLUTION/DROPS;OPHTHALMIC

DICLOFENAC SODIUM

AT AKORN 0.1% A077845 001 Apr 17, 2008

AT ALTAIRE PHARMS INC 0.1% A203383 001 Nov 16, 2015

AT BAUSCH AND LOMB 0.1% A078792 001 Dec 28, 2007

AT RISING PHARMS 0.1% A078553 001 Dec 28, 2007

AT SANDOZ INC 0.1% A078031 001 Feb 06, 2008

VOLTAREN

AT +! NOVARTIS 0.1% N020037 001 Mar 28, 1991

TABLET, DELAYED RELEASE;ORAL

DICLOFENAC SODIUM

AB ACTAVIS ELIZABETH 50MG A074514 001 Mar 26, 1996

AB 75MG A074514 002 Mar 26, 1996

AB CARLSBAD 25MG A075185 002 Nov 13, 1998

AB 50MG A075185 003 Nov 13, 1998

AB 75MG A075185 001 Nov 13, 1998

AB ! CASI PHARMS INC 25MG A074376 001 Sep 28, 1995

AB ! 50MG A074376 002 Sep 28, 1995

AB ! 75MG A074394 001 Nov 30, 1995

AB MYLAN PHARMS INC 50MG A075281 002 Feb 12, 2002

AB 75MG A075281 003 Feb 12, 2002

AB UNIQUE PHARM LABS 25MG A090066 001 Dec 01, 2010

AB 50MG A090066 002 Dec 01, 2010

AB 75MG A077863 003 Jun 08, 2007



TABLET, EXTENDED RELEASE;ORAL

DICLOFENAC SODIUM

AB ! DEXCEL LTD 100MG A076201 001 Nov 06, 2002

AB MYLAN 100MG A076152 001 Dec 13, 2001

AB VPNA 100MG A075492 001 Feb 11, 2000



DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE;ORAL

ARTHROTEC

AB + GD SEARLE LLC 50MG;0.2MG N020607 001 Dec 24, 1997

AB +! 75MG;0.2MG N020607 002 Dec 24, 1997

DICLOFENAC SODIUM AND MISOPROSTOL



AB ACTAVIS LABS FL INC 50MG;0.2MG A201089 001 Jul 09, 2012

AB 75MG;0.2MG A201089 002 Jul 09, 2012

AB AMNEAL PHARMS 50MG;0.2MG A203995 001 Nov 25, 2016

AB 75MG;0.2MG A203995 002 Nov 25, 2016

AB EXELA HOLDINGS 50MG;0.2MG A200540 001 Mar 14, 2014

AB 75MG;0.2MG A200540 002 Mar 14, 2014

AB SANDOZ 50MG;0.2MG A200158 001 May 09, 2013

AB 75MG;0.2MG A200158 002 May 09, 2013



DICLOXACILLIN SODIUM

CAPSULE;ORAL

DICLOXACILLIN SODIUM

AB SANDOZ EQ 250MG BASE A061454 001

AB ! EQ 500MG BASE A061454 003

AB TEVA EQ 250MG BASE A062286 001 Jun 03, 1982

AB EQ 500MG BASE A062286 002 Jun 03, 1982



SANDOZ EQ 125MG BASE A061454 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-137(of 452)

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL

BENTYL

AB +! ALLERGAN SALES LLC 10MG N007409 003 Oct 15, 1984

DICYCLOMINE HYDROCHLORIDE

AB LANNETT 10MG A084285 001

AB MYLAN 10MG A040319 001 Sep 07, 1999

AB WATSON LABS 10MG A085082 001 Jun 19, 1986

AB WEST WARD 10MG A040204 001 Feb 28, 1997



INJECTABLE;INJECTION

BENTYL

AP +! ALLERGAN SALES LLC 10MG/ML N008370 001 Oct 15, 1984

BENTYL PRESERVATIVE FREE



AP +! ALLERGAN SALES LLC 10MG/ML N008370 002 Oct 15, 1984

DICYCLOMINE HYDROCHLORIDE

AP AKORN INC 10MG/ML A207084 001 May 04, 2018

AP APC PHARMS LLC 10MG/ML A210979 001 Jul 02, 2018

AP LUITPOLD 10MG/ML A208353 001 Feb 17, 2017

AP RENAISSANCE SSA LLC 10MG/ML A207076 001 Nov 02, 2018

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

AP WEST-WARD PHARMS 10MG/ML A040465 001 Jun 30, 2003

INT

SYRUP;ORAL

DICYCLOMINE HYDROCHLORIDE

! GENERICS 10MG/5ML A040169 001 Mar 24, 2005

TABLET;ORAL

BENTYL

AB +! ALLERGAN SALES LLC 20MG N007409 001 Oct 15, 1984

DICYCLOMINE HYDROCHLORIDE

AB HIKMA PHARMS 20MG A040161 001 Oct 01, 1996

AB LANNETT 20MG A040230 001 Feb 26, 1999

AB MYLAN 20MG A040317 001 Sep 07, 1999

AB WATSON LABS 20MG A085223 001 Jul 30, 1986



DIDANOSINE

CAPSULE, DELAYED REL PELLETS;ORAL

DIDANOSINE

AB AUROBINDO PHARMA 125MG A090094 001 Sep 24, 2008

AB 200MG A090094 002 Sep 24, 2008

AB 250MG A090094 003 Sep 24, 2008

AB 400MG A090094 004 Sep 24, 2008

VIDEX EC

AB + BRISTOL MYERS 125MG N021183 001 Oct 31, 2000

SQUIBB

AB + 200MG N021183 002 Oct 31, 2000

AB + 250MG N021183 003 Oct 31, 2000

AB +! 400MG N021183 004 Oct 31, 2000



FOR SOLUTION;ORAL

VIDEX

+! BRISTOL-MYERS 10MG/ML N020156 001 Oct 09, 1991

SQUIBB

DIENOGEST; ESTRADIOL VALERATE

TABLET;ORAL

NATAZIA

+! BAYER HLTHCARE N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A N022252 001 May 06, 2010

DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

DIETHYLPROPION HYDROCHLORIDE

AA AVANTHI INC 25MG A201212 001 Dec 22, 2010

AA LANNETT CO INC 25MG A200177 001 Jul 18, 2011

TENUATE

AA +! TEVA BRANDED PHARM 25MG N011722 002

TABLET, EXTENDED RELEASE;ORAL

DIETHYLPROPION HYDROCHLORIDE

AB LANNETT CO INC 75MG A091680 001 Oct 24, 2011

TENUATE DOSPAN

AB +! TEVA BRANDED PHARM 75MG N012546 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-138(of 452)

DIFLORASONE DIACETATE

CREAM;TOPICAL

DIFLORASONE DIACETATE

BX ! FOUGERA PHARMS 0.05% A076263 001 Dec 20, 2002

BX ! TARO 0.05% A075508 001 Apr 24, 2000

OINTMENT;TOPICAL

DIFLORASONE DIACETATE

AB AKORN 0.05% A206572 001 Jul 24, 2015

AB FOUGERA PHARMS 0.05% A075374 001 Apr 27, 1999

AB RISING PHARMS 0.05% A207440 001 Feb 27, 2017

AB ! TARO 0.05% A075331 001 May 14, 1999

AB TELIGENT PHARMA INC 0.05% A210753 001 Jun 12, 2018



DIFLUNISAL

TABLET;ORAL

DIFLUNISAL

AB HERITAGE PHARMA 500MG A202845 001 Mar 08, 2012

AB ! TEVA 500MG A073673 001 Jul 31, 1992

AB ZYDUS PHARMS USA 500MG A203547 001 Jun 16, 2017

INC

DIFLUPREDNATE

EMULSION;OPHTHALMIC

DUREZOL

+! NOVARTIS PHARMS 0.05% N022212 001 Jun 23, 2008

CORP

DIGOXIN

ELIXIR;ORAL

DIGOXIN

+! WEST-WARD PHARMS 0.05MG/ML N021648 001 Aug 26, 2004

INT

INJECTABLE;INJECTION

DIGOXIN

AP SANDOZ INC 0.25MG/ML A040481 001 Aug 21, 2003

AP WEST-WARD PHARMS 0.25MG/ML A083391 001



INT

LANOXIN

AP +! COVIS PHARMA BV 0.25MG/ML N009330 002

LANOXIN PEDIATRIC

+! COVIS PHARMA BV 0.1MG/ML N009330 004

TABLET;ORAL

DIGOXIN

AB HIKMA INTL PHARMS 0.125MG A077002 002 Oct 30, 2007

AB 0.25MG A077002 001 Oct 30, 2007

AB IMPAX LABS 0.125MG A078556 001 Jul 20, 2009

AB 0.25MG A078556 002 Jul 20, 2009

AB MYLAN PHARMS INC 0.125MG A040282 001 Dec 23, 1999

AB 0.25MG A040282 002 Dec 23, 1999

AB STEVENS J 0.125MG A076268 001 Jul 26, 2002

AB 0.25MG A076268 002 Jul 26, 2002

AB SUN PHARM INDS INC 0.125MG A076363 001 Jan 31, 2003

AB 0.25MG A076363 002 Jan 31, 2003

LANOXIN

AB + CONCORDIA PHARMS 0.125MG N020405 002 Sep 30, 1997

INC

AB +! 0.25MG N020405 004 Sep 30, 1997

+ 0.0625MG N020405 001 Sep 30, 1997



DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION

D.H.E. 45

AP +! VALEANT 1MG/ML N005929 001

DIHYDROERGOTAMINE MESYLATE

AP HIKMA PHARMS 1MG/ML A206621 001 Sep 15, 2017

AP PADDOCK LLC 1MG/ML A040475 001 Apr 28, 2003

AP SAGENT PHARMS 1MG/ML A207264 001 Jul 11, 2018

AP WEST-WARD PHARMS 1MG/ML A040453 001 Jun 09, 2003

INT

SPRAY, METERED;NASAL

MIGRANAL

+! VALEANT 0.5MG/INH N020148 001 Dec 08, 1997

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-139(of 452)

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DILTIAZEM HYDROCHLORIDE

AB2 APOTEX 120MG A074943 003 Dec 19, 2000

AB2 180MG A074943 002 Dec 19, 2000

AB2 240MG A074943 001 Aug 06, 1998

AB2 MYLAN 120MG A075124 002 Mar 18, 1998

AB2 180MG A075124 003 Mar 18, 1998

AB2 ! 240MG A075124 001 Mar 18, 1998

CARDIZEM CD

AB3 + VALEANT INTL 120MG N020062 001 Aug 10, 1992

AB3 + 180MG N020062 002 Dec 27, 1991

AB3 + 240MG N020062 003 Dec 27, 1991

AB3 + 300MG N020062 004 Dec 27, 1991

AB3 +! 360MG N020062 005 Aug 24, 1999

CARTIA XT

AB3 ACTAVIS LABS FL INC 120MG A074752 002 Jul 09, 1998

AB3 180MG A074752 001 Jul 09, 1998

AB3 240MG A074752 003 Jul 09, 1998

AB3 300MG A074752 004 Jul 09, 1998

DILTIAZEM HYDROCHLORIDE

AB3 ACTAVIS ELIZABETH 360MG A202463 001 Dec 07, 2012

AB3 PAR PHARM 120MG A074984 001 Dec 20, 1999

AB3 180MG A074984 002 Dec 20, 1999

AB3 240MG A074984 003 Dec 20, 1999

AB3 300MG A074984 004 Dec 20, 1999

AB3 360MG A209766 001 May 30, 2018

AB3 SUN PHARM INDS LTD 120MG A203023 001 Jun 08, 2017

AB3 180MG A203023 002 Jun 08, 2017

AB3 240MG A203023 003 Jun 08, 2017

AB3 300MG A203023 004 Jun 08, 2017

AB3 360MG A203023 005 Jun 08, 2017

AB3 SUN PHARMA GLOBAL 120MG A090492 001 Oct 28, 2011

AB3 180MG A090492 002 Oct 28, 2011

AB3 240MG A090492 003 Oct 28, 2011

AB3 300MG A090492 004 Oct 28, 2011

AB3 360MG A090492 005 Oct 28, 2011

AB3 TWI PHARMS 120MG A205231 001 Aug 30, 2018

AB3 180MG A205231 002 Aug 30, 2018

AB3 240MG A205231 003 Aug 30, 2018

AB3 300MG A205231 004 Aug 30, 2018

AB3 360MG A205231 005 Aug 30, 2018

AB3 VALEANT PHARMS 120MG A075116 001 Dec 23, 1999

NORTH

AB3 180MG A075116 002 Dec 23, 1999

AB3 240MG A075116 003 Dec 23, 1999

AB3 300MG A075116 004 Dec 23, 1999

AB3 ZYDUS PHARMS USA 120MG A206534 001 Aug 08, 2017

INC

AB3 180MG A206534 002 Aug 08, 2017

AB3 240MG A206534 003 Aug 08, 2017

AB3 300MG A206534 004 Aug 08, 2017

AB3 360MG A206534 005 Aug 08, 2017

AB4 SANDOZ 120MG A091022 001 Sep 28, 2012

AB4 180MG A091022 002 Sep 28, 2012

AB4 240MG A091022 003 Sep 28, 2012

AB4 300MG A091022 004 Sep 28, 2012

AB4 360MG A091022 005 Sep 28, 2012

AB4 420MG A091022 006 Sep 28, 2012

AB4 SUN PHARMA GLOBAL 120MG A090421 001 Nov 15, 2010

AB4 180MG A090421 002 Nov 15, 2010

AB4 240MG A090421 003 Nov 15, 2010

AB4 300MG A090421 004 Nov 15, 2010

AB4 360MG A090421 005 Nov 15, 2010

AB4 ZYDUS PHARMS USA 120MG A206641 001 Aug 11, 2017

INC

AB4 180MG A206641 002 Aug 11, 2017

AB4 240MG A206641 003 Aug 11, 2017

AB4 300MG A206641 004 Aug 11, 2017

AB4 360MG A206641 005 Aug 11, 2017

AB4 420MG A206641 006 Aug 11, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-140(of 452)

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DILTZAC

AB4 APOTEX INC 120MG A076395 001 Feb 01, 2006

AB4 180MG A076395 002 Feb 01, 2006

AB4 240MG A076395 003 Feb 01, 2006

AB4 300MG A076395 004 Feb 01, 2006

AB4 360MG A076395 005 Feb 01, 2006

TAZTIA XT

AB4 ACTAVIS LABS FL INC 120MG A075401 001 Apr 10, 2003

AB4 180MG A075401 002 Apr 10, 2003

AB4 240MG A075401 003 Apr 10, 2003

AB4 300MG A075401 004 Apr 10, 2003

AB4 360MG A075401 005 Apr 10, 2003

TIAZAC

AB4 + VALEANT PHARMS 120MG N020401 001 Sep 11, 1995

NORTH

AB4 + 180MG N020401 002 Sep 11, 1995

AB4 + 240MG N020401 003 Sep 11, 1995

AB4 + 300MG N020401 004 Sep 11, 1995

AB4 + 360MG N020401 005 Sep 11, 1995

AB4 +! 420MG N020401 006 Oct 16, 1998



DILTIAZEM HYDROCHLORIDE

BC ! MYLAN 120MG A074910 003 May 02, 1997

60MG A074910 001 May 02, 1997

90MG A074910 002 May 02, 1997

INJECTABLE;INJECTION

DILTIAZEM HYDROCHLORIDE

AP AKORN INC 5MG/ML A075086 001 Apr 09, 1998

AP ! ATHENEX INC 5MG/ML A074617 001 Feb 28, 1996

AP HIKMA FARMACEUTICA 5MG/ML A202651 001 Aug 09, 2012

AP HOSPIRA 5MG/ML A074941 001 Apr 15, 1998

AP INTL MEDICATION 5MG/ML A075749 001 Nov 21, 2001

AP WEST-WARD PHARMS 5MG/ML A078538 001 Dec 17, 2008

INT

! HOSPIRA 100MG/VIAL A075853 001 Dec 17, 2002

TABLET;ORAL

CARDIZEM

AB + VALEANT INTL 30MG N018602 001 Nov 05, 1982

AB + 60MG N018602 002 Nov 05, 1982

AB + 90MG N018602 003 Dec 08, 1986

AB +! 120MG N018602 004 Dec 08, 1986

DILTIAZEM HYDROCHLORIDE

AB MYLAN 30MG A072838 004 Nov 05, 1992

AB 60MG A072838 003 Nov 05, 1992

AB 90MG A072838 002 Nov 05, 1992

AB 120MG A072838 001 Nov 05, 1992

AB TEVA 30MG A074185 001 May 31, 1995

AB 60MG A074185 002 May 31, 1995

AB 90MG A074185 003 May 31, 1995

AB 120MG A074185 004 May 31, 1995

TABLET, EXTENDED RELEASE;ORAL

CARDIZEM LA

AB + VALEANT INTL 120MG N021392 001 Feb 06, 2003

AB + 180MG N021392 002 Feb 06, 2003

AB + 240MG N021392 003 Feb 06, 2003

AB + 300MG N021392 004 Feb 06, 2003

AB + 360MG N021392 005 Feb 06, 2003

AB +! 420MG N021392 006 Feb 06, 2003

DILTIAZEM HYDROCHLORIDE

AB ACTAVIS LABS FL INC 120MG A077686 006 Mar 15, 2010

AB 180MG A077686 005 Mar 15, 2010

AB 240MG A077686 004 Mar 15, 2010

AB 300MG A077686 003 Mar 15, 2010

AB 360MG A077686 002 Mar 15, 2010

AB 420MG A077686 001 Mar 15, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-141(of 452)

DIMENHYDRINATE

INJECTABLE;INJECTION

DIMENHYDRINATE

! FRESENIUS KABI USA 50MG/ML A040519 001 Jun 23, 2004

DIMERCAPROL

INJECTABLE;INJECTION

BAL

+! AKORN 10% N005939 001

DIMETHYL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL

TECFIDERA

+ BIOGEN IDEC INC 120MG N204063 001 Mar 27, 2013

+! 240MG N204063 002 Mar 27, 2013

DIMETHYL SULFOXIDE

SOLUTION;INTRAVESICAL

DIMETHYL SULFOXIDE

AT MYLAN INSTITUTIONAL 50% A076185 001 Nov 29, 2002

RIMSO-50

AT +! MYLAN INSTITUTIONAL 50% N017788 001

DINOPROSTONE

GEL;ENDOCERVICAL

PREPIDIL

+! PHARMACIA AND 0.5MG/3GM N019617 001 Dec 09, 1992

UPJOHN

INSERT, EXTENDED RELEASE;VAGINAL

CERVIDIL

+! FERRING PHARMS INC 10MG N020411 001 Mar 30, 1995

SUPPOSITORY;VAGINAL

PROSTIN E2

+! PHARMACIA AND 20MG N017810 001

UPJOHN

DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

! BARR 50MG A080738 001

ELIXIR;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

! PHARM ASSOC 12.5MG/5ML A087513 001 Feb 10, 1982

INJECTABLE;INJECTION

DIPHENHYDRAMINE HYDROCHLORIDE

AP APP PHARMS 50MG/ML A040466 001 May 28, 2002

AP HOSPIRA 50MG/ML A040140 001 Nov 20, 1998

AP MICRO LABS 50MG/ML A205723 001 Aug 22, 2018

AP MYLAN INSTITUTIONAL 50MG/ML A040498 001 Jul 12, 2005

AP ! WEST-WARD PHARMS 50MG/ML A080817 002



INT

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

AP FRESENIUS KABI USA 50MG/ML A091526 001 Mar 26, 2013

DIPYRIDAMOLE

INJECTABLE;INJECTION

DIPYRIDAMOLE

AP ! ATHENEX INC 5MG/ML A074939 001 Apr 13, 1998

AP FRESENIUS KABI USA 5MG/ML A074956 001 Sep 30, 1998

AP WEST-WARD PHARMS 5MG/ML A074521 001 Oct 18, 1996

INT

TABLET;ORAL

DIPYRIDAMOLE

AB BARR 25MG A087184 001 Oct 03, 1990

AB 50MG A087716 001 Oct 03, 1990

AB 75MG A087717 001 Oct 03, 1990

AB IMPAX LABS 25MG A040782 001 Jul 18, 2007

AB 50MG A040782 002 Jul 18, 2007

AB 75MG A040782 003 Jul 18, 2007

AB MURTY PHARMS 25MG A040733 001 Feb 13, 2007

AB 50MG A040733 002 Feb 13, 2007

AB 75MG A040733 003 Feb 13, 2007

AB ZYDUS PHARMS USA 25MG A040874 001 Jan 28, 2008

INC

AB 50MG A040874 002 Jan 28, 2008

AB 75MG A040874 003 Jan 28, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-142(of 452)

DIPYRIDAMOLE

TABLET;ORAL

PERSANTINE

AB + BOEHRINGER 25MG N012836 003 Dec 22, 1986

INGELHEIM

AB + 50MG N012836 004 Feb 06, 1987

AB +! 75MG N012836 005 Feb 06, 1987



DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL

DISOPYRAMIDE PHOSPHATE

AB MAYNE PHARMA EQ 100MG BASE A070173 001 May 31, 1985

AB EQ 150MG BASE A070173 002 May 31, 1985

AB TEVA EQ 100MG BASE A070101 001 Feb 22, 1985

AB EQ 150MG BASE A070102 001 Feb 22, 1985

NORPACE

AB + GD SEARLE LLC EQ 100MG BASE N017447 001

AB +! EQ 150MG BASE N017447 002

CAPSULE, EXTENDED RELEASE;ORAL

NORPACE CR

+ GD SEARLE LLC EQ 100MG BASE N018655 001 Jul 20, 1982

+! EQ 150MG BASE N018655 002 Jul 20, 1982

DISULFIRAM

TABLET;ORAL

ANTABUSE

AB ODYSSEY PHARMS 250MG A088482 001 Dec 08, 1983

AB ! 500MG A088483 001 Dec 08, 1983

DISULFIRAM

AB ALVOGEN MALTA 250MG A091681 001 Aug 08, 2013

AB CHARTWELL MOLECULES 250MG A091563 001 Dec 31, 2012

AB 500MG A091563 002 Dec 31, 2012

AB MYLAN PHARMS INC 250MG A203916 001 Mar 04, 2015

AB 500MG A203916 002 Mar 04, 2015

AB SIGMAPHARM LABS LLC 250MG A091619 001 Mar 28, 2011

AB 500MG A091619 002 Mar 28, 2011

AB WEST-WARD PHARMS 250MG A202652 001 Feb 05, 2014

INT

AB 500MG A202652 002 Feb 05, 2014

DIVALPROEX SODIUM

CAPSULE, DELAYED REL PELLETS;ORAL

DEPAKOTE

AB +! ABBVIE EQ 125MG VALPROIC ACID N019680 001 Sep 12, 1989

DIVALPROEX SODIUM

AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078979 001 Jan 23, 2009

AB MYLAN EQ 125MG VALPROIC ACID A090407 001 Mar 28, 2011

AB ZYDUS PHARMS USA EQ 125MG VALPROIC ACID A078919 001 Jan 27, 2009

INC

TABLET, DELAYED RELEASE;ORAL

DEPAKOTE

AB + ABBVIE EQ 125MG VALPROIC ACID N018723 003 Oct 26, 1984

AB + EQ 250MG VALPROIC ACID N018723 001 Mar 10, 1983

AB +! EQ 500MG VALPROIC ACID N018723 002 Mar 10, 1983

DIVALPROEX SODIUM

AB ACTAVIS LABS FL INC EQ 500MG VALPROIC ACID A079080 001 Feb 25, 2011

AB ANCHEN PHARMS EQ 500MG VALPROIC ACID A078411 001 Nov 03, 2008

AB APOTEX INC EQ 125MG VALPROIC ACID A077615 003 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A077615 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A077615 001 Jul 29, 2008

AB AUROBINDO PHARMA EQ 125MG VALPROIC ACID A090554 001 Apr 21, 2011

LTD

AB EQ 250MG VALPROIC ACID A090554 002 Apr 21, 2011

AB EQ 500MG VALPROIC ACID A090554 003 Apr 21, 2011

AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078755 001 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A078755 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A078755 003 Jul 29, 2008

AB LUPIN EQ 125MG VALPROIC ACID A078790 001 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A078790 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A078790 003 Jul 29, 2008

AB MYLAN EQ 125MG VALPROIC ACID A090062 001 Mar 17, 2009

AB EQ 250MG VALPROIC ACID A090062 002 Mar 17, 2009

AB EQ 500MG VALPROIC ACID A090062 003 Mar 17, 2009

AB ORCHID HLTHCARE EQ 125MG VALPROIC ACID A078853 001 Nov 25, 2008

AB EQ 250MG VALPROIC ACID A078853 002 Nov 25, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-143(of 452)

DIVALPROEX SODIUM

TABLET, DELAYED RELEASE;ORAL

DIVALPROEX SODIUM

AB EQ 500MG VALPROIC ACID A078853 003 Nov 25, 2008

AB PRINSTON INC EQ 125MG VALPROIC ACID A090210 001 Nov 30, 2009

AB EQ 250MG VALPROIC ACID A090210 002 Nov 30, 2009

AB EQ 500MG VALPROIC ACID A090210 003 Nov 30, 2009

AB SANDOZ EQ 125MG VALPROIC ACID A078290 003 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A078290 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A078290 001 Jul 29, 2008

AB SUN PHARM INDS EQ 125MG VALPROIC ACID A078597 001 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A078597 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A078597 003 Jul 29, 2008

AB TEVA EQ 125MG VALPROIC ACID A076941 001 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A076941 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A076941 003 Jul 29, 2008

AB UNICHEM LABS LTD EQ 125MG VALPROIC ACID A079163 001 Apr 05, 2011

AB EQ 250MG VALPROIC ACID A079163 002 Apr 05, 2011

AB EQ 500MG VALPROIC ACID A079163 003 Apr 05, 2011

AB UPSHER SMITH LABS EQ 125MG VALPROIC ACID A078182 001 Jul 29, 2008

AB EQ 250MG VALPROIC ACID A078182 002 Jul 29, 2008

AB EQ 500MG VALPROIC ACID A078182 003 Jul 29, 2008

AB WOCKHARDT EQ 125MG VALPROIC ACID A077296 001 Jul 31, 2008

AB EQ 250MG VALPROIC ACID A077296 002 Jul 31, 2008

AB EQ 500MG VALPROIC ACID A077296 003 Jul 31, 2008

AB ZYDUS PHARMS USA EQ 125MG VALPROIC ACID A077100 001 Mar 05, 2009

INC

AB EQ 250MG VALPROIC ACID A077100 002 Mar 05, 2009

AB EQ 500MG VALPROIC ACID A077100 003 Mar 05, 2009



TABLET, EXTENDED RELEASE;ORAL

DEPAKOTE ER

AB + ABBVIE EQ 250MG VALPROIC ACID N021168 002 May 31, 2002

AB +! EQ 500MG VALPROIC ACID N021168 001 Aug 04, 2000

DIVALPROEX SODIUM

AB AMNEAL PHARMS EQ 250MG VALPROIC ACID A203730 001 May 29, 2015

AB EQ 500MG VALPROIC ACID A203730 002 May 29, 2015

AB ANCHEN PHARMS EQ 250MG VALPROIC ACID A078445 001 Feb 26, 2009

AB EQ 500MG VALPROIC ACID A078445 002 Aug 04, 2009

AB AUROBINDO PHARMA EQ 250MG VALPROIC ACID A202419 001 Jun 02, 2014

LTD

AB EQ 500MG VALPROIC ACID A202419 002 Jun 02, 2014

AB DR REDDYS LABS LTD EQ 250MG VALPROIC ACID A090161 001 Mar 15, 2012

AB IMPAX LABS EQ 250MG VALPROIC ACID A078791 001 May 06, 2009

AB EQ 500MG VALPROIC ACID A078791 002 Aug 04, 2009

AB MYLAN EQ 250MG VALPROIC ACID A077567 001 Jan 29, 2009

AB EQ 500MG VALPROIC ACID A077567 002 Jan 29, 2009

AB REDDYS EQ 500MG VALPROIC ACID A090070 001 Mar 12, 2012

AB WOCKHARDT EQ 250MG VALPROIC ACID A078705 002 Feb 10, 2009

AB EQ 500MG VALPROIC ACID A078705 001 Aug 04, 2009

AB ZYDUS PHARMS USA EQ 250MG VALPROIC ACID A078239 001 Feb 27, 2009

INC

AB EQ 500MG VALPROIC ACID A078239 002 Aug 04, 2009

DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOBUTAMINE HYDROCHLORIDE

AP HOSPIRA EQ 12.5MG BASE/ML A074086 001 Nov 29, 1993

AP ! EQ 12.5MG BASE/ML A074292 001 Feb 16, 1995

AP WEST-WARD PHARMS EQ 12.5MG BASE/ML A074277 001 Oct 31, 1994

INT

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE EQ 50MG BASE/100ML N020255 001 Oct 19, 1993

AP +! EQ 100MG BASE/100ML N020255 003 Oct 19, 1993

AP +! EQ 200MG BASE/100ML N020255 004 Oct 19, 1993

AP +! EQ 400MG BASE/100ML N020255 005 Oct 19, 1993

AP +! HOSPIRA EQ 50MG BASE/100ML N020201 003 Oct 19, 1993

AP +! EQ 100MG BASE/100ML N020201 002 Oct 19, 1993

AP +! EQ 200MG BASE/100ML N020201 001 Oct 19, 1993

AP +! EQ 400MG BASE/100ML N020201 006 Jul 07, 1994



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-144(of 452)

DOCETAXEL

INJECTABLE;INJECTION

DOCETAXEL

AP + ACCORD HLTHCARE 20MG/ML (20MG/ML)
N201195 003 Apr 20, 2012

AP + 80MG/4ML (20MG/ML)
N201195 004 Apr 20, 2012

AP +! 160MG/8ML (20MG/ML)
N201195 005 Apr 20, 2012

AP ACTAVIS LLC 20MG/ML (20MG/ML)


N203551 001 Apr 12, 2013

AP 80MG/4ML (20MG/ML)
N203551 002 Apr 12, 2013

AP AMNEAL PHARMS CO 20MG/ML (20MG/ML)


A209640 001 Jan 19, 2018

AP 80MG/4ML (20MG/ML)
A209640 002 Jan 19, 2018

AP 160MG/8ML (20MG/ML)
A209640 003 Jan 19, 2018

AP CIPLA 20MG/2ML (10MG/ML)


A209634 001 Aug 24, 2018

AP 80MG/8ML (10MG/ML)
A209634 002 Aug 24, 2018

AP 160MG/16ML (10MG/ML)
A209634 003 Aug 24, 2018

AP DFB ONCOLOGY LTD 20MG/ML (20MG/ML)


A206177 001 Jan 20, 2017

AP 80MG/4ML (20MG/ML)
A206177 002 Jan 20, 2017

AP DR REDDYS LABS LTD 20MG/ML (20MG/ML)


A204193 001 Nov 05, 2014

AP 80MG/4ML (20MG/ML)
A204193 002 Nov 05, 2014

AP EAGLE PHARMS 20MG/ML (20MG/ML)


N205934 001 Dec 22, 2015

AP 80MG/4ML (20MG/ML)
N205934 002 Dec 22, 2015

AP 160MG/8ML (20MG/ML)
N205934 003 Dec 22, 2015

AP +! HOSPIRA INC 20MG/2ML (10MG/ML)


N022234 001 Mar 08, 2011

AP +! 80MG/8ML (10MG/ML)
N022234 002 Mar 08, 2011

AP +! 160MG/16ML (10MG/ML)
N022234 003 Mar 08, 2011

AP INGENUS PHARMS LLC 20MG/2ML (10MG/ML)


A207563 001 Aug 31, 2017

AP 80MG/8ML (10MG/ML)
A207563 002 Aug 31, 2017

AP 160MG/16ML (10MG/ML)
A207563 003 Aug 31, 2017

AP JIANGSU HENGRUI MED 20MG/ML (20MG/ML)


A207252 001 Aug 09, 2017

AP 80MG/4ML (20MG/ML)
A207252 002 Aug 09, 2017

AP 160MG/8ML (20MG/ML)
A207252 003 Aug 09, 2017

AP MYLAN LABS LTD 20MG/2ML (10MG/ML)


A210072 001 Jul 02, 2018

AP 80MG/8ML (10MG/ML)
A210848 001 Jul 06, 2018

AP SANDOZ 20MG/2ML (10MG/ML)


N201525 001 Jun 29, 2011

AP 80MG/8ML (10MG/ML)
N201525 002 Jun 29, 2011

AP 160MG/16ML (10MG/ML)
N201525 003 Jun 29, 2011

AP TEVA PHARMS USA 20MG/ML (20MG/ML)


A203877 001 Sep 16, 2015

AP 80MG/4ML (20MG/ML)
A203877 002 Sep 16, 2015

TAXOTERE

AP +! SANOFI AVENTIS US 20MG/ML (20MG/ML)
N020449 003 Aug 03, 2010

AP +! 80MG/4ML (20MG/ML)
N020449 004 Aug 02, 2010

AP +! 160MG/8ML (20MG/ML)
N020449 005 Apr 13, 2012

DOCETAXEL

ACTAVIS LLC 140MG/7ML (20MG/ML)
N203551 003 Apr 12, 2013

DFB ONCOLOGY LTD 200MG/10ML (20MG/ML)


A206177 003 Jan 20, 2017

+ HOSPIRA INC 20MG/ML (20MG/ML)
N022234 004 Jun 23, 2016

+ 80MG/4ML (20MG/ML)
N022234 005 Jun 23, 2016

+ 160MG/8ML (20MG/ML)
N022234 007 Jan 24, 2017

! JIANGSU HENGRUI MED 40MG/ML
A203170 001 Feb 15, 2017

DOCETAXEL

INJECTABLE;INJECTION

DOCETAXEL

AP MYLAN LABS LTD 160MG/16ML (10MG/ML)
A208859 001 Apr 30, 2018

DOFETILIDE

CAPSULE;ORAL

DOFETILIDE

AB BIONPHARMA INC 0.125MG
A208625 001 Apr 10, 2018

AB 0.25MG
A208625 002 Apr 10, 2018

AB 0.5MG
A208625 003 Apr 10, 2018

AB MAYNE PHARMA INC 0.125MG


A207058 001 Jun 06, 2016

AB 0.25MG
A207058 002 Jun 06, 2016

AB 0.5MG
A207058 003 Jun 06, 2016

AB PAR PHARM INC 0.125MG


A208519 001 Oct 09, 2018

AB 0.25MG
A208519 002 Oct 09, 2018

AB 0.5MG
A208519 003 Oct 09, 2018

AB SIGMAPHARM LABS LLC 0.125MG


A207746 001 Mar 26, 2018

AB 0.25MG
A207746 002 Mar 26, 2018

AB 0.5MG
A207746 003 Mar 26, 2018

AB SUN PHARMA GLOBAL 0.125MG


A210466 001 Oct 09, 2018

AB 0.25MG
A210466 002 Oct 09, 2018

AB 0.5MG
A210466 003 Oct 09, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-145(of 452)

DOFETILIDE

CAPSULE;ORAL

TIKOSYN

AB + PFIZER 0.125MG N020931 001 Oct 01, 1999

AB + 0.25MG N020931 002 Oct 01, 1999

AB +! 0.5MG N020931 003 Oct 01, 1999



DOLUTEGRAVIR SODIUM

TABLET;ORAL

TIVICAY

+ VIIV HLTHCARE EQ 10MG BASE N204790 002 Jun 09, 2016

+ EQ 25MG BASE N204790 003 Jun 09, 2016

+! EQ 50MG BASE N204790 001 Aug 12, 2013

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

TABLET;ORAL

JULUCA

+! VIIV HLTHCARE EQ 50MG BASE;EQ 25MG BASE N210192 001 Nov 21, 2017

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL

ARICEPT

AB + EISAI INC 5MG N020690 002 Nov 25, 1996

AB +! 10MG N020690 001 Nov 25, 1996

AB +! 23MG N022568 001 Jul 23, 2010

DONEPEZIL HYDROCHLORIDE

AB ACI HEALTHCARE LTD 5MG A078662 001 May 31, 2011

AB 10MG A078662 002 May 31, 2011

AB ACTAVIS ELIZABETH 23MG A202415 001 Dec 17, 2015

AB ALEMBIC PHARMS LTD 5MG A201724 001 Feb 25, 2013

AB 10MG A201724 002 Feb 25, 2013

AB AUROBINDO 5MG A090056 001 May 31, 2011

AB 10MG A090056 002 May 31, 2011

AB CADILA PHARMS LTD 5MG A204609 001 Sep 19, 2017

AB 10MG A204609 002 Sep 19, 2017

AB CIPLA LTD 5MG A077518 001 May 31, 2011

AB 10MG A077518 002 May 31, 2011

AB CSPC OUYI PHARM CO 5MG A202114 001 Jul 05, 2013

AB 10MG A202114 002 Jul 05, 2013

AB DEXCEL PHARMA 23MG A203713 001 Feb 19, 2016

AB DR REDDYS LABS LTD 5MG A201001 001 May 31, 2011

AB 10MG A201001 002 May 31, 2011

AB 23MG A202723 001 Jul 24, 2013

AB HETERO LABS LTD V 5MG A203034 001 Jan 30, 2015

AB 10MG A203034 002 Jan 30, 2015

AB HISUN PHARM 23MG A202410 001 Mar 24, 2017

HANGZHOU

AB INDICUS PHARMA 5MG A201634 001 Jun 13, 2012

AB 10MG A201634 002 Jun 13, 2012

AB 23MG A203419 001 Apr 12, 2016

AB JUBILANT GENERICS 5MG A090768 001 May 31, 2011

AB 10MG A090768 002 May 31, 2011

AB LUPIN LTD 23MG A202782 001 Oct 30, 2015

AB MACLEODS PHARMS LTD 5MG A201146 001 Aug 17, 2012

AB 10MG A201146 002 Aug 17, 2012

AB 23MG A202631 001 Jan 22, 2014

AB MYLAN PHARMS INC 5MG A090521 001 May 31, 2011

AB 10MG A090521 002 May 31, 2011

AB 23MG A202656 001 Oct 22, 2015

AB OSMOTICA PHARM US 23MG A203114 001 Jan 26, 2016

AB PAR PHARM 23MG A202542 001 Jul 24, 2013

AB PLIVA HRVATSKA DOO 5MG A090425 001 May 31, 2011

AB 10MG A090425 002 May 31, 2011

AB PRINSTON INC 5MG A200292 001 May 31, 2011

AB 10MG A200292 002 May 31, 2011

AB SANDOZ 5MG A090290 001 May 31, 2011

AB 10MG A090290 002 May 31, 2011

AB SCIEGEN PHARMS INC 5MG A203907 001 Oct 29, 2014

AB 10MG A203907 002 Oct 29, 2014

AB STRIDES VIVIMED 5MG A090551 001 May 31, 2011

AB 10MG A090551 002 May 31, 2011

AB SUN PHARM INDS 5MG A090493 001 May 31, 2011

AB 10MG A090493 002 May 31, 2011

AB SUN PHARM INDS LTD 23MG A204293 001 Jun 05, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-146(of 452)

DONEPEZIL HYDROCHLORIDE

TABLET;ORAL

DONEPEZIL HYDROCHLORIDE

AB TEVA 5MG A077344 001 May 31, 2011

AB 10MG A077344 002 May 31, 2011

AB TORRENT PHARMS 5MG A090686 001 May 31, 2011

AB 10MG A090686 002 May 31, 2011

AB TWI PHARMS 23MG A203104 001 Oct 29, 2014

AB UNICHEM LABS LTD 5MG A203656 001 Jun 23, 2016

AB 10MG A203656 002 Jun 23, 2016

AB WOCKHARDT 5MG A091267 001 May 31, 2011

AB 10MG A091267 002 May 31, 2011

AB ZYDUS PHARMS USA 5MG A090100 001 Oct 24, 2012

INC

AB 10MG A090100 002 Oct 24, 2012

AB 23MG A203162 001 Aug 31, 2017

TABLET, ORALLY DISINTEGRATING;ORAL

DONEPEZIL HYDROCHLORIDE

AB HISUN PHARM 5MG A205269 001 Jul 27, 2018

HANGZHOU

AB 10MG A205269 002 Jul 27, 2018

AB MACLEODS PHARMS LTD 5MG A201787 001 Dec 14, 2012

AB 10MG A201787 002 Dec 14, 2012

AB SANDOZ 5MG A091198 001 May 10, 2011

AB ! 10MG A091198 002 May 10, 2011

AB UNICHEM LABS LTD 5MG A204831 001 Nov 10, 2016

AB 10MG A204831 002 Nov 10, 2016



DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NAMZARIC

+ ALLERGAN SALES LLC 10MG;7MG N206439 003 Jul 18, 2016

+ 10MG;14MG N206439 001 Dec 23, 2014

+ 10MG;21MG N206439 004 Jul 18, 2016

+! 10MG;28MG N206439 002 Dec 23, 2014

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOPAMINE HYDROCHLORIDE

AP HIKMA INTL PHARMS 40MG/ML A207707 001 Apr 11, 2018

AP 80MG/ML A207707 002 Apr 11, 2018

AP +! HOSPIRA 40MG/ML N018132 001



AP +! 80MG/100ML N018132 002 Feb 04, 1982

AP +! 80MG/ML N018132 004 Jul 09, 1982

AP +! 160MG/100ML N018132 003 Feb 04, 1982

AP ! LUITPOLD 40MG/ML A070799 001 Feb 11, 1987

AP ! 80MG/ML A070820 001 Feb 11, 1987

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%



AP +! B BRAUN 80MG/100ML N019099 002 Oct 15, 1986

AP +! 320MG/100ML N019099 004 Oct 15, 1986

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER



AP +! B BRAUN 160MG/100ML N019099 003 Oct 15, 1986

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER



AP +! BAXTER HLTHCARE 80MG/100ML N019615 001 Mar 27, 1987

AP +! 160MG/100ML N019615 002 Mar 27, 1987

AP +! 320MG/100ML N019615 003 Mar 27, 1987

AP +! HOSPIRA 80MG/100ML N018826 001 Sep 30, 1983

AP +! 160MG/100ML N018826 002 Sep 30, 1983

AP +! 320MG/100ML N018826 003 Sep 30, 1983

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER



+! B BRAUN 40MG/100ML N019099 001 Oct 15, 1986

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 640MG/100ML N019615 004 Mar 27, 1987

DORAVIRINE

TABLET;ORAL

PIFELTRO

+! MSD MERCK CO 100MG N210806 001 Aug 30, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-147(of 452)

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE



TABLET;ORAL

DELSTRIGO

+! MSD MERCK CO 100MG;300MG;300MG N210807 001 Aug 30, 2018

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

AT BAUSCH AND LOMB EQ 2% BASE A090143 001 Jun 25, 2009

AT HI TECH PHARMA EQ 2% BASE A077846 001 Oct 28, 2008

AT LUITPOLD EQ 2% BASE A079186 001 Nov 18, 2009

AT SANDOZ INC EQ 2% BASE A078748 001 Nov 06, 2008

AT EQ 2% BASE A078981 001 Apr 13, 2009

TRUSOPT

AT +! MERCK EQ 2% BASE N020408 001 Dec 09, 1994

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

COSOPT

AT +! OAK PHARMS INC EQ 2% BASE;EQ 0.5% BASE N020869 001 Apr 07, 1998

COSOPT PF

AT +! OAK PHARMS INC EQ 2% BASE;EQ 0.5% BASE N202667 001 Feb 01, 2012

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE



AT AKORN INC EQ 2% BASE;EQ 0.5% BASE A203058 001 Sep 22, 2014

AT AUROBINDO PHARMA EQ 2% BASE;EQ 0.5% BASE A207630 001 Jul 24, 2018

LTD

AT BAUSCH AND LOMB EQ 2% BASE;EQ 0.5% BASE A090037 001 Jul 14, 2009

AT HI TECH PHARMA EQ 2% BASE;EQ 0.5% BASE A077847 001 Oct 28, 2008

AT SANDOZ EQ 2% BASE;EQ 0.5% BASE A078749 001 Nov 06, 2008

AT SANDOZ INC EQ 2% BASE;EQ 0.5% BASE A090604 001 Nov 18, 2009

AT TEVA PHARMS EQ 2% BASE;EQ 0.5% BASE A078704 001 Sep 28, 2009

DOXAPRAM HYDROCHLORIDE

INJECTABLE;INJECTION

DOPRAM

AP +! WEST-WARD PHARMS 20MG/ML N014879 001

INT

DOXAPRAM HYDROCHLORIDE

AP ATHENEX INC 20MG/ML A076266 001 Jan 10, 2003

DOXAZOSIN MESYLATE

TABLET;ORAL

CARDURA

AB +! PFIZER EQ 1MG BASE N019668 001 Nov 02, 1990

AB + EQ 2MG BASE N019668 002 Nov 02, 1990

AB + EQ 4MG BASE N019668 003 Nov 02, 1990

AB + EQ 8MG BASE N019668 004 Nov 02, 1990

DOXAZOSIN MESYLATE

AB ACCORD HLTHCARE EQ 1MG BASE A202824 001 Jun 11, 2014

AB EQ 2MG BASE A202824 002 Jun 11, 2014

AB EQ 4MG BASE A202824 003 Jun 11, 2014

AB EQ 8MG BASE A202824 004 Jun 11, 2014

AB ANI PHARMS INC EQ 1MG BASE A075432 001 Oct 18, 2000

AB EQ 2MG BASE A075432 002 Oct 18, 2000

AB EQ 4MG BASE A075432 003 Oct 18, 2000

AB EQ 8MG BASE A075432 004 Oct 18, 2000

AB APOTEX EQ 1MG BASE A075580 001 Oct 18, 2000

AB EQ 2MG BASE A075580 002 Oct 18, 2000

AB EQ 4MG BASE A075580 003 Oct 18, 2000

AB EQ 8MG BASE A075580 004 Oct 18, 2000

AB DAVA PHARMS INC EQ 1MG BASE A076161 001 Jun 10, 2004

AB EQ 2MG BASE A076161 002 Jun 10, 2004

AB EQ 4MG BASE A076161 003 Jun 10, 2004

AB EQ 8MG BASE A076161 004 Jun 10, 2004

AB HERITAGE PHARMA EQ 1MG BASE A205210 001 Feb 13, 2018

AB EQ 2MG BASE A205210 002 Feb 13, 2018

AB EQ 4MG BASE A205210 003 Feb 13, 2018

AB EQ 8MG BASE A205210 004 Feb 13, 2018

AB MYLAN EQ 1MG BASE A075509 001 Oct 19, 2000

AB EQ 2MG BASE A075509 002 Oct 19, 2000

AB EQ 4MG BASE A075509 003 Oct 19, 2000

AB EQ 8MG BASE A075509 004 Oct 19, 2000

AB PLIVA EQ 1MG BASE A075750 001 Jun 08, 2001

AB EQ 2MG BASE A075750 002 Jun 08, 2001

AB EQ 4MG BASE A075750 003 Jun 08, 2001



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-148(of 452)

DOXAZOSIN MESYLATE

TABLET;ORAL

DOXAZOSIN MESYLATE

AB EQ 8MG BASE A075750 004 Jun 08, 2001

AB TEVA EQ 1MG BASE A075536 001 Oct 18, 2000

AB EQ 2MG BASE A075536 002 Oct 18, 2000

AB EQ 4MG BASE A075536 003 Oct 18, 2000

AB EQ 8MG BASE A075536 004 Oct 18, 2000

AB UPSHER SMITH LABS EQ 1MG BASE A209013 001 Apr 17, 2018

AB EQ 2MG BASE A209013 002 Apr 17, 2018

AB EQ 4MG BASE A209013 003 Apr 17, 2018

AB EQ 8MG BASE A209013 004 Apr 17, 2018

AB ZYDUS PHARMS USA EQ 1MG BASE A208719 001 Jul 07, 2017

INC

AB EQ 2MG BASE A208719 002 Jul 07, 2017

AB EQ 4MG BASE A208719 003 Jul 07, 2017

AB EQ 8MG BASE A208719 004 Jul 07, 2017



TABLET, EXTENDED RELEASE;ORAL

CARDURA XL

+ PFIZER EQ 4MG BASE N021269 001 Feb 22, 2005

+! EQ 8MG BASE N021269 002 Feb 22, 2005

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

AB AMNEAL PHARMS CO EQ 10MG BASE A207482 001 Jun 28, 2017

AB EQ 25MG BASE A207482 002 Jun 28, 2017

AB EQ 50MG BASE A207482 003 Jun 28, 2017

AB EQ 75MG BASE A207482 004 Jun 28, 2017

AB EQ 100MG BASE A207482 005 Jun 28, 2017

AB MYLAN PHARMS INC EQ 10MG BASE A070791 002 May 13, 1986

AB ! EQ 25MG BASE A070791 003 May 13, 1986

AB EQ 50MG BASE A070791 001 May 13, 1986

AB EQ 75MG BASE A070791 004 May 13, 1986

AB ! EQ 100MG BASE A070791 005 May 13, 1986

AB PAR PHARM EQ 50MG BASE A071595 001 Nov 09, 1987

AB EQ 100MG BASE A071422 001 Nov 09, 1987



! EQ 150MG BASE A071669 001 Nov 09, 1987

CONCENTRATE;ORAL

DOXEPIN HYDROCHLORIDE

AA LANNETT CO INC EQ 10MG BASE/ML A074721 001 Dec 29, 1998

AA ! TEVA PHARMS EQ 10MG BASE/ML A071609 001 Nov 09, 1987

AA WOCKHARDT BIO AG EQ 10MG BASE/ML A071918 001 Jul 20, 1988



CREAM;TOPICAL

ZONALON

+! MYLAN PHARMS INC 5% N020126 001 Apr 01, 1994

TABLET;ORAL

SILENOR

+ PERNIX THERAPS LLC EQ 3MG BASE N022036 001 Mar 17, 2010

+! EQ 6MG BASE N022036 002 Mar 17, 2010

DOXERCALCIFEROL

CAPSULE;ORAL

DOXERCALCIFEROL

AB RISING PHARMS 0.5MCG A201518 001 Sep 09, 2016

AB 1MCG A201518 002 Sep 09, 2016

AB 2.5MCG A201518 003 Sep 09, 2016

AB WEST-WARD PHARMS 0.5MCG A091433 001 Sep 23, 2011

INT

AB 1MCG A091433 002 Jan 14, 2014

AB 2.5MCG A091433 003 Jan 14, 2014

HECTOROL

AB + SANOFI 0.5MCG N020862 002 Apr 23, 2004

AB + 1MCG N020862 003 Jul 13, 2009

AB +! 2.5MCG N020862 001 Jun 09, 1999



INJECTABLE;INJECTION

DOXERCALCIFEROL

AP AKORN INC 2MCG/ML (2MCG/ML) A203929 002 Mar 28, 2016

AP 4MCG/2ML (2MCG/ML) A203929 001 May 07, 2015

AP AMNEAL PHARMS CO 2MCG/ML (2MCG/ML) A208974 001 May 24, 2017

AP 4MCG/2ML (2MCG/ML) A208974 002 May 24, 2017

AP 4MCG/2ML (2MCG/ML) A208975 001 May 24, 2017

AP HIKMA PHARMS 4MCG/2ML (2MCG/ML) A091101 001 Aug 30, 2013

AP + HOSPIRA INC 4MCG/2ML (2MCG/ML) N208614 001 Jul 24, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-149(of 452)

DOXERCALCIFEROL

INJECTABLE;INJECTION

DOXERCALCIFEROL

AP LUPIN LTD 4MCG/2ML (2MCG/ML) A210801 001 Nov 01, 2018

AP SANDOZ INC 4MCG/2ML (2MCG/ML) A091333 001 May 05, 2014

AP 4MCG/2ML (2MCG/ML) A200926 001 Feb 04, 2014

HECTOROL

AP + SANOFI 2MCG/ML (2MCG/ML) N021027 002 Apr 06, 2000

AP +! 4MCG/2ML (2MCG/ML) N021027 001 Apr 06, 2000

DOXERCALCIFEROL

+! HOSPIRA INC 10MCG/5ML (2MCG/ML) N208614 002 Jul 24, 2018

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

DOXORUBICIN HYDROCHLORIDE

AP ACTAVIS INC 2MG/ML A203622 001 Jun 27, 2014

AP 200MG/100ML A203622 002 Jun 27, 2014

AP AMNEAL PHARMS CO 20MG/VIAL A208888 001 Feb 17, 2017

AP 50MG/VIAL A208888 002 Feb 17, 2017

AP FRESENIUS KABI USA 2MG/ML A063277 001 Oct 26, 1995

AP GLAND PHARMA LTD 2MG/ML A209825 001 Aug 11, 2017

AP MYLAN LABS LTD 2MG/ML A200901 001 Feb 14, 2012

AP 50MG/VIAL A200170 002 Oct 28, 2011

AP PHARMACHEMIE BV 2MG/ML A063336 001 Feb 28, 1995

AP 10MG/VIAL A063097 001 May 21, 1990

AP 20MG/VIAL A063097 002 May 21, 1990

AP 50MG/VIAL A063097 003 May 21, 1990

AP 200MG/100ML A063336 004 Feb 28, 1995

AP +! PHARMACIA AND 2MG/ML N050629 001 Dec 23, 1987

UPJOHN

AP +! 200MG/100ML N050629 002 May 03, 1988

AP SAGENT PHARMS 2MG/ML A091495 001 Mar 18, 2013

AP SUN PHARM INDS 2MG/ML A091418 001 Feb 15, 2012

AP TEVA PHARMS USA 2MG/ML A064140 001 Jul 28, 1995

AP 200MG/100ML A064140 002 Jul 28, 1995

AP WEST-WARD PHARMS 2MG/ML A062975 001 Mar 17, 1989

INT

AP ! 10MG/VIAL A062921 001 Mar 17, 1989

AP ! 20MG/VIAL A062921 002 Mar 17, 1989

AP ! 50MG/VIAL A062921 003 Mar 17, 1989

AP 200MG/100ML A064097 001 Sep 13, 1994

+ PHARMACIA AND 150MG/75ML N050629 003 Mar 28, 2011

UPJOHN

INJECTABLE, LIPOSOMAL;INJECTION

DOXIL (LIPOSOMAL)

AB + JANSSEN RES AND DEV 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995

AB + 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

AB DR REDDYS LABS LTD 20MG/10ML (2MG/ML) A208657 001 May 15, 2017

AB 50MG/25ML (2MG/ML) A208657 002 May 15, 2017

AB ! SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013

AB ! 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013



DOXYCYCLINE

CAPSULE;ORAL

DOXYCYCLINE

AB ALEMBIC PHARMS LTD EQ 75MG BASE A209165 001 Jul 28, 2017

AB EQ 100MG BASE A209165 002 Jul 28, 2017

AB G AND W LABS INC EQ 50MG BASE A204446 001 May 28, 2015

AB EQ 75MG BASE A204446 002 May 28, 2015

AB EQ 100MG BASE A204446 003 May 28, 2015

AB IMPAX LABS INC EQ 150MG BASE A200065 001 Feb 17, 2011

AB LUPIN LTD EQ 50MG BASE A204234 001 Mar 05, 2014

AB EQ 75MG BASE A204234 002 Mar 05, 2014

AB EQ 100MG BASE A204234 003 Mar 05, 2014

AB MAYNE PHARMA INC EQ 50MG BASE A209396 001 Sep 29, 2017

AB EQ 75MG BASE A209396 002 Sep 29, 2017

AB EQ 100MG BASE A209396 003 Sep 29, 2017

AB MYLAN PHARMS INC EQ 150MG BASE A202778 001 Jun 08, 2012

AB PAR PHARM EQ 50MG BASE A065055 001 Dec 01, 2000

AB EQ 100MG BASE A065055 002 Dec 01, 2000

AB ! EQ 150MG BASE A065055 003 Jul 15, 2005

AB SUN PHARM INDS LTD EQ 50MG BASE A065053 001 Nov 22, 2000

AB EQ 75MG BASE A065053 003 Sep 10, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-150(of 452)

DOXYCYCLINE

CAPSULE;ORAL

DOXYCYCLINE

AB
EQ 100MG BASE
A065053 002 Nov 22, 2000

AB ZYDUS PHARMS USA


EQ 50MG BASE
A205115 001 Feb 18, 2016

INC

AB
EQ 75MG BASE
A205115 002 Feb 18, 2016

AB
EQ 100MG BASE
A205115 003 Feb 18, 2016

MONODOX

AB + AQUA PHARMS
EQ 50MG BASE
N050641 002 Feb 10, 1992

AB +
EQ 75MG BASE
N050641 003 Oct 18, 2006

AB +!
EQ 100MG BASE
N050641 001 Dec 29, 1989

ORACEA

+! GALDERMA LABS LP
40MG
N050805 001 May 26, 2006

FOR SUSPENSION;ORAL

DOXYCYCLINE

AB CHARTWELL LIFE SCI
EQ 25MG BASE/5ML
A065454 001 Jul 16, 2008

AB LUPIN LTD
EQ 25MG BASE/5ML
A201678 001 Mar 18, 2013

VIBRAMYCIN

AB +! PFIZER
EQ 25MG BASE/5ML
N050006 001

TABLET;ORAL

DOXYCYCLINE

AB HERITAGE PHARMS INC
EQ 50MG BASE
A091605 001 Dec 20, 2011

AB
EQ 75MG BASE
A091605 002 Dec 20, 2011

AB
EQ 100MG BASE
A091605 003 Dec 20, 2011

AB
EQ 150MG BASE
A091605 004 Dec 20, 2011

AB LANNETT CO INC
EQ 50MG BASE
A065285 001 Dec 08, 2005

AB
EQ 75MG BASE
A065285 003 Jul 30, 2008

AB
EQ 100MG BASE
A065285 002 Dec 08, 2005

AB
EQ 150MG BASE
A065285 004 Jul 30, 2008

AB MYLAN
EQ 50MG BASE
A065377 001 Nov 07, 2006

AB
EQ 75MG BASE
A065377 002 Nov 07, 2006

AB
EQ 100MG BASE
A065377 003 Nov 07, 2006

AB
EQ 150MG BASE
A065427 001 Jun 07, 2007

AB PAR PHARM
EQ 50MG BASE
A065070 001 Dec 15, 2000

AB
EQ 75MG BASE
A065070 003 Dec 30, 2002

AB
EQ 100MG BASE
A065070 002 Dec 15, 2000

AB !
EQ 150MG BASE
A065070 004 Jul 14, 2005

AB SUN PHARM INDS LTD


EQ 50MG BASE
A065356 001 May 31, 2006

AB
EQ 75MG BASE
A065356 002 May 31, 2006

AB
EQ 100MG BASE
A065356 003 May 31, 2006

AB
EQ 150MG BASE
A065356 004 Jul 29, 2010

AB ZYDUS PHARMS USA


EQ 50MG BASE
A209582 001 Sep 28, 2017

INC

AB
EQ 75MG BASE
A209582 002 Sep 28, 2017

AB
EQ 100MG BASE
A209582 003 Sep 28, 2017

AB
EQ 150MG BASE
A209582 004 Sep 28, 2017

DOXYCYCLINE CALCIUM

SUSPENSION;ORAL

VIBRAMYCIN

+! PFIZER
EQ 50MG BASE/5ML
N050480 001

DOXYCYCLINE HYCLATE

CAPSULE;ORAL

DOXYCYCLINE HYCLATE

AB ACTAVIS LABS FL INC
EQ 50MG BASE
A062031 002 Oct 13, 1982

AB
EQ 100MG BASE
A062031 001

AB AJANTA PHARMA LTD
EQ 50MG BASE
A211012 001 Sep 24, 2018

AB
EQ 100MG BASE
A211012 002 Sep 24, 2018

AB ALEMBIC PHARMS LTD


EQ 50MG BASE
A210527 001 Jun 13, 2018

AB
EQ 100MG BASE
A210527 002 Jun 13, 2018

AB AMNEAL PHARMS
EQ 100MG BASE
A207289 001 Jun 27, 2016

AB CHARTWELL LIFE SCI


EQ 50MG BASE
A062500 001 Sep 11, 1984

AB
EQ 100MG BASE
A062500 002 Sep 11, 1984

AB HIKMA INTL PHARMS


EQ 50MG BASE
A062396 002 Nov 07, 1984

AB
EQ 100MG BASE
A062396 001 May 07, 1984

AB MYLAN
EQ 50MG BASE
A062337 001 Mar 29, 1982

AB
EQ 100MG BASE
A062337 002 Mar 29, 1982

AB SUN PHARM
EQ 50MG BASE
A062676 002 Jul 10, 1986

INDUSTRIES

AB
EQ 100MG BASE
A062676 001 Jul 10, 1986

AB ZYDUS PHARMS USA


EQ 50MG BASE
A207774 001 May 31, 2018

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-151(of 452)

DOXYCYCLINE HYCLATE

CAPSULE;ORAL

DOXYCYCLINE HYCLATE

AB EQ 100MG BASE A207774 002 May 31, 2018

VIBRAMYCIN

AB +! PFIZER EQ 100MG BASE N050007 002

INJECTABLE;INJECTION

DOXY 100

AP ! FRESENIUS KABI USA EQ 100MG BASE/VIAL A062475 001 Dec 09, 1983

DOXY 200

AP ! FRESENIUS KABI USA EQ 200MG BASE/VIAL A062475 002 Dec 09, 1983

DOXYCYCLINE

AP MYLAN LABS LTD EQ 100MG BASE/VIAL A091406 001 Aug 21, 2012

AP ! WEST-WARD PHARMS EQ 100MG BASE/VIAL A062569 001 Mar 09, 1988

INT

AP ZYDUS PHARMS USA EQ 100MG BASE/VIAL A207757 001 Sep 28, 2017

INC

AP EQ 200MG BASE/VIAL A207757 002 Sep 28, 2017

SYSTEM, EXTENDED RELEASE;PERIODONTAL



ATRIDOX

+! TOLMAR 50MG N050751 001 Sep 03, 1998

TABLET;ORAL

ACTICLATE

AB + AQUA PHARMS LLC EQ 75MG BASE N205931 001 Jul 25, 2014

AB +! EQ 150MG BASE N205931 002 Jul 25, 2014

DOXYCYCLINE HYCLATE

AB ACTAVIS LABS FL INC EQ 100MG BASE A062421 001 Feb 02, 1983

AB AMNEAL PHARMS CO EQ 75MG BASE A209372 001 Oct 06, 2017

AB EQ 150MG BASE A209372 002 Oct 06, 2017

AB CARIBE HOLDINGS EQ 100MG BASE A062269 002 Nov 08, 1982

AB CHARTWELL LIFE SCI EQ 100MG BASE A062505 001 Sep 11, 1984

AB EMCURE PHARMS LTD EQ 100MG BASE A209969 001 Nov 09, 2018

AB ! HIKMA INTL PHARMS EQ 100MG BASE A065095 001 Jul 02, 2003

AB IVAX SUB TEVA EQ 20MG BASE A065163 001 May 13, 2005

PHARMS

AB ! LANNETT CO INC EQ 20MG BASE A065277 001 Nov 10, 2005

AB LARKEN LABS EQ 20MG BASE A065287 001 Feb 28, 2006

AB LUPIN LTD EQ 75MG BASE A208818 001 Sep 27, 2017

AB EQ 150MG BASE A208818 002 Sep 27, 2017

AB MAYNE PHARMA INC EQ 75MG BASE A208765 001 Jun 14, 2017

AB EQ 150MG BASE A208765 002 Jun 14, 2017

AB MYLAN EQ 100MG BASE A062432 001 Feb 15, 1983

AB NOVEL LABS INC EQ 100MG BASE A207558 001 Sep 06, 2017

AB SUN PHARM EQ 20MG BASE A065134 001 May 13, 2005

INDUSTRIES

AB EQ 100MG BASE A062677 001 Jul 10, 1986

AB ZYDUS PHARMS USA EQ 100MG BASE A207773 001 Oct 30, 2017

INC

CARIBE HOLDINGS EQ 50MG BASE A062269 003 Oct 05, 1983

TABLET, DELAYED RELEASE;ORAL

DORYX

AB + MAYNE PHARMA EQ 50MG BASE N050795 006 Dec 19, 2014

AB + EQ 75MG BASE N050795 001 May 06, 2005

AB + EQ 100MG BASE N050795 002 May 06, 2005

AB + EQ 150MG BASE N050795 003 Jun 20, 2008

AB +! EQ 200MG BASE N050795 005 Apr 11, 2013

DOXYCYCLINE HYCLATE

AB ACTAVIS ELIZABETH EQ 50MG BASE A090134 003 May 22, 2018

AB EQ 75MG BASE A090134 001 Dec 14, 2011

AB EQ 100MG BASE A090134 002 Dec 14, 2011

AB EQ 200MG BASE A090134 004 May 22, 2018

AB HERITAGE PHARMS INC EQ 75MG BASE A200856 001 Apr 30, 2013

AB EQ 100MG BASE A200856 002 Apr 30, 2013

AB EQ 150MG BASE A200856 003 Apr 30, 2013

AB EQ 200MG BASE A200856 004 Nov 13, 2018

AB MYLAN EQ 50MG BASE A090431 003 May 23, 2016

AB EQ 75MG BASE A090431 001 Dec 28, 2010

AB EQ 100MG BASE A090431 002 Dec 28, 2010

AB EQ 200MG BASE A090431 005 May 19, 2016

AB MYLAN PHARMS INC EQ 150MG BASE A091052 001 Feb 08, 2012

AB PRINSTON INC EQ 150MG BASE A207494 001 Nov 15, 2016

AB EQ 200MG BASE A207494 002 Nov 15, 2016

AB ZYDUS PHARMS USA EQ 75MG BASE A206772 001 Dec 21, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-152(of 452)

DOXYCYCLINE HYCLATE

TABLET, DELAYED RELEASE;ORAL

DOXYCYCLINE HYCLATE
INC
AB EQ 100MG BASE A206772 002 Dec 21, 2018

AB EQ 150MG BASE A206772 003 Dec 21, 2018



DORYX MPC
+! MAYNE PHARMA EQ 120MG BASE N050795 008 May 20, 2016

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, DELAYED RELEASE;ORAL

DICLEGIS

AB +! DUCHESNAY 10MG;10MG
N021876 001 Apr 08, 2013

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

AB ACTAVIS LABS FL INC
10MG;10MG
A205811 001 Aug 19, 2016

AB PAR PHARM INC


10MG;10MG
A208518 001 Dec 06, 2017

TABLET, EXTENDED RELEASE;ORAL

BONJESTA

+! DUCHESNAY
20MG;20MG
N209661 001 Nov 07, 2016

DRONABINOL

CAPSULE;ORAL

DRONABINOL

AB AKORN INC
2.5MG
A079217 001 Jun 20, 2014

AB
5MG
A079217 002 Jun 20, 2014

AB
10MG
A079217 003 Jun 20, 2014

AB LANNETT CO INC
2.5MG
A201463 001 May 18, 2018

AB
5MG
A201463 002 May 18, 2018

AB
10MG
A201463 003 May 18, 2018

AB SVC PHARMA
2.5MG
A078292 001 Jun 27, 2008

AB
5MG
A078292 002 Jun 27, 2008

AB
10MG
A078292 003 Jun 27, 2008

MARINOL

AB + ABBVIE
2.5MG
N018651 001 May 31, 1985

AB +!
5MG
N018651 002 May 31, 1985

AB +
10MG
N018651 003 May 31, 1985

SOLUTION;ORAL

SYNDROS

+! INSYS DEV CO INC
5MG/ML
N205525 001 Mar 23, 2017

DRONEDARONE HYDROCHLORIDE

TABLET;ORAL

MULTAQ

+! SANOFI AVENTIS US
EQ 400MG BASE
N022425 001 Jul 01, 2009

DROPERIDOL

INJECTABLE;INJECTION

DROPERIDOL

AP EUROHLTH INTL SARL
2.5MG/ML
A208197 001 Dec 14, 2017

AP HOSPIRA
2.5MG/ML
A071981 001 Feb 29, 1988

AP LUITPOLD
2.5MG/ML
A072123 001 Oct 24, 1988

INAPSINE

AP +! AKORN INC
2.5MG/ML
N016796 001

DROSPIRENONE; ESTRADIOL

TABLET;ORAL

ANGELIQ

+ BAYER HLTHCARE
0.25MG;0.5MG
N021355 001 Feb 29, 2012

+!
0.5MG;1MG
N021355 002 Sep 28, 2005

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET;ORAL

DROSPIRENONE AND ETHINYL ESTRADIOL



AB BARR 3MG;0.02MG
A078515 001 Mar 30, 2009

AB GLENMARK PHARMS LTD 3MG;0.02MG


A204296 001 Aug 17, 2015

AB JUBILANT CADISTA
3MG;0.02MG
A209423 001 Dec 22, 2017

AB MYLAN LABS LTD


3MG;0.02MG
A202594 001 Oct 22, 2015

AB PII
3MG;0.02MG
A203291 001 Jul 18, 2017

AB WATSON LABS
3MG;0.02MG
A078833 001 Nov 28, 2011

LO-ZUMANDIMINE

AB AUROBINDO PHARMA
3MG;0.02MG
A209632 001 Feb 27, 2018

LTD

LORYNA

AB LABS LEON FARMA
3MG;0.02MG
A079221 001 Mar 28, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-153(of 452)

DROSPIRENONE; ETHINYL ESTRADIOL



TABLET;ORAL

MELAMISA

AB NOVAST LABS 3MG;0.02MG A202016 001 Jan 26, 2016

NIKKI

AB LUPIN LTD 3MG;0.02MG A201661 001 May 27, 2014

YAZ

AB +! BAYER HLTHCARE 3MG;0.02MG N021676 001 Mar 16, 2006

TABLET;ORAL-28

DROSPIRENONE AND ETHINYL ESTRADIOL



AB ACCORD HLTHCARE 3MG;0.03MG A207245 001 Nov 22, 2016

AB APOTEX INC 3MG;0.03MG A205876 001 Sep 21, 2016

AB BARR 3MG;0.03MG A077527 001 May 09, 2008

AB GLENMARK PHARMS LTD 3MG;0.03MG A204848 001 Mar 25, 2016

AB JUBILANT CADISTA 3MG;0.03MG A210017 001 Sep 10, 2018

AB LUPIN LTD 3MG;0.03MG A201663 001 Dec 18, 2012

AB MAYNE PHARMA 3MG;0.03MG A090081 001 Sep 07, 2010

AB MYLAN LABS LTD 3MG;0.03MG A202131 001 May 04, 2015

SYEDA

AB LABS LEON FARMA 3MG;0.03MG A090114 001 Mar 28, 2011

YAELA

AB NOVAST LABS 3MG;0.03MG A202015 001 Nov 19, 2014

YASMIN

AB +! BAYER HLTHCARE 3MG;0.03MG N021098 001 May 11, 2001

ZUMANDIMINE

AB AUROBINDO PHARMA 3MG;0.03MG A209407 001 Mar 26, 2018

LTD

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

TABLET;ORAL

BEYAZ

AB BAYER HLTHCARE 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG N022532 001 Sep 24, 2010

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

AB LUPIN LTD 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG A205947 001 Jun 13, 2018

AB WATSON LABS INC 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG A203593 001 Oct 11, 2016

AB 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG A203594 001 Oct 11, 2016

SAFYRAL

AB +! BAYER HLTHCARE 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG N022574 001 Dec 16, 2010

TYDEMY

AB LUPIN LTD 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG A205948 001 Dec 12, 2017

DROXIDOPA

CAPSULE;ORAL

NORTHERA

+ LUNDBECK NA LTD 100MG N203202 001 Feb 18, 2014

+ 200MG N203202 002 Feb 18, 2014

+! 300MG N203202 003 Feb 18, 2014

DULOXETINE HYDROCHLORIDE

CAPSULE, DELAYED REL PELLETS;ORAL

CYMBALTA

AB + LILLY EQ 20MG BASE N021427 001 Aug 03, 2004

AB + EQ 30MG BASE N021427 002 Aug 03, 2004

AB +! EQ 60MG BASE N021427 004 Aug 03, 2004

DULOXETINE HYDROCHLORIDE

AB ACTAVIS ELIZABETH EQ 20MG BASE A090776 001 Dec 17, 2013

AB EQ 30MG BASE A090776 002 Dec 17, 2013

AB EQ 60MG BASE A090776 003 Dec 17, 2013

AB AJANTA PHARMA LTD EQ 20MG BASE A208706 001 Jan 06, 2017

AB EQ 30MG BASE A208706 002 Jan 06, 2017

AB EQ 60MG BASE A208706 003 Jan 06, 2017

AB ALEMBIC PHARMS LTD EQ 20MG BASE A202949 001 Jun 09, 2014

AB EQ 30MG BASE A202949 002 Jun 09, 2014

AB EQ 60MG BASE A202949 003 Jun 09, 2014

AB ALKEM LABS LTD EQ 20MG BASE A203197 001 Aug 26, 2015

AB EQ 30MG BASE A203197 002 Aug 26, 2015

AB EQ 60MG BASE A203197 003 Aug 26, 2015

AB ANCHEN PHARMS EQ 20MG BASE A090780 001 Oct 28, 2015

AB EQ 30MG BASE A090780 002 Oct 28, 2015

AB EQ 60MG BASE A090780 003 Oct 28, 2015

AB APOTEX INC EQ 20MG BASE A202045 001 Jun 11, 2014

AB EQ 30MG BASE A202045 002 Jun 11, 2014

AB EQ 60MG BASE A202045 003 Jun 11, 2014

AB AUROBINDO PHARMA EQ 20MG BASE A090778 001 Dec 11, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-154(of 452)

DULOXETINE HYDROCHLORIDE

CAPSULE, DELAYED REL PELLETS;ORAL

DULOXETINE HYDROCHLORIDE

LTD

AB EQ 30MG BASE A090778 002 Dec 11, 2013

AB EQ 60MG BASE A090778 003 Dec 11, 2013

AB BRECKENRIDGE PHARM EQ 20MG BASE A203088 001 Jun 11, 2014

AB EQ 30MG BASE A203088 002 Jun 11, 2014

AB EQ 40MG BASE A203088 004 May 18, 2018

AB EQ 60MG BASE A203088 003 Jun 11, 2014

AB CSPC OUYI PHARM CO EQ 20MG BASE A211310 001 Oct 16, 2018

AB EQ 30MG BASE A211310 002 Oct 16, 2018

AB EQ 60MG BASE A211310 003 Oct 16, 2018

AB HETERO LABS LTD III EQ 20MG BASE A204343 001 Aug 03, 2016

AB EQ 30MG BASE A204343 002 Aug 03, 2016

AB EQ 60MG BASE A204343 003 Aug 03, 2016

AB INVENTIA HLTHCARE EQ 20MG BASE A202336 001 Oct 28, 2015

AB EQ 30MG BASE A202336 002 Oct 28, 2015

AB EQ 60MG BASE A202336 003 Oct 28, 2015

AB LUPIN LTD EQ 20MG BASE A090694 001 Dec 11, 2013

AB EQ 30MG BASE A090694 002 Dec 11, 2013

AB EQ 40MG BASE A090694 003 Dec 11, 2013

AB EQ 60MG BASE A090694 004 Dec 11, 2013

AB MACLEODS PHARMS LTD EQ 20MG BASE A204815 001 Mar 23, 2017

AB EQ 30MG BASE A204815 002 Mar 23, 2017

AB EQ 60MG BASE A204815 003 Mar 23, 2017

AB MARKSANS PHARMA EQ 20MG BASE A090723 001 Dec 11, 2013

AB EQ 30MG BASE A090723 002 Dec 11, 2013

AB EQ 60MG BASE A090723 003 Dec 11, 2013

AB PRINSTON INC EQ 20MG BASE A206653 001 May 18, 2017

AB EQ 30MG BASE A206653 002 May 18, 2017

AB EQ 60MG BASE A206653 003 May 18, 2017

AB SUN PHARMA GLOBAL EQ 20MG BASE A090745 001 Dec 11, 2013

AB EQ 30MG BASE A090745 002 Dec 11, 2013

AB EQ 60MG BASE A090745 003 Dec 11, 2013

AB TEVA PHARMS USA EQ 20MG BASE A090783 001 Dec 11, 2013

AB EQ 30MG BASE A090783 002 Dec 11, 2013

AB EQ 60MG BASE A090783 003 Dec 11, 2013

AB TORRENT PHARMS LTD EQ 20MG BASE A090774 001 Dec 11, 2013

AB EQ 30MG BASE A090774 002 Dec 11, 2013

AB EQ 60MG BASE A090774 003 Dec 11, 2013

AB ZYDUS HLTHCARE EQ 20MG BASE A090739 001 Jan 08, 2014

AB EQ 30MG BASE A090739 002 Jan 08, 2014

AB EQ 60MG BASE A090739 003 Jan 08, 2014

AB ZYDUS PHARMS USA EQ 20MG BASE A090728 001 Jan 08, 2014

INC

AB EQ 30MG BASE A090728 002 Jan 08, 2014

AB EQ 60MG BASE A090728 003 Jan 08, 2014



DUTASTERIDE

CAPSULE;ORAL

AVODART

AB +! GLAXOSMITHKLINE 0.5MG N021319 001 Nov 20, 2001

DUTASTERIDE

AB ACTAVIS LABS FL INC 0.5MG A202808 001 Nov 20, 2015

AB AMNEAL PHARMS 0.5MG A203118 001 Nov 20, 2015

AB APOTEX INC 0.5MG A204292 001 Nov 24, 2015

AB ASCENT PHARMS INC 0.5MG A206574 001 Oct 21, 2016

AB AUROLIFE PHARMA LLC 0.5MG A202660 001 Nov 20, 2015

AB BARR 0.5MG A090095 001 Dec 21, 2010

AB BIONPHARMA INC 0.5MG A200899 001 Nov 20, 2015

AB BRECKENRIDGE PHARM 0.5MG A204705 001 Nov 20, 2015

AB 0.5MG A208227 001 Jun 22, 2018

AB HERITAGE PHARMS INC 0.5MG A207935 001 Oct 13, 2017

AB HUMANWELL PURACAP 0.5MG A209909 001 Nov 21, 2017

AB INTERGEL PHARMS INC 0.5MG A206373 001 Mar 17, 2016

AB MARKSANS PHARMA 0.5MG A204376 001 Apr 07, 2017

AB RISING PHARMS 0.5MG A202530 001 Nov 20, 2015

AB STRIDES PHARMA 0.5MG A204262 001 Nov 20, 2015

AB VINTAGE PHARMS LLC 0.5MG A202421 001 Nov 20, 2015

AB WEST-WARD PHARMS 0.5MG A202204 001 Nov 23, 2015

INT

AB ZYDUS PHARMS USA 0.5MG A204373 001 Oct 04, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-155(of 452)

DUTASTERIDE

CAPSULE;ORAL

DUTASTERIDE

INC

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE



AB ACTAVIS LABS FL INC 0.5MG;0.4MG A202975 001 Nov 20, 2015

AB ANCHEN PHARMS 0.5MG;0.4MG A202509 001 Feb 26, 2014

AB ZYDUS PHARMS USA 0.5MG;0.4MG A207769 001 May 24, 2018

INC

JALYN

AB +! GLAXOSMITHKLINE 0.5MG;0.4MG N022460 001 Jun 14, 2010

DUVELISIB

CAPSULE;ORAL

COPIKTRA

+ VERASTEM INC 15MG N211155 001 Sep 24, 2018

+! 25MG N211155 002 Sep 24, 2018



DYCLONINE HYDROCHLORIDE

SOLUTION;TOPICAL

DYCLOPRO

! NOVOCOL INC 0.5% A200480 001 Nov 20, 2018

! 1% A200480 002 Nov 20, 2018

ECHOTHIOPHATE IODIDE

FOR SOLUTION;OPHTHALMIC

PHOSPHOLINE IODIDE

+! WYETH PHARMS 0.125% N011963 001

ECONAZOLE NITRATE

AEROSOL, FOAM;TOPICAL

ECOZA

+! GLENMARK 1% N205175 001 Oct 24, 2013

CREAM;TOPICAL

ECONAZOLE NITRATE

AB CASI PHARMS INC 1% A076075 001 Nov 26, 2002

AB MYLAN PHARMS INC 1% A210364 001 Apr 18, 2018

AB ! PERRIGO NEW YORK 1% A076479 001 Jun 23, 2004

AB TARO 1% A076005 001 Nov 26, 2002

AB TELIGENT PHARMA INC 1% A076574 001 Dec 17, 2004

SPECTAZOLE

AB + ALVOGEN MALTA 1% N018751 001 Dec 23, 1982

EDARAVONE

SOLUTION;INTRAVENOUS

RADICAVA

+! MITSUBISHI TANABE 30MG/100ML (0.3MG/ML) N209176 001 May 05, 2017

+! 60MG/100ML (0.6MG/ML) N209176 002 Nov 15, 2018



EDETATE CALCIUM DISODIUM

INJECTABLE;INJECTION

CALCIUM DISODIUM VERSENATE

+! MEDICIS 200MG/ML N008922 001

EDOXABAN TOSYLATE

TABLET;ORAL

SAVAYSA

+ DAIICHI SANKYO INC EQ 15MG BASE N206316 001 Jan 08, 2015

+ EQ 30MG BASE N206316 002 Jan 08, 2015

+! EQ 60MG BASE N206316 003 Jan 08, 2015

EFAVIRENZ

CAPSULE;ORAL

EFAVIRENZ

AB AUROBINDO PHARMA 50MG A078064 001 Dec 15, 2017

LTD

AB 200MG A078064 003 Dec 15, 2017

SUSTIVA

AB + BRISTOL MYERS 50MG N020972 001 Sep 17, 1998

SQUIBB

AB +! 200MG N020972 003 Sep 17, 1998

EFAVIRENZ

AUROBINDO PHARMA 100MG A078064 002 Dec 15, 2017

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-156(of 452)

EFAVIRENZ

TABLET;ORAL

EFAVIRENZ

AB AUROBINDO PHARMA 600MG A077673 001 Sep 21, 2018

LTD

AB 600MG A205322 001 Aug 30, 2018

AB CIPLA 600MG A204766 001 Jun 15, 2018

AB HETERO LABS LTD III 600MG A078886 001 Apr 27, 2018

AB MYLAN PHARMS INC 600MG A091471 001 Feb 17, 2016

AB STRIDES PHARMA 600MG A204869 001 Mar 12, 2018

SUSTIVA

AB +! BRISTOL MYERS 600MG N021360 002 Feb 01, 2002

SQUIBB

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

ATRIPLA

AB +! GILEAD SCIENCES 600MG;200MG;300MG N021937 001 Jul 12, 2006

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

AB AUROBINDO PHARMA 600MG;200MG;300MG A203041 001 Sep 04, 2018

LTD

AB TEVA PHARMS USA 600MG;200MG;300MG A091215 001 Nov 09, 2018

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

SYMFI

+! MYLAN LABS LTD 600MG;300MG;300MG N022142 001 Mar 22, 2018

SYMFI LO

+! MYLAN PHARMS INC 400MG;300MG;300MG N208255 001 Feb 05, 2018

EFINACONAZOLE

SOLUTION;TOPICAL

JUBLIA

+! VALEANT PHARMS INTL 10% N203567 001 Jun 06, 2014

EFLORNITHINE HYDROCHLORIDE

CREAM;TOPICAL

VANIQA

+! SKINMEDICA 13.9% N021145 001 Jul 27, 2000

ELAGOLIX SODIUM

TABLET;ORAL

ORILISSA

+ ABBVIE INC EQ 150MG BASE N210450 001 Jul 23, 2018

+! EQ 200MG BASE N210450 002 Jul 23, 2018

ELBASVIR; GRAZOPREVIR

TABLET;ORAL

ZEPATIER

+! MERCK SHARP DOHME 50MG;100MG N208261 001 Jan 28, 2016

ELETRIPTAN HYDROBROMIDE

TABLET;ORAL

ELETRIPTAN HYDROBROMIDE

AB AJANTA PHARMA LTD EQ 20MG BASE A205186 001 Aug 29, 2017

AB EQ 40MG BASE A205186 002 Aug 29, 2017

AB AMNEAL PHARMS CO EQ 20MG BASE A206787 001 May 25, 2018

AB EQ 40MG BASE A206787 002 May 25, 2018

AB AUROBINDO PHARMA EQ 20MG BASE A210708 001 Jan 15, 2019

LTD

AB EQ 40MG BASE A210708 002 Jan 15, 2019

AB MYLAN PHARMS INC EQ 20MG BASE A205152 001 Aug 11, 2017

AB EQ 40MG BASE A205152 002 Aug 11, 2017

AB TEVA PHARMS USA EQ 20MG BASE A202040 001 Jun 27, 2017

AB EQ 40MG BASE A202040 002 Jun 27, 2017

AB ZYDUS PHARMS USA EQ 20MG BASE A206409 001 Jun 16, 2017

INC

AB EQ 40MG BASE A206409 002 Jun 16, 2017

RELPAX

AB + PFIZER IRELAND EQ 20MG BASE N021016 001 Dec 26, 2002

AB +! EQ 40MG BASE N021016 002 Dec 26, 2002



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-157(of 452)

ELIGLUSTAT TARTRATE

CAPSULE;ORAL

CERDELGA

+! GENZYME CORP EQ 84MG BASE N205494 001 Aug 19, 2014

ELTROMBOPAG OLAMINE

FOR SUSPENSION;ORAL

PROMACTA KIT

+ NOVARTIS PHARMS EQ 12.5MG ACID/PACKET N207027 002 Sep 27, 2018
CORP
+! EQ 25MG ACID/PACKET N207027 001 Aug 24, 2015
TABLET;ORAL
PROMACTA
+ NOVARTIS PHARMS EQ 12.5MG ACID N022291 004 Oct 20, 2011
CORP
+ EQ 25MG ACID N022291 001 Nov 20, 2008
+ EQ 50MG ACID N022291 002 Nov 20, 2008
+! EQ 75MG ACID N022291 003 Sep 08, 2009
+! EQ 100MG ACID N022291 005 Nov 16, 2012
ELUXADOLINE
TABLET;ORAL
VIBERZI
+ ALLERGAN HOLDINGS 75MG N206940 001 May 27, 2015
+! 100MG N206940 002 May 27, 2015
EMEDASTINE DIFUMARATE
SOLUTION/DROPS;OPHTHALMIC
EMADINE
+! NOVARTIS PHARMS 0.05% N020706 001 Dec 29, 1997
CORP
EMPAGLIFLOZIN
TABLET;ORAL
JARDIANCE
+ BOEHRINGER 10MG N204629 001 Aug 01, 2014
INGELHEIM
+! 25MG N204629 002 Aug 01, 2014
EMPAGLIFLOZIN; LINAGLIPTIN
TABLET;ORAL
GLYXAMBI
+ BOEHRINGER 10MG;5MG N206073 001 Jan 30, 2015
INGELHEIM
+! 25MG;5MG N206073 002 Jan 30, 2015
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

SYNJARDY

+ BOEHRINGER 5MG;500MG N206111 001 Aug 26, 2015

INGELHEIM

+ 5MG;1GM N206111 002 Aug 26, 2015

+ 12.5MG;500MG N206111 003 Aug 26, 2015

+! 12.5MG;1GM N206111 004 Aug 26, 2015

TABLET, EXTENDED RELEASE;ORAL



SYNJARDY XR

+ BOEHRINGER 5MG;1GM N208658 001 Dec 09, 2016

INGELHEIM

+ 10MG;1GM N208658 002 Dec 09, 2016

+ 12.5MG;1GM N208658 003 Dec 09, 2016

+! 25MG;1GM N208658 004 Dec 09, 2016

EMTRICITABINE

CAPSULE;ORAL

EMTRICITABINE

AB CIPLA 200MG A091168 001 Jul 02, 2018

EMTRIVA

AB +! GILEAD 200MG N021500 001 Jul 02, 2003

SOLUTION;ORAL

EMTRIVA

+! GILEAD 10MG/ML N021896 001 Sep 28, 2005

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-158(of 452)

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE



TABLET;ORAL

ODEFSEY

+! GILEAD SCIENCES INC 200MG;EQ 25MG BASE;EQ 25MG BASE N208351 001 Mar 01, 2016

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

COMPLERA

+! GILEAD SCIENCES INC 200MG;EQ 25MG BASE;300MG N202123 001 Aug 10, 2011

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

DESCOVY

+! GILEAD SCIENCES INC 200MG;EQ 25MG BASE N208215 001 Apr 04, 2016

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE



AB AMNEAL PHARMS CO 100MG;150MG A209721 001 Aug 22, 2018

AB 133MG;200MG A209721 002 Aug 22, 2018

AB 167MG;250MG A209721 003 Aug 22, 2018

AB 200MG;300MG A209721 004 Aug 22, 2018

AB AUROBINDO PHARMA 200MG;300MG A090513 001 Jan 26, 2018

LTD

AB MYLAN PHARMS INC 200MG;300MG A206436 001 Apr 09, 2018

AB TEVA PHARMS USA 200MG;300MG A090894 001 Jun 08, 2017

TRUVADA

AB + GILEAD 100MG;150MG N021752 002 Mar 10, 2016

AB + 133MG;200MG N021752 003 Mar 10, 2016

AB + 167MG;250MG N021752 004 Mar 10, 2016

AB +! 200MG;300MG N021752 001 Aug 02, 2004



ENALAPRIL MALEATE

FOR SOLUTION;ORAL

EPANED KIT

+! SILVERGATE PHARMS 1MG/ML N204308 001 Aug 13, 2013

SOLUTION;ORAL

EPANED

+! SILVERGATE PHARMS 1MG/ML N208686 001 Sep 20, 2016

TABLET;ORAL

ENALAPRIL MALEATE

AB APOTEX 2.5MG A075178 002 Mar 23, 2001

AB 5MG A075178 001 Mar 23, 2001

AB 10MG A075178 003 Mar 23, 2001

AB 20MG A075178 004 Mar 23, 2001

AB MYLAN 5MG A075480 002 Aug 22, 2000

AB 10MG A075480 003 Aug 22, 2000

AB SANDOZ INC 2.5MG A075496 001 Aug 22, 2000

AB 5MG A075496 002 Aug 22, 2000

AB 10MG A075459 001 Aug 22, 2000

AB 20MG A075459 002 Aug 22, 2000

AB TARO 2.5MG A075657 001 Jan 23, 2001

AB 5MG A075657 002 Jan 23, 2001

AB 10MG A075657 003 Jan 23, 2001

AB 20MG A075657 004 Jan 23, 2001

AB TEVA 2.5MG A075479 001 Aug 22, 2000

AB 5MG A075479 002 Aug 22, 2000

AB 10MG A075479 003 Aug 22, 2000

AB 20MG A075479 004 Aug 22, 2000

AB WOCKHARDT LTD 2.5MG A075483 001 Aug 22, 2000

AB 5MG A075483 002 Aug 22, 2000

AB 10MG A075483 003 Aug 22, 2000

AB 20MG A075483 004 Aug 22, 2000

VASOTEC

AB + VALEANT PHARMS 2.5MG N018998 005 Jul 26, 1988

NORTH

AB + 5MG N018998 001 Dec 24, 1985

AB + 10MG N018998 002 Dec 24, 1985

AB +! 20MG N018998 003 Dec 24, 1985



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-159(of 452)

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE



TABLET;ORAL

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE



AB APOTEX INC 5MG;12.5MG A076486 001 Oct 27, 2004

AB 10MG;25MG A076486 002 Oct 27, 2004

AB DR REDDYS LABS LTD 5MG;12.5MG A075909 001 Oct 15, 2001

AB 10MG;25MG A075909 002 Oct 15, 2001

AB G AND W LABS INC 5MG;12.5MG A075727 001 Sep 18, 2001

AB 10MG;25MG A075727 002 Sep 18, 2001

AB MYLAN 5MG;12.5MG A075624 001 Sep 18, 2001

AB 10MG;25MG A075624 002 Sep 18, 2001

AB TARO PHARM INDS 5MG;12.5MG A075788 001 Sep 18, 2001

AB 10MG;25MG A075788 002 Sep 18, 2001

VASERETIC

AB + VALEANT INTL 5MG;12.5MG N019221 003 Jul 12, 1995

AB +! 10MG;25MG N019221 001 Oct 31, 1986



ENALAPRILAT

INJECTABLE;INJECTION

ENALAPRILAT

AP ! ATHENEX INC 1.25MG/ML A075634 001 Aug 22, 2000

AP HIKMA FARMACEUTICA 1.25MG/ML A078687 001 Dec 23, 2008

AP ! HOSPIRA 1.25MG/ML A075458 001 Aug 22, 2000

AP TEVA PHARMS USA 1.25MG/ML A075578 001 Aug 22, 2000



ENASIDENIB MESYLATE

TABLET;ORAL

IDHIFA

+ CELGENE CORP EQ 50MG BASE N209606 001 Aug 01, 2017

+! EQ 100MG BASE N209606 002 Aug 01, 2017



ENCORAFENIB

CAPSULE;ORAL

BRAFTOVI

+ ARRAY BIOPHARMA INC 50MG N210496 001 Jun 27, 2018

+! 75MG N210496 002 Jun 27, 2018

ENFUVIRTIDE

INJECTABLE;SUBCUTANEOUS

FUZEON

+! ROCHE 90MG/VIAL N021481 001 Mar 13, 2003

ENOXAPARIN SODIUM

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

ENOXAPARIN SODIUM

AB SANDOZ INC 300MG/3ML (100MG/ML) A078660 001 Nov 28, 2011

LOVENOX

AB + SANOFI AVENTIS US 300MG/3ML (100MG/ML) N020164 009 Jan 23, 2003

INJECTABLE;SUBCUTANEOUS

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

AP AMPHASTAR PHARM 30MG/0.3ML (100MG/ML) A076684 001 Sep 19, 2011

AP 40MG/0.4ML (100MG/ML) A076684 002 Sep 19, 2011

AP 60MG/0.6ML (100MG/ML) A076684 003 Sep 19, 2011

AP 80MG/0.8ML (100MG/ML) A076684 004 Sep 19, 2011

AP 100MG/ML (100MG/ML) A076684 005 Sep 19, 2011

AP 120MG/0.8ML (150MG/ML) A076684 006 Sep 19, 2011

AP 150MG/ML (150MG/ML) A076684 007 Sep 19, 2011

AP APOTEX INC 30MG/0.3ML (100MG/ML) A078990 001 Sep 28, 2018

AP 40MG/0.4ML (100MG/ML) A078990 002 Sep 28, 2018

AP 60MG/0.6ML (100MG/ML) A078990 003 Sep 28, 2018

AP 80MG/0.8ML (100MG/ML) A078990 004 Sep 28, 2018

AP 100MG/ML (100MG/ML) A078990 005 Sep 28, 2018

AP 120MG/0.8ML (150MG/ML) A078990 006 Sep 28, 2018

AP 150MG/ML (150MG/ML) A078990 007 Sep 28, 2018

AP SANDOZ 30MG/0.3ML (100MG/ML) A077857 002 Jul 23, 2010

AP 40MG/0.4ML (100MG/ML) A077857 003 Jul 23, 2010

AP 60MG/0.6ML (100MG/ML) A077857 004 Jul 23, 2010

AP 80MG/0.8ML (100MG/ML) A077857 005 Jul 23, 2010

AP 100MG/ML (100MG/ML) A077857 001 Jul 23, 2010

AP 120MG/0.8ML (150MG/ML) A077857 006 Jul 23, 2010

AP 150MG/ML (150MG/ML) A077857 007 Jul 23, 2010

AP TEVA 30MG/0.3ML (100MG/ML) A076726 001 Jun 23, 2014

AP 40MG/0.4ML (100MG/ML) A076726 002 Jun 23, 2014

AP 60MG/0.6ML (100MG/ML) A076726 003 Jun 23, 2014

AP 80MG/0.8ML (100MG/ML) A076726 004 Jun 23, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-160(of 452)

ENOXAPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

AP 100MG/ML (100MG/ML) A076726 005 Jun 23, 2014

AP 120MG/0.8ML (150MG/ML) A076726 006 Jun 23, 2014

AP 150MG/ML (150MG/ML) A076726 007 Jun 23, 2014

LOVENOX (PRESERVATIVE FREE)

AP + SANOFI AVENTIS US 30MG/0.3ML (100MG/ML) N020164 001 Mar 29, 1993

AP + 40MG/0.4ML (100MG/ML) N020164 002 Jan 30, 1998

AP + 60MG/0.6ML (100MG/ML) N020164 003 Mar 27, 1998

AP + 80MG/0.8ML (100MG/ML) N020164 004 Mar 27, 1998

AP +! 100MG/ML (100MG/ML) N020164 005 Mar 27, 1998

AP + 120MG/0.8ML (150MG/ML) N020164 007 Jun 02, 2000

AP + 150MG/ML (150MG/ML) N020164 008 Jun 02, 2000



ENTACAPONE

TABLET;ORAL

COMTAN

AB +! ORION PHARMA 200MG N020796 001 Oct 19, 1999

ENTACAPONE

AB AJANTA PHARMA LTD 200MG A205792 001 Aug 31, 2017

AB AUROBINDO PHARMA 200MG A203437 001 Jun 19, 2015

LTD

AB MACLEODS PHARMS LTD 200MG A207210 001 Jun 05, 2017

AB SUN PHARMA GLOBAL 200MG A090690 001 Jul 16, 2012

AB SUNSHINE LAKE 200MG A206669 001 Oct 03, 2018

AB WOCKHARDT LTD 200MG A078941 001 Aug 16, 2012



ENTECAVIR

SOLUTION;ORAL

BARACLUDE

+! BRISTOL MYERS 0.05MG/ML N021798 001 Mar 29, 2005

SQUIBB

TABLET;ORAL

BARACLUDE

AB + BRISTOL MYERS 0.5MG N021797 001 Mar 29, 2005

SQUIBB

AB +! 1MG N021797 002 Mar 29, 2005

ENTECAVIR

AB ACCORD HLTHCARE 0.5MG A205824 001 Aug 25, 2017

AB 1MG A205824 002 Aug 25, 2017

AB AMNEAL PHARMS 0.5MG A206652 001 Nov 12, 2015

AB 1MG A206652 002 Nov 12, 2015

AB AUROBINDO PHARMA 0.5MG A206217 001 Aug 26, 2015

LTD

AB 1MG A206217 002 Aug 26, 2015

AB BRECKENRIDGE PHARM 0.5MG A208721 001 Mar 15, 2018

AB 1MG A208721 002 Mar 15, 2018

AB CASI PHARMS INC 0.5MG A206672 001 May 11, 2017

AB 1MG A206672 002 May 11, 2017

AB CIPLA 0.5MG A206872 001 Dec 06, 2016

AB 1MG A206872 002 Dec 06, 2016

AB HETERO LABS LTD V 0.5MG A205740 001 Aug 21, 2015

AB 1MG A205740 002 Aug 21, 2015

AB PAR PHARM INC 0.5MG A206294 001 Nov 23, 2016

AB 1MG A206294 002 Nov 23, 2016

AB PRINSTON INC 0.5MG A208782 001 Oct 10, 2017

AB 1MG A208782 002 Oct 10, 2017

AB TEVA PHARMS USA 0.5MG A202122 001 Aug 26, 2014

AB 1MG A202122 002 Aug 26, 2014

AB ZYDUS PHARMS USA 0.5MG A206745 001 Jun 23, 2017

INC

AB 1MG A206745 002 Jun 23, 2017

ENZALUTAMIDE

CAPSULE;ORAL

XTANDI

+! ASTELLAS 40MG N203415 001 Aug 31, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-161(of 452)

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS

AKOVAZ

AP +! FLAMEL IRELAND LTD 50MG/ML (50MG/ML) N208289 001 Apr 29, 2016

CORPHEDRA

AP PAR STERILE 50MG/ML (50MG/ML) N208943 001 Jan 27, 2017

PRODUCTS

EPHEDRINE SULFATE

AP AKORN INC 50MG/ML (50MG/ML) N208609 001 Mar 01, 2017

AP SANDOZ INC 50MG/ML (50MG/ML) A209784 001 Aug 23, 2017



EPINASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ELESTAT

AT +! ALLERGAN 0.05% N021565 001 Oct 16, 2003

EPINASTINE HYDROCHLORIDE

AT AKORN 0.05% A204055 001 May 05, 2017

AT APOTEX 0.05% A090919 001 Oct 31, 2011

AT BRECKENRIDGE PHARM 0.05% A090870 001 Mar 14, 2011

AT CASI PHARMS INC 0.05% A203384 001 Dec 07, 2016

AT SOMERSET THERAPS 0.05% A090951 001 Oct 31, 2011

LLC

AT SUN PHARM INDS 0.05% A091626 001 Oct 31, 2011

EPINEPHRINE

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

EPINEPHRINE (AUTOINJECTOR)

AB TEVA PHARMS USA 0.15MG/DELIVERY A090589 002 Aug 16, 2018

AB 0.3MG/DELIVERY A090589 001 Aug 16, 2018

EPIPEN

AB +! MYLAN SPECIALITY LP 0.3MG/DELIVERY N019430 001 Dec 22, 1987

EPIPEN JR.

AB +! MYLAN SPECIALITY LP 0.15MG/DELIVERY N019430 002 Dec 22, 1987

ADRENACLICK

BX +! IMPAX EQ 0.15MG/DELIVERY N020800 003 Nov 25, 2009

BX +! EQ 0.3MG/DELIVERY N020800 004 Nov 25, 2009

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

ADRENALIN

AP +! PAR STERILE EQ 1MG BASE/ML (EQ 1MG BASE/ML) N204200 001 Dec 07, 2012

PRODUCTS

EPINEPHRINE

AP LUITPOLD EQ 1MG BASE/ML (EQ 1MG BASE/ML) A207568 001 Jul 06, 2018

AUVI-Q

BX +! KALEO INC EQ 0.15MG/DELIVERY N201739 002 Aug 10, 2012

BX + EQ 0.3MG/DELIVERY N201739 001 Aug 10, 2012

ADRENALIN

+! PAR STERILE EQ 30MG BASE/30ML (EQ 1MG BASE/ML) N204640 001 Dec 18, 2013

PRODUCTS

AUVI-Q

+ KALEO INC EQ 0.1MG/DELIVERY N201739 003 Nov 17, 2017

SYMJEPI

+! ADAMIS PHARMS CORP 0.15MG/0.3ML (0.15MG/0.3ML) N207534 002 Sep 27, 2018

+! 0.3MG/0.3ML (0.3MG/0.3ML) N207534 001 Jun 15, 2017



SOLUTION;IV (INFUSION), INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS

EPINEPHRINE

+! BELCHER PHARMS LLC EQ 1MG BASE/ML (EQ 1MG BASE/ML) N205029 001 Jul 29, 2014

EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIGNOSPAN FORTE

! DEPROCO EQ 0.02MG BASE/ML;2% A088389 001 Jan 22, 1985

LIGNOSPAN STANDARD

! DEPROCO EQ 0.01MG BASE/ML;2% A088390 001 Jan 22, 1985

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST FORTE DENTAL



AP +! DENTSPLY PHARM 0.005MG/ML;4% N021383 001

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

AP SEPTODONT INC 0.005MG/ML;4% A078959 001 Aug 30, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-162(of 452)

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE



INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE



AP HOSPIRA
0.005MG/ML;0.5%
A089635 001 Jun 21, 1988

AP
0.005MG/ML;1.5%
A088571 001 Sep 13, 1985

AP
0.005MG/ML;1.5%
A089645 001 Jun 21, 1988

AP
0.005MG/ML;2%
A089651 001 Jun 21, 1988

AP
0.01MG/ML;1%
A089644 001 Jun 21, 1988

AP !
0.01MG/ML;2%
A089646 001 Jun 21, 1988

XYLOCAINE W/ EPINEPHRINE

AP +! FRESENIUS KABI USA


0.005MG/ML;0.5%
N006488 012

AP +!
0.005MG/ML;1.5%
N006488 017

AP +!
0.005MG/ML;2%
N006488 019 Nov 13, 1986

AP +!
0.01MG/ML;1%
N006488 004

AP +!
0.02MG/ML;2%
N006488 005

+!
0.005MG/ML;1%
N006488 018 Nov 13, 1986

EPIRUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

ELLENCE

AP +! PFIZER INC
200MG/100ML (2MG/ML)
N050778 001 Sep 15, 1999

AP +
50MG/25ML (2MG/ML)
N050778 002 Sep 15, 1999

EPIRUBICIN HYDROCHLORIDE

AP ACTAVIS TOTOWA
10MG/5ML (2MG/ML)
A065445 001 Sep 18, 2008

AP
50MG/25ML (2MG/ML)
A065445 002 Sep 18, 2008

AP
200MG/100ML (2MG/ML)
A065445 003 Sep 18, 2008

AP AKORN INC
50MG/25ML (2MG/ML)
A090163 001 Jun 24, 2009

AP CIPLA LTD
50MG/25ML (2MG/ML)
A065361 001 Oct 22, 2007

AP
200MG/100ML (2MG/ML)
A065361 002 Oct 22, 2007

AP FRESENIUS KABI USA


10MG/5ML (2MG/ML)
A065408 001 Oct 15, 2007

AP
50MG/25ML (2MG/ML)
A065408 002 Oct 15, 2007

AP
150MG/75ML (2MG/ML)
A065408 003 Oct 15, 2007

AP
200MG/100ML (2MG/ML)
A065408 004 Oct 15, 2007

AP
200MG/100ML (2MG/ML)
A065411 001 Aug 20, 2007

AP
50MG/25ML (2MG/ML)
A065411 002 Aug 20, 2007

AP HISUN PHARM
50MG/25ML (2MG/ML)
A090075 001 Mar 25, 2010

HANGZHOU

AP
200MG/100ML (2MG/ML)
A090075 002 Mar 25, 2010

AP HOSPIRA
10MG/5ML (2MG/ML)
A065343 001 Apr 19, 2007

AP
150MG/75ML (2MG/ML)
A065343 003 Apr 19, 2007

AP
200MG/100ML (2MG/ML)
A065343 004 Apr 19, 2007

AP IMPAX LABS INC


50MG/25ML (2MG/ML)
A065331 001 Aug 09, 2007

AP
200MG/100ML (2MG/ML)
A065331 002 Aug 09, 2007

AP MYLAN LABS LTD


50MG/25ML (2MG/ML)
A091599 001 Mar 12, 2012

AP
200MG/100ML (2MG/ML)
A091599 002 Mar 12, 2012

AP WEST-WARD PHARMS
50MG/25ML (2MG/ML)
A065289 001 Jun 27, 2007

INT

AP
200MG/100ML (2MG/ML)
A065289 002 Jun 27, 2007

EPLERENONE

TABLET;ORAL

EPLERENONE

AB ACCORD HLTHCARE
25MG
A206922 001 Jul 13, 2017

AB
50MG
A206922 002 Jul 13, 2017

AB APOTEX
25MG
A078482 001 Jul 30, 2008

AB
50MG
A078482 002 Jul 30, 2008

AB BRECKENRIDGE PHARM
25MG
A208283 001 Sep 14, 2018

AB
50MG
A208283 002 Sep 14, 2018

AB MYLAN PHARMS INC


25MG
A203896 001 Feb 02, 2017

AB
50MG
A203896 002 Feb 02, 2017

AB SANDOZ
25MG
A078510 001 Aug 01, 2008

AB
50MG
A078510 002 Aug 01, 2008

INSPRA

AB + GD SEARLE LLC
25MG
N021437 001 Sep 27, 2002

AB +!
50MG
N021437 002 Sep 27, 2002

EPOPROSTENOL SODIUM

INJECTABLE;INJECTION

EPOPROSTENOL SODIUM

AP TEVA PHARMS USA
EQ 0.5MG BASE/VIAL
A078396 001 Apr 23, 2008

AP
EQ 1.5MG BASE/VIAL
A078396 002 Apr 23, 2008

FLOLAN

AP +! GLAXOSMITHKLINE LLC
EQ 0.5MG BASE/VIAL
N020444 001 Sep 20, 1995

AP +!
EQ 1.5MG BASE/VIAL
N020444 002 Sep 20, 1995

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-163(of 452)

EPOPROSTENOL SODIUM

INJECTABLE;INJECTION

VELETRI

+ ACTELION PHARMS LTD EQ 0.5MG BASE/VIAL N022260 002 Jun 28, 2012

+! EQ 1.5MG BASE/VIAL N022260 001 Jun 27, 2008

EPROSARTAN MESYLATE

TABLET;ORAL

EPROSARTAN MESYLATE

AB MYLAN PHARMS INC EQ 400MG BASE A202012 001 Nov 16, 2011

AB ! EQ 600MG BASE A202012 002 Nov 16, 2011



EPTIFIBATIDE

INJECTABLE;INJECTION

EPTIFIBATIDE

AP ACCORD HLTHCARE 2MG/ML A205557 001 Nov 06, 2017

AP 75MG/100ML A205557 002 Nov 06, 2017

AP AKORN 2MG/ML A204589 001 Apr 18, 2017

AP 75MG/100ML A204589 002 Apr 18, 2017

AP AMNEAL PHARMS 2MG/ML A205581 001 Dec 08, 2016

AP 75MG/100ML A205581 002 Dec 08, 2016

AP AUROBINDO PHARMA 2MG/ML A206127 001 Dec 08, 2015

LTD

AP 75MG/100ML A206127 002 Dec 08, 2015

AP CELERITY PHARMS 2MG/ML A208554 001 Nov 23, 2018

AP 75MG/100ML A208554 002 Nov 23, 2018

AP MYLAN LABS LTD 2MG/ML A203258 001 Jul 20, 2018

AP 75MG/100ML A203258 002 Jul 20, 2018

AP SAGENT PHARMS 2MG/ML A204693 001 Mar 07, 2018

AP 75MG/100ML A204693 002 Mar 07, 2018

AP TEVA PHARMS USA 2MG/ML A090854 001 Jun 12, 2015

INTEGRILIN

AP +! SCHERING 2MG/ML N020718 001 May 18, 1998

AP +! 75MG/100ML N020718 002 May 18, 1998



ERAVACYCLINE DIHYDROCHLORIDE

POWDER;INTRAVENOUS

XERAVA

+! TETRAPHASE PHARMS EQ 50MG BASE/VIAL N211109 001 Aug 27, 2018

ERGOCALCIFEROL

CAPSULE;ORAL

DRISDOL

AA +! US PHARM HOLDINGS 50,000 IU N003444 001

ERGOCALCIFEROL

AA ORIT LABS LLC 50,000 IU A040833 001 May 20, 2009

AA PURACAP PHARM LLC 50000IU A204276 001 Dec 07, 2018

AA SIGMAPHARM LABS LLC 50,000 IU A091004 001 Jul 14, 2010

AA STRIDES PHARMA 50,000 IU A090455 001 Aug 03, 2010

AA SUN PHARM INDS INC 50,000 IU A040865 001 Dec 29, 2009

VITAMIN D

AA BIONPHARMA INC 50,000 IU A080704 001

ERGOLOID MESYLATES

TABLET;ORAL

ERGOLOID MESYLATES

! SUN PHARM 1MG A081113 001 Oct 31, 1991

INDUSTRIES

ERGOTAMINE TARTRATE

TABLET;SUBLINGUAL

ERGOMAR

! TERSERA THERAPS LLC 2MG A087693 001 Feb 24, 1983

ERIBULIN MESYLATE

SOLUTION;INTRAVENOUS

HALAVEN

+! EISAI INC 1MG/2ML (0.5MG/ML) N201532 001 Nov 15, 2010

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

TARCEVA

+ OSI PHARMS EQ 25MG BASE N021743 001 Nov 18, 2004

+ EQ 100MG BASE N021743 002 Nov 18, 2004

+! EQ 150MG BASE N021743 003 Nov 18, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-164(of 452)

ERTAPENEM SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

ERTAPENEM SODIUM

AP ACS DOBFAR SPA EQ 1GM BASE/VIAL A208790 001 Apr 16, 2018

AP AUROBINDO PHARMA EQ 1GM BASE/VIAL A209133 001 Jun 25, 2018

LTD

INVANZ

AP +! MERCK SHARP DOHME EQ 1GM BASE/VIAL N021337 001 Nov 21, 2001

ERTUGLIFLOZIN

TABLET;ORAL

STEGLATRO

+ MERCK SHARP DOHME 5MG N209803 001 Dec 19, 2017

+! 15MG N209803 002 Dec 19, 2017

ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

SEGLUROMET

+ MERCK SHARP DOHME 2.5MG;500MG N209806 001 Dec 19, 2017

+ 2.5MG;1GM N209806 002 Dec 19, 2017

+ 7.5MG;500MG N209806 003 Dec 19, 2017

+! 7.5MG;1GM N209806 004 Dec 19, 2017

ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

STEGLUJAN

+ MERCK SHARP DOHME 5MG;EQ 100MG BASE N209805 001 Dec 19, 2017

+! 15MG;EQ 100MG BASE N209805 002 Dec 19, 2017

ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS;ORAL

ERYC

AB +! MAYNE PHARMA 250MG N050536 001

ERYTHROMYCIN

AB ARBOR PHARMS LLC 250MG A062746 001 Dec 22, 1986

GEL;TOPICAL

ERYGEL

AT +! MYLAN PHARMS INC 2% N050617 001 Oct 21, 1987

ERYTHROMYCIN

AT FOUGERA PHARMS 2% A064184 001 Sep 30, 1997

AT PERRIGO CO 2% A063211 001 Jan 29, 1993

AT TELIGENT PHARMA INC 2% A208154 001 Jul 19, 2017



OINTMENT;OPHTHALMIC

ERYTHROMYCIN

AT AKORN 0.5% A064030 001 Jul 18, 1996

AT BAUSCH AND LOMB 0.5% A064067 001 Jul 29, 1994

AT ! PERRIGO CO 0.5% A062447 001 Sep 26, 1983

TENNESSEE

SOLUTION;TOPICAL

ERYTHROMYCIN

AT ! PERRIGO NEW YORK 2% A063038 001 Jan 11, 1991

AT TELIGENT PHARMA INC 2% A208100 001 Nov 20, 2017

AT WOCKHARDT BIO AG 2% A062825 001 Oct 23, 1987



SWAB;TOPICAL

ERYTHROMYCIN

AT AKORN 2% A090215 001 May 12, 2010

AT ! PERRIGO CO 2% A064126 001 Jul 03, 1996



TABLET;ORAL

ERYTHROMYCIN

AB AMNEAL PHARMS CO 250MG A209720 001 Mar 09, 2018

AB 500MG A209720 002 Mar 09, 2018

AB ARBOR PHARMS LLC 250MG A061621 001



AB ! 500MG A061621 002

TABLET, DELAYED RELEASE;ORAL

ERY-TAB

ARBOR PHARMS LLC 250MG A062298 001

333MG A062298 003 Mar 29, 1982

! 500MG A062298 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-165(of 452)

ERYTHROMYCIN ETHYLSUCCINATE

GRANULE;ORAL

ERYPED

AB +! ARBOR PHARMS LLC EQ 400MG BASE/5ML N050207 002

ERYTHROMYCIN ETHYLSUCCINATE

AB ANI PHARMS INC EQ 400MG BASE/5ML A062055 002 Nov 02, 2018

E.E.S.

AB1 + ARBOR PHARMS LLC EQ 200MG BASE/5ML N050207 001

ERYTHROMYCIN ETHYLSUCCINATE

AB1 ANI PHARMS INC EQ 200MG BASE/5ML A062055 001

ERYPED

AB2 + ARBOR PHARMS LLC EQ 200MG BASE/5ML N050207 003 Mar 30, 1987

ERYTHROMYCIN ETHYLSUCCINATE

AB2 ANI PHARMS INC EQ 200MG BASE/5ML A062055 003 Nov 02, 2018

TABLET;ORAL

E.E.S. 400

BX ! ARBOR PHARMS LLC EQ 400MG BASE A061905 002 Aug 12, 1982

ERYTHROMYCIN ETHYLSUCCINATE

BX ! ARBOR PHARMS LLC EQ 400MG BASE A061904 001

ERYTHROMYCIN LACTOBIONATE

INJECTABLE;INJECTION

ERYTHROCIN

AP HOSPIRA EQ 500MG BASE/VIAL A062638 001 Oct 31, 1986

AP +! EQ 500MG BASE/VIAL N050609 001 Sep 24, 1986



ERYTHROMYCIN STEARATE

TABLET;ORAL

ERYTHROCIN STEARATE

! ARBOR PHARMS LLC EQ 250MG BASE A060359 001

ESCITALOPRAM OXALATE

SOLUTION;ORAL

ESCITALOPRAM OXALATE

AA AMNEAL PHARMS EQ 5MG BASE/5ML A202227 001 Mar 14, 2012

AA ANTRIM PHARMS LLC EQ 5MG BASE/5ML A203967 001 May 26, 2015

AA AUROBINDO PHARMA EQ 5MG BASE/5ML A079062 001 Apr 02, 2012

LTD

AA HETERO LABS LTD III EQ 5MG BASE/5ML A202221 001 Jun 12, 2012

AA LANNETT CO INC EQ 5MG BASE/5ML A090477 001 Jun 12, 2013

AA MACLEODS PHARMS LTD EQ 5MG BASE/5ML A202754 001 Mar 31, 2016

AA TARO EQ 5MG BASE/5ML A079121 001 May 03, 2012

LEXAPRO

AA +! ALLERGAN SALES LLC EQ 5MG BASE/5ML N021365 001 Nov 27, 2002

TABLET;ORAL

ESCITALOPRAM OXALATE

AB ACCORD HLTHCARE EQ 5MG BASE A202389 001 Sep 11, 2012

AB EQ 10MG BASE A202389 002 Sep 11, 2012

AB EQ 20MG BASE A202389 003 Sep 11, 2012

AB AMNEAL PHARMS EQ 5MG BASE A205619 001 May 17, 2017

AB EQ 10MG BASE A205619 002 May 17, 2017

AB EQ 20MG BASE A205619 003 May 17, 2017

AB APOTEX INC EQ 5MG BASE A078777 001 Sep 11, 2012

AB EQ 10MG BASE A078777 002 Sep 11, 2012

AB EQ 20MG BASE A078777 003 Sep 11, 2012

AB AUROBINDO PHARMA EQ 5MG BASE A090432 001 Sep 11, 2012

LTD

AB EQ 10MG BASE A090432 002 Sep 11, 2012

AB EQ 20MG BASE A090432 003 Sep 11, 2012

AB HIKMA PHARMS EQ 5MG BASE A078766 001 Sep 11, 2012

AB EQ 10MG BASE A078766 002 Sep 11, 2012

AB EQ 20MG BASE A078766 003 Sep 11, 2012

AB INVAGEN PHARMS EQ 5MG BASE A078604 001 Sep 11, 2012

AB EQ 10MG BASE A078604 002 Sep 11, 2012

AB EQ 20MG BASE A078604 003 Sep 11, 2012

AB JUBILANT GENERICS EQ 5MG BASE A202280 001 Sep 12, 2012

AB EQ 10MG BASE A202280 002 Sep 12, 2012

AB EQ 20MG BASE A202280 003 Sep 12, 2012

AB LUPIN LTD EQ 5MG BASE A078169 001 Sep 11, 2012

AB EQ 10MG BASE A078169 002 Sep 11, 2012

AB EQ 20MG BASE A078169 003 Sep 11, 2012

AB MACLEODS PHARMS LTD EQ 5MG BASE A202210 001 Sep 11, 2012

AB EQ 10MG BASE A202210 002 Sep 11, 2012

AB EQ 20MG BASE A202210 003 Sep 11, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-166(of 452)

ESCITALOPRAM OXALATE

TABLET;ORAL

ESCITALOPRAM OXALATE

AB PHARM ASSOC EQ 5MG BASE A077512 001 Sep 12, 2012

AB EQ 10MG BASE A077512 002 Sep 12, 2012

AB EQ 20MG BASE A077512 003 Sep 12, 2012

AB PRINSTON INC EQ 5MG BASE A078032 001 Aug 28, 2015

AB EQ 10MG BASE A078032 002 Aug 28, 2015

AB EQ 20MG BASE A078032 003 Aug 28, 2015

AB TEVA PHARMS USA EQ 5MG BASE A076765 001 Mar 14, 2012

AB EQ 10MG BASE A076765 002 Mar 14, 2012

AB EQ 20MG BASE A076765 003 Mar 14, 2012

AB TORRENT PHARMS LTD EQ 5MG BASE A090939 001 Sep 11, 2012

AB EQ 10MG BASE A090939 002 Sep 11, 2012

AB EQ 20MG BASE A090939 003 Sep 11, 2012

AB ZYDUS PHARMS USA EQ 5MG BASE A077734 001 Sep 11, 2012

INC

AB EQ 10MG BASE A077734 002 Sep 11, 2012

AB EQ 20MG BASE A077734 003 Sep 11, 2012

LEXAPRO

AB + ALLERGAN SALES LLC EQ 5MG BASE N021323 001 Aug 14, 2002

AB + EQ 10MG BASE N021323 002 Aug 14, 2002

AB +! EQ 20MG BASE N021323 003 Aug 14, 2002



ESLICARBAZEPINE ACETATE

TABLET;ORAL

APTIOM

+ SUNOVION PHARMS INC 200MG N022416 001 Nov 08, 2013

+ 400MG N022416 002 Nov 08, 2013

+ 600MG N022416 003 Nov 08, 2013

+! 800MG N022416 004 Nov 08, 2013

ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION

BREVIBLOC

AP +! BAXTER HLTHCARE 10MG/ML N019386 006 Feb 25, 2003

ESMOLOL HYDROCHLORIDE

AP AUROBINDO PHARMA 10MG/ML A205520 001 Jul 23, 2015

LTD

AP FRESENIUS KABI USA 10MG/ML A076573 001 May 02, 2005

AP LUITPOLD 10MG/ML A201126 001 Feb 20, 2015

AP MYLAN INSTITUTIONAL 10MG/ML A076474 001 May 02, 2005

AP MYLAN LABS LTD 10MG/ML A206608 001 Jun 08, 2018

AP 20MG/ML A206608 002 Jun 08, 2018

AP SAGENT PHARMS 10MG/ML A207107 001 Jun 08, 2018

AP 20MG/ML A207107 002 Jun 08, 2018

AP WEST-WARD PHARMS 10MG/ML A076323 001 Aug 10, 2004

INT

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2GM/100ML N019386 005 Jan 27, 2003

BREVIBLOC IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 1GM/100ML N019386 004 Feb 16, 2001

SOLUTION;INTRAVENOUS

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

+! HQ SPCLT PHARMA 2GM/100ML (20MG/ML) N205703 002 Apr 07, 2016

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER



+! HQ SPCLT PHARMA 2.5GM/250ML (10MG/ML) N205703 001 Apr 07, 2016

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

AB ALKEM LABS LTD EQ 20MG BASE A208333 001 Oct 20, 2017

AB EQ 40MG BASE A208333 002 Oct 20, 2017

AB AUROBINDO PHARMA EQ 20MG BASE A205606 001 Apr 21, 2016

LTD

AB EQ 40MG BASE A205606 002 Apr 21, 2016

AB DR REDDYS LABS LTD EQ 20MG BASE A078279 001 Sep 25, 2015

AB EQ 40MG BASE A078279 002 Sep 25, 2015

AB HEC PHARM EQ 20MG BASE A207265 002 May 18, 2018

AB EQ 40MG BASE A207265 001 May 18, 2018

AB IVAX SUB TEVA EQ 20MG BASE A078003 001 Jan 26, 2015

PHARMS

AB EQ 40MG BASE A078003 002 Jan 26, 2015

AB LANNETT CO INC EQ 20MG BASE A205563 001 Sep 01, 2017

AB EQ 40MG BASE A205563 002 Sep 01, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-167(of 452)

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

AB MYLAN PHARMS INC EQ 20MG BASE A078936 001 Aug 02, 2015

AB EQ 40MG BASE A078936 002 Aug 03, 2015

AB SUN PHARM INDS LTD EQ 20MG BASE A209735 001 Apr 30, 2018

AB EQ 40MG BASE A209735 002 Apr 30, 2018

AB TORRENT PHARMS LTD EQ 20MG BASE A203636 001 Oct 19, 2015

AB EQ 40MG BASE A203636 002 Oct 19, 2015

NEXIUM

AB + ASTRAZENECA PHARMS EQ 20MG BASE N021153 001 Feb 20, 2001

AB +! EQ 40MG BASE N021153 002 Feb 20, 2001



ESOMEPRAZOLE MAGNESIUM

BX HETERO LABS LTD III EQ 20MG BASE A202784 001 Sep 21, 2015

BX EQ 40MG BASE A202784 002 Sep 21, 2015

FOR SUSPENSION, DELAYED RELEASE;ORAL



NEXIUM

+ ASTRAZENECA PHARMS EQ 2.5MG BASE/PACKET N021957 003 Dec 15, 2011

+ EQ 5MG BASE/PACKET N021957 004 Dec 15, 2011

+ EQ 10MG BASE/PACKET N022101 001 Feb 27, 2008

+ EQ 20MG BASE/PACKET N021957 001 Oct 20, 2006

+! EQ 40MG BASE/PACKET N021957 002 Oct 20, 2006

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE;ORAL

VIMOVO

+ HORIZON EQ 20MG BASE;375MG N022511 002 Apr 30, 2010

+! EQ 20MG BASE;500MG N022511 001 Apr 30, 2010



ESOMEPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS

ESOMEPRAZOLE SODIUM

AP ACCORD HLTHCARE EQ 40MG BASE/VIAL A205379 001 Sep 25, 2015

AP ! AUROBINDO PHARMA EQ 40MG BASE/VIAL A204657 002 Aug 10, 2016

LTD

AP DEVA HOLDING AS EQ 40MG BASE/VIAL A207181 001 Mar 06, 2017

AP MYLAN LABS LTD EQ 40MG BASE/VIAL A202686 002 May 17, 2017

AP SUN PHARMA GLOBAL EQ 40MG BASE/VIAL A200882 002 Mar 18, 2013

NEXIUM IV

AP +! ASTRAZENECA PHARMS EQ 40MG BASE/VIAL N021689 002 Mar 31, 2005

ESOMEPRAZOLE STRONTIUM

CAPSULE, DELAYED RELEASE;ORAL

ESOMEPRAZOLE STRONTIUM

+! R2 PHARMA LLC 49.3MG N202342 002 Aug 06, 2013

ESTAZOLAM

TABLET;ORAL

ESTAZOLAM

AB MAYNE PHARMA 1MG A074921 001 Jul 10, 1997

AB ! 2MG A074921 002 Jul 10, 1997

AB PAR PHARM 1MG A074826 001 Jul 03, 1997

AB 2MG A074826 002 Jul 03, 1997

AB WATSON LABS 1MG A074818 001 Aug 19, 1997

AB 2MG A074818 002 Aug 19, 1997



ESTRADIOL

CREAM;VAGINAL

ESTRACE

AB ! ALLERGAN SALES LLC 0.01% A086069 001 Jan 31, 1984

ESTRADIOL

AB ALVOGEN PINE BROOK 0.01% A209767 001 Mar 05, 2018

AB MYLAN PHARMS INC 0.01% A208788 001 Dec 29, 2017

AB PERRIGO UK FINCO 0.01% A210194 001 Jan 22, 2018

AB TEVA PHARMS USA 0.01% A210488 001 Mar 30, 2018



FILM, EXTENDED RELEASE;TRANSDERMAL

CLIMARA

AB + BAYER HLTHCARE 0.06MG/24HR N020375 006 May 27, 2003

ESTRADIOL

AB MYLAN TECHNOLOGIES 0.06MG/24HR A075182 005 Jul 20, 2006

AB1 0.025MG/24HR A201675 001 Dec 19, 2014

AB1 0.0375MG/24HR A201675 002 Dec 19, 2014

AB1 0.05MG/24HR A201675 003 Dec 19, 2014

AB1 0.075MG/24HR A201675 004 Dec 19, 2014

AB1 0.1MG/24HR A201675 005 Dec 19, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-168(of 452)

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL

VIVELLE-DOT

AB1 + NOVARTIS 0.025MG/24HR N020538 009 May 03, 2002

AB1 + 0.0375MG/24HR N020538 005 Jan 08, 1999

AB1 + 0.05MG/24HR N020538 006 Jan 08, 1999

AB1 + 0.075MG/24HR N020538 007 Jan 08, 1999

AB1 +! 0.1MG/24HR N020538 008 Jan 08, 1999

CLIMARA

AB2 + BAYER HLTHCARE 0.025MG/24HR N020375 004 Mar 05, 1999

AB2 + 0.0375MG/24HR N020375 005 May 27, 2003

AB2 + 0.05MG/24HR N020375 001 Dec 22, 1994

AB2 + 0.075MG/24HR N020375 003 Mar 23, 1998

AB2 +! 0.1MG/24HR N020375 002 Dec 22, 1994

ESTRADIOL

AB2 MYLAN TECHNOLOGIES 0.025MG/24HR A075182 003 Jan 26, 2005

AB2 0.0375MG/24HR A075182 004 Jul 20, 2006

AB2 0.05MG/24HR A075182 006 Feb 24, 2000

AB2 0.075MG/24HR A075182 002 Jan 26, 2005

AB2 0.1MG/24HR A075182 001 Feb 24, 2000

AB3 0.025MG/24HR A206685 001 Aug 15, 2018

AB3 0.0375MG/24HR A206685 002 Aug 15, 2018

AB3 0.05MG/24HR A206685 003 Aug 15, 2018

AB3 0.075MG/24HR A206685 004 Aug 15, 2018

AB3 0.1MG/24HR A206685 005 Aug 15, 2018

MINIVELLE

AB3 + NOVEN 0.025MG/24HR N203752 005 Sep 23, 2014

AB3 + 0.0375MG/24HR N203752 001 Oct 29, 2012

AB3 + 0.05MG/24HR N203752 003 Oct 29, 2012

AB3 + 0.075MG/24HR N203752 002 Oct 29, 2012

AB3 +! 0.1MG/24HR N203752 004 Oct 29, 2012



ALORA

BX ALLERGAN SALES LLC 0.025MG/24HR N020655 004 Apr 05, 2002

BX 0.05MG/24HR N020655 001 Dec 20, 1996



BX 0.075MG/24HR N020655 002 Dec 20, 1996

BX 0.1MG/24HR N020655 003 Dec 20, 1996

MENOSTAR

+! BAYER HLTHCARE 0.014MG/24HR N021674 001 Jun 08, 2004

GEL;TRANSDERMAL

DIVIGEL

+ VERTICAL PHARMS LLC 0.1% N022038 001 Jun 04, 2007

GEL, METERED;TRANSDERMAL

ELESTRIN

+! MYLAN SPECIALITY LP 0.06% (0.87GM/ACTIVATION) N021813 001 Dec 15, 2006

ESTROGEL

+! ASCEND THERAPS US 0.06% (1.25GM/ACTIVATION) N021166 002 Feb 09, 2004

INSERT;VAGINAL

IMVEXXY

+ THERAPEUTICSMD INC 0.004MG N208564 001 May 29, 2018

+! 0.01MG N208564 002 May 29, 2018

INSERT, EXTENDED RELEASE;VAGINAL



ESTRING

+! PHARMACIA AND 0.0075MG/24HR N020472 001 Apr 26, 1996

UPJOHN

SPRAY;TRANSDERMAL

EVAMIST

+! PERRIGO PHARMA INTL 1.53MG/SPRAY N022014 001 Jul 27, 2007

TABLET;ORAL

ESTRADIOL

AB BARR LABS INC 0.5MG A040197 001 Oct 22, 1997

AB 1MG A040197 002 Oct 22, 1997

AB ! 2MG A040197 003 Oct 22, 1997

AB EPIC PHARMA INC 0.5MG A040275 001 Dec 29, 1998

AB 1MG A040275 002 Dec 29, 1998

AB 2MG A040275 003 Dec 29, 1998

AB MAYNE PHARMA 0.5MG A040114 003 Mar 14, 1996

AB 1MG A040114 001 Mar 14, 1996

AB 2MG A040114 002 Mar 14, 1996

AB MYLAN 0.5MG A040326 001 Apr 21, 1999

AB 1MG A040326 002 Apr 21, 1999

AB 2MG A040326 003 Apr 21, 1999



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-169(of 452)

ESTRADIOL

TABLET;VAGINAL

ESTRADIOL

AB AMNEAL PHARMS 10MCG A205256 001 May 29, 2015

AB GLENMARK PHARMS LTD 10MCG A210264 001 Sep 14, 2018

AB TEVA PHARMS USA 10MCG A206388 001 Jul 21, 2017

VAGIFEM

AB +! NOVO NORDISK INC 10MCG N020908 002 Nov 25, 2009

ESTRADIOL ACETATE

INSERT, EXTENDED RELEASE;VAGINAL

FEMRING

+ MILLICENT EQ 0.05MG BASE/24HR N021367 001 Mar 20, 2003

+! EQ 0.1MG BASE/24HR N021367 002 Mar 20, 2003

ESTRADIOL CYPIONATE

INJECTABLE;INJECTION

DEPO-ESTRADIOL

! PHARMACIA AND 5MG/ML A085470 003

UPJOHN

ESTRADIOL VALERATE

INJECTABLE;INJECTION

DELESTROGEN

AO +! PAR STERILE 20MG/ML N009402 004

PRODUCTS

AO +! 40MG/ML N009402 003

ESTRADIOL VALERATE

AO LUITPOLD 20MG/ML A090920 001 Jan 19, 2010

AO 40MG/ML A090920 002 Jan 19, 2010



DELESTROGEN

+! PAR STERILE 10MG/ML N009402 002

PRODUCTS

ESTRADIOL; LEVONORGESTREL

FILM, EXTENDED RELEASE;TRANSDERMAL

CLIMARA PRO

+! BAYER HLTHCARE 0.045MG/24HR;0.015MG/24HR N021258 001 Nov 21, 2003

ESTRADIOL; NORETHINDRONE ACETATE

FILM, EXTENDED RELEASE;TRANSDERMAL

COMBIPATCH

+ NOVEN PHARMS INC 0.05MG/24HR;0.14MG/24HR N020870 001 Aug 07, 1998

+! 0.05MG/24HR;0.25MG/24HR N020870 002 Aug 07, 1998

TABLET;ORAL

ACTIVELLA

AB + AMNEAL PHARMS LLC 0.5MG;0.1MG N020907 002 Dec 28, 2006

AB +! 1MG;0.5MG N020907 001 Nov 18, 1998

AMABELZ

AB LUPIN LTD 0.5MG;0.1MG A203339 001 Jun 20, 2016

AB 1MG;0.5MG A203339 002 Jun 20, 2016

ESTRADIOL AND NORETHINDRONE ACETATE



AB ACCORD HLTHCARE 1MG;0.5MG A210233 001 Feb 28, 2018

AB BARR 1MG;0.5MG A079193 001 May 11, 2010

AB BRECKENRIDGE PHARM 0.5MG;0.1MG A078324 002 Jun 09, 2011

AB 1MG;0.5MG A078324 001 Apr 17, 2008

AB MYLAN LABS LTD 0.5MG;0.1MG A207261 001 Feb 10, 2017

AB 1MG;0.5MG A207261 002 Feb 10, 2017

AB TEVA PHARMS USA 0.5MG;0.1MG A200747 001 Mar 08, 2012



ESTRADIOL; NORGESTIMATE

TABLET;ORAL

ESTRADIOL AND NORGESTIMATE

! BARR 1MG,1MG;N/A,0.09MG A076812 001 Apr 29, 2005

ESTRADIOL; PROGESTERONE

CAPSULE;ORAL

BIJUVA

+! THERAPEUTICSMD INC 1MG;100MG N210132 001 Oct 28, 2018

ESTRAMUSTINE PHOSPHATE SODIUM

CAPSULE;ORAL

EMCYT

+! PHARMACIA AND EQ 140MG PHOSPHATE N018045 001

UPJOHN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-170(of 452)

ESTROGENS, CONJUGATED

CREAM;TOPICAL, VAGINAL

PREMARIN

+! WYETH PHARMS 0.625MG/GM N020216 001

INJECTABLE;INJECTION

PREMARIN

+! WYETH PHARMS 25MG/VIAL N010402 001

TABLET;ORAL

PREMARIN

+ WYETH PHARMS 0.3MG N004782 003

+ 0.45MG N004782 006 Jul 16, 2003

+! 0.625MG N004782 004

+! 0.9MG N004782 005 Jan 26, 1984

+! 1.25MG N004782 001

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET;ORAL-28

PREMPHASE 14/14

+! WYETH PHARMS 0.625MG,0.625MG;N/A,5MG N020527 002 Nov 17, 1995



PREMPRO

+! WYETH PHARMS 0.3MG;1.5MG N020527 005 Jun 04, 2003

+! 0.45MG;1.5MG N020527 004 Mar 12, 2003

+! 0.625MG;2.5MG N020527 001 Nov 17, 1995

+! 0.625MG;5MG N020527 003 Jan 09, 1998

ESTROGENS, ESTERIFIED

TABLET;ORAL

MENEST

MONARCH PHARMS 0.3MG A084951 001

0.625MG A084948 001

1.25MG A084950 001

! 2.5MG A084949 001

ESTROPIPATE

TABLET;ORAL

ESTROPIPATE

MYLAN 0.75MG A040359 001 Aug 26, 1999

1.5MG A040359 002 Aug 26, 1999

OGEN 5

PHARMACIA AND 6MG A083220 004

UPJOHN

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

AB AUROBINDO PHARMA 1MG A208451 001 Sep 15, 2016

LTD

AB 2MG A208451 002 Sep 15, 2016

AB 3MG A208451 003 Sep 15, 2016

AB DR REDDYS LABS LTD 1MG A091024 001 Apr 15, 2014

AB 2MG A091024 002 Apr 15, 2014

AB 3MG A091024 003 Apr 15, 2014

AB GLENMARK GENERICS 1MG A091166 001 Apr 15, 2014

AB 2MG A091166 002 Apr 15, 2014

AB 3MG A091166 003 Apr 15, 2014

AB LUPIN LTD 1MG A091124 001 Sep 13, 2011

AB 2MG A091124 002 Sep 13, 2011

AB 3MG A091124 003 Sep 13, 2011

AB MACLEODS PHARMS LTD 1MG A202929 001 Jan 30, 2015

AB 2MG A202929 002 Jan 30, 2015

AB 3MG A202929 003 Jan 30, 2015

AB MYLAN PHARMS INC 1MG A091151 001 Mar 26, 2013

AB 2MG A091151 002 Mar 26, 2013

AB 3MG A091151 003 Mar 26, 2013

AB ORCHID HLTHCARE 1MG A091113 001 Jun 10, 2014

AB 2MG A091113 002 Jun 10, 2014

AB 3MG A091113 003 Jun 10, 2014

AB SUN PHARMA GLOBAL 1MG A091103 001 Apr 03, 2013

AB 2MG A091103 002 Apr 03, 2013

AB 3MG A091103 003 Apr 03, 2013

AB TEVA 1MG A091169 001 May 23, 2011

AB 2MG A091169 002 May 23, 2011

AB 3MG A091169 003 May 23, 2011

AB WEST-WARD PHARMS 1MG A091153 001 Apr 15, 2014

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-171(of 452)

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

AB 2MG A091153 002 Apr 15, 2014

AB 3MG A091153 003 Apr 15, 2014

LUNESTA

AB + SUNOVION PHARMS INC 1MG N021476 001 Dec 15, 2004

AB + 2MG N021476 002 Dec 15, 2004

AB +! 3MG N021476 003 Dec 15, 2004



ETELCALCETIDE

SOLUTION;INTRAVENOUS

PARSABIV

+! KAI PHARMS INC 2.5MG/0.5ML (2.5MG/0.5ML) N208325 001 Feb 07, 2017

+! 5MG/ML (5MG/ML) N208325 002 Feb 07, 2017

+! 10MG/2ML (5MG/ML) N208325 003 Feb 07, 2017

ETEPLIRSEN

SOLUTION;INTRAVENOUS

EXONDYS 51

+! SAREPTA THERAPS INC 100MG/2ML (50MG/ML) N206488 001 Sep 19, 2016

+! 500MG/10ML (50MG/ML) N206488 002 Sep 19, 2016



ETHACRYNATE SODIUM

INJECTABLE;INJECTION

EDECRIN

AP +! ATON EQ 50MG BASE/VIAL N016093 001

ETHACRYNATE SODIUM

AP MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A204634 001 Aug 23, 2016

AP PAR STERILE EQ 50MG BASE/VIAL A205473 001 Jul 29, 2015

PRODUCTS

AP ZYDUS PHARMS USA EQ 50MG BASE/VIAL A207758 001 Nov 17, 2017

INC

ETHACRYNIC ACID

TABLET;ORAL

EDECRIN

AB +! ATON 25MG N016092 001

ETHACRYNIC ACID

AB ALVOGEN 25MG A205709 001 Jul 24, 2018

AB AMNEAL PHARMS CO 25MG A208805 001 May 08, 2018

AB EDENBRIDGE PHARMS 25MG A205609 001 Jun 30, 2016

AB PAR PHARM INC 25MG A208501 001 Jul 21, 2017

AB WEST-WARD PHARMS 25MG A207262 001 Feb 23, 2017

INT

ETHAMBUTOL HYDROCHLORIDE

TABLET;ORAL

ETHAMBUTOL HYDROCHLORIDE

AB AKORN 100MG A075095 001 Nov 30, 1999

AB 400MG A075095 002 Nov 30, 1999

AB BARR 400MG A076057 001 Nov 26, 2001

AB LUPIN 100MG A078939 001 Jun 17, 2009

AB 400MG A078939 002 Jun 17, 2009

MYAMBUTOL

AB + STI PHARMA LLC 100MG N016320 001

AB +! 400MG N016320 003

ETHANOLAMINE OLEATE

INJECTABLE;INJECTION

ETHAMOLIN

+! QOL MEDCL 50MG/ML N019357 001 Dec 22, 1988

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET;ORAL-28

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL



AB MYLAN LABS LTD 0.035MG;1MG A204703 001 Jul 28, 2016

AB 0.05MG;1MG A204704 001 Feb 09, 2016

KELNOR

AB BARR 0.035MG;1MG A076785 001 May 23, 2005

MALMOREDE

AB NOVAST LABS 0.05MG;1MG A209547 001 Jul 25, 2018

ZOVIA 1/35E-28

AB MAYNE PHARMA 0.035MG;1MG A072721 001 Dec 30, 1991

ZOVIA 1/50E-28

AB ! WATSON LABS 0.05MG;1MG A072723 001 Dec 30, 1991



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-172(of 452)

ETHINYL ESTRADIOL; ETONOGESTREL



RING;VAGINAL

NUVARING

+! ORGANON SUB MERCK 0.015MG/24HR;0.12MG/24HR N021187 001 Oct 03, 2001

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

ASHLYNA

AB GLENMARK GENERICS 0.03MG,0.01MG;0.15MG,N/A A203163 001 Feb 23, 2015

DAYSEE

AB LUPIN LTD 0.03MG,0.01MG;0.15MG,N/A A091467 001 Apr 10, 2013

FAYOSIM

AB LUPIN LTD 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.1 A205943 001 Mar 29, 2016

5MG;0.01MG,N/A

ICLEVIA

AB AUROBINDO PHARMA 0.03MG;0.15MG A206850 001 Jun 29, 2018

LTD

INTROVALE

AB LABS LEON FARMA 0.03MG;0.15MG A079064 001 Sep 27, 2010

JAIMIESS

AB LABS LEON FARMA 0.03MG,0.01MG;0.15MG,N/A A203770 001 Dec 27, 2017

LEVONORGESTREL AND ETHINYL ESTRADIOL



AB AMNEAL PHARMS 0.03MG;0.15MG A203871 001 Nov 13, 2015

AB 0.03MG,0.01MG;0.15MG,N/A A203872 001 Dec 22, 2015

AB GLENMARK GENERICS 0.02MG;0.09MG A202791 001 Apr 09, 2015

AB GLENMARK PHARMS LTD 0.03MG;0.15MG A203164 001 Jun 12, 2015

AB LUPIN LTD 0.03MG;0.15MG A091440 001 Oct 23, 2012

AB MYLAN LABS LTD 0.03MG;0.15MG A200490 001 Apr 21, 2015

AB ! WATSON LABS 0.02MG;0.09MG A079218 001 Jun 06, 2011

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL



AB LABS LEON FARMA 0.02MG,0.1MG;0.01MG,N/A A205131 001 Dec 14, 2017

AB LUPIN LTD 0.02MG,0.1MG;0.01MG,N/A A091674 001 Oct 26, 2011

AB MAYNE PHARMA 0.02MG,0.1MG;0.01MG,N/A A200407 001 Oct 25, 2011

AB 0.03MG,0.01MG;0.15MG,N/A A078834 001 May 31, 2011

AB MYLAN LABS LTD 0.02MG,0.15MG; A206053 001 Oct 02, 2017

0.025MG,0.15MG;0.03MG,0.15MG;

AB 0.02MG,0.1MG;0.01MG,N/A A200493 001 Jun 17, 2015

AB 0.03MG,0.01MG;0.15MG,N/A A200492 001 May 27, 2015

LO SIMPESSE

AB AUROBINDO PHARMA 0.02MG,0.1MG;0.01MG,N/A A206852 001 Apr 28, 2017

LTD

LOSEASONIQUE

AB TEVA BRANDED PHARM 0.02MG,0.1MG;0.01MG,N/A N022262 001 Oct 24, 2008

QUARTETTE

AB +! TEVA BRANDED PHARM 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.1 N204061 001 Mar 28, 2013

5MG;0.01MG,N/A

QUASENSE

AB WATSON LABS 0.03MG;0.15MG A077101 001 Sep 06, 2006

SEASONALE

AB +! TEVA BRANDED PHARM 0.03MG;0.15MG N021544 001 Sep 05, 2003

SEASONIQUE

AB +! TEVA BRANDED PHARM 0.03MG,0.01MG;0.15MG,N/A N021840 001 May 25, 2006

SETLAKIN

AB NOVAST LABS 0.03MG;0.15MG A090716 001 Sep 15, 2014

SIMPESSE

AB AUROBINDO PHARMA 0.03MG,0.01MG;0.15MG,N/A A206851 001 Apr 07, 2017

LTD

BALCOLTRA

AVION PHARMS 0.02MG;0.1MG N208612 001 Jan 09, 2018

TABLET;ORAL-28

ALTAVERA

AB LABS LEON FARMA 0.03MG;0.15MG A079102 001 Aug 03, 2010

AYUNA

AB AUROBINDO PHARMA 0.03MG;0.15MG A206866 001 Sep 23, 2016

LTD

ELIFEMME

AB LABS LEON FARMA 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A202507 001 Dec 04, 2015

25MG

ENPRESSE-28

AB DURAMED PHARMS BARR 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A075809 002 Jul 16, 2001

25MG

KURVELO

AB LUPIN LTD 0.03MG;0.15MG A091408 001 Oct 17, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-173(of 452)

ETHINYL ESTRADIOL; LEVONORGESTREL



TABLET;ORAL-28

LEVONEST

AB NOVAST LABS LTD 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A090719 001 Dec 29, 2010

25MG

LEVONORGESTREL AND ETHINYL ESTRADIOL

AB AMNEAL PHARMS 0.03MG;0.15MG A201095 001 Dec 08, 2014

AB LUPIN LTD 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A200248 001 Nov 19, 2015

25MG

AB MYLAN LABS LTD 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A202970 001 Mar 23, 2018

25MG

AB 0.03MG;0.15MG A091663 001 Dec 21, 2012

LEVORA 0.15/30-28

AB ! MAYNE PHARMA 0.03MG;0.15MG A073594 001 Dec 13, 1993

MARLISSA

AB GLENMARK GENERICS 0.03MG;0.15MG A091452 001 Feb 29, 2012

MYZILRA

AB VINTAGE PHARMS LLC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A077502 001 Nov 23, 2011

25MG

PORTIA-28

AB BARR 0.03MG;0.15MG A075866 002 May 23, 2002

TRIVORA-28

AB ! MAYNE PHARMA 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538 002 Dec 18, 1997

25MG

AFIRMELLE

AB1 AUROBINDO PHARMA 0.02MG;0.1MG A206886 001 Nov 14, 2016

LTD

AVIANE-28

AB1 DURAMED PHARMS BARR 0.02MG;0.1MG A075796 001 Apr 30, 2001

CERINTA

AB1 SUN PHARM INDS LTD 0.02MG;0.1MG A202817 001 Jan 07, 2019

FALMINA

AB1 NOVAST LABS LTD 0.02MG;0.1MG A090721 001 Mar 28, 2012

LEVONORGESTREL AND ETHINYL ESTRADIOL



AB1 AMNEAL PHARMS 0.02MG;0.1MG A201108 001 Feb 05, 2014

AB1 LUPIN LTD 0.02MG;0.1MG A091425 001 Jan 18, 2013

AB1 ! MAYNE PHARMA 0.02MG;0.1MG A076625 001 Nov 18, 2004

AB1 MYLAN LABS LTD 0.02MG;0.1MG A200245 001 Oct 09, 2013

ORSYTHIA

AB1 VINTAGE PHARMS LLC 0.02MG;0.1MG A077099 001 May 11, 2011

VIENVA

AB1 LABS LEON FARMA 0.02MG;0.1MG A201088 001 May 21, 2015

LESSINA-28

AB2 BARR 0.02MG;0.1MG A075803 002 Mar 20, 2002

LEVONORGESTREL AND ETHINYL ESTRADIOL



AB2 ! MAYNE PHARMA 0.02MG;0.1MG A077681 001 May 31, 2006

AB2 MYLAN LABS LTD 0.02MG;0.1MG A202247 001 Dec 08, 2014

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE;TRANSDERMAL

XULANE

! MYLAN TECHNOLOGIES 0.035MG/24HR;0.15MG/24HR A200910 001 Apr 16, 2014

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-21

NORINYL 1+35 21-DAY



AB ALLERGAN SALES LLC 0.035MG;1MG N017565 001

NORTREL 1/35-21

AB BARR 0.035MG;1MG A072693 001 Feb 28, 1992



NORTREL 7/7/7

BARR 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A075478 001 Aug 30, 2002

G

TABLET;ORAL-28

ALYACEN 1/35

AB GLENMARK GENERICS 0.035MG;1MG A091634 001 Jan 19, 2012

ALYACEN 7/7/7

AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A091636 001 Jan 19, 2012

G

ARANELLE

AB BARR 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG A076783 001 Sep 29, 2004

BALZIVA-28

AB ! BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004

BREVICON 28-DAY

AB ALLERGAN SALES LLC 0.035MG;0.5MG N017743 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-174(of 452)

ETHINYL ESTRADIOL; NORETHINDRONE



TABLET;ORAL-28

BRIELLYN

AB GLENMARK GENERICS 0.035MG;0.4MG A090538 001 Mar 22, 2011

CYCLAFEM 0.5/35

AB VINTAGE PHARMS 0.035MG;0.5MG A203413 001 Dec 16, 2015

CYCLAFEM 1/35

AB VINTAGE PHARMS LLC 0.035MG;1MG A076337 001 Nov 12, 2010

CYCLAFEM 7/7/7

AB VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A076338 001 Nov 16, 2010

G

CYONANZ

AB AUROBINDO PHARMA 0.035MG;0.5MG A207055 001 Oct 21, 2016

LTD

DASETTA 1/35

AB NOVAST LABS LTD 0.035MG;1MG A090948 001 Dec 22, 2011

DASETTA 7/7/7

AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A090946 001 Dec 22, 2011

G

GILDAGIA

AB VINTAGE PHARMS 0.035MG;0.4MG A078376 001 Nov 06, 2012

NORETHINDRONE AND ETHINYL ESTRADIOL



AB ACCORD HLTHCARE 0.035MG;1MG A206864 001 Apr 28, 2017

AB MAYNE PHARMA 0.035MG;0.5MG A070686 001 Jan 29, 1987

AB WATSON LABS 0.035MG;0.4MG A078323 001 Feb 04, 2010

AB WATSON LABS TEVA 0.035MG;1MG A070687 001 Jan 29, 1987

NORINYL 1+35 28-DAY



AB ALLERGAN SALES LLC 0.035MG;1MG N017565 002

NORTREL 0.5/35-28

AB BARR 0.035MG;0.5MG A072695 001 Feb 28, 1992

NORTREL 1/35-28

AB BARR 0.035MG;1MG A072696 001 Feb 28, 1992

NORTREL 7/7/7

AB BARR 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A075478 002 Aug 30, 2002

G

NYLIA 1/35

AB AUROBINDO PHARMA 0.035MG;1MG A207056 001 Oct 21, 2016

LTD

NYLIA 7/7/7

AB AUROBINDO PHARMA 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A207054 001 Oct 21, 2016

LTD G

ORTHO-NOVUM 1/35-28

AB +! JANSSEN PHARMS 0.035MG;1MG N017919 002



ORTHO-NOVUM 7/7/7-28

AB +! JANSSEN PHARMS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M N018985 002 Apr 04, 1984

G

PHILITH

AB NOVAST LABS LTD 0.035MG;0.4MG A090947 001 Dec 22, 2011

PIRMELLA 1/35

AB LUPIN LTD 0.035MG;1MG A201512 001 Apr 24, 2013

PIRMELLA 7/7/7

AB LUPIN LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A201510 001 Apr 24, 2013

G

TRI-NORINYL 28-DAY

AB +! MAYNE PHARMA 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG N018977 002 Apr 13, 1984

VYFEMLA

AB LUPIN LTD 0.035MG;0.4MG A201886 001 Sep 26, 2013

WERA

AB ! NOVAST LABS LTD 0.035MG;0.5MG A091204 001 Mar 27, 2012

NORETHINDRONE AND ETHINYL ESTRADIOL

! MYLAN LABS LTD 0.05MG;1MG A203006 001 Aug 05, 2013

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

WATSON LABS TEVA 0.035MG,0.035MG;0.5MG,1MG A071044 001 Apr 01, 1988

TABLET, CHEWABLE;ORAL

FEMCON FE

AB +! APIL 0.035MG;0.4MG N021490 001 Nov 14, 2003
KAITLIB FE
AB LUPIN LTD 0.025MG;0.8MG A203448 001 Dec 17, 2015
NEXESTA FE
AB AUROBINDO PHARMA 0.035MG;0.4MG A207535 001 Feb 02, 2017
LTD
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB ACCORD HLTHCARE 0.035MG;0.4MG A207066 001 Mar 29, 2017
AB AMNEAL PHARMS 0.035MG;0.4MG A078892 001 Sep 26, 2011
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-175(of 452)

ETHINYL ESTRADIOL; NORETHINDRONE



TABLET, CHEWABLE;ORAL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE



AB +! APIL 0.025MG;0.8MG N022573 001 Dec 22, 2010

AB BARR 0.035MG;0.4MG A078965 001 Aug 05, 2010

AB LUPIN LTD 0.035MG;0.4MG A091332 001 Mar 23, 2016

AB MYLAN LABS LTD 0.025MG;0.8MG A203371 001 Apr 23, 2014

AB 0.035MG;0.4MG A202086 001 Apr 01, 2015



ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

CAPSULE;ORAL

TAYTULLA

+! APIL 0.02MG;1MG N204426 001 Apr 19, 2013

TABLET;ORAL

AUROVELA 24 FE

AB AUROBINDO PHARMA 0.02MG;1MG A207504 001 Jun 15, 2017

LTD

BLISOVI 24 FE

AB LUPIN LTD 0.02MG;1MG A091398 001 Oct 28, 2015

FEMHRT

AB APIL 0.0025MG;0.5MG N021065 001 Jan 14, 2005

FYAVOLV

AB LUPIN LTD 0.005MG;1MG A204213 002 Dec 10, 2015

AB 0.0025MG;0.5MG A204213 001 Dec 10, 2015

GILDESS 24 FE

AB VINTAGE PHARMS 0.02MG;1MG A090293 001 Dec 01, 2014

LARIN 24 FE

AB NOVAST LABS 0.02MG;1MG A202994 001 Feb 18, 2015

LERIBANE

AB NOVAST LABS 0.0025MG;0.5MG A203435 002 Jun 03, 2016

AB 0.005MG;1MG A203435 001 Jun 03, 2016

LOESTRIN 24 FE

AB + APIL 0.02MG;1MG N021871 001 Feb 17, 2006

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL



AB ! BARR LABS INC 0.005MG;1MG A076221 001 Nov 06, 2009

AB GLENMARK GENERICS 0.0025MG;0.5MG A203038 001 Apr 02, 2015

AB 0.005MG;1MG A203038 002 Apr 02, 2015

AB MYLAN LABS LTD 0.0025MG;0.5MG A207260 001 Feb 02, 2017

AB 0.005MG;1MG A207259 001 Dec 27, 2016

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE



AB ! AMNEAL PHARMS 0.02MG;1MG A078267 001 Sep 01, 2009

AB BARR LABS INC 0.02MG;1MG A090938 001 Dec 01, 2014

AB GLENMARK PHARMS LTD 0.02MG;1MG A204847 001 Nov 17, 2017

AB MYLAN LABS LTD 0.02MG;1MG A202742 001 Oct 30, 2014



LO LOESTRIN FE

+! APIL 0.01MG,0.01MG;1MG,N/A N022501 001 Oct 21, 2010

TABLET;ORAL-21

AUROVELA 1.5/30

AB AUROBINDO PHARMA 0.03MG;1.5MG A207581 001 Jun 26, 2017

LTD

AUROVELA 1/20

AB AUROBINDO PHARMA 0.02MG;1MG A207506 001 Jun 16, 2017

LTD

GILDESS 1.5/30

AB VINTAGE PHARMS LLC 0.03MG;1.5MG A077075 002 Jul 24, 2012

GILDESS 1/20

AB VINTAGE PHARMS LLC 0.02MG;1MG A077077 002 Jul 24, 2012

JUNEL 1.5/30

AB BARR 0.03MG;1.5MG A076381 001 May 30, 2003

JUNEL 1/20

AB BARR 0.02MG;1MG A076380 001 May 30, 2003

LARIN 1.5/30

AB NOVAST LABS 0.03MG;1.5MG A202996 001 Mar 20, 2014

LARIN 1/20

AB NOVAST LABS 0.02MG;1MG A202995 001 Dec 04, 2013

LOESTRIN 21 1.5/30

AB APIL 0.03MG;1.5MG N017875 001



LOESTRIN 21 1/20

AB APIL 0.02MG;1MG N017876 001



MICROGESTIN 1.5/30

AB MAYNE PHARMA 0.03MG;1.5MG A075548 002 Jul 30, 2003

MICROGESTIN 1/20

AB MAYNE PHARMA 0.02MG;1MG A075647 002 Jul 30, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-176(of 452)

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE



TABLET;ORAL-21

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL



AB GLENMARK PHARMS LTD 0.02MG;1MG A206969 001 Jan 20, 2016

AB MYLAN LABS LTD 0.02MG;1MG A202771 001 Nov 06, 2013

AB 0.03MG;1.5MG A202770 001 Feb 19, 2015



TRI-LEGEST 21

BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076405 001 Oct 26, 2007

TABLET;ORAL-28

AUROVELA FE 1.5/30

AB AUROBINDO PHARMA 0.03MG;1.5MG A207580 001 Jun 15, 2017

LTD

AUROVELA FE 1/20

AB AUROBINDO PHARMA 0.02MG;1MG A207505 001 Jun 16, 2017

LTD

BLISOVI FE 1.5/30

AB LUPIN LTD 0.03MG;1.5MG A201585 001 Nov 18, 2015

BLISOVI FE 1/20

AB LUPIN LTD 0.02MG;1MG A201584 001 Nov 18, 2015

ESTROSTEP FE

AB +! APIL 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N020130 002 Oct 09, 1996

GILDESS FE 1.5/30

AB VINTAGE PHARMS LLC 0.03MG;1.5MG A077075 001 Apr 28, 2005

GILDESS FE 1/20

AB VINTAGE PHARMS LLC 0.02MG;1MG A077077 001 May 20, 2005

HAILEY 1.5/30

AB GLENMARK PHARMS 0.03MG;1.5MG A209297 001 Jun 05, 2018

HAILEY FE 1.5/30

AB GLENMARK PHARMS 0.03MG;1.5MG A209031 001 Jun 05, 2018

HAILEY FE 1/20

AB GLENMARK PHARMS LTD 0.02MG;1MG A206597 001 Nov 21, 2017

JUNEL FE 1.5/30

AB BARR 0.03MG;1.5MG A076064 001 Sep 18, 2003

JUNEL FE 1/20

AB BARR 0.02MG;1MG A076081 001 Sep 18, 2003

LARIN FE 1.5/30

AB NOVAST LABS 0.03MG;1.5MG A091453 001 Aug 23, 2013

LARIN FE 1/20

AB NOVAST LABS 0.02MG;1MG A091454 001 Aug 26, 2013

LOESTRIN FE 1.5/30

AB +! APIL 0.03MG;1.5MG N017355 001



LOESTRIN FE 1/20

AB + APIL 0.02MG;1MG N017354 001



MICROGESTIN FE 1.5/30

AB MAYNE PHARMA 0.03MG;1.5MG A075548 001 Feb 05, 2001

MICROGESTIN FE 1/20

AB MAYNE PHARMA 0.02MG;1MG A075647 001 Feb 05, 2001

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL



AB MAYNE PHARMA 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076629 001 Mar 18, 2010

AB MYLAN LABS LTD 0.02MG;1MG A202772 001 Nov 14, 2013

AB 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A205069 001 Jun 22, 2018

AB 0.03MG;1.5MG A202741 001 Feb 20, 2015

TRI-LEGEST FE

AB BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076105 001 Oct 26, 2007

TABLET, CHEWABLE;ORAL

MIBELAS 24 FE

AB LUPIN ATLANTIS 0.02MG;1MG A206287 001 May 24, 2016

MINASTRIN 24 FE

AB +! APIL 0.02MG;1MG N203667 001 May 08, 2013

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE



AB AMNEAL PHARMS 0.02MG;1MG A207514 001 Sep 11, 2017

AB CHEMO RESEARCH SL 0.02MG;1MG A209609 001 Jul 16, 2018

AB GLENMARK PHARMS LTD 0.02MG;1MG A210369 001 Dec 26, 2017

AB MYLAN LABS LTD 0.02MG;1MG A206120 001 Sep 12, 2017



ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

ESTARYLLA

AB LABS LEON FARMA 0.035MG;0.25MG A090794 001 Jan 30, 2013

MILI

AB AUROBINDO PHARMA 0.035MG;0.25MG A205449 001 Jul 07, 2016

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-177(of 452)

ETHINYL ESTRADIOL; NORGESTIMATE



TABLET;ORAL-28

MONO-LINYAH

AB NOVAST LABS LTD 0.035MG;0.25MG A090523 001 May 23, 2012

NORGESTIMATE AND ETHINYL ESTRADIOL



AB AMNEAL PHARMS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A203870 001 Nov 12, 2015

0.25MG

AB 0.035MG;0.25MG A203865 001 Oct 27, 2015

AB 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A203873 001 May 12, 2016

0.25MG

AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A200494 001 Jun 17, 2011

0.25MG

AB 0.035MG;0.25MG A200538 001 Apr 05, 2012

AB GLENMARK PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A204057 001 Feb 23, 2016

0.25MG

AB LUPIN LTD 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A205588 001 Apr 26, 2016

0.25MG

AB 0.035MG;0.25MG A205630 001 Oct 27, 2016

AB LUPIN PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A200541 001 Jun 25, 2012

0.25MG

AB MYLAN LABS LTD 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A202132 001 Sep 09, 2015

0.25MG

AB 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A201897 001 Jan 27, 2016

0.25MG

AB 0.035MG;0.25MG A201896 001 Jan 27, 2016

AB OC PHARMA 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; A200383 001 Apr 07, 2015

0.25MG

AB 0.035MG;0.25MG A200384 001 Apr 07, 2015

ORTHO CYCLEN-28

AB +! JANSSEN PHARMS 0.035MG;0.25MG N019653 002 Dec 29, 1989

ORTHO TRI-CYCLEN

AB +! JANSSEN PHARMS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, N019697 001 Jul 03, 1992

0.25MG

ORTHO TRI-CYCLEN LO

AB +! JANSSEN PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, N021241 001 Aug 22, 2002

0.25MG

PREVIFEM

AB VINTAGE PHARMS LLC 0.035MG;0.25MG A076334 001 Jan 09, 2004

SPRINTEC

AB BARR 0.035MG;0.25MG A075804 001 Sep 25, 2002

TRI LO SPRINTEC

AB BARR LABS INC 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A076784 001 Jun 29, 2009

0.25MG

TRI-ESTARYLLA

AB LABS LEON FARMA 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A090793 001 Jan 30, 2013

0.25MG

TRI-LINYAH

AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A090524 001 May 30, 2012

0.25MG

TRI-LO-ESTARYLLA

AB LABS LEON FARMA 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A091232 001 Jun 29, 2015

0.25MG

TRI-LO-MILI

AB AUROBINDO PHARMA 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A205762 001 Nov 04, 2016

LTD 0.25MG

TRI-MILI

AB AUROBINDO PHARMA 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A205441 001 Jul 06, 2016

LTD 0.25MG

TRI-PREVIFEM

AB VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A076335 001 Mar 26, 2004

0.25MG

TRI-SPRINTEC

AB BARR 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A075808 001 Dec 29, 2003

0.25MG

ETHINYL ESTRADIOL; NORGESTREL

TABLET;ORAL-21

CRYSELLE

AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 001 Nov 30, 2001

TABLET;ORAL-28

CRYSELLE

AB DURAMED PHARMS BARR 0.03MG;0.3MG A075840 002 Nov 30, 2001

ELINEST

AB NOVAST LABS LTD 0.03MG;0.3MG A091105 001 Mar 28, 2012

LOW-OGESTREL-28

AB MAYNE PHARMA 0.03MG;0.3MG A075288 002 Jul 28, 1999

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-178(of 452)

ETHINYL ESTRADIOL; NORGESTREL



TABLET;ORAL-28

OGESTREL 0.5/50-28

! WATSON LABS 0.05MG;0.5MG A075406 002 Dec 15, 1999



ETHINYL ESTRADIOL; SEGESTERONE ACETATE

RING;VAGINAL

ANNOVERA

+! THERAPEUTICSMD INC 0.013MG/24HR;0.15MG/24HR N209627 001 Aug 10, 2018

ETHIODIZED OIL

OIL;INTRALYMPHATIC, INTRAUTERINE

LIPIODOL

+! GUERBET EQ 4.8GM IODINE/10ML (EQ 480MG N009190 001

IODINE/ML)

ETHIONAMIDE

TABLET;ORAL

TRECATOR

+! WYETH PHARMS 250MG N013026 002

ETHOSUXIMIDE

CAPSULE;ORAL

ETHOSUXIMIDE

AB AKORN 250MG A040686 001 May 28, 2008

AB BIONPHARMA INC 250MG A040430 001 Oct 28, 2002

AB HERITAGE PHARMS INC 250MG A200892 001 Sep 25, 2012

ZARONTIN

AB +! PARKE DAVIS 250MG N012380 001

SYRUP;ORAL

ETHOSUXIMIDE

AA MIKART 250MG/5ML A040506 001 Dec 22, 2003

AA PHARM ASSOC 250MG/5ML A040253 001 Nov 22, 2000

AA TEVA PHARMS 250MG/5ML A081306 001 Jul 30, 1993

ZARONTIN

AA ! PARKE-DAVIS 250MG/5ML A080258 001

ETHOTOIN

TABLET;ORAL

PEGANONE

+! RECORDATI RARE 250MG N010841 001

ETIDRONATE DISODIUM

TABLET;ORAL

ETIDRONATE DISODIUM

MYLAN 200MG A075800 001 Jan 24, 2003

! 400MG A075800 002 Jan 24, 2003

ETODOLAC

CAPSULE;ORAL

ETODOLAC

AB ANI PHARMS INC 200MG A075126 001 Sep 16, 1999

AB 300MG A075126 002 Sep 16, 1999

AB APOTEX 200MG A075419 001 Jul 28, 2000

AB 300MG A075419 002 Jul 28, 2000

AB TARO 200MG A075078 001 Apr 30, 1998

AB ! 300MG A075078 002 Apr 30, 1998

TABLET;ORAL

ETODOLAC

AB AMNEAL PHARMS CO 400MG A208834 001 Jun 07, 2018

AB 500MG A208834 002 Jun 07, 2018

AB APOTEX INC 400MG A076004 001 Dec 03, 2002

AB 500MG A076004 002 Dec 03, 2002

AB EDENBRIDGE PHARMS 400MG A209888 001 Nov 30, 2018

AB 500MG A209888 002 Nov 30, 2018

AB SANDOZ 400MG A074903 001 Apr 11, 1997

AB 500MG A074903 002 Apr 19, 1999

AB TARO PHARM INDS 400MG A075074 001 Mar 11, 1998

AB ! 500MG A075074 002 Apr 25, 2000

AB TEVA 400MG A075009 001 Nov 26, 1997

AB 500MG A075009 002 Dec 28, 1999



TABLET, EXTENDED RELEASE;ORAL

ETODOLAC

AB TARO 400MG A076174 001 Mar 13, 2003

AB 500MG A076174 002 Mar 13, 2003

AB 600MG A076174 003 Mar 13, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-179(of 452)

ETODOLAC

TABLET, EXTENDED RELEASE;ORAL

ETODOLAC

AB TEVA 400MG A075665 003 Feb 05, 2001

AB 500MG A075665 002 Jul 31, 2000

AB ! 600MG A075665 001 Jul 31, 2000

AB ZYDUS PHARMS USA 400MG A091134 001 Jan 23, 2014

INC

AB 500MG A091134 002 Jan 23, 2014

AB 600MG A091134 003 Jan 23, 2014



ETOMIDATE

INJECTABLE;INJECTION

AMIDATE

AP +! HOSPIRA 2MG/ML N018227 001 Sep 07, 1982

ETOMIDATE

AP AUROBINDO PHARMA 2MG/ML A206126 001 Feb 24, 2017

LTD

AP EMCURE PHARMS LTD 2MG/ML A204618 001 Aug 13, 2014

AP GLAND PHARMA LTD 2MG/ML A209058 001 Apr 18, 2017

AP HIKMA FARMACEUTICA 2MG/ML A202354 001 Feb 25, 2016

AP LUITPOLD 2MG/ML A078867 001 Dec 22, 2009

AP MYLAN LABS LTD 2MG/ML A078289 001 Jan 02, 2009

AP 2MG/ML A201044 001 Feb 07, 2017

AP PAR STERILE 2MG/ML A091297 001 Jun 20, 2012

PRODUCTS

AP WEST-WARD PHARMS 2MG/ML A074593 001 Nov 04, 1996

INT

AP ZYDUS PHARMS USA 2MG/ML A202360 001 Jul 18, 2014

INC

ETONOGESTREL

IMPLANT;IMPLANTATION

NEXPLANON

+! ORGANON USA INC 68MG/IMPLANT N021529 002 May 31, 2011

ETOPOSIDE

CAPSULE;ORAL

ETOPOSIDE

! MYLAN 50MG A075635 001 Sep 19, 2001

INJECTABLE;INJECTION

ETOPOSIDE

AP ACCORD HLTHCARE 20MG/ML A074513 001 Mar 14, 1996

AP ! FRESENIUS KABI USA 20MG/ML A074983 001 Sep 30, 1998

AP MYLAN LABS LTD 20MG/ML A203507 001 Nov 20, 2017

AP 20MG/ML A204927 001 Oct 31, 2017

AP TEVA PHARMS USA 20MG/ML A074529 001 Jul 24, 1996

AP WEST-WARD PHARMS 20MG/ML A074290 001 Jul 17, 1995

INT

ETOPOSIDE PHOSPHATE

INJECTABLE;INJECTION

ETOPOPHOS PRESERVATIVE FREE

+! BRISTOL MYERS EQ 100MG BASE/VIAL N020457 001 May 17, 1996

SQUIBB

ETRAVIRINE

TABLET;ORAL

INTELENCE

+ JANSSEN R AND D 25MG N022187 003 Mar 26, 2012

+ 100MG N022187 001 Jan 18, 2008

+! 200MG N022187 002 Dec 22, 2010

EVEROLIMUS

TABLET;ORAL

EVEROLIMUS

AB WEST-WARD PHARMS 0.25MG A206133 001 Apr 12, 2018

INT

AB 0.5MG A206133 002 Apr 12, 2018

AB 0.75MG A206133 003 Apr 12, 2018

ZORTRESS

AB + NOVARTIS 0.25MG N021560 001 Apr 20, 2010

AB + 0.5MG N021560 002 Apr 20, 2010

AB +! 0.75MG N021560 003 Apr 20, 2010

AFINITOR

+ NOVARTIS 2.5MG N022334 003 Jul 09, 2010

+ 5MG N022334 001 Mar 30, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-180(of 452)

EVEROLIMUS

TABLET;ORAL

AFINITOR

+ 7.5MG N022334 004 Mar 30, 2012

+! 10MG N022334 002 Mar 30, 2009

TABLET, FOR SUSPENSION;ORAL

AFINITOR DISPERZ

+ NOVARTIS PHARM 2MG N203985 001 Aug 29, 2012

+ 3MG N203985 002 Aug 29, 2012

+! 5MG N203985 003 Aug 29, 2012



EXEMESTANE

TABLET;ORAL

AROMASIN

AB +! PHARMACIA AND 25MG N020753 001 Oct 21, 1999

UPJOHN

EXEMESTANE

AB ALVOGEN MALTA 25MG A200898 001 Jul 28, 2014

AB AMNEAL PHARMS 25MG A206421 001 Dec 28, 2018

AB CIPLA 25MG A210323 001 Apr 27, 2018

AB MYLAN PHARMS INC 25MG A203315 001 Mar 10, 2017

AB UPSHER SMITH LABS 25MG A209208 001 Jul 26, 2017

AB WEST-WARD PHARMS 25MG A077431 001 Apr 01, 2011

INT

AB ZYDUS PHARMS USA 25MG A202602 001 Oct 03, 2018

INC

EXENATIDE

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

BYDUREON BCISE

+! ASTRAZENECA AB 2MG/0.85ML (2MG/0.85ML) N209210 001 Oct 20, 2017

EXENATIDE SYNTHETIC

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

BYDUREON

+! ASTRAZENECA AB 2MG/VIAL N022200 001 Jan 27, 2012

BYDUREON PEN

+! ASTRAZENECA AB 2MG N022200 002 Feb 28, 2014

INJECTABLE;SUBCUTANEOUS

BYETTA

+! ASTRAZENECA AB 300MCG/1.2ML (250MCG/ML) N021773 001 Apr 28, 2005

+! 600MCG/2.4ML (250MCG/ML) N021773 002 Apr 28, 2005



EZETIMIBE

TABLET;ORAL

EZETIMIBE

AB ACCORD HLTHCARE 10MG A211550 001 Oct 26, 2018

AB ALKEM LABS LTD 10MG A209234 001 Dec 21, 2017

AB AMNEAL PHARMS CO 10MG A208803 001 Jun 12, 2017

AB APOTEX INC 10MG A208332 001 Jun 12, 2017

AB AUROBINDO PHARMA 10MG A209838 001 Aug 25, 2017

LTD

AB GLENMARK PHARMS LTD 10MG A078560 001 Jun 26, 2015

AB OHM LABS INC 10MG A207311 001 Jun 12, 2017

AB SANDOZ INC 10MG A203931 001 Jun 12, 2017

AB TEVA PHARMS USA 10MG A078724 001 Jun 12, 2017

AB WATSON LABS INC 10MG A200831 001 Jun 12, 2017

AB ZYDUS PHARMS USA 10MG A204331 001 Jun 12, 2017

INC

ZETIA

AB +! MSD INTL GMBH 10MG N021445 001 Oct 25, 2002

EZETIMIBE; SIMVASTATIN

TABLET;ORAL

EZETIMIBE AND SIMVASTATIN



AB ALKEM LABS LTD 10MG;10MG A209222 001 Dec 22, 2017

AB 10MG;20MG A209222 002 Dec 22, 2017

AB 10MG;40MG A209222 003 Dec 22, 2017

AB 10MG;80MG A209222 004 Dec 22, 2017

AB AMNEAL PHARMS CO 10MG;10MG A208831 001 Nov 21, 2017

AB 10MG;20MG A208831 002 Nov 21, 2017

AB 10MG;40MG A208831 003 Nov 21, 2017

AB 10MG;80MG A208831 004 Nov 21, 2017

AB ANI PHARMS INC 10MG;10MG A201890 001 Apr 26, 2017

AB 10MG;20MG A201890 002 Apr 26, 2017

AB 10MG;40MG A201890 003 Apr 26, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-181(of 452)

EZETIMIBE; SIMVASTATIN

TABLET;ORAL

EZETIMIBE AND SIMVASTATIN



AB 10MG;80MG A201890 004 Apr 26, 2017

AB DR REDDYS LABS SA 10MG;10MG A200909 001 Apr 26, 2017

AB 10MG;20MG A200909 002 Apr 26, 2017

AB 10MG;40MG A200909 003 Apr 26, 2017

AB 10MG;80MG A200909 004 Apr 26, 2017

AB WATSON LABS INC 10MG;10MG A202968 001 Apr 26, 2017

AB 10MG;20MG A202968 002 Apr 26, 2017

AB 10MG;40MG A202968 003 Apr 26, 2017

AB 10MG;80MG A202968 004 Apr 26, 2017

VYTORIN

AB + MSD INTL 10MG;10MG N021687 001 Jul 23, 2004

AB + 10MG;20MG N021687 002 Jul 23, 2004

AB + 10MG;40MG N021687 003 Jul 23, 2004

AB +! 10MG;80MG N021687 004 Jul 23, 2004



FAMCICLOVIR

TABLET;ORAL

FAMCICLOVIR

AB APOTEX 125MG A091480 001 Jul 22, 2011

AB 250MG A091480 002 Jul 22, 2011

AB 500MG A091480 003 Jul 22, 2011

AB AUROBINDO PHARMA 125MG A091114 001 Mar 21, 2011

LTD

AB 250MG A091114 002 Mar 21, 2011

AB 500MG A091114 003 Mar 21, 2011

AB CIPLA 125MG A078278 001 Mar 21, 2011

AB 250MG A078278 002 Mar 21, 2011

AB 500MG A078278 003 Mar 21, 2011

AB HETERO LABS LTD V 125MG A202438 001 Sep 10, 2014

AB 250MG A202438 002 Sep 10, 2014

AB 500MG A202438 003 Sep 10, 2014

AB MACLEODS PHARMS LTD 125MG A201022 001 Jan 12, 2012

AB 250MG A201022 002 Jan 12, 2012

AB 500MG A201022 003 Jan 12, 2012

AB MYLAN 125MG A201333 001 Mar 24, 2011

AB 250MG A201333 002 Mar 24, 2011

AB 500MG A201333 003 Mar 24, 2011

AB TEVA PHARMS 125MG A077487 001 Aug 24, 2007

AB 250MG A077487 002 Aug 24, 2007

AB ! 500MG A077487 003 Aug 24, 2007

AB WEST-WARD PHARMS 125MG A090128 001 Mar 21, 2011

INT

AB 250MG A090128 002 Mar 21, 2011

AB 500MG A090128 003 Mar 21, 2011



FAMOTIDINE

FOR SUSPENSION;ORAL

FAMOTIDINE

AB HI-TECH PHARMA CO 40MG/5ML A201995 001 May 30, 2014

AB LUPIN LTD 40MG/5ML A090440 001 Jun 29, 2010

AB NAVINTA LLC 40MG/5ML A091020 001 May 27, 2010

AB NOVEL LABS INC 40MG/5ML A201695 001 Dec 17, 2012

PEPCID

AB +! SALIX PHARMS 40MG/5ML N019527 001 Feb 02, 1987

INJECTABLE;INJECTION

FAMOTIDINE

AP ATHENEX INC 10MG/ML A075651 001 Apr 16, 2001

AP 10MG/ML A075684 001 Apr 16, 2001

AP FRESENIUS KABI USA 10MG/ML A075709 001 Apr 16, 2001

AP MYLAN LABS LTD 10MG/ML A078641 001 Jun 25, 2008

AP ! WEST-WARD PHARMS 10MG/ML A075488 001 Apr 16, 2001

INT

FAMOTIDINE PRESERVATIVE FREE

AP ATHENEX INC 10MG/ML A075622 001 Apr 16, 2001

AP 10MG/ML A075825 001 Apr 17, 2001

AP FRESENIUS KABI USA 10MG/ML A075813 001 Apr 16, 2001

AP MYLAN LABS LTD 10MG/ML A078642 001 Jun 25, 2008

AP ! WEST-WARD PHARMS 10MG/ML A075486 001 Apr 16, 2001

INT

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

! BAXTER HLTHCARE 0.4MG/ML A075591 001 May 10, 2001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-182(of 452)

FAMOTIDINE

TABLET;ORAL

FAMOTIDINE

AB ALEMBIC PHARMS LTD 20MG A078916 001 May 22, 2009

AB 40MG A078916 002 May 22, 2009

AB APOTEX 20MG A075611 001 Jul 23, 2001

AB 40MG A075611 002 Jul 23, 2001

AB AUROBINDO PHARMA 20MG A206530 001 Dec 22, 2015

LTD

AB 40MG A206530 002 Dec 22, 2015

AB CARLSBAD 20MG A075805 001 Apr 16, 2001

AB 40MG A075805 002 Apr 16, 2001

AB DR REDDYS LABS LTD 20MG A075718 001 Apr 16, 2001

AB 40MG A075718 002 Apr 16, 2001

AB IVAX SUB TEVA 20MG A075511 001 Apr 16, 2001

PHARMS

AB 40MG A075511 002 Apr 16, 2001

AB MYLAN 20MG A075704 001 Apr 16, 2001

AB 40MG A075704 002 Apr 16, 2001

AB PERRIGO R AND D 20MG A077352 002 Jul 27, 2005

AB 40MG A077352 001 Jul 27, 2005

AB TEVA 20MG A075311 001 Apr 16, 2001

AB 40MG A075311 002 Apr 16, 2001

AB WOCKHARDT LTD 20MG A075786 001 Apr 16, 2001

AB 40MG A075786 002 Apr 16, 2001

PEPCID

AB + VALEANT PHARMS 20MG N019462 001 Oct 15, 1986

NORTH

AB +! 40MG N019462 002 Oct 15, 1986

FAMOTIDINE; IBUPROFEN

TABLET;ORAL

DUEXIS

+! HORIZON 26.6MG;800MG N022519 001 Apr 23, 2011

FEBUXOSTAT

TABLET;ORAL

ULORIC

+ TAKEDA PHARMS USA 40MG N021856 001 Feb 13, 2009

+! 80MG N021856 002 Feb 13, 2009

FELBAMATE

SUSPENSION;ORAL

FELBAMATE

AB AMNEAL PHARMS 600MG/5ML A202385 001 Dec 16, 2011

AB TARO PHARM 600MG/5ML A206314 001 Jun 16, 2017

FELBATOL

AB +! MYLAN SPECIALITY LP 600MG/5ML N020189 003 Jul 29, 1993

TABLET;ORAL

FELBAMATE

AB ALVOGEN MALTA 400MG A204595 001 Jan 11, 2016

AB 600MG A204595 002 Jan 11, 2016

AB AMNEAL PHARMS 400MG A201680 001 Sep 13, 2011

AB 600MG A201680 002 Sep 13, 2011

AB ANI PHARMS INC 400MG A202284 001 Nov 04, 2015

AB 600MG A202284 002 Nov 04, 2015

AB TARO PHARM 400MG A207093 001 Apr 20, 2017

AB 600MG A207093 002 Apr 20, 2017

AB ZYDUS PHARMS USA 400MG A208970 001 May 30, 2017

INC

AB 600MG A208970 002 May 30, 2017

FELBATOL

AB + MYLAN SPECIALITY LP 400MG N020189 001 Jul 29, 1993

AB +! 600MG N020189 002 Jul 29, 1993



FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

AB AUROBINDO PHARMA 2.5MG A203417 001 Jan 17, 2013

LTD

AB 5MG A203417 002 Jan 17, 2013

AB 10MG A203417 003 Jan 17, 2013

AB GLENMARK GENERICS 2.5MG A090365 001 Dec 17, 2010

AB 5MG A090365 002 Dec 17, 2010

AB 10MG A090365 003 Dec 17, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-183(of 452)

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

AB HERITAGE PHARMS INC 2.5MG A201964 001 Nov 08, 2013

AB 5MG A201964 002 Nov 08, 2013

AB 10MG A201964 003 Nov 08, 2013

AB JUBILANT GENERICS 2.5MG A203983 001 Aug 19, 2016

AB 5MG A203983 002 Aug 19, 2016

AB 10MG A203983 003 Aug 19, 2016

AB MYLAN 2.5MG A078855 001 Apr 17, 2008

AB 5MG A078855 002 Apr 17, 2008

AB ! 10MG A078855 003 Apr 17, 2008

AB ORCHID HLTHCARE 2.5MG A203032 001 May 21, 2015

AB 5MG A203032 002 May 21, 2015

AB 10MG A203032 003 May 21, 2015

AB SUN PHARM INDS LTD 2.5MG A091200 001 Dec 13, 2013

AB 5MG A091200 002 Dec 13, 2013

AB 10MG A091200 003 Dec 13, 2013

AB SUN PHARM 2.5MG A075896 001 Nov 02, 2004

INDUSTRIES

AB 5MG A075896 002 Nov 02, 2004

AB 10MG A075896 003 Nov 02, 2004

AB TORRENT PHARMS LTD 2.5MG A202170 001 Nov 28, 2011

AB 5MG A202170 002 Nov 28, 2011

AB 10MG A202170 003 Nov 28, 2011

AB VINTAGE PHARMS LLC 2.5MG A200815 001 Oct 28, 2011

AB 5MG A200815 002 Oct 28, 2011

AB 10MG A200815 003 Oct 28, 2011

AB YILING PHARM LTD 2.5MG A210847 001 Oct 26, 2018

AB 5MG A210847 002 Oct 26, 2018

AB 10MG A210847 003 Oct 26, 2018



FENOFIBRATE

CAPSULE;ORAL

ANTARA (MICRONIZED)

AB + LUPIN ATLANTIS 43MG N021695 001 Nov 30, 2004

AB +! 130MG N021695 003 Nov 30, 2004

FENOFIBRATE

AB SUN PHARM INDS LTD 43MG A201748 001 Oct 31, 2014

AB 130MG A201748 002 Oct 31, 2014

FENOFIBRATE (MICRONIZED)

AB AJANTA PHARMA LTD 67MG A210705 001 Sep 10, 2018

AB 134MG A210705 002 Sep 10, 2018

AB 200MG A210705 003 Sep 10, 2018

AB AMERIGEN PHARMS LTD 67MG A209504 001 Apr 30, 2018

AB 134MG A209504 002 Apr 30, 2018

AB 200MG A209504 003 Apr 30, 2018

AB APOTEX INC 43MG A202252 001 Jul 26, 2013

AB 130MG A202252 002 Jul 26, 2013

AB CNTY LINE PHARMS 67MG A207805 001 Nov 16, 2017

AB 134MG A207805 002 Nov 16, 2017

AB 200MG A207805 003 Nov 16, 2017

AB DR REDDYS LABS SA 43MG A090859 001 Mar 01, 2012

AB 130MG A090859 002 Mar 01, 2012

AB GLENMARK PHARMS LTD 67MG A205566 001 Apr 07, 2017

AB 134MG A205566 002 Apr 07, 2017

AB 200MG A205566 003 Apr 07, 2017

AB IMPAX LABS 67MG A075868 001 Oct 27, 2003

AB 134MG A075868 002 Oct 27, 2003

AB ! 200MG A075868 003 Oct 27, 2003

AB INVAGEN PHARMS 67MG A207378 001 Mar 28, 2017

AB 134MG A207378 002 Mar 28, 2017

AB 200MG A207378 003 Mar 28, 2017

AB MYLAN PHARMS INC 43MG A202579 001 Jan 10, 2013

AB 67MG A202676 001 Oct 23, 2012

AB 130MG A202579 002 Jan 10, 2013

AB 134MG A202676 002 Oct 23, 2012

AB 200MG A202676 003 Oct 23, 2012

AB RHODES PHARMS 67MG A075753 001 Sep 03, 2002

AB 134MG A075753 002 Apr 09, 2002

AB 200MG A075753 003 Apr 09, 2002

AB TORRENT PHARMS LTD 67MG A210782 001 Jun 26, 2018

AB 134MG A210782 002 Jun 26, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-184(of 452)

FENOFIBRATE

CAPSULE;ORAL

FENOFIBRATE (MICRONIZED)

AB 200MG A210782 003 Jun 26, 2018



ANTARA (MICRONIZED)

+ LUPIN ATLANTIS 30MG N021695 004 Oct 18, 2013



+ 90MG N021695 005 Oct 18, 2013

LIPOFEN

+ CIPHER PHARMS INC 50MG N021612 001 Jan 11, 2006

+! 150MG N021612 003 Jan 11, 2006

TABLET;ORAL

FENOFIBRATE

AB AJANTA PHARMA LTD 54MG A210138 001 Jul 23, 2018

AB 160MG A210138 002 Jul 23, 2018

AB AMNEAL PHARMS LLC 48MG A209951 001 Feb 09, 2018

AB 54MG A209950 001 Mar 19, 2018

AB 145MG A209951 002 Feb 09, 2018

AB 160MG A209950 002 Mar 19, 2018

AB AUROBINDO PHARMA 48MG A205118 001 May 05, 2016

LTD

AB 145MG A205118 002 May 05, 2016

AB CIPLA 48MG A208709 001 Dec 15, 2016

AB 145MG A208709 002 Dec 15, 2016

AB CNTY LINE PHARMS 54MG A207803 001 Dec 19, 2017

AB 160MG A207803 002 Dec 19, 2017

AB GRAVITI PHARMS 54MG A210606 001 Aug 17, 2018

AB 160MG A210606 002 Aug 17, 2018

AB HETERO LABS LTD III 48MG A204598 001 Jul 12, 2016

AB 145MG A204598 002 Jul 12, 2016

AB IMPAX LABS 54MG A076509 001 Mar 26, 2008

AB ! 160MG A076509 002 Mar 26, 2008

AB LUPIN LTD 48MG A090856 001 Dec 23, 2011

AB 54MG A204019 001 Aug 17, 2015

AB 145MG A090856 002 Dec 23, 2011

AB 160MG A204019 002 Aug 17, 2015

AB MYLAN 40MG A204475 001 Jun 23, 2016

AB 54MG A076520 001 Oct 25, 2007

AB 120MG A204475 002 Jun 23, 2016

AB 160MG A076520 003 Oct 25, 2007

AB MYLAN PHARMS INC 48MG A202856 001 Dec 07, 2012

AB 145MG A202856 002 Dec 07, 2012

AB PRINSTON INC 48MG A211080 001 Aug 28, 2018

AB 145MG A211080 002 Aug 28, 2018

AB RHODES PHARMS 54MG A076433 001 May 13, 2005

AB 160MG A076433 002 May 13, 2005

AB SUN PHARM INDS LTD 48MG A200884 001 Sep 07, 2017

AB 54MG A076635 001 Oct 31, 2005

AB 145MG A200884 002 Sep 07, 2017

AB 160MG A076635 003 Oct 31, 2005

AB VALEANT PHARMS 48MG A090715 001 Apr 05, 2012

NORTH

AB 145MG A090715 002 Apr 05, 2012

FENOGLIDE

AB + SANTARUS INC 40MG N022118 001 Aug 10, 2007

AB +! 120MG N022118 002 Aug 10, 2007

TRICOR

AB + ABBVIE 48MG N021656 001 Nov 05, 2004

AB +! 145MG N021656 002 Nov 05, 2004



TRIGLIDE

BX +! SKYEPHARMA AG 160MG N021350 002 May 07, 2005

FENOFIBRATE

SUN PHARM INDS LTD 107MG A076635 002 Oct 31, 2005

FENOFIBRIC ACID
TABLET;ORAL
FIBRICOR
+ ARALEZ PHARMS INC 35MG N022418 001 Aug 14, 2009
+! 105MG N022418 002 Aug 14, 2009
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-185(of 452)

FENOLDOPAM MESYLATE

INJECTABLE;INJECTION

CORLOPAM

AP +! HOSPIRA EQ 10MG BASE/ML N019922 001 Sep 23, 1997

FENOLDOPAM MESYLATE

AP SANDOZ INC EQ 10MG BASE/ML A077155 001 Feb 15, 2005

AP WEST-WARD PHARMS EQ 10MG BASE/ML A076582 001 Oct 12, 2004

INT

FENOPROFEN CALCIUM

CAPSULE;ORAL

NALFON

+ XSPIRE PHARMA EQ 200MG BASE N017604 003

+! EQ 400MG BASE N017604 004 Jul 21, 2009

TABLET;ORAL

FENOPROFEN CALCIUM

! XSPIRE PHARMA EQ 600MG BASE A072267 001 Aug 17, 1988

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

DURAGESIC-100

AB + JANSSEN PHARMS 100MCG/HR N019813 001 Aug 07, 1990

DURAGESIC-12

AB + JANSSEN PHARMS 12.5MCG/HR N019813 005 Feb 04, 2005

DURAGESIC-25

AB +! JANSSEN PHARMS 25MCG/HR N019813 004 Aug 07, 1990

DURAGESIC-37

AB + JANSSEN PHARMS 37.5MCG/HR N019813 006 Jan 24, 2018

DURAGESIC-50

AB + JANSSEN PHARMS 50MCG/HR N019813 003 Aug 07, 1990

DURAGESIC-75

AB + JANSSEN PHARMS 75MCG/HR N019813 002 Aug 07, 1990

FENTANYL-100

AB 3M DRUG DELIVERY 100MCG/HR A202097 005 Nov 04, 2016

AB AVEVA 100MCG/HR A077449 004 Oct 20, 2008

AB LAVIPHARM LABS 100MCG/HR A077051 004 Aug 04, 2006

AB MAYNE PHARMA 100MCG/HR A077062 004 Aug 20, 2007

AB MYLAN TECHNOLOGIES 100MCG/HR A076258 004 Jan 28, 2005

AB SPECGX LLC 100MCG/HR A077154 004 Feb 09, 2011

FENTANYL-12

AB 3M DRUG DELIVERY 12.5MCG/HR A202097 001 Nov 04, 2016

AB AVEVA 12.5MCG/HR A077449 005 Sep 11, 2015

AB MYLAN TECHNOLOGIES 12.5MCG/HR A076258 005 Jan 23, 2007

AB SPECGX LLC 12.5MCG/HR A077154 005 Jun 11, 2015

FENTANYL-25

AB 3M DRUG DELIVERY 25MCG/HR A202097 002 Nov 04, 2016

AB AVEVA 25MCG/HR A077449 001 Oct 20, 2008

AB LAVIPHARM LABS 25MCG/HR A077051 001 Aug 04, 2006

AB MAYNE PHARMA 25MCG/HR A077062 001 Aug 20, 2007

AB MYLAN TECHNOLOGIES 25MCG/HR A076258 001 Jan 28, 2005

AB SPECGX LLC 25MCG/HR A077154 001 Feb 09, 2011

FENTANYL-37

AB AVEVA 37.5MCG/HR A077449 006 Dec 06, 2017

AB MYLAN TECHNOLOGIES 37.5MCG/HR A076258 006 Dec 29, 2014

FENTANYL-50

AB 3M DRUG DELIVERY 50MCG/HR A202097 003 Nov 04, 2016

AB AVEVA 50MCG/HR A077449 002 Oct 20, 2008

AB LAVIPHARM LABS 50MCG/HR A077051 002 Aug 04, 2006

AB MAYNE PHARMA 50MCG/HR A077062 002 Aug 20, 2007

AB MYLAN TECHNOLOGIES 50MCG/HR A076258 002 Jan 28, 2005

AB SPECGX LLC 50MCG/HR A077154 002 Feb 09, 2011

FENTANYL-62

AB AVEVA 62.5MCG/HR A077449 007 Dec 06, 2017

FENTANYL-75

AB 3M DRUG DELIVERY 75MCG/HR A202097 004 Nov 04, 2016

AB AVEVA 75MCG/HR A077449 003 Oct 20, 2008

AB LAVIPHARM LABS 75MCG/HR A077051 003 Aug 04, 2006

AB MAYNE PHARMA 75MCG/HR A077062 003 Aug 20, 2007

AB MYLAN TECHNOLOGIES 75MCG/HR A076258 003 Jan 28, 2005

AB SPECGX LLC 75MCG/HR A077154 003 Feb 09, 2011

FENTANYL-87

AB AVEVA 87.5MCG/HR A077449 008 Dec 06, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-186(of 452)

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-62

MYLAN TECHNOLOGIES 62.5MCG/HR A076258 007 Dec 29, 2014

FENTANYL-87

MYLAN TECHNOLOGIES 87.5MCG/HR A076258 008 Dec 29, 2014

SPRAY;SUBLINGUAL

SUBSYS

+ INSYS DEV CO INC 0.1MG N202788 001 Jan 04, 2012

+ 0.2MG N202788 002 Jan 04, 2012

+! 0.4MG N202788 003 Jan 04, 2012

+ 0.6MG N202788 004 Jan 04, 2012

+ 0.8MG N202788 005 Jan 04, 2012

+ 1.2MG N202788 006 Aug 30, 2012

+ 1.6MG N202788 007 Aug 30, 2012



FENTANYL CITRATE

INJECTABLE;INJECTION

FENTANYL CITRATE

AP HOSPIRA EQ 0.05MG BASE/ML N019115 001 Jan 12, 1985

FENTANYL CITRATE PRESERVATIVE FREE



AP HOSPIRA EQ 0.05MG BASE/ML A072786 001 Sep 24, 1991

AP +! WEST-WARD PHARMS EQ 0.05MG BASE/ML N019101 001 Jul 11, 1984

INT

SUBLIMAZE PRESERVATIVE FREE

AP +! AKORN EQ 0.05MG BASE/ML N016619 001

SPRAY, METERED;NASAL

LAZANDA

+ ELEFSEE PHARMS INTL EQ 0.1MG BASE N022569 001 Jun 30, 2011

+ EQ 0.3MG BASE N022569 003 Dec 21, 2015

+! EQ 0.4MG BASE N022569 002 Jun 30, 2011

TABLET;BUCCAL, SUBLINGUAL

FENTORA

+ CEPHALON EQ 0.1MG BASE N021947 001 Sep 25, 2006

+ EQ 0.2MG BASE N021947 002 Sep 25, 2006

+! EQ 0.4MG BASE N021947 003 Sep 25, 2006

+ EQ 0.6MG BASE N021947 004 Sep 25, 2006

+ EQ 0.8MG BASE N021947 005 Sep 25, 2006

TABLET;SUBLINGUAL

ABSTRAL

AB + SENTYNL THERAPS INC EQ 0.1MG BASE N022510 001 Jan 07, 2011

AB + EQ 0.2MG BASE N022510 002 Jan 07, 2011

AB + EQ 0.3MG BASE N022510 003 Jan 07, 2011

AB +! EQ 0.4MG BASE N022510 004 Jan 07, 2011

AB + EQ 0.6MG BASE N022510 005 Jan 07, 2011

AB + EQ 0.8MG BASE N022510 006 Jan 07, 2011

FENTANYL CITRATE

AB ACTAVIS LABS FL INC EQ 0.1MG BASE A207338 001 Nov 17, 2017

AB EQ 0.2MG BASE A207338 002 Nov 17, 2017

AB EQ 0.3MG BASE A207338 003 Nov 17, 2017

AB EQ 0.4MG BASE A207338 004 Nov 17, 2017

AB EQ 0.6MG BASE A207338 005 Nov 17, 2017

AB EQ 0.8MG BASE A207338 006 Nov 17, 2017



TROCHE/LOZENGE;TRANSMUCOSAL

ACTIQ

AB + CEPHALON EQ 0.2MG BASE N020747 001 Nov 04, 1998

AB +! EQ 0.4MG BASE N020747 002 Nov 04, 1998

AB + EQ 0.6MG BASE N020747 003 Nov 04, 1998

AB + EQ 0.8MG BASE N020747 004 Nov 04, 1998

AB + EQ 1.2MG BASE N020747 005 Nov 04, 1998

AB + EQ 1.6MG BASE N020747 006 Nov 04, 1998

FENTANYL CITRATE

AB SPECGX LLC EQ 0.2MG BASE A078907 001 Oct 30, 2009

AB EQ 0.4MG BASE A078907 002 Oct 30, 2009

AB EQ 0.6MG BASE A078907 003 Oct 30, 2009

AB EQ 0.8MG BASE A078907 004 Oct 30, 2009

AB EQ 1.2MG BASE A078907 005 Oct 30, 2009

AB EQ 1.6MG BASE A078907 006 Oct 30, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-187(of 452)

FERRIC CARBOXYMALTOSE

INJECTABLE;INTRAVENOUS

INJECTAFER

+! LUITPOLD 750MG IRON/15ML (50MG IRON/ML) N203565 001 Jul 25, 2013

FERRIC CITRATE

TABLET;ORAL

AURYXIA

+! KERYX BIOPHARMS EQ 210MG IRON N205874 001 Sep 05, 2014

FERRIC HEXACYANOFERRATE(II)

CAPSULE;ORAL

RADIOGARDASE (PRUSSIAN BLUE)

+! HEYL CHEMISCH 500MG N021626 001 Oct 02, 2003



FERRIC PYROPHOSPHATE CITRATE

FOR SOLUTION;INTRAVENOUS

TRIFERIC

+! ROCKWELL MEDICAL 272MG IRON/PACKET N208551 001 Apr 25, 2016

INC

SOLUTION;INTRAVENOUS

TRIFERIC

+! ROCKWELL MEDICAL 27.2MG IRON/5ML (5.44MG IRON/ML) N206317 001 Jan 23, 2015

INC

FERUMOXYTOL

SOLUTION;INTRAVENOUS

FERAHEME

+! AMAG PHARMS INC EQ 510MG IRON/17ML (EQ 30MG IRON/ML) N022180 001 Jun 30, 2009

FESOTERODINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

FESOTERODINE FUMARATE

AB AUROBINDO PHARMA 4MG A205007 001 Feb 17, 2017

LTD

AB 8MG A205007 002 Feb 17, 2017

AB ZYDUS PHARMS USA 4MG A204946 001 Oct 03, 2017

INC

AB 8MG A204946 002 Oct 03, 2017

TOVIAZ

AB + PFIZER 4MG N022030 001 Oct 31, 2008

AB +! 8MG N022030 002 Oct 31, 2008



FEXOFENADINE HYDROCHLORIDE

TABLET;ORAL

FEXOFENADINE HYDROCHLORIDE

AB BARR 30MG A076191 001 Aug 31, 2005

AB 60MG A076191 002 Aug 31, 2005

AB 180MG A076191 003 Aug 31, 2005

AB DR REDDYS LABS LTD 30MG A076502 001 Apr 11, 2006

AB 60MG A076502 002 Apr 11, 2006

AB 180MG A076502 003 Apr 11, 2006

AB MYLAN 30MG A077081 002 Apr 11, 2008

AB 60MG A077081 003 Apr 11, 2008

AB 180MG A077081 001 Apr 16, 2007

AB TEVA 30MG A076447 001 Sep 01, 2005

AB 60MG A076447 002 Sep 01, 2005

AB 180MG A076447 003 Sep 01, 2005



FIDAXOMICIN

TABLET;ORAL

DIFICID

+! CUBIST PHARMS LLC 200MG N201699 001 May 27, 2011

FINAFLOXACIN

SUSPENSION/DROPS;OTIC

XTORO

+! MERLION PHARMS GMBH 0.3% N206307 001 Dec 17, 2014

FINASTERIDE

TABLET;ORAL

FINASTERIDE

AB ACCORD HLTHCARE 1MG A091643 001 Nov 05, 2013

AB 5MG A090121 001 Feb 23, 2010

AB ACTAVIS TOTOWA 1MG A078371 001 Nov 05, 2013

AB ACTAVIS TOTOWA TEVA 5MG A077914 001 Mar 28, 2007

AB ALKEM LABS LTD 1MG A207750 001 Jan 06, 2017

AB 5MG A204304 001 Jan 05, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-188(of 452)

FINASTERIDE

TABLET;ORAL

FINASTERIDE

AB AUROBINDO PHARMA 5MG A078341 001 Oct 30, 2007

AB AUROBINDO PHARMA 1MG A203687 001 Nov 05, 2013

LTD

AB CIPLA 1MG A077335 001 Nov 20, 2014

AB DR REDDYS LABS INC 1MG A076436 001 Jul 28, 2006

AB DR REDDYS LABS LTD 5MG A076437 001 Feb 28, 2007

AB HETERO LABS LTD III 1MG A090060 001 Jul 01, 2013

AB 5MG A090061 001 Jun 07, 2010

AB MYLAN 5MG A077578 001 Dec 18, 2006

AB SUN PHARMA GLOBAL 1MG A090508 001 Jul 01, 2013

AB 5MG A090507 001 Aug 16, 2011

AB TEVA 1MG A076905 001 Nov 05, 2013

AB 5MG A076511 001 Dec 15, 2006

AB ZYDUS PHARMS USA 5MG A078900 001 Dec 28, 2009

INC

PROPECIA

AB +! MERCK 1MG N020788 001 Dec 19, 1997

PROSCAR

AB +! MERCK 5MG N020180 001 Jun 19, 1992

FINGOLIMOD HYDROCHLORIDE

CAPSULE;ORAL

GILENYA

+ NOVARTIS EQ 0.25MG BASE N022527 002 May 11, 2018

+! EQ 0.5MG BASE N022527 001 Sep 21, 2010



FISH OIL TRIGLYCERIDES

EMULSION;INTRAVENOUS

OMEGAVEN

+! FRESENIUS KABI USA 5GM/50ML (0.1GM/ML) N210589 001 Jul 27, 2018

+! 10GM/100ML (0.1GM/ML) N210589 002 Jul 27, 2018

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

EMULSION;INTRAVENOUS

SMOFLIPID 20%

+! FRESENIUS KABI USA 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML N207648 001 Jul 13, 2016

(100ML)

+! 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML N207648 002 Jul 13, 2016

(250ML)

+! 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML N207648 003 Jul 13, 2016

(500ML)

+! 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML N207648 004 Aug 10, 2018

(1000ML)

FLAVOXATE HYDROCHLORIDE

TABLET;ORAL

FLAVOXATE HYDROCHLORIDE

AB EPIC PHARMA 100MG A076835 001 Nov 30, 2005

AB ! PADDOCK LLC 100MG A076831 001 Dec 16, 2004



FLECAINIDE ACETATE

TABLET;ORAL

FLECAINIDE ACETATE

AB AMNEAL PHARM 50MG A075442 001 Jul 31, 2001

AB 100MG A075442 002 Jul 31, 2001

AB 150MG A075442 003 Jul 31, 2001

AB ANI PHARMS INC 50MG A075882 001 Oct 28, 2002

AB 100MG A075882 002 Oct 28, 2002

AB 150MG A075882 003 Oct 28, 2002

AB AUROBINDO PHARMA 50MG A202821 001 Nov 03, 2017

LTD

AB 100MG A202821 002 Nov 03, 2017

AB 150MG A202821 003 Nov 03, 2017

AB SUN PHARM INDS LTD 50MG A076421 001 Mar 28, 2003

AB 100MG A076421 002 Mar 28, 2003

AB 150MG A076421 003 Mar 28, 2003

AB WEST-WARD PHARMS 50MG A076278 001 Jan 14, 2003

INT

AB 100MG A076278 002 Jan 14, 2003

AB ! 150MG A076278 003 Jan 14, 2003

TAMBOCOR

AB + CNTY LINE PHARMS 50MG N018830 004 Aug 23, 1988

AB + 100MG N018830 001 Oct 31, 1985



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-189(of 452)

FLECAINIDE ACETATE

TABLET;ORAL

TAMBOCOR

AB + 150MG N018830 003 Jun 03, 1988

FLIBANSERIN

TABLET;ORAL

ADDYI

+! SPROUT PHARMS 100MG N022526 001 Aug 18, 2015

FLORBETABEN F-18

SOLUTION;INTRAVENOUS

NEURACEQ

+! LIFE MOLECULAR 30ML (1.4-135mCi/ML) N204677 001 Mar 19, 2014

FLORBETAPIR F-18

SOLUTION;INTRAVENOUS

AMYVID

+! AVID RADIOPHARMS 10-30ML (13.5-51mCi/ML) N202008 002 Apr 06, 2012

INC

+! 10-50ML (13.5-51mCi/ML) N202008 003 Apr 06, 2012

FLOXURIDINE

INJECTABLE;INJECTION

FLOXURIDINE

AP FRESENIUS KABI USA 500MG/VIAL A075837 001 Feb 22, 2001

AP LUITPOLD 500MG/VIAL A203008 001 Nov 22, 2017

AP ! WEST-WARD PHARMS 500MG/VIAL A075387 001 Apr 16, 2000

INT

FLUCICLOVINE F-18

SOLUTION;INTRAVENOUS

AXUMIN

+! BLUE EARTH 9-221mCi/ML N208054 001 May 27, 2016

FLUCONAZOLE

FOR SUSPENSION;ORAL

DIFLUCAN

AB + PFIZER 50MG/5ML N020090 001 Dec 23, 1993

AB +! 200MG/5ML N020090 002 Dec 23, 1993

FLUCONAZOLE

AB AUROBINDO PHARMA 50MG/5ML A079150 001 Sep 18, 2009

LTD

AB 200MG/5ML A079150 002 Sep 18, 2009

AB IVAX SUB TEVA 50MG/5ML A077523 001 Sep 12, 2007

PHARMS

AB 200MG/5ML A077523 002 Sep 12, 2007

AB WEST-WARD PHARMS 50MG/5ML A076246 001 Jul 29, 2004

INT

AB 200MG/5ML A076246 002 Jul 29, 2004

INJECTABLE;INJECTION

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER



AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A078764 001 Jan 30, 2012

AP 400MG/200ML (2MG/ML) A078764 002 Jan 30, 2012

AP ! HOSPIRA 200MG/100ML (2MG/ML) A076304 001 Jul 29, 2004

AP ! 400MG/200ML (2MG/ML) A076304 002 Jul 29, 2004

AP RENAISSANCE SSA LLC 200MG/100ML (2MG/ML) A077988 001 May 26, 2010

AP 400MG/200ML (2MG/ML) A077988 002 May 26, 2010

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%



AP BAXTER HLTHCARE 200MG/100ML (2MG/ML) A077947 001 May 26, 2010

CORP

AP 400MG/200ML (2MG/ML) A077947 002 May 26, 2010

AP FRESENIUS KABI USA 200MG/100ML (2MG/ML) A076145 001 Jul 29, 2004

AP 400MG/200ML (2MG/ML) A076145 002 Jul 29, 2004

AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A076736 001 Aug 23, 2005

AP WEST-WARD PHARMS 200MG/100ML (2MG/ML) A076087 001 Jul 29, 2004

INT

AP 400MG/200ML (2MG/ML) A076087 003 Jul 29, 2004

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP BAXTER HLTHCARE 200MG/100ML (2MG/ML) A076766 001 Jul 29, 2004

AP 400MG/200ML (2MG/ML) A076766 002 Jul 29, 2004

AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A078698 001 Jan 30, 2012

AP 400MG/200ML (2MG/ML) A078698 002 Jan 30, 2012

AP HOSPIRA 200MG/100ML (2MG/ML) A076303 001 Jul 29, 2004

AP 400MG/200ML (2MG/ML) A076303 002 Jul 29, 2004

AP ! INFORLIFE 200MG/100ML (2MG/ML) A079104 001 Jul 30, 2009

AP ! 400MG/200ML (2MG/ML) A079104 002 Jul 30, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-190(of 452)

FLUCONAZOLE

INJECTABLE;INJECTION

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP RENAISSANCE SSA LLC 200MG/100ML (2MG/ML) A077909 001 May 26, 2010

AP 400MG/200ML (2MG/ML) A077909 002 May 26, 2010

AP WEST-WARD PHARMS 200MG/100ML (2MG/ML) A078107 001 Jul 30, 2008

INT

AP 400MG/200ML (2MG/ML) A078107 002 Jul 30, 2008

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

WEST-WARD PHARMS 100MG/50ML (2MG/ML) A076087 002 Sep 26, 2008

INT

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

RENAISSANCE SSA LLC 100MG/50ML (2MG/ML) A077909 003 Apr 20, 2015

TABLET;ORAL

DIFLUCAN

AB + PFIZER 50MG N019949 001 Jan 29, 1990

AB + 100MG N019949 002 Jan 29, 1990

AB + 150MG N019949 004 Jun 30, 1994

AB +! 200MG N019949 003 Jan 29, 1990

FLUCONAZOLE

AB APOTEX 50MG A076665 001 Jul 29, 2004

AB 100MG A076665 002 Jul 29, 2004

AB 150MG A076665 003 Jul 29, 2004

AB 200MG A076665 004 Jul 29, 2004

AB AUROBINDO PHARMA 50MG A077731 001 Oct 07, 2008

AB 100MG A077731 002 Oct 07, 2008

AB 150MG A077731 003 Oct 07, 2008

AB 200MG A077731 004 Oct 07, 2008

AB DR REDDYS LABS INC 50MG A076658 001 Jul 29, 2004

AB 100MG A076658 002 Jul 29, 2004

AB 150MG A076658 003 Jul 29, 2004

AB 200MG A076658 004 Jul 29, 2004

AB GLENMARK GENERICS 50MG A077253 001 Jan 25, 2006

AB 100MG A077253 002 Jan 25, 2006

AB 150MG A077253 003 Jan 25, 2006

AB 200MG A077253 004 Jan 25, 2006

AB HARRIS PHARM 50MG A078423 001 Mar 07, 2011

AB 100MG A078423 002 Mar 07, 2011

AB 150MG A078423 003 Mar 07, 2011

AB 200MG A078423 004 Mar 07, 2011

AB IVAX SUB TEVA 50MG A076077 001 Jul 29, 2004

PHARMS

AB 100MG A076077 002 Jul 29, 2004

AB 150MG A076077 003 Jul 29, 2004

AB 200MG A076077 004 Jul 29, 2004

AB MYLAN 50MG A076351 001 Jul 29, 2004

AB 100MG A076351 002 Jul 29, 2004

AB 150MG A076351 003 Jul 29, 2004

AB 200MG A076351 004 Jul 29, 2004

AB TARO 50MG A076507 001 Jul 29, 2004

AB 100MG A076507 002 Jul 29, 2004

AB 150MG A076507 003 Jul 29, 2004

AB 200MG A076507 004 Jul 29, 2004

AB TEVA 50MG A074681 001 Jul 29, 2004

AB 100MG A074681 002 Jul 29, 2004

AB 150MG A074681 003 Jul 29, 2004

AB 200MG A074681 004 Jul 29, 2004

AB UNIQUE PHARM LABS 50MG A076957 001 Sep 28, 2005

AB 100MG A076957 002 Sep 28, 2005

AB 150MG A076957 004 Feb 27, 2017

AB 200MG A076957 003 Sep 28, 2005

AB ZYDUS PHARMS USA 50MG A208963 001 Feb 16, 2017

INC

AB 100MG A208963 002 Feb 16, 2017

AB 150MG A208963 003 Feb 16, 2017

AB 200MG A208963 004 Feb 16, 2017



FLUCYTOSINE

CAPSULE;ORAL

ANCOBON

AB + VALEANT 250MG N017001 001

AB +! 500MG N017001 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-191(of 452)

FLUCYTOSINE

CAPSULE;ORAL

FLUCYTOSINE

AB NOVEL LABS INC 250MG A204652 001 Jul 07, 2017

AB 500MG A204652 002 Jul 07, 2017

AB RECIPHARM 250MG A207536 001 Jun 18, 2018

AB 500MG A207536 002 Jun 18, 2018

AB SIGMAPHARM LABS LLC 250MG A201566 001 Jun 28, 2011

AB 500MG A201566 002 Jun 28, 2011

AB WEST-WARD PHARMS 250MG A206550 001 Oct 17, 2017

INT

AB 500MG A206550 002 Oct 17, 2017

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARABINE PHOSPHATE

AP ACTAVIS LLC 50MG/2ML (25MG/ML) A203738 001 Feb 28, 2017

AP ACTAVIS TOTOWA 50MG/VIAL A078610 001 Feb 11, 2009

AP AREVA PHARMS 50MG/2ML (25MG/ML) A090724 001 Sep 27, 2010

AP CUSTOPHARM INC 50MG/VIAL A076349 001 Aug 28, 2003

AP ! FRESENIUS KABI USA 50MG/2ML (25MG/ML) A078393 001 Oct 15, 2007

AP 50MG/VIAL A078544 001 Oct 15, 2007

AP ! HOSPIRA 50MG/VIAL A077790 001 Apr 06, 2007

AP MYLAN LABS LTD 50MG/2ML (25MG/ML) A200647 001 Dec 21, 2011

AP 50MG/VIAL A200648 001 Oct 16, 2012

AP SAGENT PHARMS 50MG/2ML (25MG/ML) A076661 001 Apr 28, 2004

AP +! SANDOZ 50MG/2ML (25MG/ML) N022137 001 Sep 21, 2007



FLUDEOXYGLUCOSE F-18

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

AP 3D IMAGING DRUG 20-300mCi/ML A203778 001 Oct 30, 2015

AP BIOMEDCL RES FDN 20-300mCi/ML A203710 001 May 01, 2015

AP 20-300mCi/ML A203837 001 May 01, 2015

AP BRIGHAM WOMENS 20-300mCi/ML A203816 001 Oct 30, 2014

AP CARDINAL HEALTH 414 20-300mCi/ML A203603 001 Nov 13, 2015

AP CHILDRENS HOSP MI 20-300mCi/ML A204385 001 Oct 29, 2014

AP CPDC 20-300mCi/ML A204525 001 Oct 29, 2014

AP ESSENTIAL ISOTOPES 20-300mCi/ML A203946 001 Feb 05, 2014

AP +! FEINSTEIN 20-400mCi/ML N021870 002 Nov 21, 2008

AP GLOBAL ISOTOPES LLC 20-300mCi/ML A204463 001 Oct 21, 2014

AP ! HOUSTON CYCLOTRON 20-500mCi/ML A203665 001 Feb 14, 2013

AP JUBILANT DRAXIMAGE 20-300mCi/ML A203920 001 Jun 23, 2015

AP KETTERING MEDCTR 4-40mCi/ML A204759 001 Oct 27, 2015

AP KREITCHMAN PET CTR 10-100mCi/ML A203942 001 Apr 11, 2016

AP LANTHEUS MEDICAL 20-200mCi/ML A203664 001 Feb 04, 2014

AP MA GENERAL HOSP 20-300mCi/ML A204333 001 Sep 25, 2014

AP MCPRF 20-240mCi/ML A203612 001 Aug 05, 2013

AP MEM SLOAN-KETTERING 20-300mCi/ML A208679 001 Dec 08, 2016

AP METHODIST HOSP RES 20-300mCi/ML A203904 001 Apr 23, 2015

AP MIPS CRF 20-300mCi/ML A204472 001 Sep 11, 2015

AP NCM USA BRONX LLC 20-300mCi/ML A204512 001 Jan 07, 2015

AP ! PETNET 20-200mCi/ML A079086 001 Feb 25, 2011

AP ! QUEEN HAMAMATSU PET 10-100mCi/ML A203771 001 Aug 31, 2015

AP SHERTECH LABS LLC 20-300mCi/ML A204264 001 Dec 18, 2014

AP SOFIE 20-300mCi/ML A203591 001 Aug 31, 2015

AP TRUSTEES UNIV PA 20-200mCi/ML A203801 001 Oct 29, 2014

AP ! UCLA BIOMEDICAL 4-40mCi/ML A203811 001 Jun 27, 2013

AP UCSF RODIOPHARM 20-300mCi/ML A203902 001 May 09, 2014

AP UIHC PET IMAGING 20-300mCi/ML A203990 001 Aug 06, 2014

AP UNIV MICHIGAN 20-300mCi/ML A204531 001 Jul 17, 2015

AP UNIV TX MD ANDERSON 20-300mCi/ML A203246 002 Jan 13, 2014

AP UNIV UTAH CYCLOTRON 20-300mCi/ML A204498 001 Jun 23, 2015

AP WI MEDCL CYCLOTRON 20-500mCi/ML A203709 001 Oct 23, 2013

AP WUSM CYCLOTRON 20-300mCi/ML A203935 001 Feb 05, 2014



HOT SHOTS NM LLC 4-500mCi/ML A203937 001 Oct 30, 2014

NORTHLAND 4-500mCi/ML A203994 001 Feb 04, 2015

PRECISION NUCLEAR 20-500mCi/ML A204546 001 Apr 07, 2015

SPECTRON MRC LLC 4-500mCi/ML A203911 001 Apr 22, 2015

UNIV TX MD ANDERSON 20-150mCi/ML A203246 001 Jan 13, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-192(of 452)

FLUDROCORTISONE ACETATE

TABLET;ORAL

FLUDROCORTISONE ACETATE

AB BARR 0.1MG A040425 001 Jan 21, 2003

AB HIKMA PHARMS 0.1MG A091302 001 Jul 22, 2011

AB ! IMPAX LABS 0.1MG A040431 001 Mar 18, 2002



FLUMAZENIL

INJECTABLE;INJECTION

FLUMAZENIL

AP FRESENIUS KABI USA 0.5MG/5ML (0.1MG/ML) A076955 002 Oct 12, 2004

AP 1MG/10ML (0.1MG/ML) A076955 001 Oct 12, 2004

AP HIKMA FARMACEUTICA 0.5MG/5ML (0.1MG/ML) A078527 001 Mar 23, 2009

AP 1MG/10ML (0.1MG/ML) A078527 002 Mar 23, 2009

AP MYLAN LABS LTD 0.5MG/5ML (0.1MG/ML) A078595 001 May 13, 2008

AP ! 1MG/10ML (0.1MG/ML) A078595 002 May 13, 2008

AP SAGENT PHARMS 0.5MG/5ML (0.1MG/ML) A090584 001 Aug 28, 2012

AP 1MG/10ML (0.1MG/ML) A090584 002 Aug 28, 2012

AP SANDOZ INC 0.5MG/5ML (0.1MG/ML) A077071 001 May 03, 2005

AP 1MG/10ML (0.1MG/ML) A077071 002 May 03, 2005

AP WEST-WARD PHARMS 0.5MG/5ML (0.1MG/ML) A076256 002 Oct 12, 2004

INT

AP 0.5MG/5ML (0.1MG/ML) A076787 002 Oct 12, 2004

AP 1MG/10ML (0.1MG/ML) A076256 001 Oct 12, 2004

AP 1MG/10ML (0.1MG/ML) A076787 001 Oct 12, 2004



FLUNISOLIDE

AEROSOL, METERED;INHALATION

AEROSPAN HFA

+! MYLAN SPECIALITY LP 0.078MG/INH N021247 001 Jan 27, 2006

SPRAY, METERED;NASAL

FLUNISOLIDE

AB ! BAUSCH AND LOMB 0.025MG/SPRAY A074805 001 Feb 20, 2002

AB HI TECH PHARMA CO 0.025MG/SPRAY A077704 001 Aug 03, 2006



FLUOCINOLONE ACETONIDE

CREAM;TOPICAL

FLUOCINOLONE ACETONIDE

AT FOUGERA PHARMS INC 0.01% A088170 001 Dec 16, 1982

AT 0.025% A088169 001 Dec 16, 1982

AT G AND W LABS 0.01% A089526 001 Jul 26, 1988

AT G AND W LABS INC 0.025% A210747 001 Nov 05, 2018

AT TARO 0.025% A087104 001 Apr 27, 1982

SYNALAR

AT +! MEDIMETRIKS PHARMS 0.01% N012787 004

AT +! 0.025% N012787 002

AT +! 0.025% N012787 005

IMPLANT;INTRAVITREAL

ILUVIEN

+! ALIMERA SCIENCES 0.19MG N201923 001 Sep 26, 2014

INC

RETISERT

+! BAUSCH AND LOMB 0.59MG N021737 001 Apr 08, 2005

YUTIQ

+! EYEPOINT PHARMS 0.18MG N210331 001 Oct 12, 2018

OIL;TOPICAL

DERMA-SMOOTHE/FS

AT +! HILL DERMAC 0.01% N019452 001 Feb 03, 1988

AT +! 0.01% N019452 002 Nov 09, 2005

FLUCINOLONE ACETONIDE

AT GLENMARK PHARMS LTD 0.01% A210556 001 Oct 25, 2018

FLUOCINOLONE ACETONIDE

AT AKORN 0.01% A091514 001 Jun 25, 2015

AT IDENTI PHARMS INC 0.01% A201759 001 Oct 17, 2011

AT 0.01% A201764 001 Oct 17, 2011

AT LYNE 0.01% A090982 001 Apr 25, 2016

AT 0.01% A203377 001 Apr 25, 2016

AT PERRIGO ISRAEL 0.01% A202847 001 Aug 09, 2013

AT 0.01% A202848 001 Aug 09, 2013

AT TARO 0.01% A202368 001 May 19, 2016

AT 0.01% A209336 001 May 19, 2016

FLUOCINONIDE ACETONIDE

AT GLENMARK PHARMS LTD 0.01% A210539 001 Oct 26, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-193(of 452)

FLUOCINOLONE ACETONIDE

OIL/DROPS;OTIC

DERMOTIC

AT +! HILL DERMAC 0.01% N019452 003 Nov 09, 2005

FLAC

AT PATRIN PHARMA INC 0.01% A210736 001 Apr 11, 2018

FLUOCINOLONE ACETONIDE

AT AKORN 0.01% A202705 001 Sep 09, 2016

AT IDENTI PHARMS INC 0.01% A091306 001 Oct 17, 2011

AT LYNE 0.01% A203378 001 Apr 25, 2016

AT PERRIGO ISRAEL 0.01% A202849 001 Jul 17, 2017

FLUOCINONIDE ACETONIDE

AT GLENMARK PHARMS LTD 0.01% A211815 001 Dec 14, 2018

OINTMENT;TOPICAL

FLUOCINOLONE ACETONIDE

AT FOUGERA PHARMS INC 0.025% A088168 001 Dec 16, 1982

AT G AND W LABS 0.025% A089524 001 Jul 26, 1988

AT TARO 0.025% A040041 001 Sep 15, 1994

SYNALAR

AT +! MEDIMETRIKS PHARMS 0.025% N013960 001

SHAMPOO;TOPICAL

CAPEX

+! GALDERMA LABS LP 0.01% N020001 001 Aug 27, 1990

SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

AT ACTAVIS LABS UT INC 0.01% A208386 001 Oct 21, 2016

AT FOUGERA PHARMS INC 0.01% A088167 001 Dec 16, 1982

AT GAVIS PHARMS LLC 0.01% A206422 001 Sep 02, 2015

AT TARO 0.01% A089124 001 Sep 11, 1985

SYNALAR

AT +! MEDIMETRIKS PHARMS 0.01% N015296 001

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

CREAM;TOPICAL

TRI-LUMA

+! GALDERMA LABS LP 0.01%;4%;0.05% N021112 001 Jan 18, 2002

FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-SYNALAR

! MEDIMETRIKS PHARMS 0.025%;EQ 3.5MG BASE/GM A060700 001

FLUOCINONIDE

CREAM;TOPICAL

FLUOCINONIDE

AB AMNEAL PHARMS LLC 0.1% A211111 001 Jun 04, 2018

AB FOUGERA PHARMS INC 0.1% A200735 001 Jul 14, 2014

AB GLENMARK GENERICS 0.1% A091282 001 Jul 14, 2014

AB PERRIGO ISRAEL 0.1% A090256 001 Jan 14, 2014

AB TARO 0.1% A200734 001 Jul 14, 2014

VANOS

AB +! MEDICIS 0.1% N021758 001 Feb 11, 2005

FLUOCINONIDE

AB1 AMNEAL PHARMS LLC 0.05% A210554 001 Aug 21, 2018

AB1 FOUGERA PHARMS INC 0.05% A073030 001 Oct 17, 1994

AB1 G AND W LABS INC 0.05% A073085 001 Feb 14, 1992

AB1 TARO 0.05% A071500 001 Jun 10, 1987

AB1 +! 0.05% N019117 001 Jun 26, 1984

AB1 TELIGENT PHARMA INC 0.05% A211410 001 Oct 16, 2018

AB1 TEVA 0.05% A072488 001 Feb 06, 1989

FLUOCINONIDE EMULSIFIED BASE



AB2 FOUGERA PHARMS 0.05% A076586 001 Jun 23, 2004

AB2 G AND W LABS INC 0.05% A074204 001 Jun 13, 1995

AB2 ! TARO PHARM INDS LTD 0.05% A072494 001 Jan 19, 1989

AB2 TEVA 0.05% A072490 001 Feb 07, 1989

LIDEX-E

AB2 + CNTY LINE PHARMS 0.05% N016908 003

GEL;TOPICAL
FLUOCINONIDE
AB + CNTY LINE PHARMS 0.05% N017373 001
AB FOUGERA PHARMS INC 0.05% A072933 001 Dec 30, 1994
AB G AND W LABS INC 0.05% A072537 001 Feb 07, 1989
AB ! TARO 0.05% A074935 001 Jul 29, 1997
AB TELIGENT PHARMA INC 0.05% A209030 001 Jun 19, 2018
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-194(of 452)

FLUOCINONIDE

OINTMENT;TOPICAL

FLUOCINONIDE

AB FOUGERA PHARMS 0.05% A074905 001 Aug 26, 1997

AB NOVEL LABS INC 0.05% A207538 001 Jul 31, 2017

AB ! TARO 0.05% A075008 001 Jun 30, 1999

AB TELIGENT PHARMA INC 0.05% A207680 001 Sep 28, 2018

AB TEVA 0.05% A073481 001 Dec 27, 1991

LIDEX

AB + CNTY LINE PHARMS 0.05% N016909 002

SOLUTION;TOPICAL

FLUOCINONIDE

AT ENCUBE ETHICALS 0.05% A209699 001 Nov 29, 2018

AT FOUGERA PHARMS INC 0.05% A072934 001 Feb 27, 1995

AT G AND W LABS INC 0.05% A071535 001 Dec 02, 1988

AT GLASSHOUSE PHARMS 0.05% A209118 001 Apr 23, 2018

AT MACLEODS PHARMS LTD 0.05% A209283 001 Apr 23, 2018

AT NOVEL LABS INC 0.05% A206003 001 Jul 21, 2017

AT ! TARO 0.05% A074799 001 Dec 31, 1996

AT TEVA 0.05% A072511 001 Feb 07, 1989

AT ZYDUS PHARMS USA 0.05% A208948 001 Jul 17, 2018

INC

LIDEX

AT + CNTY LINE PHARMS 0.05% N018849 001 Apr 06, 1984

FLUORESCEIN SODIUM

INJECTABLE;INTRAVENOUS

AK-FLUOR 10%

AP + AKORN EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N022186 001 Aug 08, 2008

FLUORESCITE

AP +! ALCON LABS INC EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N021980 001 Mar 28, 2006

AK-FLUOR 25%

+! AKORN EQ 500MG BASE/2ML (EQ 250MG BASE/ML) N022186 002 Aug 08, 2008

FLUOROMETHOLONE

OINTMENT;OPHTHALMIC

FML

+! ALLERGAN 0.1% N017760 001 Sep 04, 1985

SUSPENSION/DROPS;OPHTHALMIC

FML

+! ALLERGAN 0.1% N016851 002 Jul 28, 1982

FML FORTE

ALLERGAN 0.25% N019216 001 Apr 23, 1986

FLUOROMETHOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

FLAREX

+! NOVARTIS PHARMS 0.1% N019079 001 Feb 11, 1986

CORP

FLUOROURACIL

CREAM;TOPICAL

CARAC

AB +! VALEANT PHARMS 0.5% N020985 001 Oct 27, 2000

NORTH

EFUDEX

AB +! VALEANT PHARM INTL 5% N016831 003

FLUOROURACIL

AB MAYNE PHARMA 5% A077524 001 Apr 11, 2008

AB MYLAN PHARMS INC 0.5% A203122 001 Apr 20, 2015

AB TARO 5% A090368 001 Mar 05, 2010



FLUOROPLEX

+! AQUA PHARMS 1% N016988 001

TOLAK

+! HILL DERMACEUTICALS 4% N022259 001 Sep 18, 2015

INJECTABLE;INJECTION

FLUOROURACIL

AP ! ACCORD HLTHCARE 500MG/10ML (50MG/ML) A040743 002 Apr 26, 2007

AP ! 1GM/20ML (50MG/ML) A040743 001 Apr 26, 2007

AP ! 2.5GM/50ML (50MG/ML) A040798 002 Apr 26, 2007

AP ! 5GM/100ML (50MG/ML) A040798 001 Apr 26, 2007

AP ! FRESENIUS KABI USA 500MG/10ML (50MG/ML) A040279 002 Sep 30, 1998

AP ! 1GM/20ML (50MG/ML) A040279 001 Sep 30, 1998

AP ! 2.5GM/50ML (50MG/ML) A040278 001 Sep 30, 1998

AP ! 5GM/100ML (50MG/ML) A040278 002 Sep 30, 1998



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-195(of 452)

FLUOROURACIL

INJECTABLE;INJECTION

FLUOROURACIL

AP GLAND PHARMA LTD
500MG/10ML (50MG/ML)
A210123 001 Oct 27, 2017

AP
1GM/20ML (50MG/ML)
A210123 002 Oct 27, 2017

AP
2.5GM/50ML (50MG/ML)
A210124 001 Dec 26, 2017

AP
5GM/100ML (50MG/ML)
A210124 002 Dec 26, 2017

AP MYLAN LABS LTD


500MG/10ML (50MG/ML)
A202668 001 Jul 17, 2012

AP
1GM/20ML (50MG/ML)
A202668 002 Jul 17, 2012

AP
2.5GM/50ML (50MG/ML)
A202669 001 Jul 17, 2012

AP
5GM/100ML (50MG/ML)
A202669 002 Jul 17, 2012

AP SAGENT PHARMS
500MG/10ML (50MG/ML)
A203608 001 May 11, 2017

AP
1GM/20ML (50MG/ML)
A203608 002 May 11, 2017

AP
2.5GM/50ML (50MG/ML)
A203609 001 Feb 17, 2016

AP
5GM/100ML (50MG/ML)
A203609 002 Feb 17, 2016

AP ! TEVA PHARMS USA


500MG/10ML (50MG/ML)
A040333 001 Jan 27, 2000

AP !
2.5GM/50ML (50MG/ML)
A040334 001 Feb 25, 2000

AP !
5GM/100ML (50MG/ML)
A040334 002 Feb 25, 2000

SOLUTION;TOPICAL

EFUDEX

AT +! VALEANT PHARM INTL
2%
N016831 001

AT +!
5%
N016831 002

FLUOROURACIL

AT TARO PHARM
2%
A076526 001 Nov 05, 2003

AT
5%
A076526 002 Nov 05, 2003

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE

AB ALEMBIC PHARMS LTD
EQ 40MG BASE
A090223 003 Mar 19, 2009

AB AUROBINDO PHARMA
EQ 40MG BASE
A078619 003 Jan 31, 2008

AB HERITAGE PHARMS INC


EQ 40MG BASE
A201336 003 Oct 01, 2012

AB IVAX SUB TEVA


EQ 40MG BASE
A075245 003 Sep 28, 2004

PHARMS

AB MARKSANS PHARMA
EQ 40MG BASE
A075465 003 Aug 02, 2001

AB PAR PHARM
EQ 40MG BASE
A076922 003 Dec 16, 2004

AB SANDOZ
EQ 40MG BASE
A075049 003 Jan 29, 2002

AB SCIEGEN PHARMS INC


EQ 40MG BASE
A204597 003 Mar 16, 2015

AB SUN PHARM INDS LTD


EQ 40MG BASE
A076990 001 Dec 13, 2004

AB TEVA
EQ 40MG BASE
A075452 003 Jan 29, 2002

PROZAC

AB +! ELI LILLY AND CO
EQ 40MG BASE
N018936 003 Jun 15, 1999

FLUOXETINE HYDROCHLORIDE

AB1 ALEMBIC PHARMS LTD
EQ 10MG BASE
A090223 001 Mar 19, 2009

AB1
EQ 20MG BASE
A090223 002 Mar 19, 2009

AB1 AUROBINDO PHARMA


EQ 10MG BASE
A078619 001 Jan 31, 2008

AB1
EQ 20MG BASE
A078619 002 Jan 31, 2008

AB1 BARR
EQ 10MG BASE
A074803 002 Jan 30, 2002

AB1
EQ 20MG BASE
A074803 001 Aug 02, 2001

AB1 HERITAGE PHARMS INC


EQ 10MG BASE
A201336 001 Oct 01, 2012

AB1
EQ 20MG BASE
A201336 002 Oct 01, 2012

AB1 IVAX SUB TEVA


EQ 10MG BASE
A075245 002 Jan 31, 2002

PHARMS

AB1
EQ 20MG BASE
A075245 001 Jan 31, 2002

AB1 LANDELA PHARM


EQ 10MG BASE
A075464 001 Jan 30, 2002

AB1
EQ 20MG BASE
A075464 002 Jan 30, 2002

AB1 MARKSANS PHARMA


EQ 10MG BASE
A075465 001 Jan 29, 2002

AB1
EQ 20MG BASE
A075465 002 Jan 29, 2002

AB1 SANDOZ
EQ 10MG BASE
A075049 001 Aug 02, 2001

AB1
EQ 20MG BASE
A075049 002 Jan 29, 2002

AB1 SCIEGEN PHARMS INC


EQ 10MG BASE
A204597 001 Mar 16, 2015

AB1
EQ 20MG BASE
A204597 002 Mar 16, 2015

AB1 SPECGX LLC


EQ 10MG BASE
A075658 001 Jan 29, 2002

AB1
EQ 20MG BASE
A075658 002 Jan 29, 2002

AB1 TEVA
EQ 10MG BASE
A075452 001 Jan 29, 2002

AB1
EQ 20MG BASE
A075452 002 Jan 29, 2002

AB1 TEVA PHARMS USA


EQ 10MG BASE
A076001 001 Jan 29, 2002

AB1
EQ 20MG BASE
A076001 002 Jan 29, 2002

PROZAC

AB1 + ELI LILLY AND CO
EQ 10MG BASE
N018936 006 Dec 23, 1992

AB1 +
EQ 20MG BASE
N018936 001 Dec 29, 1987

FLUOXETINE HYDROCHLORIDE

MYLAN
EQ 10MG BASE
A078045 001 Nov 17, 2008

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-196(of 452)

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE

! EQ 20MG BASE A078045 002 Nov 17, 2008

CAPSULE, DELAYED REL PELLETS;ORAL

FLUOXETINE HYDROCHLORIDE

AB BARR EQ 90MG BASE A076237 001 Mar 24, 2010

AB DR REDDYS LABS LTD EQ 90MG BASE A078572 001 Mar 22, 2010

PROZAC WEEKLY

AB +! LILLY EQ 90MG BASE N021235 001 Feb 26, 2001

SOLUTION;ORAL

FLUOXETINE HYDROCHLORIDE

AA LANNETT CO INC EQ 20MG BASE/5ML A077849 001 Feb 09, 2007

AA ! PHARM ASSOC EQ 20MG BASE/5ML A076015 001 Jan 30, 2002

AA SPECGX LLC EQ 20MG BASE/5ML A075920 001 Jan 29, 2002

AA TEVA EQ 20MG BASE/5ML A075506 001 Aug 02, 2001

AA WOCKHARDT BIO AG EQ 20MG BASE/5ML A075514 001 Aug 29, 2002

TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

AB ALEMBIC PHARMS LTD EQ 10MG BASE A208698 001 Apr 05, 2017

AB EQ 20MG BASE A208698 002 Apr 05, 2017

AB +! ALVOGEN EQ 60MG BASE N202133 001 Oct 06, 2011

AB APPCO PHARMA LLC EQ 60MG BASE A211477 001 Nov 21, 2018

AB DR REDDYS LABS LTD EQ 10MG BASE A076006 001 Jan 30, 2002

AB EQ 20MG BASE A076006 002 Apr 23, 2018

AB INVENTIA HLTHCARE EQ 60MG BASE A209695 001 Nov 20, 2017

AB MYLAN EQ 10MG BASE A075755 001 Aug 02, 2001

AB ! EQ 20MG BASE A075755 002 Aug 02, 2001

AB PAR FORM EQ 10MG BASE A203836 001 Aug 19, 2016

AB EQ 20MG BASE A203836 002 Aug 19, 2016

AB PAR PHARM INC EQ 60MG BASE A209419 001 Nov 16, 2017

AB SCIEGEN PHARMS INC EQ 60MG BASE A211282 001 Jan 10, 2019

AB TEVA EQ 10MG BASE A075872 001 Jan 29, 2002

AB EQ 20MG BASE A075872 002 Jan 04, 2019

AB TEVA PHARMS USA EQ 60MG BASE A211051 001 Dec 03, 2018

AB1 TORRENT PHARMS LTD EQ 10MG BASE A206937 001 Oct 21, 2016

AB1 EQ 20MG BASE A206937 002 Oct 21, 2016

SARAFEM

AB1 + APIL EQ 10MG BASE N021860 001 May 19, 2006

AB1 + EQ 15MG BASE N021860 002 May 19, 2006

AB1 +! EQ 20MG BASE N021860 003 May 19, 2006

SELFEMRA

AB1 TEVA PHARMS USA EQ 10MG BASE A200151 001 Feb 03, 2014

AB1 EQ 15MG BASE A200151 002 Feb 03, 2014

AB1 EQ 20MG BASE A200151 003 Feb 03, 2014



FLUOXETINE HYDROCHLORIDE; OLANZAPINE

CAPSULE;ORAL

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE



AB PAR PHARM EQ 25MG BASE;EQ 3MG BASE A077742 001 Nov 02, 2012

AB EQ 25MG BASE;EQ 6MG BASE A077742 002 Nov 02, 2012

AB EQ 25MG BASE;EQ 12MG BASE A077742 003 Nov 02, 2012

AB EQ 50MG BASE;EQ 6MG BASE A077742 004 Nov 02, 2012

AB EQ 50MG BASE;EQ 12MG BASE A077742 005 Nov 02, 2012

AB SANDOZ EQ 25MG BASE;EQ 3MG BASE A078901 005 Nov 16, 2012

AB EQ 25MG BASE;EQ 6MG BASE A078901 001 Nov 16, 2012

AB EQ 25MG BASE;EQ 12MG BASE A078901 003 Nov 16, 2012

AB EQ 50MG BASE;EQ 6MG BASE A078901 002 Nov 16, 2012

AB EQ 50MG BASE;EQ 12MG BASE A078901 004 Nov 16, 2012

AB TEVA PHARMS EQ 25MG BASE;EQ 3MG BASE A202074 001 Mar 25, 2013

AB EQ 25MG BASE;EQ 6MG BASE A077528 001 Jun 19, 2012

AB EQ 25MG BASE;EQ 12MG BASE A077528 002 Jun 19, 2012

AB EQ 50MG BASE;EQ 6MG BASE A077528 003 Jun 19, 2012

AB EQ 50MG BASE;EQ 12MG BASE A077528 004 Jun 19, 2012

SYMBYAX

AB + LILLY EQ 25MG BASE;EQ 3MG BASE N021520 001 Apr 09, 2007

AB + EQ 25MG BASE;EQ 6MG BASE N021520 002 Dec 24, 2003

AB + EQ 25MG BASE;EQ 12MG BASE N021520 004 Dec 24, 2003

AB +! EQ 50MG BASE;EQ 6MG BASE N021520 003 Dec 24, 2003

AB + EQ 50MG BASE;EQ 12MG BASE N021520 005 Dec 24, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-197(of 452)

FLUOXYMESTERONE

TABLET;ORAL

FLUOXYMESTERONE

! USL PHARMA 10MG A088342 001 Oct 21, 1983

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION

FLUPHENAZINE DECANOATE

AO AUROBINDO PHARMA 25MG/ML A207739 001 Oct 17, 2017

LTD

AO ! FRESENIUS KABI USA 25MG/ML A071413 001 Jul 14, 1987

AO MYLAN LABS LTD 25MG/ML A075918 001 Aug 17, 2001

AO PAR STERILE 25MG/ML A203732 001 Jul 03, 2014

PRODUCTS

AO WEST-WARD PHARMS 25MG/ML A074531 001 Aug 30, 1996

INT

FLUPHENAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

FLUPHENAZINE HYDROCHLORIDE

! PHARM ASSOC 5MG/ML A074725 001 Sep 16, 1996

ELIXIR;ORAL

FLUPHENAZINE HYDROCHLORIDE

! PHARM ASSOC 2.5MG/5ML A040146 001 Aug 21, 1996

INJECTABLE;INJECTION

FLUPHENAZINE HYDROCHLORIDE

! FRESENIUS KABI USA 2.5MG/ML A089556 001 Apr 16, 1987

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

AB LANNETT CO INC 1MG A089743 002 Aug 25, 1988

AB 2.5MG A089743 003 Aug 25, 1988

AB 5MG A089743 004 Aug 25, 1988

AB 10MG A089743 001 Aug 25, 1988

AB MYLAN 1MG A089804 002 Aug 12, 1988

AB 2.5MG A089804 003 Aug 12, 1988

AB 5MG A089804 004 Aug 12, 1988

AB ! 10MG A089804 001 Aug 12, 1988

AB SANDOZ 1MG A089586 002 Oct 16, 1987

AB 2.5MG A089586 003 Oct 16, 1987

AB 5MG A089586 004 Oct 16, 1987

AB 10MG A089586 001 Oct 16, 1987



FLURANDRENOLIDE

CREAM;TOPICAL

CORDRAN SP

AT +! AQUA PHARMS 0.05% N012806 002

FLURANDRENOLIDE

AT CINTEX SVCS 0.05% A205342 001 Apr 13, 2016

CORDRAN SP

+! AQUA PHARMS 0.025% N012806 003

LOTION;TOPICAL

CORDRAN

AT +! AQUA PHARMS 0.05% N013790 001

FLURANDRENOLIDE

AT CINTEX SVCS 0.05% A205343 001 Dec 22, 2016

AT PERRIGO UK FINCO 0.05% A207133 001 Aug 30, 2016

OINTMENT;TOPICAL

CORDRAN

AT +! AQUA PHARMS 0.05% N012806 001

FLURANDRENOLIDE

AT TELIGENT PHARMA INC 0.05% A207851 001 Dec 30, 2016

TAPE;TOPICAL

CORDRAN

+! AQUA PHARMS LLC 0.004MG/SQ CM N016455 001

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

FLURAZEPAM HYDROCHLORIDE

MYLAN PHARMS INC 15MG A070345 002 Nov 27, 1985

! 30MG A070345 001 Nov 27, 1985

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-198(of 452)

FLURBIPROFEN

TABLET;ORAL

FLURBIPROFEN

AB MYLAN 50MG A074358 001 Jun 20, 1994

AB ! 100MG A074358 002 Jun 20, 1994

AB SUN PHARM INDS INC 50MG A075058 001 Apr 27, 2001

AB 100MG A075058 002 Apr 27, 2001

AB TEVA 100MG A074431 001 May 31, 1995



FLURBIPROFEN SODIUM

SOLUTION/DROPS;OPHTHALMIC

FLURBIPROFEN SODIUM

AT BAUSCH AND LOMB 0.03% A074447 001 Jan 04, 1995

OCUFEN

AT +! ALLERGAN 0.03% N019404 001 Dec 31, 1986

FLUTAMIDE

CAPSULE;ORAL

FLUTAMIDE

AB ACTAVIS LABS FL INC 125MG A075820 001 Sep 18, 2001

AB ! CIPLA 125MG A075780 001 Sep 19, 2001

AB PAR PHARM 125MG A075298 001 Sep 18, 2001



FLUTEMETAMOL F-18

INJECTABLE;INTRAVENOUS

VIZAMYL

+! GE HEALTHCARE 121.5mCi/30ML (4.05mCi/ML) N203137 002 Oct 25, 2013

FLUTICASONE FUROATE

POWDER;INHALATION

ARNUITY ELLIPTA

+! GLAXOSMITHKLINE 0.05MG/INH N205625 003 May 17, 2018

+! 0.1MG/INH N205625 001 Aug 20, 2014

+! 0.2MG/INH N205625 002 Aug 20, 2014



FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

POWDER;INHALATION

TRELEGY ELLIPTA

+! GLAXOSMITHKLINE 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ N209482 001 Sep 18, 2017

0.025MG BASE/INH

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

POWDER;INHALATION

BREO ELLIPTA

+! GLAXO GRP LTD 0.1MG/INH;EQ 0.025MG BASE/INH N204275 001 May 10, 2013

+! 0.2MG/INH;EQ 0.025MG BASE/INH N204275 002 Apr 30, 2015



FLUTICASONE PROPIONATE

AEROSOL, METERED;INHALATION

FLOVENT HFA

+! GLAXO GRP LTD 0.044MG/INH N021433 003 May 14, 2004

+! 0.11MG/INH N021433 002 May 14, 2004

+! 0.22MG/INH N021433 001 May 14, 2004

CREAM;TOPICAL

FLUTICASONE PROPIONATE

AB ANDA REPOSITORY 0.05% A076633 001 May 14, 2004

AB FOUGERA PHARMS 0.05% A076451 001 May 14, 2004

AB G AND W LABS 0.05% A077055 001 Jun 30, 2006

AB ! PERRIGO NEW YORK 0.05% A076793 001 May 14, 2004

LOTION;TOPICAL

CUTIVATE

AB +! FOUGERA PHARMS 0.05% N021152 001 Mar 31, 2005

FLUTICASONE PROPIONATE

AB GLENMARK GENERICS 0.05% A090759 001 May 02, 2011

AB PERRIGO ISRAEL 0.05% A091553 001 Jul 30, 2013



OINTMENT;TOPICAL

FLUTICASONE PROPIONATE

AB G AND W LABS 0.005% A077168 001 Mar 03, 2006

AB ! PERRIGO NEW YORK 0.005% A076668 001 May 14, 2004

POWDER;INHALATION

ARMONAIR RESPICLICK

+ TEVA PHARM 0.055MG/INH N208798 001 Jan 27, 2017

+ 0.113MG/INH N208798 002 Jan 27, 2017

+! 0.232MG/INH N208798 003 Jan 27, 2017

FLOVENT DISKUS 100

+! GLAXO GRP LTD 0.1MG/INH N020833 002 Sep 29, 2000

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-199(of 452)

FLUTICASONE PROPIONATE

POWDER;INHALATION

FLOVENT DISKUS 250

+! GLAXO GRP LTD 0.25MG/INH N020833 003 Sep 29, 2000

FLOVENT DISKUS 50

+! GLAXO GRP LTD 0.05MG/INH N020833 001 Sep 29, 2000

SPRAY, METERED;NASAL

FLUTICASONE PROPIONATE

AB APOTEX INC 0.05MG/SPRAY A077538 001 Sep 12, 2007

AB HI TECH PHARMA 0.05MG/SPRAY A077570 001 Jan 16, 2008

AB ! WEST-WARD PHARMS 0.05MG/SPRAY A076504 001 Feb 22, 2006

INT

AB WOCKHARDT BIO AG 0.05MG/SPRAY A078492 001 Jan 09, 2012

XHANCE

+! OPTINOSE US INC 0.093MG N209022 001 Sep 18, 2017

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

AEROSOL, METERED;INHALATION

ADVAIR HFA

+! GLAXO GRP LTD 0.045MG/INH;EQ 0.021MG BASE/INH N021254 001 Jun 08, 2006

+! 0.115MG/INH;EQ 0.021MG BASE/INH N021254 002 Jun 08, 2006

+! 0.23MG/INH;EQ 0.021MG BASE/INH N021254 003 Jun 08, 2006

POWDER;INHALATION

ADVAIR DISKUS 100/50

+! GLAXO GRP LTD 0.1MG/INH;EQ 0.05MG BASE/INH N021077 001 Aug 24, 2000

ADVAIR DISKUS 250/50

+! GLAXO GRP LTD 0.25MG/INH;EQ 0.05MG BASE/INH N021077 002 Aug 24, 2000

ADVAIR DISKUS 500/50

+! GLAXO GRP LTD 0.5MG/INH;EQ 0.05MG BASE/INH N021077 003 Aug 24, 2000

AIRDUO RESPICLICK

+ TEVA PHARM 0.055MG/INH;EQ 0.014MG BASE/INH N208799 001 Jan 27, 2017

+ 0.113MG/INH;EQ 0.014MG BASE/INH N208799 002 Jan 27, 2017

+! 0.232MG;EQ 0.014MG BASE/INH N208799 003 Jan 27, 2017

FLUVASTATIN SODIUM

CAPSULE;ORAL

FLUVASTATIN SODIUM

AB MYLAN PHARMS INC EQ 20MG BASE A090595 001 Apr 11, 2012

AB ! EQ 40MG BASE A090595 002 Apr 11, 2012

AB TEVA PHARMS EQ 20MG BASE A078407 001 Jun 12, 2012

AB EQ 40MG BASE A078407 002 Jun 12, 2012



TABLET, EXTENDED RELEASE;ORAL

FLUVASTATIN SODIUM

AB MYLAN PHARMS INC EQ 80MG BASE A202458 001 Sep 11, 2015

AB TEVA PHARMS USA EQ 80MG BASE A079011 001 Jan 27, 2016

LESCOL XL

AB +! NOVARTIS EQ 80MG BASE N021192 001 Oct 06, 2000

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

FLUVOXAMINE MALEATE

AB ACTAVIS ELIZABETH 100MG A091482 001 Apr 23, 2013

AB ! 150MG A091482 002 Nov 18, 2013

AB ANCHEN PHARMS 100MG A091476 001 Mar 13, 2013

AB 150MG A091476 002 Mar 13, 2013

AB TORRENT PHARMS LTD 100MG A203240 001 Oct 31, 2014

AB 150MG A203240 002 Oct 31, 2014



TABLET;ORAL

FLUVOXAMINE MALEATE

AB ANI PHARMS INC 25MG A075897 001 Jan 25, 2001

AB 50MG A075897 002 Jan 25, 2001

AB 100MG A075897 003 Jan 25, 2001

AB APOTEX 25MG A075902 001 May 07, 2001

AB 50MG A075902 002 May 07, 2001

AB 100MG A075902 003 May 07, 2001

AB MYLAN 25MG A075889 001 Nov 29, 2000

AB 50MG A075889 002 Nov 29, 2000

AB 100MG A075889 003 Nov 29, 2000

AB TEVA 25MG A075893 001 Sep 10, 2002

AB 50MG A075893 002 Sep 10, 2002

AB 100MG A075893 003 Sep 10, 2002

AB UPSHER SMITH LABS 25MG A075888 001 Nov 29, 2000

AB 50MG A075888 002 Nov 29, 2000

AB ! 100MG A075888 003 Nov 29, 2000



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-200(of 452)

FLUVOXAMINE MALEATE

TABLET;ORAL

LUVOX

AB ANI PHARMS 25MG N021519 001 Dec 20, 2007

AB 50MG N021519 002 Dec 20, 2007

AB 100MG N021519 003 Dec 20, 2007



FOLIC ACID

INJECTABLE;INJECTION

FOLIC ACID

! FRESENIUS KABI USA 5MG/ML A089202 001 Feb 18, 1986

TABLET;ORAL

FOLIC ACID

AA ! AMNEAL PHARM 1MG A040625 001 Jul 21, 2005

AA ANBISON LAB 1MG A091145 001 Jul 12, 2013

AA CADILA PHARMS LTD 1MG A202437 001 Jan 27, 2014

AA CHARTWELL MOLECULAR 1MG A090035 001 Jun 09, 2009

AA HIKMA PHARMS 1MG A080600 001



AA LEADING PHARMA LLC 1MG A040796 001 Jan 12, 2009

AA NUVO PHARMS INC 1MG A204418 001 Jul 28, 2015

AA VINTAGE 1MG A040756 001 Jun 04, 2010

AA ! WATSON LABS 1MG A080680 001



FOLLITROPIN ALFA/BETA

INJECTABLE;SUBCUTANEOUS

FOLLISTIM AQ

+! ORGANON USA INC 300 IU/0.36ML N021211 001 Mar 23, 2004

+! 600 IU/0.72ML N021211 002 Mar 23, 2004

+! 900 IU/1.08ML N021211 004 Feb 11, 2005

GONAL-F

+! EMD SERONO 450 IU/VIAL N020378 005 Mar 26, 2004

+ 1,050 IU/VIAL N020378 004 Feb 28, 2001

GONAL-F RFF

+! EMD SERONO 75 IU/VIAL N021765 002 Mar 25, 2004

GONAL-F RFF REDI-JECT

+! EMD SERONO 300 IU/0.5ML N021684 001 May 25, 2004

+! 450 IU/0.75ML N021684 002 May 25, 2004

+! 900 IU/1.5ML N021684 003 May 25, 2004



FOMEPIZOLE

INJECTABLE;INJECTION

ANTIZOL

AP +! PAR PHARM INC 1.5GM/1.5ML (1GM/ML) N020696 001 Dec 04, 1997

FOMEPIZOLE

AP LUITPOLD 1.5GM/1.5ML (1GM/ML) A078368 001 Dec 14, 2007

AP MYLAN INSTITUTIONAL 1.5GM/1.5ML (1GM/ML) A078639 001 Mar 03, 2008

AP NAVINTA LLC 1.5GM/1.5ML (1GM/ML) A078537 001 Mar 06, 2008



FONDAPARINUX SODIUM

INJECTABLE;SUBCUTANEOUS

ARIXTRA

AP +! MYLAN IRELAND LTD 2.5MG/0.5ML N021345 001 Dec 07, 2001

AP +! 5MG/0.4ML N021345 002 May 28, 2004

AP +! 7.5MG/0.6ML N021345 003 May 28, 2004

AP +! 10MG/0.8ML N021345 004 May 28, 2004

FONDAPARINUX SODIUM

AP AUROBINDO PHARMA 2.5MG/0.5ML A206918 001 Dec 26, 2017

LTD

AP 5MG/0.4ML A206918 002 Dec 26, 2017

AP 7.5MG/0.6ML A206918 003 Dec 26, 2017

AP 10MG/0.8ML A206918 004 Dec 26, 2017

AP DR REDDYS LABS LTD 2.5MG/0.5ML A091316 001 Jul 11, 2011

AP 5MG/0.4ML A091316 002 Jul 11, 2011

AP 7.5MG/0.6ML A091316 003 Jul 11, 2011

AP 10MG/0.8ML A091316 004 Jul 11, 2011

AP JIANGSU HENGRUI MED 2.5MG/0.5ML A206812 001 May 15, 2018

AP 5MG/0.4ML A206812 002 May 15, 2018

AP 7.5MG/0.6ML A206812 003 May 15, 2018

AP 10MG/0.8ML A206812 004 May 15, 2018

AP SCINOPHARM TAIWAN 2.5MG/0.5ML A208615 001 Nov 14, 2018

AP 5MG/0.4ML A208615 002 Nov 14, 2018

AP 7.5MG/0.6ML A208615 003 Nov 14, 2018

AP 10MG/0.8ML A208615 004 Nov 14, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-201(of 452)

FORMOTEROL FUMARATE

SOLUTION;INHALATION

PERFOROMIST

+! MYLAN SPECLT 0.02MG/2ML N022007 001 May 11, 2007

FORMOTEROL FUMARATE; GLYCOPYRROLATE

AEROSOL, METERED;INHALATION

BEVESPI AEROSPHERE

+! ASTRAZENECA PHARMS 0.0048MG/INH;0.0090MG/INH N208294 001 Apr 25, 2016

FORMOTEROL FUMARATE; MOMETASONE FUROATE

AEROSOL, METERED;INHALATION

DULERA

+! MERCK SHARP DOHME 0.005MG/INH;0.1MG/INH N022518 001 Jun 22, 2010

+! 0.005MG/INH;0.2MG/INH N022518 002 Jun 22, 2010

FOSAMPRENAVIR CALCIUM

SUSPENSION;ORAL

LEXIVA

+! VIIV HLTHCARE EQ 50MG BASE/ML N022116 001 Jun 14, 2007

TABLET;ORAL

FOSAMPRENAVIR CALCIUM

AB MYLAN PHARMS INC EQ 700MG BASE A204060 001 Apr 15, 2016

LEXIVA

AB +! VIIV HLTHCARE EQ 700MG BASE N021548 001 Oct 20, 2003

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

EMEND

AP +! MERCK AND CO INC EQ 150MG BASE/VIAL N022023 002 Nov 12, 2010

FOSAPREPITANT DIMEGLUMINE

AP FRESENIUS KABI USA EQ 150MG BASE/VIAL A206197 001 Jun 09, 2016

FOSCARNET SODIUM

INJECTABLE;INJECTION

FOSCAVIR

+! CLINIGEN HLTHCARE 2.4GM/100ML N020068 001 Sep 27, 1991

FOSFOMYCIN TROMETHAMINE

FOR SOLUTION;ORAL

MONUROL

+! ZAMBON SPA EQ 3GM BASE/PACKET N050717 001 Dec 19, 1996

FOSINOPRIL SODIUM

TABLET;ORAL

FOSINOPRIL SODIUM

AB APOTEX INC 10MG A076906 001 May 17, 2005

AB 20MG A076906 002 May 17, 2005

AB 40MG A076906 003 May 17, 2005

AB AUROBINDO PHARMA 10MG A091163 001 Mar 30, 2011

LTD

AB 20MG A091163 002 Mar 30, 2011

AB 40MG A091163 003 Mar 30, 2011

AB INVAGEN PHARMS 10MG A077222 001 Apr 20, 2005

AB 20MG A077222 002 Apr 20, 2005

AB 40MG A077222 003 Apr 20, 2005

AB PRINSTON INC 10MG A205670 001 Aug 29, 2016

AB 20MG A205670 002 Aug 29, 2016

AB 40MG A205670 003 Aug 29, 2016

AB TEVA 10MG A076139 001 Nov 25, 2003

AB 20MG A076139 002 Nov 25, 2003

AB ! 40MG A076139 003 Nov 25, 2003

AB UPSHER SMITH LABS 10MG A076483 001 Apr 23, 2004

AB 20MG A076483 002 Apr 23, 2004

AB 40MG A076483 003 Apr 23, 2004



FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET;ORAL

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE



AB AUROBINDO PHARMA 10MG;12.5MG A079245 001 Jul 09, 2009

AB 20MG;12.5MG A079245 002 Jul 09, 2009

AB EMCURE PHARMS LTD 10MG;12.5MG A079025 001 Sep 17, 2010

AB ! 20MG;12.5MG A079025 002 Sep 17, 2010

AB INVAGEN PHARMS 10MG;12.5MG A090228 001 Jul 09, 2009

AB 20MG;12.5MG A090228 002 Jul 09, 2009

AB SANDOZ 10MG;12.5MG A076961 001 Sep 28, 2005

AB 20MG;12.5MG A076961 002 Sep 28, 2005



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-202(of 452)

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE



POWDER;INTRAVENOUS

AKYNZEO

+! HELSINN HLTHCARE
EQ 235MG BASE;EQ 0.25MG BASE
N210493 001 Apr 19, 2018

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

CEREBYX

AP +! PARKE DAVIS
EQ 50MG PHENYTOIN NA/ML
N020450 001 Aug 05, 1996

FOSPHENYTOIN SODIUM

AP AMNEAL PHARMS CO
EQ 50MG PHENYTOIN NA/ML
A078476 001 Mar 18, 2008

AP FRESENIUS KABI USA


EQ 50MG PHENYTOIN NA/ML
A078052 001 Aug 06, 2007

AP HIKMA FARMACEUTICA
EQ 50MG PHENYTOIN NA/ML
A078765 001 Dec 02, 2009

AP LUITPOLD
EQ 50MG PHENYTOIN NA/ML
A078277 001 Aug 06, 2007

AP
EQ 50MG PHENYTOIN NA/ML
A090099 001 May 13, 2010

AP MYLAN LABS LTD


EQ 50MG PHENYTOIN NA/ML
A078736 001 Jun 08, 2010

AP SUN PHARMA GLOBAL


EQ 50MG PHENYTOIN NA/ML
A078417 001 Mar 18, 2008

AP WEST-WARD PHARMS
EQ 50MG PHENYTOIN NA/ML
A077481 001 Aug 06, 2007

INT

AP
EQ 50MG PHENYTOIN NA/ML
A077989 001 Aug 06, 2007

AP WOCKHARDT
EQ 50MG PHENYTOIN NA/ML
A078137 001 Aug 06, 2007

FOSTAMATINIB DISODIUM

TABLET;ORAL

TAVALISSE

+ RIGEL PHARMS INC
EQ 100MG BASE
N209299 001 Apr 17, 2018

+!
EQ 150MG BASE
N209299 002 Apr 17, 2018

FROVATRIPTAN SUCCINATE

TABLET;ORAL

FROVA

AB +! ENDO PHARMS
EQ 2.5MG BASE
N021006 001 Nov 08, 2001

FROVATRIPTAN SUCCINATE

AB AMNEAL PHARMS CO
EQ 2.5MG BASE
A211292 001 Nov 06, 2018

AB GLENMARK PHARMS LTD


EQ 2.5MG BASE
A204730 001 Mar 11, 2016

AB MYLAN PHARMS INC


EQ 2.5MG BASE
A202931 001 Aug 28, 2014

FULVESTRANT

INJECTABLE;INTRAMUSCULAR

FASLODEX

+! ASTRAZENECA
50MG/ML
N021344 001 Apr 25, 2002

FUROSEMIDE

INJECTABLE;INJECTION

FUROSEMIDE

AP AMNEAL PHARMS CO
10MG/ML
A207552 001 Jul 20, 2016

AP ! BAXTER HLTHCARE
10MG/ML
A202747 001 Jan 27, 2014

CORP

AP EMCURE PHARMS LTD
10MG/ML
A203428 001 Aug 26, 2014

AP FRESENIUS KABI USA


10MG/ML
N018902 001 May 22, 1984

AP HOSPIRA
10MG/ML
A075241 001 May 28, 1999

AP
10MG/ML
N018667 001 May 28, 1982

AP WOCKHARDT
10MG/ML
A077941 001 Mar 22, 2007

SOLUTION;ORAL

FUROSEMIDE

AA ! WEST-WARD PHARMS
10MG/ML
A070434 001 Apr 22, 1987

INT

AA WOCKHARDT BIO AG
10MG/ML
A070655 001 Oct 02, 1987

WEST-WARD PHARMS
40MG/5ML
A070433 001 Apr 22, 1987

INT

TABLET;ORAL

FUROSEMIDE

AB IPCA LABS LTD
20MG
A078010 001 Sep 18, 2006

AB
40MG
A078010 002 Sep 18, 2006

AB
80MG
A078010 003 Sep 18, 2006

AB IVAX SUB TEVA


20MG
N018413 001 Nov 30, 1983

PHARMS

AB
40MG
N018413 002 Nov 30, 1983

AB LEADING PHARMA LLC


20MG
A077293 001 Nov 09, 2005

AB
40MG
A077293 002 Nov 09, 2005

AB
80MG
A077293 003 Nov 09, 2005

AB MYLAN
20MG
N018487 001

AB
40MG
N018487 002

AB
80MG
A070082 001 Oct 29, 1986

AB PRINSTON INC
20MG
A076796 001 Mar 26, 2004

AB
40MG
A076796 002 Mar 26, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-203(of 452)

FUROSEMIDE

TABLET;ORAL

FUROSEMIDE

AB 80MG A076796 003 Mar 26, 2004

AB SANDOZ 20MG N018569 002



AB 40MG N018569 001

AB 80MG N018569 005 Aug 14, 1984

AB WEST-WARD PHARMS 20MG N018823 001 Nov 10, 1983

INT

AB 40MG N018823 002 Nov 10, 1983

AB 80MG A070086 001 Jan 24, 1986

LASIX

AB + US PHARM HOLDINGS 20MG N016273 002

AB + 40MG N016273 001

AB +! 80MG N016273 003

GABAPENTIN

CAPSULE;ORAL

GABAPENTIN

AB ACI HEALTHCARE LTD 100MG A206943 001 May 14, 2018

AB 300MG A206943 002 May 14, 2018

AB 400MG A206943 003 May 14, 2018

AB ACTAVIS ELIZABETH 100MG A075350 001 Sep 12, 2003

AB 300MG A075350 002 Sep 12, 2003

AB 400MG A075350 003 Sep 12, 2003

AB ALKEM 100MG A090858 001 Dec 17, 2010

AB 300MG A090858 002 Dec 17, 2010

AB 400MG A090858 003 Dec 17, 2010

AB AMNEAL PHARMS NY 100MG A078428 001 Jul 25, 2007

AB 300MG A078428 002 Jul 25, 2007

AB 400MG A078428 003 Jul 25, 2007

AB APOTEX INC 100MG A075360 001 Apr 06, 2005

AB 300MG A075360 002 Apr 06, 2005

AB 400MG A075360 003 Apr 06, 2005

AB AUROBINDO PHARMA 100MG A078787 001 Jan 31, 2008

LTD

AB 300MG A078787 002 Jan 31, 2008

AB 400MG A078787 003 Jan 31, 2008

AB EPIC PHARMA LLC 100MG A207099 001 Mar 24, 2017

AB 300MG A207099 002 Mar 24, 2017

AB 400MG A207099 003 Mar 24, 2017

AB INVAGEN PHARMS 100MG A090705 001 Dec 30, 2009

AB 300MG A090705 002 Dec 30, 2009

AB 400MG A090705 003 Dec 30, 2009

AB JIANGSU HENGRUI MED 100MG A091008 001 Oct 26, 2017

AB 300MG A091008 002 Oct 26, 2017

AB 400MG A091008 003 Oct 26, 2017

AB MARKSANS PHARMA 100MG A090007 001 Jul 21, 2011

AB 300MG A090007 002 Jul 21, 2011

AB 400MG A090007 003 Jul 21, 2011

AB MYLAN 100MG A090158 001 Feb 14, 2011

AB 300MG A090158 002 Feb 14, 2011

AB 400MG A090158 003 Feb 14, 2011

AB SCIEGEN PHARMS INC 100MG A204989 001 Feb 18, 2016

AB 300MG A204989 002 Feb 18, 2016

AB 400MG A204989 003 Feb 18, 2016

AB STRIDES PHARMA 100MG A211314 001 Oct 16, 2018

AB 300MG A211314 002 Oct 16, 2018

AB 400MG A211314 003 Oct 16, 2018

AB SUN PHARM INDS LTD 100MG A077242 001 Aug 24, 2006

AB 300MG A077242 002 Aug 24, 2006

AB 400MG A077242 003 Aug 24, 2006

AB TARO PHARM 100MG A077261 001 Aug 02, 2013

AB 300MG A077261 002 Aug 02, 2013

AB 400MG A077261 003 Aug 02, 2013

AB TEVA PHARMS 100MG A075435 001 Oct 08, 2004

AB 300MG A075435 002 Oct 08, 2004

AB 400MG A075435 003 Oct 08, 2004

NEURONTIN

AB + PFIZER PHARMS 100MG N020235 001 Dec 30, 1993

AB + 300MG N020235 002 Dec 30, 1993

AB +! 400MG N020235 003 Dec 30, 1993



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-204(of 452)

GABAPENTIN

SOLUTION;ORAL

GABAPENTIN

AA ACELLA PHARMS LLC 250MG/5ML A076403 001 May 01, 2012

AA AMNEAL PHARMS 250MG/5ML A202024 001 Mar 23, 2012

AA HI TECH PHARMA 250MG/5ML A078974 001 Feb 18, 2011

AA TARO 250MG/5ML A076672 001 Jul 03, 2013

AA TRIS PHARMA INC 250MG/5ML A091286 001 Mar 14, 2016

NEURONTIN

AA +! PARKE DAVIS 250MG/5ML N021129 001 Mar 02, 2000

TABLET;ORAL

GABAPENTIN

AB ACI HEALTHCARE LTD 600MG A203244 002 Jul 12, 2013

AB 800MG A203244 001 Jul 12, 2013

AB ACTAVIS ELIZABETH 600MG A075694 001 Oct 21, 2004

AB 800MG A075694 002 Oct 21, 2004

AB ALKEM LABS LTD 600MG A206402 001 Dec 23, 2015

AB 800MG A206402 002 Dec 23, 2015

AB APOTEX INC 100MG A077894 001 Oct 10, 2006

AB 300MG A077894 002 Oct 10, 2006

AB 400MG A077894 003 Oct 10, 2006

AB 600MG A077661 004 Sep 13, 2006

AB 800MG A077661 005 Sep 13, 2006

AB AUROBINDO PHARMA 600MG A200651 001 Oct 06, 2011

LTD

AB 800MG A200651 002 Oct 06, 2011

AB CSPC OUYI PHARM CO 600MG A207057 001 Oct 26, 2017

AB 800MG A207057 002 Oct 26, 2017

AB GLENMARK PHARMS LTD 600MG A077662 001 Aug 18, 2006

AB 800MG A077662 002 Aug 18, 2006

AB INVAGEN PHARMS 600MG A202764 001 Oct 16, 2012

AB 800MG A202764 002 Oct 16, 2012

AB IVAX SUB TEVA 100MG A076017 001 Apr 28, 2004

PHARMS

AB 300MG A076017 002 Apr 28, 2004

AB 400MG A076017 003 Apr 28, 2004

AB 600MG A076017 004 Apr 29, 2005

AB 800MG A076017 005 Apr 29, 2005

AB LUPIN LTD 600MG A209306 001 Aug 24, 2018

AB 800MG A209306 002 Aug 24, 2018

AB MYLAN PHARMS INC 600MG A090335 001 Jun 01, 2010

AB 800MG A090335 002 Jun 01, 2010

AB SCIEGEN PHARMS INC 600MG A205101 001 Feb 04, 2016

AB 800MG A205101 002 Feb 04, 2016

AB SUN PHARM INDS LTD 600MG A077525 001 Aug 24, 2006

AB 800MG A077525 002 Aug 24, 2006

AB TEVA PHARMS USA 600MG A205807 001 Mar 10, 2017

AB 800MG A205807 002 Mar 10, 2017

AB ZYDUS PHARMS USA 600MG A078926 001 Feb 11, 2011

INC

AB 800MG A078926 002 Feb 11, 2011

NEURONTIN

AB + PFIZER PHARMS 600MG N020882 001 Oct 09, 1998

AB +! 800MG N020882 002 Oct 09, 1998



GRALISE

BX +! ASSERTIO 300MG N022544 001 Jan 28, 2011

BX +! 600MG N022544 002 Jan 28, 2011

GABAPENTIN ENACARBIL

TABLET, EXTENDED RELEASE;ORAL

HORIZANT

+ ARBOR PHARMS LLC 300MG N022399 002 Dec 13, 2011

+! 600MG N022399 001 Apr 06, 2011

GADOBENATE DIMEGLUMINE

INJECTABLE;INTRAVENOUS

MULTIHANCE

+! BRACCO 2.645GM/5ML (529MG/ML) N021357 001 Nov 23, 2004

+! 5.29GM/10ML (529MG/ML) N021357 002 Nov 23, 2004

+! 7.935GM/15ML (529MG/ML) N021357 003 Nov 23, 2004

+! 10.58GM/20ML (529MG/ML) N021357 004 Nov 23, 2004

MULTIHANCE MULTIPACK

+! BRACCO 26.45GM/50ML (529MG/ML) N021358 001 Nov 23, 2004

+! 52.9GM/100ML (529MG/ML) N021358 002 Nov 23, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-205(of 452)

GADOBUTROL

SOLUTION;INTRAVENOUS

GADAVIST

+! BAYER HLTHCARE 1.20944GM/2ML (604.72MG/ML) N201277 006 Dec 18, 2013

+! 4.5354GM/7.5ML (604.72MG/ML) N201277 001 Mar 14, 2011

+! 6.0472GM/10ML (604.72MG/ML) N201277 002 Mar 14, 2011

+! 9.0708GM/15ML (604.72MG/ML) N201277 003 Mar 14, 2011

+! 18.1416GM/30ML (604.72MG/ML) N201277 004 Mar 14, 2011

+! 39.3068GM/65ML (604.72MG/ML) N201277 005 Mar 14, 2011

GADODIAMIDE

INJECTABLE;INJECTION

OMNISCAN

+! GE HEALTHCARE 287MG/ML N020123 001 Jan 08, 1993

+! 28.7GM/100ML (287MG/ML) N022066 002 Sep 05, 2007

GADOPENTETATE DIMEGLUMINE

INJECTABLE;INJECTION

MAGNEVIST

+! BAYER HLTHCARE 469.01MG/ML N019596 001 Jun 02, 1988

+! 469.01MG/ML N021037 001 Mar 10, 2000

GADOTERATE MEGLUMINE

SOLUTION;INTRAVENOUS

DOTAREM

+! GUERBET 37.69GM/100ML (376.9MG/ML) N204781 001 Mar 20, 2013

+! 1.8845GM/5ML (376.9MG/ML) N204781 005 Mar 31, 2017

+! 3.769GM/10ML (376.9MG/ML) N204781 002 Mar 20, 2013

+! 5.6535GM/15ML (376.9MG/ML) N204781 003 Mar 20, 2013

+! 7.538GM/20ML (376.9MG/ML) N204781 004 Mar 20, 2013

GADOTERIDOL

INJECTABLE;INJECTION

PROHANCE

+! BRACCO 279.3MG/ML N020131 001 Nov 16, 1992

PROHANCE MULTIPACK

+! BRACCO 279.3MG/ML N021489 001 Oct 09, 2003

GADOXETATE DISODIUM

SOLUTION;INTRAVENOUS

EOVIST

+! BAYER HLTHCARE 1.8143GM/10ML (181.43MG/ML) N022090 001 Jul 03, 2008

+ 2.72145GM/15ML (181.43MG/ML) N022090 002 Feb 04, 2013

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;ORAL

GALANTAMINE HYDROBROMIDE

AB AUROBINDO PHARMA EQ 8MG BASE A204895 001 Aug 05, 2016

LTD

AB EQ 16MG BASE A204895 002 Aug 05, 2016

AB EQ 24MG BASE A204895 003 Aug 05, 2016

AB BARR EQ 8MG BASE A078189 001 Sep 15, 2008

AB EQ 16MG BASE A078189 002 Sep 15, 2008

AB EQ 24MG BASE A078189 003 Sep 15, 2008

AB SUN PHARMA GLOBAL EQ 8MG BASE A090178 001 Feb 02, 2011

AB EQ 16MG BASE A090178 002 Feb 02, 2011

AB EQ 24MG BASE A090178 003 Feb 02, 2011

AB WATSON LABS EQ 8MG BASE A079028 001 Dec 15, 2008

AB EQ 16MG BASE A079028 002 Dec 15, 2008

AB EQ 24MG BASE A079028 003 Dec 15, 2008

RAZADYNE ER

AB +! JANSSEN PHARMS EQ 8MG BASE N021615 001 Apr 01, 2005

AB + EQ 16MG BASE N021615 002 Apr 01, 2005

AB + EQ 24MG BASE N021615 003 Apr 01, 2005

SOLUTION;ORAL

GALANTAMINE HYDROBROMIDE

! WEST-WARD PHARMS 4MG/ML A078185 001 Jan 30, 2009

INT

TABLET;ORAL

GALANTAMINE HYDROBROMIDE

AB APOTEX INC EQ 4MG BASE A077781 001 Sep 27, 2011

AB EQ 8MG BASE A077781 002 Sep 27, 2011

AB EQ 12MG BASE A077781 003 Sep 27, 2011

AB AUROBINDO PHARMA EQ 4MG BASE A090957 001 Mar 29, 2011

LTD

AB EQ 8MG BASE A090957 002 Mar 29, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-206(of 452)

GALANTAMINE HYDROBROMIDE

TABLET;ORAL

GALANTAMINE HYDROBROMIDE

AB EQ 12MG BASE A090957 003 Mar 29, 2011

AB BARR EQ 4MG BASE A077605 001 Aug 28, 2008

AB EQ 8MG BASE A077605 002 Aug 28, 2008

AB EQ 12MG BASE A077605 003 Aug 28, 2008

AB DR REDDYS LABS LTD EQ 4MG BASE A077593 001 Sep 11, 2008

AB EQ 8MG BASE A077593 002 Sep 11, 2008

AB EQ 12MG BASE A077593 003 Sep 11, 2008

AB MYLAN EQ 4MG BASE A077590 001 May 29, 2009

AB EQ 8MG BASE A077590 002 May 29, 2009

AB EQ 12MG BASE A077590 003 May 29, 2009

AB SANDOZ EQ 4MG BASE A077589 001 Jun 22, 2009

AB EQ 8MG BASE A077589 002 Jun 22, 2009

AB EQ 12MG BASE A077589 003 Jun 22, 2009

AB TEVA PHARMS EQ 4MG BASE A077587 001 Jul 09, 2009

AB EQ 8MG BASE A077587 002 Jul 09, 2009

AB EQ 12MG BASE A077587 003 Jul 09, 2009

AB WEST-WARD PHARMS EQ 4MG BASE A077608 001 Feb 11, 2009

INT

AB EQ 8MG BASE A077608 002 Feb 11, 2009

AB EQ 12MG BASE A077608 003 Feb 11, 2009

AB YABAO PHARM EQ 4MG BASE A077604 001 Feb 06, 2009

AB EQ 8MG BASE A077604 002 Feb 06, 2009

AB EQ 12MG BASE A077604 003 Feb 06, 2009

AB ZYDUS PHARMS USA EQ 4MG BASE A078898 001 Feb 17, 2011

INC

AB EQ 8MG BASE A078898 002 Feb 17, 2011

AB EQ 12MG BASE A078898 003 Feb 17, 2011

RAZADYNE

AB +! JANSSEN PHARMS EQ 4MG BASE N021169 001 Feb 28, 2001

AB + EQ 8MG BASE N021169 002 Feb 28, 2001

AB + EQ 12MG BASE N021169 003 Feb 28, 2001



GALLIUM CITRATE GA-67

INJECTABLE;INJECTION

GALLIUM CITRATE GA 67

BS LANTHEUS MEDCL 2mCi/ML N017478 001

BS MALLINKRODT NUCLEAR 2mCi/ML N018058 001

GALLIUM DOTATATE GA-68

POWDER;INTRAVENOUS

NETSPOT

+! AAA USA INC 2.1-5.5mCi/ML N208547 001 Jun 01, 2016

GANCICLOVIR

GEL;OPHTHALMIC

ZIRGAN

+! BAUSCH AND LOMB 0.15% N022211 001 Sep 15, 2009

GANCICLOVIR

SOLUTION;INTRAVENOUS

GANCICLOVIR

+! EXELA PHARMA SCS 500MG/250ML (2MG/ML) N209347 001 Feb 17, 2017

LLC

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

CYTOVENE

AP +! ROCHE PALO EQ 500MG BASE/VIAL N019661 001 Jun 23, 1989

GANCICLOVIR

AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A090658 001 Jun 21, 2010

AP HAINAN POLY PHARM EQ 500MG BASE/VIAL A204204 001 Nov 08, 2018

AP LUITPOLD EQ 500MG BASE/VIAL A202624 001 Sep 18, 2013

AP MYLAN LABS LTD EQ 500MG BASE/VIAL A204560 001 Nov 17, 2017

AP PAR STERILE EQ 500MG BASE/VIAL A204950 001 Dec 06, 2016

PRODUCTS

GANCICLOVIR SODIUM

AP PHARMASCIENCE INC EQ 500MG BASE/VIAL A207645 001 Dec 08, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-207(of 452)

GANIRELIX ACETATE

INJECTABLE;INJECTION

GANIRELIX ACETATE

AP +! ORGANON USA INC
EQ 250MCG BASE/0.5ML
N021057 001 Jul 29, 1999

AP SUN PHARM INDS LTD


EQ 250MCG BASE/0.5ML
A204246 001 Nov 30, 2018

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

GATIFLOXACIN

AT HI-TECH PHARMA CO
0.5%
A203189 001 Sep 03, 2014

AT LUPIN LTD
0.5%
A202653 001 Aug 28, 2013

AT MYLAN PHARMS INC


0.5%
A206446 001 Jun 08, 2018

AT SANDOZ INC
0.5%
A204227 001 Jul 11, 2016

ZYMAXID

AT +! ALLERGAN 0.5%
N022548 001 May 18, 2010

ZYMAR
+! ALLERGAN 0.3%
N021493 001 Mar 28, 2003

GEFITINIB

TABLET;ORAL

IRESSA

+! ASTRAZENECA PHARMS
250MG
N206995 001 Jul 13, 2015

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION

GEMCITABINE HYDROCHLORIDE

AP ACCORD HLTHCARE
EQ 200MG BASE/VIAL
A091594 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A091594 002 Jul 25, 2011

AP
EQ 2GM BASE/VIAL
A091594 003 Jul 25, 2011

AP ACTAVIS INC
200MG/5.26ML (38MG/ML)
A204549 001 Apr 11, 2016

AP
1GM/26.3ML (38MG/ML)
A204549 002 Apr 11, 2016

AP
2GM/52.6ML (38MG/ML)
A204549 003 Apr 11, 2016

AP ACTAVIS TOTOWA
EQ 200MG BASE/VIAL
A079160 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A079160 002 Jul 25, 2011

AP
EQ 2GM BASE/VIAL
A079160 003 Jul 28, 2016

AP APOTEX INC
200MG/5.26ML (38MG/ML)
A206776 001 May 23, 2017

AP
1GM/26.3ML (38MG/ML)
A206776 002 May 23, 2017

AP
2GM/52.6ML (38MG/ML)
A206776 003 May 23, 2017

AP CIPLA
EQ 200MG BASE/VIAL
A078759 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A078759 002 Jul 25, 2011

AP DR REDDYS LABS LTD


EQ 200MG BASE/VIAL
A091365 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A091365 002 Jul 25, 2011

AP
EQ 2GM BASE/VIAL
A202997 001 May 07, 2013

AP EMCURE PHARMS LTD


EQ 200MG BASE/VIAL
A202063 001 Sep 11, 2012

AP
EQ 1GM BASE/VIAL
A202063 002 Sep 11, 2012

AP FRESENIUS KABI
EQ 200MG BASE/VIAL
A090799 001 Jul 25, 2011

ONCOL

AP
EQ 1GM BASE/VIAL
A090799 002 Jul 25, 2011

AP
EQ 2GM BASE/VIAL
A090799 003 May 16, 2011

AP FRESENIUS KABI USA


EQ 2GM BASE/VIAL
A090242 003 May 16, 2011

AP GLAND PHARMA LTD


EQ 200MG BASE/VIAL
A204520 001 Jan 05, 2016

AP
EQ 1GM BASE/VIAL
A204520 002 Jan 05, 2016

AP HOSPIRA
EQ 200MG BASE/VIAL
A078339 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A078339 002 Jul 25, 2011

AP +! HOSPIRA INC
200MG/5.26ML (38MG/ML)
N200795 001 Aug 04, 2011

AP +!
1GM/26.3ML (38MG/ML)
N200795 002 Aug 04, 2011

AP !
EQ 2GM BASE/VIAL
A079183 001 Nov 15, 2010

AP +!
2GM/52.6ML (38MG/ML)
N200795 003 Aug 04, 2011

AP JIANGSU HANSOH
EQ 200MG BASE/VIAL
A202485 001 May 07, 2013

PHARM

AP
EQ 1GM BASE/VIAL
A202485 002 May 07, 2013

AP LUITPOLD
EQ 200MG BASE/VIAL
A202031 001 May 07, 2013

AP
EQ 1GM BASE/VIAL
A202031 002 May 07, 2013

AP MYLAN LABS LTD


EQ 200MG BASE/VIAL
A200145 001 Jul 25, 2011

AP
200MG/5.26ML (38MG/ML)
A205242 001 Dec 06, 2017

AP
EQ 1GM BASE/VIAL
A200145 002 Jul 25, 2011

AP
1GM/26.3ML (38MG/ML)
A205242 002 Dec 06, 2017

AP
EQ 2GM BASE/VIAL
A200145 003 Jul 25, 2011

AP
2GM/52.6ML (38MG/ML)
A205242 003 Dec 06, 2017

AP SAGENT PHARMS
200MG/5.26ML (38MG/ML)
A209077 001 Jul 20, 2018

AP
1GM/26.3ML (38MG/ML)
A209077 002 Jul 20, 2018

AP
2GM/52.6ML (38MG/ML)
A209077 003 Jul 20, 2018

AP SUN PHARMA GLOBAL


EQ 200MG BASE/VIAL
A078433 001 Jul 25, 2011

AP
EQ 1GM BASE/VIAL
A078433 002 Jul 25, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-208(of 452)

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION

GEMCITABINE HYDROCHLORIDE

AP TEVA PHARMS EQ 200MG BASE/VIAL A077983 002 Jan 25, 2011

AP EQ 1GM BASE/VIAL A077983 001 Jan 25, 2011

GEMZAR

AP +! LILLY EQ 200MG BASE/VIAL N020509 001 May 15, 1996

AP +! EQ 1GM BASE/VIAL N020509 002 May 15, 1996

SOLUTION;INTRAVENOUS

GEMCITABINE HYDROCHLORIDE

+! ACCORD HLTHCARE 1GM/10ML (100MG/ML) N209604 002 Aug 03, 2017

+! 1.5GM/15ML (100MG/ML) N209604 003 Aug 03, 2017

+! 2GM/20ML (100MG/ML) N209604 004 Aug 03, 2017

+! 200MG/2ML (100MG/ML) N209604 001 Aug 03, 2017

INFUGEM

+! SUN PHARM INDS LTD EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) N208313 001 Jul 16, 2018

+! EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) N208313 002 Jul 16, 2018

+! EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) N208313 003 Jul 16, 2018

+! EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) N208313 004 Jul 16, 2018

+! EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) N208313 005 Jul 16, 2018

+! EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) N208313 006 Jul 16, 2018

+! EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) N208313 007 Jul 16, 2018

+! EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) N208313 008 Jul 16, 2018

+! EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) N208313 009 Jul 16, 2018

+! EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) N208313 010 Jul 16, 2018

GEMFIBROZIL

TABLET;ORAL

GEMFIBROZIL

AB APOTEX 600MG A075034 001 Jul 20, 1998

AB AUROBINDO PHARMA 600MG A202726 001 Sep 16, 2015

LTD

AB CADILA PHARMS LTD 600MG A203266 001 Jun 17, 2016

AB CARIBE HOLDINGS 600MG A078012 001 Mar 26, 2007

AB CHARTWELL MOLECULES 600MG A074270 001 Sep 27, 1993

AB HIKMA PHARMS 600MG A078599 001 Aug 16, 2010

AB IMPAX PHARMS 600MG A078207 001 Jun 01, 2007

AB INVAGEN PHARMS 600MG A077836 001 Jul 27, 2006

AB NORTHSTAR HLTHCARE 600MG A079072 001 Sep 13, 2010

AB SUN PHARM INDS INC 600MG A079239 001 Dec 29, 2008

AB TEVA 600MG A074256 001 Oct 31, 1993

AB ZYDUS PHARMS USA 600MG A204189 001 Aug 28, 2018

INC

LOPID

AB +! PFIZER PHARMS 600MG N018422 003 Nov 20, 1986

GEMIFLOXACIN MESYLATE

TABLET;ORAL

FACTIVE

AB +! LG CHEM LTD EQ 320MG BASE N021158 001 Apr 04, 2003

GEMIFLOXACIN MESYLATE

AB ORCHID HLTHCARE EQ 320MG BASE A090466 001 Jun 15, 2015

GENTAMICIN SULFATE

CREAM;TOPICAL

GENTAMICIN SULFATE

AT G AND W LABS INC EQ 0.1% BASE A064056 001 Apr 29, 1994

AT ! PERRIGO NEW YORK EQ 0.1% BASE A062307 001



INJECTABLE;INJECTION

GENTAMICIN SULFATE

AP FRESENIUS KABI USA EQ 10MG BASE/ML A062366 002 Feb 06, 1986

AP ! EQ 40MG BASE/ML A062366 001 Aug 04, 1983

AP HOSPIRA EQ 10MG BASE/ML A062420 001 Aug 15, 1983

AP EQ 10MG BASE/ML A062612 004 Feb 20, 1986

AP EQ 40MG BASE/ML A062420 002 Aug 15, 1983

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP BAXTER HLTHCARE EQ 1.2MG BASE/ML A062373 007 Sep 07, 1982

AP EQ 1.6MG BASE/ML A062373 008 Sep 07, 1982

AP EQ 80MG BASE/100ML A062373 002 Sep 07, 1982

AP EQ 100MG BASE/100ML A062373 005 Sep 07, 1982

AP HOSPIRA EQ 1.2MG BASE/ML A062414 001 Aug 15, 1983

AP EQ 1.6MG BASE/ML A062414 003 Aug 15, 1983

AP EQ 80MG BASE/100ML A062414 008 Aug 15, 1983

AP EQ 100MG BASE/100ML A062414 010 Aug 15, 1983



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-209(of 452)

GENTAMICIN SULFATE

INJECTABLE;INJECTION

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

! BAXTER HLTHCARE EQ 2MG BASE/ML A062373 009 Sep 07, 1982

! EQ 120MG BASE/100ML A062373 006 Sep 07, 1982

OINTMENT;OPHTHALMIC

GENTAMICIN SULFATE

AT ! AKORN EQ 0.3% BASE A064093 001 Aug 31, 1995

AT PERRIGO CO EQ 0.3% BASE A065024 001 Jul 30, 2004

TENNESSEE

OINTMENT;TOPICAL

GENTAMICIN SULFATE

AT FOUGERA PHARMS INC EQ 0.1% BASE A062533 001 Oct 05, 1984

AT G AND W LABS INC EQ 0.1% BASE A064054 001 Apr 29, 1994

AT ! PERRIGO NEW YORK EQ 0.1% BASE A062351 001 Feb 18, 1982

AT TARO EQ 0.1% BASE A062477 001 Dec 23, 1983

AT TELIGENT PHARMA INC EQ 0.1% BASE A209233 001 Dec 31, 2018

SOLUTION/DROPS;OPHTHALMIC

GENOPTIC

AT ! ALLERGAN EQ 0.3% BASE A062452 001 Oct 10, 1984

GENTAK

AT AKORN EQ 0.3% BASE A064163 001 Oct 12, 2001

GENTAMICIN SULFATE

AT AKORN EQ 0.3% BASE A062635 001 Jan 08, 1987

AT BAUSCH AND LOMB EQ 0.3% BASE A064048 001 May 11, 1994

AT PERRIGO CO EQ 0.3% BASE A065121 001 Jan 30, 2004

TENNESSEE

AT SANDOZ INC EQ 0.3% BASE A062196 001

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

OINTMENT;OPHTHALMIC

PRED-G

+! ALLERGAN EQ 0.3% BASE;0.6% N050612 001 Dec 01, 1989

SUSPENSION/DROPS;OPHTHALMIC

PRED-G

+! ALLERGAN EQ 0.3% BASE;1% N050586 001 Jun 10, 1988

GILTERITINIB FUMARATE

TABLET;ORAL

XOSPATA

+! ASTELLAS EQ 40MG BASE N211349 001 Nov 28, 2018

GLASDEGIB

TABLET;ORAL

DAURISMO

+ PFIZER INC 25MG N210656 001 Nov 21, 2018

+! 100MG N210656 002 Nov 21, 2018

GLATIRAMER ACETATE

INJECTABLE;SUBCUTANEOUS

COPAXONE

AP +! TEVA PHARMS USA 20MG/ML N020622 002 Feb 12, 2002

AP +! 40MG/ML N020622 003 Jan 28, 2014

GLATIRAMER ACETATE

AP MYLAN PHARMS INC 20MG/ML A091646 001 Oct 03, 2017

AP 40MG/ML A206936 001 Oct 03, 2017

GLATOPA

AP SANDOZ INC 20MG/ML A090218 001 Apr 16, 2015

AP 40MG/ML A206921 001 Feb 12, 2018



GLECAPREVIR; PIBRENTASVIR

TABLET;ORAL

MAVYRET

+! ABBVIE INC 100MG;40MG N209394 001 Aug 03, 2017

GLIMEPIRIDE

TABLET;ORAL

AMARYL

AB +! SANOFI AVENTIS US 1MG N020496 001 Nov 30, 1995

AB + 2MG N020496 002 Nov 30, 1995

AB + 4MG N020496 003 Nov 30, 1995

GLIMEPIRIDE

AB ACCORD HLTHCARE 1MG A078181 001 Aug 23, 2007

AB 2MG A078181 002 Aug 23, 2007

AB 4MG A078181 003 Aug 23, 2007

AB AUROBINDO PHARMA 1MG A202759 001 Jun 29, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-210(of 452)

GLIMEPIRIDE

TABLET;ORAL

GLIMEPIRIDE

LTD

AB 2MG A202759 002 Jun 29, 2012

AB 4MG A202759 003 Jun 29, 2012

AB CARLSBAD 1MG A077911 001 Sep 22, 2009

AB 2MG A077911 002 Sep 22, 2009

AB 4MG A077911 003 Sep 22, 2009

AB DR REDDYS LABS LTD 1MG A077091 001 Oct 06, 2005

AB 2MG A077091 002 Oct 06, 2005

AB 4MG A077091 003 Oct 06, 2005

AB INDOCO REMEDIES 1MG A202112 001 Apr 17, 2013

AB 2MG A202112 002 Apr 17, 2013

AB 4MG A202112 003 Apr 17, 2013

AB INVAGEN PHARMS 1MG A077295 001 Oct 06, 2005

AB 2MG A077295 002 Oct 06, 2005

AB 4MG A077295 003 Oct 06, 2005

AB MYLAN 1MG A077624 001 Nov 28, 2005

AB 2MG A077624 002 Nov 28, 2005

AB 4MG A077624 003 Nov 28, 2005

AB PRINSTON INC 1MG A077370 001 Dec 23, 2005

AB 2MG A077370 002 Dec 23, 2005

AB 4MG A077370 003 Dec 23, 2005

AB 8MG A077370 004 Dec 23, 2005

AB TEVA 1MG A076802 001 Oct 06, 2005

AB 2MG A076802 002 Oct 06, 2005

AB 4MG A076802 003 Oct 06, 2005

AB VIVA HLTHCARE 1MG A091220 001 Jun 29, 2012

AB 2MG A091220 002 Jun 29, 2012

AB 4MG A091220 004 Jun 29, 2012

AB 8MG A091220 006 Jun 29, 2012



3MG A091220 003 Jun 29, 2012

6MG A091220 005 Jun 29, 2012

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

DUETACT

AB +! TAKEDA PHARMS USA 2MG;30MG N021925 001 Jul 28, 2006

AB + 4MG;30MG N021925 002 Jul 28, 2006

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE



AB SANDOZ 2MG;30MG A201049 001 Jan 04, 2013

AB 4MG;30MG A201049 002 Jan 04, 2013



GLIPIZIDE

TABLET;ORAL

GLIPIZIDE

AB ACCORD HLTHCARE 5MG A074550 001 Sep 11, 1997

AB 10MG A074550 002 Sep 11, 1997

AB ANI PHARMS INC 5MG A074497 001 Aug 31, 1995

AB 10MG A074497 002 Aug 31, 1995

AB APOTEX 5MG A075795 001 Jun 13, 2001

AB 10MG A075795 002 Jun 13, 2001

AB MYLAN 5MG A074226 001 May 10, 1994

AB 10MG A074226 002 May 10, 1994

AB SANDOZ 5MG A074305 001 Apr 07, 1995

AB 10MG A074305 002 Apr 07, 1995

AB SUN PHARM INDS INC 5MG A077820 001 Jul 11, 2006

AB 10MG A077820 002 Jul 11, 2006

AB WATSON LABS TEVA 5MG A074223 001 Feb 27, 1995

AB 10MG A074223 002 Feb 27, 1995

GLUCOTROL

AB + PFIZER 5MG N017783 001 May 08, 1984

AB +! 10MG N017783 002 May 08, 1984

TABLET, EXTENDED RELEASE;ORAL

GLIPIZIDE

AB AUROBINDO PHARMA 2.5MG A206928 001 May 12, 2017

LTD

AB 5MG A206928 002 May 12, 2017

AB 10MG A206928 003 May 12, 2017

AB MYLAN PHARMS INC 2.5MG A202298 001 May 19, 2015

AB 5MG A202298 002 May 19, 2015

AB 10MG A202298 003 May 19, 2015

AB PAR PHARM 5MG A076159 002 Sep 20, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-211(of 452)

GLIPIZIDE

TABLET, EXTENDED RELEASE;ORAL

GLIPIZIDE

AB 10MG A076159 001 Sep 20, 2013

AB UNIQUE PHARM LABS 2.5MG A204720 001 Dec 29, 2016

AB 5MG A204720 002 Dec 29, 2016

AB 10MG A204720 003 Dec 29, 2016

AB WATSON LABS 2.5MG A076467 003 Mar 27, 2006

AB 5MG A076467 001 Sep 08, 2003

AB 10MG A076467 002 Nov 07, 2003

AB ZYDUS PHARMS USA 2.5MG A203499 001 Jul 16, 2018

INC

AB 5MG A203499 002 Jul 16, 2018

AB 10MG A203499 003 Jul 16, 2018

GLUCOTROL XL

AB + PFIZER 2.5MG N020329 003 Aug 10, 1999

AB + 5MG N020329 001 Apr 26, 1994

AB +! 10MG N020329 002 Apr 26, 1994



GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLIPIZIDE AND METFORMIN HYDROCHLORIDE



AB EPIC PHARMA LLC 2.5MG;250MG A077507 001 Oct 27, 2005

AB 2.5MG;500MG A077507 002 Oct 27, 2005

AB 5MG;500MG A077507 003 Oct 27, 2005

AB HERITAGE PHARMS INC 2.5MG;250MG A078728 001 Jun 23, 2010

AB 2.5MG;500MG A078728 002 Jun 23, 2010

AB 5MG;500MG A078728 003 Jun 23, 2010

AB MYLAN 2.5MG;250MG A078083 001 Apr 12, 2007

AB 2.5MG;500MG A078083 002 Apr 12, 2007

AB 5MG;500MG A078083 003 Apr 12, 2007

AB SUN PHARM INDS INC 2.5MG;250MG A077620 001 Jan 11, 2008

AB 2.5MG;500MG A077620 002 Jan 11, 2008

AB 5MG;500MG A077620 003 Jan 11, 2008

AB TEVA PHARMS 2.5MG;250MG A077270 001 Oct 28, 2005

AB 2.5MG;500MG A077270 002 Oct 28, 2005

AB ! 5MG;500MG A077270 003 Oct 28, 2005

AB ZYDUS PHARMS USA 2.5MG;250MG A078905 001 Jan 31, 2011

INC

AB 2.5MG;500MG A078905 002 Jan 31, 2011

AB 5MG;500MG A078905 003 Jan 31, 2011



GLUCAGON

INJECTABLE;INJECTION

GLUCAGON

+! LILLY 1MG/VIAL N020928 001 Sep 11, 1998

GLUCAGON HYDROCHLORIDE

INJECTABLE;INJECTION

GLUCAGEN

+! NOVO NORDISK EQ 1MG BASE/VIAL N020918 001 Jun 22, 1998

POWDER;INTRAMUSCULAR, INTRAVENOUS

GLUCAGON

+! FRESENIUS KABI USA EQ 1MG BASE/VIAL N201849 001 May 08, 2015

GLYBURIDE

TABLET;ORAL

GLYBURIDE (MICRONIZED)

AB DAVA PHARMS INC 1.5MG A074591 001 Dec 22, 1997

AB 3MG A074591 002 Dec 22, 1997

AB 4.5MG A074591 003 Dec 22, 1997

AB 6MG A074591 004 Dec 22, 1997

AB HIKMA 1.5MG A075890 001 Jul 31, 2003

AB 3MG A075890 002 Jul 31, 2003

AB 6MG A075890 003 Jul 31, 2003

AB MYLAN 1.5MG A074792 001 Jun 26, 1998

AB 3MG A074792 002 Jun 26, 1998

AB 6MG A074792 003 Aug 17, 1999

AB TEVA 1.5MG A074686 001 Apr 20, 1999

AB 3MG A074686 002 Apr 20, 1999

AB 4.5MG A074686 003 Apr 20, 1999

AB 6MG A074686 004 Apr 20, 1999

GLYNASE

AB + PHARMACIA AND 1.5MG N020051 001 Mar 04, 1992

UPJOHN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-212(of 452)

GLYBURIDE

TABLET;ORAL

GLYNASE

AB +
3MG
N020051 002 Mar 04, 1992

AB +!
6MG
N020051 004 Sep 24, 1993

GLYBURIDE

AB1 AUROBINDO PHARMA 1.25MG
A077537 001 Oct 18, 2007

AB1 2.5MG
A077537 002 Oct 18, 2007

AB1 5MG
A077537 003 Oct 18, 2007

AB1 CADILA PHARMS LTD 1.25MG


A203379 001 Jan 04, 2019

AB1 2.5MG
A203379 002 Jan 04, 2019

AB1 5MG
A203379 003 Jan 04, 2019

AB1 EPIC PHARMA LLC 1.25MG


A076257 001 Jun 27, 2002

AB1 2.5MG
A076257 002 Jun 27, 2002

AB1 5MG
A076257 003 Jun 27, 2002

AB1 HERITAGE PHARMS INC 1.25MG


A090937 001 Feb 28, 2011

AB1 2.5MG
A090937 002 Feb 28, 2011

AB1 5MG
A090937 003 Feb 28, 2011

AB1 PHARMADAX INC 1.25MG


A203581 001 Apr 14, 2016

AB1 2.5MG
A203581 002 Apr 14, 2016

AB1 5MG
A203581 003 Apr 14, 2016

AB1 TEVA 1.25MG


A074388 001 Aug 29, 1995

AB1 2.5MG
A074388 002 Aug 29, 1995

AB1 ! 5MG
A074388 003 Aug 29, 1995

AB1 ZYDUS PHARMS USA 1.25mg


A206749 001 May 10, 2016

INC
AB1 2.5mg
A206749 002 May 10, 2016

AB1 5MG
A206749 003 May 10, 2016

DIABETA
AB2 + SANOFI AVENTIS US 1.25MG
N017532 001 May 01, 1984

AB2 + 2.5MG
N017532 002 May 01, 1984

AB2 +! 5MG
N017532 003 May 01, 1984

GLYBURIDE
AB2 IMPAX LABS INC 1.25MG
A206079 001 Sep 30, 2015

AB2 2.5MG
A206079 002 Sep 30, 2015

AB2 5MG
A206079 003 Sep 30, 2015

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLYBURIDE AND METFORMIN HYDROCHLORIDE



AB ACTAVIS ELIZABETH 1.25MG;250MG
A076716 001 Jun 28, 2005

AB 2.5MG;500MG
A076716 002 Jun 28, 2005

AB 5MG;500MG
A076716 003 Jun 28, 2005

AB AUROBINDO PHARMA 1.25MG;250MG


A077870 001 Nov 14, 2007

AB ! 2.5MG;500MG
A077870 002 Nov 14, 2007

AB 5MG;500MG
A077870 003 Nov 14, 2007

AB HERITAGE PHARMS INC 1.25MG;250MG


A079009 001 Jun 03, 2009

AB 2.5MG;500MG
A079009 002 Jun 03, 2009

AB 5MG;500MG
A079009 003 Jun 03, 2009

AB IMPAX LABS INC 1.25MG;250MG


A076345 001 Feb 18, 2004

AB 2.5MG;500MG
A076345 002 Feb 18, 2004

AB 5MG;500MG
A076345 003 Feb 18, 2004

AB ZYDUS PHARMS USA 1.25MG;250MG


A206748 001 Feb 29, 2016

INC
AB 2.5MG;500MG
A206748 002 Feb 29, 2016

AB 5MG;500MG
A206748 003 Feb 29, 2016

GLYCEROL PHENYLBUTYRATE

LIQUID;ORAL

RAVICTI

+! HORIZON THERAPS INC
1.1GM/ML
N203284 001 Feb 01, 2013

GLYCINE

SOLUTION;IRRIGATION

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER



AT +! BAXTER HLTHCARE 1.5GM/100ML
N017865 001

GLYCINE 1.5% IN PLASTIC CONTAINER

AT B BRAUN 1.5GM/100ML
N016784 001

AT ICU MEDICAL INC 1.5GM/100ML
N018315 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-213(of 452)

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

AP AMNEAL PHARMS CO 0.2MG/ML A208973 001 Jun 15, 2017

AP AUROBINDO PHARMA 0.2MG/ML A210244 001 Nov 28, 2018

LTD

AP FRESENIUS KABI USA 0.2MG/ML A209024 001 Oct 31, 2018

AP 0.2MG/ML A209328 001 Oct 27, 2017

AP ! HIKMA FARMACEUTICA 0.2MG/ML A090963 001 Sep 21, 2011

AP LUITPOLD 0.2MG/ML A089335 001 Jul 23, 1986

AP PIRAMAL CRITICAL 0.2MG/ML A210842 001 Oct 25, 2018

AP PRINSTON INC 0.2MG/ML A210927 001 Oct 31, 2018

AP SOMERSET THERAPS 0.2MG/ML A207639 001 Jun 23, 2017

LLC

POWDER;INHALATION

SEEBRI

+! SUNOVION PHARMS INC 15.6MCG/INH N207923 001 Oct 29, 2015

SOLUTION;INHALATION

LONHALA MAGNAIR KIT

+! SUNOVION RESP 25MCG/ML N208437 001 Dec 05, 2017

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

GLYRX-PF

EXELA PHARMA SCS 0.2MG/ML (0.2MG/ML) N210997 001 Jul 11, 2018

LLC

0.4MG/2ML (0.2MG/ML) N210997 002 Jul 11, 2018

SOLUTION;ORAL

CUVPOSA

+! MERZ PHARMS 1MG/5ML N022571 001 Jul 28, 2010

TABLET;ORAL

GLYCOPYRROLATE

AA AUROLIFE PHARMA LLC 1MG A202675 001 Apr 15, 2013

AA BOSCOGEN 1MG A091182 001 Feb 03, 2014

AA 2MG A091182 002 Feb 03, 2014

AA DR REDDYS LABS LTD 1MG A040847 001 Mar 21, 2008

AA 2MG A040847 002 Mar 21, 2008

AA HERITAGE PHARMS INC 1MG A207201 001 Jan 03, 2017

AA 2MG A207201 002 Jan 03, 2017

AA LEADING PHARMA LLC 1MG A090195 001 Sep 21, 2012

AA 2MG A090195 002 Sep 21, 2012

AA NATCO PHARMA LTD 1MG A091413 001 Jun 20, 2016

AA 2MG A091413 002 Jun 20, 2016

AA ORIT LABS LLC 1MG A203657 001 Nov 30, 2018

AA 2MG A203657 002 Nov 30, 2018

AA OXFORD PHARMS 1MG A090020 001 Oct 19, 2011

AA 2MG A090020 002 Oct 19, 2011

AA ! PAR PHARM 1MG A040653 001 Aug 31, 2006

AA ! 2MG A040653 002 Aug 31, 2006

AA RISING PHARMS 1MG A040821 001 Dec 29, 2008

AA 2MG A040821 002 Dec 29, 2008

AA SUN PHARM INDS LTD 1MG A040844 001 Aug 18, 2009

AA 2MG A040844 002 Aug 18, 2009

NEXGEN PHARMA 1.5MG A091522 001 Mar 12, 2012



GLYCOPYRROLATE ; INDACATEROL MALEATE

POWDER;INHALATION

UTIBRON

+! SUNOVION PHARMS INC 15.6MCG/INH;27.5MCG/INH N207930 001 Oct 29, 2015

GLYCOPYRRONIUM TOSYLATE

CLOTH;TOPICAL

QBREXZA

+! DERMIRA INC EQ 2.4% BASE N210361 001 Jun 28, 2018

GONADOTROPIN, CHORIONIC

INJECTABLE;INJECTION

CHORIONIC GONADOTROPIN

AP +! FERRING 10,000 UNITS/VIAL N017016 007

AP +! FRESENIUS KABI USA 10,000 UNITS/VIAL N017067 002

PREGNYL

AP +! ORGANON USA INC 10,000 UNITS/VIAL N017692 001

CHORIONIC GONADOTROPIN

+! FERRING 5,000 UNITS/VIAL N017016 006

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-214(of 452)

GOSERELIN ACETATE

IMPLANT;IMPLANTATION

ZOLADEX

+! TERSERA THERAPS LLC EQ 3.6MG BASE N019726 001 Dec 29, 1989

+! EQ 10.8MG BASE N020578 001 Jan 11, 1996

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN



AT AMRING PHARMS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A065187 001 Oct 28, 2005

UNITS/ML

AT ! BAUSCH AND LOMB 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A064047 001 Jan 31, 1996

UNITS/ML

NEOSPORIN

AT ! MONARCH PHARMS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060582 001

UNITS/ML

GRANISETRON

FILM, EXTENDED RELEASE;TRANSDERMAL

SANCUSO

+! KYOWA KIRIN 3.1MG/24HR N022198 001 Sep 12, 2008

INJECTION, EXTENDED RELEASE;SUBCUTANEOUS



SUSTOL

+! HERON THERAPS INC 10MG/0.4ML (10MG/0.4ML) N022445 001 Aug 09, 2016

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

GRANISETRON HYDROCHLORIDE

AP AKORN INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A079119 001 Sep 10, 2009

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A079078 001 Sep 14, 2009

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A079078 002 Sep 14, 2009

AP AUROBINDO PHARMA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A204238 001 Jul 06, 2016

LTD

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A204238 002 Jul 06, 2016

AP BLUEPHARMA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078863 001 Jun 30, 2008

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078880 001 Jun 30, 2008

AP CIPLA LTD EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078262 001 Dec 31, 2007

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078258 001 Jun 30, 2008

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078258 002 Jun 30, 2008

AP FRESENIUS KABI USA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078522 001 Dec 31, 2007

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078090 001 Jun 30, 2008

AP HIKMA FARMACEUTICA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078629 001 Dec 23, 2009

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078629 002 Dec 23, 2009

AP LUITPOLD EQ 1MG BASE/ML (EQ 1MG BASE/ML) A091274 001 Sep 22, 2010

AP MYLAN ASI EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A091136 001 Apr 09, 2010

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A091136 002 Apr 09, 2010

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A091137 002 Apr 09, 2010

AP MYLAN LABS LTD EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A203454 001 Apr 04, 2017

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A203454 002 Apr 04, 2017

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A203453 001 Jan 31, 2017

AP SANDOZ INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078534 001 Apr 30, 2009

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078531 001 Apr 30, 2009

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078835 001 Jun 30, 2008

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078531 002 Apr 30, 2009

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078835 002 Jun 30, 2008

AP ! TEVA PHARMS USA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078392 001 Dec 31, 2007

AP ! EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077297 001 Jun 30, 2008

AP WEST-WARD PHARMS EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A077913 001 Jun 26, 2008

INT

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077186 001 Jun 30, 2008

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077187 001 Jun 30, 2008

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A077177 001 Dec 31, 2007

AP WOCKHARDT USA EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078566 001 Feb 29, 2008

AP EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078564 001 Jun 30, 2008

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078565 001 Jun 30, 2008

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE



AP BLUEPHARMA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078863 002 Jun 30, 2008

AP ! FRESENIUS KABI USA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078096 001 Jun 30, 2008

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

AB APOTEX INC EQ 1MG BASE A078843 001 Feb 27, 2008

AB CHARTWELL MOLECULAR EQ 1MG BASE A078037 001 Feb 27, 2008

AB DR REDDYS LABS LTD EQ 1MG BASE A078846 001 Feb 27, 2009

AB MYLAN EQ 1MG BASE A078725 001 Jan 30, 2008

AB NATCO PHARMA EQ 1MG BASE A078969 001 Jun 22, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-215(of 452)

GRANISETRON HYDROCHLORIDE

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

AB ORCHID HLTHCARE EQ 1MG BASE A078678 001 Feb 13, 2008

AB TARO PHARM EQ 1MG BASE A090817 001 May 28, 2010

AB ! TEVA PHARMS EQ 1MG BASE A078080 001 Dec 31, 2007

AB WEST-WARD PHARMS EQ 1MG BASE A077842 001 Dec 31, 2007

INT

GRISEOFULVIN, MICROSIZE

SUSPENSION;ORAL

GRISEOFULVIN

AB ! ACTAVIS MID 125MG/5ML A065394 001 Jul 06, 2007

ATLANTIC

AB CHARTWELL RX 125MG/5ML A065200 001 Mar 02, 2005

AB CIPLA 125MG/5ML A065354 001 Sep 10, 2007

AB VINTAGE PHARMS 125MG/5ML A065438 001 Oct 08, 2010



TABLET;ORAL

GRISEOFULVIN

AB ! SANDOZ INC 500MG A091592 002 Aug 07, 2013

AB SIGMAPHARM LABS LLC 500MG A202482 001 Oct 22, 2012



SANDOZ INC 250MG A091592 001 Aug 07, 2013

GRISEOFULVIN, ULTRAMICROSIZE

TABLET;ORAL

GRIS-PEG

AB + VALEANT PHARMS INC 125MG N050475 001

AB +! 250MG N050475 002

GRISEOFULVIN, ULTRAMICROSIZE

AB MOUNTAIN 125MG A204371 001 Jan 09, 2014

AB 250MG A204371 002 Jan 09, 2014

AB SANDOZ INC 125MG A202805 001 Dec 26, 2018

AB 250MG A202805 002 Dec 26, 2018

GRISEOFULVIN,ULTRAMICROSIZE

AB SIGMAPHARM LABS LLC 125MG A202545 001 Oct 22, 2012

AB 250MG A202545 002 Oct 22, 2012



GUAIFENESIN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

OBREDON

+! SOVEREIGN PHARMS 200MG/5ML;2.5MG/5ML N205474 001 Nov 14, 2014

TABLET;ORAL

XTRELUS

+! ECI PHARMS LLC 400MG;5MG N208085 001 Apr 25, 2018

GUANABENZ ACETATE

TABLET;ORAL

GUANABENZ ACETATE

ANI PHARMS INC EQ 4MG BASE A074149 001 Apr 07, 1995

! EQ 8MG BASE A074149 002 Apr 07, 1995



GUANFACINE HYDROCHLORIDE

TABLET;ORAL

GUANFACINE HYDROCHLORIDE

AB AMNEAL PHARM EQ 1MG BASE A075109 001 Nov 25, 1998

AB EQ 2MG BASE A075109 002 Nov 25, 1998

AB ! MYLAN EQ 1MG BASE A074796 001 Jan 27, 1997

AB ! EQ 2MG BASE A074796 002 Jan 27, 1997

AB WATSON LABS EQ 1MG BASE A074145 001 Oct 17, 1995

AB EQ 2MG BASE A074145 002 Oct 17, 1995



TABLET, EXTENDED RELEASE;ORAL

GUANFACINE HYDROCHLORIDE

AB ACTAVIS ELIZABETH EQ 1MG BASE A200881 001 Oct 05, 2012

AB EQ 2MG BASE A200881 002 Oct 05, 2012

AB EQ 3MG BASE A200881 003 Oct 05, 2012

AB EQ 4MG BASE A200881 004 Oct 05, 2012

AB APOTEX INC EQ 1MG BASE A205430 001 Jul 25, 2018

AB EQ 2MG BASE A205430 002 Jul 25, 2018

AB EQ 3MG BASE A205430 003 Jul 25, 2018

AB EQ 4MG BASE A205430 004 Jul 25, 2018

AB MYLAN PHARMS INC EQ 1MG BASE A202578 001 Jun 02, 2015

AB EQ 2MG BASE A202578 002 Jun 02, 2015

AB EQ 3MG BASE A202578 003 Jun 02, 2015

AB EQ 4MG BASE A202578 004 Jun 02, 2015

AB SANDOZ INC EQ 1MG BASE A202568 001 Jun 03, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-216(of 452)

GUANFACINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GUANFACINE HYDROCHLORIDE

AB EQ 2MG BASE A202568 002 Jun 03, 2015

AB EQ 3MG BASE A202568 003 Jun 03, 2015

AB EQ 4MG BASE A202568 004 Jun 03, 2015

AB SUN PHARM INDS LTD EQ 1MG BASE A205689 001 Nov 16, 2017

AB EQ 2MG BASE A205689 002 Nov 16, 2017

AB EQ 3MG BASE A205689 003 Nov 16, 2017

AB EQ 4MG BASE A205689 004 Nov 16, 2017

AB TEVA PHARMS USA EQ 1MG BASE A201382 001 Jun 02, 2015

AB EQ 2MG BASE A201382 002 Jun 02, 2015

AB EQ 3MG BASE A201382 003 Jun 02, 2015

AB EQ 4MG BASE A201382 004 Jun 02, 2015

AB TWI PHARMS EQ 1MG BASE A201408 001 Jun 02, 2015

AB EQ 2MG BASE A201408 002 Jun 02, 2015

AB EQ 3MG BASE A201408 003 Jun 02, 2015

AB EQ 4MG BASE A201408 004 Jun 02, 2015

INTUNIV

AB + SHIRE EQ 1MG BASE N022037 001 Sep 02, 2009

AB + EQ 2MG BASE N022037 002 Sep 02, 2009

AB + EQ 3MG BASE N022037 003 Sep 02, 2009

AB +! EQ 4MG BASE N022037 004 Sep 02, 2009



GUANIDINE HYDROCHLORIDE

TABLET;ORAL

GUANIDINE HYDROCHLORIDE

MERCK SHARP DOHME 125MG N001546 001

HALCINONIDE

CREAM;TOPICAL

HALOG

+! SUN PHARM INDS INC 0.1% N017556 001

OINTMENT;TOPICAL

HALOG

+! SUN PHARM INDS INC 0.1% N017824 001

HALOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

HALOBETASOL PROPIONATE

+! MAYNE PHARMA 0.05% N210566 001 May 24, 2018

CREAM;TOPICAL

HALOBETASOL PROPIONATE

AB FOUGERA PHARMS 0.05% A077001 001 Dec 16, 2004

AB ! G AND W LABS 0.05% A078162 001 Apr 24, 2007

AB PERRIGO ISRAEL 0.05% A077123 001 Dec 16, 2004

AB TARO 0.05% A077227 001 Aug 04, 2005

ULTRAVATE

AB + SUN PHARM INDS INC 0.05% N019967 001 Dec 27, 1990

LOTION;TOPICAL

BRYHALI

DOW PHARM 0.01% N209355 001 Nov 06, 2018

ULTRAVATE

+! SUN PHARM 0.05% N208183 001 Nov 06, 2015

INDUSTRIES

OINTMENT;TOPICAL

HALOBETASOL PROPIONATE

AB ! G AND W LABS 0.05% A077721 001 Sep 07, 2006

AB G AND W LABS INC 0.05% A077109 001 Jun 14, 2005

AB PERRIGO ISRAEL 0.05% A076872 001 Dec 16, 2004

AB TARO 0.05% A076994 001 Dec 16, 2004

AB TELIGENT PHARMA INC 0.05% A209978 001 Mar 20, 2018

ULTRAVATE

AB + SUN PHARM INDS INC 0.05% N019968 001 Dec 17, 1990

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

AB MYLAN 0.5MG A070278 006 Jun 10, 1986

AB 1MG A070278 004 Jun 10, 1986

AB 2MG A070278 001 Jun 10, 1986

AB 5MG A070278 005 Jun 10, 1986

AB 10MG A070278 002 Jul 16, 2009

AB 20MG A070278 003 Jul 16, 2009

AB SANDOZ 0.5MG A071206 001 Nov 17, 1986



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-217(of 452)

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

AB 1MG A071207 001 Nov 17, 1986

AB ! 2MG A071208 001 Nov 17, 1986

AB 5MG A071209 001 Nov 17, 1986

AB 10MG A071210 001 Mar 11, 1988

AB 20MG A071211 001 Mar 11, 1988

AB ZYDUS PHARMS USA 5MG A077580 003 Nov 29, 2007

AB 10MG A077580 004 Nov 29, 2007

AB 20MG A077580 005 Nov 29, 2007



HALOPERIDOL DECANOATE

INJECTABLE;INJECTION

HALDOL

AO +! JANSSEN PHARMS EQ 50MG BASE/ML N018701 001 Jan 14, 1986

AO +! EQ 100MG BASE/ML N018701 002 Jan 31, 1997

HALOPERIDOL DECANOATE

AO FRESENIUS KABI USA EQ 50MG BASE/ML A074893 001 Dec 19, 1997

AO EQ 100MG BASE/ML A074893 002 Dec 19, 1997

AO GLAND PHARMA LTD EQ 50MG BASE/ML A205241 001 May 12, 2017

AO EQ 100MG BASE/ML A205241 002 May 12, 2017

AO MYLAN LABS LTD EQ 50MG BASE/ML A075440 001 Feb 28, 2000

AO EQ 100MG BASE/ML A075440 002 Feb 28, 2000

AO SOMERSET THERAPS EQ 50MG BASE/ML A209101 001 Jul 03, 2018

LLC

AO EQ 100MG BASE/ML A209101 002 Jul 03, 2018

AO TEVA PHARMS USA EQ 50MG BASE/ML A075393 001 May 11, 1999

AO EQ 100MG BASE/ML A075393 002 May 11, 1999

AO WEST-WARD PHARMS EQ 50MG BASE/ML A074811 001 Jan 30, 1998

INT

AO EQ 100MG BASE/ML A075305 001 Sep 28, 1998

HALOPERIDOL LACTATE

CONCENTRATE;ORAL

HALOPERIDOL

AA LANNETT CO INC EQ 2MG BASE/ML A073364 001 Sep 28, 1993

AA PHARM ASSOC EQ 2MG BASE/ML A073037 001 Feb 26, 1993

AA ! TEVA PHARMS EQ 2MG BASE/ML A071617 001 Dec 01, 1988



INJECTABLE;INJECTION

HALDOL

AP +! JANSSEN PHARMS EQ 5MG BASE/ML N015923 001

HALOPERIDOL

AP AKORN EQ 5MG BASE/ML A204849 001 Sep 06, 2017

AP FRESENIUS KABI USA EQ 5MG BASE/ML A075689 001 Mar 09, 2001

AP GLAND PHARMA LTD EQ 5MG BASE/ML A076774 001 Aug 25, 2004

AP MYLAN LABS LTD EQ 5MG BASE/ML A078347 001 Sep 14, 2009

AP SAGENT PHARMS EQ 5MG BASE/ML A091637 001 Sep 02, 2011

AP EQ 5MG BASE/ML A200742 001 Sep 02, 2011

AP TEVA PHARMS USA EQ 5MG BASE/ML A076035 001 Aug 29, 2001

AP WEST-WARD PHARMS EQ 5MG BASE/ML A075858 001 Jun 18, 2001

INT

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

AP CASI PHARMS INC 5,000 UNITS/ML A091659 001 Jun 08, 2011

AP +! FRESENIUS KABI USA 1,000 UNITS/ML N017029 001



AP 5,000 UNITS/ML A206552 001 Jun 10, 2016

AP +! 5,000 UNITS/ML N017651 006



AP +! 10,000 UNITS/ML N017029 003

AP +! 20,000 UNITS/ML N017029 004

AP GLAND PHARMA LTD 5,000 UNITS/ML A205323 001 Feb 06, 2017

AP HOSPIRA INC 1,000 UNITS/ML A090571 001 Aug 31, 2009

AP 5,000 UNITS/ML A090571 002 Aug 31, 2009

AP 10,000 UNITS/ML A090571 003 Aug 31, 2009

AP MYLAN LABS LTD 1,000 UNITS/ML A203851 001 Nov 30, 2017

AP 5,000 UNITS/ML A203851 002 Nov 30, 2017

AP 10,000 UNITS/ML A203851 003 Nov 30, 2017

AP 20,000 UNITS/ML A203852 001 Nov 30, 2017

AP NANJING KING-FRIEND 1,000 UNITS/ML A211005 001 Dec 14, 2018

AP SAGENT PHARMS 1,000 UNITS/ML A090808 001 Jun 30, 2010

AP 5,000 UNITS/ML A090808 002 Jun 30, 2010

AP 10,000 UNITS/ML A090808 003 Jun 30, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-218(of 452)

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

AP 20,000 UNITS/ML A090809 001 Jun 30, 2010

AP SANDOZ 1,000 UNITS/ML A091682 001 Jun 08, 2011

AP 5,000 UNITS/ML A091682 002 Jun 08, 2011

AP 10,000 UNITS/ML A201002 001 Jun 08, 2011

AP SHENZHEN TECHDOW 1,000 UNITS/ML A202957 001 Jun 12, 2014

AP 5,000 UNITS/ML A202733 001 Jun 12, 2014

AP 5,000 UNITS/ML A202957 002 Jun 12, 2014

AP 10,000 UNITS/ML A203198 001 Jun 12, 2014

AP 20,000 UNITS/ML A203198 002 Jun 12, 2014

AP +! WEST-WARD PHARMS 1,000 UNITS/ML N017037 001



INT

AP +! 5,000 UNITS/ML N017037 002

AP +! 10,000 UNITS/ML N017037 003

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 200 UNITS/100ML N018609 001 Apr 28, 1982

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP +! B BRAUN 200 UNITS/100ML N019953 001 Jul 20, 1992

AP +! HOSPIRA 200 UNITS/100ML N018916 010 Jun 23, 1989

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP HOSPIRA 10,000 UNITS/100ML N019339 003 Mar 27, 1985

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 200 UNITS/100ML N018609 002 Apr 28, 1982

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP +! HOSPIRA 200 UNITS/100ML N018916 011 Jun 23, 1989

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP +! B BRAUN 4,000 UNITS/100ML N019952 001 Jul 20, 1992

AP HOSPIRA 4,000 UNITS/100ML N019805 001 Jan 25, 1989

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

AP +! B BRAUN 5,000 UNITS/100ML N019952 004 Jul 20, 1992

AP +! 10,000 UNITS/100ML N019952 005 Jul 20, 1992

AP HOSPIRA 5,000 UNITS/100ML N019339 004 Mar 27, 1985

AP 5,000 UNITS/100ML N019805 002 Jan 25, 1989

AP 10,000 UNITS/100ML N019339 002 Mar 27, 1985

HEPARIN SODIUM IN PLASTIC CONTAINER



AP +! FRESENIUS KABI USA 1,000 UNITS/ML N017029 013 Dec 05, 1985

AP +! 5,000 UNITS/ML N017029 014 Dec 05, 1985

AP +! 10,000 UNITS/ML N017029 015 Dec 05, 1985

AP +! 20,000 UNITS/ML N017029 016 Dec 05, 1985

HEPARIN SODIUM PRESERVATIVE FREE



AP +! FRESENIUS KABI USA 1,000 UNITS/ML N017029 010 Apr 28, 1986

AP SAGENT PHARMS 1,000 UNITS/ML A090810 001 Jun 30, 2010

AP SHENZHEN TECHDOW 1,000 UNITS/ML A202732 001 Jun 12, 2014



HEPARIN SODIUM

+! FRESENIUS KABI USA 10,000 UNITS/ML N017029 020 Mar 31, 2011

! HOSPIRA 5,000 UNITS/ML A088100 001 Apr 28, 1983

+! PFIZER 1,000 UNITS/ML N201370 001 Jul 21, 2011



+! 5,000 UNITS/ML N201370 002 Jul 21, 2011

+! 10,000 UNITS/ML N201370 003 Jul 21, 2011

STERINOVA INC 5,000 UNITS/0.5ML A208827 001 Nov 19, 2018

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA 5,000 UNITS/100ML N019339 001 Mar 27, 1985

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

HOSPIRA 5,000 UNITS/100ML N018916 006 Jan 31, 1984

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

HOSPIRA 5,000 UNITS/100ML N018916 007 Jan 31, 1984

10,000 UNITS/100ML N018916 008 Jan 31, 1984

HEPARIN SODIUM PRESERVATIVE FREE

+! FRESENIUS KABI USA 10,000 UNITS/ML N017029 019 Nov 22, 2010

! HOSPIRA 10,000 UNITS/ML A089522 001 May 04, 1987

+! PFIZER 1,000 UNITS/ML N201370 004 Jul 21, 2011



HEXACHLOROPHENE
SPONGE;TOPICAL
PRE-OP
AT +! DAVIS AND GECK 480MG N017433 001
PRE-OP II
AT + DAVIS AND GECK 480MG N017433 002
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-219(of 452)

HEXAMINOLEVULINATE HYDROCHLORIDE

FOR SOLUTION;INTRAVESICAL

CYSVIEW KIT

+! PHOTOCURE ASA
100MG/VIAL
N022555 001 May 28, 2010

HISTRELIN ACETATE

IMPLANT;SUBCUTANEOUS

SUPPRELIN LA

+! ENDO PHARM
50MG
N022058 001 May 03, 2007

VANTAS

+! ENDO PHARM
50MG
N021732 001 Oct 12, 2004

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE



AA ABHAI LLC 1.5MG/5ML;5MG/5ML
A207487 001 Feb 21, 2017

AA ACTAVIS MID 1.5MG/5ML;5MG/5ML


A088017 001 Jul 05, 1983

ATLANTIC
AA ! HI TECH PHARMA 1.5MG/5ML;5MG/5ML
A040613 001 Feb 08, 2008

AA NOVEL LABS INC 1.5MG/5ML;5MG/5ML


A203535 001 Feb 13, 2017

AA PADDOCK LLC 1.5MG/5ML;5MG/5ML


A205731 001 Feb 15, 2017

AA WOCKHARDT BIO AG 1.5MG/5ML;5MG/5ML


A088008 001 Mar 03, 1983

TABLET;ORAL

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE



AA AVANTHI INC
1.5MG;5MG
A207176 001 Aug 07, 2017

AA NOVEL LABS INC


1.5MG;5MG
A091528 001 Apr 20, 2011

TUSSIGON

AA ! KING PHARMS
1.5MG;5MG
A088508 001 Jul 30, 1985

HYALURONIDASE

INJECTABLE;INJECTION

AMPHADASE

+! AMPHASTAR PHARM
150 UNITS/ML
N021665 001 Oct 26, 2004

VITRASE

+! BAUSCH AND LOMB
200 UNITS/VIAL
N021640 002 Dec 02, 2004

HYALURONIDASE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HYLENEX RECOMBINANT

+! HALOZYME THERAP
150 UNITS/ML
N021859 001 Dec 02, 2005

HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDRALAZINE HYDROCHLORIDE

AP ! AKORN 20MG/ML
A040730 001 Apr 21, 2009

AP FRESENIUS KABI USA 20MG/ML


A040388 001 Mar 13, 2001

AP LUITPOLD 20MG/ML
A040136 001 Jun 30, 1997

AP MYLAN INSTITUTIONAL 20MG/ML


A204680 001 Apr 28, 2016

AP NAVINTA LLC 20MG/ML


A202938 001 Mar 28, 2013

AP X-GEN PHARMS INC 20MG/ML


A203110 001 Jun 29, 2015

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

AA ALKEM LABS LTD
10MG
A200737 001 Dec 07, 2012

AA
25MG
A200737 002 Dec 07, 2012

AA
50MG
A200737 003 Dec 07, 2012

AA
100MG
A200737 004 Dec 07, 2012

AA APPCO PHARMA LLC


10MG
A209251 001 Jul 09, 2018

AA
25MG
A209251 002 Jul 09, 2018

AA
50MG
A209251 003 Jul 09, 2018

AA
100MG
A209251 004 Jul 09, 2018

AA CADILA PHARMS LTD


25MG
A203845 001 Sep 18, 2014

AA
50MG
A203845 002 Sep 18, 2014

AA
100MG
A203845 003 Sep 18, 2014

AA GLENMARK PHARMS LTD


10MG
A090527 001 May 27, 2009

AA
25MG
A090527 002 May 27, 2009

AA
50MG
A090527 003 May 27, 2009

AA
100MG
A090527 004 May 27, 2009

AA HERITAGE PHARMS INC


10MG
A086242 001 Feb 04, 2010

AA
25MG
A086242 003

AA
50MG
A086242 002

AA
100MG
A086242 004 Feb 04, 2010

AA HETERO LABS LTD III


10MG
A040901 001 Sep 12, 2008

AA
25MG
A040901 002 Sep 12, 2008

AA
50MG
A040901 003 Sep 12, 2008

AA
100MG
A040901 004 Sep 12, 2008

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-220(of 452)

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

AA INVAGEN PHARMS 10MG A090255 001 Dec 15, 2008

AA 25MG A090255 002 Dec 15, 2008

AA 50MG A090255 003 Dec 15, 2008

AA 100MG A090255 004 Dec 15, 2008

AA PAR PHARM 10MG A087836 001 Oct 05, 1982

AA 25MG A086961 002



AA 50MG A086962 001

AA 100MG A088391 001 Sep 27, 1983

AA ! PLIVA 10MG A089097 001 Dec 18, 1985

AA ! 25MG A088467 001 May 01, 1984

AA ! 50MG A088468 001 May 01, 1984

AA ! 100MG A089098 001 Dec 18, 1985

AA SCIEGEN PHARMS INC 10MG A205236 001 May 26, 2017

AA 25MG A205236 002 May 26, 2017

AA 50MG A205236 003 May 26, 2017

AA 100MG A205236 004 May 26, 2017

AA STRIDES PHARMA 25MG A200770 001 May 03, 2013

AA 50MG A200770 002 May 03, 2013

AA 100MG A200770 003 May 03, 2013



HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDRA-ZIDE

PAR PHARM 25MG;25MG A088957 001 Oct 21, 1985

! 50MG;50MG A088946 001 Oct 21, 1985

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

TABLET;ORAL

BIDIL

+! ARBOR PHARMS LLC 37.5MG;20MG N020727 001 Jun 23, 2005

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDROCHLOROTHIAZIDE

AB ALEMBIC PHARMS LTD 12.5MG A200645 001 Nov 30, 2010

AB AUROBINDO PHARMA 12.5MG A078164 001 Sep 18, 2007

AB IPCA LABS LTD 12.5MG A079237 001 Apr 02, 2009

AB IVAX SUB TEVA 12.5MG A077005 001 Jul 13, 2005

PHARMS

AB JUBILANT CADISTA 12.5MG A078391 001 Feb 11, 2008

AB MYLAN 12.5MG A075640 001 Jan 28, 2000

AB PRINSTON INC 12.5MG A075907 001 Sep 17, 2002

AB SCIEGEN PHARMS INC 12.5MG A203561 001 Jan 14, 2019

AB SUN PHARM INDS INC 12.5MG A090651 001 Apr 07, 2014

AB UNICHEM 12.5MG A090510 001 Jan 19, 2010

MICROZIDE

AB +! ALLERGAN SALES LLC 12.5MG N020504 001 Dec 27, 1996

TABLET;ORAL

HYDROCHLOROTHIAZIDE

AB ACCORD HLTHCARE 12.5MG A202556 001 Sep 24, 2012

AB 25MG A202556 002 Sep 24, 2012

AB 50MG A202556 003 Sep 24, 2012

AB ACTAVIS ELIZABETH 12.5MG A040707 001 Feb 27, 2007

AB AUROBINDO PHARMA 25MG A040780 001 Jul 20, 2007

AB 50MG A040780 002 Jul 20, 2007

AB HERITAGE PHARMS INC 25MG A085182 002



AB 50MG A085182 001

AB HIKMA INTL PHARMS 50MG A084878 001

AB IPCA LABS LTD 12.5MG A040807 001 Jul 20, 2007

AB 25MG A040807 002 Jul 20, 2007

AB 50MG A040807 003 Jul 20, 2007

AB IVAX SUB TEVA 25MG A083177 001



PHARMS

AB ! 50MG A083177 002

AB LEADING PHARMA LLC 12.5MG A040702 003 May 10, 2017

AB 25MG A040702 001 Mar 16, 2007

AB 50MG A040702 002 Mar 16, 2007

AB MYLAN PHARMS INC 25MG A040735 002 Jan 23, 2007

AB 50MG A040735 003 Jan 23, 2007

AB OXFORD PHARMS 25MG A087059 001



AB 50MG A087068 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-221(of 452)

HYDROCHLOROTHIAZIDE
TABLET;ORAL
HYDROCHLOROTHIAZIDE
AB PRINSTON INC 25MG A040412 001 Mar 29, 2002

AB 50MG A040412 002 Mar 29, 2002

AB SCIEGEN PHARMS INC 25MG A203018 001 Jul 23, 2014

AB 50MG A203018 002 Jul 23, 2014

AB SUN PHARM INDS INC 12.5MG A040857 001 May 30, 2008

AB 25MG A040810 001 Mar 27, 2007

AB 50MG A040810 002 Mar 27, 2007

AB UNICHEM 25MG A040907 001 Aug 15, 2008

AB 50MG A040907 002 Aug 15, 2008



HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET;ORAL

AVALIDE
AB +! SANOFI AVENTIS US 12.5MG;150MG N020758 002 Sep 30, 1997

AB +! 12.5MG;300MG N020758 003 Aug 31, 1998



IRBESARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 12.5MG;150MG
A091370 001 Oct 15, 2012

AB 12.5MG;300MG
A091370 002 Oct 15, 2012

AB 25MG;300MG
A091370 003 Oct 12, 2016

AB APOTEX INC 12.5MG;150MG


A201505 001 Oct 15, 2012

AB 12.5MG;300MG
A201505 002 Oct 15, 2012

AB AUROBINDO PHARMA 12.5MG;150MG


A203630 001 Feb 22, 2013

LTD
AB 12.5MG;300MG
A203630 002 Feb 22, 2013

AB 25MG;300MG
A203630 003 Mar 31, 2016

AB DR REDDYS LABS LTD 12.5MG;150MG


A203500 001 Sep 27, 2012

AB 12.5MG;300MG
A203500 002 Sep 27, 2012

AB HISUN PHARM 12.5MG;150MG


A207896 001 Oct 14, 2016

HANGZHOU
AB 12.5MG;300MG
A207896 002 Oct 14, 2016

AB LUPIN LTD 12.5MG;150MG


A201524 001 Feb 27, 2013

AB 12.5MG;300MG
A201524 002 Feb 27, 2013

AB MACLEODS PHARMS LTD 12.5MG;150MG


A202414 001 Sep 27, 2012

AB 12.5MG;300MG
A202414 002 Sep 27, 2012

AB PRINSTON INC 12.5MG;150MG


A203072 001 May 09, 2014

AB 12.5MG;300MG
A203072 002 May 09, 2014

AB SANDOZ 12.5MG;150MG
A077446 001 Sep 27, 2012

AB 12.5MG;300MG
A077446 002 Sep 27, 2012

AB TEVA 12.5MG;150MG
A077369 001 Mar 30, 2012

AB 12.5MG;300MG
A077369 002 Mar 30, 2012

AB UNICHEM LABS LTD 12.5MG;150MG


A207018 001 Sep 19, 2017

AB 12.5MG;300MG
A207018 002 Sep 19, 2017

AB WEST-WARD PHARMS 12.5MG;150MG


A090351 001 Oct 15, 2012

INT
AB 12.5MG;300MG
A090351 002 Oct 15, 2012

AB
25MG;300MG
A090351 003 Jun 08, 2017

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE



AB AUROBINDO
12.5MG;10MG
A077606 001 Mar 14, 2006

AB
12.5MG;20MG
A077606 002 Mar 14, 2006

AB
25MG;20MG
A077606 003 Mar 14, 2006

AB HIKMA INTL PHARMS


12.5MG;10MG
A076265 001 Jul 08, 2002

AB
12.5MG;20MG
A076265 002 Jul 08, 2002

AB
25MG;20MG
A076265 003 Jul 08, 2002

AB INVAGEN PHARMS
12.5MG;10MG
A204058 001 May 23, 2017

AB
12.5MG;20MG
A204058 002 May 23, 2017

AB
25MG;20MG
A204058 003 May 23, 2017

AB IVAX SUB TEVA


12.5MG;10MG
A075776 001 Jul 01, 2002

PHARMS

AB
12.5MG;20MG
A075776 002 Jul 01, 2002

AB
25MG;20MG
A075776 003 Jul 01, 2002

AB LUPIN
12.5MG;10MG
A077912 001 Sep 27, 2006

AB
12.5MG;20MG
A077912 002 Sep 27, 2006

AB
25MG;20MG
A077912 003 Sep 27, 2006

AB MYLAN
12.5MG;10MG
A076113 001 Jul 01, 2002

AB
12.5MG;20MG
A076113 002 Jul 01, 2002

AB
25MG;20MG
A076113 003 Jul 01, 2002

AB PRINSTON INC
12.5MG;10MG
A076230 001 Jul 01, 2002

AB
12.5MG;20MG
A076230 002 Jul 01, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-222(of 452)

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE



AB 25MG;20MG
A076230 003 Jul 01, 2002

AB SANDOZ 12.5MG;10MG
A076262 001 Jul 01, 2002

AB 12.5MG;20MG
A076262 002 Jul 01, 2002

AB 25MG;20MG
A076262 003 Jul 01, 2002

AB SUN PHARM INDS LTD 12.5MG;10MG


A076007 001 Jul 01, 2002

AB
12.5MG;20MG
A076007 002 Jul 01, 2002

AB
25MG;20MG
A076007 003 Jul 01, 2002

AB WATSON LABS
12.5MG;10MG
A076194 003 Jul 01, 2002

AB
12.5MG;20MG
A076194 001 Jul 01, 2002

AB
25MG;20MG
A076194 002 Jul 01, 2002

ZESTORETIC

AB + ALVOGEN MALTA
12.5MG;10MG
N019888 003 Nov 18, 1993

AB +!
12.5MG;20MG
N019888 001 Sep 20, 1990

AB +!
25MG;20MG
N019888 002 Jul 20, 1989

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

HYZAAR

AB + MERCK SHARP DOHME 12.5MG;100MG
N020387 003 Oct 20, 2005

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB ALEMBIC PHARMS LTD 12.5MG;50MG
A091617 001 Feb 17, 2012

AB 12.5MG;100MG
A091617 002 Feb 17, 2012

AB 25MG;100MG
A091617 003 Feb 17, 2012

AB AUROBINDO PHARMA 12.5MG;50MG


A091629 001 Oct 06, 2010

AB 12.5MG;100MG
A091629 002 Oct 06, 2010

AB ! 25MG;100MG
A091629 003 Jan 06, 2010

AB CADISTA PHARMS 12.5MG;50MG


A201845 001 Sep 18, 2012

AB 12.5MG;100MG
A201845 002 Sep 18, 2012

AB 25MG;100MG
A201845 003 Sep 18, 2012

AB IPCA LABS LTD 12.5MG;50MG


A201682 001 Mar 01, 2013

AB 12.5MG;100MG
A201682 002 Mar 01, 2013

AB 25MG;100MG
A201682 003 Mar 01, 2013

AB LUPIN LTD 12.5MG;50MG


A078245 001 Oct 06, 2010

AB 12.5MG;100MG
A078245 002 May 21, 2010

AB 25MG;100MG
A078245 003 Oct 06, 2010

AB MACLEODS PHARMS LTD 12.5MG;50MG


A202289 001 Aug 09, 2012

AB 12.5MG;100MG
A202289 002 Aug 09, 2012

AB 25MG;100MG
A202289 003 Aug 09, 2012

AB MYLAN 12.5MG;50MG
A091652 001 Oct 06, 2010

AB 12.5MG;100MG
A091652 002 Apr 06, 2010

AB 25MG;100MG
A091652 003 Oct 06, 2010

AB PRINSTON INC 12.5MG;50MG


A204901 001 Nov 06, 2017

AB 12.5MG;100MG
A204901 002 Nov 06, 2017

AB 25MG;100MG
A204901 003 Nov 06, 2017

AB SANDOZ 12.5MG;50MG
A077948 001 Oct 06, 2010

AB 12.5MG;100MG
A077948 003 Aug 19, 2010

AB 25MG;100MG
A077948 002 Oct 06, 2010

AB TEVA PHARMS 12.5MG;50MG


A077157 001 Apr 06, 2010

AB 12.5MG;100MG
A077157 002 Apr 06, 2010

AB 25MG;100MG
A077157 003 Apr 06, 2010

AB TORRENT PHARMS 12.5MG;50MG


A090528 001 Oct 06, 2010

AB 12.5MG;100MG
A090528 003 Apr 06, 2010

AB 25MG;100MG
A090528 002 Oct 06, 2010

AB UNICHEM LABS LTD 12.5MG;50MG


A204832 001 Jul 21, 2017

AB 12.5MG;100MG
A204832 002 Jul 21, 2017

AB 25MG;100MG
A204832 003 Jul 21, 2017

AB WEST-WARD PHARMS 12.5MG;50MG


A077732 002 Oct 06, 2010

INT
AB 12.5MG;100MG
A077732 001 Apr 06, 2010

AB 25MG;100MG
A077732 003 Oct 06, 2010

AB ZYDUS PHARMS USA 12.5MG;50MG


A078385 001 Oct 06, 2010

INC
AB
25MG;100MG
A078385 002 Oct 06, 2010

HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

METHYLDOPA AND HYDROCHLOROTHIAZIDE
MYLAN 15MG;250MG A070265 002 Jan 23, 1986
! 25MG;250MG A070265 001 Jan 23, 1986
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-223(of 452)

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE



TABLET, EXTENDED RELEASE;ORAL

DUTOPROL

+ CONCORDIA PHARMS 12.5MG;EQ 25MG TARTRATE N021956 001 Aug 28, 2006

INC

+ 12.5MG;EQ 50MG TARTRATE N021956 002 Aug 28, 2006

+! 12.5MG;EQ 100MG TARTRATE N021956 003 Aug 28, 2006



HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET;ORAL

LOPRESSOR HCT

AB + US PHARMS HOLDINGS 25MG;50MG N018303 001 Dec 31, 1984

I

AB +! 25MG;100MG N018303 002 Dec 31, 1984

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE



AB ALEMBIC PHARMS LTD 25MG;50MG A202870 001 Nov 06, 2013

AB 25MG;100MG A202870 002 Nov 06, 2013

AB 50MG;100MG A202870 003 Nov 06, 2013

AB MYLAN 25MG;50MG A076792 001 Aug 20, 2004

AB 25MG;100MG A076792 002 Aug 20, 2004

AB 50MG;100MG A076792 003 Aug 20, 2004

AB SUN PHARM INDS 25MG;50MG A090654 001 Jan 19, 2012

AB 25MG;100MG A090654 002 Jan 19, 2012

AB 50MG;100MG A090654 003 Jan 19, 2012



HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE



AB GLENMARK PHARMS 12.5MG;7.5MG A090718 001 Mar 17, 2010

AB 12.5MG;15MG A090718 002 Mar 17, 2010

AB 25MG;15MG A090718 003 Mar 17, 2010

AB HERITAGE PHARMS INC 12.5MG;7.5MG A202150 001 Mar 07, 2014

AB 12.5MG;15MG A202150 002 Mar 07, 2014

AB 25MG;15MG A202150 003 Mar 07, 2014

AB TEVA 12.5MG;7.5MG A076980 001 Mar 07, 2007

AB 12.5MG;15MG A076980 003 Mar 07, 2007

AB ! 25MG;15MG A076980 002 Mar 07, 2007



HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

BENICAR HCT

AB + DAIICHI SANKYO 12.5MG;20MG N021532 002 Jun 05, 2003

AB + 12.5MG;40MG N021532 003 Jun 05, 2003

AB +! 25MG;40MG N021532 005 Jun 05, 2003

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE



AB ALEMBIC PHARMS LTD 12.5MG;20MG A204233 001 Apr 24, 2017

AB 12.5MG;40MG A204233 002 Apr 24, 2017

AB 25MG;40MG A204233 003 Apr 24, 2017

AB AUROBINDO PHARMA 12.5MG;20MG A205391 001 Apr 24, 2017

LTD

AB 12.5MG;40MG A205391 002 Apr 24, 2017

AB 25MG;40MG A205391 003 Apr 24, 2017

AB MYLAN PHARMS INC 12.5MG;20MG A078827 001 Oct 26, 2016

AB 12.5MG;40MG A078827 002 Oct 26, 2016

AB 25MG;40MG A078827 003 Oct 26, 2016

AB PRINSTON INC 12.5MG;20MG A207804 001 Apr 24, 2017

AB 12.5MG;40MG A207804 002 Apr 24, 2017

AB 25MG;40MG A207804 003 Apr 24, 2017

AB TEVA PHARMS USA 12.5MG;20MG A200532 001 Apr 24, 2017

AB 12.5MG;40MG A200532 002 Apr 24, 2017

AB 25MG;40MG A200532 003 Apr 24, 2017

AB TORRENT PHARMS LTD 12.5MG;20MG A206515 001 May 03, 2017

AB 12.5MG;40MG A206515 002 May 03, 2017

AB 25MG;40MG A206515 003 May 03, 2017



HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE



AB ! MYLAN 25MG;80MG A070947 001 Apr 01, 1987

! 25MG;40MG A070947 002 Mar 04, 1987



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-224(of 452)

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE



TABLET;ORAL

ACCURETIC

AB + PFIZER PHARMS 12.5MG;EQ 10MG BASE N020125 001 Dec 28, 1999

AB + 12.5MG;EQ 20MG BASE N020125 002 Dec 28, 1999

AB +! 25MG;EQ 20MG BASE N020125 003 Dec 28, 1999

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB APOTEX CORP 12.5MG;EQ 10MG BASE A091524 001 Mar 12, 2013

AB 12.5MG;EQ 20MG BASE A091524 002 Mar 12, 2013

AB 25MG;EQ 20MG BASE A091524 003 Mar 12, 2013

AB AUROBINDO PHARMA 12.5MG;EQ 10MG BASE A078450 001 Aug 24, 2007

AB 12.5MG;EQ 20MG BASE A078450 002 Aug 24, 2007

AB 25MG;EQ 20MG BASE A078450 003 Aug 24, 2007

AB INVAGEN PHARMS 12.5MG;EQ 10MG BASE A201356 001 Apr 20, 2011

AB 12.5MG;EQ 20MG BASE A201356 002 Apr 20, 2011

AB 25MG;EQ 20MG BASE A201356 003 Apr 20, 2011

AB MYLAN 12.5MG;EQ 10MG BASE A077093 001 Mar 28, 2005

AB 12.5MG;EQ 20MG BASE A077093 002 Mar 28, 2005

AB 25MG;EQ 20MG BASE A077093 003 Mar 28, 2005

QUINARETIC

AB GAVIS PHARMS 12.5MG;EQ 10MG BASE A076374 001 Mar 31, 2004

AB 12.5MG;EQ 20MG BASE A076374 002 Mar 31, 2004

AB 25MG;EQ 20MG BASE A076374 003 Mar 31, 2004



HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

ALDACTAZIDE

AB + GD SEARLE LLC 25MG;25MG N012616 004 Dec 30, 1982

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE



AB MYLAN 25MG;25MG A086513 001

AB SUN PHARM 25MG;25MG A089534 001 Jul 02, 1987

INDUSTRIES

ALDACTAZIDE

+! GD SEARLE LLC 50MG;50MG N012616 005 Dec 30, 1982

HYDROCHLOROTHIAZIDE; TELMISARTAN

TABLET;ORAL

MICARDIS HCT

AB + BOEHRINGER 12.5MG;40MG N021162 001 Nov 17, 2000

INGELHEIM

AB + 12.5MG;80MG N021162 002 Nov 17, 2000

AB +! 25MG;80MG N021162 003 Apr 19, 2004

TELMISARTAN AND HYDROCHLOROTHIAZIDE



AB ALEMBIC PHARMS LTD 12.5MG;40MG A203010 001 Feb 25, 2014

AB 12.5MG;80MG A203010 002 Feb 25, 2014

AB 25MG;80MG A203010 003 Feb 25, 2014

AB AUROBINDO PHARMA 12.5MG;40MG A208727 001 Dec 15, 2016

LTD

AB 12.5MG;80MG A208727 002 Dec 15, 2016

AB 25MG;80MG A208727 003 Dec 15, 2016

AB LUPIN LTD 12.5MG;40MG A091351 001 Aug 07, 2014

AB 12.5MG;80MG A091351 002 Aug 07, 2014

AB 25MG;80MG A091351 003 Aug 07, 2014

AB MACLEODS PHARMS LTD 12.5MG;40MG A204169 001 Nov 02, 2015

AB 12.5MG;80MG A204169 002 Nov 02, 2015

AB 25MG;80MG A204169 003 Nov 02, 2015

AB MYLAN PHARMS INC 12.5MG;40MG A091648 001 Feb 25, 2014

AB 12.5MG;80MG A091648 002 Feb 25, 2014

AB 25MG;80MG A091648 003 Feb 25, 2014

AB PRINSTON INC 12.5MG;40MG A209028 001 Nov 06, 2017

AB 12.5MG;80MG A209028 002 Nov 06, 2017

AB 25MG;80MG A209028 003 Nov 06, 2017

AB TORRENT PHARMS LTD 12.5MG;40MG A201192 001 Feb 25, 2014

AB 12.5MG;80MG A201192 002 Feb 25, 2014

AB 25MG;80MG A201192 003 Feb 25, 2014

AB ZYDUS PHARMS USA 12.5MG;40MG A204221 001 Aug 15, 2017

INC

AB 12.5MG;80MG A204221 002 Aug 15, 2017

AB 25MG;80MG A204221 003 Aug 15, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-225(of 452)

HYDROCHLOROTHIAZIDE; TRIAMTERENE

CAPSULE;ORAL

DYAZIDE

AB +! GLAXOSMITHKLINE LLC 25MG;37.5MG N016042 003 Mar 03, 1994

TRIAMTERENE AND HYDROCHLOROTHIAZIDE



AB ! CASI PHARMS INC 25MG;50MG A073191 001 Jul 31, 1991

AB DURAMED PHARMS BARR 25MG;37.5MG A075052 001 Jun 18, 1999

AB IVAX SUB TEVA 25MG;50MG A074259 001 Mar 30, 1995

PHARMS

AB LANNETT CO INC 25MG;37.5MG A201407 001 Dec 09, 2011

AB MYLAN 25MG;37.5MG A074701 001 Jun 07, 1996

AB SANDOZ 25MG;37.5MG A074821 001 Jun 05, 1997



TABLET;ORAL

MAXZIDE

AB +! MYLAN PHARMS INC 50MG;75MG N019129 001 Oct 22, 1984

MAXZIDE-25

AB + MYLAN PHARMS INC 25MG;37.5MG N019129 003 May 13, 1988

TRIAMTERENE AND HYDROCHLOROTHIAZIDE



AB ANI PHARMS INC 50MG;75MG A073467 001 Jan 31, 1996

AB APOTEX INC 25MG;37.5MG A071251 002 May 05, 1998

AB 50MG;75MG A071251 001 Apr 17, 1988

AB PLIVA 25MG;37.5MG A074026 001 Apr 26, 1996

AB SANDOZ 25MG;37.5MG A073281 001 Apr 30, 1992

AB 50MG;75MG A072011 001 Jun 17, 1988

AB WATSON LABS 25MG;37.5MG A073449 001 Sep 23, 1993

AB 50MG;75MG A071851 001 Nov 30, 1988

AB ZYDUS PHARMS USA 25MG;37.5MG A208360 001 Jun 29, 2018

INC

AB 50MG;75MG A208360 002 Jun 29, 2018

HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

DIOVAN HCT

AB + NOVARTIS 12.5MG;80MG N020818 001 Mar 06, 1998

AB + 12.5MG;160MG N020818 002 Mar 06, 1998

AB + 12.5MG;320MG N020818 004 Apr 28, 2006

AB + 25MG;160MG N020818 003 Jan 17, 2002

AB +! 25MG;320MG N020818 005 Apr 28, 2006

VALSARTAN AND HYDROCHLOROTHIAZIDE



AB ALEMBIC PHARMS LTD 12.5MG;80MG A201662 001 Mar 21, 2013

AB 12.5MG;160MG A201662 002 Mar 21, 2013

AB 12.5MG;320MG A201662 003 Mar 21, 2013

AB 25MG;160MG A201662 004 Mar 21, 2013

AB 25MG;320MG A201662 005 Mar 21, 2013

AB AUROBINDO PHARMA 12.5MG;80MG A202519 001 Mar 21, 2013

LTD

AB 12.5MG;160MG A202519 002 Mar 21, 2013

AB 12.5MG;320MG A202519 003 Mar 21, 2013

AB 25MG;160MG A202519 004 Mar 21, 2013

AB 25MG;320MG A202519 005 Mar 21, 2013

AB LUPIN LTD 12.5MG;80MG A078946 003 Mar 21, 2013

AB 12.5MG;160MG A078946 004 Mar 21, 2013

AB 12.5MG;320MG A078946 001 Mar 21, 2013

AB 25MG;160MG A078946 005 Mar 21, 2013

AB 25MG;320MG A078946 002 Mar 21, 2013

AB MACLEODS PHARMS LTD 12.5MG;80MG A203145 001 Apr 19, 2013

AB 12.5MG;160MG A203145 002 Apr 19, 2013

AB 12.5MG;320MG A203145 003 Apr 19, 2013

AB 25MG;160MG A203145 004 Apr 19, 2013

AB 25MG;320MG A203145 005 Apr 19, 2013

AB MYLAN PHARMS INC 12.5MG;80MG A078020 001 Sep 21, 2012

AB 12.5MG;160MG A078020 002 Sep 21, 2012

AB 12.5MG;320MG A078020 004 Sep 21, 2012

AB 25MG;160MG A078020 003 Sep 21, 2012

AB 25MG;320MG A078020 005 Sep 21, 2012

AB PRINSTON INC 12.5MG;80MG A206083 001 Feb 08, 2016

AB 12.5MG;160MG A206083 002 Feb 08, 2016

AB 12.5MG;320MG A206083 003 Feb 08, 2016

AB 25MG;160MG A206083 004 Feb 08, 2016

AB 25MG;320MG A206083 005 Feb 08, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-226(of 452)

HYDROCODONE BITARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

ZOHYDRO ER

+! PERNIX IRELAND PAIN 10MG N202880 001 Oct 25, 2013

+ 15MG N202880 002 Oct 25, 2013

+ 20MG N202880 003 Oct 25, 2013

+ 30MG N202880 004 Oct 25, 2013

+ 40MG N202880 005 Oct 25, 2013

+ 50MG N202880 006 Oct 25, 2013

TABLET, EXTENDED RELEASE;ORAL

HYSINGLA

+! PURDUE PHARMA LP 20MG N206627 001 Nov 20, 2014

+ 30MG N206627 002 Nov 20, 2014

+ 40MG N206627 003 Nov 20, 2014

+ 60MG N206627 004 Nov 20, 2014

+ 80MG N206627 005 Nov 20, 2014

+ 100MG N206627 006 Nov 20, 2014

+ 120MG N206627 007 Nov 20, 2014

HYDROCODONE BITARTRATE; IBUPROFEN

TABLET;ORAL

HYDROCODONE BITARTRATE AND IBUPROFEN



AB ACTAVIS LABS FL INC 7.5MG;200MG A076604 001 Dec 31, 2003

AB AMNEAL PHARMS NY 5MG;200MG A076642 002 Mar 18, 2004

AB ! 7.5MG;200MG A076642 001 Oct 12, 2004

AB AUROLIFE PHARMA LLC 7.5MG;200MG A204575 001 Jun 02, 2016

AB SUN PHARM INDS INC 2.5MG;200MG A091633 001 May 28, 2013

AB 5MG;200MG A091633 002 May 28, 2013

AB 7.5MG;200MG A091633 003 May 28, 2013

AB 10MG;200MG A091633 004 May 28, 2013

AB TEVA 7.5MG;200MG A076023 001 Apr 11, 2003

AB VINTAGE PHARMS 5MG;200MG A077727 001 Nov 06, 2006

AB 7.5MG;200MG A077723 001 Nov 06, 2006

AB 10MG;200MG A077723 002 Nov 06, 2006

REPREXAIN

AB AMNEAL PHARMS NY 2.5MG;200MG A076642 003 Oct 19, 2007

AB 10MG;200MG A076642 004 Oct 19, 2007



HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE



AA MAYNE PHARMA INC 5MG/5ML;60MG/5ML A205658 001 Nov 17, 2015

AA PADDOCK LLC 5MG/5ML;60MG/5ML A204658 001 Apr 29, 2014

REZIRA

AA +! CYPRESS PHARM 5MG/5ML;60MG/5ML N022442 001 Jun 08, 2011

HYDROCORTISONE

CREAM;TOPICAL

ALA-CORT

AT CROWN LABS 2.5% A080706 007 Jan 05, 2016

AT 1% A080706 006

ANUSOL HC

AT SALIX PHARMS 2.5% A088250 001 Jun 06, 1984

HYDROCORTISONE

AT ACTAVIS MID 1% A087795 001 May 03, 1983

ATLANTIC

AT 2.5% A089682 001 Mar 10, 1988

AT ! FOUGERA PHARMS INC 1% A080693 003



AT ! 2.5% A089414 001 Dec 16, 1986

AT LANNETT CO INC 2.5% A040503 001 Mar 12, 2004

AT PERRIGO NEW YORK 2.5% A085025 001



AT RISING PHARMS 2.5% A040879 001 Aug 20, 2010

AT TARO PHARM INDS LTD 2.5% A088799 001 Nov 09, 1984

AT TELIGENT PHARMA INC 2.5% A203810 001 Jul 23, 2018



ENEMA;RECTAL

COLOCORT

AB PADDOCK LLC 100MG/60ML A075172 001 Dec 03, 1999

CORTENEMA

AB +! ANI PHARMS 100MG/60ML N016199 001

HYDROCORTISONE

AB TEVA PHARMS 100MG/60ML A074171 001 May 27, 1994

LOTION;TOPICAL

HYDROCORTISONE

AT ! FOUGERA PHARMS 2.5% A040351 001 Jul 25, 2000

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-227(of 452)

HYDROCORTISONE

LOTION;TOPICAL

HYDROCORTISONE

AT LANNETT CO INC 2.5% A040417 001 Jul 30, 2003

AT TARO 2.5% A040247 001 Jul 23, 1999

AT TELIGENT PHARMA INC 2.5% A203804 001 Jul 27, 2018

STIE-CORT

AT PERRIGO CO 2.5% A089074 001 Nov 26, 1985

ALA-SCALP

CROWN LABS 2% A083231 001

OINTMENT;TOPICAL

HYDROCORTISONE

AT ACTAVIS MID 1% A087796 001 Oct 13, 1982

ATLANTIC

AT ! FOUGERA PHARMS 1% A080692 001

AT ! FOUGERA PHARMS INC 2.5% A081203 001 May 28, 1993

AT PERRIGO NEW YORK 2.5% A085027 001



AT TARO 1% A086257 001

HYDROCORTISONE IN ABSORBASE

AT CMP PHARMA INC 1% A088138 001 Sep 06, 1985

SOLUTION;TOPICAL

TEXACORT

! MISSION PHARMA 2.5% A081271 001 Apr 17, 1992

TABLET;ORAL

CORTEF

AB + PHARMACIA AND 5MG N008697 003

UPJOHN

AB + 10MG N008697 001

AB +! 20MG N008697 002

HYDROCORTISONE

AB HIKMA INTL PHARMS 5MG A083365 002 Feb 23, 2015

AB 10MG A083365 003 Feb 23, 2015

AB 20MG A083365 001



AB IMPAX LABS INC 5MG A040646 001 Mar 30, 2007

AB 10MG A040646 002 Mar 30, 2007

AB 20MG A040646 003 Mar 30, 2007

AB PII 5MG A207029 001 Apr 27, 2017

AB 10MG A207029 002 Apr 27, 2017

AB 20MG A207029 003 Apr 27, 2017

AB VINTAGE 5MG A040761 001 Jul 16, 2007

AB 10MG A040761 002 Jul 16, 2007

AB 20MG A040761 003 Jul 16, 2007



HYDROCORTISONE ACETATE

AEROSOL, METERED;RECTAL

CORTIFOAM

+! MYLAN SPECIALITY LP 10% N017351 001 Feb 10, 1982

CREAM;TOPICAL

MICORT-HC

SEBELA IRELAND LTD 2.5% A040396 001 Feb 27, 2001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM;TOPICAL

CORTISPORIN

+! MONARCH PHARMS 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050218 001 Aug 09, 1985

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED;TOPICAL

EPIFOAM

BX MYLAN SPECIALITY LP 1%;1% A086457 001

PROCTOFOAM HC

BX MYLAN SPECIALITY LP 1%;1% A086195 001

CREAM;TOPICAL

PRAMOSONE

SEBELA IRELAND LTD 0.5%;1% A083778 001

1%;1% A085368 001

LOTION;TOPICAL

PRAMOSONE

SEBELA IRELAND LTD 1%;1% A085980 001

2.5%;1% A085979 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-228(of 452)

HYDROCORTISONE ACETATE; UREA



CREAM;TOPICAL

U-CORT

TARO 1%;10% A089472 001 Jun 13, 1988

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL

HYDROCORTISONE BUTYRATE

AB1 TARO PHARM INDS 0.1% A076654 001 Aug 03, 2005

LOCOID

AB1 +! PRECISION DERMAT 0.1% N018514 001 Mar 31, 1982

HYDROCORTISONE BUTYRATE

AB2 ACTAVIS MID 0.1% A205134 001 Dec 08, 2017

ATLANTIC

AB2 GLENMARK GENERICS 0.1% A202145 001 Sep 27, 2013

LOCOID LIPOCREAM

AB2 +! PRECISION DERMAT 0.1% N020769 001 Sep 08, 1997

LOTION;TOPICAL

HYDROCORTISONE BUTYRATE

AB LUPIN LTD 0.1% A210209 001 Aug 17, 2018

AB TELIGENT PHARMA INC 0.1% A209556 001 Nov 21, 2017

LOCOID

AB +! PRECISION DERMAT 0.1% N022076 001 May 18, 2007

OINTMENT;TOPICAL

HYDROCORTISONE BUTYRATE

AB TARO 0.1% A076842 001 Dec 27, 2004

LOCOID

AB +! PRECISION DERMAT 0.1% N018652 001 Oct 29, 1982

SOLUTION;TOPICAL

HYDROCORTISONE BUTYRATE

AT TARO PHARM INDS 0.1% A076364 001 Jan 14, 2004

LOCOID

AT +! PRECISION DERMAT 0.1% N019116 001 Feb 25, 1987

HYDROCORTISONE PROBUTATE

CREAM;TOPICAL

PANDEL

+! FOUGERA PHARMS 0.1% N020453 001 Feb 28, 1997

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION

SOLU-CORTEF

+! PHARMACIA AND EQ 100MG BASE/VIAL N009866 001

UPJOHN

+! EQ 250MG BASE/VIAL N009866 002

+! EQ 500MG BASE/VIAL N009866 003

+! EQ 1GM BASE/VIAL N009866 004

HYDROCORTISONE VALERATE

CREAM;TOPICAL

HYDROCORTISONE VALERATE

AB GLENMARK PHARMS LTD 0.2% A211129 001 Oct 12, 2018

AB PERRIGO NEW YORK 0.2% A075666 001 May 24, 2000

AB ! TARO 0.2% A075042 001 Aug 25, 1998

OINTMENT;TOPICAL

HYDROCORTISONE VALERATE

AB GLENMARK PHARMS LTD 0.2% A211750 001 Dec 14, 2018

AB ! TARO 0.2% A075043 001 Aug 25, 1998



HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE



AT ! BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064053 001 Dec 29, 1995
AT SANDOZ INC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062423 001 Aug 25, 1983
SUSPENSION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
! SANDOZ INC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062874 001 May 11, 1988
SUSPENSION/DROPS;OTIC
CASPORYN HC
AT +! CASPER PHARMA LLC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N060613 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT AMRING PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A065219 001 May 01, 2006
AT SANDOZ INC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062488 001 Nov 06, 1985
OTICAIR
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064065 001 Aug 28, 1996
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-229(of 452)

HYDROGEN PEROXIDE

SOLUTION;TOPICAL

ESKATA

+! ACLARIS 40% N209305 001 Dec 14, 2017

HYDROMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

DILAUDID

AP +! FRESENIUS KABI USA 1MG/ML N019034 003 Apr 30, 2009

AP +! 2MG/ML N019034 004 Apr 30, 2009

HYDROMORPHONE HYDROCHLORIDE

AP AKORN 10MG/ML A078228 001 Apr 14, 2010

AP 10MG/ML A078261 001 Apr 14, 2010

AP BARR 10MG/ML A076444 001 Apr 25, 2003

AP EUROHLTH INTL SARL 2MG/ML A202159 001 Apr 27, 2018

AP HOSPIRA INC 1MG/ML N200403 001 Dec 01, 2011

AP 2MG/ML N200403 002 Dec 01, 2011

AP 4MG/ML N200403 003 Dec 01, 2011

AP 10MG/ML A078591 001 Jun 17, 2008



SOLUTION;ORAL

DILAUDID

AA +! RHODES PHARMS 5MG/5ML N019891 001 Dec 07, 1992

HYDROMORPHONE HYDROCHLORIDE

AA ASCENT PHARMS INC 5MG/5ML A210176 001 Oct 27, 2017

AA WEST-WARD PHARMS 5MG/5ML A074653 001 Jul 29, 1998

INT

TABLET;ORAL

DILAUDID

AB + RHODES PHARMS 2MG N019892 003 Nov 09, 2007

AB + 4MG N019892 002 Nov 09, 2007

AB +! 8MG N019892 001 Dec 07, 1992

HYDROMORPHONE HYDROCHLORIDE

AB ASCENT PHARMS INC 2MG A210506 001 Jan 17, 2018

AB 4MG A210506 002 Jan 17, 2018

AB 8MG A210506 003 Jan 17, 2018

AB AUROLIFE PHARMA LLC 2MG A205814 001 May 13, 2016

AB 4MG A205814 002 May 13, 2016

AB 8MG A205814 003 May 13, 2016

AB ELITE LABS 8MG A076723 001 Oct 18, 2005

AB LANNETT CO INC 2MG A077471 002 Dec 09, 2009

AB 4MG A077471 003 Dec 09, 2009

AB 8MG A077471 001 Dec 09, 2009

AB SPECGX LLC 2MG A076855 002 Sep 19, 2007

AB 4MG A076855 003 Sep 19, 2007

AB 8MG A076855 001 Dec 23, 2004

AB WEST-WARD PHARMS 4MG A074597 003 May 29, 2009

INT

AB 8MG A074597 001 Jul 29, 1998

TABLET, EXTENDED RELEASE;ORAL

EXALGO

AB + SPECGX LLC 8MG N021217 001 Mar 01, 2010

AB + 12MG N021217 002 Mar 01, 2010

AB + 16MG N021217 003 Mar 01, 2010

AB +! 32MG N021217 004 Aug 24, 2012

HYDROMORPHONE HYDROCHLORIDE

AB OSMOTICA 8MG A205629 001 Jul 07, 2016

AB 12MG A205629 002 Jul 07, 2016

AB 16MG A205629 003 Jul 07, 2016

AB 32MG A205629 004 Jul 07, 2016

AB PADDOCK LLC 8MG A204278 001 Apr 06, 2015

AB 12MG A204278 002 Apr 06, 2015

AB 16MG A204278 003 Apr 06, 2015

AB 32MG A204278 004 Sep 20, 2017



HYDROXOCOBALAMIN

INJECTABLE;INJECTION

CYANOKIT

+! SERB SA 5GM/VIAL (5GM/KIT) N022041 001 Apr 08, 2011

HYDROXOCOBALAMIN

! ACTAVIS LLC 1MG/ML A085998 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-230(of 452)

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE



SOLUTION/DROPS;OPHTHALMIC

PAREMYD

+! AKORN 1%;0.25% N019261 001 Jan 30, 1992

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

AB ALKALOIDA ZRT 200MG A201691 001 May 08, 2018

AB AMNEAL PHARMS CO 200MG A210577 001 May 15, 2018

AB HIKMA PHARMS 200MG A040760 001 Aug 15, 2007

AB IPCA LABS LTD 200MG A040766 001 Jun 14, 2007

AB LUPIN LTD 200MG A210543 001 Jul 06, 2018

AB MYLAN 200MG A040274 001 May 29, 1998

AB RISING PHARMS 200MG A210959 001 Jan 15, 2019

AB SANDOZ 200MG A040104 001 Nov 30, 1995

AB TEVA PHARMS 200MG A040081 001 Sep 30, 1994

AB TWI PHARMS 200MG A210441 001 May 01, 2018

AB WATSON LABS 200MG A040133 001 Nov 30, 1995

AB ZYDUS PHARMS USA 200MG A040657 001 Sep 21, 2007

INC

PLAQUENIL

AB +! CONCORDIA PHARMS 200MG N009768 001



INC

HYDROXYPROGESTERONE CAPROATE

SOLUTION;INTRAMUSCULAR

HYDROXYPROGESTERONE CAPROATE

AP LUITPOLD 250MG/ML (250MG/ML) A210723 001 Jun 21, 2018

AP SLAYBACK PHARMA LLC 1250MG/5ML (250MG/ML) A210618 001 Dec 28, 2018

MAKENA

AP +! AMAG PHARMA USA 1250MG/5ML (250MG/ML) N021945 001 Feb 03, 2011

MAKENA PRESERVATIVE FREE



AP +! AMAG PHARMA USA 250MG/ML (250MG/ML) N021945 002 Feb 19, 2016

HYDROXYPROGESTERONE CAPROATE

! ASPEN GLOBAL INC 250MG/ML (250MG/ML) A200271 001 Aug 24, 2015

SOLUTION;SUBCUTANEOUS

MAKENA (AUTOINJECTOR)

+! AMAG PHARMA USA 275MG/1.1ML (250MG/ML) N021945 004 Feb 14, 2018

HYDROXYPROPYL CELLULOSE

INSERT;OPHTHALMIC

LACRISERT

+! ATON 5MG N018771 001

HYDROXYUREA

CAPSULE;ORAL

HYDREA

AB +! BRISTOL MYERS 500MG N016295 001

SQUIBB

HYDROXYUREA

AB BARR 500MG A075143 001 Oct 16, 1998

AB PAR PHARM 500MG A075340 001 Feb 24, 1999



DROXIA

+ BRISTOL MYERS 200MG N016295 002 Feb 25, 1998

SQUIBB

+ 300MG N016295 003 Feb 25, 1998

+ 400MG N016295 004 Feb 25, 1998

TABLET;ORAL

SIKLOS

+ ADDMEDICA SAS 100MG N208843 001 Dec 21, 2017

+ 1GM N208843 002 Dec 21, 2017

HYDROXYZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDROXYZINE HYDROCHLORIDE

! LUITPOLD 25MG/ML A087408 001

! 50MG/ML A087408 002

SYRUP;ORAL

HYDROXYZINE HYDROCHLORIDE

AA ! HI TECH PHARMA 10MG/5ML A040010 001 Oct 28, 1994

AA LANNETT CO INC 10MG/5ML A201674 001 Aug 21, 2013

AA ! VINTAGE PHARMS 10MG/5ML A040391 001 Apr 10, 2002

AA ! WOCKHARDT BIO AG 10MG/5ML A087294 001 Apr 12, 1982



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-231(of 452)

HYDROXYZINE HYDROCHLORIDE

TABLET;ORAL

HYDROXYZINE HYDROCHLORIDE

AB AMNEAL PHARM 10MG A040808 001 Sep 24, 2008

AB 25MG A040808 002 Sep 24, 2008

AB 50MG A040808 003 Sep 24, 2008

AB ECI PHARMS LLC 10MG A040804 001 Jun 30, 2008

AB 25MG A040804 002 Jun 30, 2008

AB 50MG A040804 003 Jun 30, 2008

AB ELITE LABS INC 10MG A040604 002 Dec 28, 2004

AB 25MG A040604 003 Dec 28, 2004

AB 50MG A040604 001 Dec 28, 2004

AB HERITAGE PHARMA 10MG A204279 001 Aug 20, 2014

AB 25MG A204279 002 Aug 20, 2014

AB 50MG A204279 003 Aug 20, 2014

AB HETERO LABS LTD III 10MG A040805 001 May 29, 2008

AB 25MG A040805 002 May 29, 2008

AB 50MG A040805 003 May 29, 2008

AB INVAGEN PHARMS 10MG A040812 001 Mar 12, 2008

AB 25MG A040812 002 Mar 12, 2008

AB 50MG A040812 003 Mar 12, 2008

AB KVK TECH 10MG A040786 001 Mar 20, 2007

AB 25MG A040787 001 Mar 20, 2007

AB 50MG A040788 001 Mar 20, 2007

AB MYLAN 10MG A091176 001 Jun 07, 2010

AB 25MG A091176 002 Jun 07, 2010

AB 50MG A091176 003 Jun 07, 2010

AB NORTHSTAR HLTHCARE 10MG A040840 002 Mar 31, 2008

AB 25MG A040840 003 Mar 31, 2008

AB 50MG A040840 001 Mar 31, 2008

AB NUVO PHARM 10MG A207120 001 Mar 29, 2017

AB 50MG A207122 001 Mar 29, 2017

AB NUVO PHARMS INC 25MG A207121 001 Mar 29, 2017

AB ! PLIVA 10MG A088617 001 Jan 10, 1986

AB ! 25MG A088618 001 Jan 10, 1986

AB ! 50MG A088619 001 Jan 10, 1986

AB PRINSTON INC 10MG A040579 001 May 27, 2005

AB 25MG A040574 001 May 27, 2005

AB 50MG A040580 001 May 27, 2005



HYDROXYZINE PAMOATE

CAPSULE;ORAL

HYDROXYZINE PAMOATE

AB BARR EQ 25MG HYDROCHLORIDE A088496 001 Jun 15, 1984

AB EQ 50MG HYDROCHLORIDE A088487 001 Jun 15, 1984

AB HERITAGE PHARMA EQ 25MG HYDROCHLORIDE A201507 001 Jun 03, 2013

AB EQ 50MG HYDROCHLORIDE A201507 002 Jun 03, 2013

AB IMPAX LABS INC EQ 25MG HYDROCHLORIDE A040156 001 Jul 15, 1996

AB EQ 50MG HYDROCHLORIDE A040156 002 Jul 15, 1996

AB SANDOZ EQ 25MG HYDROCHLORIDE A087479 001



AB EQ 50MG HYDROCHLORIDE A086183 001

VISTARIL

AB + PFIZER EQ 25MG HYDROCHLORIDE N011459 002

AB +! EQ 50MG HYDROCHLORIDE N011459 004

HYDROXYZINE PAMOATE

BARR EQ 100MG HYDROCHLORIDE A088488 001 Jun 15, 1984

IBANDRONATE SODIUM

INJECTABLE;INTRAVENOUS

BONIVA

AP +! ROCHE EQ 3MG BASE/3ML N021858 001 Jan 06, 2006

IBANDRONATE SODIUM

AP ACCORD HLTHCARE EQ 3MG BASE/3ML A206058 001 Feb 05, 2016

AP APOTEX INC EQ 3MG BASE/3ML A204222 001 Oct 16, 2015

AP AUROBINDO PHARMA EQ 3MG BASE/3ML A205332 001 Aug 19, 2015

LTD

AP EMCURE PHARMS LTD EQ 3MG BASE/3ML A203987 001 Sep 02, 2014

AP MYLAN LABS LTD EQ 3MG BASE/3ML A202671 001 Sep 02, 2014

AP SAGENT PHARMS EQ 3MG BASE/3ML A202235 001 Sep 02, 2014

AP SUN PHARM INDS LTD EQ 3MG BASE/3ML A090853 001 Feb 14, 2014

TABLET;ORAL

BONIVA

AB +! HOFFMANN LA ROCHE EQ 150MG BASE N021455 002 Mar 24, 2005

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-232(of 452)

IBANDRONATE SODIUM

TABLET;ORAL

IBANDRONATE SODIUM

AB APOTEX INC
EQ 150MG BASE
A078948 001 Mar 19, 2012

AB AUROBINDO PHARMA
EQ 150MG BASE
A204502 001 Mar 11, 2016

LTD

AB DR REDDYS LABS LTD
EQ 150MG BASE
A078997 001 Apr 30, 2012

AB MACLEODS PHARMS LTD


EQ 150MG BASE
A206887 001 Oct 31, 2017

AB ORCHID HLTHCARE
EQ 150MG BASE
A078998 001 Mar 19, 2012

AB SUN PHARM
EQ 150MG BASE
A078996 001 Aug 15, 2012

INDUSTRIES

AB WATSON LABS TEVA
EQ 150MG BASE
A079003 001 Mar 20, 2012

IBRUTINIB

CAPSULE;ORAL

IMBRUVICA

+ PHARMACYCLICS INC
70MG
N205552 002 Dec 20, 2017

+!
140MG
N205552 001 Nov 13, 2013

TABLET;ORAL

IMBRUVICA

+ PHARMACYCLICS INC
140MG
N210563 001 Feb 16, 2018

+
280MG
N210563 002 Feb 16, 2018

+
420MG
N210563 003 Feb 16, 2018

+!
560MG
N210563 004 Feb 16, 2018

IBUPROFEN

SOLUTION;INTRAVENOUS

CALDOLOR

+! CUMBERLAND PHARMS
800MG/8ML (100MG/ML)
N022348 002 Jun 11, 2009

SUSPENSION;ORAL

IBUPROFEN

AB ! ACTAVIS MID 100MG/5ML
A074978 001 Mar 25, 1998

ATLANTIC
AB HI-TECH PHARMACAL 100MG/5ML
A205647 001 Nov 03, 2016

AB PERRIGO R AND D 100MG/5ML


A076925 001 Sep 23, 2004

AB TARO 100MG/5ML
A209204 001 Jun 23, 2017

AUROBINDO PHARMA 100MG/5ML
A209178 001 Feb 16, 2018

LTD
TABLET;ORAL

IBU-TAB

AB ALRA
400MG
A071058 001 Aug 11, 1988

AB
600MG
A071059 001 Aug 11, 1988

IBUPROFEN

AB AMNEAL PHARMS NY
400MG
A071334 001 Nov 25, 1986

AB
400MG
A078558 001 Jun 18, 2007

AB
600MG
A071335 001 Nov 25, 1986

AB
600MG
A078558 002 Jun 18, 2007

AB
800MG
A071935 001 Oct 13, 1987

AB
800MG
A078558 003 Jun 18, 2007

AB CONTRACT PHARMACAL
400MG
A071268 002 Oct 15, 1986

AB
600MG
A071268 001 Oct 15, 1986

AB
800MG
A071268 003 Jul 01, 1988

AB DR REDDYS LA
400MG
A075682 001 Nov 14, 2001

AB
600MG
A075682 002 Nov 14, 2001

AB !
800MG
A075682 003 Nov 14, 2001

AB DR REDDYS LABS INC


400MG
A076112 001 Oct 31, 2001

AB
600MG
A076112 002 Oct 31, 2001

AB
800MG
A076112 003 Oct 31, 2001

AB GRANULES INDIA LTD


400MG
A091625 001 Sep 15, 2015

AB
600MG
A091625 002 Sep 15, 2015

AB
800MG
A091625 003 Sep 15, 2015

AB HEC PHARM
400MG
A204062 001 Sep 10, 2018

AB
600MG
A204062 002 Sep 10, 2018

AB
800MG
A204062 003 Sep 10, 2018

AB MARKSANS PHARMA
400MG
A090796 001 Dec 21, 2010

AB
600MG
A090796 002 Dec 21, 2010

AB
800MG
A090796 003 Dec 21, 2010

AB PERRIGO R AND D
400MG
A077114 001 Jul 18, 2005

AB
600MG
A077114 002 Jul 18, 2005

AB
800MG
A077114 003 Jul 18, 2005

AB SHANDONG XINHUA
400MG
A202413 001 Nov 23, 2016

AB
600MG
A202413 002 Nov 23, 2016

AB
800MG
A202413 003 Nov 23, 2016

AB STRIDES PHARMA
400MG
A078329 001 Feb 05, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-233(of 452)

IBUPROFEN

TABLET;ORAL

IBUPROFEN

AB
600MG
A078329 002 Feb 05, 2009

AB
800MG
A078329 003 Feb 05, 2009

AB VINTAGE PHARMS
400MG
A071644 001 Feb 01, 1988

IBUPROFEN LYSINE

INJECTABLE;INTRAVENOUS

IBUPROFEN LYSINE

AP X-GEN PHARMS INC EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
A202402 001 Mar 30, 2016

NEOPROFEN

AP +! RECORDATI RARE EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
N021903 001 Apr 13, 2006

IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE HYDROCHLORIDE AND IBUPROFEN



AB ACTAVIS ELIZABETH
400MG;5MG
A078769 001 Jan 04, 2008

AB ! BARR LABS INC


400MG;5MG
A078316 001 Nov 29, 2007

IBUTILIDE FUMARATE

INJECTABLE;INJECTION

CORVERT
AP +! PHARMACIA AND 0.1MG/ML
N020491 001 Dec 28, 1995

UPJOHN
IBUTILIDE FUMARATE
AP LUITPOLD 0.1MG/ML
A090240 001 Jan 11, 2010

AP MYLAN INSTITUTIONAL 0.1MG/ML


A090643 001 Jan 11, 2010

ICATIBANT ACETATE

INJECTABLE;SUBCUTANEOUS

FIRAZYR

+! SHIRE ORPHAN THERAP
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
N022150 001 Aug 25, 2011

ICODEXTRIN

SOLUTION;INTRAPERITONEAL

EXTRANEAL

+! BAXTER HLTHCARE
7.5GM/100ML
N021321 001 Dec 20, 2002

ICOSAPENT ETHYL

CAPSULE;ORAL

VASCEPA

+ AMARIN PHARMS
500MG
N202057 002 Feb 16, 2017

+!
1GM
N202057 001 Jul 26, 2012

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDAMYCIN PFS

AP +! PHARMACIA AND
1MG/ML
N050734 001 Feb 17, 1997

UPJOHN

IDARUBICIN HYDROCHLORIDE

AP FRESENIUS KABI USA
1MG/ML
A065440 001 Aug 04, 2009

AP MYLAN LABS LTD


1MG/ML
A200144 001 Oct 11, 2012

AP WEST-WARD PHARMS
1MG/ML
A065275 001 Dec 14, 2006

INT

AP
1MG/ML
A065288 001 May 15, 2007

IDARUBICIN HYDROCHLORIDE PFS

AP TEVA PHARMS USA
1MG/ML
A065036 001 May 01, 2002

IDELALISIB

TABLET;ORAL

ZYDELIG

+ GILEAD SCIENCES INC
100MG
N205858 001 Jul 23, 2014

+!
150MG
N205858 002 Jul 23, 2014

IFOSFAMIDE

INJECTABLE;INJECTION

IFEX

AP + BAXTER HLTHCARE
1GM/VIAL
N019763 001 Dec 30, 1988

AP +
3GM/VIAL
N019763 002 Dec 30, 1988

IFOSFAMIDE

AP ! FRESENIUS KABI USA 1GM/VIAL
A076078 001 May 28, 2002

AP ! 3GM/VIAL
A076078 002 May 28, 2002

AP MYLAN LABS LTD 1GM/20ML (50MG/ML)


A201689 001 Nov 26, 2012

AP 3GM/60ML (50MG/ML)
A201689 002 Nov 26, 2012

AP ! TEVA PHARMS USA 1GM/20ML (50MG/ML)


A076657 001 Apr 04, 2007

AP ! 3GM/60ML (50MG/ML)
A076657 002 Apr 04, 2007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-234(of 452)

IFOSFAMIDE

INJECTABLE;INJECTION

IFOSFAMIDE

AP WEST-WARD PHARMS 1GM/20ML (50MG/ML) A076619 001 Jun 29, 2011

INT

AP 3GM/60ML (50MG/ML) A076619 002 Jun 29, 2011

ILOPERIDONE

TABLET;ORAL

FANAPT

AB +! VANDA PHARMS INC 1MG N022192 001 May 06, 2009

AB + 2MG N022192 002 May 06, 2009

AB + 4MG N022192 003 May 06, 2009

AB + 6MG N022192 004 May 06, 2009

AB + 8MG N022192 005 May 06, 2009

AB + 10MG N022192 006 May 06, 2009

AB + 12MG N022192 007 May 06, 2009

ILOPERIDONE

AB INVENTIA HLTHCARE 1MG A207231 001 Nov 28, 2016

AB 2MG A207231 002 Nov 28, 2016

AB 4MG A207231 003 Nov 28, 2016

AB 6MG A207231 004 Nov 28, 2016

AB 8MG A207231 005 Nov 28, 2016

AB 10MG A207231 006 Nov 28, 2016

AB 12MG A207231 007 Nov 28, 2016



ILOPROST

SOLUTION;INHALATION

VENTAVIS

+! ACTELION PHARMS LTD 10MCG/ML (10MCG/ML) N021779 002 Dec 08, 2005

+! 20MCG/ML (20MCG/ML) N021779 003 Aug 07, 2009

IMATINIB MESYLATE

TABLET;ORAL

GLEEVEC

AB + NOVARTIS EQ 100MG BASE N021588 001 Apr 18, 2003

AB +! EQ 400MG BASE N021588 002 Apr 18, 2003

IMATINIB MESYLATE

AB APOTEX INC EQ 100MG BASE A079179 001 Aug 05, 2016

AB EQ 400MG BASE A079179 002 Aug 05, 2016

AB DR REDDYS LABS LTD EQ 100MG BASE A206547 001 Aug 13, 2018

AB EQ 400MG BASE A206547 002 Aug 13, 2018

AB MYLAN PHARMS INC EQ 100MG BASE A204644 001 Jun 21, 2017

AB EQ 400MG BASE A204644 002 Jun 21, 2017

AB SUN PHARMA GLOBAL EQ 100MG BASE A078340 001 Dec 03, 2015

AB EQ 400MG BASE A078340 002 Dec 03, 2015

AB TEVA PHARMS USA EQ 100MG BASE A204285 001 Aug 04, 2016

AB EQ 400MG BASE A204285 002 Aug 04, 2016

AB WEST-WARD PHARMS EQ 100MG BASE A207586 001 Jul 13, 2018

INT

AB EQ 400MG BASE A207586 002 Jul 13, 2018

IMIGLUCERASE

INJECTABLE;INJECTION

CEREZYME

+ GENZYME 200 UNITS/VIAL N020367 001 May 23, 1994

+! 400 UNITS/VIAL N020367 002 Sep 22, 1999



IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

AB LEADING PHARMA LLC 10MG A040903 001 Oct 24, 2012

AB 25MG A040903 002 Oct 24, 2012

AB 50MG A040903 003 Oct 24, 2012

AB LUPIN LTD 10MG A090441 002 Mar 11, 2010

AB 25MG A090441 003 Mar 11, 2010

AB 50MG A090441 001 Mar 11, 2010

AB PAR PHARM 10MG A088292 001 Oct 21, 1983

AB 25MG A088262 001 Oct 21, 1983

AB 50MG A088276 001 Oct 21, 1983

AB SANDOZ 10MG A084936 002



AB 25MG A083745 001

AB 50MG A084937 001

AB SPECGX LLC 10MG A087846 002 May 22, 1984

AB 25MG A087846 003 May 22, 1984



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-235(of 452)

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

AB SUN PHARM 10MG A081048 001 Jun 05, 1990

INDUSTRIES

AB 25MG A081049 001 Jun 05, 1990

AB 50MG A081050 001 Jun 05, 1990

TOFRANIL

AB ! SPECGX LLC 50MG A087846 001 May 22, 1984

IMIPRAMINE HYDROCHLORIDE

OXFORD PHARMS 10MG A040751 003 Feb 28, 2008

25MG A040751 002 Feb 28, 2008

IMIPRAMINE PAMOATE

CAPSULE;ORAL

IMIPRAMINE PAMOATE

AB LUPIN LTD EQ 75MG HYDROCHLORIDE A090444 001 Apr 16, 2010

AB EQ 100MG HYDROCHLORIDE A090444 002 Apr 16, 2010

AB EQ 125MG HYDROCHLORIDE A090444 003 Apr 16, 2010

AB EQ 150MG HYDROCHLORIDE A090444 004 Apr 16, 2010

AB ! WEST-WARD PHARMS EQ 75MG HYDROCHLORIDE A091099 001 Apr 16, 2010

INT

AB EQ 100MG HYDROCHLORIDE A091099 002 Apr 16, 2010

AB EQ 125MG HYDROCHLORIDE A091099 003 Apr 16, 2010

AB EQ 150MG HYDROCHLORIDE A091099 004 Apr 16, 2010



IMIQUIMOD

CREAM;TOPICAL

ALDARA

AB +! MEDICIS 5% N020723 001 Feb 27, 1997

IMIQUIMOD

AB ANDA REPOSITORY 5% A091044 001 Feb 28, 2011

AB APOTEX INC 5% A091308 001 Apr 06, 2012

AB FOUGERA PHARMS 5% A078548 001 Feb 25, 2010

AB GLENMARK GENERICS 5% A201994 001 Mar 06, 2012

AB PERRIGO ISRAEL 5% A078837 001 Sep 07, 2010

AB TARO 5% A200173 001 Apr 15, 2011

ZYCLARA

+! MEDICIS 2.5% N022483 002 Jul 15, 2011

+! 3.75% N022483 001 Mar 25, 2010

INAMRINONE LACTATE

INJECTABLE;INJECTION

AMRINONE LACTATE

! WEST-WARD PHARMS EQ 5MG BASE/ML A075513 001 May 09, 2000

INT

INDACATEROL MALEATE

POWDER;INHALATION

ARCAPTA NEOHALER

+! SUNOVION PHARMS INC EQ 75MCG BASE N022383 001 Jul 01, 2011

INDAPAMIDE

TABLET;ORAL

INDAPAMIDE

AB ACTAVIS ELIZABETH 1.25MG A074722 001 Jun 17, 1996

AB 2.5MG A074722 002 Jun 17, 1996

AB AMERIGEN PHARMS LTD 1.25MG A075201 001 Dec 04, 1998

AB 2.5MG A075201 002 Dec 04, 1998

AB ANI PHARMS INC 1.25MG A074299 002 Apr 29, 1996

AB 2.5MG A074299 001 Jul 27, 1995

AB MYLAN 1.25MG A074461 002 Mar 26, 1997

AB ! 2.5MG A074461 001 Mar 27, 1996



INDINAVIR SULFATE

CAPSULE;ORAL

CRIXIVAN

+ MERCK SHARP DOHME EQ 200MG BASE N020685 003 Mar 13, 1996

+! EQ 400MG BASE N020685 001 Mar 13, 1996

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-236(of 452)

INDIUM IN-111 CHLORIDE



INJECTABLE;INJECTION

INDICLOR

+! GE HEALTHCARE 2mCi/0.2ML N019862 001 Dec 29, 1992

INDIUM IN 111 CHLORIDE

+! MALLINKRODT NUCLEAR 5mCi/0.5ML N019841 001 Sep 27, 1994

INDIUM IN-111 OXYQUINOLINE

INJECTABLE;INJECTION

INDIUM IN 111 OXYQUINOLINE

+! GE HEALTHCARE 1mCi/ML N019044 001 Dec 24, 1985

INDIUM IN-111 PENTETATE DISODIUM

INJECTABLE;INTRATHECAL

MPI INDIUM DTPA IN 111

+! GE HEALTHCARE 1mCi/ML N017707 001 Feb 18, 1982

INDIUM IN-111 PENTETREOTIDE KIT

INJECTABLE;INJECTION

OCTREOSCAN

+! MALLINKRODT NUCLEAR 3mCi/ML N020314 001 Jun 02, 1994

INDOCYANINE GREEN

INJECTABLE;INJECTION

IC-GREEN

AP +! AKORN 25MG/VIAL N011525 001

INDOCYANINE GREEN

AP DIAGNOSTIC GREEN 25MG/VIAL A040811 001 Nov 21, 2007

POWDER;INTRAVENOUS, INTERSTITIAL

SPY AGENT GREEN KIT

+! NOVADAQ TECH 25MG/VIAL N211580 001 Nov 21, 2018

INDOMETHACIN

CAPSULE;ORAL

INDOMETHACIN

AB GLENMARK GENERICS 25MG A091276 001 Dec 22, 2010

AB 50MG A091276 002 Dec 22, 2010

AB HERITAGE PHARMS INC 25MG N018851 001 May 18, 1984

AB 50MG N018851 002 May 18, 1984

AB HETERO LABS LTD III 25MG A091240 001 Apr 12, 2011

AB 50MG A091240 002 Apr 12, 2011

AB IVAX SUB TEVA 25MG A070719 001 Feb 12, 1986

PHARMS

AB 50MG A070756 001 Feb 12, 1986

AB JUBILANT GENERICS 25MG A205215 001 Aug 25, 2017

AB 50MG A205215 002 Aug 25, 2017

AB MYLAN 25MG N018858 001 Apr 20, 1984

AB ! 50MG A070624 001 Sep 04, 1985

AB SANDOZ 25MG A070673 001 Apr 29, 1987

AB 50MG A070674 001 Apr 29, 1987

AB SUN PHARM INDS INC 25MG A091401 001 Mar 28, 2013

AB 50MG A091401 002 Mar 28, 2013

AB ZYDUS PHARMS USA 25MG A090403 001 Nov 15, 2010

INC

AB 50MG A090403 002 Nov 15, 2010

TIVORBEX

+ IROKO PHARMS LLC 20MG N204768 001 Feb 24, 2014

+! 40MG N204768 002 Feb 24, 2014

CAPSULE, EXTENDED RELEASE;ORAL

INDOMETHACIN

AB AMNEAL PHARMS 75MG A091549 001 Dec 01, 2010

AB AUROBINDO PHARMA 75MG A204243 001 Dec 27, 2016

LTD

AB AVANTHI INC 75MG A079175 001 Mar 06, 2009

AB CHARTWELL RX 75MG A200529 001 Nov 30, 2010

AB GLENMARK PHARMS LTD 75MG A203501 001 Jun 22, 2017

AB HETERO LABS LTD III 75MG A201807 001 Sep 28, 2012

AB JUBILANT GENERICS 75MG A202706 001 Oct 05, 2015

AB MYLAN PHARMS INC 75MG A202139 001 Mar 20, 2014

AB NOVAST LABS 75MG A204853 001 May 08, 2017

AB ! SANDOZ 75MG A074464 001 May 28, 1998

AB ZYDUS PHARMS USA 75MG A202711 001 Sep 25, 2017

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-237(of 452)

INDOMETHACIN

INJECTABLE;INJECTION

INDOMETHACIN

+! FRESENIUS KABI USA
EQ 1MG BASE/VIAL
N022536 001 Mar 17, 2010
SUPPOSITORY;RECTAL

INDOMETHACIN

! G AND W LABS
50MG
A073314 001 Aug 31, 1992
SUSPENSION;ORAL

INDOCIN

+! IROKO PHARMS
25MG/5ML
N018332 001 Oct 10, 1985
INDOMETHACIN SODIUM

INJECTABLE;INJECTION

INDOCIN
AP +! RECORDATI RARE EQ 1MG BASE/VIAL
N018878 001 Jan 30, 1985

INDOMETHACIN SODIUM
AP HOSPIRA INC EQ 1MG BASE/VIAL
A204118 001 Apr 19, 2016

AP NAVINTA LLC EQ 1MG BASE/VIAL


A206561 001 Jul 19, 2017

AP WEST-WARD PHARMS EQ 1MG BASE/VIAL


A078713 001 Jul 16, 2008

INT
INGENOL MEBUTATE

GEL;TOPICAL

INGENOL MEBUTATE

AB PERRIGO UK FINCO
0.015%
A209018 001 Jan 07, 2019

AB
0.05%
A209019 001 Jan 09, 2019

PICATO

AB +! LEO LABS
0.015%
N202833 001 Jan 23, 2012

AB +!
0.05%
N202833 002 Jan 23, 2012

INOTERSEN SODIUM

SOLUTION;SUBCUTANEOUS

TEGSEDI

+! AKCEA THERAPS
EQ 284MG BASE/1.5ML (EQ 189.3MG
N211172 001
Oct 05, 2018

BASE/ML)

INSULIN ASPART

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

FIASP

+! NOVO 1000 UNITS/10ML (100 UNITS/ML)
N208751 001
Sep 29, 2017

SOLUTION;SUBCUTANEOUS

FIASP FLEXTOUCH

+! NOVO 300 UNITS/3ML (100 UNITS/ML)
N208751 002
Sep 29, 2017

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG MIX 70/30

+! NOVO NORDISK INC


700 UNITS/10ML; 300 UNITS/10ML (70
N021172 001
Nov 01, 2001

UNITS/ML; 30 UNITS/ML)

NOVOLOG MIX 70/30 FLEXPEN

+! NOVO NORDISK INC


210 UNITS/3ML; 90 UNITS/3ML (70
N021172 004
May 03, 2002

UNITS/ML; 30 UNITS/ML)

INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG

+! NOVO NORDISK INC
1000 UNITS/10ML (100 UNITS/ML)
N020986 001
Jun 07, 2000

NOVOLOG FLEXPEN

+! NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N020986 003
Jan 19, 2001

NOVOLOG PENFILL

+! NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N020986 002
Jun 07, 2000

INSULIN ASPART; INSULIN DEGLUDEC

SOLUTION;SUBCUTANEOUS

RYZODEG 70/30

+! NOVO 90 UNITS/3ML;210 UNITS/3ML (30


N203313 001
Sep 25, 2015

UNITS/ML;70 UNITS/ML)

INSULIN DEGLUDEC

SOLUTION;SUBCUTANEOUS

TRESIBA

+ NOVO 300 UNITS/3ML (100 UNITS/ML)
N203314 001
Sep 25, 2015

+! 600 UNITS/3ML (200 UNITS/ML)


N203314 002
Sep 25, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-238(of 452)

INSULIN DEGLUDEC; LIRAGLUTIDE



SOLUTION;SUBCUTANEOUS

XULTOPHY 100/3.6

+! NOVO 300 UNITS/3ML;10.8MG/3ML (100 N208583 001 Nov 21, 2016

UNITS/ML;3.6MG/ML)

INSULIN DETEMIR RECOMBINANT

INJECTABLE;SUBCUTANEOUS

LEVEMIR

+! NOVO NORDISK INC 1000 UNITS/10ML (100 UNITS/ML) N021536 001 Jun 16, 2005

LEVEMIR FLEXTOUCH

+! NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 005 Oct 31, 2013

INSULIN GLARGINE

SOLUTION;SUBCUTANEOUS

BASAGLAR

ELI LILLY AND CO 300 UNITS/3ML (100 UNITS/ML) N205692 001 Dec 16, 2015

INSULIN GLARGINE RECOMBINANT

INJECTABLE;INJECTION

LANTUS

+! SANOFI AVENTIS US 100 UNITS/ML N021081 001 Apr 20, 2000

LANTUS SOLOSTAR

+! SANOFI AVENTIS US 300 UNITS/3ML (100 UNITS/ML) N021081 002 Apr 27, 2007

SOLUTION;SUBCUTANEOUS

TOUJEO MAX SOLOSTAR

+! SANOFI US SERVICES 900 UNITS/3ML (300 UNITS/ML) N206538 002 Mar 26, 2018

TOUJEO SOLOSTAR

+! SANOFI US SERVICES 450 UNITS/1.5ML (300 UNITS/ML) N206538 001 Feb 25, 2015

INSULIN GLARGINE; LIXISENATIDE

SOLUTION;SUBCUTANEOUS

SOLIQUA 100/33

+! SANOFI-AVENTIS US 300 UNITS/3ML;99MCG/3ML (100 N208673 001 Nov 21, 2016

UNITS/ML;33MCG/ML)

INSULIN GLULISINE RECOMBINANT

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

APIDRA

+! SANOFI AVENTIS US 1000 UNITS/10ML (100 UNITS/ML) N021629 001 Apr 16, 2004

INJECTABLE;SUBCUTANEOUS

APIDRA SOLOSTAR

+ SANOFI AVENTIS US 300 UNITS/3ML N021629 003 Feb 24, 2009

INSULIN HUMAN

SOLUTION;SUBCUTANEOUS

HUMULIN R

+! LILLY 10000 UNITS/20ML (500 UNITS/ML) N018780 004 Mar 31, 1994

HUMULIN R KWIKPEN

+! LILLY 1500 UNITS/3ML (500 UNITS/ML) N018780 002 Dec 29, 2015

INSULIN LISPRO

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

ADMELOG

+ SANOFI-AVENTIS US 300 UNITS/3ML (100 UNITS/ML) N209196 003 Oct 19, 2018

+ 1000 UNITS/10ML (100 UNITS/ML) N209196 001 Dec 11, 2017

ADMELOG SOLOSTAR

+ SANOFI-AVENTIS US 300 UNITS/3ML (100 UNITS/ML) N209196 002 Dec 11, 2017

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG MIX 50/50

+! LILLY 50 UNITS/ML;50 UNITS/ML N021018 001 Dec 22, 1999



HUMALOG MIX 50/50 KWIKPEN

+! LILLY 50 UNITS/ML;50 UNITS/ML N021018 002 Sep 06, 2007

HUMALOG MIX 75/25

+! LILLY 75 UNITS/ML;25 UNITS/ML N021017 001 Dec 22, 1999



HUMALOG MIX 75/25 KWIKPEN

+! LILLY 75 UNITS/ML;25 UNITS/ML N021017 002 Sep 06, 2007



INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG

+! LILLY 100 UNITS/ML N020563 001 Jun 14, 1996

HUMALOG KWIKPEN

+! LILLY 100 UNITS/ML N020563 003 Sep 06, 2007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-239(of 452)

INSULIN LISPRO RECOMBINANT



SOLUTION;SUBCUTANEOUS

HUMALOG KWIKPEN

+! ELI LILLY AND CO 200 UNITS/ML N205747 001 May 26, 2015

INSULIN RECOMBINANT HUMAN

POWDER;INHALATION

AFREZZA

+ MANNKIND 4 UNITS/INH N022472 001 Jun 27, 2014

+! 8 UNITS/INH N022472 002 Jun 27, 2014

+ 12 UNITS/INH N022472 003 Apr 17, 2015

IOBENGUANE I-131

SOLUTION;INTRAVENOUS

AZEDRA

+! PROGENICS PHARMS 15mCi/ML N209607 001 Jul 30, 2018

INC

IOBENGUANE SULFATE I-123

SOLUTION;INTRAVENOUS

ADREVIEW

+! GE HEALTHCARE 10mCi/5ML (2mCi/ML) N022290 001 Sep 19, 2008

IODIXANOL

INJECTABLE;INJECTION

VISIPAQUE 270

+! GE HEALTHCARE 55% N020351 001 Mar 22, 1996

VISIPAQUE 320

+! GE HEALTHCARE 65.2% N020351 002 Mar 22, 1996

65.2% N020808 002 Aug 29, 1997

IOFLUPANE I-123

SOLUTION;INTRAVENOUS

DATSCAN

+! GE HLTHCARE INC 5mCi/2.5ML (2mCi/ML) N022454 001 Jan 14, 2011

IOHEXOL

FOR SOLUTION;ORAL

ORALTAG

INTERPHARMA PRAHA 9.7GM/BOT N205383 001 Mar 26, 2015

AS

INJECTABLE;INJECTION

OMNIPAQUE 140

+! GE HEALTHCARE 30.2% N018956 005 Nov 30, 1988

SOLUTION;INJECTION, ORAL

OMNIPAQUE 350

+! GE HEALTHCARE 75.5% N018956 004 Dec 26, 1985

75.5% N020608 003 Oct 24, 1995

SOLUTION;INJECTION, ORAL, RECTAL

OMNIPAQUE 180

+! GE HEALTHCARE 38.8% N018956 001 Dec 26, 1985

OMNIPAQUE 240

+! GE HEALTHCARE 51.8% N018956 002 Dec 26, 1985

OMNIPAQUE 300

+! GE HEALTHCARE 64.7% N018956 003 Dec 26, 1985

64.7% N020608 002 Oct 24, 1995

SOLUTION;ORAL

OMNIPAQUE 12

+! GE HEALTHCARE 2.6% N018956 009 Apr 17, 2018

OMNIPAQUE 9

+! GE HEALTHCARE 1.9% N018956 008 Apr 17, 2018

IOPAMIDOL

INJECTABLE;INJECTION

ISOVUE-300

AP +! BRACCO 61% N018735 002 Dec 31, 1985

ISOVUE-370

AP +! BRACCO 76% N018735 003 Dec 31, 1985

SCANLUX-300

AP SANOCHEMIA CORP USA 61% A090394 001 Jun 18, 2010

SCANLUX-370

AP SANOCHEMIA CORP USA 76% A090394 002 Jun 18, 2010

ISOVUE-200

+! BRACCO 41% N018735 006 Jul 07, 1987

ISOVUE-250

+! BRACCO 51% N018735 007 Jul 06, 1992

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-240(of 452)

IOPAMIDOL

INJECTABLE;INJECTION

ISOVUE-250

+! 51% N020327 002 Oct 12, 1994

ISOVUE-300

+! BRACCO 61% N020327 003 Oct 12, 1994

ISOVUE-370

+! BRACCO 76% N020327 004 Oct 12, 1994

ISOVUE-M 200

+! BRACCO 41% N018735 001 Dec 31, 1985

ISOVUE-M 300

+! BRACCO 61% N018735 004 Dec 31, 1985

IOPROMIDE

INJECTABLE;INJECTION

ULTRAVIST (PHARMACY BULK)

+! BAYER HLTHCARE 49.9% N021425 003 Mar 12, 2004



+! 62.3% N021425 001 Sep 20, 2002

+! 76.9% N021425 002 Sep 20, 2002

ULTRAVIST 240

+! BAYER HLTHCARE 49.9% N020220 003 May 10, 1995

ULTRAVIST 300

+! BAYER HLTHCARE 62.3% N020220 002 May 10, 1995

ULTRAVIST 370

+! BAYER HLTHCARE 76.9% N020220 001 May 10, 1995

IOTHALAMATE MEGLUMINE

INJECTABLE;INJECTION

CONRAY

+! LIEBEL-FLARSHEIM 60% N013295 001

CONRAY 43

+! LIEBEL-FLARSHEIM 43% N013295 002

SOLUTION;INTRAVESICAL

CYSTO-CONRAY II

LIEBEL-FLARSHEIM 17.2% N017057 002

IOTHALAMATE SODIUM I-125

INJECTABLE;INJECTION

GLOFIL-125

ISOTEX 250-300uCi/ML N017279 001

IOVERSOL

INJECTABLE;INJECTION

OPTIRAY 240

+! LIEBEL-FLARSHEIM 51% N019710 002 Dec 30, 1988

OPTIRAY 300

+! LIEBEL-FLARSHEIM 64% N019710 004 Jan 22, 1992

+! 64% N020923 004 May 13, 1999

OPTIRAY 320

+! LIEBEL-FLARSHEIM 68% N019710 001 Dec 30, 1988

+! 68% N020923 002 May 29, 1998

OPTIRAY 350

+! LIEBEL-FLARSHEIM 74% N019710 005 Jan 22, 1992

+! 74% N020923 003 May 28, 1998

IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION

ATROVENT HFA

+! BOEHRINGER 0.021MG/INH N021527 001 Nov 27, 2004

INGELHEIM

SOLUTION;INHALATION

IPRATROPIUM BROMIDE

AN AUROBINDO PHARMA 0.02% A206543 001 Oct 27, 2016

LTD

AN LANDELA PHARM 0.02% A077072 001 Jul 19, 2005

AN NEPHRON 0.02% A075562 001 Sep 27, 2001

AN ! RITEDOSE CORP 0.02% A075693 001 Jan 26, 2001

AN SUN PHARMA GLOBAL 0.02% A207903 001 Jan 03, 2017

AN WATSON LABS 0.02% A076291 001 May 09, 2005

SPRAY, METERED;NASAL

IPRATROPIUM BROMIDE

AB APOTEX INC 0.042MG/SPRAY A076155 001 Apr 18, 2003

AB BAUSCH AND LOMB 0.021MG/SPRAY A076025 001 Mar 31, 2003

AB 0.042MG/SPRAY A076103 001 Mar 31, 2003

AB MYLAN SPECIALITY LP 0.021MG/SPRAY A075552 001 Mar 31, 2003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-241(of 452)

IPRATROPIUM BROMIDE

SPRAY, METERED;NASAL

IPRATROPIUM BROMIDE

AB 0.042MG/SPRAY A075553 001 Mar 31, 2003

AB ! WEST-WARD PHARMS 0.021MG/SPRAY A076664 001 Nov 05, 2003

INT

AB ! 0.042MG/SPRAY A076598 001 Nov 05, 2003

IRBESARTAN

TABLET;ORAL

AVAPRO

AB + SANOFI AVENTIS US 75MG N020757 001 Sep 30, 1997

AB + 150MG N020757 002 Sep 30, 1997

AB +! 300MG N020757 003 Sep 30, 1997

IRBESARTAN

AB ALEMBIC PHARMS LTD 75MG A091236 001 Oct 15, 2012

AB 150MG A091236 002 Oct 15, 2012

AB 300MG A091236 003 Oct 15, 2012

AB AMNEAL PHARMS 75MG A204740 001 Apr 17, 2018

AB 150MG A204740 002 Apr 17, 2018

AB 300MG A204740 003 Apr 17, 2018

AB AUROBINDO PHARMA 75MG A203081 001 Sep 27, 2012

LTD

AB 150MG A203081 002 Sep 27, 2012

AB 300MG A203081 003 Sep 27, 2012

AB CHARTWELL MOLECULAR 75MG A077205 001 Nov 14, 2012

AB 150MG A077205 002 Nov 14, 2012

AB 300MG A077205 003 Nov 14, 2012

AB HETERO LABS LTD V 75MG A202910 001 Sep 27, 2012

AB 150MG A202910 002 Sep 27, 2012

AB 300MG A202910 003 Sep 27, 2012

AB HISUN PHARM 75MG A206194 001 Jun 14, 2016

HANGZHOU

AB 150MG A206194 002 Jun 14, 2016

AB 300MG A206194 003 Jun 14, 2016

AB JUBILANT GENERICS 75MG A203534 001 Feb 23, 2015

AB 150MG A203534 002 Feb 23, 2015

AB 300MG A203534 003 Feb 23, 2015

AB LUPIN LTD 75MG A201531 001 Oct 15, 2012

AB 150MG A201531 002 Oct 15, 2012

AB 300MG A201531 003 Oct 15, 2012

AB MACLEODS PHARMS LTD 75MG A202254 001 Oct 03, 2012

AB 150MG A202254 002 Oct 03, 2012

AB 300MG A202254 003 Oct 03, 2012

AB NEOPHARMA 75MG A203161 001 Sep 27, 2012

AB 150MG A203161 002 Sep 27, 2012

AB 300MG A203161 003 Sep 27, 2012

AB PRINSTON INC 75MG A203071 001 Sep 27, 2012

AB 150MG A203071 002 Sep 27, 2012

AB 300MG A203071 003 Sep 27, 2012

AB SANDOZ 75MG A077466 001 Sep 27, 2012

AB 150MG A077466 002 Sep 27, 2012

AB 300MG A077466 003 Sep 27, 2012

AB SCIEGEN PHARMS INC 75MG A204774 001 Dec 07, 2015

AB 150MG A204774 002 Dec 07, 2015

AB 300MG A204774 003 Dec 07, 2015

AB TEVA PHARMS 75MG A077159 001 Mar 30, 2012

AB 150MG A077159 002 Mar 30, 2012

AB 300MG A077159 003 Mar 30, 2012

AB UNICHEM LABS LTD 75MG A203020 001 Dec 07, 2015

AB 150MG A203020 002 Dec 07, 2015

AB 300MG A203020 003 Dec 07, 2015

AB WEST-WARD PHARMS 75MG A090201 001 Oct 15, 2012

INT

AB 150MG A090201 002 Oct 15, 2012

AB 300MG A090201 003 Oct 15, 2012

AB ZYDUS PHARMS USA 75MG A079213 001 Sep 27, 2012

INC

AB 150MG A079213 002 Sep 27, 2012

AB 300MG A079213 003 Sep 27, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-242(of 452)

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

CAMPTOSAR

AP +! PFIZER INC
40MG/2ML (20MG/ML)
N020571 001 Jun 14, 1996

AP +!
100MG/5ML (20MG/ML)
N020571 002 Jun 14, 1996

AP +!
300MG/15ML (20MG/ML)
N020571 003 Aug 05, 2010

IRINOTECAN HYDROCHLORIDE

AP ACCORD HLTHCARE
40MG/2ML (20MG/ML)
A079068 001 Nov 21, 2008

AP
100MG/5ML (20MG/ML)
A079068 002 Nov 21, 2008

AP ACTAVIS TOTOWA
40MG/2ML (20MG/ML)
A078589 001 Feb 27, 2008

AP
100MG/5ML (20MG/ML)
A078589 002 Feb 27, 2008

AP
500MG/25ML (20MG/ML)
A078589 003 Nov 18, 2015

AP AKORN
40MG/2ML (20MG/ML)
A090726 001 Sep 16, 2009

AP
100MG/5ML (20MG/ML)
A090726 002 Sep 16, 2009

AP CIPLA LTD
40MG/2ML (20MG/ML)
A077219 001 Feb 20, 2008

AP
100MG/5ML (20MG/ML)
A077219 002 Feb 20, 2008

AP EMCURE PHARMS LTD


40MG/2ML (20MG/ML)
A200771 001 Feb 14, 2012

AP
100MG/5ML (20MG/ML)
A200771 002 Feb 14, 2012

AP FRESENIUS KABI
40MG/2ML (20MG/ML)
A078188 001 Feb 27, 2008

ONCOL

AP
100MG/5ML (20MG/ML)
A078188 002 Feb 27, 2008

AP FRESENIUS KABI USA


40MG/2ML (20MG/ML)
A077776 001 Feb 27, 2008

AP
100MG/5ML (20MG/ML)
A077776 002 Feb 27, 2008

AP HIKMA FARMACEUTICA
40MG/2ML (20MG/ML)
A091032 001 Dec 20, 2010

AP
100MG/5ML (20MG/ML)
A091032 002 Dec 20, 2010

AP HISUN PHARM
40MG/2ML (20MG/ML)
A090016 001 Jan 28, 2009

HANGZHOU

AP
100MG/5ML (20MG/ML)
A090016 002 Jan 28, 2009

AP HOSPIRA
40MG/2ML (20MG/ML)
A077915 001 Feb 27, 2008

AP
100MG/5ML (20MG/ML)
A077915 002 Feb 27, 2008

AP !
500MG/25ML (20MG/ML)
A078796 001 Feb 27, 2008

AP INGENUS PHARMS LLC


40MG/2ML (20MG/ML)
A206935 001 May 26, 2017

AP
100MG/5ML (20MG/ML)
A206935 002 May 26, 2017

AP INTAS PHARMS USA


40MG/2ML (20MG/ML)
A203054 001 Aug 31, 2017

AP
100MG/5ML (20MG/ML)
A203054 002 Aug 31, 2017

AP JIANGSU HENGRUI MED


40MG/2ML (20MG/ML)
A090675 002 Dec 16, 2011

AP
100MG/5ML (20MG/ML)
A090675 001 Dec 16, 2011

AP MUSTAFA NEVZAT ILAC


40MG/2ML (20MG/ML)
A090393 002 May 13, 2011

AP
100MG/5ML (20MG/ML)
A090393 003 May 13, 2011

AP NEOPHARMA
40MG/2ML (20MG/ML)
A078953 001 Apr 15, 2010

AP
100MG/5ML (20MG/ML)
A078953 002 Apr 15, 2010

AP PLIVA LACHEMA
40MG/2ML (20MG/ML)
A078122 001 Oct 31, 2008

AP
100MG/5ML (20MG/ML)
A078122 002 Oct 31, 2008

AP QILU PHARM CO LTD


40MG/2ML (20MG/ML)
A203380 001 May 03, 2016

AP
100MG/5ML (20MG/ML)
A203380 002 May 03, 2016

AP
300MG/15ML (20MG/ML)
A203380 003 May 03, 2016

AP SHILPA MEDICARE LTD


40MG/2ML (20MG/ML)
A208718 001 Dec 28, 2018

AP
100MG/5ML (20MG/ML)
A208718 002 Dec 28, 2018

AP TEVA PHARMS USA


40MG/2ML (20MG/ML)
A090101 002 Feb 27, 2008

AP
100MG/5ML (20MG/ML)
A090101 003 Feb 27, 2008

AP
500MG/25ML (20MG/ML)
A090101 001 Nov 26, 2008

AP WEST-WARD PHARMS
40MG/2ML (20MG/ML)
A078753 001 Dec 24, 2008

INT

AP
100MG/5ML (20MG/ML)
A078753 002 Dec 24, 2008

INJECTABLE, LIPOSOMAL;INTRAVENOUS

ONIVYDE

+! IPSEN INC
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
N207793 001 Oct 22, 2015

IRON DEXTRAN

INJECTABLE;INJECTION

DEXFERRUM

BP LUITPOLD EQ 50MG IRON/ML
N040024 001 Feb 23, 1996

INFED
BP +! ALLERGAN SALES LLC EQ 50MG IRON/ML
N017441 001

PROFERDEX

BP NEW RIVER
EQ 50MG IRON/ML
N017807 001

IRON SUCROSE

INJECTABLE;INTRAVENOUS

VENOFER

+ LUITPOLD
EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)
N021135 002 Mar 20, 2005

+!
EQ 100MG BASE/5ML (EQ 20MG BASE/ML)
N021135 001 Nov 06, 2000

+
EQ 200MG BASE/10ML (EQ 20MG BASE/ML)
N021135 004 Feb 09, 2007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-243(of 452)

ISAVUCONAZONIUM SULFATE

CAPSULE;ORAL

CRESEMBA

+! ASTELLAS 186MG N207500 001 Mar 06, 2015

POWDER;INTRAVENOUS

CRESEMBA

+! ASTELLAS 372MG N207501 001 Mar 06, 2015

ISOCARBOXAZID

TABLET;ORAL

MARPLAN

+! VALIDUS PHARMS INC 10MG N011961 001

ISOFLURANE

LIQUID;INHALATION

FORANE

AN +! BAXTER HLTHCARE 99.9% N017624 001

ISOFLURANE

AN HALOCARBON PRODS 99.9% A075225 001 Oct 20, 1999

AN PIRAMAL CRITICAL 99.9% A074416 001 Sep 30, 1994

AN PIRAMAL ENT 99.9% A074502 001 Jun 27, 1995



ISONIAZID

INJECTABLE;INJECTION

ISONIAZID

! SANDOZ INC 100MG/ML A040648 001 Jul 05, 2005

SYRUP;ORAL

ISONIAZID

! CMP PHARMA INC 50MG/5ML A088235 001 Nov 10, 1983

TABLET;ORAL

ISONIAZID

AA BARR 100MG A080936 001

AA 300MG A080937 002

AA MIKART 100MG A040090 001 Jun 26, 1997

AA 300MG A040090 002 Jun 26, 1997

AA +! SANDOZ 100MG N008678 002



AA +! 300MG N008678 003

AA THEPHARMANETWORK 100MG A202610 001 Oct 29, 2014

LLC

AA 300MG A202610 002 Oct 29, 2014

LANIAZID

AA LANNETT 300MG A089776 001 Jun 13, 1988

ISONIAZID; PYRAZINAMIDE; RIFAMPIN

TABLET;ORAL

RIFATER

+! SANOFI AVENTIS US 50MG;300MG;120MG N050705 001 May 31, 1994

ISONIAZID; RIFAMPIN

CAPSULE;ORAL

RIFAMATE

! SANOFI AVENTIS US 150MG;300MG A061884 001

ISOPROTERENOL HYDROCHLORIDE

INJECTABLE;INJECTION

ISOPROTERENOL HYDROCHLORIDE

AP AMNEAL PHARMS CO 0.2MG/ML A210576 001 Oct 17, 2018

AP AMPHASTAR PHARMS 0.2MG/ML A210106 001 Jun 18, 2018

INC

AP CIPLA 0.2MG/ML A210322 001 Jun 12, 2018

AP NEXUS PHARMS 0.2MG/ML A206961 001 Aug 02, 2017

ISUPREL

AP +! VALEANT PHARMS 0.2MG/ML N010515 001

NORTH

ISOSORBIDE DINITRATE

CAPSULE, EXTENDED RELEASE;ORAL

DILATRATE-SR

+! AUXILIUM PHARMS LLC 40MG N019790 001 Sep 02, 1988

TABLET;ORAL

ISORDIL

AB + VALEANT PHARMS 5MG N012093 007 Jul 29, 1988

NORTH

ISOSORBIDE DINITRATE

AB HIKMA INTL PHARMS 5MG A086067 001 Oct 29, 1987

AB 10MG A086066 001 Oct 29, 1987

AB 20MG A088088 001 Nov 02, 1987



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-244(of 452)

ISOSORBIDE DINITRATE

TABLET;ORAL

ISOSORBIDE DINITRATE

AB 30MG A040591 001 Jan 10, 2007

AB PAR PHARM 5MG A086923 001 Mar 12, 1987

AB 10MG A086925 001 Mar 12, 1987

AB 20MG A087537 001 Oct 02, 1987

AB ! 30MG A087946 001 Jan 12, 1988

AB SANDOZ 5MG A086221 001 Jan 07, 1988

AB 10MG A086223 001 Jan 07, 1988

AB 20MG A089367 001 Apr 07, 1988

ISORDIL

+! VALEANT PHARMS 40MG N012093 001 Jul 29, 1988

NORTH

TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE DINITRATE

! SUN PHARM INDS INC 40MG A040009 001 Dec 30, 1998

ISOSORBIDE MONONITRATE

TABLET;ORAL

ISOSORBIDE MONONITRATE

AB ACTAVIS ELIZABETH 10MG A075037 002 Oct 30, 1998

AB 20MG A075037 001 Oct 30, 1998

AB ANI PHARMS INC 20MG A075147 001 Nov 27, 1998

AB HIKMA PHARMS 20MG A075361 001 Oct 05, 2000

MONOKET

AB + LANNETT CO INC 10MG N020215 002 Jun 30, 1993

AB +! 20MG N020215 001 Jun 30, 1993



TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE MONONITRATE

AB DEXCEL LTD 30MG A075522 002 Sep 20, 2016

AB 60MG A075522 001 Apr 17, 2000

AB 120MG A210822 001 Aug 29, 2018

AB HIKMA PHARMS 30MG A076813 002 Mar 30, 2006

AB 60MG A076813 001 Jan 07, 2005

AB LANNETT CO INC 30MG A075155 002 Jan 13, 2000

AB 60MG A075155 001 Oct 30, 1998

AB ! 120MG A075155 003 Aug 04, 2000

AB NESHER PHARMS 30MG A075395 001 Mar 16, 2000

AB 60MG A075395 002 Mar 16, 2000

AB 120MG A075395 003 Mar 16, 2000

AB RICONPHARMA LLC 30MG A210918 001 Nov 05, 2018

AB 60MG A210918 002 Nov 05, 2018

AB 120MG A210918 003 Nov 05, 2018

AB TORRENT PHARMS 30MG A200270 001 Jun 03, 2011

AB 60MG A200495 001 Jun 03, 2011

AB 120MG A200495 002 Jun 03, 2011

AB VINTAGE PHARMS 30MG A090598 001 Aug 11, 2010

AB 60MG A090598 002 Aug 11, 2010

AB 120MG A090598 003 Aug 11, 2010



ISOSULFAN BLUE

INJECTABLE;INJECTION

ISOSULFAN BLUE

AP AUROBINDO PHARMA 1% A206831 001 Feb 02, 2016

LTD

AP BELOTECA INC 1% A210714 001 Jan 16, 2019

AP ! MYLAN INSTITUTIONAL 1% A090874 001 Jul 20, 2010



ISOTRETINOIN

CAPSULE;ORAL

AMNESTEEM

AB MYLAN PHARMS INC 10MG A075945 001 Nov 08, 2002

AB 20MG A075945 002 Nov 08, 2002

AB 40MG A075945 003 Nov 08, 2002

CLARAVIS

AB TEVA PHARMS USA 10MG A076356 001 Apr 11, 2003

AB 20MG A076135 002 Apr 11, 2003

AB 30MG A076135 003 May 11, 2006

AB ! 40MG A076135 001 Apr 11, 2003

ISOTRETINOIN

AB AMNEAL PHARMS NY 10MG A207792 001 Sep 29, 2017

AB 20MG A207792 002 Sep 29, 2017

AB 30MG A207792 003 Sep 29, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-245(of 452)

ISOTRETINOIN

CAPSULE;ORAL

ISOTRETINOIN

AB 40MG A207792 004 Sep 29, 2017

MYORISAN

AB DOUGLAS PHARMS 10MG A076485 001 Jan 19, 2012

AB 20MG A076485 002 Jan 19, 2012

AB 30MG A076485 004 Aug 25, 2015

AB 40MG A076485 003 Jan 19, 2012

ZENATANE

AB DR REDDYS LABS LTD 10MG A202099 001 Mar 25, 2013

AB 20MG A202099 002 Mar 25, 2013

AB 30MG A202099 004 Feb 23, 2015

AB 40MG A202099 003 Mar 25, 2013



ABSORICA

BX + SUN PHARM INDS INC 10MG N021951 001 May 25, 2012

BX + 20MG N021951 002 May 25, 2012

BX + 30MG N021951 003 May 25, 2012

BX +! 40MG N021951 004 May 25, 2012

+ 25MG N021951 005 Aug 15, 2014

+ 35MG N021951 006 Aug 15, 2014



ISRADIPINE

CAPSULE;ORAL

ISRADIPINE

AB ELITE LABS INC 2.5MG A077169 001 Apr 24, 2006

AB 5MG A077169 002 Apr 24, 2006

AB WATSON LABS TEVA 2.5MG A077317 001 Jan 05, 2006

AB ! 5MG A077317 002 Jan 05, 2006



ITRACONAZOLE

CAPSULE;ORAL

ITRACONAZOLE

AB ACCORD HLTHCARE 100MG A205991 001 May 26, 2016

AB ALEMBIC PHARMS LTD 100MG A206741 001 Dec 13, 2016

AB ALKEM LABS LTD 100MG A208591 001 Jun 12, 2017

AB AMNEAL PHARMS 100MG A205080 001 Sep 26, 2016

AB JUBILANT GENERICS 100MG A203445 001 Feb 23, 2017

AB MYLAN PHARMS INC 100MG A200463 001 Jul 20, 2012

AB PAR PHARM INC 100MG A205724 001 Dec 13, 2016

AB SANDOZ 100MG A076104 001 May 28, 2004

AB TORRENT PHARMS LTD 100MG A209460 001 Aug 24, 2018

AB ZYDUS PHARMS USA 100MG A204672 001 Sep 19, 2017

INC

SPORANOX

AB +! JANSSEN PHARMS 100MG N020083 001 Sep 11, 1992

TOLSURA

+! MAYNE PHARMA INTL 65MG N208901 001 Dec 11, 2018

SOLUTION;ORAL

ITRACONAZOLE

AA AMNEAL PHARMS 10MG/ML A205573 001 Oct 30, 2015

SPORANOX

AA +! JANSSEN PHARMS 10MG/ML N020657 001 Feb 21, 1997

TABLET;ORAL

ONMEL

+! SEBELA IRELAND LTD 200MG N022484 001 Apr 29, 2010

IVABRADINE HYDROCHLORIDE

TABLET;ORAL

CORLANOR

+ AMGEN INC EQ 5MG BASE N206143 001 Apr 15, 2015

+! EQ 7.5MG BASE N206143 002 Apr 15, 2015



IVACAFTOR

GRANULE;ORAL

KALYDECO

+ VERTEX PHARMS INC 50MG/PACKET N207925 001 Mar 17, 2015

+! 75MG/PACKET N207925 002 Mar 17, 2015

TABLET;ORAL

KALYDECO

+! VERTEX PHARMS 150MG N203188 001 Jan 31, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-246(of 452)

IVACAFTOR; IVACAFTOR, TEZACAFTOR



TABLET, TABLET;ORAL

SYMDEKO (COPACKAGED)

+! VERTEX PHARMS INC 150MG,N/A;150MG, 100MG N210491 001 Feb 12, 2018

IVACAFTOR; LUMACAFTOR

GRANULE;ORAL

ORKAMBI

+ VERTEX PHARMS INC 125MG/PACKET;100MG/PACKET N211358 001 Aug 07, 2018

+! 188MG/PACKET;150MG/PACKET N211358 002 Aug 07, 2018

TABLET;ORAL

ORKAMBI

+ VERTEX PHARMS INC 125MG;100MG N206038 002 Sep 28, 2016

+! 125MG;200MG N206038 001 Jul 02, 2015



IVERMECTIN

CREAM;TOPICAL

SOOLANTRA

+! GALDERMA LABS LP 1% N206255 001 Dec 19, 2014

LOTION;TOPICAL

SKLICE

+! ARBOR PHARMS LLC 0.5% N202736 001 Feb 07, 2012

TABLET;ORAL

IVERMECTIN

AB EDENBRIDGE PHARMS 3MG A204154 001 Oct 24, 2014

STROMECTOL

AB +! MERCK SHARP DOHME 3MG N050742 002 Oct 08, 1998

IVOSIDENIB

TABLET;ORAL

TIBSOVO

+! AGIOS PHARMS INC 250MG N211192 001 Jul 20, 2018

IXABEPILONE

INJECTABLE;INTRAVENOUS

IXEMPRA KIT

+! R-PHARM US LLC 15MG/VIAL N022065 001 Oct 16, 2007

+! 45MG/VIAL N022065 002 Oct 16, 2007

IXAZOMIB CITRATE

CAPSULE;ORAL

NINLARO

+ MILLENNIUM PHARMS EQ 2.3MG BASE N208462 001 Nov 20, 2015

+ EQ 3MG BASE N208462 002 Nov 20, 2015

+! EQ 4MG BASE N208462 003 Nov 20, 2015

KETAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

KETALAR

AP +! PAR STERILE EQ 10MG BASE/ML N016812 001

PRODUCTS

AP +! EQ 50MG BASE/ML N016812 002

AP +! EQ 100MG BASE/ML N016812 003

KETAMINE HYDROCHLORIDE

AP HOSPIRA EQ 50MG BASE/ML A074549 001 Jun 27, 1996

AP EQ 100MG BASE/ML A074549 002 Jun 27, 1996

AP MYLAN INSTITUTIONAL EQ 10MG BASE/ML A076092 001 Sep 30, 2008

AP EQ 50MG BASE/ML A076092 002 Dec 28, 2001

AP EQ 100MG BASE/ML A076092 003 Oct 25, 2002

AP WEST-WARD PHARMS EQ 50MG BASE/ML A074524 001 Mar 22, 1996

INT

AP EQ 100MG BASE/ML A074524 002 Mar 22, 1996

KETOCONAZOLE

AEROSOL, FOAM;TOPICAL

EXTINA

AT +! MYLAN PHARMS INC 2% N021738 001 Jun 12, 2007

KETOCONAZOLE

AT PERRIGO ISRAEL 2% A091550 001 Aug 25, 2011

CREAM;TOPICAL

KETOCONAZOLE

AB FOUGERA PHARMS 2% A076294 001 Apr 28, 2004

AB ! TEVA 2% A075581 001 Apr 25, 2000

KETOZOLE

AB TARO 2% A075638 001 Dec 18, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-247(of 452)

KETOCONAZOLE

GEL;TOPICAL

XOLEGEL

+! AQUA PHARMS 2% N021946 001 Jul 28, 2006

SHAMPOO;TOPICAL

KETOCONAZOLE

AB PERRIGO NEW YORK 2% A076419 001 Jan 07, 2004

AB TOLMAR 2% A076942 001 Apr 11, 2005

NIZORAL

AB +! JANSSEN PHARMS 2% N019927 001 Aug 31, 1990

TABLET;ORAL

KETOCONAZOLE

AB MYLAN 200MG A075597 001 Dec 23, 1999

AB STRIDES PHARMA 200MG A210457 001 Jun 18, 2018

AB TARO 200MG A075319 001 Jun 15, 1999

AB ! TEVA 200MG A075273 001 Jun 15, 1999



KETOPROFEN

CAPSULE;ORAL

KETOPROFEN

AB HERITAGE PHARMS INC 50MG A074014 002 Jan 29, 1993

AB 75MG A074014 003 Jan 29, 1993

AB TEVA 50MG A073516 001 Dec 22, 1992

AB ! 75MG A073517 001 Dec 22, 1992



HERITAGE PHARMS INC 25MG A074014 001 Jan 29, 1993

CAPSULE, EXTENDED RELEASE;ORAL

KETOPROFEN

! MYLAN 200MG A075679 001 Feb 20, 2002

KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

AP AMPHASTAR PHARM 15MG/ML A076209 001 Jul 21, 2004

AP 30MG/ML A076209 002 Jul 21, 2004

AP BAXTER HLTHCARE 15MG/ML A209900 002 Jul 25, 2018

CORP

AP 30MG/ML A209900 001 Sep 15, 2017

AP FRESENIUS KABI USA 15MG/ML A075784 001 Jan 11, 2002

AP 15MG/ML A203242 001 Oct 07, 2015

AP 30MG/ML A075784 002 Jan 11, 2002

AP 30MG/ML A203242 002 Oct 07, 2015

AP GLAND PHARMA LTD 15MG/ML A204216 001 Nov 01, 2016

AP 30MG/ML A204216 002 Nov 01, 2016

AP ! HOSPIRA 15MG/ML A074802 001 Jun 05, 1997

AP 15MG/ML A074993 001 Jan 27, 1999

AP ! 30MG/ML A074802 002 Jun 05, 1997

AP 30MG/ML A074993 002 Jan 27, 1999

AP SAGENT PHARMS 15MG/ML A091065 001 Nov 27, 2013

AP 30MG/ML A091065 002 Nov 27, 2013

AP SANDOZ INC 30MG/ML A076271 002 Oct 06, 2004

AP WOCKHARDT 15MG/ML A077942 001 Mar 27, 2007

AP 30MG/ML A077942 002 Mar 27, 2007



SOLUTION/DROPS;OPHTHALMIC

ACULAR

AT +! ALLERGAN 0.5% N019700 001 Nov 09, 1992

ACULAR LS

AT +! ALLERGAN 0.4% N021528 001 May 30, 2003

KETOROLAC TROMETHAMINE

AT AKORN 0.4% A078399 001 Nov 05, 2009

AT 0.5% A078434 001 Nov 05, 2009

AT APOTEX INC 0.4% A077308 001 Nov 05, 2009

AT 0.5% A076109 001 Nov 05, 2009

AT AUROBINDO PHARMA 0.4% A205191 001 Nov 15, 2018

LTD

AT SANDOZ INC 0.4% A078721 001 Nov 05, 2009

AT 0.5% A076583 001 Nov 05, 2009

AT SUN PHARMA GLOBAL 0.5% A090017 001 Nov 05, 2009



ACUVAIL

+! ALLERGAN 0.45% N022427 001 Jul 22, 2009

SPRAY, METERED;NASAL

SPRIX

+! EGALET US INC 15.75MG/SPRAY N022382 001 May 14, 2010

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-248(of 452)

KETOROLAC TROMETHAMINE

TABLET;ORAL

KETOROLAC TROMETHAMINE

AB CYCLE PHARMS LTD 10MG A210616 001 Aug 16, 2018

AB ! MYLAN 10MG A074761 001 May 16, 1997

AB PLIVA 10MG A075284 001 Jun 23, 1999

AB TEVA 10MG A074754 001 May 16, 1997



KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;IRRIGATION

OMIDRIA

+! OMEROS EQ 0.3% BASE;EQ 1% BASE N205388 001 May 30, 2014

L-GLUTAMINE

FOR SOLUTION;ORAL

ENDARI

+ EMMAUS MEDCL 5GM/PACKET N208587 001 Jul 07, 2017

NUTRESTORE

+! EMMAUS MEDCL 5GM/PACKET N021667 001 Jun 10, 2004

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION

LABETALOL HYDROCHLORIDE

AP AKORN INC 5MG/ML A075431 001 Nov 29, 1999

AP GLAND PHARMA LTD 5MG/ML A090699 001 Apr 03, 2012

AP ! HOSPIRA 5MG/ML A075239 001 Nov 29, 1999

AP ! 5MG/ML A075240 001 Nov 29, 1999

AP MYLAN ASI 5MG/ML A079134 001 Feb 03, 2010

AP WEST-WARD PHARMS 5MG/ML A075303 001 May 28, 1999

INT

TABLET;ORAL

LABETALOL HYDROCHLORIDE

AB INNOGENIX 100MG A075215 001 Jul 29, 1999

AB 200MG A075215 002 Jul 29, 1999

AB 300MG A075215 003 Jul 29, 1999

AB IVAX SUB TEVA 100MG A074787 001 Aug 03, 1998

PHARMS

AB 200MG A074787 002 Aug 03, 1998

AB 300MG A074787 003 Aug 03, 1998

AB PAR FORM 100MG A200908 001 Jul 10, 2012

AB 200MG A200908 002 Jul 10, 2012

AB 300MG A200908 003 Jul 10, 2012

AB SANDOZ 100MG A075113 001 Aug 04, 1998

AB ! 200MG A075113 002 Aug 04, 1998

AB 300MG A075113 003 Aug 04, 1998

AB TWI PHARMS 100MG A209603 001 Jun 20, 2018

AB 200MG A209603 002 Jun 20, 2018

AB 300MG A209603 003 Jun 20, 2018

AB WATSON LABS 100MG A075133 001 Aug 03, 1998

AB 200MG A075133 002 Aug 03, 1998

AB 300MG A075133 003 Aug 03, 1998

AB ZYDUS PHARMS USA 100MG A207743 001 Sep 19, 2017

INC

AB 200MG A207743 002 Sep 19, 2017

AB 300MG A207743 003 Sep 19, 2017

TRANDATE

AB CNTY LINE PHARMS 100MG N018716 001 May 24, 1985

AB 200MG N018716 002 Aug 01, 1984

AB 300MG N018716 003 Aug 01, 1984



LACOSAMIDE

SOLUTION;INTRAVENOUS

VIMPAT

+! UCB INC 200MG/20ML (10MG/ML) N022254 001 Oct 28, 2008

SOLUTION;ORAL

VIMPAT

+! UCB INC 10MG/ML N022255 001 Apr 20, 2010

TABLET;ORAL

VIMPAT

+ UCB INC 50MG N022253 001 Oct 28, 2008

+ 100MG N022253 002 Oct 28, 2008

+ 150MG N022253 003 Oct 28, 2008

+! 200MG N022253 004 Oct 28, 2008

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-249(of 452)

LACTULOSE

FOR SOLUTION;ORAL

LACTULOSE

! CUMBERLAND PHARMS 10GM/PACKET A074712 001 Dec 10, 1997

! 20GM/PACKET A074712 002 Dec 10, 1997

SOLUTION;ORAL

CONSTILAC

AA ALRA 10GM/15ML A071054 001 Jul 26, 1988

LACTULOSE

AA ANI PHARMS 10GM/15ML A078430 001 Nov 28, 2007

AA BIO-PHARM INC 10GM/15ML A207786 001 Jun 11, 2018

AA FRESENIUS KABI 10GM/15ML A090503 001 Jan 25, 2012

AA ! HI TECH PHARMA 10GM/15ML A074076 001 Jul 03, 1995

AA LANNETT CO INC 10GM/15ML A075993 001 Jul 26, 2001

AA LIFEPHARMA 10GM/15ML A209517 001 Nov 23, 2018

AA PHARM ASSOC 10GM/15ML A074623 001 Jul 30, 1996

AA VISTAPHARM 10GM/15ML A074138 001 Sep 30, 1992

AA WEST-WARD PHARMS 10GM/15ML A073591 001 May 29, 1992

INT

AA WOCKHARDT BIO AG 10GM/15ML A074602 001 Nov 14, 1996

SOLUTION;ORAL, RECTAL

CHOLAC

AA ALRA 10GM/15ML A071331 001 Jul 26, 1988

ENULOSE

AA ! ACTAVIS MID 10GM/15ML A071548 001 Aug 15, 1988

ATLANTIC

GENERLAC

AA WOCKHARDT BIO AG 10GM/15ML A074603 001 Oct 31, 1996

LACTULOSE

AA ANI PHARMS 10GM/15ML A090426 001 Nov 21, 2008

AA BIO-PHARM INC 10GM/15ML A203762 001 Mar 27, 2015

AA FRESENIUS KABI 10GM/15ML A090502 001 Jan 25, 2012

AA HI TECH PHARMA 10GM/15ML A074077 001 Jul 03, 1995



LAMIVUDINE

SOLUTION;ORAL

EPIVIR

AA +! VIIV HLTHCARE 10MG/ML N020596 001 Nov 17, 1995

LAMIVUDINE

AA AUROBINDO PHARMA 10MG/ML A077695 001 Nov 21, 2016

LTD

AA LANNETT CO INC 10MG/ML A203564 001 Oct 31, 2014

EPIVIR-HBV

+! GLAXOSMITHKLINE 5MG/ML N021004 001 Dec 08, 1998

TABLET;ORAL

EPIVIR

AB + VIIV HLTHCARE 150MG N020564 001 Nov 17, 1995

AB +! 300MG N020564 003 Jun 24, 2002

EPIVIR-HBV

AB +! GLAXOSMITHKLINE 100MG N021003 001 Dec 08, 1998

LAMIVUDINE

AB APOTEX 150MG A091606 001 Dec 02, 2011

AB 300MG A091606 002 Dec 02, 2011

AB APOTEX INC 100MG A202941 001 Jan 02, 2014

AB ARISE PHARMS 150MG A206974 001 Nov 21, 2016

AB 300MG A206974 002 Nov 21, 2016

AB AUROBINDO PHARMA 150MG A077464 001 Nov 21, 2016

LTD

AB 150MG A202032 001 Nov 17, 2011

AB 300MG A077464 002 Nov 21, 2016

AB 300MG A202032 002 Nov 17, 2011

AB CIPLA 150MG A077221 001 Mar 03, 2017

AB 300MG A077221 002 Mar 03, 2017

AB ECI PHARMS LLC 150MG A203586 001 Nov 21, 2016

AB HETERO LABS LTD V 100MG A203260 001 Jan 02, 2014

AB 150MG A203277 001 Jan 06, 2014

AB 300MG A203277 002 Jan 06, 2014

AB LUPIN LTD 150MG A205217 001 Dec 18, 2014

AB 300MG A205217 002 Dec 18, 2014

AB MYLAN PHARMS INC 100MG A204002 001 Dec 31, 2014

AB 150MG A204528 001 Mar 04, 2016

AB 300MG A204528 002 Mar 04, 2016

AB STRIDES PHARMA 150MG A090457 001 Apr 19, 2018

AB 300MG A090457 002 Apr 19, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-250(of 452)

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE



TABLET;ORAL

CIMDUO

+! MYLAN LABS LTD
300MG;300MG
N022141 001 Feb 28, 2018

TEMIXYS

CELLTRION
300MG;300MG
N211284 001 Nov 16, 2018

LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

COMBIVIR

AB +! VIIV HLTHCARE
150MG;300MG
N020857 001 Sep 26, 1997

LAMIVUDINE AND ZIDOVUDINE

AB AUROBINDO PHARMA
150MG;300MG
A077558 001 May 05, 2017

LTD

AB
150MG;300MG
A202418 001 May 15, 2012

AB CIPLA
150MG;300MG
A077411 001 Sep 07, 2018

AB HETERO LABS LTD III


150MG;300MG
A079124 001 Sep 17, 2015

AB HETERO LABS LTD V


150MG;300MG
A203259 001 Feb 03, 2014

AB LUPIN LTD
150MG;300MG
A090246 001 May 15, 2012

AB MACLEODS PHARMS LTD


150MG;300MG
A090679 001 Aug 29, 2018

AB MYLAN PHARMS INC


150MG;300MG
A204005 001 Aug 28, 2014

AB SHANGHAI DESANO
150MG;300MG
A206375 001 Apr 10, 2018

AB STRIDES PHARMA
150MG;300MG
A079128 001 May 13, 2015

LAMOTRIGINE

TABLET;ORAL

LAMICTAL

AB +! GLAXOSMITHKLINE LLC
25MG
N020241 005 Dec 27, 1994

AB +
100MG
N020241 001 Dec 27, 1994

AB +
150MG
N020241 002 Dec 27, 1994

AB +
200MG
N020241 003 Dec 27, 1994

LAMOTRIGINE

AB ALEMBIC PHARMS LTD
25MG
A090607 001 Jan 13, 2011

AB
100MG
A090607 002 Jan 13, 2011

AB
150MG
A090607 003 Jan 13, 2011

AB
200MG
A090607 004 Jan 13, 2011

AB ALKEM LABS LTD


25MG
A200694 001 Jun 14, 2013

AB
100MG
A200694 002 Jun 14, 2013

AB
150MG
A200694 003 Jun 14, 2013

AB
200MG
A200694 004 Jun 14, 2013

AB APOTEX INC
25MG
A078625 001 Jan 27, 2009

AB
100MG
A078625 002 Jan 27, 2009

AB
150MG
A078625 003 Jan 27, 2009

AB
200MG
A078625 004 Jan 27, 2009

AB AUROBINDO PHARMA
25MG
A078956 001 Jan 27, 2009

AB
100MG
A078956 002 Jan 27, 2009

AB
150MG
A078956 003 Jan 27, 2009

AB
200MG
A078956 004 Jan 27, 2009

AB CIPLA
25MG
A077783 001 Nov 01, 2010

AB
100MG
A077783 002 Nov 01, 2010

AB
150MG
A077783 003 Nov 01, 2010

AB
200MG
A077783 004 Nov 01, 2010

AB DR REDDYS LABS LTD


25MG
A076708 001 Jan 27, 2009

AB
100MG
A076708 002 Jan 27, 2009

AB
150MG
A076708 003 Jan 27, 2009

AB
200MG
A076708 004 Jan 27, 2009

AB GLENMARK GENERICS
25MG
A090169 001 May 12, 2012

AB
100MG
A090169 002 May 12, 2012

AB
150MG
A090169 003 May 12, 2012

AB
200MG
A090169 004 May 12, 2012

AB JUBILANT CADISTA
25MG
A079132 001 Jan 27, 2009

AB
100MG
A079132 002 Jan 27, 2009

AB
150MG
A079132 003 Jan 27, 2009

AB
200MG
A079132 004 Jan 27, 2009

AB LUPIN LTD
25MG
A078691 001 Jun 01, 2010

AB
100MG
A078691 002 Jun 01, 2010

AB
150MG
A078691 003 Jun 01, 2010

AB
200MG
A078691 004 Jun 01, 2010

AB MYLAN
25MG
A077420 001 Jan 27, 2009

AB
100MG
A077420 002 Jan 27, 2009

AB
150MG
A077420 003 Jan 27, 2009

AB
200MG
A077420 004 Jan 27, 2009

AB TARO PHARM INDS


25MG
A078525 001 Jan 27, 2009

AB
100MG
A078525 002 Jan 27, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-251(of 452)

LAMOTRIGINE

TABLET;ORAL

LAMOTRIGINE

AB 150MG A078525 003 Jan 27, 2009

AB 200MG A078525 004 Jan 27, 2009

AB TEVA 25MG A076388 001 Aug 30, 2006

AB 100MG A076388 002 Aug 30, 2006

AB 150MG A076388 003 Aug 30, 2006

AB 200MG A076388 004 Aug 30, 2006

AB TORRENT PHARMS 25MG A078947 001 Jan 27, 2009

AB 100MG A078947 002 Jan 27, 2009

AB 150MG A078947 003 Jan 27, 2009

AB 200MG A078947 004 Jan 27, 2009

AB UNICHEM LABS LTD 25MG A090170 001 Oct 06, 2011

AB 100MG A090170 002 Oct 06, 2011

AB 150MG A090170 003 Oct 06, 2011

AB 200MG A090170 004 Oct 06, 2011

AB ZYDUS PHARMS USA 25MG A077633 001 Jan 27, 2009

AB 100MG A077633 003 Jan 27, 2009

AB 150MG A077633 004 Jan 27, 2009

AB 200MG A077633 005 Jan 27, 2009



50MG A077633 002 Jan 27, 2009

250MG A077633 006 Jan 27, 2009

TABLET, CHEWABLE;ORAL

LAMICTAL CD

AB + GLAXOSMITHKLINE LLC 2MG N020764 004 Sep 08, 2000

AB + 5MG N020764 001 Aug 24, 1998

AB +! 25MG N020764 002 Aug 24, 1998

LAMOTRIGINE

AB ALEMBIC PHARMS LTD 5MG A201168 001 Jun 12, 2014

AB 25MG A201168 002 Jun 12, 2014

AB AUROBINDO PHARMA 5MG A090401 002 Nov 04, 2009

AB 25MG A090401 003 Nov 04, 2009

AB DR REDDYS LABS LTD 5MG A076701 001 Jan 22, 2009

AB 25MG A076701 002 Jan 22, 2009

AB GLENMARK PHARMS LTD 5MG A079099 001 Feb 19, 2009

AB 25MG A079099 002 Feb 19, 2009

AB JUBILANT GENERICS 5MG A200220 001 Feb 28, 2011

AB 25MG A200220 002 Feb 28, 2011

AB TARO 5MG A079204 001 Feb 04, 2009

AB 25MG A079204 002 Feb 04, 2009

AB TEVA 5MG A076420 001 Jun 21, 2006

AB 25MG A076420 002 Jun 21, 2006

AB WATSON LABS 2MG A076928 001 Jan 22, 2009

AB 5MG A076928 002 Jan 22, 2009

AB 25MG A076928 003 Jan 22, 2009

AB ZYDUS PHARMS USA 5MG A078009 002 Jan 22, 2009

INC

AB 25MG A078009 003 Jan 22, 2009

TABLET, EXTENDED RELEASE;ORAL

LAMICTAL XR

AB + GLAXOSMITHKLINE LLC 25MG N022115 001 May 29, 2009

AB +! 50MG N022115 002 May 29, 2009

AB + 100MG N022115 003 May 29, 2009

AB +! 200MG N022115 004 May 29, 2009

AB + 250MG N022115 006 Jun 21, 2011

AB + 300MG N022115 005 Apr 14, 2010

LAMOTRIGINE

AB ACTAVIS ELIZABETH 100MG A200672 003 Oct 17, 2013

AB 200MG A200672 004 Oct 17, 2013

AB 25MG A200672 001 Oct 17, 2013

AB 50MG A200672 002 Oct 17, 2013

AB 250MG A203733 001 Nov 13, 2013

AB 300MG A200672 005 Oct 17, 2013

AB AMNEAL PHARMS 25MG A207497 001 Nov 30, 2018

AB 50MG A207497 002 Nov 30, 2018

AB 100MG A207497 003 Nov 30, 2018

AB 200MG A207497 004 Nov 30, 2018

AB 250MG A207497 005 Nov 30, 2018

AB 300MG A207497 006 Nov 30, 2018

AB ANCHEN PHARMS 25MG A201374 001 Dec 26, 2012

AB 50MG A201374 002 Dec 26, 2012

AB 100MG A201374 003 Dec 26, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-252(of 452)

LAMOTRIGINE

TABLET, EXTENDED RELEASE;ORAL

LAMOTRIGINE

AB 200MG A201374 004 Dec 26, 2012

AB 250MG A201374 005 Dec 26, 2012

AB 300MG A201374 006 Dec 26, 2012

AB DR REDDYS LABS LTD 25MG A202383 001 Jun 19, 2013

AB 50MG A202383 002 Jun 19, 2013

AB 100MG A202383 003 Jun 19, 2013

AB 200MG A202383 004 Jun 19, 2013

AB 300MG A202383 005 Jun 19, 2013

AB HANDA PHARMS LLC 100MG A202887 003 Jun 17, 2013

AB 200MG A202887 004 Jun 17, 2013

AB PAR PHARM 25MG A201791 001 Jan 18, 2013

AB 50MG A201791 002 Jan 18, 2013

AB 100MG A201791 003 Jan 18, 2013

AB 200MG A201791 004 Jan 18, 2013

AB 250MG A201791 005 Jan 18, 2013

AB 300MG A201791 006 Jan 18, 2013

AB TORRENT PHARMS LTD 25MG A203370 001 Dec 23, 2013

AB 50MG A203370 002 Dec 23, 2013

AB 100MG A203370 003 Dec 23, 2013

AB 200MG A203370 004 Dec 23, 2013

AB WOCKHARDT LTD 25MG A202498 001 Jan 04, 2013

AB 50MG A202498 002 Jan 04, 2013

AB 100MG A202498 003 Jan 04, 2013

AB 200MG A202498 004 Jan 04, 2013

AB 300MG A202498 005 Jan 04, 2013



TABLET, ORALLY DISINTEGRATING;ORAL

LAMICTAL ODT

AB + GLAXOSMITHKLINE LLC 25MG N022251 001 May 08, 2009

AB +! 50MG N022251 002 May 08, 2009

AB + 100MG N022251 003 May 08, 2009

AB + 200MG N022251 004 May 08, 2009

LAMOTRIGINE

AB IMPAX LABS INC 25MG A200828 001 Jul 15, 2013

AB 50MG A200828 002 Jul 15, 2013

AB 100MG A200828 003 Jul 15, 2013

AB 200MG A200828 004 Jul 15, 2013

AB PAR PHARM 25MG A204158 001 Oct 27, 2015

AB 50MG A204158 002 Oct 27, 2015

AB 100MG A204158 003 Oct 27, 2015

AB 200MG A204158 004 Oct 27, 2015

AB SCIEGEN PHARMS INC 25MG A206382 001 Jun 17, 2016

AB 50MG A206382 002 Jun 17, 2016

AB 100MG A206382 003 Jun 17, 2016

AB 200MG A206382 004 Jun 17, 2016



LANREOTIDE ACETATE

SOLUTION;SUBCUTANEOUS

SOMATULINE DEPOT

+! IPSEN PHARMA EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) N022074 001 Aug 30, 2007

+! EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) N022074 002 Aug 30, 2007

+! EQ 120MG BASE/0.5ML (EQ 120MG N022074 003 Aug 30, 2007

BASE/0.5ML)

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

AB AJANTA PHARMA LTD 15MG A203957 001 Oct 14, 2016

AB 30MG A203957 002 Oct 14, 2016

AB BRECKENRIDGE PHARM 15MG A203964 001 Oct 17, 2018

AB 30MG A203964 002 Oct 17, 2018

AB DR REDDYS LABS LTD 15MG A091269 001 Oct 15, 2010

AB 30MG A091269 002 Oct 15, 2010

AB INVENTIA HLTHCARE 15MG A205868 001 Aug 30, 2017

AB 30MG A205868 002 Aug 30, 2017

AB KRKA TOVARNA 15MG A091212 001 Sep 16, 2013

ZDRAVIL

AB 30MG A091212 002 Sep 16, 2013

AB LABS LICONSA 15MG A203203 001 Jul 25, 2016

AB 30MG A203203 002 Jul 25, 2016

AB LANNETT CO INC 15MG A207156 001 Sep 28, 2017

AB 30MG A207156 002 Sep 28, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-253(of 452)

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

AB MYLAN PHARMS INC 15MG A090763 001 Nov 10, 2009

AB 30MG A090763 002 Nov 10, 2009

AB NATCO PHARMA LTD 15MG A201921 001 Dec 18, 2012

AB 30MG A201921 002 Dec 18, 2012

AB SANDOZ 15MG A090331 001 Apr 23, 2010

AB 30MG A090331 002 Apr 23, 2010

AB SUN PHARM INDS LTD 15MG A202637 001 Sep 13, 2013

AB 30MG A091509 001 Sep 13, 2013

AB TEVA PHARMS 15MG A077255 001 Nov 10, 2009

AB 30MG A077255 002 Nov 10, 2009

AB WOCKHARDT USA 15MG A202176 001 Sep 14, 2012

AB 30MG A202176 002 Sep 14, 2012

AB ZYDUS HLTHCARE 15MG A202366 001 Aug 19, 2013

AB 30MG A202366 002 Aug 19, 2013

PREVACID

AB + TAKEDA PHARMS USA 15MG N020406 001 May 10, 1995

AB +! 30MG N020406 002 May 10, 1995

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

LANSOPRAZOLE

AB MYLAN PHARMS INC 15MG A202396 001 Nov 28, 2018

AB 30MG A202396 002 Nov 28, 2018

AB TEVA PHARMS USA 15MG A208784 001 Sep 21, 2017

AB 30MG A208784 002 Sep 21, 2017

AB ZYDUS PHARMS USA 15MG A200816 001 Nov 27, 2018

INC

AB 30MG A200816 002 Nov 27, 2018

PREVACID

AB + TAKEDA PHARMS USA 15MG N021428 001 Aug 30, 2002

AB +! 30MG N021428 002 Aug 30, 2002



LANTHANUM CARBONATE

POWDER;ORAL

FOSRENOL

+ SHIRE DEV LLC EQ 750MG BASE N204734 001 Sep 24, 2014

+! EQ 1GM BASE N204734 002 Sep 24, 2014

TABLET, CHEWABLE;ORAL

FOSRENOL

AB + SHIRE LLC EQ 500MG BASE N021468 002 Oct 26, 2004

AB + EQ 750MG BASE N021468 003 Nov 23, 2005

AB +! EQ 1GM BASE N021468 004 Nov 23, 2005

LANTHANUM CARBONATE

AB NATCO PHARMA LTD EQ 500MG BASE A090978 001 Aug 11, 2017

AB EQ 750MG BASE A090978 002 Aug 11, 2017

AB EQ 1GM BASE A090978 003 Aug 11, 2017



LAPATINIB DITOSYLATE

TABLET;ORAL

TYKERB

+! NOVARTIS PHARMS EQ 250MG BASE N022059 001 Mar 13, 2007

CORP

LAROTRECTINIB

CAPSULE;ORAL

VITRAKVI

+ LOXO ONCOLOGY INC 25MG N210861 001 Nov 26, 2018

+! 100MG N210861 002 Nov 26, 2018

SOLUTION;ORAL

VITRAKVI

+! LOXO ONCOLOGY INC 20MG/ML N211710 001 Nov 26, 2018

LATANOPROST

EMULSION;OPHTHALMIC

XELPROS

+! SUN PHARMA GLOBAL 0.005% N206185 001 Sep 12, 2018

SOLUTION/DROPS;OPHTHALMIC

LATANOPROST

AT AKORN 0.005% A090887 001 Jul 19, 2011

AT AMRING PHARMS 0.005% A200925 001 Mar 22, 2011

AT BAUSCH AND LOMB 0.005% A201006 001 Mar 22, 2011

AT DR REDDYS LABS LTD 0.005% A202077 001 Feb 11, 2013

AT FDC LTD 0.005% A202442 001 Apr 22, 2016

AT MYLAN 0.005% A201786 001 Mar 22, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-254(of 452)

LATANOPROST

SOLUTION/DROPS;OPHTHALMIC

LATANOPROST

AT SANDOZ INC 0.005% A091449 001 Mar 22, 2011

XALATAN

AT +! PHARMACIA AND 0.005% N020597 001 Jun 05, 1996

UPJOHN

LATANOPROSTENE BUNOD

SOLUTION/DROPS;OPHTHALMIC

VYZULTA

+! BAUSCH AND LOMB 0.024% N207795 001 Nov 02, 2017

LEDIPASVIR; SOFOSBUVIR

TABLET;ORAL

HARVONI

+! GILEAD SCIENCES INC 90MG;400MG N205834 001 Oct 10, 2014

LEFLUNOMIDE

TABLET;ORAL

ARAVA

AB + SANOFI AVENTIS US 10MG N020905 001 Sep 10, 1998

AB +! 20MG N020905 002 Sep 10, 1998

LEFLUNOMIDE

AB ALEMBIC PHARMS LTD 10MG A091369 001 Nov 21, 2011

AB 20MG A091369 002 Nov 21, 2011

AB APOTEX INC 10MG A077090 001 Sep 13, 2005

AB 20MG A077090 002 Sep 13, 2005

AB BARR 10MG A077083 001 Sep 13, 2005

AB 20MG A077083 002 Sep 13, 2005

AB HERITAGE PHARMS INC 10MG A077086 001 Sep 13, 2005

AB 20MG A077086 002 Sep 13, 2005

AB TEVA PHARMS 10MG A077084 001 Sep 13, 2005

AB 20MG A077084 002 Sep 13, 2005

ARAVA

+! SANOFI AVENTIS US 100MG N020905 003 Sep 10, 1998

LENALIDOMIDE

CAPSULE;ORAL

REVLIMID

+ CELGENE 2.5MG N021880 005 Dec 21, 2011

+ 5MG N021880 001 Dec 27, 2005

+ 10MG N021880 002 Dec 27, 2005

+ 15MG N021880 003 Jun 29, 2006

+ 20MG N021880 006 Jun 05, 2013

+! 25MG N021880 004 Jun 29, 2006

LENVATINIB MESYLATE

CAPSULE;ORAL

LENVIMA

+ EISAI INC EQ 4MG BASE N206947 001 Feb 13, 2015

+! EQ 10MG BASE N206947 002 Feb 13, 2015

LESINURAD

TABLET;ORAL

ZURAMPIC

+! IRONWOOD PHARMS INC 200MG N207988 001 Dec 22, 2015

LETERMOVIR

SOLUTION;INTRAVENOUS

PREVYMIS

+! MERCK SHARP DOHME 240MG/12ML (20MG/ML) N209940 001 Nov 08, 2017

+! 480MG/24ML (20MG/ML) N209940 002 Nov 08, 2017

TABLET;ORAL

PREVYMIS

+ MERCK SHARP DOHME 240MG N209939 001 Nov 08, 2017

+! 480MG N209939 002 Nov 08, 2017

LETROZOLE

TABLET;ORAL

FEMARA

AB +! NOVARTIS PHARMS 2.5MG N020726 001 Jul 25, 1997

LETROZOLE

AB ACCORD HLTHCARE 2.5MG A090934 001 Jun 03, 2011

AB APOTEX INC 2.5MG A091303 001 Apr 19, 2012

AB BEIJING YILING 2.5MG A205869 001 Nov 14, 2018

AB DR REDDYS LABS LTD 2.5MG A091191 001 Jun 03, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-255(of 452)

LETROZOLE

TABLET;ORAL

LETROZOLE

AB EUGIA PHARMA 2.5MG A211717 001 Jan 11, 2019

AB FRESENIUS KABI 2.5MG A090491 001 Jun 03, 2011

ONCOL

AB HIKMA PHARMS 2.5MG A203796 001 Jun 03, 2016

AB INDICUS PHARMA 2.5MG A201804 001 Jun 03, 2011

AB JIANGSU HENGRUI MED 2.5MG A202716 001 May 16, 2013

AB NATCO PHARMA LTD 2.5MG A200161 001 Jun 03, 2011

AB TEVA PHARMS 2.5MG A090289 001 Jun 03, 2011

AB VINTAGE PHARMS LLC 2.5MG A090789 001 Jun 03, 2011

AB WEST-WARD PHARMS 2.5MG A090838 001 Jun 03, 2011

INT

LETROZOLE; RIBOCICLIB SUCCINATE

TABLET, TABLET;ORAL

KISQALI FEMARA CO-PACK (COPACKAGED)

+! NOVARTIS PHARMS 2.5MG,N/A;N/A,EQ 200MG BASE N209935 001 May 04, 2017

CORP

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

AP FRESENIUS KABI USA EQ 10MG BASE/ML A207226 001 Jul 27, 2018

AP INGENUS PHARMS LLC EQ 10MG BASE/VIAL A210917 001 Nov 23, 2018

AP TEVA PHARMS USA EQ 100MG BASE/VIAL A081277 001 Sep 28, 1993

AP EQ 350MG BASE/VIAL A040174 001 Jun 12, 1997

AP ! WEST-WARD PHARMS EQ 50MG BASE/VIAL A089384 001 Sep 14, 1987

INT

AP ! EQ 100MG BASE/VIAL A089717 001 Mar 28, 1988

LEUCOVORIN CALCIUM PRESERVATIVE FREE



AP FRESENIUS KABI USA EQ 200MG BASE/VIAL A040258 001 Feb 26, 1999

AP ! EQ 500MG BASE/VIAL A040286 001 Feb 26, 1999

AP MYLAN LABS LTD EQ 100MG BASE/VIAL A203800 001 May 19, 2017

AP EQ 200MG BASE/VIAL A203800 002 May 19, 2017

AP EQ 350MG BASE/VIAL A203800 003 May 19, 2017

AP SAGENT PHARMS EQ 50MG BASE/VIAL A200753 001 Sep 06, 2012

AP EQ 100MG BASE/VIAL A200753 002 Sep 06, 2012

AP EQ 200MG BASE/VIAL A200753 003 Sep 06, 2012

AP EQ 350MG BASE/VIAL A200855 001 Sep 06, 2012

AP EQ 500MG BASE/VIAL A209110 001 Oct 26, 2017

AP ! WEST-WARD PHARMS EQ 10MG BASE/ML A040347 001 Apr 25, 2000

INT

AP ! EQ 200MG BASE/VIAL A040056 001 May 23, 1995

AP ! EQ 350MG BASE/VIAL A040335 001 Apr 20, 2000

LEUCOVORIN CALCIUM

FRESENIUS KABI USA EQ 10MG BASE/ML A207241 001 Mar 14, 2018

TABLET;ORAL

LEUCOVORIN CALCIUM

AB BARR EQ 5MG BASE A071198 001 Sep 24, 1987

AB EQ 25MG BASE A071199 001 Sep 24, 1987

AB WEST-WARD PHARMS EQ 5MG BASE A072733 001 Feb 22, 1993

INT

AB ! EQ 25MG BASE A072736 001 Feb 22, 1993

EQ 10MG BASE A072734 001 Feb 22, 1993

EQ 15MG BASE A072735 001 Feb 22, 1993

LEUPROLIDE ACETATE

FOR SUSPENSION;INTRAMUSCULAR

LUTRATE DEPOT KIT

+! GP-PHARM SA 22.5MG/VIAL N205054 001 Aug 28, 2018

INJECTABLE;INJECTION

LEUPROLIDE ACETATE

AP ! SANDOZ 1MG/0.2ML A074728 001 Aug 04, 1998

AP SUN PHARMA GLOBAL 1MG/0.2ML A078885 001 Mar 09, 2009

AP TEVA PHARMS USA 1MG/0.2ML A075471 001 Oct 25, 2000



LUPRON DEPOT

+! ABBVIE ENDOCRINE 3.75MG N020011 002 Oct 26, 1995

INC

+! 7.5MG/VIAL N019732 001 Jan 26, 1989

+! 11.25MG/VIAL N020708 001 Mar 07, 1997

+ 22.5MG/VIAL N020517 001 Dec 22, 1995

+! 30MG/VIAL N020517 002 May 30, 1997

+! 45MG/VIAL N020517 003 Jun 17, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-256(of 452)

LEUPROLIDE ACETATE

INJECTABLE;INJECTION

LUPRON DEPOT-PED

+! ABBVIE ENDOCRINE 7.5MG/VIAL N020263 002 Apr 16, 1993

INC

+! 11.25MG/VIAL N020263 005 Jan 21, 1994

+! 11.25MG/VIAL N020263 007 Aug 15, 2011

+! 15MG/VIAL N020263 006 Jan 21, 1994



+! 30MG/VIAL N020263 008 Aug 15, 2011

INJECTABLE;SUBCUTANEOUS

ELIGARD

+! TOLMAR THERAP 7.5MG/VIAL N021343 001 Jan 23, 2002

+! 22.5MG/VIAL N021379 001 Jul 24, 2002

+! 30MG/VIAL N021488 001 Feb 13, 2003

+! 45MG/VIAL N021731 001 Dec 14, 2004

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL

LUPANETA PACK

+ ABBVIE ENDOCRINE 3.75MG/VIAL,N/A;N/A,5MG N203696 001 Dec 14, 2012

+! 11.25MG/VIAL,N/A;N/A,5MG N203696 002 Dec 14, 2012

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION

LEVALBUTEROL HYDROCHLORIDE

AN AUROBINDO PHARMA EQ 0.25% BASE A207628 001 Jan 31, 2017

LTD

AN EQ 0.0103% BASE A207625 001 Dec 30, 2016

AN EQ 0.021% BASE A207625 002 Dec 30, 2016

AN EQ 0.042% BASE A207625 003 Dec 30, 2016

AN CIPLA EQ 0.021% BASE A078171 002 Dec 13, 2013

AN EQ 0.042% BASE A078171 003 Dec 13, 2013

AN EQ 0.0103% BASE A078171 001 Dec 13, 2013

AN IMPAX LABS INC EQ 0.0103% BASE A077756 003 Apr 09, 2008

AN EQ 0.021% BASE A077756 001 Apr 09, 2008

AN EQ 0.042% BASE A077756 002 Apr 09, 2008

AN MYLAN SPECIALITY LP EQ 0.0103% BASE A077800 001 Mar 15, 2013

AN EQ 0.021% BASE A077800 002 Mar 15, 2013

AN EQ 0.042% BASE A077800 003 Mar 15, 2013

AN EQ 0.25% BASE A078309 001 Mar 20, 2009

AN RITEDOSE CORP EQ 0.0103% BASE A203653 001 Mar 22, 2016

AN EQ 0.021% BASE A203653 002 Mar 22, 2016

AN EQ 0.042% BASE A203653 003 Mar 22, 2016

AN SUN PHARMA GLOBAL EQ 0.0103% BASE A207820 001 Nov 05, 2018

AN EQ 0.021% BASE A207820 002 Nov 05, 2018

AN EQ 0.042% BASE A207820 003 Nov 05, 2018

AN TEVA PARENTERAL EQ 0.25% BASE A200875 001 Sep 11, 2014

AN TEVA PHARMS USA EQ 0.0103% BASE A090297 001 Apr 26, 2013

AN EQ 0.021% BASE A090297 002 Apr 26, 2013

AN EQ 0.042% BASE A090297 003 Apr 26, 2013

XOPENEX

AN +! OAK PHARMS INC EQ 0.0103% BASE N020837 003 Jan 30, 2002

AN +! EQ 0.021% BASE N020837 001 Mar 25, 1999

AN +! EQ 0.042% BASE N020837 002 Mar 25, 1999

AN +! EQ 0.25% BASE N020837 004 Jul 18, 2003



LEVALBUTEROL TARTRATE

AEROSOL, METERED;INHALATION

XOPENEX HFA

+! SUNOVION EQ 0.045MG BASE/INH N021730 001 Mar 11, 2005

LEVETIRACETAM

INJECTABLE;IV (INFUSION)

KEPPRA

AP +! UCB INC 500MG/5ML (100MG/ML) N021872 001 Jul 31, 2006

LEVETIRACETAM

AP AKORN 500MG/5ML (100MG/ML) A209934 001 May 04, 2018

AP AUROBINDO PHARMA 500MG/5ML (100MG/ML) A204312 001 Feb 01, 2016

LTD

AP FRESENIUS KABI USA 500MG/5ML (100MG/ML) A090813 001 May 26, 2010

AP 500MG/5ML (100MG/ML) A090876 001 Aug 13, 2015

AP HAINAN POLY PHARM 500MG/5ML (100MG/ML) A209781 001 Mar 20, 2018

AP HIKMA FARMACEUTICA 500MG/5ML (100MG/ML) A090981 001 Oct 13, 2011

AP HOSPIRA INC 500MG/5ML (100MG/ML) A202869 001 Apr 06, 2012

AP JUBILANT GENERICS 500MG/5ML (100MG/ML) A206838 001 Jun 02, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-257(of 452)

LEVETIRACETAM

INJECTABLE;IV (INFUSION)

LEVETIRACETAM

AP LUITPOLD 500MG/5ML (100MG/ML)
A202143 001 Jan 31, 2012

AP MYLAN LABS LTD 500MG/5ML (100MG/ML)


A203308 001 Sep 16, 2016

AP SAGENT PHARMS 500MG/5ML (100MG/ML)


A091627 001 Jun 26, 2013

AP SUN PHARM INDS LTD 500MG/5ML (100MG/ML)


A090754 001 Jun 16, 2010

AP X GEN PHARMS 500MG/5ML (100MG/ML)


A091485 001 Aug 05, 2011

LEVETIRACETAM IN SODIUM CHLORIDE

AP AUROBINDO PHARMA
500MG/100ML (5MG/ML)
A207160 001 Jan 04, 2017

LTD

AP
1000MG/100ML (10MG/ML)
A207160 002 Jan 04, 2017

AP
1500MG/100ML (15MG/ML)
A207160 003 Jan 04, 2017

AP GLAND PHARMA LTD


500MG/100ML (5MG/ML)
A206880 001 Oct 25, 2017

AP
1000MG/100ML (10MG/ML)
A206880 002 Oct 25, 2017

AP
1500MG/100ML (15MG/ML)
A206880 003 Oct 25, 2017

AP +! HQ SPECIALITY
500MG/100ML (5MG/ML)
N202543 001 Nov 09, 2011

PHARMA

AP +!
1000MG/100ML (10MG/ML)
N202543 002 Nov 09, 2011

AP +!
1500MG/100ML (15MG/ML)
N202543 003 Nov 09, 2011

SOLUTION;ORAL

KEPPRA

AA +! UCB INC
100MG/ML
N021505 001 Jul 15, 2003

LEVETIRACETAM

AA ACTAVIS MID
100MG/ML
A078976 001 Jan 15, 2009

ATLANTIC

AA AMNEAL PHARMS
100MG/ML
A090992 001 Oct 27, 2009

AA AUROBINDO PHARMA
100MG/ML
A079063 001 Jan 15, 2009

LTD

AA BRECKENRIDGE PHARM
100MG/ML
A079120 001 Jan 16, 2009

AA HETERO LABS LTD III


100MG/ML
A203052 001 Feb 28, 2013

AA HI-TECH PHARMACAL
100MG/ML
A090601 001 Feb 28, 2012

AA LANNETT CO INC
100MG/ML
A090079 001 Apr 11, 2012

AA
100MG/ML
A090263 001 Apr 03, 2009

AA LUPIN LTD
100MG/ML
A090893 001 Oct 17, 2011

AA ORIT LABS LLC


100MG/ML
A203067 001 May 09, 2013

AA PHARM ASSOC
100MG/ML
A201157 001 Jun 04, 2015

AA TARO
100MG/ML
A078774 001 Feb 10, 2009

AA TOLMAR
100MG/ML
A079107 001 Jan 15, 2009

AA TRIS PHARMA INC


100MG/ML
A090461 001 Sep 30, 2010

AA WOCKHARDT BIO AG
100MG/ML
A090028 001 Mar 03, 2010

TABLET;ORAL

KEPPRA

AB + UCB INC
250MG
N021035 001 Nov 30, 1999

AB +
500MG
N021035 002 Nov 30, 1999

AB +
750MG
N021035 003 Nov 30, 1999

AB +!
1GM
N021035 004 Jan 06, 2006

LEVETIRACETAM

AB ACCORD HLTHCARE
250MG
A090843 001 Feb 14, 2011

AB
500MG
A090843 002 Feb 14, 2011

AB
750MG
A090843 003 Feb 14, 2011

AB
1GM
A090843 004 Feb 14, 2011

AB ACI HEALTHCARE LTD


250MG
A078042 001 Jan 15, 2009

AB
500MG
A078042 002 Jan 15, 2009

AB
750MG
A078042 003 Jan 15, 2009

AB
1GM
A078042 004 Jan 15, 2009

AB ACIC PHARMS
250MG
A090767 001 Jul 28, 2010

AB
500MG
A090767 002 Jul 28, 2010

AB
750MG
A090767 003 Jul 28, 2010

AB
1GM
A090767 004 Jul 28, 2010

AB APOTEX INC
250MG
A078869 001 Mar 13, 2009

AB
500MG
A078869 002 Mar 13, 2009

AB
750MG
A078869 003 Mar 13, 2009

AB
1GM
A078869 004 Mar 13, 2009

AB AUROBINDO PHARMA
250MG
A078993 001 Jan 15, 2009

AB
500MG
A078993 002 Jan 15, 2009

AB
750MG
A078993 003 Jan 15, 2009

AB
1GM
A078993 004 Jan 15, 2009

AB BRECKENRIDGE PHARM
250MG
A090511 001 Aug 18, 2011

AB
500MG
A090511 002 Aug 18, 2011

AB
750MG
A090511 003 Aug 18, 2011

AB
1GM
A090511 004 Aug 18, 2011

AB CHARTWELL RX
250MG
A201293 001 Jun 14, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-258(of 452)

LEVETIRACETAM

TABLET;ORAL

LEVETIRACETAM

AB 500MG A201293 002 Jun 14, 2011

AB 750MG A201293 003 Jun 14, 2011

AB 1GM A201293 004 Jun 14, 2011

AB DR REDDYS LABS LTD 250MG A076920 001 Jan 15, 2009

AB 500MG A076920 002 Jan 15, 2009

AB 750MG A076920 003 Jan 15, 2009

AB 1GM A078904 001 Jan 15, 2009

AB HETERO LABS LTD III 250MG A090515 001 Oct 08, 2010

AB 500MG A090515 002 Oct 08, 2010

AB 750MG A090515 003 Oct 08, 2010

AB 1GM A090515 004 Oct 08, 2010

AB INVAGEN PHARMS 250MG A078234 001 Jan 15, 2009

AB 500MG A078234 002 Jan 15, 2009

AB 750MG A078234 003 Jan 15, 2009

AB LUPIN 250MG A078154 001 Jan 15, 2009

AB 500MG A078154 002 Jan 15, 2009

AB 750MG A078154 003 Jan 15, 2009

AB 1GM A090025 001 Jan 15, 2009

AB MYLAN 250MG A076919 001 Nov 04, 2008

AB 500MG A076919 002 Nov 04, 2008

AB 750MG A076919 003 Nov 04, 2008

AB 1GM A090261 001 Dec 08, 2009

AB ORCHID HLTHCARE 250MG A078526 001 Jan 15, 2009

AB 500MG A078526 002 Jan 15, 2009

AB 750MG A078526 003 Jan 15, 2009

AB 1GM A090484 001 Aug 05, 2010

AB OXFORD PHARMS 250MG A077319 001 Mar 20, 2009

AB 500MG A077319 002 Mar 20, 2009

AB 750MG A077319 003 Mar 20, 2009

AB PRINSTON INC 250MG A078106 001 Feb 10, 2009

AB 500MG A078106 002 Feb 10, 2009

AB 750MG A078106 003 Feb 10, 2009

AB 1GM A078106 004 Feb 10, 2009

AB SECAN PHARMS 500MG A205102 004 Dec 16, 2015

AB 1GM A205102 003 Dec 16, 2015

AB TARO 250MG A078960 004 Feb 01, 2010

AB 500MG A078960 003 Feb 01, 2010

AB 750MG A078960 002 Feb 01, 2010

AB 1GM A078960 001 Feb 01, 2010

AB TEVA PHARMS 250MG A078101 001 Jan 15, 2009

AB 500MG A078101 002 Jan 15, 2009

AB 750MG A078101 003 Jan 15, 2009

AB 1GM A078101 004 Jan 15, 2009

AB TORRENT PHARMS 250MG A078858 001 Jan 15, 2009

AB 500MG A078858 002 Jan 15, 2009

AB 750MG A078858 003 Jan 15, 2009

AB 1GM A078858 004 Jan 15, 2009

AB VINTAGE PHARMS 250MG A091491 001 Dec 14, 2010

AB 500MG A091491 002 Dec 14, 2010

AB 750MG A091491 003 Dec 14, 2010

AB 1GM A091491 004 Dec 14, 2010

AB WOCKHARDT 250MG A079042 001 Jan 15, 2009

AB 500MG A079042 002 Jan 15, 2009

AB 750MG A079042 003 Jan 15, 2009

AB 1GM A079042 004 Jan 15, 2009

AB ZYDUS PHARMS USA 250MG A078918 001 Apr 29, 2009

INC

AB 1GM A078918 002 Apr 29, 2009

ROWEEPRA

AB LOTUS PHARM CO LTD 250MG A090906 002 Oct 31, 2016

AB 500MG A090906 001 Nov 05, 2010

AB 750MG A090906 003 Oct 31, 2016

AB 1GM A090906 004 Oct 31, 2016



TABLET, EXTENDED RELEASE;ORAL

KEPPRA XR

AB + UCB INC 500MG N022285 001 Sep 12, 2008

AB +! 750MG N022285 002 Feb 12, 2009

LEVETIRACETAM

AB ACTAVIS ELIZABETH 500MG A091557 001 Sep 12, 2011

AB 750MG A091557 002 Sep 12, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-259(of 452)

LEVETIRACETAM

TABLET, EXTENDED RELEASE;ORAL

LEVETIRACETAM

AB ACTAVIS LABS FL INC 500MG A091093 001 Sep 12, 2011

AB 750MG A091093 002 Sep 12, 2011

AB ANCHEN PHARMS 500MG A091360 001 Oct 04, 2011

AB 750MG A091360 002 Oct 04, 2011

AB APOTEX INC 500MG A091261 001 Sep 12, 2011

AB 750MG A091261 002 Sep 12, 2011

AB DEXCEL PHARMA 500MG A202167 001 Sep 04, 2015

AB 750MG A202167 002 Sep 04, 2015

AB ECI PHARMS LLC 500MG A204754 001 Aug 26, 2016

AB 750MG A204754 002 Aug 26, 2016

AB INTELLIPHARMACEUTIC 500MG A204511 001 Feb 23, 2016

S

AB 750MG A204511 002 Feb 23, 2016

AB LOTUS PHARM CO LTD 500MG A202095 002 Jun 06, 2016

AB 750MG A202095 001 Jun 06, 2016

AB LUPIN LTD 500MG A091399 001 Sep 12, 2011

AB 750MG A091399 002 Sep 12, 2011

AB PHARMADAX INC 500MG A201464 001 May 25, 2012

AB 750MG A201464 002 May 25, 2012

AB PHARMTAK INC 500MG A207175 001 Sep 28, 2017

AB 750MG A207175 002 Sep 28, 2017

AB PRINSTON INC 500MG A202533 001 Jul 20, 2012

AB 500MG A203468 001 May 21, 2015

AB 750MG A202533 002 Jul 20, 2012

AB 750MG A203468 002 May 21, 2015

AB ROUSES POINT PHARMS 500MG A202524 001 Aug 27, 2012

AB 750MG A202524 002 Aug 27, 2012

AB SUN PHARM 500MG A091285 001 Sep 12, 2011

INDUSTRIES

AB 750MG A091285 002 Sep 12, 2011

AB SUN PHARMA GLOBAL 500MG A203059 001 Sep 09, 2013

AB 750MG A203059 002 Sep 09, 2013

AB TEVA PHARMS 500MG A091430 001 Sep 12, 2011

AB 750MG A091430 002 Sep 12, 2011

AB TORRENT PHARMS LTD 500MG A091338 001 May 29, 2012

AB 750MG A091338 002 May 29, 2012

ELEPSIA XR

+ SPARC 1GM N204417 001 Dec 20, 2018

+! 1.5GM N204417 002 Dec 20, 2018

LEVETIRACETAM

APOTEX INC 1GM A202958 001 Feb 25, 2015

TABLET, FOR SUSPENSION;ORAL

SPRITAM

+ APRECIA PHARMS 250MG N207958 001 Jul 31, 2015

+ 500MG N207958 002 Jul 31, 2015

+ 750MG N207958 003 Jul 31, 2015

+! 1GM N207958 004 Jul 31, 2015

LEVOBUNOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKBETA

AT AKORN 0.25% A074779 001 Oct 29, 1996

AT 0.5% A074780 001 Oct 29, 1996

BETAGAN

AT +! ALLERGAN 0.25% N019814 001 Jun 28, 1989

AT +! 0.5% N019219 002 Dec 19, 1985

LEVOBUNOLOL HYDROCHLORIDE

AT BAUSCH AND LOMB 0.5% A074326 001 Mar 04, 1994

AT SANDOZ INC 0.5% A074850 001 Oct 28, 1996



LEVOCARNITINE

INJECTABLE;INJECTION

CARNITOR

AP +! LEADIANT BIOSCI INC 200MG/ML N020182 001 Dec 16, 1992

LEVOCARNITINE

AP LUITPOLD 200MG/ML A075861 001 Jun 22, 2001

AP WEST-WARD PHARMS 200MG/ML A075567 001 Mar 29, 2001

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-260(of 452)

LEVOCARNITINE

SOLUTION;ORAL

CARNITOR

AA +! LEADIANT BIOSCI INC 1GM/10ML N019257 001 Apr 10, 1986

CARNITOR SF

AA + LEADIANT BIOSCI INC 1GM/10ML N019257 002 Mar 28, 2007

LEVOCARNITINE

AA HI TECH PHARMA 1GM/10ML A077399 001 Oct 25, 2007

AA LYNE 1GM/10ML A076851 001 Aug 10, 2004

TABLET;ORAL

CARNITOR

AB +! LEADIANT BIOSCI INC 330MG N018948 001 Dec 27, 1985

LEVOCARNITINE

AB ANDA REPOSITORY 330MG A076858 001 Sep 20, 2004

LEVOCETIRIZINE DIHYDROCHLORIDE

SOLUTION;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

AA APOTEX INC 2.5MG/5ML A202915 001 Aug 21, 2014

AA ! L PERRIGO CO 2.5MG/5ML A091263 001 Nov 07, 2011

AA LANNETT CO INC 2.5MG/5ML A204599 001 May 15, 2017

AA TARO PHARM INDS LTD 2.5MG/5ML A202673 001 Jul 26, 2013

XYZAL

AA + SANOFI AVENTIS US 2.5MG/5ML N022157 001 Jan 28, 2008

TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

AB APOTEX INC 5MG A203027 001 Feb 13, 2015

AB DR REDDYS LABS LTD 5MG A090392 001 Feb 24, 2011

AB GLENMARK GENERICS 5MG A090385 001 Feb 24, 2011

AB HETERO LABS LTD III 5MG A091264 001 Jun 29, 2012

AB MACLEODS PHARMS LTD 5MG A205564 001 Jan 11, 2016

AB MICRO LABS LTD 5MG A202046 001 Sep 17, 2013

INDIA

AB NEOPHARMA 5MG A204323 001 Dec 20, 2016

AB SCIEGEN PHARMS INC 5MG A203646 001 Sep 09, 2014

AB SUN PHARM INDS LTD 5MG A201653 001 Jun 26, 2015

AB SUN PHARMA GLOBAL 5MG A090362 001 Jan 31, 2013

AB SYNTHON PHARMS 5MG A090229 001 Nov 26, 2010

AB TEVA PHARMS 5MG A090199 001 Aug 22, 2011

XYZAL

AB +! SANOFI AVENTIS US 5MG N022064 001 May 25, 2007

LEVODOPA

POWDER;INHALATION

INBRIJA

+! ACORDA 42MG N209184 001 Dec 21, 2018

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN

AP ! AUROBINDO PHARMA EQ 500MG/20ML (EQ 25MG/ML) A202328 001 Jan 24, 2013

LTD

AP ! EQ 750MG/30ML (EQ 25MG/ML) A202328 002 Jan 24, 2013

AP BAXTER HLTHCARE EQ 500MG/20ML (EQ 25MG/ML) A091436 001 Jun 05, 2013

CORP

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

AP AUROBINDO PHARMA EQ 250MG/50ML (EQ 5MG/ML) A206919 001 Feb 10, 2016

LTD

AP EQ 500MG/100ML (EQ 5MG/ML) A206919 002 Feb 10, 2016

AP EQ 750MG/150ML (EQ 5MG/ML) A206919 003 Feb 10, 2016

AP BAXTER HLTHCARE EQ 250MG/50ML (EQ 5MG/ML) A091397 001 Aug 08, 2013

CORP

AP EQ 500MG/100ML (EQ 5MG/ML) A091397 002 Aug 08, 2013

AP EQ 750MG/150ML (EQ 5MG/ML) A091397 003 Aug 08, 2013

AP FRESENIUS KABI USA EQ 250MG/50ML (EQ 5MG/ML) A200674 001 Jun 19, 2013

AP EQ 500MG/100ML (EQ 5MG/ML) A200674 002 Jun 19, 2013

AP EQ 750MG/150ML (EQ 5MG/ML) A200674 003 Jun 19, 2013

AP HIKMA FARMACEUTICA EQ 250MG/50ML (EQ 5MG/ML) A091375 001 Sep 16, 2011

AP EQ 500MG/100ML (EQ 5MG/ML) A091375 002 Sep 16, 2011

AP EQ 750MG/150ML (EQ 5MG/ML) A091375 003 Sep 16, 2011

AP HOSPIRA INC EQ 250MG/50ML (EQ 5MG/ML) A078579 001 Sep 03, 2015

AP EQ 500MG/100ML (EQ 5MG/ML) A078579 002 Sep 03, 2015

AP EQ 750MG/150ML (EQ 5MG/ML) A078579 003 Sep 03, 2015

AP ! INFORLIFE EQ 250MG/50ML (EQ 5MG/ML) A090343 001 Jul 07, 2011

AP ! EQ 500MG/100ML (EQ 5MG/ML) A090343 002 Jul 07, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-261(of 452)

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER



AP ! EQ 750MG/150ML (EQ 5MG/ML) A090343 003 Jul 07, 2011

SOLUTION;ORAL

LEVOFLOXACIN

AA ! HI TECH PHARMA 250MG/10ML A091678 001 Jun 20, 2011

AA LANNETT CO INC 250MG/10ML A205222 001 May 25, 2018

SOLUTION/DROPS;OPHTHALMIC

LEVOFLOXACIN

AT AKORN 0.5% A090268 001 Dec 20, 2010

AT MYLAN LABS LTD 0.5% A204899 001 Dec 08, 2017

AT ! RISING PHARMS 0.5% A077700 001 Dec 20, 2010

AT WATSON LABS TEVA 0.5% A076826 001 Feb 10, 2011



TABLET;ORAL

LEVOFLOXACIN

AB APOTEX INC 250MG A090787 001 Sep 29, 2011

AB 500MG A090787 002 Sep 29, 2011

AB 750MG A090787 003 Sep 29, 2011

AB AUROBINDO PHARMA 250MG A201043 001 Jun 20, 2011

LTD

AB 500MG A201043 002 Jun 20, 2011

AB ! 750MG A201043 003 Jun 20, 2011

AB CIPLA LTD 250MG A076890 001 Mar 30, 2012

AB 500MG A076890 002 Mar 30, 2012

AB 750MG A076890 003 Mar 30, 2012

AB DR REDDYS LABS INC 250MG A076710 001 Jun 20, 2011

AB 500MG A076710 002 Jun 20, 2011

AB 750MG A076710 003 Jun 20, 2011

AB GLENMARK GENERICS 250MG A200250 001 Jun 20, 2011

AB 500MG A200250 002 Jun 20, 2011

AB 750MG A200250 003 Jun 20, 2011

AB HETERO LABS LTD V 250MG A202801 001 Jan 08, 2015

AB 500MG A202801 002 Jan 08, 2015

AB 750MG A202801 003 Jan 08, 2015

AB JUBILANT GENERICS 250MG A203613 001 Jun 19, 2015

AB 500MG A203613 002 Jun 19, 2015

AB LUPIN 250MG A078424 001 Jun 20, 2011

AB 500MG A078424 002 Jun 20, 2011

AB 750MG A078424 003 Jun 20, 2011

AB MACLEODS PHARMS LTD 250MG A200839 001 Mar 22, 2012

AB 500MG A200839 002 Mar 22, 2012

AB 750MG A200839 003 Mar 22, 2012

AB ORCHID HLTHCARE 250MG A202200 001 Jan 30, 2012

AB 500MG A202200 002 Jan 30, 2012

AB 750MG A202200 003 Jan 30, 2012

AB SANDOZ 250MG A077438 001 Jun 20, 2011

AB 500MG A077438 002 Jun 20, 2011

AB 750MG A077438 003 Jun 20, 2011

AB TEVA 250MG A076361 001 Jun 20, 2011

AB 500MG A076361 002 Jun 20, 2011

AB 750MG A076361 003 Jun 20, 2011

AB TORRENT PHARMS 250MG A090722 001 Jun 20, 2011

AB 500MG A090722 002 Jun 20, 2011

AB 750MG A090722 003 Jun 20, 2011

AB WOCKHARDT 250MG A090367 001 Jun 20, 2011

AB 500MG A090367 002 Jun 20, 2011

AB 750MG A090367 003 Jun 20, 2011

AB ZYDUS PHARMS USA 250MG A077652 001 Sep 07, 2012

INC

AB 500MG A077652 002 Sep 07, 2012

AB 750MG A077652 003 Sep 07, 2012



LEVOLEUCOVORIN

POWDER;INTRAVENOUS

KHAPZORY

+! SPECTRUM PHARMS 175MG/VIAL N211226 001 Oct 19, 2018

+! 300MG/VIAL N211226 002 Oct 19, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-262(of 452)

LEVOLEUCOVORIN CALCIUM

POWDER;INTRAVENOUS

FUSILEV

AP +! SPECTRUM PHARMS EQ 50MG BASE/VIAL N020140 001 Mar 07, 2008

LEVOLEUCOVORIN CALCIUM

AP ACTAVIS LLC EQ 50MG BASE/VIAL A206516 001 Feb 13, 2017

AP AMNEAL PHARMS CO EQ 50MG BASE/VIAL A207547 001 Feb 13, 2017

AP WEST-WARD PHARMS EQ 50MG BASE/VIAL A206263 001 Jun 16, 2016

INT

+! ACTAVIS LLC EQ 175MG BASE/VIAL N208723 001 Sep 29, 2016

SOLUTION;INTRAVENOUS

LEVOLEUCOVORIN CALCIUM

AP AMNEAL PHARMS CO EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) A207548 001 Sep 08, 2017

AP GLAND PHARMA LTD EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) A210892 001 Sep 14, 2018

AP EQ 250MG BASE/25ML (EQ 10MG BASE/ML) A210892 002 Sep 14, 2018

AP INGENUS PHARMS LLC EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) A210623 001 May 03, 2018

AP EQ 250MG BASE/25ML (EQ 10MG BASE/ML) A210623 002 May 03, 2018

AP MYLAN TEORANTA EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) A203576 001 Oct 20, 2015

AP EQ 250MG BASE/25ML (EQ 10MG BASE/ML) A203576 002 Oct 20, 2015

AP SANDOZ INC EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) A203563 001 Mar 09, 2015

AP ! EQ 250MG BASE/25ML (EQ 10MG BASE/ML) A203563 002 Mar 09, 2015

LEVOMILNACIPRAN HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

FETZIMA

+ ALLERGAN SALES LLC EQ 20MG BASE N204168 001 Jul 25, 2013

+ EQ 40MG BASE N204168 002 Jul 25, 2013

+ EQ 80MG BASE N204168 003 Jul 25, 2013

+! EQ 120MG BASE N204168 004 Jul 25, 2013

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

SCANDONEST L

! DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984

LEVONORGESTREL

INTRAUTERINE DEVICE;INTRAUTERINE

KYLEENA

+! BAYER HLTHCARE 19.5MG N208224 001 Sep 16, 2016

LILETTA

MEDICINES360 52MG N206229 001 Feb 26, 2015

MIRENA

+! BAYER HLTHCARE 52MG N021225 001 Dec 06, 2000

SKYLA

+! BAYER HLTHCARE 13.5MG N203159 001 Jan 09, 2013

TABLET;ORAL

LEVONORGESTREL

AB LOTUS PHARM CO LTD 0.75MG A202684 001 Sep 02, 2016

AB MYLAN LABS LTD 0.75MG A202740 001 Sep 02, 2016

AB ! PERRIGO R AND D 0.75MG A090740 001 Dec 30, 2010



LEVORPHANOL TARTRATE

TABLET;ORAL

LEVORPHANOL TARTRATE

AB ! SENTYNL THERAPS INC 2MG A074278 001 Mar 31, 2000

AB VIRTUS PHARMS 2MG A211484 001 Dec 13, 2018



SENTYNL THERAPS INC 1MG A074278 002 Jun 18, 2018

3MG A074278 003 Jun 18, 2018

LEVOTHYROXINE SODIUM

CAPSULE;ORAL

TIROSINT

+ INSTITUT 0.013MG N021924 013 Aug 01, 2007

BIOCHIMIQUE

+ 0.025MG N021924 002 Oct 13, 2006

+ 0.05MG N021924 003 Oct 13, 2006

+ 0.075MG N021924 004 Oct 13, 2006

+ 0.088MG N021924 010 Oct 02, 2009

+ 0.1MG N021924 005 Oct 13, 2006

+ 0.112MG N021924 008 Oct 02, 2009

+ 0.125MG N021924 006 Oct 13, 2006

+ 0.137MG N021924 009 Oct 02, 2009

+ 0.15MG N021924 007 Oct 13, 2006

+ 0.175MG N021924 011 Apr 25, 2017

+! 0.200MG N021924 012 Apr 25, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-263(of 452)

LEVOTHYROXINE SODIUM

POWDER;INTRAVENOUS

LEVOTHYROXINE SODIUM

AP +! FRESENIUS KABI USA 100MCG/VIAL N202231 001 Jun 24, 2011

AP +! 200MCG/VIAL N202231 002 Jun 24, 2011

AP +! 500MCG/VIAL N202231 003 Jun 24, 2011

AP MAIA PHARMS INC 100MCG/VIAL A208749 001 Dec 21, 2018

AP 200MCG/VIAL A208749 002 Dec 21, 2018

AP 500MCG/VIAL A208749 003 Dec 21, 2018

AP PAR STERILE 200MCG/VIAL A205366 001 Dec 07, 2015

PRODUCTS

AP PIRAMAL CRITICAL 100MCG/VIAL A206163 001 Jun 29, 2016

AP 500MCG/VIAL A206163 002 Jun 29, 2016



LEVOTHYROXINE SODIUM **

**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL

SYNTHROID

--> + ABBVIE --> AB1,AB2 0.025MG N021402 001 Jul 24, 2002

--> + --> AB1,AB2 0.05MG N021402 002 Jul 24, 2002

--> + --> AB1,AB2 0.075MG N021402 003 Jul 24, 2002

--> + --> AB1,AB2 0.088MG N021402 004 Jul 24, 2002

--> + --> AB1,AB2 0.1MG N021402 005 Jul 24, 2002

--> + --> AB1,AB2 0.112MG N021402 006 Jul 24, 2002

--> + --> AB1,AB2 0.125MG N021402 007 Jul 24, 2002

--> + --> AB1,AB2 0.137MG N021402 008 Jul 24, 2002

--> + --> AB1,AB2 0.15MG N021402 009 Jul 24, 2002

--> + --> AB1,AB2 0.175MG N021402 010 Jul 24, 2002

--> + --> AB1,AB2 0.2MG N021402 012 Jul 24, 2002

--> +! --> AB1,AB2 0.3MG N021402 011 Jul 24, 2002

LEVO-T

--> + CEDIPROF INC --> AB1,AB2,AB3 0.025MG N021342 001 Mar 01, 2002

--> + --> AB1,AB2,AB3 0.05MG N021342 002 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.075MG N021342 003 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.088MG N021342 004 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.1MG N021342 005 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.112MG N021342 006 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.125MG N021342 007 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.137MG N021342 012 Dec 08, 2003


--> + --> AB1,AB2,AB3 0.15MG N021342 008 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.175MG N021342 009 Mar 01, 2002


--> + --> AB1,AB2,AB3 0.2MG N021342 010 Mar 01, 2002


--> +! --> AB1,AB2,AB3 0.3MG N021342 011 Mar 01, 2002


UNITHROID

--> + STEVENS J --> AB1,AB2,AB3 0.025MG N021210 001 Aug 21, 2000

--> + --> AB1,AB2,AB3 0.05MG N021210 002 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.075MG N021210 003 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.088MG N021210 004 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.1MG N021210 005 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.112MG N021210 006 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.125MG N021210 007 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.137MG N021210 012 Feb 08, 2008


--> + --> AB1,AB2,AB3 0.15MG N021210 008 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.175MG N021210 009 Aug 21, 2000


--> + --> AB1,AB2,AB3 0.2MG N021210 010 Aug 21, 2000



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-264(of 452)

LEVOTHYROXINE SODIUM **

**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL

UNITHROID

--> +! --> AB1,AB2,AB3 0.3MG N021210 011 Aug 21, 2000

LEVOTHYROXINE SODIUM

--> MYLAN --> 0.025MG A076187 001 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.05MG A076187 002 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.075MG A076187 003 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.088MG A076187 004 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.1MG A076187 005 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.112MG A076187 006 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.125MG A076187 007 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.137MG A076187 012 Dec 13, 2006

AB1,AB2,AB3,AB4

--> --> 0.15MG A076187 008 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.175MG A076187 009 Jun 05, 2002

AB1,AB2,AB3,AB4

--> --> 0.2MG A076187 010 Jun 05, 2002

AB1,AB2,AB3,AB4

--> ! --> 0.3MG A076187 011 Jun 05, 2002

AB1,AB2,AB3,AB4

LEVOXYL

--> + KING PHARMS --> AB1,AB3 0.025MG N021301 001 May 25, 2001

--> + --> AB1,AB3 0.05MG N021301 002 May 25, 2001

--> + --> AB1,AB3 0.075MG N021301 003 May 25, 2001

--> + --> AB1,AB3 0.088MG N021301 004 May 25, 2001

--> + --> AB1,AB3 0.1MG N021301 005 May 25, 2001

--> + --> AB1,AB3 0.112MG N021301 006 May 25, 2001

--> + --> AB1,AB3 0.125MG N021301 007 May 25, 2001

--> + --> AB1,AB3 0.137MG N021301 008 May 25, 2001

--> + --> AB1,AB3 0.15MG N021301 009 May 25, 2001

--> + --> AB1,AB3 0.175MG N021301 010 May 25, 2001

--> +! --> AB1,AB3 0.2MG N021301 011 May 25, 2001

EUTHYROX

AB2 PROVELL 0.025MG N021292 001 May 31, 2002

AB2 0.05MG N021292 002 May 31, 2002

AB2 0.075MG N021292 003 May 31, 2002

AB2 0.088MG N021292 004 May 31, 2002

AB2 0.1MG N021292 005 May 31, 2002

AB2 0.112MG N021292 006 May 31, 2002

AB2 0.125MG N021292 007 May 31, 2002

AB2 0.137MG N021292 008 May 31, 2002

AB2 0.15MG N021292 009 May 31, 2002

AB2 0.175MG N021292 010 May 31, 2002

AB2 0.2MG N021292 011 May 31, 2002



LIDOCAINE

OINTMENT;TOPICAL

LIDOCAINE

AT ALEOR 5% A211469 001 Nov 23, 2018

DERMACEUTICALS

AT ALKEM LABS LTD 5% A207810 001 Mar 10, 2017

AT AMNEAL PHARMS 5% A206297 001 Aug 07, 2015

AT ! FOUGERA PHARMS INC 5% A080198 001



AT G AND W LABS INC 5% A211019 001 Dec 12, 2018

AT GLENMARK PHARMS LTD 5% A206498 001 Sep 09, 2016

AT RICONPHARMA LLC 5% A208604 001 Sep 20, 2017

AT SEPTODONT INC 5% A040911 001 May 23, 2011

AT STRIDES PHARMA 5% A210958 001 Dec 11, 2018

AT TARO 5% A086724 001



AT TELIGENT PHARMA INC 5% A205318 001 Feb 01, 2016

AT TEVA PHARMS USA 5% A210256 001 Jan 16, 2018

AT VITRUVIAS THERAP 5% A208822 001 Sep 25, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-265(of 452)

LIDOCAINE

PATCH;TOPICAL

LIDOCAINE

AB ACTAVIS LABS UT INC 5% A200675 001 Aug 23, 2012

AB MYLAN TECHNOLOGIES 5% A202346 001 Aug 07, 2015

LIDODERM

AB +! TEIKOKU PHARMA USA 5% N020612 001 Mar 19, 1999

ZTLIDO

+! SCILEX PHARMS INC 1.8% N207962 001 Feb 28, 2018

LIDOCAINE HYDROCHLORIDE

GEL;OPHTHALMIC

AKTEN

+! AKORN 3.5% N022221 001 Oct 07, 2008

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE

AP AUROBINDO PHARMA 1% A207182 001 Oct 30, 2017

LTD

AP 2% A207182 002 Oct 30, 2017

AP B BRAUN MEDICAL INC 1% A208474 001 Aug 03, 2018

AP HOSPIRA 0.5% A088328 001 May 17, 1984

AP 1% A083158 001

AP 1% A088329 001 May 17, 1984

AP 2% A040078 001 Jun 23, 1995

AP 2% A083158 002

AP 2% A088294 001 May 17, 1984

AP 20% A083158 003



AP INTL MEDICATION 1% A083173 001

AP 2% A083173 002

AP LUITPOLD 1% A080850 001

AP 1% A091564 001 Aug 14, 2015

AP SPECTRA MDCL 1% A208017 001 Apr 18, 2018

DEVICES

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP B BRAUN 200MG/100ML N019830 002 Apr 08, 1992

AP BAXTER HLTHCARE 200MG/100ML N018461 002



LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

AP B BRAUN 400MG/100ML N019830 003 Apr 08, 1992
AP BAXTER HLTHCARE 400MG/100ML N018461 003
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 800MG/100ML N019830 004 Apr 08, 1992
AP BAXTER HLTHCARE 800MG/100ML N018461 004 Feb 22, 1982
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 1% A088586 001 Jul 24, 1985
AP HOSPIRA 0.5% A088325 001 Jul 31, 1984
AP 1% A088299 001 Jul 31, 1984
AP 2% A088327 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP AUROBINDO PHARMA 1% A203040 001 Mar 14, 2013
LTD
AP 1% A203082 001 Mar 14, 2013
AP 2% A203040 002 Mar 14, 2013
AP 2% A203082 002 Mar 14, 2013
AP FRESENIUS KABI USA 1% A080404 002
AP 2% A080404 003
AP 2% N017584 001
AP 4% N017584 002
AP HOSPIRA 1% A080408 001
AP 1.5% A080408 002
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP HOSPIRA 1% A040302 001 Sep 28, 1998
AP 2% A040302 002 Sep 28, 1998
XYLOCAINE
AP +! FRESENIUS KABI USA 0.5% N006488 008
AP +! 1% N006488 007
AP +! 1.5% N006488 010
AP +! 2% N006488 002
XYLOCAINE PRESERVATIVE FREE
AP +! FRESENIUS KABI USA 1% N016801 005 Jan 19, 1988
AP +! 2% N016801 001
AP +! 4% N016801 002
AP +! 20% N016801 004
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-266(of 452)

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

! HOSPIRA 4% A088295 001 May 17, 1984

INJECTABLE;SPINAL

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

! HOSPIRA 5% A083914 001

JELLY;TOPICAL

GLYDO

AT SAGENT PHARMS 2% A201094 001 Apr 28, 2014

LIDOCAINE HYDROCHLORIDE

AT AKORN 2% A040433 001 Feb 12, 2003

AT INTL MEDICATION 2% A086283 001



XYLOCAINE

AT +! OAK PHARMS 2% N008816 001

SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE

AT HI TECH PHARMA 2% A040014 001 Jul 10, 1995

AT WOCKHARDT BIO AG 2% A087872 001 Nov 18, 1982

LIDOCAINE HYDROCHLORIDE VISCOUS



AT ! LANNETT CO INC 2% A040708 001 Feb 27, 2007

LIDOCAINE VISCOUS

AT WEST-WARD PHARMS 2% A088802 001 Apr 26, 1985

INT

SOLUTION;TOPICAL

LARYNG-O-JET KIT

AT INTL MEDICATION 4% A086364 001

LIDOCAINE HYDROCHLORIDE

AT TELIGENT PHARMA INC 4% A204494 001 Mar 12, 2014

AT ! WEST-WARD PHARMS 4% A088803 001 Apr 03, 1985

INT

SYSTEM;INTRADERMAL

ZINGO

POWDER PHARMS 0.5MG N022114 001 Aug 16, 2007

LIDOCAINE; PRILOCAINE

CREAM;TOPICAL

EMLA

AB +! ACTAVIS LABS UT INC 2.5%;2.5% N019941 001 Dec 30, 1992

LIDOCAINE AND PRILOCAINE



AB FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003

AB HI TECH PHARMA 2.5%;2.5% A076290 001 Sep 25, 2003

AB TELIGENT PHARMA INC 2.5%;2.5% A205887 001 Jun 29, 2018

AB TOLMAR 2.5%;2.5% A076320 001 Aug 27, 2003

GEL;PERIODONTAL

ORAQIX

+! DENTSPLY PHARM 2.5%;2.5% N021451 001 Dec 19, 2003

LIDOCAINE; TETRACAINE

CREAM;TOPICAL

PLIAGLIS

+! TARO PHARMS 7%;7% N021717 001 Jun 29, 2006

PATCH;TOPICAL

SYNERA

+! GALEN SPECIALTY 70MG;70MG N021623 001 Jun 23, 2005

LIFITEGRAST

SOLUTION/DROPS;OPHTHALMIC

XIIDRA

+! SHIRE DEV LLC 5% N208073 001 Jul 11, 2016

LINACLOTIDE

CAPSULE;ORAL

LINZESS

+! ALLERGAN SALES LLC 72MCG N202811 003 Jan 25, 2017

+! 145MCG N202811 001 Aug 30, 2012

+ 290MCG N202811 002 Aug 30, 2012



LINAGLIPTIN

TABLET;ORAL

TRADJENTA

+! BOEHRINGER 5MG N201280 001 May 02, 2011

INGELHEIM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-267(of 452)

LINAGLIPTIN; METFORMIN HYDROCHLORIDE



TABLET;ORAL

JENTADUETO

+ BOEHRINGER 2.5MG;500MG N201281 001 Jan 30, 2012

INGELHEIM

+ 2.5MG;850MG N201281 002 Jan 30, 2012

+! 2.5MG;1GM N201281 003 Jan 30, 2012

TABLET, EXTENDED RELEASE;ORAL

JENTADUETO XR

+ BOEHRINGER 2.5MG;1GM N208026 001 May 27, 2016

INGELHEIM

+! 5MG;1GM N208026 002 May 27, 2016

LINCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

LINCOCIN

AP +! PHARMACIA AND EQ 300MG BASE/ML N050317 001

UPJOHN

LINCOMYCIN

AP X-GEN PHARMS INC EQ 300MG BASE/ML A201746 001 Jun 04, 2015

LINDANE

LOTION;TOPICAL

LINDANE

! OLTA PHARMS 1% A087313 001

SHAMPOO;TOPICAL

LINDANE

AT OLTA PHARMS 1% A087266 001

AT ! WOCKHARDT BIO AG 1% A088191 001 Sep 18, 1984

LINEZOLID

FOR SUSPENSION;ORAL

LINEZOLID

AB WEST-WARD PHARMS 100MG/5ML A200068 001 Jun 03, 2015

INT

ZYVOX

AB +! PHARMACIA AND 100MG/5ML N021132 001 Apr 18, 2000

UPJOHN

SOLUTION;INTRAVENOUS

LINEZOLID

AP AUROBINDO PHARMA 600MG/300ML (2MG/ML) A206917 001 Aug 04, 2016

LTD

AP FRESENIUS KABI USA 600MG/300ML (2MG/ML) A204764 001 Mar 15, 2016

AP HOSPIRA INC 600MG/300ML (2MG/ML) A205442 001 Jul 07, 2015

AP HQ SPCLT PHARMA 200MG/100ML (2MG/ML) A207001 001 Jul 07, 2017

AP 600MG/300ML (2MG/ML) A207001 002 Jul 07, 2017

AP MYLAN LABS LTD 200MG/100ML (2MG/ML) A205154 001 Dec 06, 2017

AP 600MG/300ML (2MG/ML) A205154 002 Dec 06, 2017

AP NANG KUANG PHARM CO 200MG/100ML (2MG/ML) A207354 001 Dec 20, 2016

AP 600MG/300ML (2MG/ML) A207354 002 Dec 20, 2016

AP SAGENT PHARMS 200MG/100ML (2MG/ML) A204696 001 Mar 02, 2017

AP 600MG/300ML (2MG/ML) A204696 002 Mar 02, 2017

AP SANDOZ INC 200MG/100ML (2MG/ML) A200904 001 Jul 16, 2015

AP 600MG/300ML (2MG/ML) A200904 002 Jul 16, 2015

AP TEVA PHARMS 600MG/300ML (2MG/ML) A200222 001 Jun 27, 2012

ZYVOX

AP + PHARMACIA AND 200MG/100ML (2MG/ML) N021131 001 Apr 18, 2000

UPJOHN

AP +! 600MG/300ML (2MG/ML) N021131 003 Apr 18, 2000

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



+! HOSPIRA INC 600MG/300ML (2MG/ML) N206473 001 Jun 18, 2015

TABLET;ORAL

LINEZOLID

AB ALEMBIC PHARMS LTD 600MG A205233 001 Dec 21, 2015

AB ALKEM LABS LTD 600MG A205517 001 Dec 21, 2015

AB AMNEAL PHARMS 600MG A204536 001 Dec 21, 2015

AB GATE PHARMS 600MG A091210 001 Feb 05, 2016

AB GLENMARK PHARMS 600MG A078987 001 Dec 21, 2015

AB HETERO LABS LTD V 600MG A204239 001 Dec 21, 2015

AB MYLAN PHARMS INC 600MG A078845 001 Dec 21, 2015

AB NOVEL LABS INC 600MG A207526 001 Aug 22, 2016

AB TEVA PHARMS USA 600MG A078061 001 May 18, 2015

AB ZYDUS PHARMS USA 600MG A206097 001 Feb 22, 2017

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-268(of 452)

LINEZOLID

TABLET;ORAL

ZYVOX

AB +! PHARMACIA AND 600MG N021130 002 Apr 18, 2000

UPJOHN

LIOTHYRONINE SODIUM

INJECTABLE;INJECTION

LIOTHYRONINE SODIUM

AP X GEN PHARMS EQ 0.01MG BASE/ML A076923 001 Aug 17, 2005

TRIOSTAT

AP +! PAR STERILE EQ 0.01MG BASE/ML N020105 001 Dec 31, 1991

PRODUCTS

TABLET;ORAL

CYTOMEL

AB + KING PHARMS EQ 0.005MG BASE N010379 001

AB + EQ 0.025MG BASE N010379 002

AB +! EQ 0.05MG BASE N010379 003

LIOTHYRONINE SODIUM

AB MAYNE PHARMA INC EQ 0.005MG BASE A090097 001 Mar 20, 2009

AB EQ 0.025MG BASE A090097 002 Mar 20, 2009

AB EQ 0.05MG BASE A090097 003 Mar 20, 2009

AB MYLAN EQ 0.005MG BASE A090326 001 Jul 14, 2009

AB EQ 0.025MG BASE A090326 002 Jul 14, 2009

AB EQ 0.05MG BASE A090326 003 Jul 14, 2009

AB SIGMAPHARM LABS LLC EQ 0.005MG BASE A200295 001 Nov 29, 2012

AB EQ 0.025MG BASE A200295 002 Nov 29, 2012

AB EQ 0.05MG BASE A200295 003 Nov 29, 2012

AB SUN PHARM INDS LTD EQ 0.005MG BASE A091382 001 Apr 20, 2016

AB EQ 0.025MG BASE A091382 002 Apr 20, 2016

AB EQ 0.05MG BASE A091382 003 Apr 20, 2016

AB TEVA PHARMS USA EQ 0.005MG BASE A211510 001 Oct 26, 2018

AB EQ 0.025MG BASE A211510 002 Oct 26, 2018

AB EQ 0.05MG BASE A211510 003 Oct 26, 2018



LIRAGLUTIDE RECOMBINANT

SOLUTION;SUBCUTANEOUS

SAXENDA

+! NOVO 18MG/3ML (6MG/ML) N206321 001 Dec 23, 2014

VICTOZA

+! NOVO NORDISK INC 18MG/3ML (6MG/ML) N022341 001 Jan 25, 2010

LISDEXAMFETAMINE DIMESYLATE

CAPSULE;ORAL

VYVANSE

+ SHIRE DEVELOPMENT 10MG N021977 007 Oct 30, 2014

+ 20MG N021977 004 Dec 10, 2007

+ 30MG N021977 001 Feb 23, 2007

+ 40MG N021977 005 Dec 10, 2007

+ 50MG N021977 002 Feb 23, 2007

+ 60MG N021977 006 Dec 10, 2007

+! 70MG N021977 003 Feb 23, 2007

TABLET, CHEWABLE;ORAL

VYVANSE

+ SHIRE DEV LLC 10MG N208510 001 Jan 28, 2017

+ 20MG N208510 002 Jan 28, 2017

+ 30MG N208510 003 Jan 28, 2017

+ 40MG N208510 004 Jan 28, 2017

+ 50MG N208510 005 Jan 28, 2017

+! 60MG N208510 006 Jan 28, 2017

LISINOPRIL

SOLUTION;ORAL

QBRELIS

+! SILVERGATE PHARMS 1MG/ML N208401 001 Jul 29, 2016

TABLET;ORAL

LISINOPRIL

AB ACCORD HLTHCARE 2.5MG A202554 001 Jul 30, 2013

AB 5MG A202554 002 Jul 30, 2013

AB 10MG A202554 003 Jul 30, 2013

AB 20MG A202554 004 Jul 30, 2013

AB 30MG A202554 005 Jul 30, 2013

AB 40MG A202554 006 Jul 30, 2013

AB APOTEX INC 2.5MG A076102 001 Sep 30, 2002

AB 5MG A076102 002 Sep 30, 2002



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-269(of 452)

LISINOPRIL

TABLET;ORAL

LISINOPRIL

AB 10MG A076102 003 Sep 30, 2002

AB 20MG A076102 004 Sep 30, 2002

AB 30MG A076102 005 Sep 30, 2002

AB 40MG A076102 006 Sep 30, 2002

AB AUROBINDO 2.5MG A077622 001 Feb 22, 2006

AB 5MG A077622 002 Feb 22, 2006

AB 10MG A077622 003 Feb 22, 2006

AB 20MG A077622 004 Feb 22, 2006

AB 30MG A077622 005 Feb 22, 2006

AB 40MG A077622 006 Feb 22, 2006

AB CASI PHARMS INC 2.5MG A075994 001 Jul 01, 2002

AB 5MG A075994 002 Jul 01, 2002

AB 10MG A075994 003 Jul 01, 2002

AB 20MG A075994 004 Jul 01, 2002

AB 30MG A075994 005 Jul 01, 2002

AB 40MG A075994 006 Jul 01, 2002

AB HIKMA INTL PHARMS 2.5MG A076063 001 Jul 01, 2002

AB 5MG A076063 002 Jul 01, 2002

AB 10MG A076063 003 Jul 01, 2002

AB 20MG A076063 004 Jul 01, 2002

AB 30MG A076063 006 Jun 27, 2003

AB 40MG A076063 005 Jul 01, 2002

AB INVAGEN PHARMS 2.5MG A203508 001 Oct 29, 2013

AB 5MG A203508 002 Oct 29, 2013

AB 10MG A203508 003 Oct 29, 2013

AB 20MG A203508 004 Oct 29, 2013

AB 30MG A203508 005 Oct 29, 2013

AB 40MG A203508 006 Oct 29, 2013

AB IVAX SUB TEVA 2.5MG A075752 001 Jul 01, 2002

PHARMS

AB 5MG A075752 002 Jul 01, 2002

AB 10MG A075752 003 Jul 01, 2002

AB 20MG A075752 004 Jul 01, 2002

AB 30MG A075752 005 Jul 01, 2002

AB 40MG A075752 006 Jul 01, 2002

AB LUPIN 2.5MG A077321 001 Sep 09, 2005

AB 5MG A077321 002 Sep 09, 2005

AB 10MG A077321 003 Sep 09, 2005

AB 20MG A077321 004 Sep 09, 2005

AB 30MG A077321 005 Sep 09, 2005

AB 40MG A077321 006 Sep 09, 2005

AB MYLAN 2.5MG A076071 001 Jul 01, 2002

AB 5MG A076071 002 Jul 01, 2002

AB 10MG A076071 003 Jul 01, 2002

AB 20MG A076071 004 Jul 01, 2002

AB 30MG A076071 005 Jul 01, 2002

AB 40MG A076071 006 Jul 01, 2002

AB PRINSTON INC 2.5MG A075743 001 Jul 01, 2002

AB 2.5MG A076180 001 Jul 01, 2002

AB 5MG A075743 002 Jul 01, 2002

AB 5MG A076180 002 Jul 01, 2002

AB 10MG A075743 003 Jul 01, 2002

AB 10MG A076180 003 Jul 01, 2002

AB 20MG A075743 004 Jul 01, 2002

AB 20MG A076164 001 Jul 01, 2002

AB 30MG A075743 005 Jul 01, 2002

AB 30MG A076164 002 Jul 01, 2002

AB 40MG A075743 006 Jul 01, 2002

AB 40MG A076164 003 Jul 01, 2002

AB SUN PHARM INDS LTD 2.5MG A075944 001 Jul 01, 2002

AB 5MG A075944 002 Jul 01, 2002

AB 10MG A075944 003 Jul 01, 2002

AB 20MG A075944 004 Jul 01, 2002

AB 30MG A075944 006 Feb 11, 2003

AB 40MG A075944 005 Jul 01, 2002

AB WATSON LABS 2.5MG A076059 001 Jul 01, 2002

AB 5MG A076059 002 Jul 01, 2002

AB 10MG A076059 003 Jul 01, 2002

AB 20MG A076059 004 Jul 01, 2002

AB 30MG A076059 005 Jul 01, 2002



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-270(of 452)

LISINOPRIL

TABLET;ORAL

LISINOPRIL

AB 40MG A076059 006 Jul 01, 2002

AB WOCKHARDT 2.5MG A078402 001 Apr 19, 2007

AB 5MG A078402 002 Apr 19, 2007

AB 10MG A078402 003 Apr 19, 2007

AB 20MG A078402 004 Apr 19, 2007

AB 30MG A078402 005 Apr 19, 2007

AB 40MG A078402 006 Apr 19, 2007

PRINIVIL

AB MERCK 5MG N019558 001 Dec 29, 1987

AB 10MG N019558 002 Dec 29, 1987

AB 20MG N019558 003 Dec 29, 1987

AB 40MG N019558 004 Oct 25, 1988

ZESTRIL

AB + ALVOGEN MALTA 2.5MG N019777 005 Apr 29, 1993

AB + 5MG N019777 001 May 19, 1988

AB + 10MG N019777 002 May 19, 1988

AB + 20MG N019777 003 May 19, 1988

AB + 30MG N019777 006 Jan 20, 1999

AB +! 40MG N019777 004 May 19, 1988



LITHIUM CARBONATE

CAPSULE;ORAL

LITHIUM CARBONATE

AB ALEMBIC LTD 150MG A079159 001 Jan 12, 2009

AB 300MG A079159 002 Jan 12, 2009

AB 600MG A079159 003 Jan 12, 2009

AB GLENMARK GENERICS 150MG A079139 001 Feb 03, 2009

AB 300MG A079139 002 Feb 03, 2009

AB 600MG A079139 003 Feb 03, 2009

AB HETERO LABS LTD III 150MG A090702 001 Sep 25, 2009

AB 300MG A090702 002 Sep 25, 2009

AB 600MG A090702 003 Sep 25, 2009

AB MYLAN PHARMS INC 150MG A076243 002 Feb 24, 2003

AB 300MG A076243 001 Jun 27, 2002

AB 600MG A078763 001 Apr 15, 2008

AB + WEST-WARD PHARMS 150MG N017812 002 Jan 28, 1987

INT

AB + 300MG N017812 001

AB +! 600MG N017812 003 Jan 28, 1987

TABLET;ORAL

LITHIUM CARBONATE

AB SUN PHARM INDS INC 300MG A091027 001 Jun 24, 2010

AB +! WEST-WARD PHARMS 300MG N018558 001 Jan 29, 1982

INT

TABLET, EXTENDED RELEASE;ORAL

LITHIUM CARBONATE

AB ALEMBIC PHARMS LTD 300MG A204445 001 Jun 10, 2015

AB GLENMARK GENERICS 450MG A091616 001 Feb 14, 2011

AB GLENMARK PHARMS INC 300MG A091544 001 Dec 27, 2010

AB HERITAGE PHARMA 300MG A205532 001 Sep 29, 2016

AB MYLAN PHARMS INC 300MG A202288 001 Jun 29, 2012

AB 450MG A202219 001 Aug 08, 2012

AB UNIQUE PHARM LABS 300MG A204779 001 Jul 27, 2015

AB 450MG A205663 001 Jun 05, 2017

AB WEST-WARD PHARMS 300MG A076832 001 Oct 28, 2004

INT

AB ! 450MG A076691 001 Jan 05, 2004

LITHOBID

AB +! ANI PHARMS INC 300MG N018027 001

LITHIUM CITRATE

SYRUP;ORAL

LITHIUM CITRATE

AA +! WEST-WARD PHARMS EQ 300MG CARBONATE/5ML N018421 001

INT

AA WOCKHARDT BIO AG EQ 300MG CARBONATE/5ML A070755 001 May 21, 1986

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-271(of 452)

LIXISENATIDE

SOLUTION;SUBCUTANEOUS

ADLYXIN

+! SANOFI-AVENTIS US 0.15MG/3ML (0.05MG/ML) N208471 001 Jul 27, 2016

+! 0.3MG/3ML (0.1MG/ML) N208471 002 Jul 27, 2016

LODOXAMIDE TROMETHAMINE

SOLUTION/DROPS;OPHTHALMIC

ALOMIDE

+! NOVARTIS PHARMS EQ 0.1% BASE N020191 001 Sep 23, 1993

CORP

LOFEXIDINE HYDROCHLORIDE

TABLET;ORAL

LUCEMYRA

+! US WORLDMEDS LLC EQ 0.18MG BASE N209229 001 May 16, 2018

LOMITAPIDE MESYLATE

CAPSULE;ORAL

JUXTAPID

+ AEGERION EQ 5MG BASE N203858 001 Dec 21, 2012
+ EQ 10MG BASE N203858 002 Dec 21, 2012
+ EQ 20MG BASE N203858 003 Dec 21, 2012
+ EQ 30MG BASE N203858 004 Apr 23, 2015
+ EQ 40MG BASE N203858 005 Apr 23, 2015
+! EQ 60MG BASE N203858 006 Apr 23, 2015
LOMUSTINE
CAPSULE;ORAL
GLEOSTINE
+ CORDEN PHARMA 10MG N017588 001
+ 40MG N017588 002
+! 100MG N017588 003
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
AB ! MYLAN 2MG A072741 001 Sep 18, 1991
AB TEVA 2MG A073192 001 Apr 30, 1992
LOPINAVIR; RITONAVIR
SOLUTION;ORAL
KALETRA
AA +! ABBVIE 80MG/ML;20MG/ML N021251 001 Sep 15, 2000
LOPINAVIR AND RITONAVIR
AA LANNETT CO INC 80MG/ML;20MG/ML A207407 001 Dec 27, 2016
TABLET;ORAL
KALETRA
+ ABBVIE 100MG;25MG N021906 002 Nov 09, 2007
+! 200MG;50MG N021906 001 Oct 28, 2005
LORAZEPAM
CONCENTRATE;ORAL
LORAZEPAM
AA AMNEAL PHARMS 2MG/ML A091383 001 Dec 23, 2009
AA ANDA REPOSITORY 2MG/ML A079244 001 Apr 28, 2009
AA HI-TECH PHARMA CO 2MG/ML A200169 001 Jan 30, 2012
AA LUPIN LTD 2MG/ML A091407 001 Feb 19, 2013
AA PHARM ASSOC 2MG/ML A090260 001 Jun 15, 2010
LORAZEPAM INTENSOL
AA ! WEST-WARD PHARMS 2MG/ML A072755 001 Jun 28, 1991
INT
INJECTABLE;INJECTION
ATIVAN
AP +! WEST-WARD PHARMS 2MG/ML N018140 001
INT
AP +! 4MG/ML N018140 002
LORAZEPAM
AP AKORN 2MG/ML A075025 001 Jul 23, 1998
AP HOSPIRA 2MG/ML A074243 001 Apr 12, 1994
AP 2MG/ML A074282 001 May 27, 1994
AP 4MG/ML A074243 002 Apr 12, 1994
AP 4MG/ML A074282 002 May 27, 1994
AP INTL MEDICATION SYS 2MG/ML A076150 001 Nov 15, 2004
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-272(of 452)

LORAZEPAM

TABLET;ORAL

ATIVAN

AB + VALEANT INTL
0.5MG
N017794 001

AB +
1MG
N017794 002

AB +!
2MG
N017794 003

LORAZEPAM

AB AMNEAL PHARMS
0.5MG
A078826 001 Jun 23, 2010

AB
1MG
A078826 002 Jun 23, 2010

AB
2MG
A078826 003 Jun 23, 2010

AB ANI PHARMS INC


0.5MG
A077396 001 Dec 13, 2006

AB
1MG
A077396 002 Dec 13, 2006

AB
2MG
A077396 003 Dec 13, 2006

AB AUROLIFE PHARMA LLC


0.5MG
A203572 001 Dec 22, 2017

AB
1MG
A203572 002 Dec 22, 2017

AB
2MG
A203572 003 Dec 22, 2017

AB LEADING PHARMA LLC


0.5MG
A078203 001 Jul 30, 2007

AB
1MG
A078203 002 Jul 30, 2007

AB
2MG
A078203 003 Jul 30, 2007

AB MYLAN
0.5MG
A077657 001 Mar 16, 2006

AB
1MG
A077657 002 Mar 16, 2006

AB
2MG
A077657 003 Mar 16, 2006

AB OXFORD PHARMS
0.5MG
A077754 001 May 10, 2006

AB
1MG
A077754 002 May 10, 2006

AB
2MG
A077754 003 May 10, 2006

AB SANDOZ
0.5MG
A071141 002 Apr 21, 1987

AB
1MG
A071141 003 Apr 21, 1987

AB
2MG
A071141 001 Apr 21, 1987

AB WATSON LABS
0.5MG
A072926 001 Oct 31, 1991

AB
1MG
A072927 001 Oct 31, 1991

AB
2MG
A072928 001 Oct 31, 1991

LORCASERIN HYDROCHLORIDE

TABLET;ORAL

BELVIQ

+! EISAI INC
10MG
N022529 001 Jun 27, 2012

TABLET, EXTENDED RELEASE;ORAL

BELVIQ XR

+! EISAI INC
20MG
N208524 001 Jul 15, 2016

LORLATINIB

TABLET;ORAL

LORBRENA

+ PFIZER INC
25MG
N210868 001 Nov 02, 2018

+!
100MG
N210868 002 Nov 02, 2018

LOSARTAN POTASSIUM

TABLET;ORAL

COZAAR

AB +! MERCK SHARP DOHME
100MG
N020386 003 Oct 13, 1998

LOSARTAN POTASSIUM

AB ALEMBIC PHARMS LTD
25MG
A090428 001 Oct 06, 2010

AB
50MG
A090428 002 Oct 06, 2010

AB
100MG
A090428 003 Oct 06, 2010

AB AUROBINDO PHARMA
25MG
A090083 001 Oct 06, 2010

AB
50MG
A090083 002 Oct 06, 2010

AB
100MG
A090083 003 Oct 06, 2010

AB CADISTA PHARMS
25MG
A201170 001 Sep 18, 2012

AB
50MG
A201170 002 Sep 18, 2012

AB
100MG
A201170 003 Sep 18, 2012

AB HETERO LABS LTD V


25MG
A203835 001 Aug 12, 2015

AB
50MG
A203835 002 Aug 12, 2015

AB
100MG
A203835 003 Aug 12, 2015

AB IPCA LABS LTD


25MG
A200290 001 Aug 30, 2013

AB
50MG
A200290 002 Aug 30, 2013

AB
100MG
A200290 003 Aug 30, 2013

AB LUPIN LTD
25MG
A078232 001 Oct 06, 2010

AB
50MG
A078232 002 Oct 06, 2010

AB
100MG
A078232 003 Oct 06, 2010

AB MACLEODS PHARMS LTD


25MG
A202230 001 May 30, 2012

AB
50MG
A202230 002 May 30, 2012

AB
100MG
A202230 003 May 30, 2012

AB MYLAN
25MG
A091590 001 Oct 06, 2010

AB
50MG
A091590 002 Oct 06, 2010

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-273(of 452)

LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM

AB 100MG A091590 003 Oct 06, 2010

AB PRINSTON INC 25MG A091497 001 Jun 06, 2011

AB 50MG A091497 002 Jun 06, 2011

AB 100MG A091497 003 Jun 06, 2011

AB SANDOZ 25MG A077424 001 Oct 06, 2010

AB 50MG A077424 002 Oct 06, 2010

AB 100MG A077424 003 Oct 06, 2010

AB STRIDES VIVIMED 25MG A090382 001 Oct 06, 2010

AB 50MG A090382 002 Oct 06, 2010

AB 100MG A090382 003 Oct 06, 2010

AB TEVA 25MG A076958 001 Apr 06, 2010

AB 50MG A076958 002 Apr 06, 2010

AB 100MG A076958 003 Apr 06, 2010

AB TORRENT PHARMS 25MG A090467 001 Oct 06, 2010

AB 50MG A090467 002 Oct 06, 2010

AB 100MG A090467 003 Oct 06, 2010

AB UNICHEM LABS LTD 25MG A203030 001 Oct 14, 2015

AB 50MG A203030 002 Oct 14, 2015

AB 100MG A203030 003 Oct 14, 2015

AB UPSHER SMITH LABS 25MG A090544 001 Oct 06, 2010

AB 50MG A090544 002 Oct 06, 2010

AB 100MG A090544 003 Oct 06, 2010

AB VIVA HLTHCARE 25MG A091541 001 Sep 24, 2012

AB 50MG A091541 002 Sep 24, 2012

AB 100MG A091541 003 Sep 24, 2012

AB WATSON LABS 25MG A091129 001 Oct 06, 2010

AB 50MG A091129 002 Oct 06, 2010

AB 100MG A091129 003 Oct 06, 2010

AB WEST-WARD PHARMS 25MG A077459 001 Oct 06, 2010

INT

AB 50MG A077459 002 Oct 06, 2010

AB 100MG A077459 003 Oct 06, 2010

AB ZYDUS PHARMS USA 25MG A078243 001 Oct 06, 2010

INC

AB 50MG A078243 002 Oct 06, 2010

AB 100MG A078243 003 Oct 06, 2010



LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC

LOTEMAX

+! BAUSCH AND LOMB INC 0.5% N202872 001 Sep 28, 2012

OINTMENT;OPHTHALMIC

LOTEMAX

+! BAUSCH AND LOMB 0.5% N200738 001 Apr 15, 2011

SUSPENSION/DROPS;OPHTHALMIC

ALREX

+! BAUSCH AND LOMB 0.2% N020803 001 Mar 09, 1998

INVELTYS

+! KALA PHARMS INC 1% N210565 001 Aug 22, 2018

LOTEMAX

+! BAUSCH AND LOMB 0.5% N020583 001 Mar 09, 1998

LOTEPREDNOL ETABONATE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

ZYLET

+! BAUSCH AND LOMB 0.5%;0.3% N050804 001 Dec 14, 2004

LOVASTATIN

TABLET;ORAL

LOVASTATIN

AB ACTAVIS ELIZABETH 10MG A075828 001 Dec 17, 2001

AB 20MG A075828 002 Dec 17, 2001

AB 40MG A075828 003 Dec 17, 2001

AB APOTEX INC 10MG A077748 001 Feb 28, 2007

AB 20MG A077748 002 Feb 28, 2007

AB 40MG A077748 003 Feb 28, 2007

AB CARLSBAD 10MG A075991 001 Jun 05, 2002

AB 20MG A075991 002 Jun 05, 2002

AB ! 40MG A075991 003 Jun 05, 2002

AB LUPIN 10MG A078296 001 Mar 14, 2008

AB 20MG A078296 002 Nov 01, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-274(of 452)

LOVASTATIN

TABLET;ORAL

LOVASTATIN

AB 40MG A078296 003 Nov 01, 2007

AB MYLAN 10MG A075451 001 Dec 17, 2001

AB 20MG A075451 002 Dec 17, 2001

AB 40MG A075451 003 Dec 17, 2001

AB SANDOZ 10MG A075300 001 Dec 17, 2001

AB 10MG A075636 001 Dec 17, 2001

AB 20MG A075300 002 Dec 17, 2001

AB 20MG A075636 002 Dec 17, 2001

AB 40MG A075300 003 Dec 17, 2001

AB 40MG A075636 003 Dec 17, 2001

AB SUN PHARM 10MG A077520 001 Apr 14, 2006

INDUSTRIES

AB 20MG A077520 002 Apr 14, 2006

AB 40MG A077520 003 Apr 14, 2006

AB TEVA 10MG A075551 003 Dec 17, 2001

AB 20MG A075551 002 Dec 17, 2001

AB 40MG A075551 001 Dec 17, 2001



TABLET, EXTENDED RELEASE;ORAL

ALTOPREV

+ COVIS PHARMA BV 20MG N021316 002 Jun 26, 2002

+ 40MG N021316 003 Jun 26, 2002

+! 60MG N021316 004 Jun 26, 2002

LOXAPINE

POWDER;INHALATION

ADASUVE

+! GALEN UK 10MG N022549 001 Dec 21, 2012

LOXAPINE SUCCINATE

CAPSULE;ORAL

LOXAPINE SUCCINATE

AB ELITE LABS INC EQ 5MG BASE A076868 001 Aug 04, 2005

AB EQ 10MG BASE A076868 002 Aug 04, 2005

AB EQ 25MG BASE A076868 003 Aug 04, 2005

AB EQ 50MG BASE A076868 004 Aug 04, 2005

AB LANNETT CO INC EQ 5MG BASE A090695 001 Sep 26, 2011

AB EQ 10MG BASE A090695 002 Sep 26, 2011

AB EQ 25MG BASE A090695 003 Sep 26, 2011

AB EQ 50MG BASE A090695 004 Sep 26, 2011

AB MYLAN EQ 5MG BASE A076762 001 Nov 01, 2004

AB EQ 10MG BASE A076762 002 Nov 01, 2004

AB EQ 25MG BASE A076762 003 Nov 01, 2004

AB EQ 50MG BASE A076762 004 Nov 01, 2004

AB WATSON LABS EQ 5MG BASE A072204 001 Jun 15, 1988

AB EQ 10MG BASE A072205 001 Jun 15, 1988

AB ! EQ 25MG BASE A072206 001 Jun 15, 1988

AB EQ 50MG BASE A072062 001 Jun 15, 1988



LUBIPROSTONE

CAPSULE;ORAL

AMITIZA

+ SUCAMPO PHARMA LLC 8MCG N021908 002 Apr 29, 2008

+! 24MCG N021908 001 Jan 31, 2006



LULICONAZOLE

CREAM;TOPICAL

LUZU

+! MEDICIS 1% N204153 001 Nov 14, 2013

LURASIDONE HYDROCHLORIDE

TABLET;ORAL

LATUDA

AB + SUNOVION PHARMS INC 20MG N200603 003 Dec 07, 2011

AB +! 40MG N200603 001 Oct 28, 2010

AB + 60MG N200603 005 Jul 12, 2013

AB + 80MG N200603 002 Oct 28, 2010

AB + 120MG N200603 004 Apr 26, 2012

LURASIDONE HYDROCHLORIDE

AB ACCORD HLTHCARE 20MG A208049 001 Jan 03, 2019

AB 40MG A208049 002 Jan 03, 2019

AB 60MG A208049 003 Jan 03, 2019

AB 80MG A208049 004 Jan 03, 2019



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-275(of 452)

LURASIDONE HYDROCHLORIDE

TABLET;ORAL

LURASIDONE HYDROCHLORIDE
AB 120MG
A208049 005 Jan 03, 2019

AB AMNEAL PHARMS CO 20MG


A208002 001 Jan 03, 2019

AB 40MG
A208002 002 Jan 03, 2019

AB 60MG
A208002 003 Jan 03, 2019

AB 80MG
A208002 004 Jan 03, 2019

AB 120MG
A208002 005 Jan 03, 2019

AB INVAGEN PHARMS 20MG


A208028 001 Jan 03, 2019

AB 40MG
A208028 002 Jan 03, 2019

AB 60MG
A208028 003 Jan 03, 2019

AB 80MG
A208028 004 Jan 03, 2019

AB 120MG
A208028 005 Jan 03, 2019

AB LUPIN LTD 20MG


A208031 001 Jan 03, 2019

AB 40MG
A208031 002 Jan 03, 2019

AB 60MG
A208031 003 Jan 03, 2019

AB 80MG
A208031 004 Jan 03, 2019

AB 120MG
A208031 005 Jan 03, 2019

AB SUN PHARMA GLOBAL 20MG


A208066 001 Jan 04, 2019

AB 40MG
A208066 002 Jan 04, 2019

AB 60MG
A208066 003 Jan 04, 2019

AB 80MG
A208066 004 Jan 04, 2019

AB 120MG
A208066 005 Jan 04, 2019

AB TORRENT PHARMS LTD 20MG


A208055 001 Jan 03, 2019

AB 40MG
A208055 002 Jan 03, 2019

AB 80MG
A208055 003 Jan 03, 2019

AB 120MG
A208055 004 Jan 03, 2019

LUSUTROMBOPAG

TABLET;ORAL

MULPLETA

+! SHIONOGI INC
3MG
N210923 001 Jul 31, 2018

LUTETIUM DOTATATE LU-177

SOLUTION;INTRAVENOUS

LUTATHERA

+! AAA USA INC
10mCi/ML
N208700 001 Jan 26, 2018

MACIMORELIN ACETATE

FOR SOLUTION;ORAL

MACRILEN

+! NOVO
EQ 60MG BASE/POUCH
N205598 001 Dec 20, 2017

MACITENTAN

TABLET;ORAL

OPSUMIT

+! ACTELION PHARMS LTD
10MG
N204410 001 Oct 18, 2013

MAFENIDE ACETATE

CREAM;TOPICAL

SULFAMYLON

+! MYLAN INSTITUTIONAL
EQ 85MG BASE/GM
N016763 001

FOR SOLUTION;TOPICAL

MAFENIDE ACETATE

AT NOVAST LABS
5%
A206716 001 Jul 31, 2017

AT PAR FORM
5%
A201511 001 Feb 12, 2013

SULFAMYLON

AT +! MYLAN INSTITUTIONAL
5%
N019832 003 Jun 05, 1998

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE



INJECTABLE;INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

+! B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019696 001 Sep 29, 1989

G/100ML;530MG/100ML;500MG/100ML;12MG/10

0ML

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019711 001 Sep 29, 1989
/100ML;500MG/100ML
NORMOSOL-R IN PLASTIC CONTAINER
ICU MEDICAL INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017586 001
/100ML;502MG/100ML
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-276(of 452)

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 001

/100ML;502MG/100ML

PLASMA-LYTE A IN PLASTIC CONTAINER



+! BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 002 Nov 22, 1982

/100ML;502MG/100ML

SOLUTION;IRRIGATION

PHYSIOLYTE IN PLASTIC CONTAINER

B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019024 001 Jun 08, 1984

/100ML;500MG/100ML

PHYSIOSOL IN PLASTIC CONTAINER



ICU MEDICAL INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017637 002 Jul 08, 1982

/100ML;502MG/100ML

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

SOLUTION;INJECTION

NORMOCARB HF 25

+! DIALYSIS SUPS 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML N021910 001 Jul 26, 2006

NORMOCARB HF 35

+! DIALYSIS SUPS 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML N021910 002 Jul 26, 2006

MAGNESIUM SULFATE

INJECTABLE;INJECTION

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER



AP FRESENIUS KABI USA 1GM/100ML A206486 001 Mar 07, 2016

AP +! HOSPIRA 1GM/100ML N020488 001 Jul 11, 1995

AP HQ SPCLT PHARMA 1GM/100ML A207349 001 Mar 02, 2016

AP MYLAN LABS LTD 1GM/100ML A209932 001 Sep 10, 2018

MAGNESIUM SULFATE IN PLASTIC CONTAINER



AP FRESENIUS KABI USA 4GM/100ML (40MG/ML) A206485 001 Mar 15, 2016

AP 4GM/50ML (80MG/ML) A206485 002 Mar 15, 2016

AP 2GM/50ML (40MG/ML) A206485 003 Mar 15, 2016

AP 20GM/500ML (40MG/ML) A206485 004 Mar 15, 2016

AP 40GM/1000ML (40MG/ML) A206485 005 Mar 15, 2016

AP + HOSPIRA 2GM/50ML (40MG/ML) N020309 003 Jan 26, 2007

AP +! 4GM/100ML (40MG/ML) N020309 001 Jun 24, 1994

AP +! 4GM/50ML (80MG/ML) N020309 002 Jun 24, 1994

AP + 20GM/500ML (40MG/ML) N020309 004 Jan 18, 1995

AP + 40GM/1000ML (40MG/ML) N020309 005 Jan 18, 1995

AP HQ SPCLT PHARMA 2GM/50ML (40MG/ML) A207350 001 Dec 06, 2017

AP 4GM/100ML (40MG/ML) A207350 002 Dec 06, 2017

AP 4GM/50ML (80MG/ML) A207350 003 Dec 06, 2017

AP 20GM/500ML (40MG/ML) A207350 004 Dec 06, 2017

AP 40GM/1000ML (40MG/ML) A207350 005 Dec 06, 2017

AP MYLAN LABS LTD 2GM/50ML (40MG/ML) A209911 001 Sep 14, 2018

AP 4GM/100ML (40MG/ML) A209911 002 Sep 14, 2018

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER



+! HOSPIRA 2GM/100ML N020488 002 Jul 11, 1995

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

AP EXELA PHARMA SCS 5GM/10ML (500MG/ML) A206039 001 Dec 18, 2014

LLC

AP +! FRESENIUS KABI USA 5GM/10ML (500MG/ML) N019316 001 Sep 08, 1986

AP ! HOSPIRA 5GM/10ML (500MG/ML) A075151 001 Apr 25, 2000

+! FRESENIUS KABI USA 10GM/20ML (500MG/ML) N019316 003 Jan 29, 2016

+! 25GM/50ML (500MG/ML) N019316 004 Jan 29, 2016

HOSPIRA INC 10GM/20ML (500MG/ML) A202411 001 May 14, 2015

MAGNESIUM SULFATE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MAGNESIUM SULFATE

+! FRESENIUS KABI USA 1GM/2ML (500MG/ML) N019316 002 Sep 08, 1986

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM

PHOSPHATE

SOLUTION;IRRIGATION

TIS-U-SOL

AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018508 001 Feb 19, 1982

G/100ML;8.75MG/100ML

TIS-U-SOL IN PLASTIC CONTAINER



AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018336 001

G/100ML;8.75MG/100ML

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-277(of 452)

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE



POWDER;ORAL

COLPREP KIT

+! GATOR PHARMS 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
N204553 001 Dec 27, 2016

SOLUTION;ORAL

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

AA NOVEL LABS INC 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT


A202511 001 Feb 23, 2017

SUPREP BOWEL PREP KIT

AA +! BRAINTREE LABS 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
N022372 001 Aug 05, 2010

MALATHION

LOTION;TOPICAL

MALATHION

AT SUVEN LIFE 0.5% A091559 001 May 23, 2012

OVIDE
AT +! TARO PHARM INDS LTD 0.5% N018613 001 Aug 02, 1982

MANGANESE CHLORIDE

INJECTABLE;INJECTION

MANGANESE CHLORIDE IN PLASTIC CONTAINER

+! HOSPIRA EQ 0.1MG MANGANESE/ML
N018962 001 Jun 26, 1986

MANNITOL

INJECTABLE;INJECTION

MANNITOL 10% IN PLASTIC CONTAINER



AP B BRAUN 10GM/100ML
N020006 002 Jul 26, 1993

MANNITOL 15% IN PLASTIC CONTAINER

AP B BRAUN 15GM/100ML
N020006 003 Jul 26, 1993

MANNITOL 20% IN PLASTIC CONTAINER

AP B BRAUN 20GM/100ML
N020006 004 Jul 26, 1993

AP ICU MEDICAL INC 20GM/100ML


N019603 004 Jan 08, 1990

MANNITOL 25%

AP FRESENIUS KABI USA 12.5GM/50ML
A080677 001

AP HOSPIRA 12.5GM/50ML
N016269 006 Aug 25, 1994

AP INTL MEDICATION 12.5GM/50ML


A083051 001

AP LUITPOLD 12.5GM/50ML
A087409 001 Jan 21, 1982

MANNITOL 5% IN PLASTIC CONTAINER

AP B BRAUN 5GM/100ML
N020006 001 Jul 26, 1993

OSMITROL 10% IN WATER

AP BAXTER HLTHCARE 10GM/100ML
N013684 002

OSMITROL 10% IN WATER IN PLASTIC CONTAINER

AP BAXTER HLTHCARE 10GM/100ML N013684 006

OSMITROL 15% IN WATER
AP BAXTER HLTHCARE 15GM/100ML N013684 004

OSMITROL 15% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 15GM/100ML N013684 008

OSMITROL 20% IN WATER
AP BAXTER HLTHCARE 20GM/100ML N013684 003

OSMITROL 20% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20GM/100ML N013684 007

OSMITROL 5% IN WATER
AP BAXTER HLTHCARE 5GM/100ML N013684 001

OSMITROL 5% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML
N013684 005

POWDER;INHALATION

ARIDOL KIT

+! PHARMAXIS LTD N/A,5MG,10MG,20MG,40MG
N022368 001 Oct 05, 2010

SOLUTION;IRRIGATION

RESECTISOL IN PLASTIC CONTAINER

B BRAUN 5GM/100ML
N016772 002

MANNITOL; SORBITOL

SOLUTION;IRRIGATION

SORBITOL-MANNITOL IN PLASTIC CONTAINER

+! ICU MEDICAL INC 540MG/100ML;2.7GM/100ML
N018316 001

MAPROTILINE HYDROCHLORIDE

TABLET;ORAL

MAPROTILINE HYDROCHLORIDE

MYLAN 25MG
A072285 002 Oct 03, 1988

! 50MG
A072285 001 Oct 03, 1988

75MG
A072285 003 Oct 03, 1988

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-278(of 452)

MARAVIROC

SOLUTION;ORAL

SELZENTRY

+! VIIV HLTHCARE 20MG/ML N208984 001 Nov 04, 2016

TABLET;ORAL

SELZENTRY

+ VIIV HLTHCARE 25MG N022128 003 Nov 04, 2016

+ 75MG N022128 004 Nov 04, 2016

+ 150MG N022128 001 Aug 06, 2007

+! 300MG N022128 002 Aug 06, 2007



MEBENDAZOLE

TABLET, CHEWABLE;ORAL

EMVERM

! IMPAX LABS INC 100MG A073580 001 Jan 04, 1995

MECAMYLAMINE HYDROCHLORIDE

TABLET;ORAL

MECAMYLAMINE HYDROCHLORIDE

! NEXGEN PHARMA 2.5MG A204054 001 Mar 19, 2013

MECASERMIN RECOMBINANT

INJECTABLE;SUBCUTANEOUS

INCRELEX

+! IPSEN INC 40MG/4ML (10MG/ML) N021839 001 Aug 30, 2005

MECHLORETHAMINE HYDROCHLORIDE

GEL;TOPICAL

VALCHLOR

+! HELSINN EQ 0.016% BASE N202317 001 Aug 23, 2013

MECLIZINE HYDROCHLORIDE

TABLET;ORAL

MECLIZINE HYDROCHLORIDE

AA AMNEAL PHARMS 12.5MG A201451 001 Feb 23, 2011

AA 25MG A201451 002 Feb 23, 2011

AA EPIC PHARMA LLC 12.5MG A200294 001 Apr 13, 2012

AA 25MG A200294 002 Apr 13, 2012

AA JUBILANT CADISTA 12.5MG A040659 001 Jun 04, 2010

AA 25MG A040659 002 Jun 04, 2010

AA MYLAN PHARMS INC 12.5MG A202640 001 Sep 17, 2012

AA 25MG A202640 002 Sep 17, 2012

AA PAR PHARM 12.5MG A087127 001



AA 25MG A087128 001

AA SANDOZ 12.5MG A084843 002 May 22, 1989

AA 25MG A084092 003 May 22, 1989



MECLOFENAMATE SODIUM

CAPSULE;ORAL

MECLOFENAMATE SODIUM

MYLAN EQ 50MG BASE A071081 002 Sep 03, 1986

! EQ 100MG BASE A071081 001 Sep 03, 1986



MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

DEPO-PROVERA

AB +! PHARMACIA AND 150MG/ML N020246 001 Oct 29, 1992

UPJOHN

MEDROXYPROGESTERONE ACETATE

AB AMPHASTAR PHARMS 150MG/ML A077235 001 Nov 28, 2017

INC

AB 150MG/ML A077334 001 Nov 28, 2017

AB MYLAN LABS LTD 150MG/ML A210227 001 Oct 12, 2018

AB TEVA PHARMS USA 150MG/ML A076553 001 Jul 28, 2004



DEPO-PROVERA

+! PHARMACIA AND 400MG/ML N012541 003

UPJOHN

INJECTABLE;SUBCUTANEOUS

DEPO-SUBQ PROVERA 104

+! PHARMACIA AND 104MG/0.65ML N021583 001 Dec 17, 2004

UPJOHN

TABLET;ORAL

MEDROXYPROGESTERONE ACETATE

AB BARR 2.5MG A040159 001 Aug 09, 1996

AB 5MG A040159 002 Aug 09, 1996

AB 10MG A040159 003 Aug 09, 1996



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-279(of 452)

MEDROXYPROGESTERONE ACETATE

TABLET;ORAL

PROVERA

AB + PHARMACIA AND 2.5MG N011839 001

UPJOHN

AB + 5MG N011839 003

AB +! 10MG N011839 004

MEFENAMIC ACID

CAPSULE;ORAL

MEFENAMIC ACID

AB BELCHER PHARMS LLC 250MG A091608 001 Jun 02, 2014

AB BRECKENRIDGE PHARM 250MG A090359 001 Feb 05, 2013

AB LUPIN LTD 250MG A091322 001 Jul 22, 2011

AB MICRO LABS 250MG A090562 001 Nov 19, 2010

PONSTEL

AB +! SHIONOGI INC 250MG N015034 003

MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL

MEFLOQUINE HYDROCHLORIDE

AB ! BARR 250MG A076392 001 Dec 29, 2003

AB WEST-WARD PHARMS 250MG A076523 001 Oct 01, 2004

INT

MEGESTROL ACETATE

SUSPENSION;ORAL

MEGACE ES

AB +! ENDO PHARMS INC 125MG/ML N021778 001 Jul 05, 2005

MEGESTROL ACETATE

AB BRECKENRIDGE PHARM 125MG/ML A204688 001 Dec 01, 2017

AB HI-TECH PHARMACAL 40MG/ML A203960 001 Jun 09, 2017

AB PAR PHARM 40MG/ML A075671 001 Jul 25, 2001

AB TEVA PHARMS 40MG/ML A075681 001 May 05, 2003

AB TWI PHARMS 125MG/ML A203139 001 Aug 27, 2014

AB ! WEST-WARD PHARMS 40MG/ML A075997 001 Feb 15, 2002

INT

AB WOCKHARDT BIO AG 40MG/ML A076721 001 Nov 01, 2004

TABLET;ORAL

MEGESTROL ACETATE

AB BARR 20MG A074621 002 Aug 16, 1996

AB 40MG A074621 001 Nov 30, 1995

AB PAR PHARM 20MG A072422 001 Aug 08, 1988

AB ! 40MG A072423 001 Aug 08, 1988

AB WEST-WARD PHARMS 20MG A074458 001 Sep 29, 1995

INT

AB 40MG A074458 002 Sep 29, 1995

MELOXICAM

CAPSULE;ORAL

VIVLODEX

+ IROKO PHARMS LLC 5MG N207233 001 Oct 22, 2015

+! 10MG N207233 002 Oct 22, 2015

TABLET;ORAL

MELOXICAM

AB APOTEX INC 7.5MG A077882 001 Jul 20, 2006

AB 15MG A077882 002 Jul 20, 2006

AB AUROBINDO PHARMA 7.5MG A078008 001 Oct 02, 2006

AB 15MG A078008 002 Oct 02, 2006

AB BRECKENRIDGE PHARM 7.5MG A077920 001 Jul 19, 2006

AB 15MG A077920 002 Jul 19, 2006

AB CIPLA 7.5MG A077929 001 Jul 19, 2006

AB 15MG A077929 002 Jul 19, 2006

AB DR REDDYS LABS INC 7.5MG A077931 001 Jul 25, 2006

AB 15MG A077931 002 Jul 25, 2006

AB GLENMARK GENERICS 7.5MG A077932 001 Jul 19, 2006

AB 15MG A077932 002 Jul 19, 2006

AB LUPIN PHARMS 7.5MG A077944 001 Jul 19, 2006

AB 15MG A077944 002 Jul 19, 2006

AB PURACAP PHARM 7.5MG A077938 001 Jul 19, 2006

AB 15MG A077938 002 Jul 19, 2006

AB STRIDES PHARMA 7.5MG A077928 001 May 13, 2009

AB 15MG A077928 002 May 13, 2009

AB TARO 7.5MG A078102 001 Nov 07, 2006

AB 15MG A078102 002 Nov 07, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-280(of 452)

MELOXICAM

TABLET;ORAL

MELOXICAM

AB TEVA PHARMS 7.5MG A077936 001 Jul 19, 2006

AB 15MG A077936 002 Jul 19, 2006

AB UNICHEM 7.5MG A077927 001 Dec 20, 2006

AB 15MG A077927 002 Dec 20, 2006

AB YUNG SHIN PHARM 7.5MG A077918 001 Dec 07, 2006

AB 15MG A077918 002 Dec 07, 2006

AB ZYDUS PHARMS USA 7.5MG A077921 001 Jul 19, 2006

AB 15MG A077921 002 Jul 19, 2006

MOBIC

AB + BOEHRINGER 7.5MG N020938 001 Apr 13, 2000

INGELHEIM

AB +! 15MG N020938 002 Aug 23, 2000

TABLET, ORALLY DISINTEGRATING;ORAL



QMIIZ ODT

+ TERSERA THERAPS LLC 7.5MG N211210 001 Oct 19, 2018

+! 15MG N211210 002 Oct 19, 2018

MELPHALAN

TABLET;ORAL

ALKERAN

AB +! APOTEX INC 2MG N014691 002

MELPHALAN

AB ALVOGEN MALTA 2MG A207809 001 Mar 22, 2017

MELPHALAN HYDROCHLORIDE

INJECTABLE;INJECTION

MELPHALAN HYDROCHLORIDE

AP ACTAVIS LLC EQ 50MG BASE/VIAL A206018 001 Dec 19, 2016

AP DR REDDYS LABS LTD EQ 50MG BASE/VIAL A203655 001 Dec 08, 2017

AP FRESENIUS KABI USA EQ 50MG BASE/VIAL A203393 001 Dec 22, 2017

AP ! MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090270 001 Jun 09, 2009

AP PAR STERILE EQ 50MG BASE/VIAL A204773 001 Aug 22, 2016

PRODUCTS

AP SAGENT PHARMS EQ 50MG BASE/VIAL A201379 001 Feb 28, 2017

AP WEST-WARD PHARMS EQ 50MG BASE/VIAL A090303 001 Oct 28, 2010

INT

POWDER;INTRAVENOUS

EVOMELA

+! SPECTRUM PHARMS EQ 50MG BASE/VIAL N207155 001 Mar 10, 2016

MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

MEMANTINE HYDROCHLORIDE

AB AMNEAL PHARMS 7MG A205825 001 Oct 12, 2016

AB 14MG A205825 002 Oct 12, 2016

AB 21MG A205825 003 Oct 12, 2016

AB 28MG A205825 004 Oct 12, 2016

AB ANCHEN PHARMS 7MG A205784 001 Jun 09, 2017

AB 14MG A205784 002 Jun 09, 2017

AB 21MG A205784 003 Jun 09, 2017

AB 28MG A205784 004 Jun 09, 2017

AB APOTEX INC 7MG A206135 001 Nov 22, 2016

AB 14MG A206135 002 Nov 22, 2016

AB 21MG A206135 003 Nov 22, 2016

AB 28MG A206135 004 Nov 22, 2016

AB LUPIN LTD 7MG A206028 001 Sep 28, 2016

AB 14MG A206028 002 Sep 28, 2016

AB 21MG A206028 003 Sep 28, 2016

AB 28MG A206028 004 Sep 28, 2016

AB MYLAN PHARMS INC 7MG A206032 001 Sep 28, 2016

AB 14MG A206032 002 Sep 28, 2016

AB 21MG A206032 003 Sep 28, 2016

AB 28MG A206032 004 Sep 28, 2016

AB SUN PHARMA GLOBAL 7MG A205905 001 Sep 28, 2016

AB 14MG A205905 002 Sep 28, 2016

AB 21MG A205905 003 Sep 28, 2016

AB 28MG A205905 004 Sep 28, 2016

AB ZYDUS PHARMS USA 7MG A203293 001 Aug 03, 2017

INC

AB 14MG A203293 002 Aug 03, 2017

AB 21MG A203293 003 Aug 03, 2017

AB 28MG A203293 004 Aug 03, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-281(of 452)

MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NAMENDA XR

AB + FOREST LABS LLC 7MG N022525 001 Jun 21, 2010

AB + 14MG N022525 002 Jun 21, 2010

AB + 21MG N022525 003 Jun 21, 2010

AB +! 28MG N022525 004 Jun 21, 2010



SOLUTION;ORAL

MEMANTINE HYDROCHLORIDE

AA APOTEX INC 2MG/ML A209955 001 Feb 09, 2018

AA ! BIO-PHARM INC 2MG/ML A205446 001 Dec 07, 2015

AA LANNETT CO INC 2MG/ML A204033 001 Oct 13, 2015

AA MACLEODS PHARMS LTD 2MG/ML A202790 001 Oct 13, 2015



TABLET;ORAL

MEMANTINE HYDROCHLORIDE

AB AJANTA PHARMA LTD 5MG A206528 001 Nov 30, 2015

AB 10MG A206528 002 Nov 30, 2015

AB ALEMBIC PHARMS LTD 5MG A200891 001 Oct 13, 2015

AB 10MG A200891 002 Oct 13, 2015

AB AMNEAL PHARMS 5MG A090041 001 Apr 10, 2015

AB 10MG A090041 002 Apr 10, 2015

AB APOTEX INC 5MG A090244 001 Jul 11, 2018

AB 10MG A090244 002 Jul 11, 2018

AB AUROBINDO PHARMA 5MG A203175 001 Oct 13, 2015

LTD

AB 10MG A203175 002 Oct 13, 2015

AB CSPC OUYI PHARM CO 5MG A209527 001 May 07, 2018

AB 10MG A209527 002 May 07, 2018

AB DR REDDYS LABS LTD 5MG A090048 001 Apr 14, 2010

AB 10MG A090048 002 Apr 14, 2010

AB JUBILANT GENERICS 5MG A091585 001 Oct 13, 2015

AB 10MG A091585 002 Oct 13, 2015

AB LANNETT CO INC 5MG A207236 001 Nov 10, 2016

AB 10MG A207236 002 Nov 10, 2016

AB LUPIN LTD 5MG A090051 001 Apr 10, 2015

AB 10MG A090051 002 Apr 10, 2015

AB MACLEODS PHARMS LTD 5MG A202840 001 Oct 13, 2015

AB 10MG A202840 002 Oct 13, 2015

AB MYLAN PHARMS INC 5MG A079225 001 Jan 30, 2015

AB 10MG A079225 002 Jan 30, 2015

AB PURACAP PHARM LLC 5MG A206855 001 Nov 17, 2015

AB 10MG A206855 002 Nov 17, 2015

AB STRIDES PHARMA 5MG A202350 001 May 23, 2017

AB 10MG A202350 002 May 23, 2017

AB SUN PHARMA GLOBAL 5MG A090058 001 May 05, 2010

AB 10MG A090058 002 May 05, 2010

AB TEVA PHARMS 5MG A090052 001 Oct 25, 2011

AB 10MG A090052 002 Oct 25, 2011

AB TORRENT PHARMS LTD 5MG A200155 001 Oct 13, 2015

AB 10MG A200155 002 Oct 13, 2015

AB UNICHEM LABS LTD 5MG A200022 001 Oct 13, 2015

AB 10MG A200022 002 Oct 13, 2015

AB UPSHER SMITH LABS 5MG A090043 001 Jul 31, 2015

AB 10MG A090043 002 Jul 31, 2015

AB WOCKHARDT LTD 5MG A090073 001 Sep 04, 2015

AB 10MG A090073 002 Sep 04, 2015

AB ZYDUS PHARMS USA 5MG A090961 001 Jul 10, 2017

INC

AB 10MG A090961 002 Jul 10, 2017

NAMENDA

AB + ALLERGAN SALES LLC 5MG N021487 001 Oct 16, 2003

AB +! 10MG N021487 002 Oct 16, 2003



MENOTROPINS (FSH;LH)

INJECTABLE;SUBCUTANEOUS

MENOPUR

+! FERRING 75 IU/VIAL;75 IU/VIAL N021663 001 Oct 29, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-282(of 452)

MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEMEROL

AP +! HOSPIRA 25MG/ML N021171 001

AP +! 50MG/ML N021171 002

AP +! 75MG/ML N021171 003

AP +! 100MG/ML N021171 004

MEPERIDINE HYDROCHLORIDE

AP WEST-WARD PHARMS 25MG/ML A080445 001

INT

AP 25MG/ML A080455 007

AP 50MG/ML A080445 002

AP 50MG/ML A080455 008

AP 75MG/ML A080445 003

AP 75MG/ML A080455 009

AP 100MG/ML A080445 004

AP 100MG/ML A080455 010

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

! WEST-WARD PHARMS 10MG/ML A081002 001 Jul 30, 1993

INT

SYRUP;ORAL

MEPERIDINE HYDROCHLORIDE

! WEST-WARD PHARMS 50MG/5ML A088744 001 Jan 30, 1985

INT

TABLET;ORAL

DEMEROL

AA +! US PHARM HOLDINGS 50MG N005010 001

AA +! 100MG N005010 004

MEPERIDINE HYDROCHLORIDE

AA EPIC PHARMA 50MG A040331 001 May 28, 1999

AA 100MG A040331 002 May 28, 1999

AA MIKART 50MG A040893 001 Jun 24, 2009

AA 100MG A040893 003 Jun 24, 2009

AA SPECGX LLC 50MG A040352 001 Jun 13, 2000

AA 100MG A040352 002 Jun 13, 2000

AA SUN PHARM INDS INC 50MG A040446 001 Aug 08, 2002

AA 100MG A040446 002 Aug 08, 2002

AA VINTAGE PHARMS 50MG A040191 001 Dec 17, 1998

AA 100MG A040191 002 Dec 17, 1998

AA WEST-WARD PHARMS 50MG A040110 001 Mar 12, 1997

INT

AA 100MG A040110 002 Mar 12, 1997

MIKART 75MG A040893 002 Jun 24, 2009

150MG A040893 004 Jun 24, 2009

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CARBOCAINE

AP +! HOSPIRA 1% N012250 001

AP +! 1.5% N012250 005

AP +! 2% N012250 002

POLOCAINE

AP FRESENIUS KABI USA 1% A089407 001 Dec 01, 1986

AP 2% A089410 001 Dec 01, 1986

POLOCAINE-MPF

AP FRESENIUS KABI USA 1% A089406 001 Dec 01, 1986

AP 1.5% A089408 001 Dec 01, 1986

AP 2% A089409 001 Dec 01, 1986

SCANDONEST PLAIN

AP ! DEPROCO 3% A088387 001 Oct 10, 1984

MEPROBAMATE

TABLET;ORAL

MEPROBAMATE

AA ALEMBIC PHARMS LTD 200MG A090122 001 Feb 18, 2009

AA 400MG A090122 002 Feb 18, 2009

AA INVAGEN PHARMS 200MG A040797 001 Feb 27, 2008

AA 400MG A040797 002 Feb 27, 2008

AA ! WATSON LABS 200MG A083304 001



AA ! 400MG A083308 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-283(of 452)

MERCAPTOPURINE

SUSPENSION;ORAL

PURIXAN

+! NOVA LABS LTD 20MG/ML N205919 001 Apr 28, 2014

TABLET;ORAL

MERCAPTOPURINE

AB DR REDDYS LABS SA 50MG A040461 001 Feb 11, 2004

AB MYLAN 50MG A040594 001 Jul 01, 2005

AB ! WEST-WARD PHARMS 50MG A040528 001 Feb 13, 2004

INT

PURINETHOL

AB + STASON PHARMS 50MG N009053 002

MEROPENEM

INJECTABLE;INJECTION

MEROPENEM

AP ACS DOBFAR 500MG/VIAL A091404 001 Oct 26, 2011

AP 1GM/VIAL A091404 002 Oct 26, 2011

AP ACS DOBFAR SPA 500MG/VIAL A204139 001 Jun 09, 2016

AP 1GM/VIAL A204139 002 Jun 09, 2016

AP AMNEAL PHARMS 500MG/VIAL A205883 001 Apr 12, 2016

AP 1GM/VIAL A205883 002 Apr 12, 2016

AP AUROBINDO PHARMA 500MG/VIAL A205835 001 Mar 27, 2017

LTD

AP 1GM/VIAL A205835 002 Mar 27, 2017

AP DAEWOONG PHARM CO 500MG/VIAL A204854 001 Dec 18, 2015

AP 1GM/VIAL A204854 002 Dec 18, 2015

AP GLAND PHARMA LTD 500MG/VIAL A206141 001 Jun 08, 2016

AP 1GM/VIAL A206141 002 Jun 08, 2016

AP HOSPIRA INC 500MG/VIAL A090940 001 Jun 22, 2010

AP 1GM/VIAL A090940 002 Jun 22, 2010

AP SAVIOR LIFETEC CORP 500MG/VIAL A206086 001 Apr 19, 2016

AP 1GM/VIAL A206086 002 Apr 19, 2016

MERREM

AP +! PFIZER 500MG/VIAL N050706 003 Jun 21, 1996

AP +! 1GM/VIAL N050706 001 Jun 21, 1996



POWDER;INTRAVENOUS

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER

B BRAUN MEDICAL INC 500MG/VIAL N202106 001 Apr 30, 2015

1GM/VIAL N202106 002 Apr 30, 2015



MEROPENEM; VABORBACTAM

POWDER;INTRAVENOUS

VABOMERE

+! REMPEX PHARMS 1GM/VIAL;1GM/VIAL N209776 001 Aug 29, 2017

MESALAMINE

CAPSULE, DELAYED RELEASE;ORAL

DELZICOL

+! APIL 400MG N204412 001 Feb 01, 2013

CAPSULE, EXTENDED RELEASE;ORAL

APRISO

+! VALEANT PHARMS INTL 375MG N022301 001 Oct 31, 2008

PENTASA

+ SHIRE 250MG N020049 001 May 10, 1993

+! 500MG N020049 002 Jul 08, 2004



ENEMA;RECTAL

MESALAMINE

AB PERRIGO ISRAEL 4GM/60ML A076751 001 Sep 17, 2004

ROWASA

AB +! MYLAN SPECIALITY LP 4GM/60ML N019618 001 Dec 24, 1987

SFROWASA

AB + MYLAN SPECIALITY LP 4GM/60ML N019618 002 Jun 20, 2008

SUPPOSITORY;RECTAL

CANASA

AB +! ALLERGAN SALES LLC 1GM N021252 002 Nov 05, 2004

MESALAMINE

AB MYLAN PHARMS INC 1GM A204354 001 Nov 24, 2015

TABLET, DELAYED RELEASE;ORAL

ASACOL HD

AB +! APIL 800MG N021830 001 May 29, 2008

LIALDA

AB +! SHIRE 1.2GM N022000 001 Jan 16, 2007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-284(of 452)

MESALAMINE

TABLET, DELAYED RELEASE;ORAL

MESALAMINE

AB ACTAVIS LABS FL 1.2GM A203817 001 Mar 23, 2018

AB MYLAN PHARMS INC 1.2GM A203574 001 Nov 20, 2018

AB ZYDUS PHARMS USA 800MG A203286 001 Jul 21, 2017

INC

AB 1.2GM A091640 001 Jun 05, 2017

MESNA

INJECTABLE;INTRAVENOUS

MESNA

AP FRESENIUS KABI USA 100MG/ML A075811 001 Apr 26, 2001

AP GLAND PHARMA LTD 100MG/ML A206992 001 Dec 18, 2017

AP SAGENT PHARMS 100MG/ML A090913 001 Apr 13, 2010

AP TEVA PHARMS USA 100MG/ML A075764 001 Apr 27, 2001

AP WEST-WARD PHARMS 100MG/ML A075739 001 Jan 09, 2004

INT

MESNEX

AP +! BAXTER HLTHCARE 100MG/ML N019884 001 Dec 30, 1988

TABLET;ORAL

MESNEX

+! BAXTER HLTHCARE 400MG N020855 001 Mar 21, 2002

MESTRANOL; NORETHINDRONE

TABLET;ORAL-28

NORINYL 1+50 28-DAY

+! ACTAVIS LABS UT INC 0.05MG;1MG N016659 001

METAPROTERENOL SULFATE

SYRUP;ORAL

METAPROTERENOL SULFATE

! LANNETT CO INC 10MG/5ML A073632 001 Jul 22, 1992

TABLET;ORAL

METAPROTERENOL SULFATE

PAR PHARM 10MG A072024 001 Jun 28, 1988

! 20MG A072025 001 Jun 28, 1988

METAXALONE

TABLET;ORAL

METAXALONE

AB ACTAVIS LABS FL INC 800MG A203695 001 Jun 15, 2017

AB AMNEAL PHARMS 800MG A203399 001 Jun 21, 2013

AB LANNETT CO INC 800MG A204770 001 Nov 22, 2016

AB RISING PHARMS 800MG A208774 001 Sep 24, 2018

AB SANDOZ 800MG A040445 001 Mar 31, 2010

AB SCIEGEN PHARMS INC 800MG A207466 001 Aug 31, 2017

SKELAXIN

AB +! KING PHARMS 800MG N013217 003 Aug 30, 2002

METAXALONE

MOUNTAIN 400MG A040486 001 Feb 27, 2015

METFORMIN HYDROCHLORIDE

SOLUTION;ORAL

RIOMET

+! SUN PHARM INDS LTD 500MG/5ML N021591 001 Sep 11, 2003

TABLET;ORAL

GLUCOPHAGE

AB + BRISTOL MYERS 500MG N020357 001 Mar 03, 1995

SQUIBB

AB + 850MG N020357 002 Mar 03, 1995

AB +! 1GM N020357 005 Nov 05, 1998

METFORMIN HYDROCHLORIDE

AB ALKEM 500MG A091184 001 Nov 01, 2010

AB 850MG A091184 002 Nov 01, 2010

AB 1GM A091184 003 Nov 01, 2010

AB AMNEAL PHARMS NY 500MG A077880 001 Jun 05, 2006

AB 850MG A077880 002 Jun 05, 2006

AB 1GM A077880 003 Jun 05, 2006

AB APOTEX 500MG A075984 001 Apr 23, 2002

AB 500MG A090666 001 Dec 07, 2011

AB 850MG A075984 002 Apr 23, 2002

AB 850MG A090666 002 Dec 07, 2011

AB 1GM A075984 003 Apr 23, 2002

AB 1GM A090666 003 Dec 07, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-285(of 452)

METFORMIN HYDROCHLORIDE

TABLET;ORAL

METFORMIN HYDROCHLORIDE

AB ATLAS PHARMS LLC 500MG A076033 001 Jan 24, 2002

AB 850MG A076033 002 Jan 24, 2002

AB 1GM A076033 003 Jan 24, 2002

AB AUROBINDO 500MG A077095 001 Jan 14, 2005

AB 850MG A077095 002 Jan 14, 2005

AB 1GM A077095 003 Jan 14, 2005

AB CHARTWELL LIFE SCI 500MG A075972 001 Jan 24, 2002

AB 850MG A075972 002 Jan 24, 2002

AB 1GM A075972 003 Jan 24, 2002

AB CSPC OUYI PHARM CO 500MG A205096 001 Jul 11, 2016

AB 850MG A205096 002 Jul 11, 2016

AB 1GM A205096 003 Jul 11, 2016

AB DR REDDYS LABS INC 500MG A077787 001 Aug 23, 2006

AB 850MG A077787 002 Aug 23, 2006

AB 1GM A077787 003 Aug 23, 2006

AB GLENMARK GENERICS 500MG A078170 001 May 23, 2008

AB 850MG A078170 002 May 23, 2008

AB 1GM A078170 003 May 23, 2008

AB GRANULES INDIA 500MG A090564 001 Apr 22, 2010

AB 850MG A090564 002 Apr 22, 2010

AB 1GM A090564 003 Apr 22, 2010

AB INDICUS PHARMA 500MG A079148 001 Nov 25, 2008

AB 850MG A079148 002 Nov 25, 2008

AB 1GM A079148 003 Nov 25, 2008

AB LAURUS LABS LTD 500MG A209882 001 Aug 27, 2018

AB 850MG A209882 002 Aug 27, 2018

AB 1GM A209882 003 Aug 27, 2018

AB MACLEODS PHARMS LTD 500MG A205330 001 Oct 31, 2017

AB 850MG A205330 002 Oct 31, 2017

AB 1GM A205330 003 Oct 31, 2017

AB MARKSANS PHARMA 500MG A090888 001 Mar 12, 2012

AB 850MG A090888 002 Mar 12, 2012

AB 1GM A090888 003 Mar 12, 2012

AB MYLAN 500MG A075973 001 Jan 25, 2002

AB 500MG A075976 001 Jan 24, 2002

AB 850MG A075973 002 Jan 25, 2002

AB 850MG A075976 002 Jan 24, 2002

AB 1GM A075973 003 Jan 25, 2002

AB 1GM A075976 003 Jan 24, 2002

AB SANDOZ 500MG A075965 001 Jan 25, 2002

AB 850MG A075965 002 Jan 25, 2002

AB 1GM A075965 003 Jan 25, 2002

AB SCIEGEN PHARMS INC 500MG A203769 001 Sep 11, 2013

AB 850MG A203769 002 Sep 11, 2013

AB 1GM A203769 003 Sep 11, 2013

AB SUN PHARM INDS INC 500MG A075967 001 Jan 29, 2002

AB 850MG A075967 002 Jan 29, 2002

AB 1GM A075967 003 Jan 29, 2002

AB SUN PHARM 500MG A076038 001 Feb 21, 2002

INDUSTRIES

AB 850MG A076038 002 Feb 21, 2002

AB 1GM A076038 003 Feb 21, 2002

AB SUNSHINE LAKE 500MG A208999 001 Oct 12, 2018

AB 850MG A208999 002 Oct 12, 2018

AB 1GM A208999 003 Oct 12, 2018

AB TEVA 500MG A075978 001 Jan 25, 2002

AB 850MG A075978 002 Jan 25, 2002

AB 1GM A075978 003 Nov 05, 2002

AB TORRENT PHARMS 500MG A077711 001 Jan 24, 2007

AB 850MG A077711 002 Jan 24, 2007

AB 1GM A077711 003 Jan 24, 2007

AB ZYDUS HLTHCARE 500MG A203686 001 Aug 28, 2014

AB 850MG A203686 002 Aug 28, 2014

AB 1GM A203686 003 Aug 28, 2014

AB ZYDUS PHARMS USA 500MG A077064 001 Apr 18, 2005

AB 850MG A077064 002 Apr 18, 2005

AB 1GM A077064 003 Apr 18, 2005

CHARTWELL LIFE SCI 625MG A075972 005 Jan 24, 2002



750MG A075972 004 Jan 24, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-286(of 452)

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GLUCOPHAGE XR

AB +! BRISTOL MYERS 750MG N021202 004 Apr 11, 2003

SQUIBB

METFORMIN HYDROCHLORIDE

AB ACTAVIS LABS FL INC 750MG A076869 001 Apr 12, 2005
AB ALKEM LABS LTD 750MG A206145 002 Oct 22, 2018
AB AMNEAL PHARMS NY 750MG A078596 002 Jan 03, 2008
AB APOTEX 750MG A076706 002 Dec 29, 2005
AB AUROBINDO PHARMA 750MG A079118 002 Jul 20, 2012
LTD
AB BARR 750MG A076863 001 Oct 14, 2004
AB BEXIMCO PHARMS USA 750MG A207427 002 Dec 13, 2016
AB CSPC OUYI PHARM CO 750MG A078321 002 Apr 17, 2008
AB GRANULES INDIA LTD 750MG A209313 002 Mar 16, 2018
AB INTELLIPHARMACEUTIC 750MG A202306 002 Feb 23, 2017
S
AB MACLEODS PHARMS LTD 750MG A206955 002 Dec 07, 2016
AB MARKSANS PHARMA 750MG A090295 002 Apr 29, 2016
AB NOSTRUM PHARMS LLC 750MG A076756 002 Dec 12, 2011
AB PRINSTON INC 750MG A208880 002 Sep 10, 2018
AB SUN PHARM INDS (IN) 750MG A077336 002 Feb 09, 2006
AB TEVA 750MG A076864 001 Apr 12, 2005
AB YICHANG HUMANWELL 750MG A211052 002 Sep 24, 2018
AB ZYDUS PHARMS USA 750MG A077078 001 Apr 21, 2005
GLUCOPHAGE XR
AB1 + BRISTOL MYERS 500MG N021202 001 Oct 13, 2000
SQUIBB
METFORMIN HYDROCHLORIDE
AB1 ACTAVIS LABS FL INC 500MG A076172 001 Jun 16, 2004
AB1 ALIGNSCIENCE PHARMA 500MG A209303 001 Mar 19, 2018
AB1 ALKEM LABS LTD 500MG A206145 001 Oct 22, 2018
AB1 AMNEAL PHARMS NY 500MG A078596 001 Jan 03, 2008
AB1 APOTEX 500MG A076706 001 Dec 14, 2004
AB1 AUROBINDO PHARMA 500MG A079118 001 Jul 20, 2012
LTD
AB1 BEXIMCO PHARMS USA 500MG A207427 001 Dec 13, 2016

AB1 CSPC OUYI PHARM CO 500MG A078321 001 Apr 17, 2008

AB1 GRANULES INDIA LTD 500MG A209313 001 Mar 16, 2018

AB1 INTELLIPHARMACEUTIC 500MG A202306 001 Feb 23, 2017

S

AB1 INVENTIA HLTHCARE 500MG A201991 001 Jan 18, 2012

AB1 MACLEODS PHARMS LTD 500MG A206955 001 Dec 07, 2016

AB1 MARKSANS PHARMA 500MG A090295 001 Apr 29, 2016

AB1 NOSTRUM PHARMS LLC 500MG A076756 001 Jul 26, 2006

AB1 PRINSTON INC 500MG A208880 001 Sep 10, 2018

AB1 SANDOZ 500MG A076873 001 Dec 14, 2004

AB1 SUN PHARM INDS (IN) 500MG A077336 001 Feb 09, 2006

AB1 TEVA 500MG A076269 001 Jun 18, 2004

AB1 TORRENT PHARMS LTD 500MG A090014 001 Dec 30, 2009

AB1 YICHANG HUMANWELL 500MG A211052 001 Sep 24, 2018

AB1 ZYDUS PHARMS USA 500MG A077060 001 Apr 20, 2005

FORTAMET

AB2 + ANDRX LABS LLC 500MG N021574 001 Apr 27, 2004

AB2 +! 1GM N021574 002 Apr 27, 2004

METFORMIN HYDROCHLORIDE

AB2 LUPIN LTD 500MG A090692 001 Jun 29, 2011

AB2 1GM A090692 002 Jun 29, 2011

AB2 MYLAN PHARMS INC 500MG A200690 001 Aug 01, 2012

AB2 1GM A200690 002 Aug 01, 2012

AB2 NOSTRUM LABS INC 500MG A203832 001 Dec 26, 2017

AB2 1GM A203832 002 Dec 26, 2017

AB2 NOVAST LABS 500MG A209674 001 Nov 02, 2018

AB2 1GM A209674 002 Nov 02, 2018

AB2 QINGDAO BAHEAL 500MG A209993 001 Dec 27, 2018

PHARM

AB2 1GM A209993 002 Dec 27, 2018
GLUMETZA
AB3 + SANTARUS INC 500MG N021748 001 Jun 03, 2005
AB3 +! 1GM N021748 002 Jun 03, 2005
METFORMIN HYDROCHLORIDE
AB3 ACTAVIS LABS FL INC 500MG A203755 001 Aug 01, 2016
AB3 1GM A203755 002 Aug 01, 2016
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-287(of 452)

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

AB3 LUPIN LTD 500MG A091664 001 Jul 19, 2013

AB3 1GM A091664 002 Jul 19, 2013

AB3 SUN PHARMA GLOBAL 500MG A202917 001 Aug 01, 2016

AB3 1GM A202917 002 Aug 01, 2016



METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

ACTOPLUS MET

AB + TAKEDA PHARMS USA 500MG;EQ 15MG BASE N021842 001 Aug 29, 2005

AB +! 850MG;EQ 15MG BASE N021842 002 Aug 29, 2005

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE



AB AUROBINDO PHARMA 500MG;EQ 15MG BASE A200823 001 Feb 13, 2013

LTD

AB 850MG;EQ 15MG BASE A200823 002 Feb 13, 2013

AB MACLEODS PHARMS LTD 500MG;EQ 15MG BASE A204802 001 Nov 05, 2015

AB 850MG;EQ 15MG BASE A204802 002 Nov 05, 2015

AB MYLAN 500MG;EQ 15MG BASE A090406 001 Feb 25, 2011

AB 850MG;EQ 15MG BASE A090406 002 Feb 25, 2011

AB SANDOZ 500MG;EQ 15MG BASE A091273 001 Apr 16, 2013

AB 850MG;EQ 15MG BASE A091273 002 Apr 16, 2013

AB TEVA PHARMS USA 500MG;EQ 15MG BASE A091155 001 Mar 10, 2014

AB 850MG;EQ 15MG BASE A091155 002 Mar 10, 2014

AB TORRENT PHARMS LTD 500MG;EQ 15MG BASE A202001 001 Feb 13, 2013

AB 850MG;EQ 15MG BASE A202001 002 Feb 13, 2013



TABLET, EXTENDED RELEASE;ORAL

ACTOPLUS MET XR

+ TAKEDA PHARMS USA 1GM;EQ 15MG BASE N022024 001 May 12, 2009

+! 1GM;EQ 30MG BASE N022024 002 May 12, 2009



METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

KOMBIGLYZE XR

+ ASTRAZENECA AB 500MG;EQ 5MG BASE N200678 001 Nov 05, 2010

+ 1GM;EQ 2.5MG BASE N200678 003 Nov 05, 2010

+! 1GM;EQ 5MG BASE N200678 002 Nov 05, 2010

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JANUMET

+ MERCK SHARP DOHME 500MG;EQ 50MG BASE N022044 001 Mar 30, 2007

+! 1GM;EQ 50MG BASE N022044 002 Mar 30, 2007

TABLET, EXTENDED RELEASE;ORAL

JANUMET XR

+ MERCK SHARP DOHME 500MG;EQ 50MG BASE N202270 001 Feb 02, 2012

+ 1GM;EQ 50MG BASE N202270 002 Feb 02, 2012

+! 1GM;EQ 100MG BASE N202270 003 Feb 02, 2012

METHACHOLINE CHLORIDE

FOR SOLUTION;INHALATION

PROVOCHOLINE

+! METHAPHARM 100MG/VIAL N019193 001 Oct 31, 1986

METHADONE HYDROCHLORIDE

CONCENTRATE;ORAL

METHADONE HYDROCHLORIDE

AA VISTAPHARM 10MG/ML A040088 001 Nov 30, 1994

AA WEST-WARD PHARMS 10MG/ML A040180 001 Apr 30, 1998

INT

METHADONE HYDROCHLORIDE INTENSOL

AA WEST-WARD PHARMS 10MG/ML A089897 001 Sep 06, 1988

INT

METHADOSE

AA +! SPECGX LLC 10MG/ML N017116 002

INJECTABLE;INJECTION

METHADONE HYDROCHLORIDE

AP AKORN 10MG/ML A208306 001 Oct 27, 2017

AP +! MYLAN INSTITUTIONAL 10MG/ML N021624 001



SOLUTION;ORAL

METHADONE HYDROCHLORIDE

AA VISTAPHARM 5MG/5ML A090707 001 Jun 30, 2010

AA 10MG/5ML A090707 002 Jun 30, 2010

AA ! WEST-WARD PHARMS 5MG/5ML A087393 001



INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-288(of 452)

METHADONE HYDROCHLORIDE

SOLUTION;ORAL

METHADONE HYDROCHLORIDE

AA ! 10MG/5ML A087997 001 Aug 30, 1982

TABLET;ORAL

DOLOPHINE HYDROCHLORIDE

AA +! WEST-WARD PHARMS 5MG N006134 002

INT

AA +! 10MG N006134 010

METHADONE HYDROCHLORIDE

AA ASCENT PHARMS INC 5MG A211228 001 Jan 03, 2019

AA 10MG A211228 002 Jan 03, 2019

AA AUROLIFE PHARMA LLC 5MG A203502 001 Aug 31, 2015

AA 10MG A203502 002 Aug 31, 2015

AA ELITE LABS INC 5MG A210484 001 Aug 02, 2018

AA 10MG A210484 002 Aug 02, 2018

AA EPIC PHARMA LLC 5MG A090065 001 Aug 18, 2015

AA 10MG A090065 002 Aug 18, 2015

AA SPECGX LLC 5MG A040517 001 Apr 27, 2004

AA 10MG A040517 002 Apr 27, 2004

AA SUN PHARM 5MG A208305 001 Mar 30, 2018

INDUSTRIES

AA 10MG A208305 002 Mar 30, 2018

AA THEPHARMANETWORK 10MG A090635 001 Nov 25, 2009

LLC

AA VISTAPHARM 10MG A040241 002 May 29, 1998

METHADOSE

AA SPECGX LLC 5MG A040050 001 Apr 15, 1993

AA 10MG A040050 002 Apr 15, 1993

TABLET, FOR SUSPENSION;ORAL

METHADONE HYDROCHLORIDE

AA SPECGX LLC 40MG A077142 001 Jul 12, 2005

AA VISTAPHARM 40MG A075082 001 Mar 25, 1998

AA +! WEST-WARD PHARMS 40MG N017058 001



INT

METHADOSE

AA SPECGX LLC 40MG A074184 001 Apr 29, 1993

METHAMPHETAMINE HYDROCHLORIDE

TABLET;ORAL

DESOXYN

AA +! RECORDATI RARE 5MG N005378 002

METHAMPHETAMINE HYDROCHLORIDE

AA MAYNE PHARMA INC 5MG A091189 001 Apr 21, 2010

AA WEST-WARD PHARMS 5MG A203846 001 Nov 17, 2015

INT

METHAZOLAMIDE

TABLET;ORAL

METHAZOLAMIDE

AB ANI PHARMS INC 25MG A040001 001 Jun 30, 1993

AB 50MG A040001 002 Jun 30, 1993

AB MICRO LABS 25MG A207438 001 Oct 05, 2018

AB 50MG A207438 002 Oct 05, 2018

AB MIKART 25MG A040062 001 Jan 27, 1994

AB ! 50MG A040062 002 Jan 27, 1994

AB SANDOZ 25MG A040036 001 Jun 30, 1993

AB 50MG A040036 002 Jun 30, 1993



METHENAMINE HIPPURATE

TABLET;ORAL

HIPREX

AB +! US PHARM HOLDINGS 1GM N017681 001

METHENAMINE HIPPURATE

AB AUROBINDO PHARMA 1GM A205661 001 Jul 05, 2016

LTD

AB IMPAX LABS INC 1GM A076411 001 Jun 20, 2003

UREX

AB CNTY LINE PHARMS 1GM N016151 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-289(of 452)

METHIMAZOLE

TABLET;ORAL

METHIMAZOLE

AB CASI PHARMS INC 5MG A040411 001 Mar 27, 2001

AB 10MG A040411 002 Mar 27, 2001

AB ECI PHARMS LLC 5MG A040547 001 Feb 18, 2005

AB 10MG A040547 002 Feb 18, 2005

AB HERITAGE PHARMA 5MG A040734 001 Dec 14, 2007

AB 10MG A040734 002 Dec 14, 2007

AB MYLAN 5MG A040350 001 Mar 29, 2000

AB ! 10MG A040350 002 Mar 29, 2000

AB RISING PHARMS 5MG A202068 001 Mar 07, 2012

AB 10MG A202068 002 Mar 07, 2012

AB SUN PHARM INDS INC 5MG A040870 001 Sep 25, 2007

AB 10MG A040870 002 Sep 25, 2007

TAPAZOLE

AB KING PHARMS LLC 5MG A040320 001 Mar 31, 2000

AB 10MG A040320 002 Mar 31, 2000



METHOCARBAMOL

SOLUTION;IM-IV

METHOCARBAMOL

AP AUROBINDO PHARMA 1GM/10ML (100MG/ML) A206128 001 May 27, 2016

LTD

AP FRESENIUS KABI USA 1GM/10ML (100MG/ML) A209331 001 Apr 17, 2018

AP GLAND PHARMA LTD 1GM/10ML (100MG/ML) A211504 001 Oct 26, 2018

AP LUITPOLD 1GM/10ML (100MG/ML) A207496 001 Jun 22, 2017

AP MONTEREY PHARMS LLC 1GM/10ML (100MG/ML) A205354 001 Oct 27, 2016

AP MYLAN INSTITUTIONAL 1GM/10ML (100MG/ML) A204404 001 Dec 05, 2014

AP NAVINTA LLC 1GM/10ML (100MG/ML) A206071 001 Nov 24, 2017

AP RENAISSANCE SSA LLC 1GM/10ML (100MG/ML) A208116 001 Jan 19, 2017

AP SAGENT PHARMS 1GM/10ML (100MG/ML) A205404 001 Jul 18, 2017

AP SOMERSET THERAPS 1GM/10ML (100MG/ML) A207522 001 Jul 31, 2017

LLC

ROBAXIN

AP +! WEST-WARD PHARMS 1GM/10ML (100MG/ML) N011790 001

INT

TABLET;ORAL

METHOCARBAMOL

AA AUSTARPHARMA LLC 500MG A200958 001 Oct 21, 2011

AA 750MG A200958 002 Oct 21, 2011

AA BEXIMCO PHARMS USA 500MG A208507 001 Jul 21, 2017

AA 750MG A208507 002 Jul 21, 2017

AA DBL PHARMS 500MG A203550 001 Feb 08, 2017

AA 750MG A203550 002 Feb 08, 2017

AA GRANULES INDIA LTD 500MG A209312 001 May 07, 2018

AA 750MG A209312 002 May 07, 2018

AA HETERO LABS LTD III 500MG A090200 001 Nov 06, 2009

AA 750MG A090200 002 Nov 06, 2009

AA HIKMA INTL PHARMS 500MG A085159 001



AA 750MG A085123 001

AA OXFORD PHARMS 500MG A040489 001 Jan 29, 2003

AA 750MG A040489 002 Jan 29, 2003

AA PRINSTON INC 500MG A086989 001



AA 750MG A086988 001

AA WATSON LABS 500MG A084277 001

AA 750MG A084276 002

ROBAXIN

AA +! AUXILIUM PHARMS LLC 500MG N011011 004

ROBAXIN-750

AA +! AUXILIUM PHARMS LLC 750MG N011011 006

METHOHEXITAL SODIUM

INJECTABLE;INJECTION

BREVITAL SODIUM

+! PAR STERILE 500MG/VIAL N011559 001

PRODUCTS

+! 2.5GM/VIAL N011559 002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-290(of 452)

METHOTREXATE

SOLUTION;SUBCUTANEOUS

OTREXUP

+! ANTARES PHARMA INC 10MG/0.4ML (10MG/0.4ML) N204824 001 Oct 11, 2013

+! 12.5MG/0.4ML (12.5MG/0.4ML) N204824 006 Mar 24, 2016

+! 15MG/0.4ML (15MG/0.4ML) N204824 002 Oct 11, 2013

+! 17.5MG/0.4ML (17.5MG/0.4ML) N204824 007 Mar 24, 2016

+! 20MG/0.4ML (20MG/0.4ML) N204824 003 Oct 11, 2013

+! 22.5MG/0.4ML (22.5MG/0.4ML) N204824 008 Mar 24, 2016

+! 25MG/0.4ML (25MG/0.4ML) N204824 004 Oct 11, 2013

RASUVO

+! MEDAC PHARMA INC 7.5MG/0.15ML (7.5MG/0.15ML) N205776 001 Jul 10, 2014

+! 10MG/0.20ML (10MG/0.20ML) N205776 002 Jul 10, 2014

+! 12.5MG/0.25ML (12.5MG/0.25ML) N205776 003 Jul 10, 2014

+! 15MG/0.30ML (15MG/0.30ML) N205776 004 Jul 10, 2014

+! 17.5MG/0.35ML (17.5MG/0.35ML) N205776 005 Jul 10, 2014

+! 20MG/0.4ML (20MG/0.4ML) N205776 006 Jul 10, 2014

+! 22.5MG/0.45ML (22.5MG/0.45ML) N205776 007 Jul 10, 2014

+! 25MG/0.5ML (25MG/0.5ML) N205776 008 Jul 10, 2014

+! 30MG/0.6ML (30MG/0.6ML) N205776 010 Jul 10, 2014

METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE PRESERVATIVE FREE



AP FRESENIUS KABI USA EQ 25MG BASE/ML A040265 001 Feb 26, 1999

AP EQ 1GM BASE/VIAL A040266 001 Feb 26, 1999

METHOTREXATE SODIUM

AP ! FRESENIUS KABI USA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040263 001 Feb 26, 1999

AP +! HOSPIRA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) N011719 010 Dec 15, 2004

AP ! WEST-WARD PHARMS EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A089341 001 Sep 16, 1986

INT

METHOTREXATE SODIUM PRESERVATIVE FREE

AP ! ACCORD HLTHCARE EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040767 001 Apr 30, 2007

AP ! EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040768 001 Apr 30, 2007

AP ! EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040716 001 Apr 30, 2007

AP +! HOSPIRA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) N011719 012 Apr 13, 2005

AP MYLAN LABS LTD EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A201529 001 Mar 29, 2012

AP EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A201529 002 Mar 29, 2012

AP EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A201529 003 Mar 29, 2012

AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A201529 004 Mar 29, 2012

AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A201530 001 Mar 29, 2012

AP PHARMACHEMIE BV EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040843 002 Jan 11, 2010

AP EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A040843 003 Feb 27, 2012

AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040843 004 Jan 11, 2010

AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040843 001 Jan 11, 2010

AP SAGENT PHARMS EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A203407 001 Aug 09, 2018

AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A203407 002 Aug 09, 2018

AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A203407 003 Aug 09, 2018

AP SANDOZ INC EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A090039 001 Mar 31, 2009

AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A090039 002 Mar 31, 2009

AP EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A090029 001 Mar 31, 2009

AP ! WEST-WARD PHARMS EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A089340 001 Sep 16, 1986

INT

AP ! EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A089343 001 Sep 16, 1986

METHOTREXATE SODIUM

! WEST-WARD PHARMS EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A089342 001 Sep 16, 1986

INT

METHOTREXATE SODIUM PRESERVATIVE FREE

! WEST-WARD PHARMS EQ 1GM BASE/VIAL A040632 001 Aug 12, 2005

INT

SOLUTION;ORAL

XATMEP

+! SILVERGATE PHARMS EQ 2MG BASE/ML N208400 001 Apr 25, 2017

TABLET;ORAL

METHOTREXATE SODIUM

AB AMNEAL PHARMS EQ 2.5MG BASE A210040 001 Dec 22, 2017

AB BARR EQ 2.5MG BASE A081099 001 Oct 15, 1990

AB +! DAVA PHARMS INC EQ 2.5MG BASE N008085 002



AB MYLAN EQ 2.5MG BASE A081235 001 May 15, 1992

AB SUN PHARMA GLOBAL EQ 2.5MG BASE A201749 001 May 21, 2015

AB WEST-WARD PHARMS EQ 2.5MG BASE A040054 001 Aug 01, 1994

INT

AB ZYDUS PHARMS USA EQ 2.5MG BASE A207812 001 Jan 13, 2017

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-291(of 452)

METHOTREXATE SODIUM

TABLET;ORAL

TREXALL

BARR EQ 5MG BASE A040385 001 Mar 21, 2001

EQ 7.5MG BASE A040385 002 Mar 21, 2001

EQ 10MG BASE A040385 003 Mar 21, 2001

! EQ 15MG BASE A040385 004 Mar 21, 2001

METHOXSALEN

CAPSULE;ORAL

METHOXSALEN

AB ACTAVIS INC 10MG A202603 001 Jun 09, 2015

AB STRIDES PHARMA 10MG A202687 001 Jun 05, 2014

OXSORALEN-ULTRA

AB +! DOW PHARM 10MG N019600 001 Oct 30, 1986

INJECTABLE;INJECTION

UVADEX

+! MALLINCKRODT HOSP 0.02MG/ML N020969 001 Feb 25, 1999

METHSCOPOLAMINE BROMIDE

TABLET;ORAL

METHSCOPOLAMINE BROMIDE

AA BAYSHORE PHARMS LLC 2.5MG A200602 001 Sep 24, 2012

AA 5MG A200602 002 Sep 24, 2012

AA BRECKENRIDGE PHARM 2.5MG A040642 001 Dec 06, 2011

AA 5MG A040642 002 Dec 06, 2011

AA ! VINTAGE PHARMS 2.5MG A040624 001 Dec 28, 2006

AA ! 5MG A040624 002 Dec 28, 2006



METHSUXIMIDE

CAPSULE;ORAL

CELONTIN

+! PARKE DAVIS 300MG N010596 008

METHYCLOTHIAZIDE

TABLET;ORAL

METHYCLOTHIAZIDE

! MYLAN PHARMS INC 5MG A087672 001 Aug 17, 1982

METHYLDOPA

TABLET;ORAL

METHYLDOPA

AB ACCORD HLTHCARE 250MG A070084 001 Oct 15, 1985

AB 500MG A070085 001 Oct 15, 1985

AB IVAX SUB TEVA 250MG A070098 001 Feb 20, 1986

PHARMS

AB 500MG A070343 001 Feb 20, 1986

AB MYLAN 250MG A070076 002 Apr 18, 1985

AB ! 500MG A070076 001 Apr 18, 1985

AB WATSON LABS 500MG A070625 001 Jun 06, 1986



METHYLDOPATE HYDROCHLORIDE

INJECTABLE;INJECTION

METHYLDOPATE HYDROCHLORIDE

! LUITPOLD 50MG/ML A071279 001 Oct 02, 1987

METHYLENE BLUE

SOLUTION;INTRAVENOUS

PROVAYBLUE

+! PROVEPHARM SAS 50MG/10ML (5MG/ML) N204630 001 Apr 08, 2016

METHYLERGONOVINE MALEATE

INJECTABLE;INJECTION

METHERGINE

AP +! EDISON THERAPS LLC 0.2MG/ML N006035 004

METHYLERGONOVINE MALEATE

AP BRECKENRIDGE PHARM 0.2MG/ML A040889 001 Sep 13, 2010

AP LUITPOLD 0.2MG/ML A090193 001 Nov 24, 2008



TABLET;ORAL

METHYLERGONOVINE MALEATE

AB AMNEAL PHARMS 0.2MG A211483 001 Sep 10, 2018

AB GRANULES PHARMS 0.2MG A210424 001 May 15, 2018

AB ! NOVEL LABS INC 0.2MG A091577 001 May 02, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-292(of 452)

METHYLNALTREXONE BROMIDE

SOLUTION;SUBCUTANEOUS

RELISTOR

+! SALIX PHARMS 8MG/0.4ML (8MG/0.4ML) N021964 002 Sep 27, 2010

+! 12MG/0.6ML (12MG/0.6ML) N021964 001 Apr 24, 2008

+! 12MG/0.6ML (12MG/0.6ML) N021964 003 Sep 27, 2010

TABLET;ORAL

RELISTOR

+! SALIX PHARMS INC 150MG N208271 001 Jul 19, 2016

METHYLPHENIDATE

FILM, EXTENDED RELEASE;TRANSDERMAL

DAYTRANA

+ NOVEN PHARMS INC 10MG/9HR (1.1MG/HR) N021514 001 Apr 06, 2006

+ 15MG/9HR (1.6MG/HR) N021514 002 Apr 06, 2006

+ 20MG/9HR (2.2MG/HR) N021514 003 Apr 06, 2006

+! 30MG/9HR (3.3MG/HR) N021514 004 Apr 06, 2006

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL



COTEMPLA XR-ODT

+ NEOS THERAPS INC 8.6MG N205489 001 Jun 19, 2017

+ 17.3MG N205489 002 Jun 19, 2017

+ 25.9MG N205489 003 Jun 19, 2017

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB1 BARR LABS INC 10MG A079031 004 Oct 15, 2014

AB1 20MG A079031 001 Jul 13, 2012

AB1 30MG A079031 002 Jul 13, 2012

AB1 40MG A079031 003 Jul 13, 2012

AB1 MAYNE PHARMA 10MG A200886 001 Feb 26, 2018

AB1 20MG A078458 001 Dec 01, 2011

AB1 30MG A078458 002 Dec 01, 2011

AB1 40MG A078458 003 Dec 01, 2011

RITALIN LA

AB1 + NOVARTIS 10MG N021284 004 Apr 10, 2004

AB1 + 20MG N021284 001 Jun 05, 2002

AB1 + 30MG N021284 002 Jun 05, 2002

AB1 + 40MG N021284 003 Jun 05, 2002

METADATE CD

AB2 + LANNETT CO INC 10MG N021259 003 May 27, 2003

AB2 + 20MG N021259 001 Apr 03, 2001

AB2 + 30MG N021259 002 Jun 19, 2003

AB2 + 40MG N021259 004 Feb 19, 2006

AB2 + 50MG N021259 005 Feb 19, 2006

AB2 +! 60MG N021259 006 Feb 19, 2006

METHYLPHENIDATE HYDROCHLORIDE

AB2 IMPAX LABS INC 10MG A205105 001 Jul 28, 2016

AB2 20MG A205105 002 Jul 28, 2016

AB2 30MG A205105 003 Jul 28, 2016

AB2 40MG A205105 004 Jul 28, 2016

AB2 50MG A205105 005 Jul 28, 2016

AB2 60MG A205105 006 Jul 28, 2016

AB2 SPECGX LLC 10MG A203583 001 Sep 29, 2015

AB2 20MG A203583 002 Sep 29, 2015

AB2 30MG A203583 003 Sep 29, 2015

AB2 40MG A203583 004 Sep 29, 2015

AB2 50MG A203583 005 Sep 29, 2015

AB2 60MG A203583 006 Sep 29, 2015

AB2 TEVA PHARMS 10MG A077707 001 Jul 19, 2012

AB2 20MG A077707 002 Jul 19, 2012

AB2 30MG A077707 003 Jul 19, 2012

AB2 40MG A078873 001 Jul 19, 2012

AB2 50MG A078873 002 Jul 19, 2012

AB2 60MG A078873 003 Jul 19, 2012

APTENSIO XR

AB3 + RHODES PHARMS 10MG N205831 001 Apr 17, 2015

AB3 + 15MG N205831 002 Apr 17, 2015

AB3 + 20MG N205831 003 Apr 17, 2015

AB3 + 30MG N205831 004 Apr 17, 2015

AB3 + 40MG N205831 005 Apr 17, 2015

AB3 + 50MG N205831 006 Apr 17, 2015

AB3 +! 60MG N205831 007 Apr 17, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-293(of 452)

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB3 ACTAVIS ELIZABETH 10MG A208861 001 Dec 13, 2018

AB3 15MG A208861 002 Dec 13, 2018

AB3 20MG A208861 003 Dec 13, 2018

AB3 30MG A208861 004 Dec 13, 2018

AB3 40MG A208861 005 Dec 13, 2018

AB3 50MG A208861 006 Dec 13, 2018

AB3 60MG A208861 007 Dec 13, 2018



JORNAY PM

+ IRONSHORE PHARMS 20MG N209311 001 Aug 08, 2018

+ 40MG N209311 002 Aug 08, 2018

+ 60MG N209311 003 Aug 08, 2018

+ 80MG N209311 004 Aug 08, 2018

+ 100MG N209311 005 Aug 08, 2018

METHYLPHENIDATE HYDROCHLORIDE

! MAYNE PHARMA 60MG A078458 004 Jun 23, 2016

FOR SUSPENSION, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB ACTAVIS LABS FL INC 5MG/ML A206049 001 May 17, 2018

QUILLIVANT XR

AB +! NEXTWAVE PHARMS 5MG/ML N202100 001 Sep 27, 2012

SOLUTION;ORAL

METHYLIN

AA +! SPECGX LLC 5MG/5ML N021419 001 Dec 19, 2002

AA +! 10MG/5ML N021419 002 Dec 19, 2002

METHYLPHENIDATE HYDROCHLORIDE

AA ABHAI LLC 5MG/5ML A207485 001 Nov 18, 2016

AA 10MG/5ML A207485 002 Nov 18, 2016

AA BRECKENRIDGE PHARM 5MG/5ML A201466 001 Nov 12, 2013

AA 10MG/5ML A201466 002 Nov 12, 2013

AA NOVEL LABS INC 5MG/5ML A204602 001 Aug 14, 2015

AA 10MG/5ML A204602 002 Aug 14, 2015

AA TRIS PHARMA INC 5MG/5ML A091601 001 Jul 23, 2010

AA 10MG/5ML A091601 002 Jul 23, 2010

AA WES PHARMA INC 5MG/5ML A210139 001 Oct 03, 2018

AA 10MG/5ML A210139 002 Oct 03, 2018



TABLET;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB ABHAI INC 5MG A206932 001 May 11, 2017

AB 10MG A206932 002 May 11, 2017

AB 20MG A206932 003 May 11, 2017

AB ACTAVIS LABS FL INC 5MG A040220 001 Aug 29, 1997

AB 10MG A040220 002 Aug 29, 1997

AB 20MG A040220 003 Aug 29, 1997

AB ASCENT PHARMS INC 5MG A207416 001 Sep 22, 2015

AB 10MG A207416 002 Sep 22, 2015

AB 20MG A207416 003 Sep 22, 2015

AB AUROLIFE PHARMA LLC 5MG A209276 001 Oct 25, 2018

AB 10MG A209276 002 Oct 25, 2018

AB 20MG A209276 003 Oct 25, 2018

AB BIONPHARMA INC 5MG A209753 001 Mar 02, 2018

AB 10MG A209753 002 Mar 02, 2018

AB 20MG A209753 003 Mar 02, 2018

AB BRECKENRIDGE PHARM 5MG A207587 001 Mar 03, 2017

AB 10MG A207587 002 Mar 03, 2017

AB 20MG A207587 003 Mar 03, 2017

AB CNTY LINE PHARMS 5MG A206840 001 Sep 15, 2016

AB 10MG A206840 002 Sep 15, 2016

AB 20MG A206840 003 Sep 15, 2016

AB LANNETT CO INC 5MG A086429 001



AB 10MG A085799 001

AB 20MG A086428 001

AB MOUNTAIN 5MG A091159 001 Mar 12, 2014

AB 10MG A091159 002 Mar 12, 2014

AB 20MG A091159 003 Mar 12, 2014

AB NOVEL LABS INC 5MG A207884 001 Nov 13, 2015

AB 10MG A207884 002 Nov 13, 2015

AB 20MG A207884 003 Nov 13, 2015

AB OXFORD PHARMS 5MG A202892 001 Sep 23, 2014

AB 10MG A202892 002 Sep 23, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-294(of 452)

METHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB 20MG A202892 003 Sep 23, 2014

AB SPECGX LLC 5MG A040300 001 Nov 27, 1998

AB 10MG A040300 002 Nov 27, 1998

AB 20MG A040300 003 Nov 27, 1998

AB SUN PHARM INDS INC 5MG A090710 001 Mar 15, 2012

AB 10MG A090710 002 Mar 15, 2012

AB 20MG A090710 003 Mar 15, 2012

RITALIN

AB + NOVARTIS 5MG N010187 003

AB + 10MG N010187 006

AB +! 20MG N010187 010

TABLET, CHEWABLE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

AB ASCENT PHARMS INC 2.5MG A210354 001 Dec 29, 2017

AB 5MG A210354 002 Dec 29, 2017

AB 10MG A210354 003 Dec 29, 2017

AB BRECKENRIDGE PHARM 2.5MG A204954 001 Jan 26, 2017

AB 5MG A204954 002 Jan 26, 2017

AB 10MG A204954 003 Jan 26, 2017

AB NOVEL LABS INC 2.5MG A204115 001 Feb 25, 2015

AB 5MG A204115 002 Feb 25, 2015

AB ! 10MG A204115 003 Feb 25, 2015

AB RISING PHARMS 2.5MG A205756 001 Nov 07, 2016

AB 5MG A205756 002 Nov 07, 2016

AB 10MG A205756 003 Nov 07, 2016



TABLET, EXTENDED RELEASE;ORAL

CONCERTA

AB + JANSSEN PHARMS 18MG N021121 001 Aug 01, 2000

AB + 27MG N021121 004 Apr 01, 2002

AB + 36MG N021121 002 Aug 01, 2000

AB +! 54MG N021121 003 Dec 08, 2000

METADATE ER

AB ! LANNETT CO INC 20MG A089601 001 Jun 01, 1988

METHYLIN ER

AB SPECGX LLC 10MG A075629 001 May 09, 2000

AB 20MG A075629 002 May 09, 2000

METHYLPHENIDATE HYDROCHLORIDE

AB ABHAI LLC 10MG A207488 001 Jun 09, 2015

AB 20MG A207488 002 Jun 09, 2015

AB ACTAVIS LABS FL 18MG A076772 001 Mar 22, 2018

AB 27MG A076772 002 Mar 22, 2018

AB 36MG A076772 003 Mar 22, 2018

AB 54MG A076655 001 Mar 21, 2018

AB ALVOGEN PINE BROOK 18MG A210818 001 Nov 30, 2018

AB 27MG A210818 002 Nov 30, 2018

AB 36MG A210818 003 Nov 30, 2018

AB 54MG A210818 004 Nov 30, 2018

AB AMNEAL PHARMS 18MG A207515 001 Feb 01, 2018

AB 27MG A207515 002 Feb 01, 2018

AB 36MG A207515 003 Feb 01, 2018

AB 54MG A207515 004 Feb 01, 2018

AB ANI PHARMS INC 18MG A208607 001 Jul 14, 2017

AB 27MG A208607 002 Jul 14, 2017

AB 36MG A208607 003 Jul 14, 2017

AB 54MG A208607 004 Jul 14, 2017

AB CNTY LINE PHARMS 10MG A204772 001 Feb 29, 2016

AB 20MG A204772 002 Feb 29, 2016

AB GRANULES PHARMS 10MG A210992 001 Nov 21, 2018

AB 20MG A210992 002 Nov 21, 2018

AB MYLAN PHARMS INC 18MG A206726 001 Oct 21, 2016

AB 27MG A206726 002 Oct 21, 2016

AB 36MG A206726 003 Oct 21, 2016

AB 54MG A206726 004 Oct 21, 2016

AB OSMOTICA 18MG A205327 001 Jul 28, 2017

AB 27MG A205327 002 Jul 28, 2017

AB 36MG A205327 003 Jul 28, 2017

AB 54MG A205327 004 Jul 28, 2017



BX LANNETT CO INC 18MG A091695 001 Jul 09, 2013

BX 27MG A091695 002 Jul 09, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-295(of 452)

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

BX 36MG A091695 003 Sep 23, 2013

BX 54MG A091695 004 Sep 23, 2013

BX SPECGX LLC 27MG A202608 001 Dec 28, 2012



BX 36MG A202608 002 Dec 28, 2012

BX 54MG A202608 003 Dec 28, 2012

! OSMOTICA 72MG A205327 005 Jul 28, 2017

TABLET, EXTENDED RELEASE, CHEWABLE;ORAL

QUILLICHEW ER

+ NEXTWAVE PHARMS 20MG N207960 001 Dec 04, 2015

+ 30MG N207960 002 Dec 04, 2015

+! 40MG N207960 003 Dec 04, 2015

METHYLPREDNISOLONE

TABLET;ORAL

MEDROL

AB + PHARMACIA AND 4MG N011153 001

UPJOHN

AB + 8MG N011153 004

AB + 16MG N011153 003

AB +! 32MG N011153 006

METHYLPREDNISOLONE

AB DURAMED PHARMS BARR 4MG A088497 001 Feb 21, 1984

AB JUBILANT CADISTA 4MG A040189 001 Oct 31, 1997

AB 8MG A040189 002 Oct 31, 1997

AB 16MG A040189 003 Jul 20, 2007

AB 32MG A040189 004 Jul 20, 2007

AB RICONPHARMA LLC 4MG A210985 001 Jan 09, 2019

AB SANDOZ 4MG A040194 001 Oct 31, 1997

AB VINTAGE PHARMS 4MG A040183 001 Dec 22, 1998

AB WATSON LABS 4MG A040232 001 Oct 16, 1997

AB ZYDUS PHARMS USA 4MG A206751 001 Apr 23, 2018

INC

AB 8MG A206751 002 Apr 23, 2018

AB 16MG A206751 003 Apr 23, 2018

AB 32MG A206751 004 Apr 23, 2018

MEDROL

+ PHARMACIA AND 2MG N011153 002

UPJOHN

METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION

DEPO-MEDROL

AB +! PHARMACIA AND 20MG/ML N011757 002

UPJOHN

AB +! 40MG/ML N011757 001

AB +! 80MG/ML N011757 004

METHYLPREDNISOLONE ACETATE

AB SAGENT PHARMS 20MG/ML A201835 001 Jun 27, 2018

AB 40MG/ML A201835 002 Jun 27, 2018

AB 80MG/ML A201835 003 Jun 27, 2018

AB SANDOZ INC 40MG/ML A040719 001 Jan 29, 2009

AB 40MG/ML A040794 001 Mar 05, 2009

AB 80MG/ML A040719 002 Jan 29, 2009

AB 80MG/ML A040794 002 Mar 05, 2009

AB TEVA PHARMS USA 40MG/ML A040557 001 Feb 23, 2005

AB 40MG/ML A040620 001 Oct 27, 2006

AB 80MG/ML A040557 002 Feb 23, 2005

AB 80MG/ML A040620 002 Oct 27, 2006



METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-METHAPRED

AP HOSPIRA EQ 40MG BASE/VIAL A040664 001 Dec 20, 2005

AP EQ 125MG BASE/VIAL A040665 001 Dec 20, 2005

METHYLPREDNISOLONE SODIUM SUCCINATE



AP AMNEAL PHARMS CO EQ 40MG BASE/VIAL A207549 001 Nov 09, 2016

AP EQ 125MG BASE/VIAL A207549 002 Nov 09, 2016

AP AUROBINDO PHARMA EQ 40MG BASE/VIAL A207667 001 Dec 15, 2015

LTD

AP EQ 125MG BASE/VIAL A207667 002 Dec 15, 2015

AP EQ 500MG BASE/VIAL A207667 003 Dec 15, 2015

AP EQ 2GM BASE/VIAL A207667 004 Dec 15, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-296(of 452)

METHYLPREDNISOLONE SODIUM SUCCINATE



INJECTABLE;INJECTION

METHYLPREDNISOLONE SODIUM SUCCINATE



AP FRESENIUS KABI USA EQ 40MG BASE/VIAL A040583 001 Jul 30, 2004

AP EQ 125MG BASE/VIAL A040583 002 Jul 30, 2004

AP EQ 1GM BASE/VIAL A040612 001 Aug 12, 2004

AP HIKMA FARMACEUTICA EQ 500MG BASE/VIAL A202691 001 Feb 16, 2016

AP EQ 1GM BASE/VIAL A202691 002 Feb 16, 2016

AP SAGENT PHARMS EQ 40MG BASE/VIAL A040888 001 Jul 18, 2011

AP EQ 125MG BASE/VIAL A040888 002 Jul 18, 2011

AP EQ 500MG BASE/VIAL A040888 003 Jul 18, 2011

AP EQ 1GM BASE/VIAL A040888 004 Jul 18, 2011

AP EQ 2GM BASE/VIAL A040888 005 Jul 18, 2011

SOLU-MEDROL

AP +! PHARMACIA AND EQ 40MG BASE/VIAL N011856 003

UPJOHN

AP +! EQ 125MG BASE/VIAL N011856 004

AP +! EQ 500MG BASE/VIAL N011856 005

AP +! EQ 1GM BASE/VIAL N011856 006

AP +! EQ 2GM BASE/VIAL N011856 007 Feb 27, 1985

METHYLTESTOSTERONE

CAPSULE;ORAL

METHYLTESTOSTERONE

AB IMPAX LABS INC 10MG A204851 001 Sep 21, 2015

TESTRED

AB ! VALEANT PHARM INTL 10MG A083976 001

TABLET;ORAL

ANDROID 25

BP VALEANT PHARM INTL 25MG A087147 001

METHYLTESTOSTERONE

BP IMPAX LABS 10MG A080767 002

METIPRANOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

METIPRANOLOL

AT SANDOZ INC 0.3% A075720 001 Aug 06, 2001

OPTIPRANOLOL

AT +! BAUSCH AND LOMB 0.3% N019907 001 Dec 29, 1989

METOCLOPRAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

METOCLOPRAMIDE

AP EMCURE PHARMS LTD EQ 5MG BASE/ML A204756 001 Dec 20, 2013

METOCLOPRAMIDE HYDROCHLORIDE

AP FRESENIUS KABI USA EQ 5MG BASE/ML A091392 001 Apr 19, 2013

AP ! HOSPIRA EQ 5MG BASE/ML A073118 001 Jan 17, 1991

AP TEVA PHARMS USA EQ 5MG BASE/ML A073135 001 Nov 27, 1991

SOLUTION;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AA ANI PHARMS EQ 5MG BASE/5ML A071402 001 Jun 25, 1993

AA PHARM ASSOC EQ 5MG BASE/5ML A072744 001 May 28, 1991

AA VISTAPHARM EQ 5MG BASE/5ML A075051 001 Jan 26, 2001

AA ! WOCKHARDT BIO AG EQ 5MG BASE/5ML A074703 001 Oct 31, 1997



TABLET;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AB IMPAX LABS INC EQ 5MG BASE A071250 002 Dec 28, 1995

AB EQ 10MG BASE A071250 001 Feb 03, 1988

AB IPCA LABS LTD EQ 5MG BASE A078807 001 Jun 12, 2008

AB EQ 10MG BASE A078807 002 Jun 12, 2008

AB PAR PHARM INC EQ 10MG BASE A070581 001 Oct 17, 1985

AB TEVA EQ 5MG BASE A072801 001 Jun 15, 1993

AB EQ 10MG BASE A070184 001 Jul 29, 1985

AB VINTAGE PHARMS EQ 5MG BASE A077878 001 Aug 28, 2006

AB EQ 10MG BASE A077878 002 Aug 28, 2006

REGLAN

AB + ANI PHARMS EQ 5MG BASE N017854 002 May 05, 1987

AB +! EQ 10MG BASE N017854 001



TABLET, ORALLY DISINTEGRATING;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

NOVEL LABS INC EQ 5MG BASE A202191 001 Aug 15, 2014

! EQ 10MG BASE A202191 002 Aug 15, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-297(of 452)

METOLAZONE

TABLET;ORAL

METOLAZONE

AB MYLAN
2.5MG
A076698 001 Dec 23, 2003

AB
5MG
A076698 002 Oct 19, 2004

AB
10MG
A076698 003 Oct 19, 2004

AB SANDOZ
2.5MG
A076732 001 Dec 19, 2003

AB
5MG
A076466 001 Dec 19, 2003

AB
10MG
A076466 002 Dec 19, 2003

ZAROXOLYN

AB + LANNETT CO INC
2.5MG
N017386 001

AB +!
5MG
N017386 002

AB +!
10MG
N017386 003

METOPROLOL SUCCINATE

CAPSULE, EXTENDED RELEASE;ORAL

KAPSPARGO SPRINKLE

+ SPIL
EQ 25MG TARTRATE
N210428 001 Jan 26, 2018

+
EQ 50MG TARTRATE
N210428 002 Jan 26, 2018

+
EQ 100MG TARTRATE
N210428 003 Jan 26, 2018

+!
EQ 200MG TARTRATE
N210428 004 Jan 26, 2018

TABLET, EXTENDED RELEASE;ORAL

METOPROLOL SUCCINATE

AB ACTAVIS ELIZABETH
EQ 25MG TARTRATE
A204161 001 Nov 25, 2016

AB
EQ 50MG TARTRATE
A204161 002 Nov 25, 2016

AB
EQ 100MG TARTRATE
A204161 003 Nov 25, 2016

AB
EQ 200MG TARTRATE
A204161 004 Nov 25, 2016

AB ACTAVIS LABS FL INC


EQ 25MG TARTRATE
A076862 002 Aug 03, 2009

AB
EQ 50MG TARTRATE
A076862 001 Aug 03, 2009

AB
EQ 100MG TARTRATE
A077298 001 Apr 15, 2010

AB
EQ 200MG TARTRATE
A077298 002 Apr 15, 2010

AB CIPLA
EQ 50MG TARTRATE
A207465 001 Oct 26, 2018

AB
EQ 100MG TARTRATE
A207465 002 Oct 26, 2018

AB
EQ 200MG TARTRATE
A207465 003 Oct 26, 2018

AB DR REDDYS LABS LTD


EQ 25MG TARTRATE
A090617 001 Aug 01, 2012

AB
EQ 50MG TARTRATE
A090617 002 Aug 01, 2012

AB MYLAN PHARMS INC


EQ 25MG TARTRATE
A202033 001 Dec 15, 2011

AB
EQ 50MG TARTRATE
A202033 002 Dec 15, 2011

AB
EQ 100MG TARTRATE
A202033 003 Dec 15, 2011

AB
EQ 200MG TARTRATE
A202033 004 Dec 15, 2011

AB NOVAST LABS
EQ 25MG TARTRATE
A204106 001 Feb 06, 2018

AB
EQ 50MG TARTRATE
A204106 002 Feb 06, 2018

AB
EQ 100MG TARTRATE
A204106 003 Feb 06, 2018

AB
EQ 200MG TARTRATE
A204106 004 Feb 06, 2018

AB REDDYS
EQ 100MG TARTRATE
A078889 001 Aug 15, 2012

AB
EQ 200MG TARTRATE
A078889 002 Aug 15, 2012

AB TWI PHARMS
EQ 25MG TARTRATE
A207206 001 Dec 19, 2018

AB
EQ 50MG TARTRATE
A207206 002 Dec 19, 2018

AB
EQ 100MG TARTRATE
A207206 003 Dec 19, 2018

AB
EQ 200MG TARTRATE
A207206 004 Dec 19, 2018

AB WOCKHARDT
EQ 25MG TARTRATE
A090615 001 Jul 22, 2010

AB
EQ 50MG TARTRATE
A090615 002 Jul 22, 2010

AB
EQ 100MG TARTRATE
A090615 003 Jul 22, 2010

AB
EQ 200MG TARTRATE
A090615 004 Jul 22, 2010

AB ZYDUS PHARMS USA


EQ 25MG TARTRATE
A203894 001 Mar 23, 2018

INC

AB
EQ 50MG TARTRATE
A203894 002 Mar 23, 2018

AB
EQ 100MG TARTRATE
A203894 003 Mar 23, 2018

AB
EQ 200MG TARTRATE
A203894 004 Mar 23, 2018

TOPROL-XL

AB + ARALEZ PHARMS
EQ 25MG TARTRATE
N019962 004 Feb 05, 2001

AB +!
EQ 50MG TARTRATE
N019962 001 Jan 10, 1992

AB +
EQ 100MG TARTRATE
N019962 002 Jan 10, 1992

AB +!
EQ 200MG TARTRATE
N019962 003 Jan 10, 1992

METOPROLOL TARTRATE
INJECTABLE;INJECTION
LOPRESSOR
AP +! NOVARTIS 1MG/ML N018704 001 Mar 30, 1984
METOPROLOL TARTRATE
AP BAXTER HLTHCARE 1MG/ML A078950 001 Apr 29, 2013
CORP
AP FRESENIUS KABI USA 1MG/ML A091045 001 Oct 25, 2010
AP GLAND PHARMA LTD 1MG/ML A204205 001 Aug 27, 2014
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-298(of 452)

METOPROLOL TARTRATE

INJECTABLE;INJECTION

METOPROLOL TARTRATE

AP HIKMA FARMACEUTICA 1MG/ML A077761 001 May 30, 2007

AP HOSPIRA 1MG/ML A074133 001 Dec 21, 1993

AP 1MG/ML A075160 001 Jul 06, 1998

AP 1MG/ML A078085 001 Apr 29, 2008

AP LUITPOLD 1MG/ML A090386 001 Sep 30, 2009

AP 1MG/ML A091307 001 Dec 29, 2010

AP MYLAN ASI 1MG/ML A090317 001 Apr 19, 2010

AP SANDOZ INC 1MG/ML A077360 001 Oct 02, 2007

AP WEST-WARD PHARMS 1MG/ML A076495 001 Jul 07, 2003

INT

TABLET;ORAL

LOPRESSOR

AB + US PHARMS HOLDINGS 50MG N017963 001

I

AB + 100MG N017963 002

METOPROLOL TARTRATE

AB ALEMBIC PHARMS LTD 25MG A202871 001 May 28, 2013

AB 50MG A202871 002 May 28, 2013

AB 100MG A202871 003 May 28, 2013

AB AUROBINDO PHARMA 25MG A077739 001 Sep 11, 2007

AB 50MG A077739 002 Sep 11, 2007

AB 100MG A077739 003 Sep 11, 2007

AB IPCA LABS LTD 25MG A078459 001 Jun 17, 2008

AB 50MG A078459 002 Jun 17, 2008

AB 100MG A078459 003 Jun 17, 2008

AB MYLAN 25MG A076704 001 Jan 16, 2004

AB 50MG A076704 002 Jan 16, 2004

AB ! 100MG A076704 003 Jan 16, 2004

AB RUBICON RES PVT LTD 25MG A200981 001 Oct 28, 2014

AB 50MG A200981 002 Oct 28, 2014

AB 100MG A200981 003 Oct 28, 2014

AB SUN PHARM INDS INC 25MG A076670 001 Jan 15, 2004

AB 50MG A074644 001 Dec 10, 1996

AB 100MG A074644 002 Dec 10, 1996

AB SUN PHARM 25MG A073654 002 Jul 15, 2009

INDUSTRIES

AB 50MG A073654 003 Dec 21, 1993

AB 100MG A073654 001 Dec 21, 1993

AB TEVA 50MG A074141 001 Jan 31, 1995

AB 100MG A074141 002 Jan 31, 1995

AB WATSON LABS 50MG A074217 001 May 27, 1994

AB 100MG A074217 002 May 27, 1994

MYLAN 37.5MG A076704 004 Mar 18, 2015



75MG A076704 005 Mar 18, 2015

METRONIDAZOLE

CAPSULE;ORAL

FLAGYL

AB +! GD SEARLE LLC 375MG N020334 001 May 03, 1995

METRONIDAZOLE

AB ALEMBIC PHARMS LTD 375MG A079065 001 Jun 23, 2009

AB PAR PHARM 375MG A076522 001 Jan 29, 2004



CREAM;TOPICAL

METROCREAM

AB +! GALDERMA LABS LP 0.75% N020531 001 Sep 20, 1995

METRONIDAZOLE

AB FOUGERA PHARMS 0.75% A076408 001 May 28, 2004

AB G AND W LABS 0.75% A077549 001 Dec 19, 2007



NORITATE

+! VALEANT PHARMS 1% N020743 001 Sep 26, 1997

NORTH

GEL;TOPICAL

METROGEL

AB +! GALDERMA LABS LP 0.75% N019737 001 Nov 22, 1988

AB +! 1% N021789 001 Jun 30, 2005

METRONIDAZOLE

AB FOUGERA PHARMS 0.75% A077018 001 Jun 06, 2006

AB G AND W LABS INC 0.75% A078178 001 Jan 19, 2011

AB TARO 0.75% A077819 001 Jul 18, 2006

AB TARO PHARM 1% A204651 001 Mar 14, 2017

AB TOLMAR 0.75% A077547 001 Jul 13, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-299(of 452)

METRONIDAZOLE

GEL;TOPICAL

METRONIDAZOLE

AB 1% A090903 001 Jul 22, 2011

GEL;VAGINAL

METROGEL-VAGINAL

AB +! MEDICIS 0.75% N020208 001 Aug 17, 1992

METRONIDAZOLE

AB TOLMAR 0.75% A077264 001 Oct 31, 2006

VANDAZOLE

BX TEVA PHARMS 0.75% N021806 001 May 20, 2005

NUVESSA

+! CHEMO RESEARCH SL 1.3% N205223 001 Mar 24, 2014

INJECTABLE;INJECTION

FLAGYL I.V. RTU IN PLASTIC CONTAINER



AP +! BAXTER HLTHCARE 500MG/100ML N018657 001

METRO I.V. IN PLASTIC CONTAINER

AP +! B BRAUN 500MG/100ML N018900 001 Sep 29, 1983

METRONIDAZOLE IN PLASTIC CONTAINER



AP BAXTER HLTHCARE 500MG/100ML A078084 001 Mar 31, 2008

CORP

AP +! HOSPIRA 500MG/100ML N018890 002 Nov 18, 1983

AP MYLAN LABS LTD 500MG/100ML A205531 001 May 09, 2017

LOTION;TOPICAL

METROLOTION

AB +! GALDERMA LABS LP 0.75% N020901 001 Nov 24, 1998

METRONIDAZOLE

AB FOUGERA PHARMS 0.75% A077197 001 May 24, 2006

TABLET;ORAL

FLAGYL

AB + GD SEARLE LLC 250MG N012623 001

AB +! 500MG N012623 003

METRONIDAZOLE

AB ALEMBIC PHARMS LTD 250MG A079067 001 Mar 13, 2009

AB 500MG A079067 002 Mar 13, 2009

AB AUROBINDO PHARMA 250MG A203974 001 May 29, 2015

LTD

AB 500MG A203974 002 May 29, 2015

AB CADILA PHARMS LTD 250MG A209794 001 Dec 12, 2017

AB 500MG A209794 002 Dec 12, 2017

AB FLAMINGO PHARMS 250MG A207309 001 May 16, 2016

AB 500MG A207309 002 May 16, 2016

AB HERITAGE PHARMS INC 250MG A205245 001 Sep 23, 2015

AB 500MG A205245 002 Sep 23, 2015

AB INNOGENIX 250MG A070772 001 Jul 16, 1986

AB 500MG A070772 002 Jul 16, 1986

AB LUPIN LTD 250MG A209096 001 Sep 12, 2017

AB 500MG A209096 002 Sep 12, 2017

AB ORIT LABS LLC 250MG A208681 001 Jun 20, 2017

AB 500MG A208681 002 Jun 20, 2017

AB PLIVA 500MG A070033 001 Dec 06, 1984

AB STRIDES PHARMA 250MG A208162 001 May 25, 2016

AB 500MG A208162 002 May 25, 2016

AB STRIDES VIVIMED 250MG A070040 001 Jan 29, 1985

AB 500MG A070039 001 Jan 29, 1985

AB TEVA PHARMS USA 250MG A070027 001 Nov 06, 1984

AB UNICHEM LABS LTD 250MG A203458 001 Jan 22, 2014

AB 500MG A203458 002 Jan 22, 2014

AB WATSON LABS 250MG A070035 001 Dec 20, 1984

AB WATSON LABS INC 500MG A070044 001 Feb 08, 1985

AB ZYDUS PHARMS USA 250MG A206560 001 Nov 16, 2016

INC

AB 500MG A206560 002 Nov 16, 2016

METYRAPONE

CAPSULE;ORAL

METOPIRONE

+! LABORATORIE HRA 250MG N012911 002 Aug 09, 1996

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-300(of 452)

METYROSINE

CAPSULE;ORAL

DEMSER

+! ATON PHARMA VPNA 250MG N017871 001

MEXILETINE HYDROCHLORIDE

CAPSULE;ORAL

MEXILETINE HYDROCHLORIDE

TEVA 150MG A074377 001 May 16, 1995

200MG A074377 002 May 16, 1995

! 250MG A074377 003 May 16, 1995



MICAFUNGIN SODIUM

INJECTABLE;INTRAVENOUS

MYCAMINE

+! ASTELLAS EQ 50MG BASE/VIAL N021506 002 Mar 16, 2005

+! EQ 100MG BASE/VIAL N021506 003 Jun 27, 2006

MICONAZOLE

TABLET;BUCCAL

ORAVIG

+! MIDATECH PHARMA US 50MG N022404 001 Apr 16, 2010

MICONAZOLE NITRATE

SUPPOSITORY;VAGINAL

MICONAZOLE NITRATE

AB ACTAVIS PHARMA 200MG A073508 001 Nov 19, 1993

MONISTAT 3

AB +! MEDTECH PRODUCTS 200MG N018888 001 Aug 15, 1984

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

OINTMENT;TOPICAL

VUSION

+! MYLAN PHARMS INC 0.25%;81.35%;15% N021026 001 Feb 16, 2006

MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE

AP AKORN INC EQ 1MG BASE/ML A075494 001 Jun 30, 2000

AP EQ 5MG BASE/ML A075494 002 Jun 30, 2000

AP FRESENIUS KABI USA EQ 1MG BASE/ML A075154 002 Jun 20, 2000

AP EQ 5MG BASE/ML A075154 001 Jun 20, 2000

AP GLAND PHARMA LTD EQ 1MG BASE/ML A090696 001 Feb 29, 2012

AP EQ 5MG BASE/ML A090850 001 Jan 25, 2012

AP ! HOSPIRA EQ 1MG BASE/ML A075293 001 Jun 20, 2000

AP EQ 1MG BASE/ML A075856 001 Jun 13, 2002

AP ! EQ 5MG BASE/ML A075293 002 Jun 20, 2000

AP EQ 5MG BASE/ML A075856 002 Jun 13, 2002

AP WEST-WARD PHARMS EQ 1MG BASE/ML A075243 001 Jun 20, 2000

INT

AP EQ 1MG BASE/ML A075247 002 Jun 23, 2000

AP EQ 1MG BASE/ML A075324 001 Jun 20, 2000

AP EQ 1MG BASE/ML A075421 002 Jun 20, 2000

AP EQ 5MG BASE/ML A075243 002 Jun 20, 2000

AP EQ 5MG BASE/ML A075247 001 Jun 23, 2000

AP EQ 5MG BASE/ML A075324 002 Jun 20, 2000

AP EQ 5MG BASE/ML A075421 001 Jun 20, 2000

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE



AP FRESENIUS KABI USA EQ 1MG BASE/ML A203460 001 Aug 22, 2014

AP EQ 5MG BASE/ML A203460 002 Aug 22, 2014

AP ! HOSPIRA EQ 1MG BASE/ML A075857 001 Jul 22, 2002

AP ! EQ 5MG BASE/ML A075857 002 Jul 22, 2002

AP MYLAN ASI EQ 1MG BASE/ML A090315 001 Nov 29, 2010

AP EQ 5MG BASE/ML A090315 002 Nov 29, 2010

MIDOZALAM HYDROCHLORIDE

AP SAGENT STRIDES EQ 1MG BASE/ML A090316 001 May 04, 2011

AP EQ 5MG BASE/ML A090316 002 May 04, 2011

MIDAZOLAM HYDROCHLORIDE

FRESENIUS KABI USA EQ 5MG BASE/ML A208878 001 Mar 28, 2017

SOLUTION;INTRAMUSCULAR

SEIZALAM

+! MERIDIAN MEDCL EQ 50MG BASE/10ML (EQ 5MG BASE/ML) N209566 001 Sep 14, 2018

TECHN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-301(of 452)

MIDAZOLAM HYDROCHLORIDE

SYRUP;ORAL

MIDAZOLAM HYDROCHLORIDE

AA HI TECH PHARMA EQ 2MG BASE/ML A075958 001 Sep 04, 2003

AA PADDOCK LLC EQ 2MG BASE/ML A076379 001 May 02, 2005

AA ! WEST-WARD PHARMS EQ 2MG BASE/ML A075873 001 Apr 30, 2002

INT

MIDODRINE HYDROCHLORIDE

TABLET;ORAL

MIDODRINE HYDROCHLORIDE

AB APOTEX INC 2.5MG A077746 001 Sep 12, 2006

AB 5MG A077746 002 Sep 12, 2006

AB 10MG A077746 003 Sep 12, 2006

AB CASI PHARMS INC 2.5MG A076514 001 Sep 11, 2003

AB 5MG A076514 002 Sep 11, 2003

AB 10MG A076514 003 Jul 02, 2004

AB IMPAX PHARMS 2.5MG A076449 001 May 27, 2004

AB 5MG A076449 002 May 27, 2004

AB 10MG A076449 003 Dec 16, 2005

AB MYLAN PHARMS INC 2.5MG A076577 001 Sep 10, 2003

AB ! 5MG A076577 002 Sep 10, 2003

AB 10MG A076577 003 Sep 10, 2003

AB PAR PHARM INC 2.5MG A207169 001 Oct 29, 2018

AB 5MG A207169 002 Oct 29, 2018

AB 10MG A207169 003 Oct 29, 2018

AB UNIQUE PHARM LABS 2.5MG A207613 001 Nov 02, 2018

AB 5MG A207613 002 Nov 02, 2018

AB 10MG A207613 003 Nov 02, 2018

ORVATEN

AB UPSHER SMITH LABS 2.5MG A076725 001 Nov 03, 2004

AB 5MG A076725 002 Nov 03, 2004

AB 10MG A076725 003 Nov 03, 2004



MIDOSTAURIN

CAPSULE;ORAL

RYDAPT

+! NOVARTIS PHARMS 25MG N207997 001 Apr 28, 2017

CORP

MIFEPRISTONE

TABLET;ORAL

KORLYM

+! CORCEPT THERAP 300MG N202107 001 Feb 17, 2012

MIFEPREX

+! DANCO LABS LLC 200MG N020687 001 Sep 28, 2000

MIGALASTAT HYDROCHLORIDE

CAPSULE;ORAL

GALAFOLD

+! AMICUS THERAPS US EQ 123MG BASE N208623 001 Aug 10, 2018

MIGLITOL

TABLET;ORAL

GLYSET

AB +! PHARMACIA AND 25MG N020682 001 Dec 18, 1996

UPJOHN

AB + 50MG N020682 002 Dec 18, 1996

AB + 100MG N020682 003 Dec 18, 1996

MIGLITOL

AB ORIENT PHARMA CO 25MG A203965 001 Feb 24, 2015

LTD

AB 50MG A203965 002 Feb 24, 2015

AB 100MG A203965 003 Feb 24, 2015



MIGLUSTAT

CAPSULE;ORAL

MIGLUSTAT

AB AMERIGEN PHARMS LTD 100MG A208342 001 Apr 17, 2018

ZAVESCA

AB +! ACTELION PHARMS LTD 100MG N021348 001 Jul 31, 2003

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-302(of 452)

MILNACIPRAN HYDROCHLORIDE

TABLET;ORAL

SAVELLA

+ ALLERGAN SALES LLC 12.5MG N022256 001 Jan 14, 2009

+ 25MG N022256 002 Jan 14, 2009

+! 50MG N022256 003 Jan 14, 2009

+ 100MG N022256 004 Jan 14, 2009

MILRINONE LACTATE

INJECTABLE;INJECTION

MILRINONE LACTATE

AP FRESENIUS KABI USA EQ 1MG BASE/ML A075936 001 May 28, 2002

AP GLAND PHARMA LTD EQ 1MG BASE/ML A077190 001 Oct 31, 2006

AP ! HIKMA FARMACEUTICA EQ 1MG BASE/ML A077966 001 Dec 03, 2010

AP HOSPIRA INC EQ 1MG BASE/ML A203280 001 Sep 03, 2014

AP INTL MEDICATED EQ 1MG BASE/ML A076013 001 Aug 02, 2002

AP WEST-WARD PHARMS EQ 1MG BASE/ML A075530 001 May 28, 2002

INT

AP EQ 1MG BASE/ML A075660 001 May 28, 2002

MILRINONE LACTATE IN DEXTROSE 5%



AP RENAISSANCE SSA LLC EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A077151 002 Jul 20, 2005

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER



AP ! BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075834 001 May 28, 2002

AP ! EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075834 002 May 28, 2002

AP HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075885 001 May 28, 2002

AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075885 002 May 28, 2002

AP WEST-WARD PHARMS EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A078113 001 May 21, 2008

INT

AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A078113 002 May 21, 2008

MILRINONE LACTATE IN PLASTIC CONTAINER



AP HIKMA FARMACEUTICA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A090038 001 Jan 21, 2010

AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A090038 002 Jan 21, 2010

MILTEFOSINE

CAPSULE;ORAL

IMPAVIDO

+! KNIGHT THERAPS 50MG N204684 001 Mar 19, 2014

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DYNACIN

AB CNTY LINE PHARMS EQ 50MG BASE A063067 003 Aug 14, 1990

AB EQ 75MG BASE A063067 002 Sep 15, 1999

AB EQ 100MG BASE A063067 001 Jul 31, 1990

MINOCIN

AB + PRECISION DERMAT EQ 50MG BASE N050649 001 May 31, 1990

AB + EQ 100MG BASE N050649 002 May 31, 1990

MINOCYCLINE HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 50MG BASE A065470 001 Mar 11, 2008

AB EQ 75MG BASE A065470 002 Mar 11, 2008

AB EQ 100MG BASE A065470 003 Mar 11, 2008

AB IMPAX LABS EQ 50MG BASE A065005 001 Mar 23, 1999

AB EQ 75MG BASE A065005 003 Apr 18, 2001

AB EQ 100MG BASE A065005 002 Mar 23, 1999

AB SUN PHARM INDS INC EQ 50MG BASE A090867 001 May 13, 2013

AB EQ 75MG BASE A090867 002 May 13, 2013

AB EQ 100MG BASE A090867 003 May 13, 2013

AB TORRENT PHARMA INC EQ 50MG BASE A065062 001 Nov 30, 2000

AB EQ 75MG BASE A065062 002 Nov 30, 2000

AB EQ 100MG BASE A065062 003 Nov 30, 2000

AB WATSON LABS EQ 75MG BASE A063065 002 Jun 10, 1999

AB EQ 100MG BASE A063065 001 Dec 30, 1991

AB WATSON LABS TEVA EQ 50MG BASE A063181 001 Dec 30, 1991

AB ZYDUS WORLDWIDE EQ 50MG BASE A063011 001 Mar 02, 1992

AB EQ 75MG BASE A063009 002 Aug 12, 2003

AB ! EQ 100MG BASE A063009 001 Mar 02, 1992



CAPSULE, EXTENDED RELEASE;ORAL

XIMINO

SUN PHARM INDS LTD EQ 45MG BASE N201922 001 Jul 11, 2012

EQ 90MG BASE N201922 003 Jul 11, 2012

EQ 135MG BASE N201922 005 Jul 11, 2012

INJECTABLE;INJECTION

MINOCIN

+! REMPEX PHARMS EQ 100MG BASE/VIAL N050444 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-303(of 452)

MINOCYCLINE HYDROCHLORIDE

POWDER, EXTENDED RELEASE;DENTAL

ARESTIN

+! ORAPHARMA EQ 1MG BASE N050781 001 Feb 16, 2001

TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

AB DR REDDYS LABS LTD EQ 50MG BASE A065436 001 Dec 26, 2007

AB EQ 75MG BASE A065436 002 Dec 26, 2007

AB EQ 100MG BASE A065436 003 Dec 26, 2007

AB PAR PHARM EQ 50MG BASE A065131 001 Apr 16, 2003

AB EQ 75MG BASE A065131 002 Apr 16, 2003

AB ! EQ 100MG BASE A065131 003 Apr 16, 2003

AB SUN PHARM EQ 50MG BASE A090217 001 Jan 29, 2016

INDUSTRIES

AB EQ 75MG BASE A090217 002 Jan 29, 2016

AB EQ 100MG BASE A090217 003 Jan 29, 2016

AB TORRENT PHARMA INC EQ 50MG BASE A065156 001 Jan 06, 2004

AB EQ 75MG BASE A065156 002 Jan 06, 2004

AB EQ 100MG BASE A065156 003 Jan 06, 2004



TABLET, EXTENDED RELEASE;ORAL

MINOCYCLINE HYDROCHLORIDE

AB ALKEM LABS LTD EQ 45MG BASE A204453 001 Sep 28, 2016

AB EQ 65MG BASE A204453 006 Mar 16, 2018

AB EQ 80MG BASE A204453 002 Sep 28, 2016

AB EQ 90MG BASE A204453 003 Sep 28, 2016

AB EQ 105MG BASE A204453 004 Sep 28, 2016

AB EQ 115MG BASE A204453 007 Mar 16, 2018

AB EQ 135MG BASE A204453 005 Sep 28, 2016

AB AUROBINDO PHARMA EQ 45MG BASE A202261 001 Nov 19, 2012

LTD

AB EQ 65MG BASE A202261 002 Sep 28, 2018

AB EQ 80MG BASE A202261 006 Jun 13, 2016

AB EQ 90MG BASE A202261 003 Nov 19, 2012

AB EQ 105MG BASE A202261 007 Jun 13, 2016

AB EQ 115MG BASE A202261 004 Sep 28, 2018

AB EQ 135MG BASE A202261 005 Nov 19, 2012

AB BARR LABS INC EQ 65MG BASE A065485 004 May 18, 2012

AB EQ 115MG BASE A065485 005 May 18, 2012

AB LUPIN LTD EQ 45MG BASE A091424 001 Nov 30, 2011

AB EQ 55MG BASE A091424 002 Nov 30, 2011

AB EQ 90MG BASE A091424 003 Nov 30, 2011

AB EQ 135MG BASE A091424 004 Nov 30, 2011

AB MYLAN PHARMS INC EQ 80MG BASE A203443 002 Aug 22, 2014

AB EQ 105MG BASE A203443 003 Aug 22, 2014

AB SANDOZ EQ 45MG BASE A090422 001 Aug 13, 2009

AB EQ 90MG BASE A090422 002 Aug 13, 2009

AB ! EQ 135MG BASE A090422 003 Aug 13, 2009

AB SIDMAK LABS INDIA EQ 45MG BASE A204394 001 Dec 30, 2015

AB EQ 80MG BASE A204394 004 Dec 30, 2015

AB EQ 105MG BASE A204394 005 Dec 30, 2015

AB EQ 135MG BASE A204394 007 Dec 30, 2015

AB SUN PHARM INDS LTD EQ 45MG BASE A091118 001 Sep 25, 2014

AB EQ 80MG BASE A091118 004 Sep 25, 2014

AB EQ 90MG BASE A091118 005 Sep 25, 2014

AB EQ 105MG BASE A091118 006 Sep 25, 2014

AB EQ 135MG BASE A091118 008 Sep 25, 2014

AB ZYDUS PHARMS USA EQ 45MG BASE A203553 001 Nov 16, 2017

INC

AB EQ 80MG BASE A203553 004 Nov 16, 2017

AB EQ 90MG BASE A203553 005 Nov 16, 2017

AB EQ 105MG BASE A203553 006 Nov 16, 2017

AB EQ 135MG BASE A203553 008 Nov 16, 2017

SOLODYN

AB + MEDICIS EQ 55MG BASE N050808 008 Aug 27, 2010

AB + EQ 65MG BASE N050808 004 Jul 23, 2009

AB + EQ 80MG BASE N050808 007 Aug 27, 2010

AB + EQ 105MG BASE N050808 006 Aug 27, 2010

AB +! EQ 115MG BASE N050808 005 Jul 23, 2009



MINOLIRA

EPI HLTH EQ 105MG BASE N209269 001 May 08, 2017

EQ 135MG BASE N209269 002 May 08, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-304(of 452)

MINOXIDIL

TABLET;ORAL

MINOXIDIL

AB PAR PHARM 2.5MG A071826 001 Nov 14, 1988

AB 10MG A071839 001 Nov 14, 1988

AB SUN PHARM 2.5MG A072709 002 Dec 14, 1995

INDUSTRIES

AB 10MG A072709 001 Dec 14, 1995

AB WATSON LABS 2.5MG A071344 001 Mar 03, 1987

AB ! 10MG A071345 001 Mar 03, 1987



MIRABEGRON

TABLET, EXTENDED RELEASE;ORAL

MYRBETRIQ

+! APGDI 25MG N202611 001 Jun 28, 2012

+! 50MG N202611 002 Jun 28, 2012

MIRTAZAPINE

TABLET;ORAL

MIRTAZAPINE

AB APOTEX INC 15MG A077666 001 Aug 22, 2007

AB 30MG A077666 002 Aug 22, 2007

AB 45MG A077666 003 Aug 22, 2007

AB AUROBINDO 7.5MG A076921 001 Oct 22, 2004

AB 15MG A076921 002 Oct 22, 2004

AB 30MG A076921 003 Oct 22, 2004

AB 45MG A076921 004 Oct 22, 2004

AB MYLAN 15MG A076122 001 Jun 19, 2003

AB 30MG A076122 002 Jun 19, 2003

AB 45MG A076122 003 Jun 19, 2003

AB SUN PHARM INDS INC 7.5MG A076541 004 Apr 22, 2004

AB 15MG A076541 001 Apr 22, 2004

AB 30MG A076541 002 Apr 22, 2004

AB 45MG A076541 003 Apr 22, 2004

AB TEVA 15MG A076119 001 Jan 24, 2003

AB 30MG A076119 002 Jan 24, 2003

AB 45MG A076119 003 Jun 19, 2003

AB UPSHER SMITH LABS 15MG A076219 001 Jun 19, 2003

AB 30MG A076219 002 Jun 19, 2003

AB 45MG A076219 003 Jun 19, 2003

AB WATSON LABS 15MG A076312 001 Jun 19, 2003

AB 30MG A076312 002 Jun 19, 2003

AB 45MG A076312 003 Jun 19, 2003

REMERON

AB +! ORGANON USA INC 15MG N020415 001 Jun 14, 1996

AB + 30MG N020415 002 Jun 14, 1996



TABLET, ORALLY DISINTEGRATING;ORAL

MIRTAZAPINE

AB AUROBINDO PHARMA 15MG A077376 002 Dec 08, 2005

LTD

AB 30MG A077376 003 Dec 08, 2005

AB 45MG A077376 004 Feb 28, 2006

AB IMPAX LABS INC 15MG A076901 001 Jun 28, 2005

AB 30MG A076901 002 Jun 28, 2005

AB 45MG A076901 003 Jun 28, 2005

AB ZYDUS PHARMS USA 15MG A205798 001 Jun 01, 2017

INC

AB 30MG A205798 002 Jun 01, 2017

AB 45MG A205798 003 Jun 01, 2017

REMERON SOLTAB

AB +! ORGANON USA INC 15MG N021208 001 Jan 12, 2001

AB + 30MG N021208 002 Jan 12, 2001

AB + 45MG N021208 003 Jan 12, 2001



MISOPROSTOL

TABLET;ORAL

CYTOTEC

AB + GD SEARLE LLC 0.1MG N019268 003 Sep 21, 1990

AB +! 0.2MG N019268 001 Dec 27, 1988

MISOPROSTOL

AB IVAX SUB TEVA 0.1MG A076095 001 Jul 10, 2002

PHARMS

AB 0.2MG A076095 002 Jul 10, 2002

AB NOVEL LABS INC 0.1MG A091667 001 Jul 25, 2012

AB 0.2MG A091667 002 Jul 25, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-305(of 452)

MITOMYCIN

FOR SOLUTION;TOPICAL

MITOSOL

+! MOBIUS THERAP 0.2MG/VIAL N022572 001 Feb 07, 2012

INJECTABLE;INJECTION

MITOMYCIN

AP ! ACCORD HLTHCARE 5MG/VIAL A064144 001 Apr 30, 1998

AP ! 20MG/VIAL A064144 002 Apr 30, 1998

AP ! 40MG/VIAL A064144 003 Aug 11, 2009

AP MYLAN LABS LTD 5MG/VIAL A202670 001 Oct 13, 2017

AP 20MG/VIAL A202670 002 Oct 13, 2017

AP 40MG/VIAL A203386 001 Oct 13, 2017

AP WEST-WARD PHARMS 5MG/VIAL A064180 001 Dec 23, 1999

INT

AP 20MG/VIAL A064180 002 Dec 23, 1999

MITOTANE

TABLET;ORAL

LYSODREN

+! LABORATOIRE HRA 500MG N016885 001

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

MITOXANTRONE HYDROCHLORIDE

AP FRESENIUS KABI USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077496 001 Apr 11, 2006

AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077496 002 Apr 11, 2006

AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077496 003 Apr 11, 2006

AP ! HOSPIRA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076871 001 Apr 11, 2006

AP ! EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076871 002 Apr 11, 2006

AP ! EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076871 003 Apr 11, 2006

AP MYLAN INSTITUTIONAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078980 001 Apr 13, 2009

AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078980 002 Apr 13, 2009

AP MYLAN LABS LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A201014 001 Dec 11, 2012

AP TEVA PHARMS USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356 001 Apr 11, 2006

AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077356 002 Apr 11, 2006

AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356 003 Apr 11, 2006

AP WEST-WARD PHARMS EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076611 001 Apr 11, 2006

INT

AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076611 002 Apr 11, 2006

AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076611 003 Apr 11, 2006

MODAFINIL

TABLET;ORAL

MODAFINIL

AB ALEMBIC PHARMS LTD 100MG A202700 001 Oct 18, 2012

AB 200MG A202700 002 Oct 18, 2012

AB APOTEX INC 100MG A077667 001 Feb 03, 2014

AB 200MG A077667 002 Feb 03, 2014

AB AUROBINDO PHARMA 100MG A202566 001 Sep 27, 2012

LTD

AB 200MG A202566 002 Sep 27, 2012

AB HERITAGE PHARMS INC 100MG A207196 001 Aug 16, 2017

AB 200MG A207196 002 Aug 16, 2017

AB HIKMA PHARMS 100MG A090543 001 Sep 26, 2012

AB 200MG A090543 002 Sep 26, 2012

AB MYLAN PHARMS INC 100MG A076594 001 Jul 16, 2012

AB 200MG A076594 002 Jul 16, 2012

AB ORCHID HLTHCARE 100MG A078963 001 Sep 26, 2012

AB 200MG A078963 002 Sep 26, 2012

AB WATSON LABS INC 100MG A076715 001 Nov 01, 2012

AB 200MG A076715 002 Nov 01, 2012

AB ZYDUS PHARMS USA 100MG A209966 001 Sep 14, 2017

INC

AB 200MG A209966 002 Sep 14, 2017

PROVIGIL

AB + CEPHALON 100MG N020717 001 Dec 24, 1998

AB +! 200MG N020717 002 Dec 24, 1998



MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE

AB APOTEX INC 7.5MG A078454 001 Jun 02, 2008

AB 15MG A078454 002 Jun 02, 2008

AB CHARTWELL RX 7.5MG A077536 001 Nov 30, 2006

AB 15MG A077536 002 Nov 30, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-306(of 452)

MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE

AB GLENMARK GENERICS 7.5MG A090416 001 Mar 30, 2010

AB 15MG A090416 002 Mar 30, 2010

AB TEVA 7.5MG A076204 001 May 08, 2003

AB ! 15MG A076204 002 May 08, 2003



MOLINDONE HYDROCHLORIDE

TABLET;ORAL

MOLINDONE HYDROCHLORIDE

EPIC PHARMA LLC 5MG A090453 001 Mar 20, 2015

10MG A090453 002 Mar 20, 2015

! 25MG A090453 003 Mar 20, 2015

MOMETASONE FUROATE

AEROSOL, METERED;INHALATION

ASMANEX HFA

+ MERCK SHARP DOHME 0.10MG/INH N205641 001 Apr 25, 2014

+! 0.20MG/INH N205641 002 Apr 25, 2014

CREAM;TOPICAL

ELOCON

AB +! MERCK SHARP DOHME 0.1% N019625 002 Apr 19, 2013

MOMETASONE FUROATE

AB ANDA REPOSITORY 0.1% A076591 001 Apr 18, 2007

AB FOUGERA PHARMS 0.1% A076171 001 Apr 08, 2005

AB G AND W LABS 0.1% A077447 001 May 22, 2006

AB GLENMARK GENERICS 0.1% A078541 001 May 28, 2008

AB TARO 0.1% A076679 001 Dec 21, 2004



IMPLANT;IMPLANTATION

SINUVA

+ INTERSECT ENT INC 1.35MG N209310 001 Dec 08, 2017

LOTION;TOPICAL

ELOCON

AB +! MERCK SHARP DOHME 0.1% N019796 001 Mar 30, 1989

MOMETASONE FUROATE

AB ANDA REPOSITORY 0.1% A076499 001 Nov 21, 2007

AB FOUGERA PHARMS 0.1% A075919 001 Nov 29, 2007

AB G AND W LABS 0.1% A077678 001 Nov 21, 2007

AB GLENMARK GENERICS 0.1% A090506 001 Aug 09, 2010

AB PERRIGO ISRAEL 0.1% A077180 001 Apr 06, 2005

AB TARO 0.1% A076788 001 Mar 15, 2006



OINTMENT;TOPICAL

ELOCON

AB +! MERCK SHARP DOHME 0.1% N019543 001 Apr 30, 1987

MOMETASONE FUROATE

AB ANDA REPOSITORY 0.1% A076481 001 Nov 14, 2003

AB FOUGERA PHARMS 0.1% A077061 001 Mar 28, 2005

AB G AND W LABS 0.1% A077401 001 Jun 20, 2006

AB GLENMARK GENERICS 0.1% A078571 001 May 28, 2008

AB PERRIGO NEW YORK 0.1% A076067 001 Mar 18, 2002

AB TORRENT PHARMS LTD 0.1% A207899 001 Jul 13, 2018



POWDER;INHALATION

ASMANEX TWISTHALER

+ MERCK SHARP DOHME 0.11MG/INH N021067 002 Feb 01, 2008

+! 0.22MG/INH N021067 001 Mar 30, 2005

SPRAY, METERED;NASAL

MOMETASONE FUROATE

AB AMNEAL PHARMS EQ 0.05MG BASE/SPRAY A207989 001 Apr 03, 2017

AB APOTEX INC EQ 0.05MG BASE/SPRAY A091161 001 Mar 22, 2016

NASONEX

AB +! MERCK SHARP DOHME EQ 0.05MG BASE/SPRAY N020762 001 Oct 01, 1997

MONTELUKAST SODIUM

GRANULE;ORAL

MONTELUKAST SODIUM

AB AJANTA PHARMA LTD EQ 4MG BASE/PACKET A203438 001 Jul 31, 2015

AB DR REDDYS LABS LTD EQ 4MG BASE/PACKET A202906 001 Sep 17, 2012

AB MYLAN PHARMS INC EQ 4MG BASE/PACKET A202776 001 Dec 18, 2012

AB TEVA PHARMS EQ 4MG BASE/PACKET A090955 001 Aug 03, 2012

AB TORRENT PHARMS LLC EQ 4MG BASE/PACKET A210431 001 Jul 31, 2018

SINGULAIR

AB +! MERCK EQ 4MG BASE/PACKET N021409 001 Jul 26, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-307(of 452)

MONTELUKAST SODIUM

TABLET;ORAL

MONTELUKAST SODIUM
AB ACCORD HLTHCARE EQ 10MG BASE
A202717 001 Sep 21, 2012

AB AJANTA PHARMA LTD EQ 10MG BASE


A203432 001 Jul 31, 2015

AB AMNEAL PHARMS EQ 10MG BASE


A204604 001 Sep 04, 2015

AB ANBISON LAB EQ 10MG BASE


A205683 001 Jan 12, 2016

AB AUROBINDO PHARMA EQ 10MG BASE


A202468 001 Aug 03, 2012

LTD
AB CIPLA EQ 10MG BASE
A207463 001 Oct 28, 2016

AB CSPC OUYI PHARM CO EQ 10MG BASE


A209012 001 Apr 24, 2017

AB DR REDDYS LABS LTD EQ 10MG BASE


A201582 001 Aug 06, 2012

AB GLENMARK GENERICS EQ 10MG BASE


A090926 001 Aug 03, 2012

AB HETERO LABS LTD V EQ 10MG BASE


A202843 001 Sep 10, 2014

AB LANNETT CO INC EQ 10MG BASE


A201522 001 Aug 03, 2012

AB MACLEODS PHARMS LTD EQ 10MG BASE


A203366 001 Sep 11, 2014

AB MYLAN PHARMS INC EQ 10MG BASE


A079103 001 Aug 03, 2012

AB PERRIGO R AND D EQ 10MG BASE


A206112 001 Apr 26, 2017

AB SANDOZ INC EQ 10MG BASE


A200889 001 Aug 03, 2012

AB TEVA PHARMS EQ 10MG BASE


A078605 001 Aug 03, 2012

AB TORRENT PHARMS LTD EQ 10MG BASE


A201515 001 Aug 03, 2012

AB UNICHEM LABS LTD EQ 10MG BASE


A204290 001 Oct 08, 2015

AB UNIMARK REMEDIES EQ 10MG BASE


A202859 001 Oct 30, 2014

LTD
AB VINTAGE PHARMS LLC EQ 10MG BASE
A091576 001 Aug 03, 2012

AB WEST-WARD PHARMS EQ 10MG BASE


A090655 001 Aug 03, 2012

INT
SINGULAIR
AB +! MSD MERCK CO EQ 10MG BASE
N020829 002 Feb 20, 1998

TABLET, CHEWABLE;ORAL

MONTELUKAST SODIUM

AB AJANTA PHARMA LTD
EQ 4MG BASE
A203328 001 Jul 31, 2015

AB
EQ 5MG BASE
A203328 002 Jul 31, 2015

AB ANBISON LAB
EQ 4MG BASE
A205695 001 Nov 05, 2015

AB
EQ 5MG BASE
A205695 002 Nov 05, 2015

AB AUROBINDO PHARMA
EQ 4MG BASE
A202096 001 Aug 03, 2012

LTD

AB
EQ 5MG BASE
A202096 002 Aug 03, 2012

AB CIPLA
EQ 4MG BASE
A207464 001 Dec 06, 2018

AB
EQ 5MG BASE
A207464 002 Dec 06, 2018

AB CSPC OUYI PHARM CO


EQ 4MG BASE
A209011 001 Apr 18, 2017

AB
EQ 5MG BASE
A209011 002 Apr 18, 2017

AB DR REDDYS LABS LTD


EQ 4MG BASE
A201581 001 Aug 06, 2012

AB
EQ 5MG BASE
A201581 002 Aug 06, 2012

AB HETERO LABS LTD V


EQ 4MG BASE
A204093 001 May 22, 2015

AB
EQ 5MG BASE
A204093 002 May 22, 2015

AB JUBILANT GENERICS
EQ 4MG BASE
A203795 001 Feb 27, 2015

AB
EQ 5MG BASE
A203795 002 Feb 27, 2015

AB LANNETT CO INC
EQ 4MG BASE
A200405 001 Aug 03, 2012

AB
EQ 5MG BASE
A200405 002 Aug 03, 2012

AB MACLEODS PHARMS LTD


EQ 4MG BASE
A203582 001 Mar 12, 2015

AB
EQ 5MG BASE
A203582 002 Mar 12, 2015

AB MYLAN PHARMS INC


EQ 4MG BASE
A079142 001 Aug 03, 2012

AB
EQ 5MG BASE
A079142 002 Aug 03, 2012

AB SANDOZ INC
EQ 4MG BASE
A091414 001 Aug 03, 2012

AB
EQ 5MG BASE
A091414 002 Aug 03, 2012

AB TEVA PHARMS
EQ 4MG BASE
A078723 001 Aug 03, 2012

AB
EQ 5MG BASE
A078723 002 Aug 03, 2012

AB TORRENT PHARMS LTD


EQ 4MG BASE
A090984 001 Aug 03, 2012

AB
EQ 5MG BASE
A090984 002 Aug 03, 2012

AB UNICHEM LABS LTD


EQ 4MG BASE
A208621 001 Jul 02, 2018

AB
EQ 5MG BASE
A208621 002 Jul 02, 2018

AB UNIMARK REMEDIES
EQ 4MG BASE
A203037 001 Oct 30, 2014

LTD

AB
EQ 5MG BASE
A203037 002 Oct 30, 2014

AB VINTAGE PHARMS LLC


EQ 4MG BASE
A091588 001 Aug 03, 2012

AB
EQ 5MG BASE
A091588 002 Aug 03, 2012

AB WEST-WARD PHARMS
EQ 4MG BASE
A091128 001 Aug 03, 2012

INT

AB
EQ 5MG BASE
A091128 002 Aug 03, 2012

SINGULAIR

AB + MSD MERCK CO
EQ 4MG BASE
N020830 002 Mar 03, 2000

AB +!
EQ 5MG BASE
N020830 001 Feb 20, 1998

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-308(of 452)

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

KADIAN
AB +! ALLERGAN SALES LLC 10MG N020616 008 Apr 20, 2007

AB + 20MG N020616 001 Jul 03, 1996

AB + 30MG N020616 004 Mar 09, 2001

AB + 40MG N020616 009 Jul 09, 2012

AB + 50MG N020616 002 Jul 03, 1996

AB + 60MG N020616 005 Mar 09, 2001

AB + 70MG N020616 010 Jul 09, 2012

AB + 80MG N020616 006 Oct 27, 2006

AB +! 100MG N020616 003 Jul 03, 1996



MORPHINE SULFATE
AB IMPAX LABS INC 20MG A200411 001 Apr 12, 2016

AB 30MG A200411 002 Apr 12, 2016

AB 50MG A200411 003 Apr 12, 2016

AB 60MG A200411 004 Apr 12, 2016

AB 80MG A200411 005 Apr 12, 2016

AB 100MG A200411 006 Apr 12, 2016

AB PAR PHARM INC 20MG A200812 001 Nov 10, 2011

AB 30MG A200812 002 Nov 10, 2011

AB 50MG A200812 003 Nov 10, 2011

AB 60MG A200812 004 Nov 10, 2011

AB 80MG A200812 005 Nov 10, 2011

AB 100MG A200812 006 Nov 10, 2011

AB TEVA PHARMS USA 20MG A202718 001 Dec 29, 2014

AB 30MG A202718 002 Dec 29, 2014

AB 40MG A202718 007 Jun 03, 2015

AB 50MG A202718 003 Dec 29, 2014

AB 60MG A202718 004 Dec 29, 2014

AB 70MG A202718 008 Jun 03, 2015

AB 80MG A202718 005 Dec 29, 2014

AB 100MG A202718 006 Dec 29, 2014

AB UPSHER SMITH LABS 10MG A202104 001 Jun 03, 2013

AB 20MG A202104 002 Jun 03, 2013

AB 30MG A202104 003 Jun 03, 2013

AB 50MG A202104 004 Jun 03, 2013

AB 60MG A202104 005 Jun 03, 2013

AB 80MG A202104 006 Jun 03, 2013

AB 100MG A202104 007 Jun 03, 2013



KADIAN
+ ALLERGAN SALES LLC 130MG N020616 011 Jul 09, 2012

+ 150MG N020616 012 Jul 09, 2012

+! 200MG N020616 007 Feb 27, 2007

MORPHINE SULFATE
ACTAVIS ELIZABETH 30MG A079040 001 Jan 16, 2013

45MG A079040 002 Jan 16, 2013

60MG A079040 003 Jan 16, 2013

75MG A079040 004 Jan 16, 2013

90MG A079040 005 Jan 16, 2013

! 120MG A079040 006 Jan 16, 2013

INJECTABLE;INJECTION
ASTRAMORPH PF
AP FRESENIUS KABI USA 0.5MG/ML A071050 001 Oct 07, 1986

AP 0.5MG/ML A071051 001 Oct 07, 1986

AP 1MG/ML A071052 001 Oct 07, 1986

AP 1MG/ML A071053 001 Oct 07, 1986



DURAMORPH PF
AP +! WEST-WARD PHARMS 0.5MG/ML N018565 001 Sep 18, 1984

INT
AP +! 1MG/ML N018565 002 Sep 18, 1984

INFUMORPH
AP +! WEST-WARD PHARMS 10MG/ML N018565 003 Jul 19, 1991

INT
AP +! 25MG/ML N018565 004 Jul 19, 1991

MITIGO
AP PIRAMAL CRITICAL 10MG/ML A204393 001 Jul 16, 2018

AP 25MG/ML A204393 002 Jul 16, 2018



MORPHINE SULFATE
AP EUROHLTH INTL SARL 4MG/ML A205758 001 May 21, 2015

AP 8MG/ML A205758 002 May 21, 2015

AP 10MG/ML A205758 003 May 21, 2015

AP HOSPIRA 0.5MG/ML A071849 001 May 11, 1988



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-309(of 452)

MORPHINE SULFATE

INJECTABLE;INJECTION

MORPHINE SULFATE

AP 0.5MG/ML A073509 001 Sep 30, 1992

AP 1MG/ML A071850 001 May 11, 1988

AP 1MG/ML A073510 001 Sep 30, 1992

AP +! HOSPIRA INC 4MG/ML N202515 002 Nov 14, 2011

AP +! 8MG/ML N202515 003 Nov 14, 2011

AP +! 10MG/ML N202515 004 Nov 14, 2011

AP +! ICU MEDICAL INC 1MG/ML N019916 001 Oct 30, 1992



+! HOSPIRA INC 2MG/ML N202515 001 Nov 14, 2011

+! ICU MEDICAL INC 5MG/ML N019916 002 Oct 27, 2006

+! MERIDIAN MEDCL 15MG/ML N019999 001 Jul 12, 1990

TECHN

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

MORPHINE SULFATE

+! FRESENIUS KABI USA 2MG/ML (2MG/ML) N204223 001 Oct 30, 2013

+! 4MG/ML (4MG/ML) N204223 002 Oct 30, 2013

+! 5MG/ML (5MG/ML) N204223 003 Oct 30, 2013

+! 8MG/ML (8MG/ML) N204223 004 Oct 30, 2013

+! 10MG/ML (10MG/ML) N204223 005 Oct 30, 2013

SOLUTION;ORAL

MORPHINE SULFATE

AA ANI PHARMS INC 10MG/5ML A205509 001 Apr 17, 2018

AA 20MG/5ML A205509 002 Apr 17, 2018

AA 100MG/5ML A205509 003 Apr 17, 2018

AA HI-TECH PHARMACAL 100MG/5ML A208809 001 Jul 06, 2017

AA LANNETT CO INC 10MG/5ML A202309 001 Nov 25, 2015

AA 20MG/5ML A202310 001 Oct 30, 2015

AA NOSTRUM LABS INC 10MG/5ML A201011 001 Feb 05, 2014

AA 20MG/5ML A201011 002 Feb 05, 2014

AA 100MG/5ML A201011 003 Oct 06, 2016

AA PADDOCK LLC 100MG/5ML A201574 001 Aug 06, 2012

AA PHARM ASSOC 100MG/5ML A206573 001 Nov 14, 2016

AA RHODES PHARMS 10MG/5ML A206308 001 Jun 22, 2017

AA 20MG/5ML A206420 001 Jul 12, 2016

AA 100MG/5ML A206308 002 Jun 22, 2017

AA SPECGX LLC 100MG/5ML A202348 001 Jul 15, 2011

AA TRIS PHARMA INC 10MG/5ML A203518 001 May 12, 2015

AA 20MG/5ML A203519 001 May 18, 2016

AA 100MG/5ML A203518 002 May 12, 2015

AA VISTAPHARM 10MG/5ML A201947 001 Jan 05, 2012

AA 20MG/5ML A201947 002 Jan 05, 2012

AA + WEST-WARD PHARMS 10MG/5ML N022195 001 Mar 17, 2008

INT

AA + 20MG/5ML N022195 002 Mar 17, 2008

AA +! 100MG/5ML N022195 003 Jan 25, 2010



LANNETT CO INC 100MG/5ML N201517 001 Jun 23, 2011

TABLET;ORAL

MORPHINE SULFATE

+ WEST-WARD PHARMS 15MG N022207 001 Mar 17, 2008

INT

+! 30MG N022207 002 Mar 17, 2008

TABLET, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

AB ACTAVIS ELIZABETH 15MG A203849 001 Apr 06, 2015

AB 30MG A203849 002 Apr 06, 2015

AB 60MG A203849 003 Apr 06, 2015

AB 100MG A203849 004 Apr 06, 2015

AB 200MG A203849 005 Apr 06, 2015

AB DAVA PHARMS INC 15MG A075407 001 Jan 28, 2000

AB MAYNE PHARMA INC 15MG A205386 001 Oct 28, 2016

AB 30MG A205386 002 Oct 28, 2016

AB 60MG A205386 003 Oct 28, 2016

AB 100MG A205386 004 Oct 28, 2016

AB MYLAN PHARMS INC 15MG A200824 001 Oct 18, 2011

AB 30MG A200824 002 Oct 18, 2011

AB 60MG A200824 003 Oct 18, 2011

AB 100MG A200824 004 Oct 18, 2011

AB 200MG A200824 005 Oct 18, 2011

AB NESHER PHARMS 15MG A076733 001 May 19, 2004

AB 30MG A076720 002 Dec 23, 2005

AB 60MG A076720 001 May 19, 2004



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-310(of 452)

MORPHINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

AB 100MG A077855 001 Sep 27, 2007

AB 200MG A077855 002 Sep 27, 2007

AB NOVEL LABS INC 15MG A203602 001 Dec 16, 2015

AB 30MG A203602 002 Dec 16, 2015

AB 60MG A203602 003 Dec 16, 2015

AB 100MG A203602 004 Dec 16, 2015

AB 200MG A203602 005 Dec 16, 2015

AB RHODES PHARMS 15MG A074862 001 Jul 07, 1998

AB 30MG A074862 002 Jul 07, 1998

AB 60MG A074862 003 Jul 07, 1998

AB 100MG A074769 001 Jul 02, 1998

AB 200MG A074769 002 Jul 02, 1998

AB SPECGX LLC 15MG A076412 001 Jul 31, 2003

AB 30MG A076412 002 Jul 31, 2003

AB 60MG A076412 003 Jul 31, 2003

AB 100MG A076438 001 Jul 03, 2003

AB 200MG A076438 002 Jul 03, 2003

AB SUN PHARM INDS LTD 15MG A078761 001 May 11, 2012

AB 30MG A078761 002 May 11, 2012

AB 60MG A078761 003 May 11, 2012

AB 100MG A078761 004 May 11, 2012

AB 200MG A078761 005 May 11, 2012

AB SUN PHARM 15MG A205634 001 Aug 25, 2016

INDUSTRIES

AB 30MG A205634 002 Aug 25, 2016

AB 60MG A205634 003 Aug 25, 2016

AB 100MG A205634 004 Aug 25, 2016

AB 200MG A205634 005 Aug 25, 2016

AB VINTAGE PHARMS LLC 15MG A075295 001 Oct 28, 1998

AB 30MG A075295 002 Oct 28, 1998

AB 60MG A075295 003 Oct 28, 1998

AB 100MG A075295 004 Sep 15, 2000

AB 200MG A075295 005 Sep 15, 2000

MS CONTIN

AB + PURDUE PHARMA LP 15MG N019516 003 Sep 12, 1989

AB + 30MG N019516 001 May 29, 1987

AB + 60MG N019516 002 Apr 08, 1988

AB +! 100MG N019516 004 Jan 16, 1990

AB + 200MG N019516 005 Nov 08, 1993



MORPHABOND ER

+ DAIICHI SANKYO INC 15MG N206544 001 Oct 02, 2015

+ 30MG N206544 002 Oct 02, 2015

+ 60MG N206544 003 Oct 02, 2015

+! 100MG N206544 004 Oct 02, 2015

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EMBEDA

+ ALPHARMA PHARMS 20MG;0.8MG N022321 001 Aug 13, 2009

+ 30MG;1.2MG N022321 002 Aug 13, 2009

+ 50MG;2MG N022321 003 Aug 13, 2009

+! 60MG;2.4MG N022321 004 Aug 13, 2009

+ 80MG;3.2MG N022321 005 Aug 13, 2009

+ 100MG;4MG N022321 006 Aug 13, 2009



MOXIDECTIN

TABLET;ORAL

MOXIDECTIN

+! MDGH 2MG N210867 001 Jun 13, 2018

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION;INTRAVENOUS

MOXIFLOXACIN HYDROCHLORIDE

+! FRESENIUS KABI USA EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML) N205572 001 Apr 03, 2015

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER



! MYLAN LABS LTD 400MG/250ML (1.6MG/ML) A205833 001 May 05, 2017

SOLUTION/DROPS;OPHTHALMIC

MOXIFLOXACIN HYDROCHLORIDE

AT1 AKORN EQ 0.5% BASE A202916 001 Nov 09, 2017

AT1 APOTEX INC EQ 0.5% BASE A090080 001 Jun 30, 2017

AT1 AUROBINDO PHARMA EQ 0.5% BASE A206242 001 Oct 04, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-311(of 452)

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

MOXIFLOXACIN HYDROCHLORIDE

LTD

AT1 LUPIN LTD EQ 0.5% BASE A202867 001 Sep 04, 2014

AT1 WATSON LABS INC EQ 0.5% BASE A202525 001 Mar 06, 2015

VIGAMOX

AT1 +! NOVARTIS PHARMS EQ 0.5% BASE N021598 001 Apr 15, 2003

CORP

MOXEZA

AT2 +! NOVARTIS PHARMS EQ 0.5% BASE N022428 001 Nov 19, 2010

CORP

MOXIFLOXACIN HYDROCHLORIDE

AT2 LUPIN LTD EQ 0.5% BASE A204079 001 May 28, 2015

TABLET;ORAL

AVELOX

AB +! BAYER HLTHCARE EQ 400MG BASE N021085 001 Dec 10, 1999

MOXIFLOXACIN HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 400MG BASE A202632 001 Mar 04, 2014

LTD

AB CROSSMEDIKA SA EQ 400MG BASE A205348 001 Jan 14, 2016

AB DR REDDYS LABS LTD EQ 400MG BASE A076938 001 Mar 04, 2014

AB MSN LABS PVT LTD EQ 400MG BASE A208682 001 Sep 22, 2017

AB MYLAN PHARMS INC EQ 400MG BASE A204635 001 Aug 31, 2015

AB NOVEL LABS INC EQ 400MG BASE A207285 001 Feb 13, 2017

AB SUNSHINE LAKE EQ 400MG BASE A206295 001 Sep 28, 2018

AB TEVA PHARMS USA EQ 400MG BASE A077437 001 Feb 18, 2014

AB TORRENT PHARMS LTD EQ 400MG BASE A200160 001 Apr 03, 2014

MUPIROCIN

OINTMENT;TOPICAL

MUPIROCIN

AB FOUGERA PHARMS 2% A065192 001 Nov 30, 2005

AB GLENMARK PHARMS 2% A090480 001 Jun 08, 2011

AB ! PERRIGO NEW YORK 2% A065123 001 Nov 07, 2003

AB TARO 2% A065170 001 Sep 23, 2005

AB TEVA 2% A065085 001 Nov 07, 2003



CENTANY

BX PERRIGO NEW YORK 2% N050788 001 Dec 04, 2002

MUPIROCIN CALCIUM

CREAM;TOPICAL

MUPIROCIN

! GLENMARK PHARMS INC EQ 2% BASE A201587 001 Jan 24, 2013

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL

CELLCEPT

AB +! ROCHE PALO 250MG N050722 001 May 03, 1995

MYCOPHENOLATE MOFETIL

AB ACCORD HLTHCARE 250MG A090253 001 May 04, 2009

AB ALKEM LABS LTD 250MG A200197 001 Jun 13, 2013

AB CONCORD BIOTECH LTD 250MG A210181 001 Jan 08, 2019

AB MYLAN 250MG A065520 001 May 04, 2009

AB SANDOZ 250MG A065379 001 Oct 15, 2008

AB STRIDES PHARMA 250MG A090055 001 Jun 10, 2010

AB TEVA PHARMS 250MG A065491 001 May 06, 2009

AB VINTAGE PHARMS LLC 250MG A090111 001 Dec 22, 2009

AB WEST-WARD PHARMS 250MG A065410 001 Jul 29, 2008

INT

AB ZHEJIANG HISUN 250MG A204077 001 Nov 13, 2017

PHARM

SUSPENSION;ORAL
CELLCEPT
AB +! ROCHE PALO 200MG/ML N050759 001 Oct 01, 1998
MYCOPHENOLATE MOFETIL
AB ALKEM LABS LTD 200MG/ML A203005 001 Nov 14, 2014
TABLET;ORAL
CELLCEPT
AB +! ROCHE PALO 500MG N050723 001 Jun 19, 1997
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE 500MG A065416 001 May 04, 2009
AB ALKEM LABS LTD 500MG A091249 001 Nov 04, 2011
AB MYLAN 500MG A065521 001 May 04, 2009
AB OXFORD PHARMS 500MG A090606 001 Jul 16, 2010
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-312(of 452)

MYCOPHENOLATE MOFETIL

TABLET;ORAL

MYCOPHENOLATE MOFETIL

AB SANDOZ 500MG A065451 001 Oct 15, 2008

AB STRIDES PHARMA 500MG A090456 001 Jun 10, 2010

AB TEVA PHARMS 500MG A065457 001 May 04, 2009

AB WEST-WARD PHARMS 500MG A065413 001 Jul 29, 2008

INT

AB ZHEJIANG HISUN 500MG A204076 001 Nov 16, 2017

PHARM

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE;INJECTION

CELLCEPT

AP +! ROCHE PALO 500MG/VIAL N050758 001 Aug 12, 1998

MYCOPHENOLATE MOFETIL HYDROCHLORIDE



AP AKORN INC 500MG/VIAL A204043 001 Feb 28, 2017

AP MYLAN LABS LTD 500MG/VIAL A203859 001 Mar 31, 2017

AP PAR STERILE 500MG/VIAL A203575 001 Oct 28, 2016

PRODUCTS

AP ZYDUS PHARMS USA 500MG/VIAL A204473 001 Aug 31, 2017

INC

MYCOPHENOLIC ACID

TABLET, DELAYED RELEASE;ORAL

MYCOPHENOLIC ACID

AB ACCORD HLTHCARE 180MG A202555 001 Aug 23, 2017

AB 360MG A202555 002 Aug 23, 2017

AB APOTEX INC 180MG A091558 001 Aug 21, 2012

AB 360MG A091558 002 Aug 19, 2014

AB MYLAN PHARMS INC 180MG A091248 002 Jan 08, 2014

AB 360MG A091248 001 Jan 08, 2014

AB TEVA PHARMS USA 180MG A202720 001 Oct 30, 2014

AB 360MG A202720 002 Oct 30, 2014

MYFORTIC

AB + NOVARTIS 180MG N050791 001 Feb 27, 2004

AB +! 360MG N050791 002 Feb 27, 2004



NABILONE

CAPSULE;ORAL

CESAMET

+! MYLAN SPECIALITY LP 1MG N018677 001 Dec 26, 1985

NABUMETONE

TABLET;ORAL

NABUMETONE

AB APOTEX INC 500MG A090427 001 Dec 30, 2011

AB 750MG A090427 002 Dec 30, 2011

AB CASI PHARMS INC 500MG A075280 001 Feb 25, 2002

AB 750MG A075280 002 Feb 25, 2002

AB CHARTWELL MOLECULES 500MG A076009 001 Jan 24, 2003

AB 750MG A076009 002 Jan 24, 2003

AB IMPAX LABS INC 500MG A075189 001 May 26, 2000

AB ! 750MG A075189 002 Sep 24, 2001

AB INVAGEN PHARMS 500MG A078671 001 Mar 07, 2008

AB 750MG A078671 002 Mar 07, 2008

AB LUPIN LTD 500MG A090445 001 Jan 12, 2011

AB 750MG A090445 002 Jan 12, 2011

AB MYLAN PHARMS INC 500MG A090516 001 Jul 12, 2010

AB 750MG A090516 002 Jul 12, 2010

AB WATSON LABS 500MG A091083 001 Jun 13, 2011

AB 750MG A091083 002 Jun 13, 2011



NADOLOL

TABLET;ORAL

CORGARD

AB + US WORLDMEDS LLC 20MG N018063 005 Oct 28, 1986

AB + 40MG N018063 001



AB +! 80MG N018063 002

NADOLOL

AB AMNEAL PHARMS CO 20MG A208832 001 Jun 02, 2017

AB 40MG A208832 002 Jun 02, 2017

AB 80MG A208832 003 Jun 02, 2017

AB AUROBINDO PHARMA 40MG A201893 001 Sep 16, 2015

LTD

AB 80MG A201893 002 Sep 16, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-313(of 452)

NADOLOL

TABLET;ORAL

NADOLOL

AB BEXIMCO PHARMS USA 20MG A210955 001 Jul 23, 2018

AB 40MG A210955 002 Jul 23, 2018

AB 80MG A210955 003 Jul 23, 2018

AB INVAGEN PHARMS 20MG A203455 001 Dec 18, 2015

AB 40MG A203455 002 Dec 18, 2015

AB 80MG A203455 003 Dec 18, 2015

AB IVAX SUB TEVA 20MG A074229 001 Aug 30, 1996

PHARMS

AB 40MG A074229 002 Aug 30, 1996

AB 80MG A074255 001 Jan 24, 1996

AB LUPIN LTD 20MG A209309 001 Oct 05, 2017

AB 40MG A209309 002 Oct 05, 2017

AB 80MG A209309 003 Oct 05, 2017

AB MYLAN 20MG A074172 001 Oct 31, 1993

AB 40MG A074172 002 Oct 31, 1993

AB 80MG A074172 003 Oct 31, 1993

AB NOVAST LABS 20MG A210786 001 Jun 01, 2018

AB 40MG A210786 002 Jun 01, 2018

AB 80MG A210786 003 Jun 01, 2018

AB SANDOZ 20MG A074501 001 Nov 09, 1995

AB 40MG A074501 002 Nov 09, 1995

AB 80MG A074501 003 Nov 09, 1995

AB ZYDUS PHARMS USA 20MG A207761 001 Jul 28, 2017

INC

AB 40MG A207761 002 Jul 28, 2017

AB 80MG A207761 003 Jul 28, 2017



NAFARELIN ACETATE

SPRAY, METERED;NASAL

SYNAREL

+! GD SEARLE LLC EQ 0.2MG BASE/SPRAY N019886 001 Feb 13, 1990

NAFCILLIN SODIUM

INJECTABLE;INJECTION

NAFCILLIN SODIUM

AP ANTIBIOTICE EQ 1GM BASE/VIAL A090560 001 Oct 03, 2011

AP EQ 2GM BASE/VIAL A090560 002 Oct 03, 2011

AP AUROBINDO PHARMA EQ 1GM BASE/VIAL A091613 001 Dec 26, 2012

LTD

AP EQ 2GM BASE/VIAL A091613 002 Dec 26, 2012

AP EQ 10GM BASE/VIAL A091614 001 Dec 26, 2012

AP ISTITUTO BIO ITA EQ 1GM BASE/VIAL A090002 001 Jun 30, 2011

SPA

AP EQ 2GM BASE/VIAL A090002 002 Jun 30, 2011

AP EQ 10GM BASE/VIAL A090005 001 Apr 20, 2011

AP MYLAN LABS LTD EQ 1GM BASE/VIAL A200002 001 Apr 07, 2014

AP EQ 2GM BASE/VIAL A200002 002 Apr 07, 2014

AP SAGENT PHARMS EQ 1GM BASE/VIAL A090582 001 Aug 24, 2012

AP EQ 2GM BASE/VIAL A090582 002 Aug 24, 2012

AP EQ 10GM BASE/VIAL A090580 001 Aug 24, 2012

AP ! SANDOZ EQ 1GM BASE/VIAL A062527 002 Aug 02, 1984

AP ! EQ 1GM BASE/VIAL A062732 001 Dec 23, 1986

AP ! EQ 2GM BASE/VIAL A062527 003 Aug 02, 1984

AP ! EQ 2GM BASE/VIAL A062732 002 Dec 23, 1986

AP ! EQ 10GM BASE/VIAL A062527 004 Aug 02, 1984

NALLPEN IN PLASTIC CONTAINER



+! BAXTER HLTHCARE EQ 20MG BASE/ML N050655 001 Oct 31, 1989

+! EQ 2GM BASE/100ML N050655 002 Oct 31, 1989

NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL

NAFTIFINE HYDROCHLORIDE

AB TARO PHARMS 2% A206901 001 Jan 06, 2016

AB TOLMAR 2% A206960 001 Apr 10, 2017

NAFTIN

AB +! SEBELA IRELAND LTD 2% N019599 002 Jan 13, 2012

NAFTIFINE HYDROCHLORIDE

! TARO PHARMS 1% A205975 001 Sep 08, 2016

GEL;TOPICAL

NAFTIN

+! SEBELA IRELAND LTD 1% N019356 001 Jun 18, 1990

+! 2% N204286 001 Jun 27, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-314(of 452)

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION

NALBUPHINE HYDROCHLORIDE

AP ! HOSPIRA 10MG/ML
A070914 001 Feb 03, 1989

AP ! 10MG/ML
A070915 001 Feb 03, 1989

AP ! 20MG/ML
A070916 001 Feb 03, 1989

AP ! 20MG/ML
A070918 001 Feb 03, 1989

AP MYLAN LABS LTD 10MG/ML


A207595 001 Jan 11, 2019

AP 20MG/ML
A207595 002 Jan 11, 2019

NALDEMEDINE TOSYLATE

TABLET;ORAL

SYMPROIC

+! SHIONOGI INC
EQ 0.2MG BASE
N208854 001 Mar 23, 2017

NALOXEGOL OXALATE

TABLET;ORAL

MOVANTIK

+ ASTRAZENECA PHARMS
EQ 12.5MG BASE
N204760 001 Sep 16, 2014

+!
EQ 25MG BASE
N204760 002 Sep 16, 2014

NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION

NALOXONE

AP WEST-WARD PHARMS
0.4MG/ML
A070299 001 Sep 24, 1986

INT

NALOXONE HYDROCHLORIDE

AP AKORN
0.4MG/ML
A208871 001 Feb 28, 2017

AP
0.4MG/ML
A208872 001 Mar 14, 2017

AP ! HOSPIRA
0.4MG/ML
A070172 001 Sep 24, 1986

AP !
0.4MG/ML
A070254 001 Jan 07, 1987

AP !
0.4MG/ML
A070256 001 Jan 07, 1987

AP !
0.4MG/ML
A070257 001 Jan 07, 1987

AP INTL MEDICATION
0.4MG/ML
A070639 001 Sep 24, 1986

AP MYLAN INSTITUTIONAL
0.4MG/ML
A204997 001 Mar 06, 2014

AP
0.4MG/ML
A205014 001 Jun 29, 2016

AP RENAISSANCE SSA LLC


0.4MG/ML
A207846 001 Dec 17, 2018

AP SOMERSET THERAPS
0.4MG/ML
A207633 001 Aug 08, 2017

LLC

AP
0.4MG/ML
A207634 001 Jul 26, 2017

! INTL MEDICATION
1MG/ML
A072076 001 Mar 24, 1988

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

EVZIO

+! KALEO INC 2MG/0.4ML (2MG/0.4ML)
N209862 001 Oct 19, 2016

SPRAY, METERED;NASAL

NARCAN

+! ADAPT 4MG/SPRAY
N208411 001 Nov 18, 2015

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE



AB GAVIS PHARMS EQ 0.5MG BASE;EQ 50MG BASE
A075735 001 Jul 11, 2001

AB SUN PHARM INDS LTD EQ 0.5MG BASE;EQ 50MG BASE


A075523 001 Mar 17, 2000

AB ! WATSON LABS EQ 0.5MG BASE;EQ 50MG BASE


A074736 001 Jan 21, 1997

NALTREXONE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

VIVITROL
+! ALKERMES 380MG/VIAL N021897 001 Apr 13, 2006

NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
AB ACCORD HLTHCARE 50MG A091205 001 Aug 17, 2011

AB APOTEX INC 50MG A207905 001 Jul 21, 2017

AB BARR 50MG A074918 001 May 08, 1998

AB ELITE LABS 50MG A075274 001 May 26, 1999

AB ! SPECGX LLC 50MG A076264 002 Mar 22, 2002

AB SUN PHARMA GLOBAL 50MG A090356 001 Feb 24, 2012



SPECGX LLC 25MG A076264 001 Mar 22, 2002

100MG A076264 003 Mar 22, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-315(of 452)

NANDROLONE DECANOATE

INJECTABLE;INJECTION

NANDROLONE DECANOATE

! LUITPOLD 200MG/ML A091252 001 Aug 30, 2010

NAPROXEN

SUSPENSION;ORAL

NAPROSYN

AB +! ATNAHS PHARMA US 25MG/ML N018965 001 Mar 23, 1987

NAPROXEN

AB WEST-WARD PHARMS 25MG/ML A074190 001 Mar 30, 1994

INT

TABLET;ORAL

NAPROSYN

AB +! ATNAHS PHARMA US 500MG N017581 004 Apr 15, 1982

NAPROXEN

AB AMNEAL PHARMS NY 250MG A075927 001 Dec 18, 2001

AB 375MG A075927 002 Dec 18, 2001

AB 500MG A075927 003 Dec 18, 2001

AB AUROBINDO PHARMA 250MG A200429 001 Nov 08, 2011

LTD

AB 375MG A200429 002 Nov 08, 2011

AB 500MG A200429 003 Nov 08, 2011

AB GLENMARK GENERICS 250MG A078250 001 Mar 28, 2007

AB 375MG A078250 002 Mar 28, 2007

AB 500MG A078250 003 Mar 28, 2007

AB INVAGEN PHARMS 250MG A091305 001 Aug 24, 2011

AB 375MG A091305 002 Aug 24, 2011

AB 500MG A091305 003 Aug 24, 2011

AB MARKSANS PHARMA 250MG A091416 001 Feb 14, 2011

AB 375MG A091416 002 Feb 14, 2011

AB 500MG A091416 003 Feb 14, 2011

AB MYLAN 250MG A074121 001 Dec 21, 1993

AB 375MG A074121 002 Dec 21, 1993

AB 500MG A074121 003 Dec 21, 1993

AB PERRIGO R AND D 250MG A077339 001 Apr 27, 2005

AB 375MG A077339 002 Apr 27, 2005

AB 500MG A077339 003 Apr 27, 2005

AB TEVA 250MG A074201 001 Dec 21, 1993

AB 375MG A074201 002 Dec 21, 1993

AB 500MG A074201 003 Dec 21, 1993

AB ZYDUS PHARMS USA 250MG A078620 001 Jun 07, 2007

AB 375MG A078620 002 Jun 07, 2007

AB 500MG A078620 003 Jun 07, 2007



TABLET, DELAYED RELEASE;ORAL

EC-NAPROSYN

AB +! ATNAHS PHARMA US 375MG N020067 002 Oct 14, 1994

AB +! 500MG N020067 003 Oct 14, 1994

NAPROXEN

AB INVAGEN PHARMS 375MG A091432 001 Sep 19, 2011

AB 500MG A091432 002 Sep 19, 2011

AB PLIVA 375MG A075337 001 May 26, 1999

AB 500MG A075337 002 May 26, 1999

AB TEVA 375MG A075227 001 Jun 30, 1998

AB 500MG A075227 002 Jun 30, 1998



NAPROXEN SODIUM

TABLET;ORAL

ANAPROX DS

AB +! ATNAHS PHARMA US EQ 500MG BASE N018164 003 Sep 30, 1987

NAPROXEN SODIUM

AB AMNEAL PHARMS NY EQ 250MG BASE A078432 001 Apr 25, 2007

AB EQ 500MG BASE A078432 002 Apr 25, 2007

AB AUROBINDO PHARMA EQ 250MG BASE A200629 001 Oct 31, 2011

LTD

AB EQ 500MG BASE A200629 002 Oct 31, 2011

AB DR REDDYS LABS LTD EQ 250MG BASE A078486 001 Jul 26, 2007

AB EQ 500MG BASE A078486 002 Jul 26, 2007

AB GLENMARK PHARMS LTD EQ 250MG BASE A078314 001 Apr 27, 2007

AB EQ 500MG BASE A078314 002 Apr 27, 2007

AB TEVA EQ 250MG BASE A074198 001 Dec 21, 1993

AB EQ 500MG BASE A074198 002 Dec 21, 1993



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-316(of 452)

NAPROXEN SODIUM

TABLET, EXTENDED RELEASE;ORAL

NAPRELAN

AB + ALVOGEN MALTA EQ 375MG BASE N020353 001 Jan 05, 1996

AB + EQ 500MG BASE N020353 002 Jan 05, 1996

AB +! EQ 750MG BASE N020353 003 Jan 05, 1996

NAPROXEN SODIUM

AB ACTAVIS LABS FL INC EQ 375MG BASE A075416 002 Apr 23, 2003

AB EQ 500MG BASE A075416 001 Aug 27, 2002

AB EQ 750MG BASE A075416 003 Aug 11, 2016



NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET;ORAL

SUMATRIPTAN AND NAPROXEN SODIUM



AB AUROBINDO PHARMA 500MG;EQ 85MG BASE A207457 001 Feb 15, 2018

LTD

AB MYLAN PHARMS INC 500MG;EQ 85MG BASE A090872 001 Sep 04, 2018

AB SUN PHARMA GLOBAL 500MG;EQ 85MG BASE A202803 001 Jul 20, 2018

TREXIMET

AB +! PERNIX IRELAND LTD 500MG;EQ 85MG BASE N021926 001 Apr 15, 2008

NARATRIPTAN HYDROCHLORIDE

TABLET;ORAL

AMERGE

AB + GLAXOSMITHKLINE LLC EQ 1MG BASE N020763 002 Feb 10, 1998

AB +! EQ 2.5MG BASE N020763 001 Feb 10, 1998

NARATRIPTAN

AB CASI PHARMS INC EQ 1MG BASE A090288 001 Jul 07, 2010

AB EQ 2.5MG BASE A090288 002 Jul 07, 2010

AB HERITAGE PHARMS INC EQ 1MG BASE A200502 001 Feb 28, 2011

AB EQ 2.5MG BASE A200502 002 Feb 28, 2011

AB MYLAN PHARMS INC EQ 1MG BASE A202431 001 May 31, 2012

AB EQ 2.5MG BASE A202431 002 May 31, 2012

AB ORCHID HLTHCARE EQ 1MG BASE A091441 001 Apr 30, 2012

AB EQ 2.5MG BASE A091441 002 Apr 30, 2012

AB PADDOCK LLC EQ 1MG BASE A091326 001 Jul 08, 2010

AB EQ 2.5MG BASE A091326 002 Jul 08, 2010

AB SUN PHARM INDS LTD EQ 2.5MG BASE A091552 001 Feb 14, 2011

AB TEVA PHARMS EQ 1MG BASE A078751 001 Jul 07, 2010

AB EQ 2.5MG BASE A078751 002 Jul 07, 2010

AB WEST-WARD PHARMS EQ 1MG BASE A090381 001 Jul 07, 2010

INT

AB EQ 2.5MG BASE A090381 002 Jul 07, 2010

NATAMYCIN

SUSPENSION;OPHTHALMIC

NATACYN

+! NOVARTIS PHARMS 5% N050514 001

CORP

NATEGLINIDE

TABLET;ORAL

NATEGLINIDE

AB ALVOGEN MALTA 60MG A205055 001 Dec 11, 2015

AB 120MG A205055 002 Dec 11, 2015

AB DR REDDYS LABS LTD 60MG A077461 001 Sep 09, 2009

AB 120MG A077461 002 Sep 09, 2009

AB PAR PHARM 60MG A077463 001 Sep 09, 2009

AB 120MG A077463 002 Sep 09, 2009

AB WATSON LABS 60MG A077462 001 Mar 30, 2011

AB 120MG A077462 002 Mar 30, 2011

AB WILSHIRE PHARMS INC 60MG A205544 001 Jun 18, 2018

AB 120MG A205544 002 Jun 18, 2018

AB ZYDUS PHARMS USA 60MG A205248 001 Jul 06, 2016

INC

AB 120MG A205248 002 Jul 06, 2016

STARLIX

AB + NOVARTIS 60MG N021204 001 Dec 22, 2000

AB +! 120MG N021204 002 Dec 22, 2000



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-317(of 452)

NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

BYSTOLIC

AB + ALLERGAN SALES LLC EQ 2.5MG BASE N021742 002 Dec 17, 2007

AB + EQ 5MG BASE N021742 003 Dec 17, 2007

AB + EQ 10MG BASE N021742 004 Dec 17, 2007

AB +! EQ 20MG BASE N021742 005 Oct 08, 2008



NEBIVOLOL HYDROCHLORIDE; VALSARTAN

TABLET;ORAL

BYVALSON

+! ALLERGAN SALES LLC EQ 5MG BASE;80MG N206302 001 Jun 03, 2016

NEDOCROMIL SODIUM

SOLUTION/DROPS;OPHTHALMIC

ALOCRIL

AT +! ALLERGAN 2% N021009 001 Dec 08, 1999

NEDOCROMIL SODIUM

AT AKORN 2% A090638 001 Aug 22, 2012

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

TEVA 50MG A076037 001 Sep 16, 2003

100MG A076037 002 Sep 16, 2003

150MG A076037 003 Sep 16, 2003

200MG A076037 004 Sep 16, 2003

! 250MG A076037 005 Sep 16, 2003



NELARABINE

INJECTABLE;INTRAVENOUS

ARRANON

+! NOVARTIS PHARMS 250MG/50ML (5MG/ML) N021877 001 Oct 28, 2005

CORP

NELFINAVIR MESYLATE

TABLET;ORAL

VIRACEPT

+! AGOURON PHARMS EQ 250MG BASE N020779 001 Mar 14, 1997

+! EQ 625MG BASE N021503 001 Apr 30, 2003

NEOMYCIN SULFATE

TABLET;ORAL

NEOMYCIN SULFATE

AA BRECKENRIDGE PHARM 500MG A065468 001 Mar 29, 2010

AA LANNETT CO INC 500MG A204435 001 Jun 10, 2016

AA ! TEVA 500MG A060304 001



AA X GEN PHARMS 500MG A065220 001 Jul 28, 2006

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION;IRRIGATION

NEOMYCIN AND POLYMYXIN B SULFATE



AT WATSON LABS EQ 40MG BASE/ML;200,000 UNITS/ML A062664 001 Apr 08, 1986

AT X GEN PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A065106 001 Jan 31, 2006

AT EQ 40MG BASE/ML;200,000 UNITS/ML A065108 001 Jan 31, 2006

NEOSPORIN G.U. IRRIGANT



AT ! MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A060707 001

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS

BLOXIVERZ

AP +! AVADEL LEGACY 5MG/10ML (0.5MG/ML) N204078 001 May 31, 2013

AP +! 10MG/10ML (1MG/ML) N204078 002 May 31, 2013

NEOSTIGMINE METHYLSULFATE

AP AMNEAL PHARMS CO 5MG/10ML (0.5MG/ML) A210051 001 Jun 15, 2018

AP 10MG/10ML (1MG/ML) A210051 002 Jun 15, 2018

AP AMPHASTAR PHARMS 5MG/10ML (0.5MG/ML) A209933 001 Sep 25, 2017

INC

AP 10MG/10ML (1MG/ML) A209933 002 Sep 25, 2017

AP DR REDDYS LABS LTD 5MG/10ML (0.5MG/ML) A209135 001 Jul 10, 2018

AP 10MG/10ML (1MG/ML) A209135 002 Jul 10, 2018

AP EUROHLTH INTL SARL 5MG/10ML (0.5MG/ML) A207042 001 Dec 28, 2015

AP 10MG/10ML (1MG/ML) A207042 002 Dec 28, 2015

AP LUITPOLD 5MG/10ML (0.5MG/ML) A209182 001 May 04, 2018

AP 10MG/10ML (1MG/ML) A209182 002 May 04, 2018

AP PAR STERILE 5MG/10ML (0.5MG/ML) A208405 001 Apr 26, 2017

PRODUCTS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-318(of 452)

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS

NEOSTIGMINE METHYLSULFATE

AP 10MG/10ML (1MG/ML) A208405 002 Apr 26, 2017

AP RENAISSANCE SSA LLC 5MG/10ML (0.5MG/ML) A210989 001 Aug 22, 2018

AP 10MG/10ML (1MG/ML) A210989 002 Aug 22, 2018

FRESENIUS KABI USA 3MG/3ML (1MG/ML) N203629 003 Sep 18, 2018

5MG/10ML (0.5MG/ML) N203629 001 Jan 08, 2015



10MG/10ML (1MG/ML) N203629 002 Jan 08, 2015

NEPAFENAC

SUSPENSION/DROPS;OPHTHALMIC

ILEVRO

+! NOVARTIS PHARMS 0.3% N203491 001 Oct 16, 2012

CORP

NEVANAC

+! NOVARTIS PHARMS 0.1% N021862 001 Aug 19, 2005

CORP

NERATINIB MALEATE

TABLET;ORAL

NERLYNX

+! PUMA BIOTECH EQ 40MG BASE N208051 001 Jul 17, 2017

NESIRITIDE RECOMBINANT

FOR SOLUTION;INTRAVENOUS

NATRECOR

+! SCIOS LLC 1.5MG/VIAL N020920 001 Aug 10, 2001

NETARSUDIL DIMESYLATE

SOLUTION/DROPS;OPHTHALMIC

RHOPRESSA

+! AERIE PHARMS INC EQ 0.02% BASE N208254 001 Dec 18, 2017

NETUPITANT; PALONOSETRON HYDROCHLORIDE

CAPSULE;ORAL

AKYNZEO

+! HELSINN HLTHCARE 300MG;EQ 0.5MG BASE N205718 001 Oct 10, 2014

NEVIRAPINE

SUSPENSION;ORAL

NEVIRAPINE

AA AUROBINDO 50MG/5ML A077702 001 May 22, 2012

AA CIPLA 50MG/5ML A207684 001 Aug 03, 2017

VIRAMUNE

AA +! BOEHRINGER 50MG/5ML N020933 001 Sep 11, 1998

INGELHEIM

TABLET;ORAL

NEVIRAPINE

AB AUROBINDO 200MG A077521 001 May 22, 2012

AB CIPLA 200MG A077956 001 May 22, 2012

AB HETERO LABS LTD III 200MG A078584 001 May 22, 2012

AB MACLEODS PHARMS LTD 200MG A090688 001 Jan 14, 2019

AB MICRO LABS LTD 200MG A203080 001 May 22, 2012

AB MYLAN LABS 200MG A078864 001 May 22, 2012

AB MYLAN PHARMS INC 200MG A202523 001 May 22, 2012

AB PRINSTON INC 200MG A078644 001 May 22, 2012

AB STRIDES PHARMA 200MG A078195 001 May 22, 2012

VIRAMUNE

AB +! BOEHRINGER 200MG N020636 001 Jun 21, 1996

INGELHEIM

TABLET, EXTENDED RELEASE;ORAL

NEVIRAPINE

AB ALVOGEN MALTA 100MG A204621 002 Nov 09, 2015

AB 400MG A204621 001 Jul 10, 2015

AB AUROBINDO PHARMA 100MG A208616 001 Nov 23, 2016

LTD

AB 400MG A207698 001 Feb 28, 2017

AB CIPLA 400MG A206448 001 Oct 15, 2015

AB MACLEODS PHARMS LTD 400MG A206879 001 Oct 06, 2017

AB MYLAN PHARMS INC 100MG A206271 001 Nov 09, 2015

AB 400MG A205651 001 Oct 27, 2014

AB SANDOZ INC 400MG A203411 001 Apr 03, 2014

VIRAMUNE XR

AB + BOEHRINGER 100MG N201152 002 Nov 08, 2012

INGELHEIM

AB +! 400MG N201152 001 Mar 25, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-319(of 452)

NIACIN

TABLET;ORAL

NIACIN

AA WOCKHARDT 500MG A081134 001 Apr 28, 1992

NIACOR

AA ! AVONDALE PHARMS 500MG A040378 001 May 03, 2000

TABLET, EXTENDED RELEASE;ORAL

NIACIN

AB AMNEAL PHARMS 500MG A203578 001 Jul 24, 2015

AB 750MG A204178 001 Dec 11, 2015

AB 1GM A203578 002 Jul 24, 2015

AB AUROBINDO PHARMA 500MG A209236 001 Feb 01, 2018

LTD

AB 750MG A209236 002 Feb 01, 2018

AB 1GM A209236 003 Feb 01, 2018

AB BARR 500MG A076378 001 Apr 26, 2005

AB 750MG A076378 002 Apr 26, 2005

AB 1GM A076250 001 Apr 14, 2005

AB JUBILANT GENERICS 500MG A209156 001 May 14, 2018

AB 750MG A209156 002 May 14, 2018

AB 1GM A209156 003 May 14, 2018

AB LANNETT CO INC 500MG A203899 001 Jun 16, 2017

AB 1GM A203899 002 Jun 16, 2017

AB LUPIN LTD 500MG A090860 001 Mar 20, 2014

AB 750MG A090892 001 Mar 20, 2014

AB 1GM A090446 001 Mar 20, 2014

AB SUN PHARMA GLOBAL 500MG A200484 001 Apr 23, 2014

AB 750MG A201273 001 Apr 23, 2014

AB 1GM A200484 002 Apr 23, 2014

NIASPAN

AB + ABBVIE 500MG N020381 002 Jul 28, 1997

AB +! 750MG N020381 003 Jul 28, 1997

AB +! 1GM N020381 004 Jul 28, 1997



NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

NICARDIPINE HYDROCHLORIDE

AB ANI PHARMS INC 20MG A074439 001 Dec 10, 1996

AB 20MG A074540 001 Oct 28, 1996

AB 30MG A074439 002 Dec 10, 1996

AB 30MG A074540 002 Oct 28, 1996

AB EPIC PHARMA 20MG A074928 001 Mar 19, 1998

AB 30MG A074928 002 Mar 19, 1998

AB MYLAN 20MG A074642 001 Jul 18, 1996

AB ! 30MG A074642 002 Jul 18, 1996



INJECTABLE;INJECTION

NICARDIPINE HYDROCHLORIDE

EXELA PHARMA 25MG/10ML (2.5MG/ML) N022276 001 Jul 24, 2008

SCIENCE

INJECTABLE;INTRAVENOUS

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

+! CHIESI USA INC 40MG/200ML (0.2MG/ML) N019734 004 Nov 07, 2008

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

+! CHIESI USA INC 20MG/200ML (0.1MG/ML) N019734 003 Jul 31, 2008

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

+! CHIESI USA INC 20MG/200ML (0.1MG/ML) N019734 002 Jul 31, 2008

NICOTINE

INHALANT;ORAL

NICOTROL

+! PHARMACIA AND 4MG/CARTRIDGE N020714 001 May 02, 1997

UPJOHN

SPRAY, METERED;NASAL

NICOTROL

+! PFIZER INC 0.5MG/SPRAY N020385 001 Mar 22, 1996

NIFEDIPINE

CAPSULE;ORAL

NIFEDIPINE

AB ACTAVIS ELIZABETH 10MG A072579 001 Jan 08, 1991

AB 20MG A072556 001 Sep 20, 1990

AB HERITAGE PHARMA 10MG A202644 001 Apr 25, 2013

AB 20MG A202644 002 Apr 25, 2013

AB INTERGEL PHARM 10MG A072781 001 Jul 30, 1993



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-320(of 452)

NIFEDIPINE

CAPSULE;ORAL

NIFEDIPINE

AB LEADING PHARMA LLC 10MG A073250 001 Oct 08, 1991

AB 20MG A074045 001 Apr 30, 1992

PROCARDIA

AB +! PFIZER 10MG N018482 001

TABLET, EXTENDED RELEASE;ORAL

ADALAT CC

AB1 + ALVOGEN 30MG N020198 001 Apr 21, 1993

AB1 +! 60MG N020198 002 Apr 21, 1993

AB1 +! 90MG N020198 003 Apr 21, 1993

NIFEDIPINE

AB1 MYLAN 30MG A201071 001 Dec 03, 2010

AB1 60MG A201071 002 Dec 03, 2010

AB1 90MG A201071 003 Dec 03, 2010

AB1 NOVAST LABS 30MG A202987 001 Aug 25, 2016

AB1 60MG A202987 002 Aug 25, 2016

AB1 90MG A202987 003 Aug 25, 2016

AB1 PAR PHARM 30MG A077899 001 Dec 13, 2006

AB1 60MG A077899 002 Dec 13, 2006

AB1 90MG A077899 003 May 25, 2012

AB1 VALEANT PHARMS 30MG A075269 001 Dec 04, 2000

NORTH

AB1 60MG A075269 002 Dec 04, 2000

AB1 90MG A076070 001 Aug 16, 2002

AB1 ZYDUS PHARMS USA 30MG A210184 001 Jun 29, 2018

INC

AB1 60MG A210184 002 Jun 29, 2018

AB1 90MG A210184 003 Jun 29, 2018

AB2 MYLAN 30MG A090649 001 Jun 21, 2010

AB2 60MG A090649 002 Jun 21, 2010

AB2 90MG A090649 003 Jun 21, 2010

AB2 OSMOTICA PHARM US 30MG A077127 001 Nov 21, 2005

AB2 60MG A077127 002 Nov 21, 2005

AB2 90MG A077410 001 Oct 03, 2007

AB2 TWI PHARMS 30MG A203126 001 Apr 03, 2014

AB2 60MG A203126 002 Apr 03, 2014

AB2 90MG A203126 003 Apr 03, 2014

AB2 VALEANT PHARMS 30MG A075289 002 Feb 06, 2001

NORTH

AB2 60MG A075289 001 Sep 27, 2000

AB2 ZYDUS PHARMS USA 30MG A210012 001 Dec 19, 2017

INC

AB2 60MG A210012 002 Dec 19, 2017

AB2 90MG A210012 003 Dec 19, 2017

PROCARDIA XL

AB2 + PFIZER 30MG N019684 001 Sep 06, 1989

AB2 + 60MG N019684 002 Sep 06, 1989

AB2 +! 90MG N019684 003 Sep 06, 1989



NILOTINIB HYDROCHLORIDE

CAPSULE;ORAL

TASIGNA

+ NOVARTIS EQ 50MG BASE N022068 003 Mar 22, 2018

+ EQ 150MG BASE N022068 002 Jun 17, 2010

+! EQ 200MG BASE N022068 001 Oct 29, 2007

NILUTAMIDE

TABLET;ORAL

NILANDRON

AB +! CONCORDIA PHARMS 150MG N020169 002 Apr 30, 1999

INC

NILUTAMIDE

AB ANI PHARMS INC 150MG A207631 001 Jul 15, 2016

NIMODIPINE

CAPSULE;ORAL

NIMODIPINE

AB ! BIONPHARMA INC 30MG A076740 001 Jan 17, 2008

AB HERITAGE PHARMS INC 30MG A077811 001 May 02, 2007

AB SOFGEN PHARMS 30MG A201832 001 Jul 24, 2015

AB SUN PHARM INDS INC 30MG A077067 001 Apr 17, 2007

AB THEPHARMANETWORK 30MG A090103 001 Apr 07, 2014

LLC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-321(of 452)

NIMODIPINE

SOLUTION;ORAL

NYMALIZE

+! ARBOR PHARMS LLC 60MG/20ML N203340 001 May 10, 2013

NINTEDANIB ESYLATE

CAPSULE;ORAL

OFEV
+ BOEHRINGER EQ 100MG BASE N205832 001 Oct 15, 2014
INGELHEIM
+! EQ 150MG BASE N205832 002 Oct 15, 2014
NIRAPARIB TOSYLATE

CAPSULE;ORAL

ZEJULA

+! TESARO INC EQ 100MG BASE N208447 001 Mar 27, 2017

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL

NISOLDIPINE

AB MYLAN 8.5MG A091001 001 Jan 26, 2011

AB 17MG A091001 002 Jan 26, 2011

AB 34MG A091001 004 Jan 26, 2011

SULAR

AB +! COVIS PHARMA BV 8.5MG N020356 008 Jan 02, 2008

AB +! 17MG N020356 007 Jan 02, 2008

AB +! 34MG N020356 005 Jan 02, 2008



NISOLDIPINE

MYLAN 20MG A079051 001 Jul 25, 2008

25.5MG A091001 003 Jan 26, 2011

! 30MG A079051 002 Jul 25, 2008

! 40MG A079051 003 Jul 25, 2008

NITAZOXANIDE

FOR SUSPENSION;ORAL

ALINIA

+! ROMARK 100MG/5ML N021498 001 Nov 22, 2002

TABLET;ORAL

ALINIA

+! ROMARK 500MG N021497 001 Jul 21, 2004

NITISINONE

CAPSULE;ORAL

ORFADIN

+ SWEDISH ORPHAN 2MG N021232 001 Jan 18, 2002

+ 5MG N021232 002 Jan 18, 2002

+ 10MG N021232 003 Jan 18, 2002

+! 20MG N021232 004 Jun 13, 2016

SUSPENSION;ORAL

ORFADIN

+! SWEDISH ORPHAN 4MG/ML N206356 001 Apr 22, 2016

TABLET;ORAL

NITYR

+ CYCLE PHARMS LTD 2MG N209449 001 Jul 26, 2017

+ 5MG N209449 002 Jul 26, 2017

+! 10MG N209449 003 Jul 26, 2017

NITRIC OXIDE

GAS;INHALATION

INOMAX

AA +! MALLINCKRODT HOSP 800PPM N020845 003 Dec 23, 1999

NOXIVENT

AA PRAXAIR 800PPM A207141 002 Oct 02, 2018

DISTRIBUTION

100PPM A207141 001 Oct 02, 2018

NITROFURANTOIN

SUSPENSION;ORAL

FURADANTIN

AB +! CASPER PHARMA LLC 25MG/5ML N009175 001

NITROFURANTOIN

AB ACTAVIS MID 25MG/5ML A205180 001 May 03, 2016

ATLANTIC

AB AMNEAL PHARMS 25MG/5ML A201679 001 May 11, 2011

AB NOSTRUM LABS INC 25MG/5ML A201355 001 Aug 14, 2013

AB NOVEL LABS INC 25MG/5ML A201693 001 Sep 08, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-322(of 452)

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

MACRODANTIN

AB + ALVOGEN MALTA 25MG N016620 003

AB + 50MG N016620 001

AB +! 100MG N016620 002

NITROFURANTOIN

AB ACTAVIS LABS FL INC 25MG A091095 001 Jun 18, 2015

AB 50MG A091095 002 Jun 18, 2015

AB 100MG A091095 003 Jun 18, 2015

AB IMPAX LABS INC 50MG A073671 001 Jan 28, 1993

AB 100MG A073652 001 Jan 28, 1993

AB MYLAN 50MG A074967 001 Jul 09, 1997

AB 100MG A077025 001 Aug 18, 2004

AB NOVEL LABS INC 50MG A203233 001 Jul 09, 2018

AB 100MG A203233 002 Jul 09, 2018

AB SUN PHARM 25MG A201722 001 Feb 16, 2016

INDUSTRIES

AB 50MG A201722 002 Feb 16, 2016

AB 100MG A201722 003 Feb 16, 2016

AB ZYDUS PHARMS USA 50MG A205005 001 Dec 12, 2017

INC

AB 100MG A205005 002 Dec 12, 2017

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

MACROBID

AB +! ALVOGEN MALTA 75MG;25MG N020064 001 Dec 24, 1991

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

AB AMNEAL PHARMS 75MG;25MG A207372 001 May 15, 2017

AB MYLAN 75MG;25MG A076648 001 Mar 22, 2004

AB SANDOZ 75MG;25MG A077066 001 Apr 05, 2005

AB SUNNY PHARMTECH INC 75MG;25MG A208516 001 May 24, 2018

AB WATSON LABS INC 75MG;25MG A202250 001 Jul 08, 2015



NITROGLYCERIN

AEROSOL, METERED;SUBLINGUAL

NITROMIST

+! MIST PHARMS LLC 0.4MG/SPRAY N021780 001 Nov 02, 2006

FILM, EXTENDED RELEASE;TRANSDERMAL

MINITRAN

AB1 MEDICIS 0.4MG/HR A089773 001 Aug 30, 1996

AB1 VALEANT PHARMS 0.1MG/HR A089771 001 Aug 30, 1996

AB1 0.6MG/HR A089774 001 Aug 30, 1996

AB1 VALEANT PHARMS 0.2MG/HR A089772 001 Aug 30, 1996

NORTH

NITRO-DUR

AB1 +! USPHARMA 0.1MG/HR N020145 001 Apr 04, 1995

AB1 +! 0.2MG/HR N020145 002 Apr 04, 1995

AB1 +! 0.4MG/HR N020145 004 Apr 04, 1995

AB1 +! 0.6MG/HR N020145 005 Apr 04, 1995

NITROGLYCERIN

AB2 HERCON PHARM 0.2MG/HR A089884 001 Oct 30, 1998

AB2 0.4MG/HR A089885 001 Oct 30, 1998

AB2 0.6MG/HR A089886 001 Oct 30, 1998

AB2 ! MYLAN TECHNOLOGIES 0.2MG/HR A074559 003 Aug 30, 1996

AB2 ! 0.4MG/HR A074559 002 Aug 30, 1996

AB2 ! 0.6MG/HR A074559 001 Aug 30, 1996

NITRO-DUR

+! USPHARMA 0.3MG/HR N020145 003 Apr 04, 1995

+! 0.8MG/HR N020145 006 Apr 04, 1995

NITROGLYCERIN

! MYLAN TECHNOLOGIES 0.1MG/HR A074559 004 Feb 06, 1998

INJECTABLE;INJECTION

NITROGLYCERIN IN DEXTROSE 5%

AP +! BAXTER HLTHCARE 10MG/100ML N019970 001 Dec 29, 1989

AP +! 20MG/100ML N019970 002 Dec 29, 1989

AP +! 40MG/100ML N019970 003 Dec 29, 1989



NITROGLYCERIN

! LUITPOLD 5MG/ML A072034 001 May 24, 1988

OINTMENT;INTRA-ANAL

RECTIV

+! ALLERGAN SALES LLC 0.4% N021359 001 Jun 21, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-323(of 452)

NITROGLYCERIN

OINTMENT;TRANSDERMAL

NITROGLYCERIN

! FOUGERA PHARMS INC 2% A087355 001 Jul 08, 1988

POWDER;SUBLINGUAL

GONITRO

+! POHL BOSKAMP 0.4MG/PACKET N208424 001 Jun 08, 2016

SPRAY, METERED;SUBLINGUAL

NITROGLYCERIN

AB PERRIGO ISRAEL 0.4MG/SPRAY A091496 001 Sep 20, 2013

NITROLINGUAL PUMPSPRAY

AB +! POHL BOSKAMP 0.4MG/SPRAY N018705 002 Jan 10, 1997

TABLET;SUBLINGUAL

NITROGLYCERIN

AB ACTAVIS LABS FL INC 0.3MG A203693 001 Oct 16, 2017

AB 0.4MG A203693 002 Oct 16, 2017

AB 0.6MG A203693 003 Oct 16, 2017

AB DR REDDYS LABS INC 0.3MG A208191 001 Aug 26, 2016

AB 0.4MG A208191 002 Aug 26, 2016

AB 0.6MG A208191 003 Aug 26, 2016

AB GLENMARK PHARMS SA 0.3MG A206391 001 Sep 19, 2017

AB 0.4MG A206391 002 Sep 19, 2017

AB 0.6MG A206391 003 Sep 19, 2017

AB SIGMAPHARM LABS LLC 0.3MG A207745 001 May 07, 2018

AB 0.4MG A207745 002 May 07, 2018

AB 0.6MG A207745 003 May 07, 2018

NITROSTAT

AB + PFIZER PHARMS 0.3MG N021134 001 May 01, 2000

AB + 0.4MG N021134 002 May 01, 2000

AB +! 0.6MG N021134 003 May 01, 2000



NIZATIDINE

CAPSULE;ORAL

NIZATIDINE

AB ANI PHARMS INC 150MG A075668 001 Sep 12, 2002

AB 300MG A075668 002 Sep 12, 2002

AB DR REDDYS LABS LTD 150MG A077314 001 Sep 15, 2005

AB 300MG A077314 002 Sep 15, 2005

AB GLENMARK GENERICS 150MG A090618 001 Jul 15, 2011

AB 300MG A090618 002 Jul 15, 2011

AB MYLAN PHARMS INC 150MG A075806 001 Jul 05, 2002

AB ! 300MG A075806 002 Jul 05, 2002

AB SANDOZ 150MG A076178 001 Jul 05, 2002

AB 300MG A076178 002 Jul 05, 2002

AB WATSON LABS 150MG A075616 001 Jul 09, 2002

AB 300MG A075616 002 Jul 09, 2002



SOLUTION;ORAL

NIZATIDINE

! AMNEAL PHARMS 15MG/ML A090576 001 Nov 18, 2009

NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

LEVOPHED

AP +! HOSPIRA EQ 1MG BASE/ML N007513 001

NOREPINEPHRINE BITARTRATE

AP AMNEAL PHARMS CO EQ 1MG BASE/ML A210839 001 Dec 17, 2018

AP BAXTER HLTHCARE EQ 1MG BASE/ML A040859 001 Mar 27, 2012

CORP

AP HIKMA FARMACEUTICA EQ 1MG BASE/ML A203662 001 Nov 07, 2018

AP MYLAN LABS LTD EQ 1MG BASE/ML A211242 001 Oct 04, 2018

AP SANDOZ INC EQ 1MG BASE/ML A211359 001 Oct 18, 2018

AP TEVA PHARMS USA EQ 1MG BASE/ML A040455 001 Mar 03, 2003

AP WEST-WARD PHARMS EQ 1MG BASE/ML A040462 001 Oct 31, 2003

INT

NORETHINDRONE

TABLET;ORAL-28

CAMILA

AB1 MAYNE PHARMA 0.35MG A076177 001 Oct 21, 2002

HEATHER

AB1 GLENMARK GENERICS 0.35MG A090454 001 Apr 23, 2010

INCASSIA

AB1 AUROBINDO PHARMA 0.35MG A207304 001 Sep 23, 2016

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-324(of 452)

NORETHINDRONE

TABLET;ORAL-28

NOR-QD

AB1 +! APIL 0.35MG N017060 001



NORETHINDRONE

AB1 ACCORD HLTHCARE 0.35MG A206807 001 Dec 13, 2016

AB1 AMNEAL PHARMS 0.35MG A202260 001 Aug 01, 2013

AB1 LUPIN LTD 0.35MG A091325 001 Sep 19, 2011

AB1 MYLAN LABS LTD 0.35MG A201483 001 Jun 24, 2013

AB1 NOVAST LABS 0.35MG A202014 001 Sep 13, 2013

ERRIN

AB2 MAYNE PHARMA 0.35MG A076225 001 Oct 21, 2002

JENCYCLA

AB2 LUPIN LTD 0.35MG A091323 001 Mar 28, 2013

MICRONOR

AB2 +! JANSSEN PHARMS 0.35MG N016954 001

NORETHINDRONE

AB2 GLENMARK GENERICS 0.35MG A091209 001 Jul 22, 2010

AB2 MYLAN LABS LTD 0.35MG A200980 001 Jun 12, 2013

AB2 NOVAST LABS 0.35MG A200961 001 Sep 13, 2013



NORETHINDRONE ACETATE

TABLET;ORAL

NORETHINDRONE ACETATE

AB AMNEAL PHARMS 5MG A200275 001 Jul 30, 2012

AB AUROBINDO PHARMA 5MG A204236 001 Jan 08, 2016

LTD

AB ! BARR 5MG A075951 001 May 25, 2001

AB GLENMARK GENERICS 5MG A091090 001 Jul 21, 2010

AB MYLAN LABS LTD 5MG A205278 001 Nov 10, 2016

AB PACK PHARMS LLC 5MG A206490 001 Nov 05, 2018



NORTRIPTYLINE HYDROCHLORIDE

CAPSULE;ORAL

NORTRIPTYLINE HYDROCHLORIDE

AB MAYNE PHARMA EQ 10MG BASE A073556 002 Mar 30, 1992

AB EQ 25MG BASE A073556 003 Mar 30, 1992

AB EQ 50MG BASE A073556 004 Mar 30, 1992

AB EQ 75MG BASE A073556 001 Mar 30, 1992

AB TARO PHARM EQ 10MG BASE A075520 004 May 08, 2000

AB EQ 25MG BASE A075520 003 May 08, 2000

AB EQ 50MG BASE A075520 001 May 08, 2000

AB EQ 75MG BASE A075520 002 May 08, 2000

AB TEVA EQ 10MG BASE A074132 001 Mar 27, 1995

AB EQ 25MG BASE A074132 002 Mar 27, 1995

AB EQ 50MG BASE A074132 003 Mar 27, 1995

AB EQ 75MG BASE A074132 004 Mar 27, 1995

PAMELOR

AB + SPECGX LLC EQ 10MG BASE N018013 001

AB + EQ 25MG BASE N018013 002

AB + EQ 50MG BASE N018013 004

AB +! EQ 75MG BASE N018013 003

SOLUTION;ORAL

NORTRIPTYLINE HYDROCHLORIDE

AA ! PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 28, 2000

AA TARO EQ 10MG BASE/5ML A077965 001 Jun 20, 2006



NUSINERSEN SODIUM

SOLUTION;INTRATHECAL

SPINRAZA

+! BIOGEN IDEC 12MG/5ML (2.4MG/ML) N209531 001 Dec 23, 2016

NYSTATIN

CREAM;TOPICAL

NYSTATIN

AT ACTAVIS MID 100,000 UNITS/GM A062949 001 Jun 13, 1988

ATLANTIC

AT CROWN LABS INC 100,000 UNITS/GM A207733 001 Sep 26, 2017

AT FOUGERA PHARMS 100,000 UNITS/GM A062129 001



AT G AND W LABS INC 100,000 UNITS/GM A061966 001

AT PERRIGO NEW YORK 100,000 UNITS/GM A062225 001

AT ! TARO 100,000 UNITS/GM A064022 001 Jan 29, 1993

AT VINTAGE 100,000 UNITS/GM A065315 001 May 31, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-325(of 452)

NYSTATIN

OINTMENT;TOPICAL

NYSTATIN

AT ACTAVIS MID 100,000 UNITS/GM A062840 001 Nov 13, 1987

ATLANTIC

AT ! FOUGERA PHARMS 100,000 UNITS/GM A062124 002 Sep 23, 1982

AT G AND W LABS INC 100,000 UNITS/GM A209114 001 Oct 06, 2017

AT LYNE 100,000 UNITS/GM A209082 001 May 21, 2018

AT PERRIGO NEW YORK 100,000 UNITS/GM A062472 001 Feb 13, 1984

AT ZYDUS PHARMS USA 100,000 UNITS/GM A207767 001 May 25, 2018

INC

POWDER;TOPICAL

NYSTATIN

AT EPIC PHARMA LLC 100,000 UNITS/GM A210532 001 Apr 30, 2018

AT GAVIS PHARMS 100,000 UNITS/GM A065138 001 Jul 23, 2004

AT LYNE 100,000 UNITS/GM A208838 001 May 30, 2017

AT ! MAYNE PHARMA INC 100,000 UNITS/GM A065203 001 Jul 15, 2004

AT NESHER PHARMS 100,000 UNITS/GM A208581 001 Jun 08, 2017

AT UPSHER SMITH LABS 100,000 UNITS/GM A065183 001 May 03, 2005

AT X GEN PHARMS 100,000 UNITS/GM A065175 001 Dec 17, 2004

NYSTOP

AT PADDOCK LLC 100,000 UNITS/GM A064118 001 Aug 16, 1996

SUSPENSION;ORAL

NYSTATIN

AA FOUGERA PHARMS INC 100,000 UNITS/ML A062517 001 Jun 07, 1984

AA HI TECH PHARMA 100,000 UNITS/ML A064042 001 Feb 28, 1994

AA LANNETT CO INC 100,000 UNITS/ML A065148 001 Jun 28, 2005

AA PHARM ASSOC 100,000 UNITS/ML A203621 001 Jan 07, 2016

AA TARO PHARM 100,000 UNITS/ML A062876 001 Feb 29, 1988

AA VISTAPHARM 100,000 UNITS/ML A064142 001 Jun 25, 1998

AA 100,000 UNITS/ML A065422 001 Mar 07, 2011

AA ! WOCKHARDT BIO AG 100,000 UNITS/ML A062512 001 Oct 29, 1984



TABLET;ORAL

NYSTATIN

AA HERITAGE PHARMS INC 500,000 UNITS A062474 001 Dec 22, 1983

AA SUN PHARM 500,000 UNITS A062838 001 Dec 22, 1988

INDUSTRIES

AA ! TEVA 500,000 UNITS A062506 001 Jan 16, 1984

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYKACET

AT G AND W LABS INC 100,000 UNITS/GM;0.1% A062367 001 May 28, 1985

NYSTATIN AND TRIAMCINOLONE ACETONIDE



AT AMNEAL PHARMS LLC 100,000 UNITS/GM;0.1% A209990 001 Feb 15, 2018

AT CROWN LABS INC 100,000 UNITS/GM;0.1% A207730 001 Dec 26, 2017

AT DR REDDYS LABS LTD 100,000 UNITS/GM;0.1% A208326 001 Oct 26, 2016

AT FOUGERA PHARMS INC 100,000 UNITS/GM;0.1% A062599 001 Oct 08, 1985

AT GLENMARK PHARMS LTD 100,000 UNITS/GM;0.1% A208136 001 Oct 24, 2016

AT LUPIN LTD 100,000 UNITS/GM;0.1% A208205 001 May 31, 2018

AT PERRIGO UK FINCO 100,000 UNITS/GM;0.1% A208479 001 Aug 14, 2017

AT ! TARO 100,000 UNITS/GM;0.1% A062364 001 Dec 22, 1987



OINTMENT;TOPICAL

MYKACET

AT G AND W LABS INC 100,000 UNITS/GM;0.1% A062733 001 Mar 06, 1987

NYSTATIN AND TRIAMCINOLONE ACETONIDE



AT AKORN 100,000 UNITS/GM;0.1% A207217 001 Aug 04, 2017

AT CROWN LABS INC 100,000 UNITS/GM;0.1% A207731 001 Dec 26, 2017

AT DR REDDYS LABS LTD 100,000 UNITS/GM;0.1% A207741 001 Jan 31, 2017

AT FOUGERA PHARMS INC 100,000 UNITS/GM;0.1% A062602 001 Oct 09, 1985

AT GLENMARK PHARMS LTD 100,000 UNITS/GM;0.1% A208300 001 Jun 23, 2016

AT PERRIGO UK FINCO 100,000 UNITS/GM;0.1% A207380 001 Dec 20, 2016

AT RISING PHARMS 100,000 UNITS/GM;0.1% A206785 001 Dec 29, 2016

AT STRIDES PHARMA 100,000 UNITS/GM;0.1% A210077 001 Jan 29, 2018

AT ! TARO 100,000 UNITS/GM;0.1% A063305 001 Mar 29, 1993

AT TELIGENT PHARMA INC 100,000 UNITS/GM;0.1% A208287 001 Dec 30, 2016

AT ZYDUS PHARMS USA 100,000 UNITS/GM;0.1% A207764 001 Nov 08, 2018

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-326(of 452)

OBETICHOLIC ACID

TABLET;ORAL

OCALIVA

+ INTERCEPT PHARMS 5MG N207999 001 May 27, 2016

INC

+! 10MG N207999 002 May 27, 2016

OCTREOTIDE ACETATE

INJECTABLE;INJECTION

OCTREOTIDE ACETATE

AP FRESENIUS KABI USA EQ 0.2MG BASE/ML A077450 001 Feb 10, 2006

AP EQ 1MG BASE/ML A077450 002 Feb 10, 2006

AP SAGENT PHARMS EQ 0.2MG BASE/ML A091041 001 Nov 12, 2013

AP EQ 1MG BASE/ML A091041 002 Nov 12, 2013

AP SUN PHARM INDS EQ 0.05MG BASE/ML A077372 001 Aug 14, 2007

AP EQ 0.1MG BASE/ML A077372 002 Aug 14, 2007

AP EQ 0.2MG BASE/ML A077373 001 Aug 14, 2007

AP EQ 0.5MG BASE/ML A077372 003 Aug 14, 2007

AP EQ 1MG BASE/ML A077373 002 Aug 14, 2007

AP TEVA PHARMS USA EQ 0.05MG BASE/ML A075957 001 Oct 03, 2005

AP EQ 0.1MG BASE/ML A075957 002 Oct 03, 2005

AP EQ 0.2MG BASE/ML A075959 001 Nov 21, 2005

AP EQ 0.5MG BASE/ML A075957 003 Oct 03, 2005

AP EQ 1MG BASE/ML A075959 002 Nov 21, 2005

AP USV NORTH AMERICA EQ 0.05MG BASE/ML A204669 001 Dec 27, 2018

AP EQ 0.1MG BASE/ML A204669 002 Dec 27, 2018

AP EQ 0.2MG BASE/ML A203765 001 Sep 07, 2018

AP EQ 0.5MG BASE/ML A204669 003 Dec 27, 2018

AP EQ 1MG BASE/ML A203765 002 Sep 07, 2018

AP ! WEST-WARD PHARMS EQ 0.2MG BASE/ML A076330 001 Apr 08, 2005

INT

AP ! EQ 1MG BASE/ML A076330 002 Apr 08, 2005

OCTREOTIDE ACETATE (PRESERVATIVE FREE)

AP FRESENIUS KABI USA EQ 0.05MG BASE/ML A077457 001 Feb 10, 2006

AP EQ 0.1MG BASE/ML A077457 002 Feb 10, 2006

AP EQ 0.5MG BASE/ML A077457 003 Feb 10, 2006

AP MYLAN INSTITUTIONAL EQ 0.05MG BASE/ML A079198 001 Feb 10, 2011

AP EQ 0.1MG BASE/ML A079198 002 Feb 10, 2011

AP EQ 0.5MG BASE/ML A079198 003 Feb 10, 2011

AP SAGENT PHARMS EQ 0.05MG BASE/ML A090834 001 Nov 12, 2013

AP EQ 0.1MG BASE/ML A090834 002 Nov 12, 2013

AP EQ 0.5MG BASE/ML A090834 003 Nov 12, 2013

AP ! WEST-WARD PHARMS EQ 0.05MG BASE/ML A076313 001 Mar 28, 2005

INT

AP ! EQ 0.1MG BASE/ML A076313 003 Mar 28, 2005

AP ! EQ 0.5MG BASE/ML A076313 002 Mar 28, 2005

SANDOSTATIN

AP +! NOVARTIS EQ 0.05MG BASE/ML N019667 001 Oct 21, 1988

AP +! EQ 0.1MG BASE/ML N019667 002 Oct 21, 1988

AP +! EQ 0.2MG BASE/ML N019667 004 Jun 12, 1991

AP +! EQ 0.5MG BASE/ML N019667 003 Oct 21, 1988

AP +! EQ 1MG BASE/ML N019667 005 Jun 12, 1991



SANDOSTATIN LAR

+ NOVARTIS EQ 10MG BASE/VIAL N021008 001 Nov 25, 1998

+ EQ 20MG BASE/VIAL N021008 002 Nov 25, 1998

+! EQ 30MG BASE/VIAL N021008 003 Nov 25, 1998

OFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

OCUFLOX

AT +! ALLERGAN 0.3% N019921 001 Jul 30, 1993

OFLOXACIN

AT AKORN 0.3% A076407 001 Apr 15, 2008

AT ALTAIRE PHARMS INC 0.3% A202692 001 Apr 29, 2013

AT ALVOGEN 0.3% A076830 001 Aug 31, 2004

AT BAUSCH AND LOMB 0.3% A076622 001 May 14, 2004

AT FDC LTD 0.3% A078559 001 Feb 25, 2009

AT HI TECH PHARMA 0.3% A076615 001 May 14, 2004

AT SANDOZ INC 0.3% A076231 001 May 14, 2004

SOLUTION/DROPS;OTIC

OFLOXACIN

AT ALVOGEN 0.3% A090395 001 Aug 11, 2009

AT APOTEX INC 0.3% A076527 001 Sep 28, 2007

AT ! BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-327(of 452)

OFLOXACIN

SOLUTION/DROPS;OTIC

OFLOXACIN

AT HI TECH PHARMA 0.3% A076616 001 Mar 17, 2008

AT SANDOZ INC 0.3% A078222 001 Mar 17, 2008



TABLET;ORAL

OFLOXACIN

AB CADILA PHARMS LTD 200MG A091656 001 Sep 18, 2014

AB 300MG A091656 002 Sep 18, 2014

AB 400MG A091656 003 Sep 18, 2014

AB DR REDDYS LABS LTD 200MG A077098 001 Feb 10, 2006

AB 300MG A077098 002 Feb 10, 2006

AB 400MG A077098 003 Feb 10, 2006

AB LARKEN LABS 400MG A076093 003 Sep 02, 2003

AB TEVA 200MG A076182 001 Sep 02, 2003

AB 300MG A076182 002 Sep 02, 2003

AB ! 400MG A076182 003 Sep 02, 2003



OLANZAPINE

INJECTABLE;INTRAMUSCULAR

OLANZAPINE

AP LUITPOLD 10MG/VIAL A201741 001 Mar 20, 2012

AP SANDOZ INC 10MG/VIAL A201588 001 Oct 24, 2011

ZYPREXA

AP +! LILLY 10MG/VIAL N021253 001 Mar 29, 2004

TABLET;ORAL

OLANZAPINE

AB ALKEM LABS LTD 2.5MG A202295 001 Oct 20, 2015

AB 5MG A202295 002 Oct 20, 2015

AB 7.5MG A202295 003 Oct 20, 2015

AB 10MG A202295 004 Oct 20, 2015

AB 15MG A202295 005 Oct 20, 2015

AB 20MG A202295 006 Oct 20, 2015

AB APOTEX INC 2.5MG A090798 001 Apr 23, 2012

AB 5MG A090798 002 Apr 23, 2012

AB 7.5MG A090798 003 Apr 23, 2012

AB 10MG A090798 004 Apr 23, 2012

AB 15MG A090798 005 Apr 23, 2012

AB 20MG A090798 006 Apr 23, 2012

AB AUROBINDO PHARMA 2.5MG A202050 001 Apr 23, 2012

LTD

AB 5MG A202050 002 Apr 23, 2012

AB 7.5MG A202050 003 Apr 23, 2012

AB 10MG A202050 004 Apr 23, 2012

AB 15MG A202050 005 Apr 23, 2012

AB 20MG A202050 006 Apr 23, 2012

AB DR REDDYS LABS LTD 2.5MG A076255 001 Apr 23, 2012

AB 5MG A076255 002 Apr 23, 2012

AB 7.5MG A076255 003 Apr 23, 2012

AB 10MG A076255 004 Apr 23, 2012

AB 15MG A076133 001 Apr 23, 2012

AB 20MG A076133 002 Oct 24, 2011

AB HIKMA PHARMS 2.5MG A204866 001 Jun 16, 2017

AB 5MG A204866 002 Jun 16, 2017

AB 7.5MG A204866 003 Jun 16, 2017

AB 10MG A204866 004 Jun 16, 2017

AB 15MG A204866 005 Jun 16, 2017

AB 20MG A204866 006 Jun 16, 2017

AB INVAGEN PHARMS 2.5MG A203333 001 Mar 15, 2016

AB 5MG A203333 002 Mar 15, 2016

AB 7.5MG A203333 003 Mar 15, 2016

AB 10MG A203333 004 Mar 15, 2016

AB 15MG A203333 005 Mar 15, 2016

AB 20MG A203333 006 Mar 15, 2016

AB IVAX PHARMS INC 20MG A077301 001 Apr 29, 2015

AB JIANGSU HANSOH 2.5MG A209399 001 Sep 24, 2018

PHARM

AB 5MG A209399 002 Sep 24, 2018

AB 10MG A209399 003 Sep 24, 2018

AB MACLEODS PHARMS LTD 2.5MG A202862 001 Aug 15, 2014

AB 5MG A202862 002 Aug 15, 2014

AB 7.5MG A202862 003 Aug 15, 2014

AB 10MG A202862 004 Aug 15, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-328(of 452)

OLANZAPINE

TABLET;ORAL

OLANZAPINE

AB 15MG A202862 005 Aug 15, 2014

AB 20MG A202862 006 Aug 15, 2014

AB ORCHID HLTHCARE 2.5MG A202287 001 Apr 23, 2012

AB 5MG A202287 002 Apr 23, 2012

AB 7.5MG A202287 003 Apr 23, 2012

AB 10MG A202287 004 Apr 23, 2012

AB 15MG A202287 005 Apr 23, 2012

AB 20MG A202287 006 Apr 23, 2012

AB QILU PHARM CO LTD 2.5MG A204319 001 Jan 27, 2016

AB 5MG A204319 002 Jan 27, 2016

AB 7.5MG A204319 003 Jan 27, 2016

AB 10MG A204319 004 Jan 27, 2016

AB 15MG A204319 005 Jan 27, 2016

AB 20MG A204319 006 Jan 27, 2016

AB SUN PHARM INDS 2.5MG A091038 001 Apr 23, 2012

AB 5MG A091038 002 Apr 23, 2012

AB 7.5MG A091038 003 Apr 23, 2012

AB 10MG A091038 004 Apr 23, 2012

AB 15MG A091038 005 Apr 23, 2012

AB 20MG A091038 006 Apr 23, 2012

AB SUNSHINE LAKE 2.5MG A206238 001 Nov 19, 2018

AB 5MG A206238 002 Nov 19, 2018

AB 7.5MG A206238 003 Nov 19, 2018

AB 10MG A206238 004 Nov 19, 2018

AB 15MG A206238 005 Nov 19, 2018

AB 20MG A206238 006 Nov 19, 2018

AB TEVA PHARMS 2.5MG A076000 001 Oct 24, 2011

AB 5MG A076000 002 Oct 24, 2011

AB 7.5MG A076000 003 Oct 24, 2011

AB 10MG A076000 004 Oct 24, 2011

AB 15MG A076000 005 Oct 24, 2011

AB TORRENT PHARMS LTD 2.5MG A091434 001 Apr 23, 2012

AB 5MG A091434 002 Apr 23, 2012

AB 7.5MG A091434 003 Apr 23, 2012

AB 10MG A091434 004 Apr 23, 2012

AB 15MG A091434 005 Apr 23, 2012

AB 20MG A091434 006 Apr 23, 2012

AB ZYDUS PHARMS USA 2.5MG A090459 001 Jul 16, 2018

INC

AB 5MG A090459 002 Jul 16, 2018

AB 7.5MG A090459 003 Jul 16, 2018

AB 10MG A090459 004 Jul 16, 2018

AB 15MG A090459 005 Jul 16, 2018

AB 20MG A090459 006 Jul 16, 2018

ZYPREXA

AB + LILLY 2.5MG N020592 001 Sep 30, 1996

AB +! 5MG N020592 002 Sep 30, 1996

AB + 7.5MG N020592 003 Sep 30, 1996

AB + 10MG N020592 004 Sep 30, 1996

AB + 15MG N020592 005 Sep 09, 1997

AB + 20MG N020592 006 Sep 09, 1997

TABLET, ORALLY DISINTEGRATING;ORAL

OLANZAPINE

AB APOTEX INC 5MG A091265 001 Oct 24, 2011

AB 10MG A091265 002 Oct 24, 2011

AB 15MG A091265 003 Oct 24, 2011

AB 20MG A091265 004 Oct 24, 2011

AB AUROBINDO PHARMA 5MG A203708 001 May 15, 2014

LTD

AB 10MG A203708 002 May 15, 2014

AB 15MG A203708 003 May 15, 2014

AB 20MG A203708 004 May 15, 2014

AB BARR LABS INC 5MG A077243 001 Jan 30, 2012

AB 10MG A077243 002 Jan 30, 2012

AB 15MG A077243 003 Jan 30, 2012

AB 20MG A077243 004 Jan 30, 2012

AB DR REDDYS LABS LTD 5MG A076534 001 Oct 24, 2011

AB 10MG A076534 002 Oct 24, 2011

AB 15MG A076534 003 Oct 24, 2011

AB 20MG A076534 004 Oct 24, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-329(of 452)

OLANZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL

OLANZAPINE

AB HEC PHARM 5MG
A208146 001 Jul 02, 2018

AB 10MG
A208146 002 Jul 02, 2018

AB 15MG
A208146 003 Jul 02, 2018

AB 20MG
A208146 004 Jul 02, 2018

AB INVAGEN PHARMS 5MG


A203456 001 Mar 16, 2016

AB 10MG
A203456 002 Mar 16, 2016

AB 15MG
A203456 003 Mar 16, 2016

AB 20MG
A203456 004 Mar 16, 2016

AB JUBILANT GENERICS 5MG


A200221 001 Sep 12, 2012

AB 10MG
A200221 002 Sep 12, 2012

AB 15MG
A200221 003 Sep 12, 2012

AB 20MG
A200221 004 Sep 12, 2012

AB MACLEODS PHARMS LTD 5MG


A203044 001 Feb 20, 2015

AB 10MG
A203044 002 Feb 20, 2015

AB 15MG
A203044 003 Feb 20, 2015

AB 20MG
A203044 004 Feb 20, 2015

AB MYLAN PHARMS INC 5MG


A202285 001 May 12, 2014

AB 10MG
A202285 002 May 12, 2014

AB 15MG
A202285 003 May 12, 2014

AB 20MG
A202285 004 May 12, 2014

AB ORCHID HLTHCARE 5MG


A202937 001 Mar 02, 2015

AB 10MG
A202937 002 Mar 02, 2015

AB 15MG
A202937 003 Mar 02, 2015

AB 20MG
A202937 004 Mar 02, 2015

AB PAR PHARM 5MG


A078109 001 Oct 24, 2011

AB 10MG
A078109 002 Oct 24, 2011

AB 15MG
A078109 003 Oct 24, 2011

AB 20MG
A078109 004 Oct 24, 2011

AB SUN PHARM INDS 5MG


A090881 001 Feb 28, 2012

AB 10MG
A090881 002 Feb 28, 2012

AB 15MG
A090881 003 Feb 28, 2012

AB 20MG
A090881 004 Feb 28, 2012

AB TORRENT PHARMS LLC 5MG


A091415 001 Oct 25, 2011

AB 10MG
A091415 002 Oct 25, 2011

AB 15MG
A091415 003 Oct 25, 2011

AB 20MG
A091415 004 Oct 25, 2011

ZYPREXA ZYDIS

AB +! LILLY 5MG
N021086 001 Apr 06, 2000

AB + 10MG
N021086 002 Apr 06, 2000

AB + 15MG
N021086 003 Apr 06, 2000

AB + 20MG
N021086 004 Apr 06, 2000

OLANZAPINE PAMOATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ZYPREXA RELPREVV

+ ELI LILLY CO
EQ 210MG BASE/VIAL
N022173 001 Dec 11, 2009

+
EQ 300MG BASE/VIAL
N022173 002 Dec 11, 2009

+!
EQ 405MG BASE/VIAL
N022173 003 Dec 11, 2009

OLAPARIB

CAPSULE;ORAL

LYNPARZA

+! ASTRAZENECA PHARMS
50MG
N206162 001 Dec 19, 2014

TABLET;ORAL

LYNPARZA

+ ASTRAZENECA PHARMS
100MG
N208558 001 Aug 17, 2017

+!
150MG
N208558 002 Aug 17, 2017

OLMESARTAN MEDOXOMIL

TABLET;ORAL

BENICAR

AB + DAIICHI SANKYO
5MG
N021286 001 Apr 25, 2002

AB +
20MG
N021286 003 Apr 25, 2002

AB +!
40MG
N021286 004 Apr 25, 2002

OLMESARTAN MEDOXOMIL

AB ACCORD HLTHCARE
5MG
A207662 001 Apr 24, 2017

AB
20MG
A207662 002 Apr 24, 2017

AB
40MG
A207662 003 Apr 24, 2017

AB ALEMBIC PHARMS LTD


5MG
A203012 001 Apr 24, 2017

AB
20MG
A203012 002 Apr 24, 2017

AB
40MG
A203012 003 Apr 24, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-330(of 452)

OLMESARTAN MEDOXOMIL

TABLET;ORAL

OLMESARTAN MEDOXOMIL
AB ALKEM LABS LTD 5MG A206763 001 Apr 24, 2017

AB 20MG A206763 002 Apr 24, 2017

AB 40MG A206763 003 Apr 24, 2017

AB AUROBINDO PHARMA 5MG A204798 001 Apr 24, 2017



LTD
AB 20MG A204798 002 Apr 24, 2017

AB 40MG A204798 003 Apr 24, 2017

AB GLENMARK PHARMS LTD 5MG A203281 001 May 25, 2017

AB 20MG A203281 002 May 25, 2017

AB 40MG A203281 003 May 25, 2017

AB JUBILANT GENERICS 5MG A205482 001 Apr 24, 2017

AB 20MG A205482 002 Apr 24, 2017

AB 40MG A205482 003 Apr 24, 2017

AB LUPIN LTD 5MG A206631 001 Apr 27, 2017

AB 20MG A206631 002 Apr 27, 2017

AB 40MG A206631 003 Apr 27, 2017

AB MACLEODS PHARMS LTD 5MG A204814 001 Apr 24, 2017

AB 20MG A204814 002 Apr 24, 2017

AB 40MG A204814 003 Apr 24, 2017

AB MYLAN PHARMS INC 5MG A078276 001 Oct 26, 2016

AB 20MG A078276 002 Oct 26, 2016

AB 40MG A078276 003 Oct 26, 2016

AB QILU PHARM CO LTD 5MG A210552 001 Jan 10, 2019

AB 20MG A210552 002 Jan 10, 2019

AB 40MG A210552 003 Jan 10, 2019

AB SCIEGEN PHARMS INC 5MG A208130 001 Jun 29, 2018

AB 20MG A208130 002 Jun 29, 2018

AB 40MG A208130 003 Jun 29, 2018

AB TEVA PHARMS USA 5MG A091079 001 Apr 24, 2017

AB 20MG A091079 002 Apr 24, 2017

AB 40MG A091079 003 Apr 24, 2017

AB TORRENT PHARMS LTD 5MG A202375 001 Apr 24, 2017

AB 20MG A202375 002 Apr 24, 2017

AB 40MG A202375 003 Apr 24, 2017

AB ZYDUS PHARMS USA 5MG A205192 001 Apr 24, 2017



INC
AB 20MG A205192 002 Apr 24, 2017

AB 40MG A205192 003 Apr 24, 2017



OLODATEROL HYDROCHLORIDE

SPRAY, METERED;INHALATION

STRIVERDI RESPIMAT

+! BOEHRINGER EQ 0.0025MG BASE/INH
N203108 001 Jul 31, 2014

INGELHEIM

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

SPRAY, METERED;INHALATION

STIOLTO RESPIMAT

+! BOEHRINGER
EQ 0.0025MG BASE/INH;EQ 0.0025MG
N206756 001 May 21, 2015

INGELHEIM
BASE/INH

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

AT AKORN
EQ 0.2% BASE
A204723 001 Dec 05, 2017

AT AKORN INC
EQ 0.1% BASE
A204532 001 Jan 10, 2017

AT ALEMBIC PHARMS LTD


EQ 0.1% BASE
A209919 001 Dec 07, 2018

AT APOTEX INC
EQ 0.1% BASE
A078350 001 Dec 07, 2015

AT
EQ 0.2% BASE
A090918 001 Dec 05, 2017

AT AUROBINDO PHARMA
EQ 0.1% BASE
A204812 001 Dec 18, 2015

LTD

AT BARR LABS INC
EQ 0.2% BASE
A090848 001 Jul 13, 2015

AT CIPLA
EQ 0.1% BASE
A206046 001 Jul 26, 2017

AT
EQ 0.2% BASE
A206087 001 Dec 05, 2017

AT MYLAN PHARMS INC


EQ 0.1% BASE
A204392 001 Mar 21, 2018

AT SOMERSET THERAPS
EQ 0.1% BASE
A206306 001 Dec 07, 2015

LLC

AT USV NORTH AMERICA
EQ 0.1% BASE
A203152 001 Dec 07, 2015

AT WOCKHARDT LTD
EQ 0.1% BASE
A200810 001 Jun 28, 2017

PATADAY

AT +! NOVARTIS PHARMS
EQ 0.2% BASE
N021545 001 Dec 22, 2004

CORP

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-331(of 452)

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

PATANOL

AT +! NOVARTIS PHARMS EQ 0.1% BASE N020688 001 Dec 18, 1996

CORP

PAZEO

+! NOVARTIS PHARMS EQ 0.7% BASE N206276 001 Jan 30, 2015

CORP

SPRAY, METERED;NASAL

OLOPATADINE HYDROCHLORIDE

AB APOTEX INC 0.665MG/SPRAY A091572 001 Oct 08, 2014

AB PERRIGO ISRAEL 0.665MG/SPRAY A202853 001 Jan 31, 2017

PATANASE

AB +! NOVARTIS PHARMS 0.665MG/SPRAY N021861 001 Apr 15, 2008

CORP

OLSALAZINE SODIUM

CAPSULE;ORAL

DIPENTUM

+! MYLAN SPECIALITY LP 250MG N019715 001 Jul 31, 1990

OMACETAXINE MEPESUCCINATE

POWDER;SUBCUTANEOUS

SYNRIBO

+! TEVA PHARMS INTL 3.5MG/VIAL N203585 001 Oct 26, 2012

OMADACYCLINE TOSYLATE

POWDER;INTRAVENOUS

NUZYRA

+! PARATEK PHARMS INC EQ 100MG BASE/VIAL N209817 001 Oct 02, 2018

TABLET;ORAL

NUZYRA

+! PARATEK PHARMS INC EQ 150MG BASE N209816 001 Oct 02, 2018

OMBITASVIR; PARITAPREVIR; RITONAVIR

TABLET;ORAL

TECHNIVIE

+! ABBVIE INC 12.5MG;75MG;50MG N207931 001 Jul 24, 2015

OMEGA-3-ACID ETHYL ESTERS

CAPSULE;ORAL

LOVAZA

AB +! SMITHKLINE BEECHAM 1GM CONTAINS AT LEAST 900MG OF THE N021654 001 Nov 10, 2004

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



OMEGA-3-ACID ETHYL ESTERS

AB AMNEAL PHARMS 1GM CONTAINS AT LEAST 900MG OF THE A204940 001 Nov 27, 2015

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



AB APOTEX INC 1GM CONTAINS AT LEAST 900MG OF THE A090973 001 Sep 30, 2014

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



AB PAR PHARM INC 1GM CONTAINS AT LEAST 900MG OF THE A091018 001 Jun 24, 2014

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



AB STRIDES PHARMA 1GM CONTAINS AT LEAST 900MG OF THE A203893 001 Sep 19, 2017

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



AB TEVA PHARMS USA 1GM CONTAINS AT LEAST 900MG OF THE A091028 001 Apr 07, 2014

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE

AB ACTAVIS LABS FL INC 10MG A075347 001 May 30, 2008

AB 20MG A075347 002 May 30, 2008

AB 40MG A075347 003 May 30, 2008

AB APOTEX 10MG A076048 001 Oct 22, 2007

AB 20MG A076048 002 Oct 22, 2007

AB 40MG A076048 003 Jan 21, 2009

AB AUROBINDO PHARMA 10MG A203270 001 Aug 19, 2015

LTD

AB 20MG A203270 002 Aug 19, 2015

AB 40MG A203270 003 Aug 19, 2015

AB BRECKENRIDGE PHARM 10MG A203481 001 Jul 03, 2017

AB 20MG A203481 002 Jul 03, 2017

AB 40MG A203481 003 Jul 03, 2017

AB DR REDDYS LABS LTD 10MG A075576 003 Oct 22, 2007

AB 10MG A078490 002 Mar 16, 2009

AB 20MG A075576 002 Oct 22, 2007

AB 20MG A078490 003 Mar 16, 2009

AB 40MG A075576 001 Jan 21, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-332(of 452)

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE

AB 40MG A078490 001 Apr 17, 2009

AB GLENMARK GENERICS 10MG A091672 001 Oct 31, 2014

AB 20MG A091672 002 Oct 31, 2014

AB 40MG A091672 003 Oct 31, 2014

AB IMPAX LABS 10MG A075785 001 Oct 22, 2007

AB 20MG A075785 002 Oct 22, 2007

AB 40MG A075785 003 Jan 21, 2009

AB LANNETT CO INC 10MG A075410 001 Nov 01, 2002

AB 20MG A075410 002 Nov 01, 2002

AB 40MG A075410 003 Jan 23, 2009

AB LUPIN LTD 40MG A202384 001 Aug 25, 2015

AB MYLAN 10MG A075876 001 May 29, 2003

AB 20MG A075876 002 May 29, 2003

AB 40MG A075876 003 Jan 21, 2009

AB MYLAN PHARMS INC 10MG A205070 001 Jun 29, 2018

AB 20MG A205070 002 Jun 29, 2018

AB 40MG A205070 003 Jun 29, 2018

AB SANDOZ 10MG A075757 001 Jan 28, 2003

AB ! 20MG A075757 002 Jan 28, 2003

AB ! 40MG A076515 001 Jan 21, 2009

AB TEVA PHARMS USA 20MG A204661 001 Jun 13, 2017

AB 40MG A204661 002 Jun 13, 2017

AB ZYDUS PHARMS USA 10MG A091352 001 Nov 19, 2012

INC

AB 20MG A091352 002 Nov 19, 2012

AB 40MG A091352 003 Nov 19, 2012



OMEPRAZOLE MAGNESIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL

PRILOSEC

+ COVIS PHARMA BV EQ 2.5MG BASE/PACKET N022056 001 Mar 20, 2008

+! EQ 10MG BASE/PACKET N022056 002 Mar 20, 2008

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE



AB AJANTA PHARMA LTD 20MG;1.1GM A204228 001 Jul 15, 2016

AB 40MG;1.1GM A204228 002 Jul 15, 2016

AB AUROLIFE PHARMA LLC 20MG;1.1GM A204922 001 Aug 19, 2016

AB 40MG;1.1GM A204922 002 Aug 19, 2016

AB DR REDDYS LABS LTD 20MG;1.1GM A204068 001 Jul 15, 2016

AB 40MG;1.1GM A204068 002 Jul 15, 2016

AB PAR PHARM 20MG;1.1GM A078966 001 May 25, 2010

AB 40MG;1.1GM A078966 002 May 25, 2010

AB SCIEGEN PHARMS INC 20MG;1.1GM A207476 001 Dec 06, 2016

AB 40MG;1.1GM A207476 002 Dec 06, 2016

AB ZYDUS PHARMS USA 20MG;1.1GM A203290 001 May 25, 2018

INC

AB 40MG;1.1GM A203290 002 May 25, 2018

ZEGERID

AB + SANTARUS INC 20MG;1.1GM N021849 001 Feb 27, 2006

AB +! 40MG;1.1GM N021849 002 Feb 27, 2006



FOR SUSPENSION;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE



AB AJANTA PHARMA LTD 20MG/PACKET;1.68GM/PACKET A205545 001 Jul 27, 2016

AB 40MG/PACKET;1.68GM/PACKET A205545 002 Jul 27, 2016

AB PAR PHARM 20MG/PACKET;1.68GM/PACKET A079182 001 Apr 19, 2013

AB 40MG/PACKET;1.68GM/PACKET A079182 002 Apr 19, 2013

ZEGERID

AB + SANTARUS INC 20MG/PACKET;1.68GM/PACKET N021636 001 Jun 15, 2004

AB +! 40MG/PACKET;1.68GM/PACKET N021636 002 Dec 21, 2004



ONDANSETRON

FILM;ORAL

ZUPLENZ

+ MIDATECH PHARMA US 4MG N022524 001 Jul 02, 2010

+! 8MG N022524 002 Jul 02, 2010

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

AB AUROBINDO PHARMA 4MG A090469 001 Apr 12, 2010

AB 8MG A090469 002 Apr 12, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-333(of 452)

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

AB BARR 4MG A076693 001 Jun 25, 2007

AB 8MG A076693 002 Jun 25, 2007

AB GLENMARK GENERICS 4MG A078152 001 Jun 27, 2007

AB 8MG A078152 002 Jun 27, 2007

AB MYLAN 4MG A078139 001 Jun 25, 2007

AB 8MG A078139 002 Jun 25, 2007

AB SANDOZ 4MG A078050 001 Aug 13, 2007

AB 8MG A078050 002 Aug 13, 2007

AB SUN PHARM INDS 4MG A077557 001 Aug 02, 2007

AB 8MG A077557 002 Aug 02, 2007

AB SUN PHARM INDS LTD 4MG A078602 001 Feb 24, 2011

AB 8MG A078602 002 Feb 24, 2011

AB TEVA 4MG A076810 001 Jun 25, 2007

AB 8MG A076810 002 Jun 25, 2007

ZOFRAN ODT

AB + NOVARTIS PHARMS 4MG N020781 001 Jan 27, 1999

CORP

AB +! 8MG N020781 002 Jan 27, 1999

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ONDANSETRON HYDROCHLORIDE

AP ACCORD HLTHCARE EQ 2MG BASE/ML A206846 001 Jul 13, 2015

AP AUROBINDO PHARMA EQ 2MG BASE/ML A202599 001 Dec 21, 2012

LTD

AP ! BAXTER HLTHCARE EQ 2MG BASE/ML A078288 001 Feb 22, 2013

CORP

AP EMCURE PHARMS EQ 2MG BASE/ML A090424 001 Apr 16, 2010

AP FRESENIUS KABI USA EQ 2MG BASE/ML A076974 001 Dec 26, 2006

AP GLAND PHARMA LTD EQ 2MG BASE/ML A079224 001 Sep 25, 2009

AP EQ 2MG BASE/ML A090648 001 Jun 15, 2012

AP HIKMA FARMACEUTICA EQ 2MG BASE/ML A076781 001 Dec 26, 2006

AP HOSPIRA EQ 2MG BASE/ML A077473 001 Dec 26, 2006

AP EQ 2MG BASE/ML A077840 001 Jan 19, 2007

AP LUITPOLD EQ 2MG BASE/ML A079039 001 Nov 18, 2008

AP MYLAN LABS LTD EQ 2MG BASE/ML A204906 001 Jul 31, 2017

AP QILU PHARM CO LTD EQ 2MG BASE/ML A203711 001 Sep 08, 2014

AP SANDOZ INC EQ 2MG BASE/ML A077430 001 Jun 27, 2007

AP TEVA EQ 2MG BASE/ML A076876 001 Nov 22, 2006

AP WEST-WARD PHARMS EQ 2MG BASE/ML A076967 001 Dec 26, 2006

INT

AP EQ 2MG BASE/ML A077365 001 Dec 26, 2006

AP WOCKHARDT EQ 2MG BASE/ML A077577 001 Dec 26, 2006

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE



AP ACCORD HLTHCARE EQ 2MG BASE/ML A206845 001 Mar 10, 2016

AP AUROBINDO PHARMA EQ 2MG BASE/ML A202600 001 Dec 21, 2012

LTD

AP ! BAXTER HLTHCARE EQ 2MG BASE/ML A078287 001 Feb 22, 2013

CORP

AP EMCURE PHARMS LTD EQ 2MG BASE/ML A078945 001 Jan 03, 2013

AP FRESENIUS KABI USA EQ 2MG BASE/ML A076972 001 Dec 26, 2006

AP EQ 2MG BASE/ML A202253 001 Jul 19, 2013

AP HIKMA FARMACEUTICA EQ 2MG BASE/ML A076780 001 Dec 26, 2006

AP HOSPIRA EQ 2MG BASE/ML A077548 001 Dec 26, 2006

AP LUITPOLD EQ 2MG BASE/ML A079032 001 Nov 18, 2008

AP SANDOZ INC EQ 2MG BASE/ML A077551 001 Jun 27, 2007

AP TEVA EQ 2MG BASE/ML A076759 001 Nov 22, 2006

AP WEST-WARD PHARMS EQ 2MG BASE/ML A077011 001 Dec 26, 2006

INT

AP EQ 2MG BASE/ML A077541 001 Dec 26, 2006

AP WOCKHARDT EQ 2MG BASE/ML A077716 001 Dec 26, 2006



SOLUTION;ORAL

ONDANSETRON HYDROCHLORIDE

AA AMNEAL PHARMS EQ 4MG BASE/5ML A091483 001 Jan 31, 2011

AA APOTEX EQ 4MG BASE/5ML A078127 001 Jun 25, 2007

AA AUROBINDO PHARMA EQ 4MG BASE/5ML A078776 001 Nov 28, 2007

AA LANNETT CO INC EQ 4MG BASE/5ML A091342 001 Jan 27, 2011

AA TARO EQ 4MG BASE/5ML A077009 001 Nov 30, 2007

AA WEST-WARD PHARMS EQ 4MG BASE/5ML A076960 001 Dec 26, 2006

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-334(of 452)

ONDANSETRON HYDROCHLORIDE

SOLUTION;ORAL

ZOFRAN

AA +! NOVARTIS PHARMS EQ 4MG BASE/5ML N020605 001 Jan 24, 1997

CORP

TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

AB APOTEX EQ 4MG BASE A077306 001 Jun 25, 2007

AB EQ 8MG BASE A077306 002 Jun 25, 2007

AB AUROBINDO PHARMA EQ 4MG BASE A078539 001 Jul 31, 2007

AB EQ 8MG BASE A078539 002 Jul 31, 2007

AB EQ 24MG BASE A078539 003 Jul 31, 2007

AB CASI PHARMS INC EQ 4MG BASE A077517 001 Jun 25, 2007

AB EQ 8MG BASE A077517 002 Jun 25, 2007

AB EQ 24MG BASE A077517 003 Jun 25, 2007

AB DR REDDYS LABS LTD EQ 4MG BASE A076183 003 Dec 26, 2006

AB EQ 8MG BASE A076183 002 Dec 26, 2006

AB EQ 24MG BASE A076183 001 Dec 26, 2006

AB GLENMARK GENERICS EQ 4MG BASE A077535 001 Jun 25, 2007

AB EQ 8MG BASE A077535 002 Jun 25, 2007

AB EQ 24MG BASE A077535 003 Jun 25, 2007

AB IPCA LABS LTD EQ 4MG BASE A203761 001 Jan 23, 2014

AB EQ 8MG BASE A203761 002 Jan 23, 2014

AB MYLAN EQ 4MG BASE A076930 001 Jun 25, 2007

AB EQ 8MG BASE A076930 002 Jun 25, 2007

AB EQ 24MG BASE A076930 004 Jun 25, 2007

AB NATCO PHARMA LTD EQ 4MG BASE A077851 001 Jun 25, 2007

AB EQ 8MG BASE A077851 002 Jun 25, 2007

AB PLIVA HRVATSKA DOO EQ 4MG BASE A077112 001 Jun 25, 2007

AB EQ 8MG BASE A077112 002 Jun 25, 2007

AB EQ 24MG BASE A077112 003 Jun 25, 2007

AB SUN PHARM INDS (IN) EQ 4MG BASE A077050 001 Jun 25, 2007

AB EQ 8MG BASE A077050 002 Jun 25, 2007

AB TEVA EQ 4MG BASE A076252 001 Jun 25, 2007

AB EQ 8MG BASE A076252 002 Jun 25, 2007

AB EQ 24MG BASE A076252 003 Jun 25, 2007

ZOFRAN

AB + NOVARTIS PHARMS EQ 4MG BASE N020103 001 Dec 31, 1992

CORP

AB + EQ 8MG BASE N020103 002 Dec 31, 1992

AB +! EQ 24MG BASE N020103 003 Aug 27, 1999

ONDANSETRON HYDROCHLORIDE

DR REDDYS LABS LTD EQ 16MG BASE A076183 004 Dec 26, 2006

ORITAVANCIN DIPHOSPHATE

POWDER;INTRAVENOUS

ORBACTIV

+! MELINTA THERAP EQ 400MG BASE/VIAL N206334 001 Aug 06, 2014

ORLISTAT

CAPSULE;ORAL

XENICAL

+! CHEPLAPHARM 120MG N020766 001 Apr 23, 1999

ORPHENADRINE CITRATE

INJECTABLE;INJECTION

ORPHENADRINE CITRATE

AP ! AKORN 30MG/ML A040484 001 May 24, 2006

AP SAGENT PHARMS 30MG/ML A090585 001 Aug 30, 2011

AP WATSON LABS 30MG/ML A084779 001 Mar 15, 1982

AP WEST-WARD PHARMS 30MG/ML A040463 001 Mar 04, 2003

INT

TABLET, EXTENDED RELEASE;ORAL

ORPHENADRINE CITRATE

AB ANDA REPOSITORY 100MG A040249 001 Jan 29, 1999

AB GAVIS PHARMS 100MG A040284 001 Jun 19, 1998

AB IMPAX PHARMS 100MG A040368 001 Jun 23, 2000

AB INVAGEN PHARMS 100MG A091158 001 Jul 27, 2012

AB ! SANDOZ 100MG A040327 001 Feb 15, 2000



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-335(of 452)

OSELTAMIVIR PHOSPHATE

CAPSULE;ORAL

OSELTAMIVIR PHOSPHATE

AB AMNEAL PHARMS EQ 30MG BASE A209093 001 May 17, 2017

AB EQ 45MG BASE A209093 002 May 17, 2017

AB EQ 75MG BASE A209093 003 May 17, 2017

AB HETERO LABS LTD III EQ 30MG BASE A209438 001 Feb 23, 2018

AB EQ 45MG BASE A209438 002 Feb 23, 2018

AB EQ 75MG BASE A209438 003 Feb 23, 2018

AB LUPIN ATLANTIS EQ 30MG BASE A208348 001 Jan 09, 2018

AB EQ 45MG BASE A208348 002 Jan 09, 2018

AB EQ 75MG BASE A208348 003 Jan 09, 2018

AB MACLEODS PHARMS LTD EQ 30MG BASE A207211 001 Sep 14, 2017

AB EQ 45MG BASE A207211 002 Sep 14, 2017

AB EQ 75MG BASE A207211 003 Sep 14, 2017

AB NATCO PHARMA LTD EQ 30MG BASE A202595 001 Aug 03, 2016

AB EQ 45MG BASE A202595 002 Aug 03, 2016

AB EQ 75MG BASE A202595 003 Aug 03, 2016

AB NESHER PHARMS EQ 30MG BASE A208578 001 Feb 24, 2017

AB EQ 45MG BASE A208578 002 Feb 24, 2017

AB EQ 75MG BASE A208578 003 Feb 24, 2017

AB STRIDES PHARMA EQ 30MG BASE A209421 001 Jun 08, 2018

AB EQ 45MG BASE A209421 002 Jun 08, 2018

AB EQ 75MG BASE A209421 003 Jun 08, 2018

TAMIFLU

AB + ROCHE EQ 30MG BASE N021087 003 Jul 02, 2007

AB + EQ 45MG BASE N021087 002 Jul 02, 2007

AB +! EQ 75MG BASE N021087 001 Oct 27, 1999



FOR SUSPENSION;ORAL

OSELTAMIVIR PHOSPHATE

AB ALVOGEN PINE BROOK EQ 6MG BASE/ML A208823 001 Oct 31, 2017

AB AMNEAL PHARMS NY EQ 6MG BASE/ML A210186 001 Feb 27, 2018

AB LUPIN ATLANTIS EQ 6MG BASE/ML A208347 001 Feb 20, 2018

AB NESHER PHARMS EQ 6MG BASE/ML A209113 001 Sep 14, 2017

TAMIFLU

AB +! ROCHE EQ 6MG BASE/ML N021246 002 Mar 21, 2011

OSIMERTINIB MESYLATE

TABLET;ORAL

TAGRISSO

+ ASTRAZENECA PHARMS EQ 40MG BASE N208065 001 Nov 13, 2015

+! EQ 80MG BASE N208065 002 Nov 13, 2015

OSPEMIFENE

TABLET;ORAL

OSPHENA

+! DUCHESNAY 60MG N203505 001 Feb 26, 2013

OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

AP AUROBINDO PHARMA EQ 1GM BASE/VIAL A201539 001 Jan 18, 2013

LTD

AP EQ 2GM BASE/VIAL A201539 002 Jan 18, 2013

AP EQ 10GM BASE/VIAL A201538 001 Jan 18, 2013

AP HOSPIRA INC EQ 1GM BASE/VIAL A203950 001 Dec 11, 2015

AP EQ 2GM BASE/VIAL A203950 002 Dec 11, 2015

AP RENAISSANCE SSA LLC EQ 1GM BASE/VIAL A206681 001 Sep 11, 2017

AP EQ 2GM BASE/VIAL A206681 002 Sep 11, 2017

AP EQ 10GM BASE/VIAL A206760 001 Oct 26, 2017

AP ! SAGENT PHARMS EQ 1GM BASE/VIAL A091246 001 Mar 30, 2012

AP ! EQ 2GM BASE/VIAL A091246 002 Mar 30, 2012

AP ! EQ 10GM BASE/VIAL A091245 001 Mar 30, 2012

AP WOCKHARDT BIO AG EQ 1GM BASE/VIAL A207147 001 Jul 31, 2017

AP EQ 2GM BASE/VIAL A207147 002 Jul 31, 2017

AP EQ 10GM BASE/VIAL A207148 001 Nov 24, 2017



BACTOCILL IN PLASTIC CONTAINER

+! BAXTER HLTHCARE EQ 20MG BASE/ML N050640 001 Oct 26, 1989

+! EQ 40MG BASE/ML N050640 002 Oct 26, 1989

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-336(of 452)

OXALIPLATIN

INJECTABLE;IV (INFUSION)

ELOXATIN

AP +! SANOFI AVENTIS US
50MG/10ML (5MG/ML)
N021759 001 Jan 31, 2005

AP +!
100MG/20ML (5MG/ML)
N021759 002 Jan 31, 2005

OXALIPLATIN

AP ACCORD HLTHCARE 50MG/10ML (5MG/ML)
A207474 001 Mar 21, 2017

AP 100MG/20ML (5MG/ML)
A207474 002 Mar 21, 2017

AP 200MG/40ML (5MG/ML)
A207474 003 Mar 21, 2017

AP ACTAVIS LLC 50MG/10ML (5MG/ML)


A204880 001 Mar 05, 2018

AP 100MG/20ML (5MG/ML)
A204880 002 Mar 05, 2018

AP ACTAVIS TOTOWA 50MG/VIAL


A078803 001 Aug 08, 2012

AP 100MG/VIAL
A078803 002 Aug 08, 2012

AP CIPLA 50MG/10ML (5MG/ML)


A208523 001 Feb 10, 2017

AP 100MG/20ML (5MG/ML)
A208523 002 Feb 10, 2017

AP EUGIA PHARMA 50MG/10ML (5MG/ML)


A205529 001 Sep 06, 2017

AP 100MG/20ML (5MG/ML)
A205529 002 Sep 06, 2017

AP FRESENIUS KABI USA 50MG/10ML (5MG/ML)


A078811 001 Jun 10, 2010

AP 100MG/20ML (5MG/ML)
A078811 002 Jun 10, 2010

AP 50MG/VIAL
A078819 001 Jun 02, 2010

AP 50MG/10ML (5MG/ML)
A090030 001 Jan 31, 2017

AP 100MG/VIAL
A078819 002 Jun 02, 2010

AP 100MG/20ML (5MG/ML)
A090030 002 Jan 31, 2017

AP 200MG/40ML (5MG/ML)
A090030 003 Jan 31, 2017

AP GLAND PHARMA LTD 50MG/10ML (5MG/ML)


A207325 001 Feb 10, 2017

AP 50MG/VIAL
A207385 001 May 23, 2017

AP 100MG/20ML (5MG/ML)
A207325 002 Feb 10, 2017

AP 100MG/VIAL
A207385 002 May 23, 2017

AP 200MG/40ML (5MG/ML)
A207325 003 Oct 18, 2017

AP HOSPIRA INC 50MG/VIAL


A078815 001 Sep 30, 2009

AP 100MG/VIAL
A078815 002 Sep 30, 2009

AP HOSPIRA WORLDWIDE 50MG/10ML (5MG/ML)


A078813 001 Aug 07, 2009

AP 100MG/20ML (5MG/ML)
A078813 002 Aug 07, 2009

AP INGENUS PHARMS LLC 50MG/10ML (5MG/ML)


A207562 001 Oct 16, 2018

AP 100MG/20ML (5MG/ML)
A207562 002 Oct 16, 2018

AP JIANGSU HENGRUI MED 50MG/10ML (5MG/ML)


A203869 001 Jun 18, 2014

AP 100MG/20ML (5MG/ML)
A203869 002 Jun 18, 2014

AP LUITPOLD 50MG/10ML (5MG/ML)


A204378 001 May 12, 2017

AP 100MG/20ML (5MG/ML)
A204378 002 May 12, 2017

AP MYLAN LABS LTD 50MG/10ML (5MG/ML)


A091358 001 Aug 07, 2012

AP 50MG/VIAL
A200979 001 Aug 08, 2012

AP 100MG/20ML (5MG/ML)
A091358 002 Aug 07, 2012

AP 100MG/VIAL
A200979 002 Aug 08, 2012

AP 200MG/40ML (5MG/ML)
A091358 003 Nov 14, 2017

AP QILU PHARM CO LTD 50MG/10ML (5MG/ML)


A204368 001 Jun 07, 2016

AP 50MG/VIAL
A204616 001 May 11, 2016

AP 100MG/20ML (5MG/ML)
A204368 002 Jun 07, 2016

AP 100MG/VIAL
A204616 002 May 11, 2016

AP ! 200MG/40ML (5MG/ML)
A204368 003 Jun 07, 2016

AP SANDOZ 50MG/10ML (5MG/ML)


A078817 001 Jan 24, 2011

AP 100MG/20ML (5MG/ML)
A078817 002 Jan 24, 2011

AP ! SUN PHARMA GLOBAL 50MG/VIAL


A078818 001 Aug 07, 2009

AP 50MG/10ML (5MG/ML)
A202922 001 Apr 08, 2014

AP ! 100MG/VIAL
A078818 002 Aug 07, 2009

AP 100MG/20ML (5MG/ML)
A202922 002 Apr 08, 2014

AP +! TEVA PHARMS 50MG/10ML (5MG/ML)


N022160 001 Aug 07, 2009

AP +! 100MG/20ML (5MG/ML)
N022160 002 Aug 07, 2009

OXANDROLONE

TABLET;ORAL

OXANDROLONE

AB PAR PHARM
2.5MG
A077827 001 Jun 22, 2007

AB !
10MG
A077827 002 Jun 22, 2007

AB UPSHER SMITH LABS


2.5MG
A076761 001 Dec 01, 2006

AB
10MG
A078033 001 Mar 22, 2007

OXAPROZIN

TABLET;ORAL

DAYPRO

AB +! GD SEARLE
600MG
N018841 004 Oct 29, 1992

OXAPROZIN

AB AMNEAL PHARMS CO
600MG
A208633 001 May 04, 2017

AB APOTEX INC
600MG
A075987 001 Sep 02, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-337(of 452)

OXAPROZIN

TABLET;ORAL

OXAPROZIN

AB DR REDDYS LABS LTD 600MG A075855 001 Jan 31, 2001

AB IVAX SUB TEVA 600MG A075846 001 May 13, 2002

PHARMS

AB SANDOZ 600MG A075845 001 Jan 31, 2001

AB SUN PHARM INDS INC 600MG A075844 001 Jan 03, 2002

AB TEVA 600MG A075849 001 Jul 03, 2002



OXAZEPAM

CAPSULE;ORAL

OXAZEPAM

AB ACTAVIS ELIZABETH 10MG A072253 002 Apr 14, 1988

AB 15MG A072253 003 Apr 14, 1988

AB ! 30MG A072253 001 Apr 14, 1988

AB SANDOZ 10MG A071813 001 Apr 19, 1988

AB 15MG A071756 001 Apr 19, 1988

AB 30MG A071814 001 Apr 19, 1988



OXCARBAZEPINE

SUSPENSION;ORAL

OXCARBAZEPINE

AB AMNEAL PHARMS 300MG/5ML A202961 001 Sep 17, 2012

AB SUN PHARM INDS LTD 300MG/5ML A078734 001 Jun 26, 2009

AB WEST-WARD PHARMS 300MG/5ML A201193 001 Oct 03, 2012

INT

TRILEPTAL

AB +! NOVARTIS 300MG/5ML N021285 001 May 25, 2001

TABLET;ORAL

OXCARBAZEPINE

AB ANI PHARMS INC 150MG A078005 001 Dec 11, 2007

AB 300MG A078005 002 Dec 11, 2007

AB 600MG A078005 003 Dec 11, 2007

AB APOTEX INC 150MG A077747 001 Apr 09, 2008

AB 300MG A077747 002 Apr 09, 2008

AB 600MG A077747 003 Apr 09, 2008

AB BRECKENRIDGE PHARM 150MG A078069 001 Jan 11, 2008

AB 300MG A078069 002 Jan 11, 2008

AB 600MG A078069 003 Jan 11, 2008

AB GLENMARK PHARMS LTD 150MG A077802 001 Oct 09, 2007

AB 300MG A077802 002 Oct 09, 2007

AB 600MG A077802 003 Oct 09, 2007

AB SUN PHARM INDS 150MG A077794 001 Oct 09, 2007

AB 300MG A077794 002 Oct 09, 2007

AB 600MG A077794 003 Oct 09, 2007

AB TARO 150MG A077801 001 Nov 15, 2007

AB 300MG A077801 002 Nov 15, 2007

AB 600MG A077801 003 Nov 15, 2007

AB WEST-WARD PHARMS 150MG A077795 001 Oct 09, 2007

INT

AB 300MG A077795 002 Oct 09, 2007

AB 600MG A077795 003 Oct 09, 2007

TRILEPTAL

AB + NOVARTIS 150MG N021014 001 Jan 14, 2000

AB + 300MG N021014 002 Jan 14, 2000

AB +! 600MG N021014 003 Jan 14, 2000



TABLET, EXTENDED RELEASE;ORAL

OXTELLAR XR

+ SUPERNUS PHARMS 150MG N202810 001 Oct 19, 2012

+ 300MG N202810 002 Oct 19, 2012

+! 600MG N202810 003 Oct 19, 2012

OXICONAZOLE NITRATE

CREAM;TOPICAL

OXICONAZOLE NITRATE

AB TARO PHARMS EQ 1% BASE A205076 001 Mar 07, 2016

OXISTAT

AB +! FOUGERA PHARMS EQ 1% BASE N019828 001 Dec 30, 1988

LOTION;TOPICAL

OXISTAT

+! FOUGERA PHARMS EQ 1% BASE N020209 001 Sep 30, 1992

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-338(of 452)

OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYTROL

+! ALLERGAN SALES LLC 3.9MG/24HR N021351 002 Feb 26, 2003

OXYBUTYNIN CHLORIDE

GEL;TRANSDERMAL

GELNIQUE

AB +! ALLERGAN SALES LLC 10% (100MG/PACKET) N022204 001 Jan 27, 2009

OXYBUTYNIN CHLORIDE

AB PAR PHARM INC 10% (100MG/PACKET) A207329 001 May 31, 2018

SYRUP;ORAL

OXYBUTYNIN CHLORIDE

AA LANNETT CO INC 5MG/5ML A074520 001 Mar 29, 1996

AA 5MG/5ML A076682 001 Dec 28, 2004

AA PHARM ASSOC 5MG/5ML A075137 001 Dec 18, 1998

AA ! WOCKHARDT BIO AG 5MG/5ML A074868 001 Feb 12, 1997



TABLET;ORAL

OXYBUTYNIN CHLORIDE

AB ABHAI LLC 5MG A209335 001 Dec 22, 2017

AB APPCO PHARMA LLC 5MG A209025 001 Dec 21, 2017

AB NOVITIUM PHARMA 5MG A209823 001 Oct 23, 2017

AB TEVA PHARMS USA 5MG A071655 001 Nov 14, 1988

AB TULEX PHARMS INC 5MG A210125 001 Sep 06, 2018

AB UPSHER SMITH LABS 5MG A074625 001 Jul 31, 1996

AB ! VINTAGE PHARMS 5MG A075079 001 Oct 31, 1997



TABLET, EXTENDED RELEASE;ORAL

DITROPAN XL

AB + JANSSEN PHARMS 5MG N020897 001 Dec 16, 1998

AB + 10MG N020897 002 Dec 16, 1998

OXYBUTYNIN CHLORIDE

AB ACCORD HLTHCARE 5MG A207138 001 Feb 29, 2016

AB 10MG A207138 002 Feb 29, 2016

AB 15MG A207138 003 Feb 29, 2016

AB AMNEAL PHARMS 5MG A204010 001 Nov 23, 2015

AB 10MG A204010 002 Nov 23, 2015

AB 15MG A204010 003 Nov 23, 2015

AB IMPAX PHARMS 5MG A076745 002 May 09, 2007

AB 10MG A076745 003 May 09, 2007

AB 15MG A076745 001 Nov 09, 2006

AB MYLAN 5MG A076702 001 Nov 09, 2006

AB MYLAN PHARMS INC 10MG A076644 001 Nov 09, 2006

AB ! 15MG A076644 002 May 10, 2007

AB OSMOTICA PHARM US 5MG A078503 001 Feb 04, 2009

AB 10MG A078503 002 Feb 04, 2009

AB 15MG A078503 003 Feb 04, 2009

AB UNIQUE PHARM LABS 5MG A206121 001 May 27, 2016

AB 10MG A206121 002 May 27, 2016

AB 15MG A206121 003 May 27, 2016

AB ZYDUS PHARMS USA 5MG A202332 001 Jun 26, 2017

INC

AB 10MG A202332 002 Jun 26, 2017

AB 15MG A202332 003 Jun 26, 2017



OXYCODONE

CAPSULE, EXTENDED RELEASE;ORAL

XTAMPZA ER

+ COLLEGIUM PHARM INC 9MG N208090 001 Apr 26, 2016

+ 13.5MG N208090 002 Apr 26, 2016

+ 18MG N208090 003 Apr 26, 2016

+ 27MG N208090 004 Apr 26, 2016

+! 36MG N208090 005 Apr 26, 2016



OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL

OXYCODONE HYDROCHLORIDE

AB ANI PHARMS INC 5MG A205177 001 Mar 31, 2016

AB AVANTHI INC 5MG A202773 001 Aug 17, 2015

AB +! GENUS LIFESCIENCES 5MG N200534 001 Oct 20, 2010

AB LANNETT CO INC 5MG A203823 001 Aug 01, 2014

AB MAYNE PHARMA INC 5MG A203107 001 Jul 26, 2012

AB NOVEL LABS INC 5MG A204752 001 Aug 24, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-339(of 452)

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL

OXYCODONE HYDROCHLORIDE

AA ABHAI LLC 5MG/5ML
A208593 001 Jul 21, 2017

AA 100MG/5ML
A208593 002 Jul 21, 2017

AA ANI PHARMS INC 5MG/5ML


A204979 001 Jun 01, 2015

AA 100MG/5ML
A203447 001 Aug 30, 2017

AA ASCENT PHARMS INC 5MG/5ML


A209021 001 Nov 09, 2017

AA 100MG/5ML
A209021 002 Nov 09, 2017

AA + GENUS LIFESCIENCES 5MG/5ML


N200535 002 Aug 22, 2013

AA +! 100MG/5ML
N200535 001 Oct 20, 2010

AA HI-TECH PHARMACAL 5MG/5ML


A208817 001 Aug 10, 2017

AA 100MG/5ML
A208795 001 Aug 07, 2017

AA LANNETT CO INC 100MG/5ML


A204085 001 Sep 09, 2014

AA MAYNE PHARMA INC 100MG/5ML


A204092 001 Jun 05, 2014

AA NOVEL LABS INC 100MG/5ML


A204603 001 Apr 29, 2015

AA PHARM ASSOC 100MG/5ML


A206822 001 Aug 15, 2017

AA SPECGX LLC 5MG/5ML


A210758 001 Apr 30, 2018

AA 100MG/5ML
A210758 002 Apr 30, 2018

AA +! VISTAPHARM 5MG/5ML
N201194 001 Jan 12, 2012

AA 100MG/5ML
A202537 001 Jul 30, 2012

AA WES PHARMA INC 5MG/5ML


A207511 001 Nov 23, 2016

AA 100MG/5ML
A209897 001 Sep 06, 2017

AA WEST-WARD PHARMS 5MG/5ML


A204037 001 Jul 15, 2013

INT
AA 100MG/5ML
A203208 001 Jul 12, 2013

AA WOCKHARDT BIO AG 5MG/5ML


A206456 001 Jun 16, 2015

TABLET;ORAL

OXYCODONE HYDROCHLORIDE

AB ACTAVIS ELIZABETH
5MG
A076636 003 Apr 07, 2015

AB
15MG
A076636 001 Feb 06, 2004

AB
30MG
A076636 002 Feb 06, 2004

AB ALVOGEN MALTA
5MG
A202116 001 Dec 30, 2011

AB
15MG
A202116 002 Dec 30, 2011

AB
30MG
A202116 003 Dec 30, 2011

AB AMNEAL PHARMS
5MG
A203638 001 Jun 03, 2014

AB
10MG
A203638 002 Jun 03, 2014

AB
15MG
A203638 003 Jun 03, 2014

AB
20MG
A203638 004 Jun 03, 2014

AB
30MG
A203638 005 Jun 03, 2014

AB ASCENT PHARMS INC


15MG
A207418 001 Aug 07, 2017

AB
30MG
A207418 002 Aug 07, 2017

AB AUROLIFE PHARMA LLC


5MG
A202160 001 Nov 19, 2012

AB
15MG
A202160 002 Nov 19, 2012

AB
30MG
A202160 003 Nov 19, 2012

AB AVANTHI INC
5MG
A091393 001 Aug 31, 2009

AB
10MG
A091393 002 Aug 31, 2009

AB
15MG
A091393 003 Aug 31, 2009

AB
20MG
A091393 004 Aug 31, 2009

AB
30MG
A091393 005 Aug 31, 2009

AB EPIC PHARMA LLC


5MG
A090895 001 Aug 24, 2009

AB
5MG
A202662 001 Sep 22, 2015

AB
10MG
A202662 002 Sep 22, 2015

AB
15MG
A090895 002 Aug 24, 2009

AB
15MG
A202662 003 Sep 22, 2015

AB
20MG
A202662 005 Apr 27, 2017

AB
30MG
A090895 003 Aug 24, 2009

AB
30MG
A202662 004 Sep 22, 2015

AB MAYNE PHARMA INC


5MG
A091313 001 Feb 18, 2011

AB
10MG
A091313 004 Apr 29, 2016

AB
15MG
A091313 002 Feb 18, 2011

AB
20MG
A091313 005 Apr 29, 2016

AB
30MG
A091313 003 Feb 18, 2011

AB NESHER PHARMS
5MG
A077290 001 Dec 08, 2005

AB
10MG
A077290 002 Dec 08, 2005

AB
15MG
A077290 003 Dec 08, 2005

AB
20MG
A077290 004 Dec 08, 2005

AB
30MG
A077290 005 Dec 08, 2005

AB NOVEL LABS INC


5MG
A204021 001 Jun 12, 2017

AB
10MG
A204021 002 Jun 12, 2017

AB
15MG
A204021 003 Jun 12, 2017

AB
20MG
A204021 004 Jun 12, 2017

AB
30MG
A204021 005 Jun 12, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-340(of 452)

OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE HYDROCHLORIDE

AB NUVO PHARM 5MG A207119 001 Apr 12, 2016

AB 10MG A207119 002 Apr 12, 2016

AB 15MG A207119 003 Apr 12, 2016

AB 20MG A207119 004 Apr 12, 2016

AB 30MG A207119 005 Apr 12, 2016

AB RHODES PHARMS 5MG A091490 001 Mar 09, 2011

AB 10MG A091490 002 Mar 09, 2011

AB 15MG A091490 003 Mar 09, 2011

AB 20MG A091490 004 Mar 09, 2011

AB 30MG A091490 005 Mar 09, 2011

AB SPECGX LLC 5MG A076758 003 Mar 19, 2007

AB 15MG A076758 001 Jun 30, 2004

AB 30MG A076758 002 Jun 30, 2004

AB SUN PHARM INDS INC 5MG A090659 001 Apr 10, 2009

AB 10MG A090659 005 Nov 06, 2012

AB 15MG A090659 002 Apr 10, 2009

AB 20MG A090659 004 Nov 06, 2012

AB 30MG A090659 003 Apr 10, 2009

AB VINTAGE PHARMS 5MG A077712 003 Mar 02, 2009

AB 10MG A077712 004 Apr 13, 2015

AB 15MG A077712 001 Jan 31, 2007

AB 20MG A077712 005 Apr 13, 2015

AB 30MG A077712 002 Jan 31, 2007

ROXICODONE

AB + SPECGX LLC 5MG N021011 003 May 15, 2009

AB +! 15MG N021011 001 Aug 31, 2000

AB + 30MG N021011 002 Aug 31, 2000

OXAYDO

EGALET US INC 5MG N202080 001 Jun 17, 2011

7.5MG N202080 002 Jun 17, 2011

TABLET, EXTENDED RELEASE;ORAL

OXYCONTIN

+ PURDUE PHARMA LP 10MG N022272 001 Apr 05, 2010

+ 15MG N022272 002 Apr 05, 2010

+ 20MG N022272 003 Apr 05, 2010

+ 30MG N022272 004 Apr 05, 2010

+! 40MG N022272 005 Apr 05, 2010

+ 60MG N022272 006 Apr 05, 2010

+ 80MG N022272 007 Apr 05, 2010



OXYMETAZOLINE HYDROCHLORIDE

CREAM;TOPICAL

RHOFADE

+! ACLARIS 1% N208552 001 Jan 18, 2017

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

SPRAY, METERED;NASAL

KOVANAZE

+! ST RENATUS 0.1MG/SPRAY;6MG/SPRAY N208032 001 Jun 29, 2016

OXYMETHOLONE

TABLET;ORAL

ANADROL-50

+! MYLAN SPECIALITY LP 50MG N016848 001

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL

OPANA

AB + ENDO PHARMS 5MG N021611 001 Jun 22, 2006

AB +! 10MG N021611 002 Jun 22, 2006

OXYMORPHONE HYDROCHLORIDE

AB ASCENT PHARMS INC 5MG A210175 001 Feb 02, 2018

AB 10MG A210175 002 Feb 02, 2018

AB AUROLIFE PHARMA LLC 5MG A204459 001 Apr 26, 2016

AB 10MG A204459 002 Apr 26, 2016

AB AVANTHI INC 5MG A203601 001 Jan 30, 2013

AB 10MG A203601 002 Jan 30, 2013

AB EPIC PHARMA LLC 5MG A201187 001 Dec 15, 2014

AB 10MG A201187 002 Dec 15, 2014

AB SPECGX LLC 5MG A202321 001 Apr 25, 2013

AB 10MG A202321 002 Apr 25, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-341(of 452)

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL

OXYMORPHONE HYDROCHLORIDE

AB TEVA 5MG A091443 002 Feb 15, 2011

AB 10MG A091443 001 Feb 15, 2011

AB WEST-WARD PHARMS 5MG A090964 001 Sep 27, 2010

INT

AB 10MG A090964 002 Sep 27, 2010

TABLET, EXTENDED RELEASE;ORAL

OXYMORPHONE HYDROCHLORIDE

AB ACTAVIS ELIZABETH 5MG A079046 003 Jul 11, 2013

AB 7.5MG A079046 001 Dec 13, 2010

AB 10MG A079046 004 Jul 11, 2013

AB 15MG A079046 002 Dec 13, 2010

AB 20MG A079046 005 Jul 11, 2013

AB 30MG A079046 006 Jul 11, 2013

AB 40MG A079046 007 Jul 11, 2013

AB IMPAX LABS 5MG A079087 001 Jun 14, 2010

AB 7.5MG A079087 002 Dec 21, 2010

AB 10MG A079087 003 Jun 14, 2010

AB 15MG A079087 004 Dec 21, 2010

AB 20MG A079087 005 Jun 14, 2010

AB 30MG A079087 006 Jul 22, 2010

AB SPECGX LLC 5MG A202946 001 Jun 27, 2014

AB 7.5MG A202946 002 Jun 27, 2014

AB 10MG A202946 003 Jun 27, 2014

AB 15MG A202946 004 Jun 27, 2014

AB 20MG A202946 005 Jun 27, 2014

AB 30MG A202946 006 Jun 27, 2014

AB 40MG A202946 007 Jun 27, 2014

AB WEST-WARD PHARMS 5MG A200822 002 Jul 15, 2013

INT

AB 7.5MG A200822 003 Jul 15, 2013

AB 10MG A200822 004 Jul 15, 2013

AB 15MG A200822 005 Jul 15, 2013

AB 20MG A200822 006 Jul 15, 2013

AB 30MG A200822 007 Jul 15, 2013

AB 40MG A200822 001 Jul 15, 2013



! IMPAX LABS 40MG A079087 007 Jun 14, 2010

OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN

AP +! FRESENIUS KABI USA 10USP UNITS/ML (10USP UNITS/ML) N018248 001

AP +! 100USP UNITS/10ML (10USP UNITS/ML) N018248 002

AP HIKMA FARMACEUTICA 10USP UNITS/ML (10USP UNITS/ML) A200219 001 Feb 13, 2013

AP SAGENT PHARMS 10USP UNITS/ML (10USP UNITS/ML) A091676 001 Jul 13, 2018

AP 100USP UNITS/10ML (10USP UNITS/ML) A091676 002 Jul 13, 2018

AP +! WEST-WARD PHARMS 10USP UNITS/ML (10USP UNITS/ML) N018243 001



INT

AP +! 100USP UNITS/10ML (10USP UNITS/ML) N018243 002 Jan 10, 2007

PITOCIN

AP +! PAR STERILE 10USP UNITS/ML (10USP UNITS/ML) N018261 001

PRODUCTS

AP + 100USP UNITS/10ML (10USP UNITS/ML) N018261 002 Jul 27, 2007

OXYTOCIN

+! FRESENIUS KABI USA 300USP UNITS/30ML (10USP UNITS/ML) N018248 003 Jul 27, 2007

PITOCIN

+ PAR STERILE 500USP UNITS/50ML (10USP UNITS/ML) N018261 003 Sep 05, 2012

PRODUCTS

OZENOXACIN

CREAM;TOPICAL

XEPI

+! FERRER 1% N208945 001 Dec 11, 2017

INTERNACIONAL

PACLITAXEL

FOR SUSPENSION;IV (INFUSION)

ABRAXANE

+! ABRAXIS BIOSCIENCE 100MG/VIAL N021660 001 Jan 07, 2005

INJECTABLE;INJECTION

PACITAXEL

AP GLAND PHARMA LTD 6MG/ML A207326 001 Aug 23, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-342(of 452)

PACLITAXEL

INJECTABLE;INJECTION

PACLITAXEL

AP ACCORD HLTHCARE 6MG/ML A205720 001 Aug 17, 2018

AP ACTAVIS TOTOWA 6MG/ML A090130 001 Dec 09, 2009

AP FRESENIUS KABI USA 6MG/ML A077574 001 Nov 27, 2006

AP ! HOSPIRA 6MG/ML A076131 001 May 08, 2002

AP MYLAN LABS LTD 6MG/ML A091540 001 Sep 29, 2011

AP SANDOZ INC 6MG/ML A078167 001 Dec 26, 2007

AP TEVA PHARMS 6MG/ML A075184 001 Jan 25, 2002

AP WEST-WARD PHARMS 6MG/ML A075190 001 Jan 28, 2002

INT

TAXOL

AP + HQ SPCLT PHARMA 6MG/ML N020262 001 Dec 29, 1992

PALBOCICLIB

CAPSULE;ORAL

IBRANCE

+ PFIZER INC 75MG N207103 001 Feb 03, 2015

+ 100MG N207103 002 Feb 03, 2015

+! 125MG N207103 003 Feb 03, 2015

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

INVEGA

AB + JANSSEN PHARMS 1.5MG N021999 006 Aug 26, 2008

AB + 3MG N021999 001 Dec 19, 2006

AB +! 6MG N021999 002 Dec 19, 2006

AB + 9MG N021999 003 Dec 19, 2006

PALIPERIDONE

AB ACTAVIS LABS FL INC 1.5MG A202645 001 Aug 03, 2015

AB 3MG A202645 002 Aug 03, 2015

AB 6MG A202645 003 Aug 03, 2015

AB 9MG A202645 004 Aug 03, 2015

AB MYLAN PHARMS INC 1.5MG A203802 001 Sep 24, 2015

AB 3MG A203802 002 Sep 24, 2015

AB 6MG A203802 003 Sep 24, 2015

AB 9MG A203802 004 Sep 24, 2015

AB SUN PHARMA GLOBAL 1.5mg A205618 001 Apr 06, 2018

AB 3MG A205618 002 Apr 06, 2018

AB 6MG A205618 003 Apr 06, 2018

AB 9MG A205618 004 Apr 06, 2018



PALIPERIDONE PALMITATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

INVEGA SUSTENNA

+ JANSSEN PHARMS 39MG/0.25ML (39MG/0.25ML) N022264 001 Jul 31, 2009

+ 78MG/0.5ML (78MG/0.5ML) N022264 002 Jul 31, 2009

+ 117MG/0.75ML (117MG/0.75ML) N022264 003 Jul 31, 2009

+! 156MG/ML (156MG/ML) N022264 004 Jul 31, 2009

+ 234MG/1.5ML (156MG/ML) N022264 005 Jul 31, 2009

INVEGA TRINZA

+ JANSSEN PHARMS 273MG/0.875ML (273MG/0.875ML) N207946 001 May 18, 2015

+ 410MG/1.315ML (311.79MG/ML) N207946 002 May 18, 2015

+ 546MG/1.75ML (312MG/ML) N207946 003 May 18, 2015

+! 819MG/2.625ML (312MG/ML) N207946 004 May 18, 2015



PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

ALOXI

AP +! HELSINN HLTHCARE EQ 0.075MG BASE/1.5ML (EQ 0.05MG N021372 002 Feb 29, 2008

BASE/ML)

AP +! EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N021372 001 Jul 25, 2003

PALONOSETRON HYDROCHLORIDE

AP AUROBINDO PHARMA EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A204702 001 Nov 06, 2018

LTD

AP CIPLA EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A206396 001 Sep 19, 2018

AP DR REDDYS LABS LTD EQ 0.075MG BASE/1.5ML (EQ 0.05MG A201533 001 Apr 21, 2016

BASE/ML)

AP EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A201533 002 Apr 21, 2016

AP FRESENIUS KABI USA EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A206801 001 Sep 19, 2018

AP EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A206802 001 Sep 19, 2018

AP HOSPIRA INC EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A207005 001 Sep 19, 2018

AP EQ 0.075MG BASE/1.5ML (EQ 0.05MG A207005 002 Sep 19, 2018

BASE/ML)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-343(of 452)

PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

PALONOSETRON HYDROCHLORIDE

AP MYLAN INSTITUTIONAL EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A206416 001 Sep 19, 2018

AP QILU PHARM CO LTD EQ 0.075MG BASE/1.5ML (EQ 0.05MG A205648 002 Sep 19, 2018

BASE/ML)

AP EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A205648 001 Sep 19, 2018

AP SAGENT PHARMS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A204289 001 Sep 19, 2018

AP EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A205870 001 Sep 19, 2018

AP SANDOZ INC EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A202521 001 Oct 13, 2015

AP TEVA PHARMS USA EQ 0.075MG BASE/1.5ML (EQ 0.05MG A090713 002 Mar 23, 2018

BASE/ML)

AP EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A090713 001 Mar 23, 2018

AP VIRTUS PHARM EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) A209287 001 Sep 19, 2018

SOLUTION;INTRAVENOUS

PALONOSETRON HYDROCHLORIDE

EXELA PHARMA EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) N207963 001 Aug 22, 2016

SCIENCE

+ FRESENIUS KABI USA EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N208109 001 Nov 21, 2017

PAMIDRONATE DISODIUM

INJECTABLE;INJECTION

PAMIDRONATE DISODIUM

AP AREVA PHARMS 30MG/VIAL A077433 001 Nov 26, 2008

AP 90MG/VIAL A077433 003 Nov 26, 2008

AP FRESENIUS KABI USA 30MG/VIAL A075773 001 May 06, 2002

AP 30MG/10ML (3MG/ML) A076207 001 May 17, 2002

AP 90MG/VIAL A075773 002 May 06, 2002

AP 90MG/10ML (9MG/ML) A076207 002 May 17, 2002

AP ! HOSPIRA 30MG/10ML (3MG/ML) A075841 001 Jun 27, 2002

AP ! 60MG/10ML (6MG/ML) A075841 002 Jun 27, 2002

AP ! 90MG/10ML (9MG/ML) A075841 003 Jun 27, 2002

AP LUITPOLD 30MG/10ML (3MG/ML) A078942 001 Jul 25, 2008

AP 90MG/10ML (9MG/ML) A078942 002 Jul 25, 2008

AP MYLAN LABS LTD 30MG/10ML (3MG/ML) A078520 001 Oct 31, 2008

AP 90MG/10ML (9MG/ML) A078520 002 Oct 31, 2008

AP PLIVA LACHEMA 30MG/10ML (3MG/ML) A078156 001 Aug 19, 2008

AP 60MG/10ML (6MG/ML) A078156 002 Aug 19, 2008

AP 90MG/10ML (9MG/ML) A078156 003 Aug 19, 2008

AP SAGENT PHARMS 30MG/10ML (3MG/ML) A078373 001 Dec 23, 2008

AP 90MG/10ML (9MG/ML) A078373 002 Dec 23, 2008

AP SUN PHARMA GLOBAL 30MG/VIAL A077703 001 Dec 24, 2008

AP 90MG/VIAL A077703 002 Dec 24, 2008

AP TEVA PHARMS USA 30MG/10ML (3MG/ML) A076153 001 Mar 27, 2002

AP 90MG/10ML (9MG/ML) A076153 002 Mar 27, 2002

AP WEST-WARD PHARMS 30MG/VIAL A075290 001 Apr 30, 2001

INT

AP +! 30MG/10ML (3MG/ML) N021113 001 Mar 04, 2002

AP 90MG/VIAL A075290 003 Apr 30, 2001

AP +! 90MG/10ML (9MG/ML) N021113 002 Mar 04, 2002



AREVA PHARMS 60MG/VIAL A077433 002 Nov 26, 2008

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE, DELAYED RELEASE;ORAL



CREON

+ ABBVIE 60,000USP UNITS;12,000USP N020725 002 Apr 30, 2009

UNITS;38,000USP UNITS

+ 15,000USP UNITS;3,000USP UNITS;9,500USP N020725 004 Jul 12, 2011

UNITS

+ 30,000USP UNITS;6,000USP N020725 001 Apr 30, 2009

UNITS;19,000USP UNITS

+ 180,000USP UNITS;36,000USP N020725 005 Mar 14, 2013

UNITS;114,000USP UNITS

+! 120,000USP UNITS;24,000USP N020725 003 Apr 30, 2009

UNITS;76,000USP UNITS

PANCREAZE

+ VIVUS INC 10,850USP UNITS;2,600USP UNITS;6,200USP N022523 005 Mar 07, 2014

UNITS

+ 24,600USP UNITS; 4,200USP UNITS; N022523 001 Apr 12, 2010

14,200USP UNITS

+ 61,500USP UNITS; 10,500USP UNITS; N022523 002 Apr 12, 2010

35,500USP UNITS

+ 83,900USP UNITS; 21,000USP UNITS; N022523 004 Apr 12, 2010

54,700USP UNITS

+! 98,400USP UNITS; 16,800USP UNITS; N022523 003 Apr 12, 2010

56,800USP UNITS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-344(of 452)

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)

CAPSULE, DELAYED RELEASE;ORAL



PERTZYE

+ DIGESTIVE CARE INC 30,250USP UNITS;8,000USP N022175 001 May 17, 2012

UNITS;28,750USP UNITS

+! 60,500USP UNITS;16,000USP N022175 002 May 17, 2012

UNITS;57,500USP UNITS

+ 15,125USP UNITS;4,000USP N022175 003 Oct 06, 2016

UNITS;14,375USP UNITS

+ 90,750USP UNITS;24,000USP N022175 004 Jul 13, 2017

UNITS;86,250USP UNITS

ZENPEP

+ FOREST LABS INC 168,000USP UNITS;40,000USP N022210 007 Mar 25, 2014

UNITS;126,000USP UNITS

+ 14,000USP UNITS;3,000USP N022210 005 Jun 15, 2011

UNITS;10,000USP UNITS

+ 24,000USP UNITS;5,000USP N022210 001 Aug 27, 2009

UNITS;17,000USP UNITS

+ 42,000USP UNITS;10,000USP N022210 002 Aug 27, 2009

UNITS;32,000USP UNITS

+ 63,000USP UNITS;15,000USP N022210 003 Aug 27, 2009

UNITS;47,000USP UNITS

+ 84,000USP UNITS;20,000USP N022210 004 Aug 27, 2009

UNITS;63,000USP UNITS

+! 105,000USP UNITS;25,000USP N022210 006 Jul 13, 2011

UNITS;79,000USP UNITS

TABLET;ORAL

VIOKACE

+ FOREST LABS INC 39,150USP UNITS;10,440USP N022542 001 Mar 01, 2012

UNITS;39,150USP UNITS

+! 78,300USP UNITS;20,880USP N022542 002 Mar 01, 2012

UNITS;78,300USP UNITS

PANCURONIUM BROMIDE

INJECTABLE;INJECTION

PANCURONIUM BROMIDE

AP HOSPIRA 1MG/ML A072320 001 Jan 19, 1989

AP ! TEVA PHARMS USA 1MG/ML A072759 001 Jul 31, 1990



! 2MG/ML A072760 001 Jul 31, 1990

PANOBINOSTAT LACTATE

CAPSULE;ORAL

FARYDAK

+ NOVARTIS PHARMS EQ 10MG BASE N205353 001 Feb 23, 2015

CORP

+ EQ 15MG BASE N205353 002 Feb 23, 2015

+! EQ 20MG BASE N205353 003 Feb 23, 2015

PANTOPRAZOLE SODIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL

PROTONIX

+! WYETH PHARMS EQ 40MG BASE N022020 001 Nov 14, 2007

INJECTABLE;IV (INFUSION)

PANTOPRAZOLE SODIUM

AP AKORN INC EQ 40MG BASE/VIAL A079197 001 Nov 08, 2012

AP AUROBINDO PHARMA EQ 40MG BASE/VIAL A205675 001 Mar 30, 2016

LTD

AP MYLAN LABS LTD EQ 40MG BASE/VIAL A208580 001 May 04, 2018

AP SANDOZ INC EQ 40MG BASE/VIAL A090296 001 Jul 14, 2015

PROTONIX IV

AP +! WYETH PHARMS EQ 40MG BASE/VIAL N020988 001 Mar 22, 2001

POWDER;IV (INFUSION)

PANTOPRAZOLE SODIUM

EXELA PHARMA SCS EQ 40MG BASE/VIAL N209463 001 Jun 30, 2017

LLC

TABLET, DELAYED RELEASE;ORAL

PANTOPRAZOLE SODIUM

AB ACTAVIS TOTOWA EQ 20MG BASE A090797 001 Feb 07, 2011

AB EQ 40MG BASE A090797 002 Feb 07, 2011

AB AMNEAL PHARMS EQ 20MG BASE A205119 001 Jan 26, 2016

AB EQ 40MG BASE A205119 002 Jan 26, 2016

AB APOTEX INC EQ 20MG BASE A090807 001 May 02, 2012

AB EQ 40MG BASE A090807 002 May 02, 2012

AB AUROBINDO PHARMA EQ 20MG BASE A202038 001 Sep 28, 2012

LTD

AB EQ 40MG BASE A202038 002 Sep 28, 2012

AB DR REDDYS LABS LTD EQ 20MG BASE A077619 001 Jan 19, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-345(of 452)

PANTOPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL

PANTOPRAZOLE SODIUM

AB EQ 40MG BASE A077619 002 Jan 19, 2011

AB HETERO LABS LTD V EQ 20MG BASE A202882 001 Sep 10, 2014

AB EQ 40MG BASE A202882 002 Sep 10, 2014

AB JUBILANT GENERICS EQ 20MG BASE A090901 001 Aug 30, 2011

AB EQ 40MG BASE A090901 002 Aug 30, 2011

AB LANNETT CO INC EQ 20MG BASE A078281 001 Jan 20, 2011

AB EQ 40MG BASE A078281 002 Jan 20, 2011

AB MACLEODS PHARMS LTD EQ 20MG BASE A200821 001 Feb 16, 2012

AB EQ 40MG BASE A200821 002 Feb 16, 2012

AB MYLAN PHARMS INC EQ 20MG BASE A090970 001 Jan 19, 2011

AB EQ 40MG BASE A090970 002 Jan 19, 2011

AB ORCHID HLTHCARE EQ 20MG BASE A202052 001 Dec 02, 2014

AB EQ 40MG BASE A202052 002 Dec 02, 2014

AB PERRIGO R AND D EQ 20MG BASE A203024 001 May 07, 2014

AB TEVA EQ 20MG BASE A077056 001 Aug 02, 2007

AB EQ 40MG BASE A077056 002 Aug 02, 2007

AB TORRENT PHARMS EQ 20MG BASE A090074 001 Jan 19, 2011

AB EQ 40MG BASE A090074 002 Jan 19, 2011

AB WOCKHARDT EQ 20MG BASE A091231 001 Jan 19, 2011

AB EQ 40MG BASE A091231 002 Jan 19, 2011

PROTONIX

AB + WYETH PHARMS EQ 20MG BASE N020987 002 Jun 12, 2001

AB +! EQ 40MG BASE N020987 001 Feb 02, 2000



PARICALCITOL

CAPSULE;ORAL

PARICALCITOL

AB AMNEAL PHARMS 1MCG A204327 001 Jan 13, 2016

AB 2MCG A204327 002 Jan 13, 2016

AB 4MCG A204327 003 Jan 13, 2016

AB AUROBINDO PHARMA 1MCG A207672 001 Jan 14, 2016

LTD

AB 2MCG A207672 002 Jan 14, 2016

AB 4MCG A207672 003 Jan 14, 2016

AB BIONPHARMA INC 1MCG A202539 001 Mar 27, 2014

AB 2MCG A202539 002 Mar 27, 2014

AB 4MCG A202539 003 Mar 27, 2014

AB DR REDDYS LABS LTD 1MCG A091412 001 Jun 24, 2014

AB 2MCG A091412 002 Jun 24, 2014

AB 4MCG A091412 003 Jun 24, 2014

AB LOTUS PHARM CO LTD 1MCG A206710 001 Feb 24, 2016

AB 2MCG A206710 002 Feb 24, 2016

AB 4MCG A206710 003 Feb 24, 2016

AB MARKSANS PHARMA 1MCG A204948 001 Oct 07, 2016

AB 2MCG A204948 002 Oct 07, 2016

AB 4MCG A204948 003 Oct 07, 2016

AB RISING PHARMS 1MCG A202124 001 Jun 24, 2014

AB 2MCG A202124 002 Jun 24, 2014

AB 4MCG A202124 003 Jun 24, 2014

AB TEVA PHARMS USA 1MCG A090829 001 Sep 27, 2013

AB 2MCG A090829 002 Sep 27, 2013

AB ! 4MCG A090829 003 Sep 27, 2013

ZEMPLAR

AB + ABBVIE 1MCG N021606 001 May 26, 2005

AB + 2MCG N021606 002 May 26, 2005

SOLUTION;INTRAVENOUS

PARICALCITOL

AP ACCORD HLTHCARE 0.002MG/ML (0.002MG/ML) N207174 001 Feb 04, 2016

AP 0.005MG/ML (0.005MG/ML) N207174 002 Feb 04, 2016

AP 0.01MG/2ML (0.005MG/ML) N207174 003 Feb 04, 2016

AP AKORN 0.005MG/ML (0.005MG/ML) A207692 001 Oct 16, 2017

AP AMNEAL PHARMS CO 0.002MG/ML (0.002MG/ML) A206699 001 Mar 09, 2017

AP 0.005MG/ML (0.005MG/ML) A206699 002 Mar 09, 2017

AP 0.01MG/2ML (0.005MG/ML) A206699 003 Mar 09, 2017

AP AUROBINDO PHARMA 0.002MG/ML (0.002MG/ML) A205982 001 Oct 09, 2018

LTD

AP 0.005MG/ML (0.005MG/ML) A205982 002 Oct 09, 2018

AP 0.01MG/2ML (0.005MG/ML) A205982 003 Oct 09, 2018

AP DR REDDYS LABS LTD 0.002MG/ML (0.002MG/ML) A204910 001 Aug 17, 2016

AP 0.005MG/ML (0.005MG/ML) A204910 002 Aug 17, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-346(of 452)

PARICALCITOL

SOLUTION;INTRAVENOUS

PARICALCITOL

AP
0.01MG/2ML (0.005MG/ML)
A204910 003 Aug 17, 2016

AP HIKMA PHARMS
0.002MG/ML (0.002MG/ML)
N205917 001 Nov 18, 2014

AP
0.005MG/ML (0.005MG/ML)
N205917 002 Nov 18, 2014

AP
0.01MG/2ML (0.005MG/ML)
N205917 003 Nov 18, 2014

AP HOSPIRA INC
0.002MG/ML (0.002MG/ML)
N201657 001 Oct 21, 2014

AP
0.005MG/ML (0.005MG/ML)
N201657 002 Oct 21, 2014

AP
0.01MG/2ML (0.005MG/ML)
N201657 003 Oct 21, 2014

AP MYLAN LABS LTD


0.002MG/ML (0.002MG/ML)
A203897 001 Nov 02, 2017

AP
0.005MG/ML (0.005MG/ML)
A203897 002 Nov 02, 2017

AP
0.01MG/2ML (0.005MG/ML)
A203897 003 Nov 02, 2017

AP SANDOZ INC
0.002MG/ML (0.002MG/ML)
A091108 001 Jul 27, 2011

AP
0.005MG/ML (0.005MG/ML)
A091108 002 Jul 27, 2011

AP
0.01MG/2ML (0.005MG/ML)
A091108 003 Jul 27, 2011

ZEMPLAR

AP +! ABBVIE
0.002MG/ML (0.002MG/ML)
N020819 002 Feb 01, 2000

AP +!
0.005MG/ML (0.005MG/ML)
N020819 001 Apr 17, 1998

AP +!
0.01MG/2ML (0.005MG/ML)
N020819 003 Feb 01, 2000

PAROMOMYCIN SULFATE

CAPSULE;ORAL

PAROMOMYCIN SULFATE

AA HERITAGE PHARMS INC
EQ 250MG BASE
A065173 001 Dec 14, 2007

AA ! SUN PHARM INDS INC


EQ 250MG BASE
A064171 001 Jun 30, 1997

PAROXETINE HYDROCHLORIDE

SUSPENSION;ORAL

PAXIL

+! APOTEX TECHNOLOGIES
EQ 10MG BASE/5ML
N020710 001 Jun 25, 1997

TABLET;ORAL

PAROXETINE
AB PRINSTON INC EQ 10MG BASE
A203854 001 Oct 31, 2014

AB EQ 20MG BASE
A203854 002 Oct 31, 2014

AB EQ 30MG BASE
A203854 003 Oct 31, 2014

AB EQ 40MG BASE
A203854 004 Oct 31, 2014

PAROXETINE HYDROCHLORIDE
AB APOTEX EQ 10MG BASE
A075356 001 Jul 30, 2003

AB EQ 20MG BASE
A075356 002 Jul 30, 2003

AB EQ 30MG BASE
A075356 003 Jul 30, 2003

AB EQ 40MG BASE
A075356 004 Jul 30, 2003

AB AUROBINDO PHARMA EQ 10MG BASE


A078406 001 Jul 25, 2007

AB EQ 20MG BASE
A078406 002 Jul 25, 2007

AB EQ 30MG BASE
A078406 003 Jul 25, 2007

AB EQ 40MG BASE
A078406 004 Jul 25, 2007

AB JUBILANT GENERICS EQ 10MG BASE


A205528 001 Nov 27, 2015

AB EQ 20MG BASE
A205528 002 Nov 27, 2015

AB EQ 30MG BASE
A205528 003 Nov 27, 2015

AB EQ 40MG BASE
A205528 004 Nov 27, 2015

AB MYLAN EQ 10MG BASE


A078902 001 Mar 13, 2008

AB EQ 20MG BASE
A078902 002 Mar 13, 2008

AB EQ 30MG BASE
A078902 003 Mar 13, 2008

AB EQ 40MG BASE
A078902 004 Mar 13, 2008

AB OXFORD PHARMS EQ 10MG BASE


A076968 001 Jun 21, 2010

AB EQ 20MG BASE
A076968 002 Jun 21, 2010

AB EQ 30MG BASE
A076968 003 Jun 21, 2010

AB EQ 40MG BASE
A076968 004 Jun 21, 2010

AB SUN PHARM INDS INC EQ 10MG BASE


A078194 001 Jun 29, 2007

AB EQ 20MG BASE
A078194 002 Jun 29, 2007

AB EQ 30MG BASE
A078194 003 Jun 29, 2007

AB EQ 40MG BASE
A078194 004 Jun 29, 2007

AB TEVA EQ 10MG BASE


A076618 001 Aug 15, 2005

AB EQ 20MG BASE
A076618 002 Aug 15, 2005

AB EQ 30MG BASE
A076618 003 Aug 15, 2005

AB EQ 40MG BASE
A076618 004 Aug 15, 2005

AB ZYDUS PHARMS USA EQ 10MG BASE


A077584 001 Mar 07, 2007

AB EQ 20MG BASE
A077584 002 Mar 07, 2007

AB EQ 30MG BASE
A077584 003 Mar 07, 2007

AB EQ 40MG BASE
A077584 004 Mar 07, 2007

PAXIL
AB + APOTEX TECHNOLOGIES EQ 10MG BASE
N020031 001 Dec 29, 1992

AB + EQ 20MG BASE
N020031 002 Dec 29, 1992

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-347(of 452)

PAROXETINE HYDROCHLORIDE

TABLET;ORAL

PAXIL

AB + EQ 30MG BASE N020031 003 Dec 29, 1992

AB +! EQ 40MG BASE N020031 005 Dec 29, 1992



TABLET, EXTENDED RELEASE;ORAL

PAROXETINE HYDROCHLORIDE

AB LANNETT CO INC EQ 12.5MG BASE A204744 001 Jun 10, 2016

AB EQ 25MG BASE A204744 002 Jun 10, 2016

AB EQ 37.5MG BASE A204744 003 Jun 10, 2016

AB LUPIN LTD EQ 12.5MG BASE A204134 001 Jan 20, 2017

AB EQ 25MG BASE A204134 002 Jan 20, 2017

AB EQ 37.5MG BASE A204134 003 Jan 20, 2017

AB MYLAN EQ 12.5MG BASE A077873 001 Jun 29, 2007

AB EQ 25MG BASE A077873 002 Jun 29, 2007

AB EQ 37.5MG BASE A091427 001 Apr 14, 2011

AB SCIECURE PHARMA INC EQ 12.5MG BASE A209293 001 Jun 12, 2018

AB EQ 25MG BASE A209293 002 Jun 12, 2018

AB EQ 37.5MG BASE A209293 003 Jun 12, 2018

PAXIL CR

AB + APOTEX TECHNOLOGIES EQ 12.5MG BASE N020936 001 Feb 16, 1999

AB + EQ 25MG BASE N020936 002 Feb 16, 1999

AB +! EQ 37.5MG BASE N020936 003 Dec 06, 2000



PAROXETINE MESYLATE

CAPSULE;ORAL

BRISDELLE

AB +! SEBELA IRELAND LTD EQ 7.5MG BASE N204516 001 Jun 28, 2013

PAROXETINE MESYLATE

AB ACTAVIS LABS FL INC EQ 7.5MG BASE A207139 001 Jun 20, 2017

AB PRINSTON INC EQ 7.5MG BASE A207188 001 Aug 18, 2017

TABLET;ORAL

PEXEVA

+ SEBELA IRELAND LTD EQ 10MG BASE N021299 001 Jul 03, 2003

+ EQ 20MG BASE N021299 002 Jul 03, 2003

+ EQ 30MG BASE N021299 003 Jul 03, 2003

+! EQ 40MG BASE N021299 004 Jul 03, 2003

PASIREOTIDE DIASPARTATE

SOLUTION;SUBCUTANEOUS

SIGNIFOR

+ NOVARTIS EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) N200677 001 Dec 14, 2012

+ EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) N200677 002 Dec 14, 2012

+! EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) N200677 003 Dec 14, 2012

PASIREOTIDE PAMOATE

FOR SUSPENSION;INTRAMUSCULAR

SIGNIFOR LAR KIT

+ NOVARTIS PHARMS EQ 10MG BASE/VIAL N203255 004 Jun 29, 2018

CORP

+ EQ 20MG BASE/VIAL N203255 001 Dec 15, 2014

+ EQ 30MG BASE/VIAL N203255 005 Jun 29, 2018

+ EQ 40MG BASE/VIAL N203255 002 Dec 15, 2014

+! EQ 60MG BASE/VIAL N203255 003 Dec 15, 2014

PATIROMER SORBITEX CALCIUM

POWDER;ORAL

VELTASSA

+ RELYPSA INC EQ 8.4GM BASE/PACKET N205739 001 Oct 21, 2015

+ EQ 16.8GM BASE/PACKET N205739 002 Oct 21, 2015

+! EQ 25.2GM BASE/PACKET N205739 003 Oct 21, 2015

PATISIRAN SODIUM

SOLUTION;INTRAVENOUS

ONPATTRO

+! ALNYLAM PHARMS INC EQ 10MG BASE/5ML (EQ 2MG BASE/ML) N210922 001 Aug 10, 2018

PAZOPANIB HYDROCHLORIDE

TABLET;ORAL

VOTRIENT

+! NOVARTIS PHARMS EQ 200MG BASE N022465 001 Oct 19, 2009

CORP

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-348(of 452)

PEGADEMASE BOVINE

INJECTABLE;INJECTION

ADAGEN

+! LEADIANT BIOSCI INC 250 UNITS/ML N019818 001 Mar 21, 1990

PEGAPTANIB SODIUM

INJECTABLE;INTRAVITREAL

MACUGEN

+! VALEANT PHARMS LLC EQ 0.3MG ACID/0.09ML N021756 001 Dec 17, 2004

PEGVISOMANT

INJECTABLE;SUBCUTANEOUS

SOMAVERT

+! PHARMACIA AND 10MG/VIAL N021106 001 Mar 25, 2003

UPJOHN

+! 15MG/VIAL N021106 002 Mar 25, 2003

+! 20MG/VIAL N021106 003 Mar 25, 2003

+! 25MG/VIAL N021106 004 Jul 31, 2014

+! 30MG/VIAL N021106 005 Jul 31, 2014

PEMETREXED DISODIUM

POWDER;INTRAVENOUS

ALIMTA

+! LILLY EQ 100MG BASE/VIAL N021462 002 Sep 07, 2007

+! EQ 500MG BASE/VIAL N021462 001 Feb 04, 2004



PENCICLOVIR

CREAM;TOPICAL

DENAVIR

+! MYLAN PHARMS INC 1% N020629 001 Sep 24, 1996

PENICILLAMINE

CAPSULE;ORAL

CUPRIMINE

+! ATON 250MG N019853 001

TABLET;ORAL

DEPEN

+! MYLAN SPECIALITY LP 250MG N019854 001

PENICILLIN G BENZATHINE

INJECTABLE;INJECTION

BICILLIN L-A

BC +! KING PHARMS LLC 600,000 UNITS/ML N050141 001

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE

INJECTABLE;INJECTION

BICILLIN C-R

+! KING PHARMS LLC 300,000 UNITS/ML;300,000 UNITS/ML N050138 001

BICILLIN C-R 900/300

+! KING PHARMS LLC 900,000 UNITS/2ML;300,000 UNITS/2ML N050138 003



PENICILLIN G POTASSIUM

INJECTABLE;INJECTION

PENICILLIN G POTASSIUM

AP ACS DOBFAR SPA 20,000,000 UNITS/VIAL A205043 002 Oct 26, 2018

AP 5,000,000 UNITS/VIAL A205043 001 Oct 26, 2018

AP HANFORD GC 5,000,000 UNITS/VIAL A065149 002 Jul 23, 2009

AP 20,000,000 UNITS/VIAL A065149 003 Jul 23, 2009

AP ISTITUTO BIO ITA 5,000,000 UNITS/VIAL A065448 001 Aug 18, 2009

SPA

AP 20,000,000 UNITS/VIAL A065448 002 Aug 18, 2009

AP SANDOZ 5,000,000 UNITS/VIAL A065079 002 Aug 30, 2002

AP 20,000,000 UNITS/VIAL A065079 003 Aug 30, 2002

PFIZERPEN

AP ! PFIZER 5,000,000 UNITS/VIAL A060657 002

AP ! 20,000,000 UNITS/VIAL A060657 003

PENICILLIN G POTASSIUM

HANFORD GC 1,000,000 UNITS/VIAL A065149 001 Jul 23, 2009

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 20,000 UNITS/ML N050638 001 Jun 25, 1990

+! 40,000 UNITS/ML N050638 002 Jun 25, 1990

+! 60,000 UNITS/ML N050638 003 Jun 25, 1990

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-349(of 452)

PENICILLIN G PROCAINE

INJECTABLE;INJECTION

PENICILLIN G PROCAINE

! KING PHARMS LLC 300,000 UNITS/ML
A060101 002

! 600,000 UNITS/ML
A060101 001

PENICILLIN G SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

PENICILLIN G SODIUM

! SANDOZ
5,000,000 UNITS/VIAL
A065068 001 Feb 26, 2001

PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

PENICILLIN V POTASSIUM
AA DAVA PHARMS INC EQ 125MG BASE/5ML
A062981 001 Feb 10, 1989

AA EQ 250MG BASE/5ML
A062981 002 Feb 10, 1989

PENICILLIN-VK
AA TEVA EQ 125MG BASE/5ML
A060456 001

AA ! EQ 250MG BASE/5ML
A060456 002

TABLET;ORAL

PENICILLIN V POTASSIUM

AB AUROBINDO PHARMA
EQ 250MG BASE
A065435 001 Apr 29, 2008

AB
EQ 500MG BASE
A065435 002 Apr 29, 2008

AB DAVA PHARMS INC


EQ 250MG BASE
A062936 001 Nov 25, 1988

AB
EQ 500MG BASE
A062935 001 Nov 23, 1988

AB HIKMA PHARMS
EQ 250MG BASE
A090549 001 Oct 11, 2013

AB
EQ 500MG BASE
A090549 002 Oct 11, 2013

AB SANDOZ
EQ 250MG BASE
A064071 001 Nov 30, 1995

AB !
EQ 500MG BASE
A064071 002 Nov 30, 1995

PENICILLIN-VK

AB TEVA
EQ 250MG BASE
A060711 002

AB
EQ 500MG BASE
A060711 003

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION

NEBUPENT

+! FRESENIUS KABI USA
300MG/VIAL
N019887 001 Jun 15, 1989

INJECTABLE;INJECTION

PENTAM

AP +! FRESENIUS KABI USA
300MG/VIAL
N019264 001 Oct 16, 1984

PENTAMIDINE ISETHIONATE

AP SETON PHARMS
300MG/VIAL
A206666 001 Sep 28, 2017

PENTETATE CALCIUM TRISODIUM

SOLUTION;INHALATION, INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

+! HAMELN PHARMA PLUS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
N021749 001 Aug 11, 2004
PENTETATE ZINC TRISODIUM

SOLUTION;INHALATION, INTRAVENOUS

PENTETATE ZINC TRISODIUM

+! HAMELN PHARMA PLUS
EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
N021751 001 Aug 11, 2004
PENTOBARBITAL SODIUM

INJECTABLE;INJECTION

NEMBUTAL SODIUM
AP ! OAK PHARMS 50MG/ML
A083246 001
PENTOBARBITAL SODIUM
AP CUSTOPHARM INC 50MG/ML
A203619 001 Nov 13, 2017

AP RENAISSANCE SSA LLC 50MG/ML


A206677 001 Nov 27, 2017

AP SAGENT PHARMS 50MG/ML


A206404 001 May 23, 2016

PENTOSAN POLYSULFATE SODIUM

CAPSULE;ORAL

ELMIRON

+! JANSSEN PHARMS
100MG
N020193 001 Sep 26, 1996

PENTOSTATIN

INJECTABLE;INJECTION

NIPENT

AP +! HOSPIRA INC
10MG/VIAL
N020122 001 Oct 11, 1991

PENTOSTATIN

AP MYLAN INSTITUTIONAL
10MG/VIAL
A203554 001 Sep 19, 2014

AP WEST-WARD PHARMS
10MG/VIAL
A077841 001 Aug 07, 2007

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-350(of 452)

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL

PENTOXIFYLLINE

AB ! APOTEX 400MG A075191 001 Jun 09, 1999

AB MYLAN 400MG A074425 001 Jul 08, 1997

AB VALEANT PHARMS 400MG A075028 001 Jul 20, 1998

PENTOXIL

AB UPSHER SMITH LABS 400MG A074962 001 Mar 31, 1999

PERAMIVIR

SOLUTION;INTRAVENOUS

RAPIVAB

+! BIOCRYST 200MG/20ML (10MG/ML) N206426 001 Dec 19, 2014

PERAMPANEL

SUSPENSION;ORAL

FYCOMPA

+! EISAI INC 0.5MG/ML N208277 001 Apr 29, 2016

TABLET;ORAL

FYCOMPA

+ EISAI INC 2MG N202834 001 Oct 22, 2012

+ 4MG N202834 002 Oct 22, 2012

+ 6MG N202834 003 Oct 22, 2012

+ 8MG N202834 004 Oct 22, 2012

+ 10MG N202834 005 Oct 22, 2012

+! 12MG N202834 006 Oct 22, 2012

PERFLUTREN

INJECTABLE;INTRAVENOUS

DEFINITY

+! LANTHEUS MEDCL 6.52MG/ML N021064 001 Jul 31, 2001

PERINDOPRIL ERBUMINE

TABLET;ORAL

PERINDOPRIL ERBUMINE

AB ANI PHARMS INC 2MG A078138 001 Nov 10, 2009

AB 4MG A078138 002 Nov 10, 2009

AB 8MG A078138 003 Nov 10, 2009

AB AUROBINDO PHARMA 2MG A079070 001 Nov 10, 2009

AB 4MG A079070 002 Nov 10, 2009

AB ! 8MG A079070 003 Nov 10, 2009

AB WEST-WARD PHARMS 2MG A090072 001 Nov 10, 2009

INT

AB 4MG A090072 002 Nov 10, 2009

AB 8MG A090072 003 Nov 10, 2009



PERMETHRIN

CREAM;TOPICAL

ELIMITE

AB +! MYLAN PHARMS INC 5% N019855 001 Aug 25, 1989

PERMETHRIN

AB ACTAVIS LABS 5% A074806 001 Jan 23, 1998

AB PERRIGO NEW YORK 5% A076369 001 Apr 21, 2003



PERPHENAZINE

TABLET;ORAL

PERPHENAZINE

AB MYLAN PHARMS INC 2MG A206691 001 Apr 14, 2017

AB 4MG A206691 002 Apr 14, 2017

AB 8MG A206691 003 Apr 14, 2017

AB 16MG A206691 004 Apr 14, 2017

AB SANDOZ 2MG A089685 002 Dec 08, 1988

AB 4MG A089685 003 Dec 08, 1988

AB 8MG A089685 001 Dec 08, 1988

AB ! 16MG A089685 004 Dec 08, 1988

AB VINTAGE PHARMS 2MG A040226 001 Dec 31, 1998

AB 4MG A040226 002 Dec 31, 1998

AB 8MG A040226 003 Dec 31, 1998

AB 16MG A040226 004 Dec 31, 1998

AB WATSON LABS INC 2MG A207582 001 Oct 17, 2016

AB 4MG A207582 002 Oct 17, 2016

AB 8MG A207582 003 Oct 17, 2016

AB 16MG A207582 004 Oct 17, 2016

AB WILSHIRE PHARMS INC 2MG A205973 001 Dec 17, 2015

AB 4MG A205973 002 Dec 17, 2015

AB 8MG A205973 003 Dec 17, 2015



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-351(of 452)

PERPHENAZINE

TABLET;ORAL

PERPHENAZINE

AB 16MG A205973 004 Dec 17, 2015

PHENDIMETRAZINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

PHENDIMETRAZINE TARTRATE

+! VIRTUS PHARMS 105MG N018074 001

TABLET;ORAL

BONTRIL PDM

AA ! VALEANT 35MG A085272 001

PHENDIMETRAZINE TARTRATE

AA ELITE LABS INC 35MG A040762 001 Jan 28, 2008

AA 35MG A203600 001 Dec 27, 2017

AA KVK TECH 35MG A091042 001 Aug 31, 2010

AA MIKART 35MG A089452 001 Oct 30, 1991

AA VIRTUS PHARMS 35MG A085588 001



PHENELZINE SULFATE

TABLET;ORAL

NARDIL

AB +! PARKE DAVIS EQ 15MG BASE N011909 002

PHENELZINE SULFATE

AB NOVEL LABS INC EQ 15MG BASE A200181 001 Dec 08, 2010

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIBENZYLINE

AB +! CONCORDIA PHARMS 10MG N008708 001

INC

PHENOXYBENZAMINE HYDROCHLORIDE

AB PAR PHARM INC 10MG A204522 001 Jan 24, 2017

AB WEST-WARD PHARMS 10MG A201050 001 Jul 16, 2012

INT

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

ADIPEX-P

AA ! TEVA 37.5MG A088023 001 Aug 02, 1983

PHENTERMINE HYDROCHLORIDE

AA AUROLIFE PHARMA LLC 15MG A204318 001 Nov 09, 2016

AA 30MG A204318 002 Nov 09, 2016

AA BARR 15MG A090591 001 Mar 18, 2010

AA 30MG A090591 002 Mar 18, 2010

AA ELITE LABS 15MG A202248 001 Sep 28, 2012

AA 30MG A202248 002 Sep 28, 2012

AA ELITE LABS INC 37.5MG A040228 001 Jun 19, 1997

AA INVAGEN PHARMS 15MG A202858 001 Feb 14, 2014

AA 30MG A202858 002 Feb 14, 2014

AA 30MG A204414 001 May 05, 2014

AA 37.5MG A202846 001 Feb 05, 2014

AA KVK TECH 15MG A040886 002 Mar 31, 2008

AA 30MG A040875 001 Mar 21, 2008

AA 30MG A040886 001 Mar 31, 2008

AA 37.5MG A040887 001 Apr 24, 2008

AA LANNETT 15MG A087022 002 Jan 20, 2012

AA 30MG A087022 001 Feb 03, 1983

AA LANNETT CO INC 30MG A091359 001 Jul 16, 2010

AA 37.5MG A201961 001 Jul 20, 2011

AA NUVO PHARM 15MG A205019 001 Dec 05, 2014

AA 30MG A205019 002 Dec 05, 2014

AA 37.5MG A205017 001 Sep 25, 2014

AA ! SANDOZ 15MG A087190 002



AA ! 30MG A086945 001 Jul 20, 1983

AA ! 30MG A087190 001



AA SUN PHARM 30MG A040525 001 Oct 23, 2003

INDUSTRIES

TABLET;ORAL

ADIPEX-P

AA ! TEVA 37.5MG A085128 001

LOMAIRA

AA ! AVANTHI INC 8MG A203495 001 Sep 12, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-352(of 452)

PHENTERMINE HYDROCHLORIDE

TABLET;ORAL

PHENTERMINE HYDROCHLORIDE

AA AUROLIFE PHARMA LLC 37.5MG A203068 001 Aug 06, 2014

AA BARR 37.5MG A090470 001 Aug 31, 2009

AA ELITE LABS 37.5MG A200272 001 Jan 31, 2011

AA ELITE LABS INC 37.5MG A040190 001 May 30, 1997

AA INVAGEN PHARMS 37.5MG A202942 001 Feb 05, 2014

AA KVK TECH 37.5MG A040876 001 Mar 31, 2008

AA KVK TECH INC 8MG A203436 001 Mar 17, 2017

AA LANNETT 37.5MG A040555 001 Apr 15, 2005

AA NOVAST LABS 37.5MG A091451 001 Sep 21, 2012

AA NUVO PHARM 37.5MG A205008 001 Sep 25, 2014

AA POLYGEN PHARMS 37.5MG A206342 001 Nov 18, 2016

AA PRINSTON INC 37.5MG A040377 001 Jan 04, 2002

AA SUN PHARM INDS INC 37.5MG A040790 001 Aug 21, 2007

AA SUN PHARM 37.5MG A040526 001 Oct 23, 2003

INDUSTRIES

TABLET, ORALLY DISINTEGRATING;ORAL

PHENTERMINE HYDROCHLORIDE

ZYDUS PHARMS USA 15MG A204663 001 Jun 28, 2017

INC

30MG A204663 002 Jun 28, 2017

37.5MG A204663 003 Jun 28, 2017

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

CAPSULE, EXTENDED RELEASE;ORAL

QSYMIA

+ VIVUS EQ 3.75MG BASE;23MG N022580 001 Jul 17, 2012

+ EQ 7.5MG BASE;46MG N022580 002 Jul 17, 2012

+ EQ 11.25MG BASE;69MG N022580 003 Jul 17, 2012

+! EQ 15MG BASE;92MG N022580 004 Jul 17, 2012

PHENTOLAMINE MESYLATE

INJECTABLE;INJECTION

PHENTOLAMINE MESYLATE

AP PRECISION DOSE INC 5MG/VIAL A207686 001 Jul 14, 2017

AP ! WEST-WARD PHARMS 5MG/VIAL A040235 001 Mar 11, 1998

INT

ORAVERSE

+! SEPTODONT HOLDING 0.4MG/1.7ML N022159 001 May 09, 2008

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS

PHENYLEPHRINE HYDROCHLORIDE

AP AMNEAL PHARMS CO 10MG/ML (10MG/ML) A211079 001 Jul 05, 2018

AP 50MG/5ML (10MG/ML) A211078 001 Jul 19, 2018

AP 100MG/10ML (10MG/ML) A211078 002 Jul 19, 2018

AP CIPLA 10MG/ML (10MG/ML) A210334 001 Apr 27, 2018

AP 50MG/5ML (10MG/ML) A210333 001 Apr 27, 2018

AP 100MG/10ML (10MG/ML) A210333 002 Apr 27, 2018

AP PAR STERILE 10MG/ML (10MG/ML) A210025 001 Dec 21, 2018

PRODUCTS

AP 50MG/5ML (10MG/ML) A210025 002 Dec 21, 2018

AP 100MG/10ML (10MG/ML) A210025 003 Dec 21, 2018

AP +! WEST WARD PHARM 10MG/ML (10MG/ML) N203826 001 Dec 20, 2012

CORP

VAZCULEP

AP + AVADEL LEGACY 10MG/ML (10MG/ML) N204300 001 Jun 27, 2014

AP + 50MG/5ML (10MG/ML) N204300 002 Jun 27, 2014

AP +! 100MG/10ML (10MG/ML) N204300 003 Jun 27, 2014



SOLUTION/DROPS;OPHTHALMIC

PHENYLEPHRINE HYDROCHLORIDE

+! AKORN INC 2.5% N207926 001 Jan 15, 2015

+! 10% N207926 002 Jan 15, 2015

+! PARAGON BIOTECK 2.5% N203510 001 Mar 21, 2013

+! 10% N203510 002 Mar 21, 2013

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE



AA HI-TECH PHARMACAL 5MG/5ML;6.25MG/5ML A040675 001 Dec 23, 2014

AA ! VINTAGE 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE



AA AMNEAL PHARMS 5MG/5ML;6.25MG/5ML A040902 001 Aug 25, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-353(of 452)

PHENYTOIN

SUSPENSION;ORAL

DILANTIN-125

AB +! PARKE DAVIS 125MG/5ML N008762 001

PHENYTOIN

AB TARO 125MG/5ML A040521 001 Mar 08, 2004

AB VISTAPHARM 125MG/5ML A040342 001 Jan 31, 2001

AB 125MG/5ML A040610 001 Aug 18, 2005

AB WOCKHARDT BIO AG 125MG/5ML A040420 001 Apr 19, 2002

TABLET, CHEWABLE;ORAL

DILANTIN

AB ! PFIZER 50MG A084427 001

PHENYTOIN

AB EPIC PHARMA LLC 50MG A040884 001 Nov 28, 2014

AB MYLAN PHARMS INC 50MG A200691 001 Dec 26, 2012

AB TARO 50MG A200565 001 Apr 17, 2014



PHENYTOIN SODIUM

CAPSULE;ORAL

DILANTIN

AB ! PARKE-DAVIS 100MG EXTENDED A084349 002

EXTENDED PHENYTOIN SODIUM

AB AMNEAL PHARMS NY 100MG EXTENDED A040765 001 Nov 12, 2008

AB MYLAN 100MG EXTENDED A040298 001 Dec 28, 1998

AB SUN PHARM INDS 200MG EXTENDED A040731 001 Jun 30, 2008

AB 300MG EXTENDED A040731 002 Jun 30, 2008

AB SUN PHARM INDS (IN) 100MG EXTENDED A040621 001 Dec 11, 2006

AB TARO 100MG EXTENDED A040684 001 Sep 05, 2006

PHENYTEK

AB MYLAN 200MG EXTENDED A040298 002 Dec 06, 2001

AB ! 300MG EXTENDED A040298 003 Dec 06, 2001

PHENYTOIN SODIUM

AB AUROBINDO PHARMA 100MG EXTENDED A204309 001 Jun 10, 2015

LTD

DILANTIN

! PARKE-DAVIS 30MG EXTENDED A084349 001

INJECTABLE;INJECTION

PHENYTOIN SODIUM

AP ACELLA PHARMS LLC 50MG/ML A040573 001 Sep 13, 2006

AP LUITPOLD 50MG/ML A040781 001 Dec 04, 2007

AP ! WEST-WARD PHARMS 50MG/ML A084307 001



INT

PHYTONADIONE

INJECTABLE;INJECTION

PHYTONADIONE

BP ! INTL MEDICATION 1MG/0.5ML A083722 001

VITAMIN K1

BP ! HOSPIRA 1MG/0.5ML A087954 001 Jul 25, 1983

! 10MG/ML A087955 001 Jul 25, 1983

TABLET;ORAL

MEPHYTON

AB +! VALEANT PHARMS 5MG N010104 003

PHYTONADIONE

AB AMNEAL PHARMS CO 5MG A209373 001 May 11, 2018

PILOCARPINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC

ISOPTO CARPINE

AT + NOVARTIS PHARMS 1% N200890 001 Jun 22, 2010

CORP

AT + 2% N200890 002 Jun 22, 2010

AT +! 4% N200890 003 Jun 22, 2010

PILOCARPINE HYDROCHLORIDE

AT AKORN INC 1% A204398 001 Sep 27, 2017

AT 2% A204398 002 Sep 27, 2017

AT 4% A204398 003 Sep 27, 2017

TABLET;ORAL

PILOCARPINE HYDROCHLORIDE

AB IMPAX LABS 5MG A077248 001 Mar 31, 2006

AB 7.5MG A077248 002 Mar 31, 2006

AB INNOGENIX 5MG A076963 001 Dec 22, 2004

AB 7.5MG A076963 002 Feb 27, 2007

AB LANNETT CO INC 5MG A077220 001 Oct 14, 2005



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-354(of 452)

PILOCARPINE HYDROCHLORIDE

TABLET;ORAL

PILOCARPINE HYDROCHLORIDE

AB 7.5MG A077220 002 May 06, 2009

AB PERRIGO PHARMA INTL 5MG A076746 001 Nov 16, 2004

SALAGEN

AB + EISAI INC 5MG N020237 001 Mar 22, 1994

AB +! 7.5MG N020237 002 Apr 18, 2003



PIMAVANSERIN TARTRATE

CAPSULE;ORAL

NUPLAZID

+! ACADIA PHARMS INC EQ 34MG BASE N210793 001 Jun 28, 2018

TABLET;ORAL

NUPLAZID

+! ACADIA PHARMS INC EQ 10MG BASE N207318 002 Jun 28, 2018

+! EQ 17MG BASE N207318 001 Apr 29, 2016

PIMECROLIMUS

CREAM;TOPICAL

ELIDEL

AB +! VALEANT BERMUDA 1% N021302 001 Dec 13, 2001

PIMECROLIMUS

AB ACTAVIS LABS UT INC 1% A209345 001 Dec 27, 2018

PIMOZIDE

TABLET;ORAL

ORAP

AB + TEVA 1MG N017473 003 Aug 27, 1997

AB +! 2MG N017473 001 Jul 31, 1984

PIMOZIDE

AB PAR PHARM 1MG A204521 001 Sep 28, 2015

AB 2MG A204521 002 Sep 28, 2015



PINDOLOL

TABLET;ORAL

PINDOLOL

AB ANI PHARMS INC 5MG A073609 002 Mar 29, 1993

AB 10MG A073609 001 Mar 29, 1993

AB MYLAN PHARMS INC 5MG A074019 001 Sep 03, 1992

AB ! 10MG A074019 002 Sep 03, 1992

AB NOSTRUM LABS INC 5MG A205415 001 Jan 13, 2016

AB 10MG A205415 002 Jan 13, 2016

AB SUN PHARM 5MG A074063 001 Jan 27, 1994

INDUSTRIES

AB 10MG A074063 002 Jan 27, 1994

AB ZYDUS PHARMS USA 5MG A209866 001 Aug 18, 2017

INC

AB 10MG A209866 002 Aug 18, 2017

PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

ACTOS

AB + TAKEDA PHARMS USA EQ 15MG BASE N021073 001 Jul 15, 1999

AB + EQ 30MG BASE N021073 002 Jul 15, 1999

AB +! EQ 45MG BASE N021073 003 Jul 15, 1999

PIOGLITAZONE HYDROCHLORIDE

AB ACCORD HLTHCARE EQ 15MG BASE A200044 001 Feb 13, 2013

AB EQ 30MG BASE A200044 002 Feb 13, 2013

AB EQ 45MG BASE A200044 003 Feb 13, 2013

AB AUROBINDO PHARMA EQ 15MG BASE A200268 001 Feb 13, 2013

LTD

AB EQ 30MG BASE A200268 002 Feb 13, 2013

AB EQ 45MG BASE A200268 003 Feb 13, 2013

AB BRECKENRIDGE PHARM EQ 15MG BASE A078472 001 Feb 13, 2013

AB EQ 30MG BASE A078472 002 Feb 13, 2013

AB EQ 45MG BASE A078472 003 Feb 13, 2013

AB CELLTRION EQ 15MG BASE A076798 001 Oct 26, 2012

AB EQ 30MG BASE A076798 002 Oct 26, 2012

AB EQ 45MG BASE A076798 003 Oct 26, 2012

AB LUPIN LTD EQ 15MG BASE A204133 001 Apr 07, 2014

AB EQ 30MG BASE A204133 002 Apr 07, 2014

AB EQ 45MG BASE A204133 003 Apr 07, 2014

AB MACLEODS PHARMS LTD EQ 15MG BASE A202467 001 Feb 06, 2013

AB EQ 30MG BASE A202467 002 Feb 06, 2013



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-355(of 452)

PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

PIOGLITAZONE HYDROCHLORIDE

AB EQ 45MG BASE A202467 003 Feb 06, 2013

AB MYLAN PHARMS INC EQ 15MG BASE A076801 001 Aug 17, 2012

AB EQ 30MG BASE A076801 002 Aug 17, 2012

AB EQ 45MG BASE A076801 003 Aug 17, 2012

AB NEOPHARMA EQ 15MG BASE A078383 001 Mar 12, 2013

AB EQ 30MG BASE A078383 002 Mar 12, 2013

AB EQ 45MG BASE A078383 003 Mar 12, 2013

AB PRINSTON INC EQ 15MG BASE A207806 001 Apr 17, 2018

AB EQ 30MG BASE A207806 002 Apr 17, 2018

AB EQ 45MG BASE A207806 003 Apr 17, 2018

AB PURACAP PHARM LLC EQ 15MG BASE A206738 001 Oct 06, 2017

AB EQ 30MG BASE A206738 002 Oct 06, 2017

AB EQ 45MG BASE A206738 003 Oct 06, 2017

AB SANDOZ EQ 15MG BASE A078670 001 Feb 13, 2013

AB EQ 30MG BASE A078670 002 Feb 13, 2013

AB EQ 45MG BASE A078670 003 Feb 13, 2013

AB TEVA PHARMS USA EQ 15MG BASE A077210 001 Jan 10, 2014

AB EQ 30MG BASE A077210 002 Jan 10, 2014

AB EQ 45MG BASE A077210 003 Jan 10, 2014

AB TORRENT PHARMS LTD EQ 15MG BASE A091298 001 Feb 13, 2013

AB EQ 30MG BASE A091298 002 Feb 13, 2013

AB EQ 45MG BASE A091298 003 Feb 13, 2013

AB ZYDUS PHARMS USA EQ 15MG BASE A202456 001 Feb 13, 2013

INC

AB EQ 30MG BASE A202456 002 Feb 13, 2013

AB EQ 45MG BASE A202456 003 Feb 13, 2013



PIPERACILLIN SODIUM

INJECTABLE;INJECTION

PIPERACILLIN

! ISTITUTO BIO ITA EQ 2GM BASE/VIAL A065114 001 Nov 14, 2003

SPA

! EQ 3GM BASE/VIAL A065114 002 Nov 14, 2003

! EQ 4GM BASE/VIAL A065114 003 Nov 14, 2003

! EQ 40GM BASE/VIAL A065157 001 Jul 12, 2004

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

INJECTABLE;INJECTION

PIPERACILLIN AND TAZOBACTAM



AP APOLLO PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A207847 001 Jan 13, 2017

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A207847 002 Jan 13, 2017

AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A207848 002 Jan 13, 2017

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A207847 003 Jan 13, 2017

AP EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL A207848 001 May 11, 2018

AP AUROBINDO PHARMA EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065498 001 May 23, 2011

LTD

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065498 002 May 23, 2011

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065498 003 May 23, 2011

AP FRESENIUS KABI EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A203719 001 May 18, 2018

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A203719 002 May 18, 2018

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A203719 003 May 18, 2018

AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A203720 001 May 11, 2018

AP FRESENIUS KABI USA EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL A206204 001 May 11, 2018

AP HOSPIRA INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065386 001 Sep 15, 2009

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065386 002 Sep 15, 2009

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065386 003 Sep 15, 2009

AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A065446 001 Sep 15, 2009

AP ISTITUTO BIO ITA EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065523 001 May 31, 2011

SPA

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065523 002 May 31, 2011

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065523 003 May 31, 2011

AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A090498 001 May 31, 2011

AP MYLAN LABS LTD EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065458 001 Aug 15, 2014

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065458 002 Aug 15, 2014

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065458 003 Aug 15, 2014

AP QILU TIANHE EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A204959 001 Aug 10, 2018

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A204959 002 Aug 10, 2018

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A204959 003 Aug 10, 2018

AP SANDOZ EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065362 001 Oct 21, 2010

AP EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065363 001 Oct 21, 2010

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065362 002 Oct 21, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-356(of 452)

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM



INJECTABLE;INJECTION

PIPERACILLIN AND TAZOBACTAM



AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065363 002 Oct 21, 2010

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065362 003 Oct 21, 2010

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065363 003 Oct 21, 2010

AP SANDOZ INC EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL A203557 001 Oct 29, 2014

AP WOCKHARDT BIO AG EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A206996 001 Mar 22, 2017

AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A206996 002 Mar 22, 2017

AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A206996 003 Mar 22, 2017

AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A207146 001 Mar 17, 2017

ZOSYN

AP +! WYETH PHARMS EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL N050684 001 Oct 22, 1993

AP +! EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL N050684 002 Oct 22, 1993

AP +! EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL N050684 003 Oct 22, 1993

AP +! EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL N050684 004 Oct 22, 1993



ZOSYN IN PLASTIC CONTAINER

+! WYETH PHARMS EQ 40MG BASE/ML;EQ 5MG BASE/ML N050750 001 Feb 24, 1998

+! EQ 60MG BASE/ML;EQ 7.5MG BASE/ML N050750 002 Feb 24, 1998

+! EQ 4GM BASE/100ML;EQ 500MG BASE/100ML N050750 003 Feb 24, 1998

PIRFENIDONE

CAPSULE;ORAL

ESBRIET

+! GENENTECH INC 267MG N022535 001 Oct 15, 2014

TABLET;ORAL

ESBRIET

+ GENENTECH INC 267MG N208780 001 Jan 11, 2017

+! 801MG N208780 003 Jan 11, 2017

PIROXICAM

CAPSULE;ORAL

FELDENE

AB + PFIZER 10MG N018147 002 Apr 06, 1982

AB +! 20MG N018147 003 Apr 06, 1982

PIROXICAM

AB BRECKENRIDGE PHARM 10MG A208991 001 Feb 21, 2018

AB 20MG A208991 002 Feb 21, 2018

AB FLAMINGO PHARMS 10MG A207938 001 Sep 09, 2016

AB 20MG A207938 002 Sep 09, 2016

AB HIKMA PHARMS 10MG A209256 001 Aug 11, 2017

AB 20MG A209256 002 Aug 11, 2017

AB MICRO LABS 10MG A206152 001 Dec 29, 2017

AB 20MG A206152 002 Dec 29, 2017

AB MYLAN IRELAND LTD 10MG A074116 001 Jun 15, 1993

AB 20MG A074118 001 Jun 15, 1993

AB PII 10MG A206136 001 Jun 20, 2017

AB 20MG A206136 002 Jun 20, 2017

AB STRIDES PHARMA 10MG A210347 001 Jan 26, 2018

AB 20MG A210347 002 Jan 26, 2018

AB SUN PHARM 10MG A073536 002 Jan 23, 2008

INDUSTRIES

AB 20MG A073536 001 Mar 12, 1993

AB TEVA 10MG A074131 001 Dec 11, 1992

AB 20MG A074131 002 Dec 11, 1992

AB UNICHEM LABS LTD 10MG A208340 001 Apr 13, 2017

AB 20MG A208340 002 Apr 13, 2017

AB ZYDUS PHARMS USA 10MG A205585 001 Jul 17, 2018

INC

AB 20MG A205585 002 Jul 17, 2018

PITAVASTATIN CALCIUM

TABLET;ORAL

LIVALO

AB + KOWA CO EQ 1MG BASE N022363 001 Aug 03, 2009

AB + EQ 2MG BASE N022363 002 Aug 03, 2009

AB +! EQ 4MG BASE N022363 003 Aug 03, 2009

PITAVASTATIN CALCIUM

AB AUROBINDO PHARMA EQ 1MG BASE A206015 001 Dec 20, 2016

LTD

AB EQ 2MG BASE A206015 002 Dec 20, 2016

AB EQ 4MG BASE A206015 003 Dec 20, 2016

AB ORIENT PHARMA CO EQ 1MG BASE A205932 001 Feb 03, 2017

LTD

AB EQ 2MG BASE A205932 002 Feb 03, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-357(of 452)

PITAVASTATIN CALCIUM

TABLET;ORAL

PITAVASTATIN CALCIUM

AB EQ 4MG BASE A205932 003 Feb 03, 2017

AB SAWAI USA EQ 1MG BASE A205955 001 Feb 03, 2017

AB EQ 2MG BASE A205955 002 Feb 03, 2017

AB EQ 4MG BASE A205955 003 Feb 03, 2017



PITAVASTATIN MAGNESIUM

TABLET;ORAL

ZYPITAMAG

+ ZYDUS PHARMS USA EQ 1MG BASE N208379 001 Jul 14, 2017

INC

+ EQ 2MG BASE N208379 002 Jul 14, 2017

+! EQ 4MG BASE N208379 003 Jul 14, 2017

PLAZOMICIN SULFATE

SOLUTION;INTRAVENOUS

ZEMDRI

+! ACHAOGEN INC EQ 500MG BASE/10ML (EQ 50MG BASE/ML) N210303 001 Jun 25, 2018

PLECANATIDE

TABLET;ORAL

TRULANCE

+! SYNERGY PHARMS 3MG N208745 001 Jan 19, 2017

PLERIXAFOR

SOLUTION;SUBCUTANEOUS

MOZOBIL

+! GENZYME 24MG/1.2ML (20MG/ML) N022311 001 Dec 15, 2008

PODOFILOX

GEL;TOPICAL

CONDYLOX

+! ALLERGAN SALES LLC 0.5% N020529 001 Mar 13, 1997

SOLUTION;TOPICAL

CONDYLOX

AT +! ALLERGAN SALES LLC 0.5% N019795 001 Dec 13, 1990

PODOFILOX

AT PADDOCK LLC 0.5% A075600 001 Jan 29, 2002

POLIDOCANOL

SOLUTION;INTRAVENOUS

ASCLERA

+ CHEMISCH FBRK 10MG/2ML (5MG/ML) N021201 001 Mar 30, 2010

KRSSLR

+! 20MG/2ML (10MG/ML) N021201 002 Mar 30, 2010

VARITHENA

+! PROVENSIS 77.5MG/7.75ML (10MG/ML) N205098 002 Dec 21, 2017

+! 180MG/18ML (10MG/ML) N205098 001 Nov 25, 2013

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

GLYCOLAX

AA LANNETT CO INC 17GM/SCOOPFUL A076652 001 Jul 02, 2004

POLYETHYLENE GLYCOL 3350



AA NEXGEN PHARMA INC 17GM/SCOOPFUL A077706 001 Sep 27, 2006

AA PADDOCK LLC 17GM/SCOOPFUL A077893 001 May 26, 2006



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

FOR SOLUTION;ORAL

LAX-LYTE WITH FLAVOR PACKS



AA PADDOCK LLC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A079232 001 Feb 25, 2010

BOT

NULYTELY

AA +! BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 001 Apr 22, 1991

BOT

NULYTELY-FLAVORED

AA +! BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 002 Nov 18, 1994

BOT

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

AA BRECKENRIDGE PHARM 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A202060 001 Mar 08, 2017

BOT

AA NOVEL LABS INC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090019 001 May 27, 2009

BOT

AA STRIDES PHARMA 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A204559 001 Apr 13, 2015

BOT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-358(of 452)

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



FOR SOLUTION;ORAL

TRILYTE

AA MYLAN PHARMS INC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A076491 001 Feb 05, 2004

BOT

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

ANHYDROUS

FOR SOLUTION;ORAL

COLYTE WITH FLAVOR PACKS



AA MYLAN SPECIALITY LP 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 012 Oct 08, 1998

BOT;22.72GM/BOT

GOLYTELY

AA +! BRAINTREE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ N019011 001 Jul 13, 1984

BOT;22.74GM/BOT

PEG 3350 AND ELECTROLYTES



AA NOVEL LABS INC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090231 001 Jun 01, 2009

BOT;22.74GM/BOT

AA 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090186 001 Jun 01, 2009

BOT;22.72GM/BOT

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES



AA STRIDES PHARMA 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A204558 001 Dec 21, 2018

BOT;22.74GM/BOT

GOLYTELY

+! BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N019011 002 Jun 02, 1992

KET;5.53GM/PACKET;21.5GM/PACKET

POLYMYXIN B SULFATE

INJECTABLE;INJECTION

POLYMYXIN B SULFATE

AP AUROBINDO PHARMA EQ 500,000 UNITS BASE/VIAL A206589 001 Apr 04, 2016

LTD

AP FRESENIUS KABI USA EQ 500,000 UNITS BASE/VIAL A065372 001 Jan 10, 2008

AP GLAND PHARMA LTD EQ 500,000 UNITS BASE/VIAL A207322 001 Apr 14, 2016

AP MYLAN ASI EQ 500,000 UNITS BASE/VIAL A090110 001 Jun 29, 2011

AP ! WEST-WARD PHARMS EQ 500,000 UNITS BASE/VIAL A060716 001



INT

AP X GEN PHARMS EQ 500,000 UNITS BASE/VIAL A063000 001 Sep 30, 1994

AP XELLIA PHARMS APS EQ 500,000 UNITS BASE/VIAL A202766 001 Jan 15, 2014

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

SOLUTION/DROPS;OPHTHALMIC

POLYTRIM

AT +! ALLERGAN 10,000 UNITS/ML;EQ 1MG BASE/ML N050567 001 Oct 20, 1988

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE



AT AKORN INC 10,000 UNITS/ML;EQ 1MG BASE/ML A065006 001 Dec 17, 1998

AT BAUSCH AND LOMB 10,000 UNITS/ML;EQ 1MG BASE/ML A064120 001 Feb 14, 1997

AT SANDOZ INC 10,000 UNITS/ML;EQ 1MG BASE/ML A064211 001 Apr 13, 1998

POMALIDOMIDE

CAPSULE;ORAL

POMALYST

+ CELGENE 1MG N204026 001 Feb 08, 2013

+ 2MG N204026 002 Feb 08, 2013

+ 3MG N204026 003 Feb 08, 2013

+! 4MG N204026 004 Feb 08, 2013

PONATINIB HYDROCHLORIDE

TABLET;ORAL

ICLUSIG

+ ARIAD EQ 15MG BASE N203469 001 Dec 14, 2012

+ EQ 30MG BASE N203469 003 Apr 23, 2015

+! EQ 45MG BASE N203469 002 Dec 14, 2012



PORACTANT ALFA

SUSPENSION;INTRATRACHEAL

CUROSURF

+! CHIESI USA INC 80MG/ML N020744 001 Nov 18, 1999

PORFIMER SODIUM

INJECTABLE;INJECTION

PHOTOFRIN

CONCORDIA LABS INC 75MG/VIAL N020451 001 Dec 27, 1995

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-359(of 452)

POSACONAZOLE

SOLUTION;INTRAVENOUS

NOXAFIL

+! MERCK SHARP DOHME 300MG/16.7ML (18MG/ML) N205596 001 Mar 13, 2014

SUSPENSION;ORAL

NOXAFIL

+! SCHERING 40MG/ML N022003 001 Sep 15, 2006

TABLET, DELAYED RELEASE;ORAL



NOXAFIL

+! MERCK SHARP DOHME 100MG N205053 001 Nov 25, 2013

POTASSIUM ACETATE

INJECTABLE;INJECTION

POTASSIUM ACETATE

AP EXELA PHARMA SCS 2MEQ/ML A206203 001 Dec 29, 2015

LLC

AP +! HOSPIRA 2MEQ/ML N018896 001 Jul 20, 1984

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

KLOR-CON

AB UPSHER SMITH LABS 8MEQ A203106 001 Jul 10, 2015

AB 10MEQ A203106 002 Jul 10, 2015

MICRO-K

AB + NESHER PHARMS 8MEQ N018238 001

MICRO-K 10

AB + NESHER PHARMS 10MEQ N018238 002 May 14, 1984

POTASSIUM CHLORIDE

AB ACTAVIS LABS FL INC 8MEQ A077419 001 Jun 02, 2008

AB ! 10MEQ A077419 002 Jun 02, 2008

AB ADARE PHARMS INC 8MEQ A208864 001 Mar 17, 2017

AB 10MEQ A208864 002 Mar 17, 2017

AB AMNEAL PHARMS 10MEQ A202128 001 Feb 22, 2013

AB ANCHEN PHARMS 8MEQ A202886 001 Dec 26, 2013

AB 10MEQ A202886 002 Dec 26, 2013

AB GLENMARK PHARMS LTD 10MEQ A202868 001 Jan 19, 2016

AB LANNETT CO INC 8MEQ A204210 001 Mar 28, 2016

AB 10MEQ A204210 002 Mar 28, 2016

AB LUPIN LTD 8MEQ A203002 001 Dec 18, 2015

AB 10MEQ A203002 002 Dec 18, 2015

AB NOVEL LABS INC 8MEQ A204828 001 Aug 16, 2016

AB 10MEQ A204828 002 Aug 16, 2016

AB PADDOCK LLC 8MEQ A200185 001 May 18, 2011

AB 10MEQ A200185 002 May 18, 2011

AB PII 8MEQ A205549 001 Dec 08, 2015

AB 10MEQ A205549 002 Dec 08, 2015

AB TRIS PHARMA INC 8MEQ A201944 001 Mar 04, 2016

AB 10MEQ A201944 002 Mar 04, 2016



FOR SOLUTION;ORAL

KLOR-CON

AA UPSHER SMITH LABS 20MEQ A209662 001 Oct 23, 2017

POTASSIUM CHLORIDE

AA EPIC PHARMA LLC 20MEQ A210200 001 Nov 23, 2018

AA NOVEL LABS INC 20MEQ A210241 001 Nov 21, 2018

AA +! PHARMA RES SOFTWARE 20MEQ N208019 001 Aug 19, 2015

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

AP B BRAUN 2MEQ/ML A085870 001

AP FRESENIUS KABI USA 2MEQ/ML A080225 001

AP ! HOSPIRA 2MEQ/ML A080205 001

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 14.9MG/ML N019904 001 Dec 26, 1989

AP +! 746MG/100ML N019904 005 Dec 17, 1990

AP + ICU MEDICAL INC 14.9MG/ML N020161 005 Nov 30, 1992

AP + 745MG/100ML N020161 001 Nov 30, 1992

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 29.8MG/ML N019904 002 Dec 26, 1989

AP +! 1.49GM/100ML N019904 006 Dec 17, 1990

AP +! ICU MEDICAL INC 29.8MG/ML N020161 006 Aug 11, 1998

AP + 1.49GM/100ML N020161 002 Nov 30, 1992

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 2.98GM/100ML N019904 004 Dec 26, 1989

AP +! ICU MEDICAL INC 2.98GM/100ML N020161 004 Aug 11, 1998



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-360(of 452)

POTASSIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE IN PLASTIC CONTAINER



AP FRESENIUS KABI USA 2MEQ/ML A088901 001 Jan 25, 1985

AP 2MEQ/ML A088908 001 Jan 25, 1985



POTASSIUM CHLORIDE

! FRESENIUS KABI USA 3MEQ/ML A080225 003

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2.24GM/100ML N019904 003 Dec 26, 1989

SOLUTION;ORAL

POTASSIUM CHLORIDE

AA AMNEAL PHARMS LLC 20MEQ/15ML A210041 001 Jul 19, 2018

AA 40MEQ/15ML A210041 002 Jul 19, 2018

AA APOTEX INC 20MEQ/15ML A211067 001 Aug 08, 2018

AA 40MEQ/15ML A211067 002 Aug 08, 2018

AA + GENUS LIFESCIENCES 20MEQ/15ML N206814 001 Dec 22, 2014

AA +! 40MEQ/15ML N206814 002 Dec 22, 2014

AA NOVEL LABS INC 20MEQ/15ML A209786 001 Aug 29, 2018

AA 40MEQ/15ML A209786 002 Aug 29, 2018

TABLET, EXTENDED RELEASE;ORAL

KLOR-CON M10

AB1 UPSHER SMITH LABS 10MEQ A074726 002 Aug 09, 2000

KLOR-CON M20

AB1 ! UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998

POTASSIUM CHLORIDE

AB1 ACTAVIS LABS FL INC 10MEQ A075604 001 Apr 10, 2002

AB1 20MEQ A075604 002 Apr 10, 2002

AB1 ADARE PHARMS INC 20MEQ A076368 001 Aug 18, 2004

AB1 GLENMARK PHARMS LTD 10MEQ A203562 001 Jul 26, 2016

AB1 20MEQ A203562 002 Jul 26, 2016

AB1 NOVEL LABS INC 10MEQ A206347 001 Jan 21, 2016

AB1 20MEQ A206347 002 Jan 21, 2016

K-TAB

AB2 +! ABBVIE 20MEQ N018279 003 Nov 25, 2013

KLOR-CON

AB2 + UPSHER SMITH LABS 8MEQ N019123 001 Apr 17, 1986

AB2 +! 10MEQ N019123 002 Apr 17, 1986

POTASSIUM CHLORIDE

AB2 AUROBINDO PHARMA 8MEQ A210921 001 Dec 19, 2018

LTD

AB2 10MEQ A210921 002 Dec 19, 2018

AB2 MYLAN PHARMS INC 8MEQ A204662 001 Aug 21, 2014

AB2 10MEQ A204662 002 Aug 21, 2014

AB2 NOVEL LABS INC 8MEQ A206759 001 Aug 09, 2016

AB2 10MEQ A206759 002 Aug 09, 2016

AB2 PADDOCK LLC 8MEQ A205993 001 Nov 05, 2015

AB2 10MEQ A205993 002 Nov 05, 2015

AB2 SIGMAPHARM LABS LLC 8MEQ A207528 001 Aug 19, 2016

AB2 10MEQ A207528 002 Aug 19, 2016

AB2 STRIDES PHARMA 8MEQ A210733 001 Aug 31, 2018

AB2 10MEQ A210733 002 Aug 31, 2018

AB2 VITRUVIAS THERAP 20MEQ A209688 002 Jan 12, 2018

AB2 YICHANG HUMANWELL 8MEQ A209314 001 Jun 22, 2018

AB2 10MEQ A209314 002 Jun 22, 2018

K-TAB

AB3 + ABBVIE 10MEQ N018279 001

POTASSIUM CHLORIDE

AB3 VITRUVIAS THERAP 10MEQ A209688 001 Jan 12, 2018

K-TAB

BC + ABBVIE 8MEQ N018279 002 Aug 01, 1988

KLOR-CON M15

UPSHER SMITH LABS 15MEQ A074726 003 Jun 06, 2003

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER



AP ICU MEDICAL INC 149MG/100ML;450MG/100ML A078446 001 Sep 10, 2008

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER



AP +! BAXTER HLTHCARE 150MG/100ML;450MG/100ML N017648 005 Nov 26, 2002

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP B BRAUN 150MG/100ML;900MG/100ML N019708 004 Sep 29, 1989

AP + BAXTER HLTHCARE 150MG/100ML;900MG/100ML N017648 001



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-361(of 452)

POTASSIUM CHLORIDE; SODIUM CHLORIDE



INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP + BAXTER HLTHCARE 300MG/100ML;900MG/100ML N017648 002

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP ICU MEDICAL INC 149MG/100ML;900MG/100ML N019686 001 Oct 17, 1988

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP ICU MEDICAL INC 298MG/100ML;900MG/100ML N019686 002 Oct 17, 1988



POTASSIUM CITRATE

TABLET, EXTENDED RELEASE;ORAL

POTASSIUM CITRATE

AB MOUNTAIN 5MEQ A077440 001 Jun 09, 2006

AB 10MEQ A077440 002 Jun 09, 2006

AB STRIDES PHARMA 5MEQ A206813 001 Sep 11, 2017

AB 10MEQ A206813 002 Sep 11, 2017

AB 15MEQ A206813 003 Sep 11, 2017

AB TEVA PHARMS USA INC 5MEQ A209758 001 Mar 05, 2018

AB 10MEQ A209758 002 Mar 05, 2018

AB 15MEQ A209758 003 Mar 05, 2018

AB ZYDUS PHARMS USA 5MEQ A203546 001 Aug 06, 2014

INC

AB 10MEQ A203546 002 Aug 06, 2014

AB 15MEQ A203546 003 Aug 06, 2014

UROCIT-K

AB + MISSION PHARMA 5MEQ N019071 001 Aug 30, 1985

AB + 10MEQ N019071 002 Aug 31, 1992

AB +! 15MEQ N019071 003 Dec 30, 2009



POVIDONE-IODINE

SOLUTION/DROPS;OPHTHALMIC

BETADINE

+! ALCON PHARMS LTD 5% N018634 001 Dec 17, 1986

PRALATREXATE

SOLUTION;INTRAVENOUS

FOLOTYN

+ ALLOS 20MG/ML (20MG/ML) N022468 001 Sep 24, 2009

+! 40MG/2ML (20MG/ML) N022468 002 Sep 24, 2009



PRALIDOXIME CHLORIDE

INJECTABLE;INJECTION

PRALIDOXIME CHLORIDE

+! MERIDIAN MEDCL 300MG/ML N018986 001 Apr 26, 1983

TECHN

PROTOPAM CHLORIDE

+! BAXTER HLTHCARE 1GM/VIAL N014134 001

CORP

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

MIRAPEX

AB + BOEHRINGER 0.125MG N020667 001 Jul 01, 1997

INGELHEIM

AB +! 0.25MG N020667 002 Jul 01, 1997

AB + 0.5MG N020667 006 Feb 12, 1998

AB + 0.75MG N020667 007 Jul 30, 2007

AB + 1MG N020667 003 Jul 01, 1997

AB + 1.5MG N020667 005 Jul 01, 1997

PRAMIPEXOLE DIHYDROCHLORIDE

AB ALEMBIC PHARMS LTD 0.125MG A078894 001 Oct 08, 2010

AB 0.25MG A078894 002 Oct 08, 2010

AB 0.5MG A078894 003 Oct 08, 2010

AB 1MG A078894 004 Oct 08, 2010

AB 1.5MG A078894 005 Oct 08, 2010

AB APOTEX INC 0.125MG A090151 001 Apr 30, 2012

AB 0.25MG A090151 002 Apr 30, 2012

AB 0.5MG A090151 003 Apr 30, 2012

AB 0.75MG A090151 006 Apr 30, 2012

AB 1MG A090151 004 Apr 30, 2012

AB 1.5MG A090151 005 Apr 30, 2012

AB AUROBINDO PHARMA 0.125MG A202633 001 Oct 26, 2012

LTD

AB 0.25MG A202633 002 Oct 26, 2012

AB 0.5MG A202633 003 Oct 26, 2012

AB 0.75MG A202633 004 Oct 26, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-362(of 452)

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

PRAMIPEXOLE DIHYDROCHLORIDE

AB 1MG A202633 005 Oct 26, 2012

AB 1.5MG A202633 006 Oct 26, 2012

AB BARR 0.125MG A077724 001 Feb 19, 2008

AB 0.25MG A077724 002 Feb 19, 2008

AB 0.5MG A077724 003 Feb 19, 2008

AB 1MG A077724 004 Feb 19, 2008

AB 1.5MG A077724 005 Feb 19, 2008

AB BRECKENRIDGE PHARM 0.125MG A091450 001 Oct 08, 2010

AB 0.25MG A091450 002 Oct 08, 2010

AB 0.5MG A091450 003 Oct 08, 2010

AB 1MG A091450 004 Oct 08, 2010

AB 1.5MG A091450 005 Oct 08, 2010

AB CSPC OUYI PHARM CO 0.25MG A211088 001 Oct 03, 2018

AB 0.5MG A211088 002 Oct 03, 2018

AB 0.75MG A211088 003 Oct 03, 2018

AB 1MG A211088 004 Oct 03, 2018

AB 1.5MG A211088 005 Oct 03, 2018

AB GLENMARK GENERICS 0.125MG A090781 001 Oct 08, 2010

AB 0.25MG A090781 002 Oct 08, 2010

AB 0.5MG A090781 003 Oct 08, 2010

AB 0.75MG A090781 006 Sep 11, 2015

AB 1MG A090781 004 Oct 08, 2010

AB 1.5MG A090781 005 Oct 08, 2010

AB MACLEODS PHARMS LTD 0.125MG A202164 001 Sep 20, 2012

AB 0.25MG A202164 002 Sep 20, 2012

AB 0.5MG A202164 003 Sep 20, 2012

AB 1MG A202164 004 Sep 20, 2012

AB 1.5MG A202164 005 Sep 20, 2012

AB MYLAN 0.125MG A077854 001 Oct 08, 2010

AB 0.25MG A077854 002 Oct 08, 2010

AB 0.5MG A077854 003 Oct 08, 2010

AB 0.75MG A090764 001 Apr 09, 2010

AB 1MG A077854 004 Oct 08, 2010

AB 1.5MG A077854 005 Oct 08, 2010

AB SCIEGEN PHARMS INC 0.125MG A203855 001 Oct 28, 2014

AB 0.25MG A203855 002 Oct 28, 2014

AB 0.5MG A203855 003 Oct 28, 2014

AB 0.75MG A203855 004 Oct 28, 2014

AB 1MG A203855 005 Oct 28, 2014

AB 1.5MG A203855 006 Oct 28, 2014

AB STRIDES PHARMA 0.125MG A202702 001 Jun 03, 2014

AB 0.25MG A202702 002 Jun 03, 2014

AB 0.5MG A202702 003 Jun 03, 2014

AB 0.75MG A202702 004 Jun 03, 2014

AB 1MG A202702 005 Jun 03, 2014

AB 1.5MG A202702 006 Jun 03, 2014

AB SUN PHARM INDS INC 0.125MG A091683 001 Mar 27, 2013

AB 0.25MG A091683 002 Mar 27, 2013

AB 0.5MG A091683 003 Mar 27, 2013

AB 0.75MG A091683 004 Mar 27, 2013

AB 1MG A091683 005 Mar 27, 2013

AB 1.5MG A091683 006 Mar 27, 2013

AB TEVA PHARMS 0.125MG A090241 001 Oct 08, 2010

AB 0.25MG A090241 002 Oct 08, 2010

AB 0.5MG A090241 003 Oct 08, 2010

AB 0.75MG A090241 004 Oct 08, 2010

AB 1MG A090241 005 Oct 08, 2010

AB 1.5MG A090241 006 Oct 08, 2010

AB TORRENT PHARMS 0.125MG A090865 001 Oct 08, 2010

AB 0.25MG A090865 002 Oct 08, 2010

AB 0.5MG A090865 003 Oct 08, 2010

AB 0.75MG A090865 004 Oct 08, 2010

AB 1MG A090865 005 Oct 08, 2010

AB 1.5MG A090865 006 Oct 08, 2010

AB UNICHEM LABS LTD 0.125MG A207011 001 Dec 19, 2018

AB 0.25MG A207011 002 Dec 19, 2018

AB 0.5MG A207011 003 Dec 19, 2018

AB 0.75MG A207011 004 Dec 19, 2018

AB 1MG A207011 005 Dec 19, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-363(of 452)

PRAMIPEXOLE DIHYDROCHLORIDE

TABLET;ORAL

PRAMIPEXOLE DIHYDROCHLORIDE

AB 1.5MG A207011 006 Dec 19, 2018

AB ZYDUS PHARMS USA 0.125MG A078920 001 Jul 06, 2010

INC

AB 0.25MG A078920 002 Jul 06, 2010

AB 0.5MG A078920 003 Jul 06, 2010

AB 1MG A078920 004 Jul 06, 2010

AB 1.5MG A078920 005 Jul 06, 2010



TABLET, EXTENDED RELEASE;ORAL

MIRAPEX ER

AB +! BOEHRINGER 0.375MG N022421 001 Feb 19, 2010

INGELHEIM

AB + 0.75MG N022421 002 Feb 19, 2010

AB + 1.5MG N022421 003 Feb 19, 2010

AB + 2.25MG N022421 006 Jun 17, 2011

AB + 3MG N022421 004 Feb 19, 2010

AB + 3.75MG N022421 007 Jun 17, 2011

AB + 4.5MG N022421 005 Feb 19, 2010

PRAMIPEXOLE DIHYDROCHLORIDE

AB ACTAVIS ELIZABETH 0.375MG A201963 001 Apr 21, 2016

AB 0.75MG A201963 002 Apr 21, 2016

AB 1.5MG A201963 003 Apr 21, 2016

AB 2.25MG A203615 001 Oct 14, 2016

AB 3MG A201963 004 Apr 21, 2016

AB 3.75MG A203615 002 Jan 03, 2017

AB 4.5MG A201963 005 Apr 21, 2016

AB ALEMBIC PHARMS LTD 0.375MG A204518 001 Jan 02, 2019

AB 0.75MG A204518 002 Jan 02, 2019

AB 1.5MG A204518 003 Jan 02, 2019

AB 2.25MG A204518 004 Jan 02, 2019

AB 3MG A204518 005 Jan 02, 2019

AB 3.75MG A204518 006 Jan 02, 2019

AB 4.5MG A204518 007 Jan 02, 2019

AB ANCHEN PHARMS 0.375MG A202206 001 Feb 06, 2014

AB 0.75MG A202206 002 Feb 06, 2014

AB 1.5MG A202206 003 Feb 06, 2014

AB 2.25MG A202206 004 Feb 06, 2014

AB 3MG A202206 005 Feb 06, 2014

AB 3.75MG A202206 006 Feb 06, 2014

AB 4.5MG A202206 007 Feb 06, 2014

AB DR REDDYS LABS LTD 0.375MG A203354 001 Aug 07, 2015

AB 0.75MG A203354 002 Aug 07, 2015

AB 1.5MG A203354 003 Aug 07, 2015

AB 3MG A203354 004 Aug 07, 2015

AB 4.5MG A203354 005 Aug 07, 2015

AB MACLEODS PHARMS LTD 0.375MG A206156 001 Jun 24, 2016

AB 0.75MG A206156 002 Jun 24, 2016

AB 1.5MG A206156 003 Jun 24, 2016

AB 2.25MG A206156 004 Jun 24, 2016

AB 3MG A206156 005 Jun 24, 2016

AB 3.75MG A206156 007 Jan 23, 2017

AB 4.5MG A206156 006 Jun 24, 2016

AB SANDOZ INC 0.375MG A202353 001 Dec 04, 2014

AB 0.75MG A202353 002 Dec 04, 2014

AB 1.5MG A202353 003 Dec 04, 2014

AB 3MG A202353 004 Dec 04, 2014

AB 4.5MG A202353 005 Dec 04, 2014

AB ZYDUS PHARMS USA 0.375MG A202891 001 Dec 12, 2017

INC

AB 0.75MG A202891 002 Dec 12, 2017

AB 1.5MG A202891 003 Dec 12, 2017

AB 2.25MG A202891 004 Dec 12, 2017

AB 3MG A202891 005 Dec 12, 2017

AB 3.75MG A202891 006 Dec 12, 2017

AB 4.5MG A202891 007 Dec 12, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-364(of 452)

PRAMLINTIDE ACETATE

INJECTABLE;SUBCUTANEOUS

SYMLIN

+ ASTRAZENECA AB EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) N021332 002 Sep 25, 2007

+! EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) N021332 003 Sep 25, 2007

PRASTERONE

INSERT;VAGINAL

INTRAROSA

+! AMAG PHARMS INC 6.5MG N208470 001 Nov 16, 2016

PRASUGREL HYDROCHLORIDE

TABLET;ORAL

EFFIENT

AB + ELI LILLY AND CO EQ 5MG BASE N022307 001 Jul 10, 2009

AB +! EQ 10MG BASE N022307 002 Jul 10, 2009

PRASUGREL

AB ACCORD HLTHCARE EQ 5MG BASE A205987 001 Feb 02, 2018

AB EQ 10MG BASE A205987 002 Feb 02, 2018

AB AMNEAL PHARMS EQ 5MG BASE A205913 001 Jun 19, 2018

AB EQ 10MG BASE A205913 002 Jun 19, 2018

AB AUROBINDO PHARMA EQ 5MG BASE A205888 001 Oct 16, 2017

LTD

AB EQ 10MG BASE A205888 002 Oct 16, 2017

AB HEC PHARM EQ 5MG BASE A206021 001 Jan 16, 2019

AB EQ 10MG BASE A206021 002 Jan 16, 2019

AB MYLAN PHARMS INC EQ 5MG BASE A205927 001 Jul 12, 2017

AB EQ 10MG BASE A205927 002 Jul 12, 2017

AB PANACEA BIOTEC LTD EQ 5MG BASE A205897 001 Oct 16, 2017

AB EQ 10MG BASE A205897 002 Oct 16, 2017

AB USPHARMA WINDLAS EQ 5MG BASE A205790 001 Oct 16, 2017

AB EQ 10MG BASE A205790 002 Oct 16, 2017



PRAVASTATIN SODIUM

TABLET;ORAL

PRAVACHOL

AB + BRISTOL MYERS 20MG N019898 003 Oct 31, 1991

SQUIBB

AB + 40MG N019898 004 Mar 22, 1993

AB +! 80MG N019898 008 Dec 18, 2001

PRAVASTATIN SODIUM

AB ACCORD HLTHCARE 10MG A207068 001 Nov 17, 2016

AB 20MG A207068 002 Nov 17, 2016

AB 40MG A207068 003 Nov 17, 2016

AB 80MG A207068 004 Nov 17, 2016

AB APOTEX INC 10MG A076341 001 Oct 23, 2006

AB 20MG A076341 002 Oct 23, 2006

AB 40MG A076341 003 Oct 23, 2006

AB 80MG A076341 004 Dec 28, 2007

AB AUROBINDO PHARMA 10MG A203367 001 Feb 02, 2017

LTD

AB 20MG A203367 002 Feb 02, 2017

AB 40MG A203367 003 Feb 02, 2017

AB 80MG A203367 004 Feb 02, 2017

AB CHARTWELL RX 10MG A209869 001 Apr 13, 2018

AB 20MG A209869 002 Apr 13, 2018

AB 40MG A209869 003 Apr 13, 2018

AB 80MG A209869 004 Apr 13, 2018

AB CIPLA 10MG A077904 001 Oct 23, 2006

AB 20MG A077904 002 Oct 23, 2006

AB 40MG A077904 003 Oct 23, 2006

AB 80MG A077904 004 Mar 22, 2016

AB DR REDDYS LABS INC 10MG A076714 001 Oct 23, 2006

AB 20MG A076714 002 Oct 23, 2006

AB 40MG A076714 003 Oct 23, 2006

AB 80MG A076714 004 Dec 28, 2007

AB GLENMARK GENERICS 10MG A077987 001 May 11, 2007

AB 20MG A077987 002 May 11, 2007

AB 40MG A077987 003 May 11, 2007

AB 80MG A077987 004 Dec 28, 2007

AB HISUN PHARM 20MG A206061 001 Nov 23, 2018

HANGZHOU

AB 40MG A206061 002 Nov 23, 2018

AB 80MG A206061 003 Nov 23, 2018

AB LUPIN PHARMS 10MG A077917 001 Jan 08, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-365(of 452)

PRAVASTATIN SODIUM

TABLET;ORAL

PRAVASTATIN SODIUM

AB 20MG A077917 002 Jan 08, 2008

AB 40MG A077917 003 Jan 08, 2008

AB 80MG A077917 004 Jan 08, 2008

AB MYLAN PHARMS INC 10MG A079187 001 May 27, 2010

AB 20MG A079187 002 May 27, 2010

AB 40MG A079187 003 May 27, 2010

AB 80MG A079187 004 May 27, 2010

AB SANDOZ 10MG A076397 003 Oct 23, 2006

AB 20MG A076397 002 Oct 23, 2006

AB 40MG A076397 001 Oct 23, 2006

AB 80MG A077491 001 Feb 11, 2008

AB TEVA 10MG A076056 001 Apr 24, 2006

AB 20MG A076056 002 Apr 24, 2006

AB 40MG A076056 003 Apr 24, 2006

AB TEVA PHARMS 80MG A077793 001 Jan 15, 2008

AB WATSON LABS 10MG A076939 004 Oct 23, 2006

AB 20MG A076939 003 Oct 23, 2006

AB 40MG A076939 002 Oct 23, 2006

AB 80MG A076939 001 Dec 28, 2007

AB ZYDUS PHARMS USA 10MG A077751 001 Apr 30, 2008

AB 20MG A077751 002 Apr 30, 2008

AB 40MG A077751 003 Apr 30, 2008

AB 80MG A077751 004 Apr 30, 2008



PRAZIQUANTEL

TABLET;ORAL

BILTRICIDE

AB +! BAYER HLTHCARE 600MG N018714 001 Dec 29, 1982

PRAZIQUANTEL

AB PAR PHARM INC 600MG A208820 001 Nov 27, 2017



PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

MINIPRESS

AB + PFIZER EQ 1MG BASE N017442 002

AB +! EQ 2MG BASE N017442 003

AB + EQ 5MG BASE N017442 001

PRAZOSIN HYDROCHLORIDE

AB MYLAN EQ 1MG BASE A072575 003 May 16, 1989

AB EQ 2MG BASE A072575 002 May 16, 1989

AB EQ 5MG BASE A072575 001 May 16, 1989

AB NOVITIUM PHARMA EQ 1MG BASE A210971 001 Oct 03, 2018

AB EQ 2MG BASE A210971 002 Oct 03, 2018

AB EQ 5MG BASE A210971 003 Oct 03, 2018

AB TEVA PHARMS EQ 1MG BASE A071745 002 Sep 12, 1988

AB EQ 2MG BASE A071745 003 Sep 12, 1988

AB EQ 5MG BASE A071745 001 Sep 12, 1988



PREDNICARBATE

CREAM;TOPICAL

DERMATOP E EMOLLIENT

AB +! VALEANT BERMUDA 0.1% N020279 001 Oct 29, 1993

PREDNICARBATE

AB FOUGERA PHARMS 0.1% A077287 001 Sep 19, 2006

OINTMENT;TOPICAL

DERMATOP

AB +! VALEANT PHARMS 0.1% N019568 001 Sep 23, 1991

NORTH

PREDNICARBATE

AB FOUGERA PHARMS 0.1% A077236 001 Mar 09, 2007

PREDNISOLONE

SYRUP;ORAL

PREDNISOLONE

AA ! HI TECH PHARMA CO 15MG/5ML A040401 001 Feb 27, 2003

AA LANNETT CO INC 15MG/5ML A040775 001 Sep 21, 2007

AA PHARM ASSOC 15MG/5ML A040399 001 Mar 05, 2003

AA VISTAPHARM 15MG/5ML A040323 001 May 13, 1999

AA WOCKHARDT BIO AG 15MG/5ML A040313 001 Sep 10, 2003

PRELONE

AA TEVA 15MG/5ML A089081 001 Feb 04, 1986

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-366(of 452)

PREDNISOLONE

TABLET;ORAL

PREDNISOLONE

! WATSON LABS 5MG A080354 001

PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

OMNIPRED

AB NOVARTIS PHARMS 1% N017469 001

CORP

PRED FORTE

AB +! ALLERGAN 1% N017011 001

PRED MILD

+! ALLERGAN 0.12% N017100 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

BLEPHAMIDE S.O.P.

! ALLERGAN 0.2%;10% A087748 001 Dec 03, 1986

SUSPENSION;OPHTHALMIC

BLEPHAMIDE

+! ALLERGAN 0.2%;10% N012813 002

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL

PEDIAPRED

AA +! SETON PHARM EQ 5MG BASE/5ML N019157 001 May 28, 1986

PREDNISOLONE SODIUM PHOSPHATE



AA CHARTWELL RX EQ 5MG BASE/5ML A075988 001 May 25, 2004

AA EDENBRIDGE PHARMS EQ 10MG BASE/5ML A203559 001 Dec 20, 2016

AA EQ 20MG BASE/5ML A203559 002 Dec 20, 2016

AA HI TECH PHARMA EQ 5MG BASE/5ML A075183 001 Mar 26, 2003

AA ! PHARM ASSOC EQ 10MG BASE/5ML A078465 001 Mar 07, 2008

AA EQ 15MG BASE/5ML A076913 001 Apr 25, 2005

AA ! EQ 20MG BASE/5ML A078988 001 Jun 09, 2008

AA VINTAGE EQ 15MG BASE/5ML A079010 001 May 26, 2009

AA WOCKHARDT BIO AG EQ 5MG BASE/5ML A075099 001 Jun 28, 2002

AA ! EQ 15MG BASE/5ML A076895 001 Oct 04, 2004



! MISSION PHARMA EQ 25MG BASE/5ML A091396 001 Sep 13, 2010

SOLUTION/DROPS;OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE



! BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994

TABLET, ORALLY DISINTEGRATING;ORAL

ORAPRED ODT

AB + CONCORDIA PHARMS EQ 10MG BASE N021959 001 Jun 01, 2006

INC

AB + EQ 15MG BASE N021959 002 Jun 01, 2006

AB +! EQ 30MG BASE N021959 003 Jun 01, 2006

PREDNISOLONE SODIUM PHOSPHATE



AB MYLAN PHARMS INC EQ 10MG BASE A202179 001 Apr 10, 2013

AB EQ 15MG BASE A202179 002 Apr 10, 2013

AB EQ 30MG BASE A202179 003 Apr 10, 2013



PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE



AT ! BAUSCH AND LOMB EQ 0.23% PHOSPHATE;10% A074449 001 Dec 29, 1995
AT SANDOZ INC EQ 0.23% PHOSPHATE;10% A073630 001 May 27, 1993
PREDNISONE
SOLUTION;ORAL
PREDNISONE
! WEST-WARD PHARMS 5MG/5ML A088703 001 Nov 08, 1984
INT
PREDNISONE INTENSOL
! WEST-WARD PHARMS 5MG/ML A088810 001 Feb 20, 1985
INT
TABLET;ORAL
PREDNISONE
AB GENEYORK PHARMS 1MG A211496 001 Dec 28, 2018
AB 2.5MG A211495 001 Dec 07, 2018
AB 5MG A211495 002 Dec 07, 2018
AB 10MG A210525 001 Dec 04, 2018
AB 20MG A210525 002 Dec 04, 2018
AB 50MG A210525 003 Dec 04, 2018
AB HIKMA PHARMS 50MG A088465 001 Jun 01, 1984
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-367(of 452)

PREDNISONE

TABLET;ORAL

PREDNISONE

AB JUBILANT CADISTA 1MG A040611 001 Jun 06, 2005

AB 5MG A040362 002 Aug 29, 2001

AB 10MG A040362 001 Aug 29, 2001

AB 20MG A040362 003 Jun 29, 2005

AB MUTUAL PHARM 5MG A089245 001 Dec 04, 1985

AB MYLAN PHARMS INC 5MG A080292 001



AB 10MG A088832 001 Dec 04, 1985

AB 20MG A083677 001



AB SUN PHARM 10MG A089246 001 Dec 04, 1985

INDUSTRIES

AB 20MG A089247 001 Dec 04, 1985

AB VINTAGE PHARMS 1MG A040584 001 Dec 21, 2004

AB 2.5MG A040581 001 Dec 21, 2004

AB 5MG A040256 001 Jul 12, 2002

AB 10MG A040256 002 Jul 12, 2002

AB 20MG A040392 001 Feb 12, 2003

AB WATSON LABS 5MG A080356 001



AB 10MG A085162 001

AB 20MG A085161 001

AB ! WEST-WARD PHARMS 1MG A087800 001 Apr 22, 1982

INT

AB ! 2.5MG A087801 001 Apr 22, 1982

AB ! 5MG A080352 001



AB ! 10MG A084122 001

AB ! 20MG A087342 001

AB ! 50MG A084283 001

TABLET, DELAYED RELEASE;ORAL

PREDNISONE

AB ACTAVIS LABS FL INC 1MG A204867 001 Apr 25, 2017

AB 2MG A204867 002 Apr 25, 2017

AB 5MG A204867 003 Apr 25, 2017

RAYOS

AB + HORIZON PHARMA USA 1MG N202020 001 Jul 26, 2012

AB + 2MG N202020 002 Jul 26, 2012

AB +! 5MG N202020 003 Jul 26, 2012



PREGABALIN

CAPSULE;ORAL

LYRICA

+ PF PRISM CV 25MG N021446 001 Dec 30, 2004

+ 50MG N021446 002 Dec 30, 2004

+ 75MG N021446 003 Dec 30, 2004

+ 100MG N021446 004 Dec 30, 2004

+ 150MG N021446 005 Dec 30, 2004

+ 200MG N021446 006 Dec 30, 2004

+ 225MG N021446 007 Dec 30, 2004

+! 300MG N021446 008 Dec 30, 2004

SOLUTION;ORAL

LYRICA

+! PF PRISM CV 20MG/ML N022488 001 Jan 04, 2010

TABLET, EXTENDED RELEASE;ORAL

LYRICA CR

+ PF PRISM CV 82.5MG N209501 001 Oct 11, 2017

+ 165MG N209501 002 Oct 11, 2017

+! 330MG N209501 003 Oct 11, 2017

PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

PRILOCAINE HYDROCHLORIDE

! SEPTODONT INC 4% A079235 001 Sep 29, 2010

PRIMAQUINE PHOSPHATE

TABLET;ORAL

PRIMAQUINE

AB +! SANOFI AVENTIS US EQ 15MG BASE N008316 001



PRIMAQUINE PHOSPHATE

AB ALVOGEN INC EQ 15MG BASE A203924 001 Feb 03, 2014

AB BAYSHORE PHARMS LLC EQ 15MG BASE A204476 001 Feb 25, 2014

AB NOVAST LABS EQ 15MG BASE A206043 001 Jun 23, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-368(of 452)

PRIMIDONE

TABLET;ORAL

MYSOLINE

AB +! VALEANT
50MG
N009170 003

AB +
250MG
N009170 002

PRIMIDONE

AB AMNEAL PHARM
50MG
A040866 001 Apr 23, 2008

AB
250MG
A040866 002 Apr 23, 2008

AB ANDA REPOSITORY
50MG
A040626 001 Sep 29, 2005

AB
250MG
A040626 002 Sep 29, 2005

AB HIKMA INTL PHARMS


250MG
A040667 002 Jul 27, 2006

AB LANNETT
50MG
A084903 002 May 24, 2001

AB
250MG
A084903 001

AB OXFORD PHARMS
50MG
A040586 001 Feb 24, 2005

AB
250MG
A040586 002 Feb 24, 2005

AB WATSON LABS
250MG
A083551 001

PROBENECID

TABLET;ORAL

PROBALAN

AB LANNETT
500MG
A080966 001

PROBENECID

AB ! MYLAN
500MG
A084211 002

AB WATSON LABS TEVA
500MG
A084442 004 Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

PROCAINAMIDE HYDROCHLORIDE

AP ! HOSPIRA 100MG/ML
A089069 001 Feb 12, 1986

AP INTL MEDICATION 100MG/ML


A088636 001 Jul 31, 1984

AP NEXUS PHARMS 100MG/ML


A206332 001 Oct 13, 2017

AP 500MG/ML
A206332 002 Oct 13, 2017

! HOSPIRA 500MG/ML
A089070 001 Feb 12, 1986

PROCARBAZINE HYDROCHLORIDE

CAPSULE;ORAL

MATULANE

+! LEADIANT BIOSCI INC
EQ 50MG BASE
N016785 001

PROCHLORPERAZINE

SUPPOSITORY;RECTAL

COMPRO

AB PADDOCK LLC
25MG
A040246 001 Jun 28, 2000

PROCHLORPERAZINE

AB ! G AND W LABS
25MG
A040058 001 Nov 24, 1993

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION

PROCHLORPERAZINE EDISYLATE

AP ATHENEX INC
EQ 5MG BASE/ML
A040540 001 May 28, 2004

AP ! EMCURE PHARMS LTD


EQ 5MG BASE/ML
A204147 001 Oct 15, 2013

AP MYLAN LABS LTD


EQ 5MG BASE/ML
A210710 001 Oct 25, 2018

AP WEST-WARD PHARMS
EQ 5MG BASE/ML
A089903 001 Aug 29, 1989

INT

PROCHLORPERAZINE MALEATE

TABLET;ORAL

PROCHLORPERAZINE MALEATE

AB MYLAN
EQ 5MG BASE
A040185 002 Oct 28, 1996

AB
EQ 10MG BASE
A040185 001 Oct 28, 1996

AB SANDOZ
EQ 5MG BASE
A040101 001 Jul 19, 1996

AB !
EQ 10MG BASE
A040101 002 Jul 19, 1996

AB TEVA PHARMS
EQ 5MG BASE
A040120 001 Jul 11, 1996

AB
EQ 10MG BASE
A040120 002 Jul 11, 1996

PROCOMP

AB JUBILANT CADISTA
EQ 5MG BASE
A040268 001 Feb 27, 1998

AB
EQ 10MG BASE
A040268 002 Feb 27, 1998

PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

AB AMNEAL PHARMS NY
100MG
A207724 001 Sep 07, 2017

AB
200MG
A207724 002 Sep 07, 2017

AB BIONPHARMA INC
100MG
A200900 001 Aug 16, 2013

AB
200MG
A200900 002 Aug 16, 2013

AB DR REDDYS LABS INC


100MG
A208801 001 Feb 28, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-369(of 452)

PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

AB 200MG A208801 002 Feb 28, 2017

AB EUGIA PHARMA 100MG A211285 001 Oct 26, 2018

AB 200MG A211285 002 Oct 26, 2018

AB SANDOZ INC 100MG A205229 001 Oct 20, 2017

AB 200MG A205229 002 Oct 20, 2017

AB SOFGEN PHARMS 100MG A200456 001 Sep 28, 2012

AB 200MG A200456 002 Sep 28, 2012

PROMETRIUM

AB + VIRTUS PHARMS 100MG N019781 001 May 14, 1998

AB +! 200MG N019781 002 Oct 15, 1999



GEL;VAGINAL

CRINONE

+! ALLERGAN SALES LLC 4% N020701 001 Jul 31, 1997

+! 8% N020701 002 Jul 31, 1997

INJECTABLE;INJECTION

PROGESTERONE

AO +! ACTAVIS LABS UT INC 50MG/ML N017362 002

AO EUGIA PHARMA 50MG/ML A210965 001 Dec 06, 2018

AO FRESENIUS KABI USA 50MG/ML A075906 001 Apr 25, 2001

AO HIKMA FARMACEUTICA 50MG/ML A091033 001 Oct 28, 2010

AO LUITPOLD 50MG/ML A090845 001 Jun 22, 2009



INSERT;VAGINAL

ENDOMETRIN

+! FERRING 100MG N022057 001 Jun 21, 2007

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROMETHAZINE HYDROCHLORIDE

AP ! WEST-WARD PHARMS 25MG/ML A083312 001

INT

AP ! 50MG/ML A083312 002

AP X-GEN PHARMS 25MG/ML A040737 001 Apr 24, 2008

AP 50MG/ML A040737 002 Apr 24, 2008

SUPPOSITORY;RECTAL

PROMETHAZINE HYDROCHLORIDE

AB G AND W LABS 12.5MG A040428 002 Mar 31, 2003

AB ! 25MG A040428 001 Feb 05, 2002

AB PERRIGO NEW YORK 12.5MG A040500 001 Jun 30, 2003

AB 25MG A040500 002 Jun 30, 2003

AB TARO 12.5MG A040603 001 Oct 26, 2006

AB 25MG A040603 002 Oct 26, 2006

AB WATSON LABS INC 12.5MG A040479 001 Jun 24, 2003

AB 25MG A040479 002 Jun 24, 2003



PROMETHEGAN

! G AND W LABS 50MG A087165 001 Aug 14, 1987

SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE

AA AMNEAL PHARMS 6.25MG/5ML A040882 001 Dec 30, 2009

AA HI TECH PHARMA 6.25MG/5ML A040026 001 Sep 25, 1998

AA NOSTRUM LABS INC 6.25MG/5ML A040891 001 Mar 13, 2009

AA TARO 6.25MG/5ML A040718 001 Apr 04, 2007

AA TRIS PHARMA INC 6.25MG/5ML A091675 001 Jun 28, 2012

AA VINTAGE 6.25MG/5ML A040643 001 Apr 26, 2006

PROMETHAZINE PLAIN

AA ! WOCKHARDT BIO AG 6.25MG/5ML A087953 001 Nov 15, 1982

TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

AB AMNEAL PHARMS NY 12.5MG A091179 001 Dec 13, 2010

AB 25MG A091179 002 Dec 13, 2010

AB 50MG A091179 003 Dec 13, 2010

AB KVK TECH 12.5MG A040712 002 May 04, 2007

AB 25MG A040712 001 Jul 31, 2006

AB 50MG A040712 003 Jul 31, 2006

AB PRINSTON INC 12.5MG A040622 001 Jul 18, 2006

AB 25MG A040622 002 Jul 18, 2006

AB 50MG A040622 003 Jul 18, 2006

AB QUAGEN 12.5MG A040673 001 Mar 05, 2008

AB 25MG A040673 002 Mar 05, 2008

AB 50MG A040673 003 Mar 05, 2008

AB SANDOZ 25MG A084176 003



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-370(of 452)

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

AB ! 50MG A084176 001

AB STRIDES PHARMA 12.5MG A209177 001 Jun 30, 2017

AB 25MG A209177 002 Jun 30, 2017

AB 50MG A209177 003 Jun 30, 2017

AB SUN PHARM INDS INC 12.5MG A040863 001 Dec 30, 2008

AB 25MG A040863 002 Dec 30, 2008

AB 50MG A040863 003 Dec 30, 2008

AB WATSON LABS 25MG A083426 001



AB 50MG A083711 001

AB ZYDUS PHARMS USA 12.5MG A040596 001 Nov 18, 2005

AB 25MG A040596 002 Nov 18, 2005

AB 50MG A040596 003 Nov 18, 2005



IMPAX LABS 12.5MG A040791 002 Feb 12, 2008

25MG A040791 003 Feb 12, 2008

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPAFENONE HYDROCHLORIDE

AB GLENMARK PHARMS LTD 225MG A205268 001 Sep 08, 2017

AB 325MG A205268 002 Sep 08, 2017

AB 425MG A205268 003 Sep 08, 2017

AB MYLAN PHARMS INC 225MG A203803 001 Apr 29, 2016

AB 325MG A203803 002 Apr 29, 2016

AB 425MG A203803 003 Apr 29, 2016

AB PAR PHARM 225MG A078540 001 Oct 18, 2010

AB 325MG A078540 002 Oct 18, 2010

AB 425MG A078540 003 Oct 18, 2010

AB SINOTHERAPEUTICS 225MG A210339 001 Jan 04, 2019

INC

AB 325MG A210339 002 Jan 04, 2019

AB 425MG A210339 003 Jan 04, 2019

AB WATSON LABS INC 225MG A202688 001 Aug 24, 2015

AB 325MG A202688 002 Aug 24, 2015

AB 425MG A202688 003 Aug 24, 2015

AB WILSHIRE PHARMS INC 225MG A205956 001 Jul 02, 2018

AB 325MG A205956 002 Jul 02, 2018

AB 425MG A205956 003 Jul 02, 2018

RYTHMOL SR

AB + GLAXOSMITHKLINE LLC 225MG N021416 001 Sep 04, 2003

AB + 325MG N021416 002 Sep 04, 2003

AB +! 425MG N021416 003 Sep 04, 2003

TABLET;ORAL

PROPAFENONE HYDROCHLORIDE

AB ANI PHARMS INC 150MG A076550 001 Apr 23, 2004

AB 225MG A076550 002 Apr 23, 2004

AB 300MG A076550 003 Apr 23, 2004

AB AUROBINDO PHARMA 150MG A202445 001 May 11, 2016

LTD

AB 225MG A202445 002 May 11, 2016

AB 300MG A202445 003 May 11, 2016

AB SUN PHARM 150MG A075998 001 Nov 29, 2001

INDUSTRIES

AB 225MG A075998 002 Nov 29, 2001

AB 300MG A075998 003 Nov 29, 2001

AB VINTAGE PHARMS 150MG A075938 001 Oct 17, 2002

AB 225MG A075938 002 Oct 17, 2002

AB ! 300MG A075938 003 Oct 17, 2002

AB WATSON LABS 150MG A075203 001 Oct 24, 2000

AB 225MG A075203 002 Oct 24, 2000



PROPANTHELINE BROMIDE

TABLET;ORAL

PROPANTHELINE BROMIDE

! WEST-WARD PHARMS 15MG A080927 002

INT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-371(of 452)

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ALCAINE

AT ALCON LABS INC 0.5% A080027 001

PROPARACAINE HYDROCHLORIDE

AT ! AKORN INC 0.5% A040277 001 Mar 16, 2000

AT BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995



PROPOFOL

INJECTABLE;INJECTION

DIPRIVAN

AB +! FRESENIUS KABI USA 10MG/ML N019627 002 Jun 11, 1996

PROPOFOL

AB DR REDDYS LABS INC 10MG/ML A205067 001 Nov 15, 2018

AB HOSPIRA 10MG/ML A077908 001 Mar 17, 2006

AB SAGENT PHARMS 10MG/ML A075102 001 Jan 04, 1999

AB WATSON LABS INC 10MG/ML A205307 001 Dec 22, 2015



PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

INDERAL LA

AB + ANI PHARMS INC 60MG N018553 004 Mar 18, 1987

AB + 80MG N018553 002 Apr 19, 1983

AB + 120MG N018553 003 Apr 19, 1983

AB +! 160MG N018553 001 Apr 19, 1983

PROPRANOLOL HYDROCHLORIDE

AB ACTAVIS ELIZABETH 60MG A078494 001 Aug 10, 2007

AB 80MG A078494 002 Aug 10, 2007

AB 120MG A078494 003 Aug 10, 2007

AB 160MG A078494 004 Aug 10, 2007

AB NORTEC DEV ASSOC 60MG A078065 001 Jan 26, 2007

AB 80MG A078065 002 Jan 26, 2007

AB 120MG A078065 003 Jan 26, 2007

AB 160MG A078065 004 Jan 26, 2007

AB RP SCHERER 60MG A078703 001 Jul 15, 2011

AB 80MG A078703 002 Jul 15, 2011

AB 120MG A078703 003 Jul 15, 2011

AB 160MG A078703 004 Jul 15, 2011

AB ZYDUS PHARMS USA 60MG A090321 001 Mar 25, 2011

INC

AB 80MG A090321 002 Mar 25, 2011

AB 120MG A090321 003 Mar 25, 2011

AB 160MG A090321 004 Mar 25, 2011



INNOPRAN XL

BX ANI PHARMS INC 80MG N021438 001 Mar 12, 2003

BX 120MG N021438 002 Mar 12, 2003

INJECTABLE;INJECTION

PROPRANOLOL HYDROCHLORIDE

AP ATHENEX INC 1MG/ML A075792 001 Aug 29, 2000

AP FRESENIUS KABI USA 1MG/ML A075826 001 Aug 31, 2001

! HIKMA FARMACEUTICA 1MG/ML A077760 001 Jan 31, 2008



SOLUTION;ORAL

HEMANGEOL

+! PIERRE FABRE DERMA 4.28MG/ML N205410 001 Mar 14, 2014

PROPRANOLOL HYDROCHLORIDE

! WEST-WARD PHARMS 20MG/5ML A070979 001 May 15, 1987

INT

! 40MG/5ML A070690 001 May 15, 1987

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

AB IMPAX LABS INC 10MG A071972 001 Apr 06, 1988

AB 20MG A071972 002 Apr 06, 1988

AB 40MG A071972 003 Apr 06, 1988

AB 60MG A071976 002 May 13, 1986

AB ! 80MG A071976 001 Apr 06, 1988

AB IPCA LABS LTD 10MG A078955 001 Jun 02, 2008

AB 20MG A078955 002 Jun 02, 2008

AB 40MG A078955 003 Jun 02, 2008

AB 60MG A078955 004 Jun 02, 2008

AB 80MG A078955 005 Jun 02, 2008

AB MYLAN 10MG A070213 002 Nov 19, 1985

AB 20MG A070213 003 Nov 19, 1985

AB 40MG A070213 001 Nov 19, 1985

AB 60MG A070213 005 Apr 08, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-372(of 452)

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

AB 80MG A070213 004 Nov 19, 1985

AB NORTHSTAR HLTHCARE 10MG A078213 001 Jan 10, 2008

AB 20MG A078213 002 Jan 10, 2008

AB 40MG A078213 003 Jan 10, 2008

AB 60MG A078213 004 Jan 10, 2008

AB 80MG A078213 005 Jan 10, 2008

AB VINTAGE PHARMS 10MG A070221 002 Aug 01, 1986

AB 20MG A070221 003 Aug 01, 1986

AB 40MG A070219 001 Aug 01, 1986

AB 40MG A070221 004 Aug 01, 1986

AB 60MG A070221 005 Sep 24, 1986

AB 80MG A070221 001 Apr 14, 1986

AB WATSON LABS 10MG A070175 001 May 13, 1986

AB 20MG A070176 001 May 13, 1986

AB 40MG A070177 001 May 13, 1986

AB 60MG A070178 002 Apr 23, 2018

AB 80MG A070178 001 May 13, 1986



PROPYLTHIOURACIL

TABLET;ORAL

PROPYLTHIOURACIL

BD ACTAVIS ELIZABETH 50MG A080172 001

BD +! DAVA PHARMS INC 50MG N006188 001

PROTAMINE SULFATE

INJECTABLE;INJECTION

PROTAMINE SULFATE

! FRESENIUS KABI USA 10MG/ML A089454 001 Apr 07, 1987

PROTRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

PROTRIPTYLINE HYDROCHLORIDE

AB EPIC PHARMA LLC 5MG A202220 001 Nov 19, 2012

AB 10MG A202220 002 Nov 19, 2012

AB SIGMAPHARM LABS LLC 5MG A090462 001 May 03, 2010

AB 10MG A090462 002 May 03, 2010

AB WEST-WARD PHARMS 5MG A078913 001 Sep 16, 2008

INT

AB 10MG A078913 002 Sep 16, 2008

VIVACTIL

AB ODYSSEY PHARMS 5MG A073644 001 Aug 24, 1995

AB ! 10MG A073645 001 Aug 24, 1995



PRUCALOPRIDE SUCCINATE

TABLET;ORAL

MOTEGRITY

+ SHIRE DEV LLC EQ 1MG BASE N210166 001 Dec 14, 2018

+! EQ 2MG BASE N210166 002 Dec 14, 2018

PYRAZINAMIDE

TABLET;ORAL

PYRAZINAMIDE

AB AKORN 500MG A081319 001 Jun 30, 1992

AB ! DAVA PHARMS INC 500MG A080157 001



PYRIDOSTIGMINE BROMIDE

INJECTABLE;INJECTION

MESTINON

AP +! VALEANT PHARM INTL 5MG/ML N009830 001

REGONOL

AP SANDOZ INC 5MG/ML N017398 001

SYRUP;ORAL

MESTINON

+! VALEANT PHARMS 60MG/5ML N015193 001

TABLET;ORAL

MESTINON

AB +! VALEANT PHARMS LLC 60MG N009829 002

PYRIDOSTIGMINE BROMIDE

AB APNAR PHARMA LP 60MG A211181 001 Jul 20, 2018

AB IMPAX LABS 60MG A040502 001 Apr 24, 2003

AB ZYDUS PHARMS USA 60MG A205650 001 Jun 22, 2015

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-373(of 452)

PYRIDOSTIGMINE BROMIDE

TABLET, EXTENDED RELEASE;ORAL

MESTINON

AB +! VALEANT PHARMS LLC 180MG N011665 001

PYRIDOSTIGMINE BROMIDE

AB ALVOGEN MALTA 180MG A204737 001 Jun 26, 2015

AB IMPAX LABS INC 180MG A203184 001 Sep 15, 2015

AB RISING PHARMS 180MG A205464 001 Aug 15, 2017



PYRIDOXINE HYDROCHLORIDE

INJECTABLE;INJECTION

PYRIDOXINE HYDROCHLORIDE

! FRESENIUS KABI USA 100MG/ML A080618 001

PYRIMETHAMINE

TABLET;ORAL

DARAPRIM

+! VYERA PHARMS LLC 25MG N008578 001

QUAZEPAM

TABLET;ORAL

DORAL

+! GALT PHARMS 15MG N018708 001 Dec 27, 1985

QUETIAPINE FUMARATE

TABLET;ORAL

QUETIAPINE FUMARATE

AB ACCORD HLTHCARE EQ 25MG BASE A202152 001 Mar 27, 2012

AB EQ 50MG BASE A202152 002 Mar 27, 2012

AB EQ 100MG BASE A202152 003 Mar 27, 2012

AB EQ 200MG BASE A202152 004 Mar 27, 2012

AB EQ 300MG BASE A202152 005 Mar 27, 2012

AB EQ 400MG BASE A202152 006 Mar 27, 2012

AB ALEMBIC PHARMS LTD EQ 25MG BASE A203390 001 Oct 28, 2014

AB EQ 50MG BASE A203390 002 Oct 28, 2014

AB EQ 100MG BASE A203390 003 Oct 28, 2014

AB EQ 200MG BASE A203390 004 Oct 28, 2014

AB EQ 300MG BASE A203390 005 Oct 28, 2014

AB EQ 400MG BASE A203390 006 Oct 28, 2014

AB ALKEM LABS LTD EQ 25MG BASE A201504 001 Feb 12, 2013

AB EQ 50MG BASE A201504 002 Feb 12, 2013

AB EQ 100MG BASE A201504 003 Feb 12, 2013

AB EQ 150MG BASE A201504 004 Feb 12, 2013

AB EQ 200MG BASE A201504 005 Feb 12, 2013

AB EQ 300MG BASE A201504 006 Feb 12, 2013

AB EQ 400MG BASE A201504 007 Feb 12, 2013

AB APOTEX INC EQ 25MG BASE A090960 001 Mar 27, 2012

AB EQ 50MG BASE A090960 002 Mar 27, 2012

AB EQ 100MG BASE A090960 003 Mar 27, 2012

AB EQ 200MG BASE A090960 004 Mar 27, 2012

AB EQ 300MG BASE A090960 005 Mar 27, 2012

AB EQ 400MG BASE A090960 006 Mar 27, 2012

AB AUROBINDO PHARMA EQ 25MG BASE A091388 001 Mar 27, 2012

LTD

AB EQ 50MG BASE A091388 002 Mar 27, 2012

AB EQ 100MG BASE A091388 003 Mar 27, 2012

AB EQ 150MG BASE A091388 004 Mar 27, 2012

AB EQ 200MG BASE A091388 005 Mar 27, 2012

AB EQ 300MG BASE A091388 006 Mar 27, 2012

AB EQ 400MG BASE A091388 007 Mar 27, 2012

AB DR REDDYS LABS LTD EQ 25MG BASE A077380 001 Mar 27, 2012

AB EQ 50MG BASE A077380 002 Mar 27, 2012

AB EQ 100MG BASE A077380 003 Mar 27, 2012

AB EQ 150MG BASE A077380 004 Mar 27, 2012

AB EQ 200MG BASE A077380 005 Mar 27, 2012

AB EQ 300MG BASE A077380 006 Mar 27, 2012

AB EQ 400MG BASE A077380 007 Mar 27, 2012

AB JUBILANT GENERICS EQ 25MG BASE A203150 001 Nov 26, 2013

AB LUPIN LTD EQ 25MG BASE A201109 001 Mar 27, 2012

AB EQ 50MG BASE A201109 002 Mar 27, 2012

AB EQ 100MG BASE A201109 003 Mar 27, 2012

AB EQ 200MG BASE A201109 004 Mar 27, 2012

AB EQ 300MG BASE A201109 005 Mar 27, 2012

AB EQ 400MG BASE A201109 006 Mar 27, 2012

AB MACLEODS PHARMS LTD EQ 25MG BASE A203359 001 May 17, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-374(of 452)

QUETIAPINE FUMARATE

TABLET;ORAL

QUETIAPINE FUMARATE

AB EQ 50MG BASE A203359 002 May 17, 2016

AB EQ 100MG BASE A203359 003 May 17, 2016

AB EQ 200MG BASE A203359 004 May 17, 2016

AB EQ 300MG BASE A203359 005 May 17, 2016

AB EQ 400MG BASE A203359 006 May 17, 2016

AB SANDOZ EQ 25MG BASE A078679 001 Dec 14, 2012

AB EQ 50MG BASE A078679 002 Dec 14, 2012

AB EQ 100MG BASE A078679 003 Dec 14, 2012

AB EQ 150MG BASE A078679 004 Dec 14, 2012

AB EQ 200MG BASE A078679 005 Dec 14, 2012

AB EQ 300MG BASE A078679 006 Dec 14, 2012

AB EQ 400MG BASE A078679 007 Dec 14, 2012

AB SUN PHARMA GLOBAL EQ 25MG BASE A201190 001 Mar 27, 2012

AB EQ 50MG BASE A201190 002 Mar 27, 2012

AB EQ 100MG BASE A201190 003 Mar 27, 2012

AB EQ 200MG BASE A201190 004 Mar 27, 2012

AB EQ 300MG BASE A201190 005 Mar 27, 2012

AB EQ 400MG BASE A201190 006 Mar 27, 2012

AB TEVA PHARMS EQ 25MG BASE A077745 001 Mar 27, 2012

AB EQ 50MG BASE A077745 002 Mar 27, 2012

AB EQ 100MG BASE A077745 003 Mar 27, 2012

AB EQ 150MG BASE A077745 004 Mar 27, 2012

AB EQ 200MG BASE A077745 005 Mar 27, 2012

AB EQ 300MG BASE A077745 006 Mar 27, 2012

AB EQ 400MG BASE A077745 007 Mar 27, 2012

AB TORRENT PHARMS LTD EQ 25MG BASE A200363 001 Mar 27, 2012

AB EQ 50MG BASE A200363 002 Mar 27, 2012

AB EQ 100MG BASE A200363 003 Mar 27, 2012

AB EQ 200MG BASE A200363 004 Mar 27, 2012

AB EQ 300MG BASE A200363 005 Mar 27, 2012

AB EQ 400MG BASE A200363 006 Mar 27, 2012

AB UNICHEM LABS LTD EQ 25MG BASE A202674 001 Mar 08, 2016

AB EQ 50MG BASE A202674 002 Mar 08, 2016

AB EQ 100MG BASE A202674 003 Mar 08, 2016

AB EQ 200MG BASE A202674 004 Mar 08, 2016

AB EQ 300MG BASE A202674 005 Mar 08, 2016

AB EQ 400MG BASE A202674 006 Mar 08, 2016

AB WEST-WARD PHARMS EQ 25MG BASE A090120 001 Mar 27, 2012

INT

AB EQ 50MG BASE A090749 001 Mar 27, 2012

AB EQ 100MG BASE A090749 002 Mar 27, 2012

AB EQ 200MG BASE A090749 003 Mar 27, 2012

AB EQ 300MG BASE A090749 004 Mar 27, 2012

AB EQ 400MG BASE A090749 005 Mar 27, 2012

SEROQUEL

AB +! ASTRAZENECA PHARMS EQ 25MG BASE N020639 001 Sep 26, 1997

AB + EQ 50MG BASE N020639 007 Oct 04, 2005

AB + EQ 100MG BASE N020639 002 Sep 26, 1997

AB + EQ 200MG BASE N020639 003 Sep 26, 1997

AB +! EQ 300MG BASE N020639 005 Jul 26, 2000

AB + EQ 400MG BASE N020639 006 Oct 04, 2005



TABLET, EXTENDED RELEASE;ORAL

QUETIAPINE FUMARATE

AB ACCORD HLTHCARE EQ 50MG BASE A206252 001 Nov 29, 2017

AB EQ 150MG BASE A090681 001 May 09, 2017

AB EQ 200MG BASE A090681 002 May 09, 2017

AB EQ 300MG BASE A090681 003 May 09, 2017

AB EQ 400MG BASE A090681 004 Nov 01, 2016

AB ALIGNSCIENCE PHARMA EQ 150MG BASE A209497 001 Sep 28, 2018

AB EQ 200MG BASE A209497 002 Sep 28, 2018

AB AMNEAL PHARMS EQ 400MG BASE A211405 001 Oct 26, 2018

AB ANCHEN PHARMS EQ 150MG BASE A090757 001 Dec 01, 2017

AB EQ 200MG BASE A090757 002 Dec 01, 2017

AB EQ 300MG BASE A090757 003 Dec 01, 2017

AB EQ 400MG BASE A090757 004 Dec 01, 2017

AB AUROBINDO PHARMA EQ 50MG BASE A207655 001 Nov 29, 2017

LTD

AB EQ 150MG BASE A207655 002 Nov 29, 2017

AB EQ 200MG BASE A207655 003 Nov 29, 2017

AB EQ 300MG BASE A207655 004 Nov 29, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-375(of 452)

QUETIAPINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

QUETIAPINE FUMARATE

AB EQ 400MG BASE A207655 005 Nov 29, 2017

AB INTELLIPHARMACEUTIC EQ 50MG BASE A202939 001 May 09, 2017

S

AB EQ 150MG BASE A202939 002 May 09, 2017

AB EQ 200MG BASE A202939 003 May 09, 2017

AB EQ 300MG BASE A202939 004 May 09, 2017

AB EQ 400MG BASE A202939 005 May 09, 2017

AB LUPIN LTD EQ 50MG BASE A204203 001 May 17, 2017

AB EQ 150MG BASE A204203 002 May 17, 2017

AB EQ 200MG BASE A204203 003 May 17, 2017

AB EQ 300MG BASE A204203 004 May 17, 2017

AB EQ 400MG BASE A204203 005 May 17, 2017

AB MACLEODS PHARMS LTD EQ 150MG BASE A204253 001 Nov 29, 2017

AB EQ 200MG BASE A204253 002 Nov 29, 2017

AB EQ 300MG BASE A204253 003 Nov 29, 2017

AB EQ 400MG BASE A204253 004 Nov 29, 2017

AB NOVAST LABS EQ 50MG BASE A208947 001 Nov 29, 2017

AB EQ 150MG BASE A208947 002 Nov 29, 2017

AB EQ 200MG BASE A208947 003 Nov 29, 2017

AB EQ 300MG BASE A208947 004 Nov 29, 2017

AB EQ 400MG BASE A208947 005 Nov 29, 2017

AB PAR PHARM EQ 50MG BASE A090482 001 May 09, 2017

AB EQ 150MG BASE A090482 002 May 09, 2017

AB EQ 200MG BASE A090482 003 May 09, 2017

AB EQ 300MG BASE A090482 004 May 09, 2017

AB EQ 400MG BASE A090482 005 May 09, 2017

AB PHARMADAX INC EQ 50MG BASE A206260 001 May 09, 2017

AB EQ 150MG BASE A206260 002 May 09, 2017

AB EQ 200MG BASE A206260 003 May 09, 2017

AB EQ 300MG BASE A206260 004 May 09, 2017

AB EQ 400MG BASE A206260 005 May 09, 2017

AB SCIEGEN PHARMS INC EQ 50MG BASE A209635 005 Nov 16, 2018

AB EQ 150MG BASE A209635 001 Nov 29, 2017

AB EQ 200MG BASE A209635 002 Nov 29, 2017

AB EQ 300MG BASE A209635 003 Nov 29, 2017

AB EQ 400MG BASE A209635 004 Nov 29, 2017

SEROQUEL XR

AB + ASTRAZENECA EQ 50MG BASE N022047 001 May 17, 2007

AB + EQ 150MG BASE N022047 005 Aug 11, 2008

AB +! EQ 200MG BASE N022047 002 May 17, 2007

AB + EQ 300MG BASE N022047 003 May 17, 2007

AB + EQ 400MG BASE N022047 004 May 17, 2007



QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

ACCUPRIL

AB + PFIZER PHARMS EQ 5MG BASE N019885 001 Nov 19, 1991

AB + EQ 10MG BASE N019885 002 Nov 19, 1991

AB + EQ 20MG BASE N019885 003 Nov 19, 1991

AB +! EQ 40MG BASE N019885 004 Nov 19, 1991

QUINAPRIL HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 5MG BASE A202725 001 Apr 29, 2013

LTD

AB EQ 10MG BASE A202725 002 Apr 29, 2013

AB EQ 20MG BASE A202725 003 Apr 29, 2013

AB EQ 40MG BASE A202725 004 Apr 29, 2013

AB INVAGEN PHARMS EQ 5MG BASE A078457 001 Aug 24, 2007

AB EQ 10MG BASE A078457 002 Aug 24, 2007

AB EQ 20MG BASE A078457 003 Aug 24, 2007

AB EQ 40MG BASE A078457 004 Aug 24, 2007

AB LUPIN EQ 5MG BASE A077690 001 Jun 20, 2006

AB EQ 10MG BASE A077690 002 Jun 20, 2006

AB EQ 20MG BASE A077690 003 Jun 20, 2006

AB EQ 40MG BASE A077690 004 Jun 20, 2006

AB MYLAN EQ 5MG BASE A076694 001 Dec 23, 2004

AB EQ 10MG BASE A076694 002 Dec 23, 2004

AB EQ 20MG BASE A076694 003 Dec 23, 2004

AB EQ 40MG BASE A076694 004 Dec 23, 2004

AB PRINSTON INC EQ 5MG BASE A205823 001 Sep 15, 2016

AB EQ 10MG BASE A205823 002 Sep 15, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-376(of 452)

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE

AB EQ 20MG BASE A205823 003 Sep 15, 2016

AB EQ 40MG BASE A205823 004 Sep 15, 2016

AB TEVA EQ 5MG BASE A075504 001 Aug 24, 2007

AB EQ 10MG BASE A075504 002 Aug 24, 2007

AB EQ 20MG BASE A075504 003 Aug 24, 2007

AB EQ 40MG BASE A075504 004 Aug 24, 2007



QUINIDINE GLUCONATE

TABLET, EXTENDED RELEASE;ORAL

QUINIDINE GLUCONATE

BX ! SUN PHARM 324MG A089338 001 Feb 11, 1987

INDUSTRIES

QUINIDINE SULFATE

TABLET;ORAL

QUINIDINE SULFATE

AB SANDOZ 200MG A088072 002



AB 300MG A088072 001 Sep 26, 1983

AB SUN PHARM 200MG A081030 001 Apr 14, 1989

INDUSTRIES

AB 300MG A081031 001 Apr 14, 1989

AB ! WATSON LABS 200MG A083288 001



AB ! 300MG A085583 001

QUININE SULFATE

CAPSULE;ORAL

QUALAQUIN

AB +! SUN PHARM 324MG N021799 001 Aug 12, 2005

INDUSTRIES

QUININE SULFATE

AB AMNEAL PHARMS 324MG A203729 001 Jul 15, 2015

AB LUPIN LTD 324MG A203112 001 Apr 24, 2015

AB MYLAN PHARMS INC 324MG A202581 001 Dec 14, 2012

AB NOVAST LABS 324MG A204372 001 Jul 22, 2015

AB TEVA PHARMS 324MG A091661 001 Sep 28, 2012



RABEPRAZOLE SODIUM

CAPSULE, DELAYED RELEASE;ORAL

ACIPHEX SPRINKLE

+ CERECOR INC 5MG N204736 001 Mar 26, 2013

+! 10MG N204736 002 Mar 26, 2013

TABLET, DELAYED RELEASE;ORAL

ACIPHEX

AB +! EISAI INC 20MG N020973 002 Aug 19, 1999

RABEPRAZOLE SODIUM

AB ALKEM LABS LTD 20MG A208644 001 Apr 24, 2018

AB AMNEAL PHARMS 20MG A204179 001 Jul 31, 2015

AB AUROBINDO PHARMA 20MG A205761 001 Feb 17, 2017

LTD

AB BRECKENRIDGE PHARM 20MG A204237 001 Nov 18, 2015

AB DR REDDYS LABS LTD 20MG A076824 001 Nov 08, 2013

AB LANNETT CO INC 20MG A090678 001 Nov 08, 2013

AB LUPIN LTD 20MG A078964 001 Nov 08, 2013

AB MYLAN PHARMS INC 20MG A076885 001 Nov 08, 2013

AB TEVA PHARMS USA 20MG A076822 001 Nov 08, 2013

AB TORRENT PHARMS LTD 20MG A202376 001 Nov 08, 2013



RADIUM RA-223 DICHLORIDE

SOLUTION;INTRAVENOUS

XOFIGO

+! BAYER HLTHCARE 162mCi/6ML (27mCi/ML) N203971 001 May 15, 2013

RALOXIFENE HYDROCHLORIDE

TABLET;ORAL

EVISTA

AB +! LILLY 60MG N020815 001 Dec 09, 1997

RALOXIFENE HYDROCHLORIDE

AB AMNEAL PHARMS 60MG A208206 001 Apr 08, 2016

AB AUROBINDO PHARMA 60MG A204310 001 Aug 28, 2015

LTD

AB GLENMARK PHARMS LTD 60MG A204491 001 Mar 22, 2016

AB INVAGEN PHARMS 60MG A090842 001 Sep 24, 2014

AB SCIEGEN PHARMS INC 60MG A206384 001 Oct 12, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-377(of 452)

RALOXIFENE HYDROCHLORIDE

TABLET;ORAL

RALOXIFENE HYDROCHLORIDE

AB TEVA PHARMS USA 60MG A078193 001 Mar 04, 2014

AB WATSON LABS INC 60MG A200825 001 Jan 21, 2015



RALTEGRAVIR POTASSIUM

POWDER;ORAL

ISENTRESS

+! MERCK SHARP DOHME EQ 100MG BASE/PACKET N205786 001 Dec 20, 2013

TABLET;ORAL

ISENTRESS

+! MERCK SHARP DOHME EQ 400MG BASE N022145 001 Oct 12, 2007

ISENTRESS HD

+! MERCK SHARP DOHME EQ 600MG BASE N022145 002 May 26, 2017

TABLET, CHEWABLE;ORAL

ISENTRESS

+ MERCK SHARP DOHME EQ 25MG BASE N203045 001 Dec 21, 2011

+! EQ 100MG BASE N203045 002 Dec 21, 2011

RAMELTEON

TABLET;ORAL

RAMELTEON

AB ACTAVIS LABS FL INC 8MG A091610 001 Aug 19, 2015

AB DR REDDYS LABS SA 8MG A091693 001 Jul 26, 2013

ROZEREM

AB +! TAKEDA PHARMS USA 8MG N021782 001 Jul 22, 2005

RAMIPRIL

CAPSULE;ORAL

ALTACE

AB + KING PHARMS LLC 1.25MG N019901 001 Jan 28, 1991

AB + 2.5MG N019901 002 Jan 28, 1991

AB + 5MG N019901 003 Jan 28, 1991

AB +! 10MG N019901 004 Jan 28, 1991

RAMIPRIL

AB ACCORD HLTHCARE 1.25MG A202392 001 Apr 15, 2014

AB 2.5MG A202392 002 Apr 15, 2014

AB 5MG A202392 003 Apr 15, 2014

AB 10MG A202392 004 Apr 15, 2014

AB APOTEX 1.25MG A079116 001 Jun 20, 2008

AB 2.5MG A079116 002 Jun 20, 2008

AB 5MG A079116 003 Jun 20, 2008

AB 10MG A079116 004 Jun 20, 2008

AB AUROBINDO PHARMA 1.25MG A091604 001 Jun 08, 2011

LTD

AB 2.5MG A091604 002 Jun 08, 2011

AB 5MG A091604 003 Jun 08, 2011

AB 10MG A091604 004 Jun 08, 2011

AB CHARTWELL MOLECULAR 1.25MG A078745 001 Jun 18, 2008

AB 2.5MG A078745 002 Jun 18, 2008

AB 5MG A078745 003 Jun 18, 2008

AB 10MG A078745 004 Jun 18, 2008

AB DR REDDYS LABS LTD 1.25MG A078191 001 Jun 18, 2008

AB 2.5MG A078191 002 Jun 18, 2008

AB 5MG A078191 003 Jun 18, 2008

AB 10MG A078191 004 Jun 18, 2008

AB LUPIN 1.25MG A077626 001 Jun 09, 2008

AB 2.5MG A077626 002 Jun 09, 2008

AB 5MG A077626 003 Jun 09, 2008

AB 10MG A077626 004 Jun 09, 2008

AB TEVA PHARMS 1.25MG A077470 001 Jun 18, 2008

AB 2.5MG A077470 002 Jun 18, 2008

AB 5MG A077470 003 Jun 18, 2008

AB 10MG A077470 004 Jun 18, 2008

AB WATSON LABS 1.25MG A076549 001 Oct 24, 2005

AB 2.5MG A076549 002 Oct 24, 2005

AB 10MG A076549 004 Oct 24, 2005

AB WEST-WARD PHARMS 1.25MG A077900 001 Jun 18, 2008

INT

AB 2.5MG A077900 002 Jun 18, 2008

AB 5MG A077900 003 Jun 18, 2008

AB 10MG A077900 004 Jun 18, 2008

AB ZYDUS PHARMS USA 1.25MG A078832 001 Sep 02, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-378(of 452)

RAMIPRIL

CAPSULE;ORAL

RAMIPRIL

AB
2.5MG
A078832 002 Sep 02, 2008

AB
5MG
A078832 003 Sep 02, 2008

AB
10MG
A078832 004 Sep 02, 2008

RANITIDINE

CAPSULE;ORAL

RANITIDINE

AB NOVITIUM PHARMA
EQ 150MG BASE
A210681 001 Nov 23, 2018

AB
EQ 300MG BASE
A210681 002 Nov 23, 2018

RANITIDINE HYDROCHLORIDE

CAPSULE;ORAL

RANITIDINE HYDROCHLORIDE

AB AJANTA PHARMA LTD
EQ 150MG BASE
A209859 001 Sep 27, 2018

AB
EQ 300MG BASE
A209859 002 Sep 27, 2018

AB AUROBINDO PHARMA
EQ 150MG BASE
A211058 001 Jul 16, 2018

LTD

AB
EQ 300MG BASE
A211058 002 Jul 16, 2018

AB DR REDDYS LABS LTD


EQ 150MG BASE
A075742 001 Nov 29, 2000

AB
EQ 300MG BASE
A075742 002 Nov 29, 2000

AB SANDOZ
EQ 150MG BASE
A074655 001 Oct 22, 1997

AB !
EQ 300MG BASE
A074655 002 Oct 22, 1997

INJECTABLE;INJECTION

RANITIDINE HYDROCHLORIDE

AP MYLAN LABS LTD
EQ 25MG BASE/ML
A079076 001 Jun 09, 2016

AP WEST-WARD PHARMS
EQ 25MG BASE/ML
A074777 001 Mar 02, 2005

INT

AP
EQ 25MG BASE/ML
A077458 001 Feb 16, 2006

AP ZYDUS PHARMS USA


EQ 25MG BASE/ML
A091534 001 Feb 22, 2013

INC

ZANTAC

AP +! TELIGENT
EQ 25MG BASE/ML
N019090 001 Oct 19, 1984

SYRUP;ORAL

RANITIDINE HYDROCHLORIDE

AA ACTAVIS MID EQ 15MG BASE/ML
A076124 001 Feb 21, 2007

ATLANTIC
AA AMNEAL PHARMS EQ 15MG BASE/ML
A078312 001 Sep 02, 2008

AA ANDA REPOSITORY EQ 15MG BASE/ML


A090054 001 Nov 15, 2010

AA AUROBINDO PHARMA EQ 15MG BASE/ML


A090623 001 Jul 28, 2010

LTD
AA BIO PHARM INC EQ 15MG BASE/ML
A090102 001 May 26, 2009

AA BRECKENRIDGE PHARM EQ 15MG BASE/ML


A078684 001 Aug 27, 2009

AA HI TECH PHARMA EQ 15MG BASE/ML


A091078 001 Mar 22, 2011

AA LANNETT CO INC EQ 15MG BASE/ML


A078890 001 Jul 01, 2010

AA EQ 15MG BASE/ML
A091288 001 Dec 09, 2010

AA NOSTRUM LABS INC EQ 15MG BASE/ML


A091091 001 Sep 20, 2011

AA ! PHARM ASSOC EQ 15MG BASE/ML


A077405 001 Sep 21, 2007

AA TARO EQ 15MG BASE/ML


A077476 001 Jun 13, 2011

TABLET;ORAL

RANITIDINE HYDROCHLORIDE

AB ACIC PHARMS
EQ 150MG BASE
A203694 001 Nov 30, 2017

AB
EQ 300MG BASE
A203694 002 Nov 30, 2017

AB AMNEAL PHARMS NY
EQ 150MG BASE
A077824 001 Oct 13, 2006

AB !
EQ 300MG BASE
A077824 002 Oct 13, 2006

AB APOTEX
EQ 150MG BASE
A074680 001 Sep 12, 1997

AB
EQ 300MG BASE
A074680 002 Sep 12, 1997

AB DR REDDYS LABS INC


EQ 150MG BASE
A076705 001 Jul 27, 2005

AB
EQ 300MG BASE
A076705 002 Jul 27, 2005

AB GLENMARK PHARMS INC


EQ 150MG BASE
A078542 001 Nov 19, 2008

AB
EQ 300MG BASE
A078542 002 Nov 19, 2008

AB IVAX SUB TEVA


EQ 150MG BASE
A075165 001 Sep 30, 1998

PHARMS

AB
EQ 300MG BASE
A075165 002 Sep 30, 1998

AB PAR PHARM
EQ 150MG BASE
A075180 001 Jan 28, 1999

AB
EQ 300MG BASE
A075180 002 Jan 28, 1999

AB SANDOZ
EQ 150MG BASE
A074467 001 Aug 29, 1997

AB
EQ 300MG BASE
A074467 002 Aug 29, 1997

AB STRIDES PHARMA
EQ 150MG BASE
A205512 001 Aug 22, 2016

AB
EQ 300MG BASE
A205512 002 Aug 22, 2016

AB TEVA
EQ 150MG BASE
A074488 001 Jul 31, 1997

AB
EQ 300MG BASE
A074488 002 Jul 31, 1997

AB VIVIMED GLOBAL
EQ 150MG BASE
A210010 001 Aug 01, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-379(of 452)

RANITIDINE HYDROCHLORIDE

TABLET;ORAL

RANITIDINE HYDROCHLORIDE

AB EQ 300MG BASE A210010 002 Aug 01, 2018

AB WOCKHARDT LTD EQ 150MG BASE A075208 001 Dec 17, 1998

AB EQ 300MG BASE A075208 002 Dec 17, 1998



RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL

RANEXA

+ GILEAD 500MG N021526 002 Jan 27, 2006

+! 1GM N021526 001 Feb 12, 2007

RASAGILINE MESYLATE

TABLET;ORAL

AZILECT

AB + TEVA EQ 0.5MG BASE N021641 001 May 16, 2006

AB +! EQ 1MG BASE N021641 002 May 16, 2006

RASAGILINE MESYLATE

AB ALKEM LABS LTD EQ 0.5MG BASE A201889 001 Oct 30, 2017

AB EQ 1MG BASE A201889 002 Oct 30, 2017

AB MYLAN PHARMS INC EQ 0.5MG BASE A201971 001 May 15, 2017

AB EQ 1MG BASE A201971 002 May 15, 2017

AB ORCHID HLTHCARE EQ 0.5MG BASE A201970 001 Mar 15, 2016

AB EQ 1MG BASE A201970 002 Mar 15, 2016

AB SANDOZ INC EQ 0.5MG BASE A201892 001 Jul 27, 2018

AB EQ 1MG BASE A201892 002 Jul 27, 2018

AB WATSON LABS INC EQ 0.5MG BASE A201823 001 Jul 01, 2013

AB EQ 1MG BASE A201823 002 Jul 01, 2013



REGADENOSON

SOLUTION;INTRAVENOUS

LEXISCAN

+! ASTELLAS 0.4MG/5ML (0.08MG/ML) N022161 001 Apr 10, 2008

REGORAFENIB

TABLET;ORAL

STIVARGA

+! BAYER HLTHCARE 40MG N203085 001 Sep 27, 2012

REMIFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION

REMIFENTANIL HYDROCHLORIDE

AP FRESENIUS KABI USA EQ 1MG BASE/VIAL A206223 001 Jan 16, 2018

AP EQ 2MG BASE/VIAL A206223 002 Jan 16, 2018

AP EQ 5MG BASE/VIAL A206223 003 Jan 16, 2018

ULTIVA

AP + MYLAN INSTITUTIONAL EQ 1MG BASE/VIAL N020630 001 Jul 12, 1996

AP + EQ 2MG BASE/VIAL N020630 002 Jul 12, 1996

AP +! EQ 5MG BASE/VIAL N020630 003 Jul 12, 1996



REPAGLINIDE

TABLET;ORAL

PRANDIN

AB + GEMINI LABS LLC 0.5MG N020741 001 Dec 22, 1997

AB + 1MG N020741 002 Dec 22, 1997

AB +! 2MG N020741 003 Dec 22, 1997

REPAGLINIDE

AB ACTAVIS TOTOWA 0.5MG A090008 001 Jan 22, 2014

AB 1MG A090008 002 Jan 22, 2014

AB 2MG A090008 003 Jan 22, 2014

AB AUROBINDO PHARMA 0.5MG A203820 001 Jan 22, 2014

LTD

AB 1MG A203820 002 Jan 22, 2014

AB 2MG A203820 003 Jan 22, 2014

AB BOSCOGEN 0.5MG A091517 001 Apr 24, 2015

AB 1MG A091517 002 Apr 24, 2015

AB 2MG A091517 003 Apr 24, 2015

AB CASI PHARMS INC 0.5MG A078555 001 Nov 22, 2013

AB 1MG A078555 002 Jan 22, 2014

AB 2MG A078555 003 Jan 22, 2014

AB MYLAN PHARMS INC 0.5MG A090252 001 Aug 23, 2013

AB 1MG A090252 002 Jan 22, 2014

AB 2MG A090252 003 Jan 22, 2014

AB PADDOCK LLC 0.5MG A201189 001 Jul 17, 2013

AB 1MG A201189 002 Jan 22, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-380(of 452)

REPAGLINIDE

TABLET;ORAL

REPAGLINIDE

AB 2MG A201189 003 Jan 22, 2014

AB SUN PHARM INDS INC 1MG A077571 002 Jul 11, 2013

AB 2MG A077571 003 Jul 11, 2013



RETAPAMULIN

OINTMENT;TOPICAL

ALTABAX

+! AQUA PHARMS LLC 1% N022055 001 Apr 12, 2007

REVEFENACIN

SOLUTION;INHALATION

YUPELRI

+! MYLAN IRELAND LTD 175MCG/3ML N210598 001 Nov 09, 2018

RIBAVIRIN

CAPSULE;ORAL

REBETOL

AB +! MERCK SHARP DOHME 200MG N020903 002 Jul 25, 2001

RIBASPHERE

AB KADMON PHARMS LLC 200MG A076203 001 Apr 06, 2004

RIBAVIRIN

AB AUROBINDO PHARMA 200MG A079117 001 Sep 17, 2009

AB CASI PHARMS INC 200MG A076192 001 Apr 06, 2004

AB TEVA 200MG A076277 001 Oct 04, 2004

AB ZYDUS PHARMS USA 200MG A077224 001 Oct 28, 2005



FOR SOLUTION;INHALATION

RIBAVIRIN

AN NAVINTA LLC 6GM/VIAL A207366 001 Oct 06, 2016

VIRAZOLE

AN +! VALEANT PHARM INTL 6GM/VIAL N018859 001 Dec 31, 1985

SOLUTION;ORAL

REBETOL

+! SCHERING 40MG/ML N021546 001 Jul 29, 2003

TABLET;ORAL

RIBAVIRIN

AB AUROBINDO PHARMA 200MG A079111 001 Sep 17, 2009

AB KADMON PHARMS LLC 200MG A077456 001 Dec 05, 2005

AB 400MG A077456 002 Dec 05, 2005

AB ! 600MG A077456 003 Dec 05, 2005

AB SANDOZ 200MG A077743 001 Oct 03, 2006

AB SANDOZ INC 200MG A202546 001 Aug 12, 2014

AB 400MG A202546 002 Aug 12, 2014

AB 500MG A202546 003 Aug 12, 2014

AB 600MG A202546 004 Aug 12, 2014

AB TEVA 200MG A077053 001 Dec 05, 2005

AB ZYDUS PHARMS USA 200MG A077094 001 Dec 05, 2005

AB 400MG A077094 002 Mar 16, 2007

AB 500MG A077094 004 Apr 18, 2008

AB 600MG A077094 003 Mar 16, 2007



RIBOCICLIB SUCCINATE

TABLET;ORAL

KISQALI

+! NOVARTIS PHARMS EQ 200MG BASE N209092 001 Mar 13, 2017

CORP

RIBOFLAVIN 5'-PHOSPHATE SODIUM

SOLUTION/DROPS;OPHTHALMIC

PHOTREXA

+! AVEDRO INC 0.146% N203324 001 Apr 15, 2016

PHOTREXA VISCOUS IN DEXTRAN 20%



+! AVEDRO INC 0.146% N203324 002 Apr 15, 2016

RIFABUTIN

CAPSULE;ORAL

MYCOBUTIN

AB +! PHARMACIA AND 150MG N050689 001 Dec 23, 1992

UPJOHN

RIFABUTIN

AB LUPIN LTD 150MG A090033 001 Feb 24, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-381(of 452)

RIFAMPIN

CAPSULE;ORAL

RIFADIN

AB SANOFI AVENTIS US 150MG A062303 001

AB +! 300MG N050420 001

RIFAMPIN

AB AKORN 150MG A065028 001 Mar 14, 2001

AB 300MG A065028 002 Mar 14, 2001

AB LANNETT CO INC 150MG A065390 001 Mar 28, 2008

AB 300MG A065390 002 Mar 28, 2008

AB LUPIN PHARMS 150MG A090034 001 Aug 21, 2013

AB 300MG A090034 002 Aug 21, 2013

AB SANDOZ 150MG A064150 002 Jan 02, 1998

AB 300MG A064150 001 May 28, 1997

RIMACTANE

AB OXFORD PHARMS 300MG N050429 001

INJECTABLE;INJECTION

RIFADIN

AP +! SANOFI AVENTIS US 600MG/VIAL N050627 001 May 25, 1989

RIFAMPIN

AP AKORN 600MG/VIAL A065502 001 Sep 21, 2010

AP EMCURE PHARMS LTD 600MG/VIAL A204101 001 Aug 18, 2014

AP FRESENIUS KABI USA 600MG/VIAL A091181 001 Aug 21, 2014

AP HIKMA PHARMS 600MG/VIAL A205039 001 Mar 03, 2016

AP MYLAN LABS LTD 600MG/VIAL A065421 001 May 22, 2008

AP WATSON PHARMS TEVA 600MG/VIAL A206736 001 Jan 19, 2016

AP WEST-WARD PHARMS 600MG/VIAL A064217 001 Oct 29, 1999

INT

RIFAMYCIN

TABLET, DELAYED RELEASE;ORAL

AEMCOLO

+! COSMO TECHNOLOGIES 194MG N210910 001 Nov 16, 2018

RIFAPENTINE

TABLET;ORAL

PRIFTIN

+! SANOFI AVENTIS US 150MG N021024 001 Jun 22, 1998

RIFAXIMIN

TABLET;ORAL

XIFAXAN

+! SALIX PHARMS 200MG N021361 001 May 25, 2004

+! 550MG N022554 001 Mar 24, 2010



RILPIVIRINE HYDROCHLORIDE

TABLET;ORAL

EDURANT

+! JANSSEN PRODS EQ 25MG BASE N202022 001 May 20, 2011

RILUZOLE

SUSPENSION;ORAL

TIGLUTIK KIT

+! ITALFARMACO SPA 50MG/10ML N209080 001 Sep 05, 2018

TABLET;ORAL

RILUTEK

AB +! COVIS PHARMA BV 50MG N020599 001 Dec 12, 1995

RILUZOLE

AB ALKEM LABS LTD 50MG A204048 001 Mar 30, 2016

AB APOTEX CORP 50MG A091300 001 Jun 18, 2013

AB DAITO PHARMS CO LTD 50MG A204430 001 Oct 16, 2018

AB GLENMARK PHARMS LTD 50MG A091394 001 Jun 18, 2013

AB IMPAX LABS 50MG A076173 001 Jan 29, 2003

AB MYLAN PHARMS INC 50MG A203042 001 Jul 01, 2013

AB SUN PHARM INDS LTD 50MG A091417 001 Jun 18, 2013

RIMANTADINE HYDROCHLORIDE

TABLET;ORAL

FLUMADINE

AB +! SUN PHARM INDS INC 100MG N019649 001 Sep 17, 1993

RIMANTADINE HYDROCHLORIDE

AB IMPAX LABS 100MG A076132 001 Aug 30, 2002

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-382(of 452)

RIOCIGUAT

TABLET;ORAL

ADEMPAS

+ BAYER HLTHCARE 0.5MG N204819 001 Oct 08, 2013

+ 1MG N204819 002 Oct 08, 2013

+ 1.5MG N204819 003 Oct 08, 2013

+ 2MG N204819 004 Oct 08, 2013

+! 2.5MG N204819 005 Oct 08, 2013

RISEDRONATE SODIUM

TABLET;ORAL

ACTONEL

AB + APIL 5MG N020835 002 Apr 14, 2000

AB + 30MG N020835 001 Mar 27, 1998

AB +! 35MG N020835 003 May 25, 2002

AB +! 150MG N020835 005 Apr 22, 2008

RISEDRONATE SODIUM

AB APOTEX INC 35MG A090877 001 Nov 30, 2015

AB 75MG A090877 002 Jun 10, 2014

AB 150MG A090877 003 Jun 10, 2014

AB AUROBINDO PHARMA 5MG A200296 001 Nov 30, 2015

LTD

AB 30MG A200296 002 Nov 30, 2015

AB 35MG A200296 003 Nov 30, 2015

AB 150MG A206768 001 Oct 21, 2016

AB MACLEODS PHARMS LTD 5MG A203533 001 Dec 09, 2015

AB 30MG A203533 002 Dec 09, 2015

AB 35MG A203533 003 Nov 29, 2016

AB MYLAN PHARMS INC 5MG A200477 001 Nov 30, 2015

AB 30MG A200477 002 Nov 30, 2015

AB 35MG A200477 003 Nov 30, 2015

AB 75MG A200477 004 Jun 10, 2014

AB 150MG A200477 005 Jun 10, 2014

AB SUN PHARMA GLOBAL 5MG A090886 001 Nov 30, 2015

AB 30MG A090886 002 Nov 30, 2015

AB 35MG A090886 003 Nov 30, 2015

AB 75MG A090886 004 Jun 10, 2014

AB 150MG A090886 005 Jun 10, 2014

AB TEVA PHARMS USA 5MG A077132 001 Oct 05, 2007

AB 30MG A077132 002 Oct 05, 2007

AB 35MG A077132 003 Oct 05, 2007

AB 150MG A079215 001 Jun 13, 2014



TABLET, DELAYED RELEASE;ORAL

ATELVIA

AB +! APIL 35MG N022560 001 Oct 08, 2010

RISEDRONATE SODIUM

AB TEVA PHARMS USA 35MG A203217 001 May 18, 2015

AB ZYDUS PHARMS USA 35MG A203822 001 Sep 11, 2018

INC

RISPERIDONE

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

PERSERIS KIT

+ INDIVIOR INC 90MG N210655 001 Jul 27, 2018

+! 120MG N210655 002 Jul 27, 2018

INJECTABLE;INTRAMUSCULAR

RISPERDAL CONSTA

+ JANSSEN PHARMS 12.5MG/VIAL N021346 004 Apr 12, 2007

+! 25MG/VIAL N021346 001 Oct 29, 2003



+ 37.5MG/VIAL N021346 002 Oct 29, 2003

+ 50MG/VIAL N021346 003 Oct 29, 2003

SOLUTION;ORAL

RISPERDAL

AA +! JANSSEN PHARMS 1MG/ML N020588 001 Jun 10, 1996

RISPERIDONE

AA AMNEAL PHARMS 1MG/ML A091384 001 May 25, 2011

AA ANI PHARMS INC 1MG/ML A076440 001 Jan 30, 2009

AA APOTEX INC 1MG/ML A077719 001 Jul 29, 2009

AA AUROBINDO PHARMA 1MG/ML A078452 001 Sep 04, 2009

LTD

AA BIO PHARM INC 1MG/ML A078909 001 Jul 29, 2009

AA LANNETT CO INC 1MG/ML A079158 001 Dec 03, 2010

AA TARO 1MG/ML A090347 001 Feb 07, 2011

AA TRIS PHARMA INC 1MG/ML A079059 001 Dec 12, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-383(of 452)

RISPERIDONE

SOLUTION;ORAL

RISPERIDONE

AA WEST-WARD PHARMS 1MG/ML A076904 001 Jul 29, 2009

INT

TABLET;ORAL

RISPERDAL

AB + JANSSEN PHARMS 0.25MG N020272 008 May 10, 1999

AB + 0.5MG N020272 007 Jan 27, 1999

AB +! 1MG N020272 001 Dec 29, 1993

AB + 2MG N020272 002 Dec 29, 1993

AB + 3MG N020272 003 Dec 29, 1993

AB + 4MG N020272 004 Dec 29, 1993

RISPERIDONE

AB AJANTA PHARMA LTD 0.25MG A201003 001 Aug 24, 2011

AB 0.5MG A201003 002 Aug 24, 2011

AB 1MG A201003 003 Aug 24, 2011

AB 2MG A201003 004 Aug 24, 2011

AB 3MG A201003 005 Aug 24, 2011

AB 4MG A201003 006 Aug 24, 2011

AB APOTEX INC 0.25MG A077953 001 Sep 15, 2008

AB 0.5MG A077953 002 Sep 15, 2008

AB 1MG A077953 003 Sep 15, 2008

AB 2MG A077953 004 Sep 15, 2008

AB 3MG A077953 005 Sep 15, 2008

AB 4MG A077953 006 Sep 15, 2008

AB CEYONE 0.25MG A078269 001 Oct 08, 2008

AB 0.5MG A078269 002 Oct 08, 2008

AB 1MG A078269 003 Oct 08, 2008

AB 2MG A078269 004 Oct 08, 2008

AB 3MG A078269 005 Oct 08, 2008

AB 4MG A078269 006 Oct 08, 2008

AB CHARTWELL MOLECULAR 0.25MG A077543 001 May 18, 2011

AB 0.5MG A077543 002 May 18, 2011

AB 1MG A077543 003 May 18, 2011

AB 2MG A077543 004 May 18, 2011

AB 3MG A077543 005 May 18, 2011

AB 4MG A077543 006 May 18, 2011

AB DR REDDYS LABS LTD 0.25MG A076879 001 Oct 24, 2008

AB 0.5MG A076879 002 Oct 24, 2008

AB 1MG A076879 003 Oct 24, 2008

AB 2MG A076879 004 Oct 24, 2008

AB 3MG A076879 005 Oct 24, 2008

AB 4MG A076879 006 Oct 24, 2008

AB MYLAN 0.25MG A076288 001 Sep 15, 2008

AB 0.5MG A076288 002 Sep 15, 2008

AB 1MG A076288 003 Sep 15, 2008

AB 2MG A076288 004 Sep 15, 2008

AB 3MG A076288 005 Sep 15, 2008

AB 4MG A076288 006 Sep 15, 2008

AB OXFORD PHARMS 0.25MG A078071 001 Jun 17, 2009

AB 0.5MG A078071 002 Jun 17, 2009

AB 1MG A078071 003 Jun 17, 2009

AB 2MG A078071 004 Jun 17, 2009

AB 3MG A078071 005 Jun 17, 2009

AB 4MG A078071 006 Jun 17, 2009

AB PLIVA HRVATSKA DOO 0.25MG A077769 001 Oct 16, 2008

AB 0.5MG A077769 002 Oct 16, 2008

AB 1MG A077769 003 Oct 16, 2008

AB 2MG A077769 004 Oct 16, 2008

AB 3MG A077769 005 Oct 16, 2008

AB 4MG A077769 006 Oct 16, 2008

AB PRINSTON INC 0.25MG A077493 001 Nov 29, 2011

AB 0.5MG A077493 002 Nov 29, 2011

AB 1MG A077493 003 Nov 29, 2011

AB 2MG A077493 004 Nov 29, 2011

AB 3MG A077493 005 Nov 29, 2011

AB 4MG A077493 006 Nov 29, 2011

AB RENATA 0.25MG A078707 001 Dec 29, 2008

AB 0.5MG A078707 002 Dec 29, 2008

AB 1MG A078707 003 Dec 29, 2008

AB 2MG A078707 004 Dec 29, 2008

AB 3MG A078707 005 Dec 29, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-384(of 452)

RISPERIDONE

TABLET;ORAL

RISPERIDONE

AB 4MG A078707 006 Dec 29, 2008

AB SANDOZ 0.25MG A078528 001 Oct 16, 2009

AB 0.5MG A078528 002 Oct 16, 2009

AB 1MG A078528 003 Oct 16, 2009

AB 2MG A078528 004 Oct 16, 2009

AB 3MG A078528 005 Oct 16, 2009

AB 4MG A078528 006 Oct 16, 2009

AB SUN PHARM INDS INC 0.25MG A078036 001 Mar 10, 2014

AB 0.5MG A078036 002 Mar 10, 2014

AB 1MG A078036 003 Mar 10, 2014

AB 2MG A078036 004 Mar 10, 2014

AB 3MG A078036 005 Mar 10, 2014

AB 4MG A078036 006 Mar 10, 2014

AB TEVA 0.25MG A076228 001 Jun 30, 2008

AB 0.5MG A076228 002 Jun 30, 2008

AB 1MG A076228 003 Jun 30, 2008

AB 2MG A076228 004 Jun 30, 2008

AB 3MG A076228 005 Jun 30, 2008

AB 4MG A076228 006 Jun 30, 2008

AB TORRENT PHARMS 0.25MG A079088 001 Oct 30, 2008

AB 0.5MG A079088 002 Oct 30, 2008

AB 1MG A079088 003 Oct 30, 2008

AB 2MG A079088 004 Oct 30, 2008

AB 3MG A079088 005 Oct 30, 2008

AB 4MG A079088 006 Oct 30, 2008

AB WOCKHARDT 0.25MG A078871 001 Oct 09, 2008

AB 0.5MG A078871 002 Oct 09, 2008

AB 1MG A078871 003 Oct 09, 2008

AB 2MG A078871 004 Oct 09, 2008

AB 3MG A078871 005 Oct 09, 2008

AB 4MG A078871 006 Oct 09, 2008

AB ZYDUS PHARMS USA 0.25MG A078040 001 Oct 16, 2008

INC

AB 0.5MG A078040 002 Oct 16, 2008

AB 1MG A078040 003 Oct 16, 2008

AB 2MG A078040 004 Oct 16, 2008

AB 3MG A078040 005 Oct 16, 2008

AB 4MG A078040 006 Oct 16, 2008



TABLET, ORALLY DISINTEGRATING;ORAL

RISPERDAL

AB + JANSSEN PHARMS 0.5MG N021444 001 Apr 02, 2003

AB +! 1MG N021444 002 Apr 02, 2003

AB + 2MG N021444 003 Apr 02, 2003

AB + 3MG N021444 004 Dec 23, 2004

AB + 4MG N021444 005 Dec 23, 2004

RISPERIDONE

AB ACTAVIS LABS FL INC 0.5MG A076996 001 Apr 19, 2011

AB 1MG A076996 002 Apr 19, 2011

AB 2MG A076996 003 Apr 19, 2011

AB 3MG A076996 004 Apr 19, 2011

AB 4MG A076996 005 Apr 19, 2011

AB DR REDDYS LABS LTD 0.5MG A077328 001 Feb 24, 2009

AB 1MG A077328 002 Oct 05, 2009

AB 2MG A077328 003 Feb 24, 2009

AB 3MG A077328 004 Nov 30, 2009

AB 4MG A077328 005 Nov 30, 2009

AB JUBILANT GENERICS 0.5MG A090839 001 Nov 04, 2011

AB 1MG A090839 002 Nov 04, 2011

AB 2MG A090839 003 Nov 04, 2011

AB 3MG A090839 004 Nov 04, 2011

AB 4MG A090839 005 Nov 04, 2011

AB PAR PHARM 0.5MG A077494 002 Apr 30, 2009

AB 1MG A077494 003 Oct 26, 2009

AB 2MG A077494 004 Apr 30, 2009

AB 3MG A077494 005 Apr 30, 2009

AB 4MG A077494 006 Apr 30, 2009

AB SANDOZ 0.5MG A078116 001 Dec 22, 2009

AB 1MG A078116 002 Dec 22, 2009

AB 2MG A078116 003 Dec 22, 2009

AB 3MG A078116 004 Dec 22, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-385(of 452)

RISPERIDONE

TABLET, ORALLY DISINTEGRATING;ORAL

RISPERIDONE

AB 4MG A078116 005 Dec 22, 2009

AB SUN PHARM INDS LTD 0.5MG A077542 001 Aug 06, 2010

AB 0.5MG A078464 001 Apr 08, 2013

AB 1MG A077542 002 Aug 06, 2010

AB 1MG A078464 002 Apr 08, 2013

AB 2MG A077542 003 Aug 06, 2010

AB 2MG A078464 003 Apr 08, 2013

AB 3MG A078464 004 Apr 08, 2013

AB 3MG A078474 001 Aug 06, 2010

AB 4MG A078464 005 Apr 08, 2013

AB 4MG A078474 002 Aug 06, 2010

AB TEVA 0.5MG A076908 001 Mar 12, 2012

AB 1MG A076908 002 Mar 12, 2012

AB 2MG A076908 003 Mar 12, 2012

AB ZYDUS PHARMS USA 0.5MG A078516 001 May 01, 2009

AB 2MG A078516 003 May 01, 2009

PAR PHARM 0.25MG A077494 001 Apr 30, 2009



RITONAVIR

POWDER;ORAL

NORVIR

+! ABBVIE INC 100MG/PACKET N209512 001 Jun 07, 2017

SOLUTION;ORAL

NORVIR

+! ABBVIE 80MG/ML N020659 001 Mar 01, 1996

TABLET;ORAL

NORVIR

AB +! ABBVIE 100MG N022417 001 Feb 10, 2010

RITONAVIR

AB AMNEAL PHARMS LLC 100MG A208890 001 Sep 17, 2018

AB AUROBINDO PHARMA 100MG A206614 001 Sep 17, 2018

LTD

AB HETERO LABS LTD III 100MG A204587 001 Sep 17, 2018

AB WEST-WARD PHARMS 100MG A202573 001 Jan 15, 2015

INT

RIVAROXABAN

TABLET;ORAL

XARELTO

+ JANSSEN PHARMS 2.5MG N022406 004 Oct 11, 2018

+ 10MG N022406 001 Jul 01, 2011

+ 15MG N022406 002 Nov 04, 2011

+! 20MG N022406 003 Nov 04, 2011

RIVASTIGMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EXELON

AB + NOVARTIS 4.6MG/24HR N022083 001 Jul 06, 2007

AB +! 9.5MG/24HR N022083 002 Jul 06, 2007

AB + 13.3MG/24HR N022083 005 Aug 31, 2012

RIVASTIGMINE

AB ALVOGEN MALTA 4.6MG/24HR A204403 001 Sep 03, 2015

AB 9.5MG/24HR A204403 002 Sep 03, 2015

AB 13.3MG/24HR A204403 003 Aug 31, 2015

AB AMNEAL PHARMS 4.6MG/24HR A207308 001 Jan 08, 2019

AB 9.5MG/24HR A207308 002 Jan 08, 2019

AB 13.3MG/24HR A207308 003 Jan 08, 2019

AB MYLAN TECHNOLOGIES 4.6MG/24HR A205622 001 Jun 20, 2018

AB 9.5MG/24HR A205622 002 Jun 20, 2018

AB 13.3MG/24HR A205622 003 Jun 20, 2018



RIVASTIGMINE TARTRATE

CAPSULE;ORAL

EXELON

AB +! NOVARTIS EQ 1.5MG BASE N020823 003 Apr 21, 2000

AB + EQ 3MG BASE N020823 004 Apr 21, 2000

AB + EQ 4.5MG BASE N020823 005 Apr 21, 2000

AB +! EQ 6MG BASE N020823 006 Apr 21, 2000

RIVASTIGMINE TARTRATE

AB ALEMBIC PHARMS LTD EQ 1.5MG BASE A091689 001 Jun 12, 2012

AB EQ 3MG BASE A091689 002 Jun 12, 2012

AB EQ 4.5MG BASE A091689 003 Jun 12, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-386(of 452)

RIVASTIGMINE TARTRATE

CAPSULE;ORAL

RIVASTIGMINE TARTRATE
AB EQ 6MG BASE
A091689 004 Jun 12, 2012

AB APOTEX INC EQ 1.5MG BASE


A091072 001 May 16, 2013

AB EQ 3MG BASE
A091072 002 May 16, 2013

AB EQ 4.5MG BASE
A091072 003 May 16, 2013

AB EQ 6MG BASE
A091072 004 May 16, 2013

AB AUROBINDO PHARMA EQ 1.5MG BASE


A204572 001 Mar 25, 2016

LTD
AB EQ 3MG BASE
A204572 002 Mar 25, 2016

AB EQ 4.5MG BASE
A204572 003 Mar 25, 2016

AB EQ 6MG BASE
A204572 004 Mar 25, 2016

AB CADILA PHARMS LTD EQ 1.5MG BASE


A203844 001 Feb 13, 2017

AB EQ 3MG BASE
A203844 002 Feb 13, 2017

AB EQ 4.5MG BASE
A203844 003 Feb 13, 2017

AB EQ 6MG BASE
A203844 004 Feb 13, 2017

AB CHARTWELL RX EQ 1.5MG BASE


A207797 001 Sep 28, 2017

AB EQ 3MG BASE
A207797 002 Sep 28, 2017

AB EQ 4.5MG BASE
A207797 003 Sep 28, 2017

AB EQ 6MG BASE
A207797 004 Sep 28, 2017

AB DR REDDYS LABS INC EQ 1.5MG BASE


A077130 001 Oct 31, 2007

AB EQ 3MG BASE
A077130 002 Oct 31, 2007

AB EQ 4.5MG BASE
A077130 003 Oct 31, 2007

AB EQ 6MG BASE
A077130 004 Oct 31, 2007

AB MACLEODS PHARMS LTD EQ 1.5MG BASE


A203148 001 Aug 22, 2014

AB EQ 3MG BASE
A203148 002 Aug 22, 2014

AB EQ 4.5MG BASE
A203148 003 Aug 22, 2014

AB EQ 6MG BASE
A203148 004 Aug 22, 2014

AB ORCHID HLTHCARE EQ 1.5MG BASE


A090879 001 Jun 10, 2015

AB EQ 3MG BASE
A090879 002 Jun 10, 2015

AB EQ 4.5MG BASE
A090879 003 Jun 10, 2015

AB EQ 6MG BASE
A090879 004 Jun 10, 2015

AB SUN PHARM INDS LTD EQ 1.5MG BASE


A077131 001 Oct 22, 2007

AB EQ 3MG BASE
A077131 002 Oct 22, 2007

AB EQ 4.5MG BASE
A077131 003 Oct 22, 2007

AB EQ 6MG BASE
A077131 004 Oct 22, 2007

AB WATSON LABS EQ 1.5MG BASE


A077129 001 Jan 08, 2008

AB EQ 3MG BASE
A077129 002 Jan 08, 2008

AB EQ 4.5MG BASE
A077129 003 Jan 08, 2008

AB EQ 6MG BASE
A077129 004 Jan 08, 2008

RIZATRIPTAN BENZOATE

TABLET;ORAL

MAXALT

AB +! MERCK
EQ 10MG BASE
N020864 002 Jun 29, 1998

RIZATRIPTAN BENZOATE

AB ALKEM LABS LTD
EQ 5MG BASE
A203269 001 Feb 18, 2016

AB
EQ 10MG BASE
A203269 002 Feb 18, 2016

AB AUROBINDO PHARMA
EQ 5MG BASE
A202490 001 Dec 31, 2012

LTD

AB
EQ 10MG BASE
A202490 002 Dec 31, 2012

AB CELLTRION
EQ 5MG BASE
A077526 001 Mar 26, 2013

AB
EQ 10MG BASE
A077526 002 Mar 26, 2013

AB ECI PHARMS LLC


EQ 5MG BASE
A202047 001 Dec 31, 2012

AB
EQ 10MG BASE
A202047 002 Dec 31, 2012

AB EMCURE PHARMS LTD


EQ 5MG BASE
A204090 001 Nov 26, 2013

AB
EQ 10MG BASE
A204090 002 Nov 26, 2013

AB GLENMARK GENERICS
EQ 5MG BASE
A201967 001 Dec 31, 2012

AB
EQ 10MG BASE
A201967 002 Dec 31, 2012

AB INVAGEN PHARMS
EQ 5MG BASE
A204339 001 Jul 01, 2013

AB
EQ 10MG BASE
A204339 002 Jul 01, 2013

AB JUBILANT GENERICS
EQ 5MG BASE
A203252 001 Dec 31, 2014

AB
EQ 10MG BASE
A203252 002 Dec 31, 2014

AB MACLEODS PHARMS LTD


EQ 5MG BASE
A203147 001 Feb 11, 2014

AB
EQ 10MG BASE
A203147 002 Feb 11, 2014

AB MYLAN PHARMS INC


EQ 5MG BASE
A201993 001 Dec 31, 2012

AB
EQ 10MG BASE
A201993 002 Dec 31, 2012

AB NATCO PHARMA LTD


EQ 5MG BASE
A200482 001 Dec 31, 2012

AB
EQ 10MG BASE
A200482 002 Dec 31, 2012

AB SANDOZ
EQ 5MG BASE
A079230 001 Dec 31, 2012

AB
EQ 10MG BASE
A079230 002 Dec 31, 2012

AB TEVA PHARMS
EQ 5MG BASE
A077263 001 Dec 31, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-387(of 452)

RIZATRIPTAN BENZOATE

TABLET;ORAL

RIZATRIPTAN BENZOATE
AB EQ 10MG BASE A077263 002 Dec 31, 2012

AB UNICHEM LABS LTD EQ 5MG BASE A207836 001 Mar 07, 2017

AB EQ 10MG BASE A207836 002 Mar 07, 2017



TABLET, ORALLY DISINTEGRATING;ORAL

MAXALT-MLT

AB +! MERCK
EQ 10MG BASE
N020865 002 Jun 29, 1998

RIZATRIPTAN BENZOATE

AB AUROBINDO PHARMA
EQ 5MG BASE
A203062 001 Jul 01, 2013

LTD

AB
EQ 10MG BASE
A203062 002 Jul 01, 2013

AB GLENMARK PHARMS LTD


EQ 5MG BASE
A201914 001 Jul 01, 2013

AB
EQ 10MG BASE
A201914 002 Jul 01, 2013

AB JUBILANT GENERICS
EQ 5MG BASE
A203334 001 Oct 16, 2015

AB
EQ 10MG BASE
A203334 002 Oct 16, 2015

AB MACLEODS PHARMS LTD


EQ 5MG BASE
A203146 001 Sep 19, 2014

AB
EQ 10MG BASE
A203146 002 Sep 19, 2014

AB MYLAN PHARMS INC


EQ 5MG BASE
A078173 001 Dec 31, 2012

AB
EQ 10MG BASE
A078173 002 Dec 31, 2012

AB NATCO PHARMA LTD


EQ 5MG BASE
A203478 001 Jul 01, 2013

AB
EQ 10MG BASE
A203478 002 Jul 01, 2013

AB PANACEA BIOTEC LTD


EQ 5MG BASE
A204722 001 Jan 11, 2017

AB
EQ 10MG BASE
A204722 002 Jan 11, 2017

AB SANDOZ
EQ 5MG BASE
A078739 001 Jul 01, 2013

AB
EQ 10MG BASE
A078739 002 Jul 01, 2013

AB UNICHEM LABS LTD


EQ 5MG BASE
A207835 001 Mar 07, 2017

AB
EQ 10MG BASE
A207835 002 Mar 07, 2017

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ROCURONIUM BROMIDE

AP AUROBINDO PHARMA 50MG/5ML (10MG/ML)
A206206 001 Apr 12, 2017

LTD
AP 100MG/10ML (10MG/ML)
A206206 002 Apr 12, 2017

AP FRESENIUS KABI USA 50MG/5ML (10MG/ML)


A078651 001 Dec 29, 2008

AP 100MG/10ML (10MG/ML)
A078651 002 Dec 29, 2008

AP GLAND PHARMA LTD 50MG/5ML (10MG/ML)


A205656 001 Apr 04, 2018

AP 100MG/10ML (10MG/ML)
A205656 002 Apr 04, 2018

AP HOSPIRA 50MG/5ML (10MG/ML)


A078519 001 Nov 26, 2008

AP 100MG/10ML (10MG/ML)
A078519 002 Nov 26, 2008

AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML)


A079199 001 Nov 26, 2008

AP 100MG/10ML (10MG/ML)
A079199 002 Nov 26, 2008

AP SAGENT PHARMS 50MG/5ML (10MG/ML)


A091458 001 Jul 28, 2010

AP 100MG/10ML (10MG/ML)
A091458 002 Jul 28, 2010

AP ! SANDOZ INC 50MG/5ML (10MG/ML)


A079195 001 Dec 05, 2008

AP ! 100MG/10ML (10MG/ML)
A079195 002 Dec 05, 2008

AP TAMARANG 50MG/5ML (10MG/ML)


A091115 001 Aug 27, 2012

AP 100MG/10ML (10MG/ML)
A091115 002 Aug 27, 2012

AP TEVA PHARMS 50MG/5ML (10MG/ML)


A078717 001 Nov 26, 2008

AP 100MG/10ML (10MG/ML)
A078717 002 Nov 26, 2008

AP WEST WARD PHARM 50MG/5ML (10MG/ML)


A204679 001 Feb 28, 2017

CORP
AP 100MG/10ML (10MG/ML)
A204679 002 Feb 28, 2017

ROFLUMILAST

TABLET;ORAL

DALIRESP

AB +! ASTRAZENECA PHARMS
500MCG
N022522 001 Feb 28, 2011

ROFLUMILAST

AB BRECKENRIDGE PHARM
500MCG
A208236 001 Oct 03, 2018

AB HETERO LABS LTD III


500MCG
A208213 001 Nov 23, 2018

AB TORRENT PHARMS LTD


500MCG
A208272 001 Aug 06, 2018

DALIRESP

+ ASTRAZENECA PHARMS
250MCG
N022522 002 Jan 23, 2018

ROLAPITANT HYDROCHLORIDE

TABLET;ORAL

VARUBI

+! TERSERA THERAPS LLC
EQ 90MG BASE
N206500 001 Sep 01, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-388(of 452)

ROMIDEPSIN

POWDER;INTRAVENOUS

ISTODAX

+! CELGENE
10MG/VIAL
N022393 001 Nov 05, 2009

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

REQUIP

AB +! GLAXOSMITHKLINE LLC
EQ 0.25MG BASE
N020658 001 Sep 19, 1997

AB +
EQ 0.5MG BASE
N020658 002 Sep 19, 1997

AB +
EQ 1MG BASE
N020658 003 Sep 19, 1997

AB +
EQ 2MG BASE
N020658 004 Sep 19, 1997

AB +
EQ 3MG BASE
N020658 006 Jan 27, 1999

AB +
EQ 4MG BASE
N020658 007 Jan 27, 1999

AB +
EQ 5MG BASE
N020658 005 Sep 19, 1997

ROPINIROLE HYDROCHLORIDE

AB ACCORD HLTHCARE
EQ 0.25MG BASE
A204022 001 Feb 28, 2017

AB
EQ 0.5MG BASE
A204022 002 Feb 28, 2017

AB
EQ 1MG BASE
A204022 003 Feb 28, 2017

AB
EQ 2MG BASE
A204022 004 Feb 28, 2017

AB
EQ 3MG BASE
A204022 005 Feb 28, 2017

AB
EQ 4MG BASE
A204022 006 Feb 28, 2017

AB
EQ 5MG BASE
A204022 007 Feb 28, 2017

AB ALEMBIC LTD
EQ 0.25MG BASE
A090429 001 Mar 24, 2010

AB
EQ 0.5MG BASE
A090429 002 Mar 24, 2010

AB
EQ 1MG BASE
A090429 003 Mar 24, 2010

AB
EQ 2MG BASE
A090429 004 Mar 24, 2010

AB
EQ 3MG BASE
A090429 005 Mar 24, 2010

AB
EQ 4MG BASE
A090429 006 Mar 24, 2010

AB
EQ 5MG BASE
A090429 007 Mar 24, 2010

AB APOTEX
EQ 0.25MG BASE
A079165 001 Feb 07, 2012

AB
EQ 0.5MG BASE
A079165 002 Feb 07, 2012

AB
EQ 1MG BASE
A079165 003 Feb 07, 2012

AB
EQ 2MG BASE
A079165 004 Feb 07, 2012

AB
EQ 3MG BASE
A079165 005 Feb 07, 2012

AB
EQ 4MG BASE
A079165 006 Feb 07, 2012

AB
EQ 5MG BASE
A079165 007 Feb 07, 2012

AB GLENMARK GENERICS
EQ 0.25MG BASE
A090135 001 Feb 25, 2010

AB
EQ 0.5MG BASE
A090135 002 Feb 25, 2010

AB
EQ 1MG BASE
A090135 003 Feb 25, 2010

AB
EQ 2MG BASE
A090135 004 Feb 25, 2010

AB
EQ 3MG BASE
A090135 005 Feb 25, 2010

AB
EQ 4MG BASE
A090135 006 Feb 25, 2010

AB
EQ 5MG BASE
A090135 007 Feb 25, 2010

AB MYLAN
EQ 0.25MG BASE
A078881 001 May 05, 2008

AB
EQ 0.5MG BASE
A078881 002 May 05, 2008

AB
EQ 1MG BASE
A078881 003 May 05, 2008

AB
EQ 2MG BASE
A078881 004 May 05, 2008

AB
EQ 3MG BASE
A078881 005 May 05, 2008

AB
EQ 4MG BASE
A078881 006 May 05, 2008

AB
EQ 5MG BASE
A078881 007 May 19, 2008

AB ORCHID HLTHCARE
EQ 0.25MG BASE
A079229 001 Nov 28, 2012

AB
EQ 0.5MG BASE
A079229 002 Nov 28, 2012

AB
EQ 1MG BASE
A079229 003 Nov 28, 2012

AB
EQ 2MG BASE
A079229 004 Nov 28, 2012

AB
EQ 3MG BASE
A079229 005 Nov 28, 2012

AB
EQ 4MG BASE
A079229 006 Nov 28, 2012

AB
EQ 5MG BASE
A079229 007 Nov 28, 2012

AB PRINSTON INC
EQ 0.25MG BASE
A078110 001 May 05, 2008

AB
EQ 0.5MG BASE
A078110 002 May 05, 2008

AB
EQ 1MG BASE
A078110 003 May 05, 2008

AB
EQ 2MG BASE
A078110 004 May 05, 2008

AB
EQ 3MG BASE
A078110 005 May 05, 2008

AB
EQ 4MG BASE
A078110 006 May 05, 2008

AB
EQ 5MG BASE
A078110 007 Jul 11, 2008

AB WEST-WARD PHARMS
EQ 0.25MG BASE
A077852 001 May 05, 2008

INT

AB
EQ 0.5MG BASE
A077852 002 May 05, 2008

AB
EQ 1MG BASE
A077852 003 May 05, 2008

AB
EQ 2MG BASE
A077852 004 May 05, 2008

AB
EQ 3MG BASE
A077852 005 May 05, 2008

AB
EQ 4MG BASE
A077852 006 May 05, 2008

AB
EQ 5MG BASE
A077852 007 May 19, 2008

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-389(of 452)

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

ROPINIROLE HYDROCHLORIDE

AB WOCKHARDT EQ 0.25MG BASE A079050 001 May 29, 2008

AB EQ 0.5MG BASE A079050 002 May 29, 2008

AB EQ 1MG BASE A079050 003 May 29, 2008

AB EQ 2MG BASE A079050 004 May 29, 2008

AB EQ 3MG BASE A079050 005 May 29, 2008

AB EQ 4MG BASE A079050 006 May 29, 2008

AB EQ 5MG BASE A079050 007 May 29, 2008

AB ZYDUS PHARMS USA EQ 0.25MG BASE A090411 001 Jun 01, 2009

INC

AB EQ 0.5MG BASE A090411 002 Jun 01, 2009

AB EQ 1MG BASE A090411 003 Jun 01, 2009

AB EQ 2MG BASE A090411 004 Jun 01, 2009

AB EQ 3MG BASE A090411 005 Jun 01, 2009

AB EQ 4MG BASE A090411 006 Jun 01, 2009

AB EQ 5MG BASE A090411 007 Jun 01, 2009



TABLET, EXTENDED RELEASE;ORAL

REQUIP XL

AB +! GLAXOSMITHKLINE LLC EQ 2MG BASE N022008 001 Jun 13, 2008

AB + EQ 4MG BASE N022008 003 Jun 13, 2008

AB + EQ 6MG BASE N022008 006 Apr 10, 2009

AB + EQ 8MG BASE N022008 004 Jun 13, 2008

AB + EQ 12MG BASE N022008 005 Oct 31, 2008

ROPINIROLE HYDROCHLORIDE

AB ACTAVIS ELIZABETH EQ 2MG BASE A090869 001 May 17, 2012

AB EQ 4MG BASE A090869 002 May 17, 2012

AB EQ 6MG BASE A090869 003 May 17, 2012

AB EQ 8MG BASE A090869 004 May 17, 2012

AB EQ 12MG BASE A090869 005 May 17, 2012

AB ALEMBIC PHARMS LTD EQ 2MG BASE A202786 001 Apr 22, 2013

AB EQ 4MG BASE A202786 002 Apr 22, 2013

AB EQ 6MG BASE A202786 003 Apr 22, 2013

AB EQ 8MG BASE A202786 004 Apr 22, 2013

AB EQ 12MG BASE A202786 005 Apr 22, 2013

AB DR REDDYS LABS LTD EQ 2MG BASE A201576 001 Jun 06, 2012

AB EQ 4MG BASE A201576 002 Jun 06, 2012

AB EQ 6MG BASE A201576 003 Jun 06, 2012

AB EQ 8MG BASE A201576 004 Jun 06, 2012

AB EQ 12MG BASE A201576 005 Jun 06, 2012

AB SANDOZ INC EQ 2MG BASE A201047 001 Jun 06, 2012

AB EQ 4MG BASE A201047 003 Jun 06, 2012

AB EQ 6MG BASE A201047 004 Jun 06, 2012

AB EQ 8MG BASE A201047 005 Jun 06, 2012

AB EQ 12MG BASE A201047 006 Jun 06, 2012

AB WATSON LABS INC EQ 2MG BASE A200431 001 Jun 06, 2012

AB EQ 4MG BASE A200431 002 Jun 06, 2012

AB EQ 6MG BASE A200431 003 Jun 06, 2012

AB EQ 8MG BASE A200431 004 Jun 06, 2012

AB EQ 12MG BASE A200431 005 Jun 06, 2012

AB WOCKHARDT LTD EQ 2MG BASE A091395 001 Aug 27, 2012

AB EQ 4MG BASE A091395 002 Aug 27, 2012

AB EQ 6MG BASE A091395 003 Aug 27, 2012

AB EQ 8MG BASE A091395 004 Aug 27, 2012

AB EQ 12MG BASE A091395 005 Aug 27, 2012



ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION

NAROPIN

AP + FRESENIUS KABI USA 20MG/10ML (2MG/ML) N020533 001 May 01, 1998

AP + 40MG/20ML (2MG/ML) N020533 002 Sep 24, 1996

AP + 100MG/20ML (5MG/ML) N020533 003 May 01, 1998

AP + 100MG/10ML (10MG/ML) N020533 005 Sep 24, 1996

AP + 150MG/20ML (7.5MG/ML) N020533 004 Sep 24, 1996

AP + 150MG/30ML (5MG/ML) N020533 008 Sep 24, 1996

AP + 200MG/100ML (2MG/ML) N020533 006 Sep 24, 1996

AP +! 200MG/20ML (10MG/ML) N020533 011 Sep 24, 1996

AP + 400MG/200ML (2MG/ML) N020533 007 Sep 24, 1996

AP + 500MG/100ML (5MG/ML) N020533 009 Jan 04, 2011

AP + 1GM/200ML (5MG/ML) N020533 010 Jan 04, 2011

ROPIVACAINE HYDROCHLORIDE

AP AKORN 200MG/100ML (2MG/ML) A204636 001 Mar 16, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-390(of 452)

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION

ROPIVACAINE HYDROCHLORIDE

AP 400MG/200ML (2MG/ML) A204636 002 Mar 16, 2018

AP AKORN INC 150MG/30ML (5MG/ML) A203955 001 Apr 11, 2016

AP AUROBINDO PHARMA 40MG/20ML (2MG/ML) A205612 001 Jul 13, 2016

LTD

AP 100MG/20ML (5MG/ML) A205612 003 Jul 13, 2016

AP 100MG/10ML (10MG/ML) A205612 006 Jul 13, 2016

AP 150MG/30ML (5MG/ML) A205612 004 Jul 13, 2016

AP 150MG/20ML (7.5MG/ML) A205612 005 Jul 13, 2016

AP 200MG/100ML (2MG/ML) A205612 002 Jul 13, 2016

AP 200MG/20ML (10MG/ML) A205612 007 Jul 13, 2016

AP HOSPIRA 20MG/10ML (2MG/ML) A090194 001 Sep 23, 2014

AP 40MG/20ML (2MG/ML) A090194 005 Sep 23, 2014

AP 100MG/10ML (10MG/ML) A090194 004 Sep 23, 2014

AP 150MG/30ML (5MG/ML) A090194 002 Sep 23, 2014

AP 150MG/20ML (7.5MG/ML) A090194 003 Sep 23, 2014

AP 200MG/20ML (10MG/ML) A090194 006 Sep 23, 2014

AP INFORLIFE 200MG/100ML (2MG/ML) A206166 001 Jun 11, 2018

AP 400MG/200ML (2MG/ML) A206166 002 Jun 11, 2018

AP 500MG/100ML (5MG/ML) A206166 003 Jun 11, 2018

AP 1GM/200ML (5MG/ML) A206166 004 Jun 11, 2018

AP MYLAN ASI 40MG/20ML (2MG/ML) A090318 001 Sep 23, 2014

AP 150MG/30ML (5MG/ML) A090318 002 Sep 23, 2014

AP 150MG/20ML (7.5MG/ML) A090318 003 Sep 23, 2014

AP 200MG/20ML (10MG/ML) A090318 004 Sep 23, 2014

AP NAVINTA LLC 150MG/30ML (5MG/ML) A078601 002 Jul 17, 2014

AP 200MG/20ML (10MG/ML) A078601 003 Jul 17, 2014

AP SOMERSET THERAPS 20MG/10ML (2MG/ML) A207636 001 Jun 15, 2018

LLC

AP 40MG/20ML (2MG/ML) A207636 002 Jun 15, 2018

AP 100MG/20ML (5MG/ML) A207636 003 Jun 15, 2018

AP 100MG/10ML (10MG/ML) A207636 006 Jun 15, 2018

AP 150MG/30ML (5MG/ML) A207636 004 Jun 15, 2018

AP 150MG/20ML (7.5MG/ML) A207636 005 Jun 15, 2018

AP 200MG/20ML (10MG/ML) A207636 007 Jun 15, 2018



ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDIA

+ SB PHARMCO EQ 2MG BASE N021071 002 May 25, 1999

+ EQ 4MG BASE N021071 003 May 25, 1999



ROSUVASTATIN CALCIUM

CAPSULE;ORAL

EZALLOR

+ SUN PHARMA GLOBAL EQ 5MG BASE N208647 001 Dec 18, 2018

+ EQ 10MG BASE N208647 002 Dec 18, 2018

+ EQ 20MG BASE N208647 003 Dec 18, 2018

+! EQ 40MG BASE N208647 004 Dec 18, 2018

TABLET;ORAL

CRESTOR

AB + IPR 5MG N021366 002 Aug 12, 2003

AB + 10MG N021366 003 Aug 12, 2003

AB + 20MG N021366 004 Aug 12, 2003

AB +! 40MG N021366 005 Aug 12, 2003

ROSUVASTATIN CALCIUM

AB ACCORD HLTHCARE 5MG A206434 001 Oct 31, 2016

AB 10MG A206434 002 Oct 31, 2016

AB 20MG A206434 003 Oct 31, 2016

AB 40MG A206434 004 Oct 31, 2016

AB ALKEM LABS LTD 5MG A206465 001 Mar 21, 2017

AB 10MG A206465 002 Mar 21, 2017

AB 20MG A206465 003 Mar 21, 2017

AB 40MG A206465 004 Mar 21, 2017

AB ALLIED 5MG A079168 001 Jul 19, 2016

AB 10MG A079168 002 Jul 19, 2016

AB 20MG A079168 003 Jul 19, 2016

AB 40MG A079168 004 Jul 19, 2016

AB AMNEAL PHARMS CO 5MG A208850 001 Oct 16, 2018

AB 10MG A208850 002 Oct 16, 2018

AB 20MG A208850 003 Oct 16, 2018

AB 40MG A208850 004 Oct 16, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-391(of 452)

ROSUVASTATIN CALCIUM

TABLET;ORAL

ROSUVASTATIN CALCIUM

AB APOTEX INC 5MG A079145 001 Jul 19, 2016

AB 10MG A079145 002 Jul 19, 2016

AB 20MG A079145 003 Jul 19, 2016

AB 40MG A079145 004 Jul 19, 2016

AB AUROBINDO PHARMA 5MG A079170 001 Jul 19, 2016

LTD

AB 10MG A079170 002 Jul 19, 2016

AB 20MG A079170 003 Jul 19, 2016

AB 40MG A079170 004 Jul 19, 2016

AB BIOCON LTD 5MG A207752 001 Oct 31, 2016

AB 10MG A207752 002 Oct 31, 2016

AB 20MG A207752 003 Oct 31, 2016

AB 40MG A207752 004 Oct 31, 2016

AB CADILA PHARMS LTD 5MG A207453 001 Nov 23, 2016

AB 10MG A207453 002 Nov 23, 2016

AB 20MG A207453 003 Nov 23, 2016

AB 40MG A207453 004 Nov 23, 2016

AB CHANGZHOU PHARM 5MG A207408 001 Oct 31, 2016

AB 10MG A207408 002 Oct 31, 2016

AB 20MG A207408 003 Oct 31, 2016

AB 40MG A207408 004 Oct 31, 2016

AB GLENMARK PHARMS 5MG A079172 001 Jul 19, 2016

AB 10MG A079172 002 Jul 19, 2016

AB 20MG A079172 003 Jul 19, 2016

AB 40MG A079172 004 Jul 19, 2016

AB HETERO LABS LTD V 5MG A207616 001 Oct 31, 2016

AB 10MG A207616 002 Oct 31, 2016

AB 20MG A207616 003 Oct 31, 2016

AB 40MG A207616 004 Oct 31, 2016

AB JUBILANT GENERICS 5MG A207062 001 Oct 31, 2016

AB 10MG A207062 002 Oct 31, 2016

AB 20MG A207062 003 Oct 31, 2016

AB 40MG A207062 004 Oct 31, 2016

AB LUPIN LTD 5MG A205587 001 Jul 31, 2017

AB 10MG A205587 002 Jul 31, 2017

AB 20MG A205587 003 Jul 31, 2017

AB 40MG A205587 004 Jul 31, 2017

AB MSN LABS PVT LTD 5MG A208898 001 Nov 22, 2017

AB 10MG A208898 002 Nov 22, 2017

AB 20MG A208898 003 Nov 22, 2017

AB 40MG A208898 004 Nov 22, 2017

AB MYLAN PHARMS INC 5MG A079161 001 Jul 19, 2016

AB 10MG A079161 002 Jul 19, 2016

AB 20MG A079161 003 Jul 19, 2016

AB 40MG A079161 004 Jul 19, 2016

AB SANDOZ INC 5MG A079171 001 Jul 19, 2016

AB 10MG A079171 002 Jul 19, 2016

AB 20MG A079171 003 Jul 19, 2016

AB 40MG A079171 004 Jul 19, 2016

AB SUN PHARMA GLOBAL 5MG A079169 001 Jul 19, 2016

AB 10MG A079169 002 Jul 19, 2016

AB 20MG A079169 003 Jul 19, 2016

AB 40MG A079169 004 Jul 19, 2016

AB TEVA PHARMS USA 5MG A079166 001 Jul 19, 2016

AB 10MG A079166 002 Jul 19, 2016

AB 20MG A079166 003 Jul 19, 2016

AB 40MG A079166 004 Jul 19, 2016

AB TORRENT PHARMS LTD 5MG A201619 001 Oct 31, 2016

AB 10MG A201619 002 Oct 31, 2016

AB 20MG A201619 003 Oct 31, 2016

AB 40MG A201619 004 Oct 31, 2016

AB WATSON LABS INC 5MG A079167 001 Apr 29, 2016

AB 10MG A079167 002 Apr 29, 2016

AB 20MG A079167 003 Apr 29, 2016

AB 40MG A079167 004 Apr 29, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-392(of 452)

ROTIGOTINE

FILM, EXTENDED RELEASE;TRANSDERMAL

NEUPRO

+ UCB INC 1MG/24HR N021829 004 Apr 02, 2012

+! 2MG/24HR N021829 001 May 09, 2007

+ 3MG/24HR N021829 005 Apr 02, 2012

+ 4MG/24HR N021829 002 May 09, 2007

+ 6MG/24HR N021829 003 May 09, 2007

+ 8MG/24HR N021829 006 Apr 02, 2012



RUBIDIUM CHLORIDE RB-82

INJECTABLE;INJECTION

CARDIOGEN-82

BRACCO N/A N019414 001 Dec 29, 1989

SOLUTION;INTRAVENOUS

RUBY-FILL

JUBILANT DRAXIMAGE N/A N202153 001 Sep 30, 2016

RUCAPARIB CAMSYLATE

TABLET;ORAL

RUBRACA

+ CLOVIS ONCOLOGY INC EQ 200MG BASE N209115 001 Dec 19, 2016

+ EQ 250MG BASE N209115 003 May 01, 2017

+! EQ 300MG BASE N209115 002 Dec 19, 2016



RUFINAMIDE

SUSPENSION;ORAL

BANZEL

+! EISAI INC 40MG/ML N201367 001 Mar 03, 2011

TABLET;ORAL

BANZEL

AB + EISAI INC 200MG N021911 002 Nov 14, 2008

AB +! 400MG N021911 003 Nov 14, 2008

RUFINAMIDE

AB GLENMARK PHARMS LTD 200MG A205075 001 May 16, 2016

AB 400MG A205075 002 May 16, 2016

AB MYLAN PHARMS INC 200MG A205095 001 May 16, 2016

AB 400MG A205095 002 May 16, 2016

AB WEST-WARD PHARMS 200MG A204988 001 May 16, 2016

INT

AB 400MG A204988 002 May 16, 2016

RUXOLITINIB PHOSPHATE

TABLET;ORAL

JAKAFI

+ INCYTE CORP EQ 5MG BASE N202192 001 Nov 16, 2011

+ EQ 10MG BASE N202192 002 Nov 16, 2011

+ EQ 15MG BASE N202192 003 Nov 16, 2011

+ EQ 20MG BASE N202192 004 Nov 16, 2011

+! EQ 25MG BASE N202192 005 Nov 16, 2011

SACROSIDASE

SOLUTION;ORAL

SUCRAID

+! QOL MEDCL 8,500 IU/ML N020772 001 Apr 09, 1998

SACUBITRIL; VALSARTAN

TABLET;ORAL

ENTRESTO

+ NOVARTIS PHARMS 24MG;26MG N207620 001 Jul 07, 2015

CORP

+ 49MG;51MG N207620 002 Jul 07, 2015

+! 97MG;103MG N207620 003 Jul 07, 2015

SAFINAMIDE MESYLATE

TABLET;ORAL

XADAGO

+ US WORLDMEDS LLC 50MG N207145 001 Mar 21, 2017

+! 100MG N207145 002 Mar 21, 2017

SALMETEROL XINAFOATE

POWDER;INHALATION

SEREVENT

+! GLAXOSMITHKLINE EQ 0.05MG BASE/INH N020692 001 Sep 19, 1997

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-393(of 452)

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM



INJECTABLE;INJECTION

QUADRAMET

+! LANTHEUS MEDICAL 50mCi/ML N020570 001 Mar 28, 1997

SAPROPTERIN DIHYDROCHLORIDE

POWDER;ORAL

KUVAN

+! BIOMARIN PHARM 100MG/PACKET N205065 001 Dec 19, 2013

+ 500MG/PACKET N205065 002 Oct 27, 2015

TABLET;ORAL

KUVAN

+! BIOMARIN PHARM 100MG N022181 001 Dec 13, 2007

SAQUINAVIR MESYLATE

TABLET;ORAL

INVIRASE

+! HOFFMANN-LA ROCHE EQ 500MG BASE N021785 001 Dec 17, 2004

SARECYCLINE HYDROCHLORIDE

TABLET;ORAL

SEYSARA

+ ALMIRALL EQ 60MG BASE N209521 001 Oct 01, 2018

+ EQ 100MG BASE N209521 002 Oct 01, 2018

+! EQ 150MG BASE N209521 003 Oct 01, 2018

SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL

ONGLYZA

+ ASTRAZENECA AB EQ 2.5MG BASE N022350 001 Jul 31, 2009

+! EQ 5MG BASE N022350 002 Jul 31, 2009

SCOPOLAMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

SCOPOLAMINE

AB PERRIGO PHARMS CO 1MG/72HR A078830 001 Jan 30, 2015

TRANSDERM SCOP

AB +! GLAXOSMITHKLINE CON 1MG/72HR N017874 001

SECNIDAZOLE

GRANULE;ORAL

SOLOSEC

+! LUPIN 2GM/PACKET N209363 001 Sep 15, 2017

SECOBARBITAL SODIUM

CAPSULE;ORAL

SECONAL SODIUM

! VALEANT PHARMS 50MG A086101 001 Oct 03, 1983

NORTH

! 100MG A086101 002 Oct 03, 1983

SECRETIN SYNTHETIC HUMAN

FOR SOLUTION;INTRAVENOUS

CHIRHOSTIM

+! CHIRHOCLIN 16MCG/VIAL N021256 001 Apr 09, 2004

+ 40MCG/VIAL N021256 002 Jun 21, 2007



SELEGILINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EMSAM

+! SOMERSET 6MG/24HR N021336 001 Feb 27, 2006

+ 9MG/24HR N021336 002 Feb 27, 2006

+ 12MG/24HR N021336 003 Feb 27, 2006

SELEGILINE HYDROCHLORIDE

CAPSULE;ORAL

SELEGILINE HYDROCHLORIDE

AB ! APOTEX 5MG A075321 001 Dec 04, 1998

AB DAVA PHARMS INC 5MG A075352 001 Nov 30, 1998



TABLET;ORAL

SELEGILINE HYDROCHLORIDE

AB ! APOTEX INC 5MG A074871 001 Jun 06, 1997

AB BOSCOGEN 5MG A074912 001 Apr 30, 1998

AB MYLAN 5MG A074866 001 Nov 26, 1997



TABLET, ORALLY DISINTEGRATING;ORAL

ZELAPAR

+! VALEANT PHARM INTL 1.25MG N021479 001 Jun 14, 2006

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-394(of 452)

SELENIUM SULFIDE

LOTION/SHAMPOO;TOPICAL

SELENIUM SULFIDE

AT ! PERRIGO NEW YORK 2.5% A089996 001 Jan 10, 1991

AT WOCKHARDT BIO AG 2.5% A088228 001 Sep 01, 1983



SELEXIPAG

TABLET;ORAL

UPTRAVI

+ ACTELION PHARMS LTD 0.2MG N207947 001 Dec 21, 2015

+ 0.4MG N207947 002 Dec 21, 2015

+ 0.6MG N207947 003 Dec 21, 2015

+ 0.8MG N207947 004 Dec 21, 2015

+ 1MG N207947 005 Dec 21, 2015

+ 1.2MG N207947 006 Dec 21, 2015

+ 1.4MG N207947 007 Dec 21, 2015

+! 1.6MG N207947 008 Dec 21, 2015

SEMAGLUTIDE

SOLUTION;SUBCUTANEOUS

OZEMPIC

+! NOVO 2MG/1.5ML (1.34MG/ML) N209637 001 Dec 05, 2017

SERTACONAZOLE NITRATE

CREAM;TOPICAL

ERTACZO

+! VALEANT LUXEMBOURG 2% N021385 001 Dec 10, 2003

SERTRALINE HYDROCHLORIDE

CONCENTRATE;ORAL

SERTRALINE HYDROCHLORIDE

AA AUROBINDO PHARMA EQ 20MG BASE/ML A078861 001 Oct 31, 2008

ZOLOFT

AA +! PFIZER EQ 20MG BASE/ML N020990 001 Dec 07, 1999

TABLET;ORAL

SERTRALINE HYDROCHLORIDE

AB ACCORD HLTHCARE EQ 25MG BASE A202825 001 Nov 07, 2014

AB EQ 50MG BASE A202825 002 Nov 07, 2014

AB EQ 100MG BASE A202825 003 Nov 07, 2014

AB APOTEX INC EQ 25MG BASE A076882 001 Feb 06, 2007

AB EQ 50MG BASE A076882 002 Feb 06, 2007

AB EQ 100MG BASE A076882 003 Feb 06, 2007

AB AUROBINDO PHARMA EQ 25MG BASE A077206 001 Feb 06, 2007

AB EQ 50MG BASE A077206 002 Feb 06, 2007

AB EQ 100MG BASE A077206 003 Feb 06, 2007

AB AUSTARPHARMA LLC EQ 25MG BASE A078677 001 Mar 04, 2009

AB EQ 50MG BASE A078677 002 Mar 04, 2009

AB EQ 100MG BASE A078677 003 Mar 04, 2009

AB INVAGEN PHARMS EQ 25MG BASE A077397 001 Feb 06, 2007

AB EQ 50MG BASE A077397 002 Feb 06, 2007

AB EQ 100MG BASE A077397 003 Feb 06, 2007

AB LUPIN EQ 25MG BASE A077670 001 Feb 06, 2007

AB EQ 50MG BASE A077670 002 Feb 06, 2007

AB EQ 100MG BASE A077670 003 Feb 06, 2007

AB MYLAN PHARMS INC EQ 25MG BASE A078626 001 Jan 31, 2008

AB EQ 50MG BASE A078626 002 Jan 31, 2008

AB OXFORD PHARMS EQ 25MG BASE A078175 001 Jul 21, 2010

AB EQ 50MG BASE A078175 002 Jul 21, 2010

AB EQ 100MG BASE A078175 003 Jul 21, 2010

AB SUN PHARM INDS LTD EQ 25MG BASE A077977 001 Feb 06, 2007

AB EQ 50MG BASE A077977 002 Feb 06, 2007

AB EQ 100MG BASE A077977 003 Feb 06, 2007

AB TEVA EQ 25MG BASE A076465 001 Aug 11, 2006

AB EQ 50MG BASE A076465 002 Aug 11, 2006

AB EQ 100MG BASE A076465 003 Aug 11, 2006

AB TORRENT PHARMS EQ 25MG BASE A077765 001 Feb 06, 2007

AB EQ 50MG BASE A077765 002 Feb 06, 2007

AB EQ 100MG BASE A077765 003 Feb 06, 2007

AB WOCKHARDT EQ 25MG BASE A078403 001 Jan 08, 2008

AB EQ 50MG BASE A078403 002 Jan 08, 2008

AB EQ 100MG BASE A078403 003 Jan 08, 2008

AB ZYDUS PHARMS USA EQ 25MG BASE A077106 001 Feb 06, 2007

AB EQ 50MG BASE A077106 002 Feb 06, 2007

AB EQ 100MG BASE A077106 003 Feb 06, 2007



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-395(of 452)

SERTRALINE HYDROCHLORIDE

TABLET;ORAL

ZOLOFT

AB + PFIZER EQ 25MG BASE N019839 005 Mar 06, 1996

AB + EQ 50MG BASE N019839 001 Dec 30, 1991

AB +! EQ 100MG BASE N019839 002 Dec 30, 1991



SERTRALINE HYDROCHLORIDE

SUN PHARM INDS LTD EQ 150MG BASE A077977 004 Feb 06, 2007

EQ 200MG BASE A077977 005 Feb 06, 2007

SEVELAMER CARBONATE

FOR SUSPENSION;ORAL

RENVELA

AB + GENZYME 800MG/PACKET N022318 001 Aug 12, 2009

AB +! 2.4GM/PACKET N022318 002 Feb 18, 2009

SEVELAMER CARBONATE

AB AUROBINDO PHARMA 800MG/PACKET A207624 001 Jun 13, 2017

LTD

AB 2.4GM/PACKET A207624 002 Jun 13, 2017

AB DR REDDYS LABS LTD 800MG/PACKET A210464 001 Oct 25, 2018

AB 2.4GM/PACKET A210464 002 Oct 25, 2018



TABLET;ORAL

RENVELA

AB +! SANOFI 800MG N022127 001 Oct 19, 2007

SEVELAMER CARBONATE

AB AMNEAL PHARMS CO 800MG A207288 001 Nov 28, 2017

AB AUROBINDO PHARMA 800MG A207179 001 Jul 17, 2017

LTD

AB DR REDDYS LABS LTD 800MG A206094 001 Sep 29, 2017

AB IMPAX LABS INC 800MG A090975 001 Oct 23, 2017

AB INVAGEN PHARMS 800MG A203860 001 Oct 26, 2017

AB TWI PHARMS 800MG A200959 001 Mar 20, 2018

AB WILSHIRE PHARMS INC 800MG A204451 001 Nov 29, 2018



SEVELAMER HYDROCHLORIDE

TABLET;ORAL

RENAGEL

+ GENZYME 400MG N021179 001 Jul 12, 2000

+! 800MG N021179 002 Jul 12, 2000

SEVOFLURANE

LIQUID;INHALATION

SEVOFLURANE

AN BAXTER HLTHCARE 100% A075895 001 Jul 02, 2002

AN HALOCARBON PRODS 100% A078650 001 Nov 19, 2007

AN SHANGHAI HENGRUI 100% A203793 001 Nov 03, 2015

SOJOURN

AN PIRAMAL CRITICAL 100% A077867 001 May 02, 2007

ULTANE

AN +! ABBVIE 100% N020478 001 Jun 07, 1995

SILDENAFIL CITRATE

FOR SUSPENSION;ORAL

REVATIO

+! PFIZER EQ 10MG BASE/ML N203109 001 Aug 30, 2012

SOLUTION;INTRAVENOUS

REVATIO

AP +! PFIZER EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) N022473 001 Nov 18, 2009

SILDENAFIL CITRATE

AP AUROBINDO PHARMA EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) A203988 001 Apr 01, 2015

LTD

TABLET;ORAL

REVATIO

AB +! PFIZER EQ 20MG BASE N021845 001 Jun 03, 2005

SILDENAFIL CITRATE

AB AJANTA PHARMA LTD EQ 20MG BASE A210394 001 May 04, 2018

AB EQ 25MG BASE A206401 001 Oct 12, 2018

AB EQ 50MG BASE A206401 002 Oct 12, 2018

AB EQ 100MG BASE A206401 003 Oct 12, 2018

AB AMNEAL PHARMS EQ 20MG BASE A202025 001 Feb 28, 2013

AB AMNEAL PHARMS NY EQ 25MG BASE A202023 001 Jun 27, 2018

AB EQ 50MG BASE A202023 002 Jun 27, 2018

AB EQ 100MG BASE A202023 003 Jun 27, 2018

AB AUROBINDO PHARMA EQ 20MG BASE A203963 001 Nov 18, 2015

LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-396(of 452)

SILDENAFIL CITRATE

TABLET;ORAL

SILDENAFIL CITRATE

AB EQ 25MG BASE A203962 001 Jun 11, 2018

AB EQ 50MG BASE A203962 002 Jun 11, 2018

AB EQ 100MG BASE A203962 003 Jun 11, 2018

AB HEBEI CHANGSHAN EQ 20MG BASE A202598 001 Nov 06, 2012

AB HETERO LABS LTD V EQ 20MG BASE A203623 001 Nov 26, 2014

AB EQ 25MG BASE A202659 001 Jun 11, 2018

AB EQ 50MG BASE A202659 002 Jun 11, 2018

AB EQ 100MG BASE A202659 003 Jun 11, 2018

AB MACLEODS PHARMS LTD EQ 20MG BASE A203814 001 Dec 17, 2013

AB MYLAN PHARMS INC EQ 20MG BASE A201150 001 Nov 09, 2012

AB RUBICON RES PVT LTD EQ 20MG BASE A204883 001 Jun 20, 2016

AB EQ 25MG BASE A204882 001 Jun 11, 2018

AB EQ 50MG BASE A204882 002 Jun 11, 2018

AB EQ 100MG BASE A204882 003 Jun 11, 2018

AB TEVA EQ 25MG BASE A077342 001 Mar 09, 2016

AB EQ 50MG BASE A077342 002 Mar 09, 2016

AB EQ 100MG BASE A077342 003 Mar 09, 2016

AB TEVA PHARMS EQ 20MG BASE A078380 001 Jan 07, 2013

AB TORRENT PHARMS LTD EQ 20MG BASE A091479 001 Nov 06, 2012

AB EQ 25MG BASE A091448 001 Jun 11, 2018

AB EQ 50MG BASE A091448 002 Jun 11, 2018

AB EQ 100MG BASE A091448 003 Jun 11, 2018

AB WATSON LABS INC EQ 20MG BASE A202503 001 Nov 06, 2012

VIAGRA

AB + PFIZER INC EQ 25MG BASE N020895 001 Mar 27, 1998

AB + EQ 50MG BASE N020895 002 Mar 27, 1998

AB +! EQ 100MG BASE N020895 003 Mar 27, 1998



SILODOSIN

CAPSULE;ORAL

RAPAFLO

AB +! ALLERGAN SALES LLC 4MG N022206 001 Oct 08, 2008

AB + 8MG N022206 002 Oct 08, 2008

SILODOSIN

AB AJANTA PHARMA LTD 4MG A211060 001 Dec 03, 2018

AB 8MG A211060 002 Dec 03, 2018

AB AMNEAL PHARMS CO 4MG A209745 001 Dec 03, 2018

AB 8MG A209745 002 Dec 03, 2018

AB AUROBINDO PHARMA 4MG A210626 001 Dec 10, 2018

LTD

AB 8MG A210626 002 Dec 10, 2018

AB LUPIN LTD 4MG A206541 001 Dec 03, 2018

AB 8MG A206541 002 Dec 03, 2018

AB MACLEODS PHARMS LTD 4MG A211166 001 Dec 03, 2018

AB 8MG A211166 002 Dec 03, 2018

AB MSN LABS PVT LTD 4MG A210687 001 Dec 03, 2018

AB 8MG A210687 002 Dec 03, 2018

AB SANDOZ INC 4MG A204726 001 Mar 31, 2017

AB 8MG A204726 002 Mar 31, 2017



SILVER SULFADIAZINE

CREAM;TOPICAL

SILVADENE

AB +! KING PHARMS LLC 1% N017381 001

SSD

AB DR REDDYS LA 1% N018578 001 Feb 25, 1982

THERMAZENE

AB THEPHARMANETWORK 1% N018810 001 Dec 23, 1985

LLC

SIMVASTATIN

SUSPENSION;ORAL

FLOLIPID

+ TCG FLUENT PHARMA 20MG/5ML N206679 001 Apr 21, 2016

+! 40MG/5ML N206679 002 Apr 21, 2016

TABLET;ORAL

SIMVASTATIN

AB ACCORD HLTHCARE 5MG A078155 005 Apr 05, 2013

AB 10MG A078155 002 Feb 26, 2008

AB 20MG A078155 003 Feb 26, 2008

AB 40MG A078155 004 Feb 26, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-397(of 452)

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN

AB 80MG
A078155 001 Feb 26, 2008

AB AUROBINDO PHARMA 5MG


A077691 001 Dec 20, 2006

AB 10MG
A077691 002 Dec 20, 2006

AB 20MG
A077691 003 Dec 20, 2006

AB 40MG
A077691 004 Dec 20, 2006

AB 80MG
A077691 005 Dec 20, 2006

AB BIOCON LIMITED 5MG


A078034 001 Dec 20, 2006

AB 10MG
A078034 002 Dec 20, 2006

AB 20MG
A078034 003 Dec 20, 2006

AB 40MG
A078034 004 Dec 20, 2006

AB 80MG
A078034 005 Dec 20, 2006

AB DR REDDYS LABS INC 5MG


A077752 005 Jan 23, 2008

AB 10MG
A077752 001 Dec 20, 2006

AB 20MG
A077752 002 Dec 20, 2006

AB 40MG
A077752 003 Dec 20, 2006

AB 80MG
A077752 004 Dec 20, 2006

AB HETERO LABS LTD III 5MG


A200895 001 Nov 25, 2014

AB 10MG
A200895 002 Nov 25, 2014

AB 20MG
A200895 003 Nov 25, 2014

AB 40MG
A200895 004 Nov 25, 2014

AB 80MG
A200895 005 Nov 25, 2014

AB LUPIN 5MG
A078103 005 Apr 14, 2009

AB 10MG
A078103 001 May 11, 2007

AB 20MG
A078103 002 May 11, 2007

AB 40MG
A078103 003 May 11, 2007

AB 80MG
A078103 004 May 11, 2007

AB OXFORD PHARMS 5MG


A078735 001 Aug 30, 2010

AB 10MG
A078735 002 Aug 30, 2010

AB 20MG
A078735 003 Aug 30, 2010

AB 40MG
A078735 004 Aug 30, 2010

AB 80MG
A078735 005 Aug 30, 2010

AB VIVA HLTHCARE 5MG


A090383 001 Sep 16, 2011

AB 10MG
A090383 002 Sep 16, 2011

AB 20MG
A090383 003 Sep 16, 2011

AB 40MG
A090383 004 Sep 16, 2011

AB 80MG
A090383 005 Sep 16, 2011

AB WATSON LABS TEVA 5MG


A076685 001 Dec 20, 2006

AB 10MG
A076685 002 Dec 20, 2006

AB 20MG
A076685 003 Dec 20, 2006

AB 40MG
A076685 004 Dec 20, 2006

AB 80MG
A076685 005 Dec 20, 2006

AB ZYDUS PHARMS USA 5MG


A077837 001 Dec 20, 2006

AB 10MG
A077837 002 Dec 20, 2006

AB 20MG
A077837 003 Dec 20, 2006

AB 40MG
A077837 004 Dec 20, 2006

AB 80MG
A077837 005 Dec 20, 2006

ZOCOR
AB + MSD MERCK CO 5MG
N019766 001 Dec 23, 1991

AB + 10MG
N019766 002 Dec 23, 1991

AB + 20MG
N019766 003 Dec 23, 1991

AB + 40MG
N019766 004 Dec 23, 1991

AB +! 80MG
N019766 005 Jul 10, 1998

SINCALIDE

INJECTABLE;INJECTION

KINEVAC

+! BRACCO
0.005MG/VIAL
N017697 001

SINECATECHINS

OINTMENT;TOPICAL

VEREGEN

+! FOUGERA PHARMS INC
15%
N021902 001 Oct 31, 2006

SIROLIMUS

SOLUTION;ORAL

RAPAMUNE

+! PF PRISM CV
1MG/ML
N021083 001 Sep 15, 1999

TABLET;ORAL

RAPAMUNE

AB + PF PRISM CV
0.5MG
N021110 004 Jan 25, 2010

AB +
1MG
N021110 001 Aug 25, 2000

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-398(of 452)

SIROLIMUS

TABLET;ORAL

RAPAMUNE

AB +! 2MG N021110 002 Aug 22, 2002

SIROLIMUS

AB DR REDDYS LABS LTD 1MG A201578 001 Oct 27, 2014

AB 2MG A201578 002 Oct 27, 2014

AB ZYDUS PHARMS USA 0.5MG A201676 003 Jan 08, 2014

INC

SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JANUVIA

+ MERCK SHARP DOHME EQ 25MG BASE N021995 001 Oct 16, 2006

+ EQ 50MG BASE N021995 002 Oct 16, 2006

+! EQ 100MG BASE N021995 003 Oct 16, 2006

SODIUM ACETATE

INJECTABLE;INJECTION

SODIUM ACETATE

FRESENIUS KABI USA 4MEQ/ML A206687 001 Oct 30, 2017

+! HOSPIRA 2MEQ/ML N018893 001 May 04, 1983

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION;INTRAVENOUS

AMMONUL

AP +! MEDICIS 10%;10% (5GM/50ML;5GM/50ML) N020645 001 Feb 17, 2005

SODIUM PHENYLACETATE AND SODIUM BENZOATE



AP AILEX PHARMS LLC 10%;10% (5GM/50ML;5GM/50ML) A207096 001 Feb 24, 2016

AP MAIA PHARMS INC 10%;10% (5GM/50ML;5GM/50ML) A208521 001 May 08, 2017

AP NAVINTA LLC 10%;10% (5GM/50ML;5GM/50ML) A205880 001 Aug 04, 2016



SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE

AP ! HOSPIRA 0.9MEQ/ML A077394 001 Nov 09, 2005

AP ! 1MEQ/ML A077394 002 Nov 09, 2005

AP HOSPIRA INC 0.9MEQ/ML A202494 001 Mar 06, 2017

AP 1MEQ/ML A202432 001 Sep 26, 2017

AP 1MEQ/ML A202494 002 Mar 06, 2017

AP INTL MEDICATION SYS 1MEQ/ML A203449 001 Sep 19, 2017

HOSPIRA INC 1MEQ/ML A202495 001 Mar 06, 2017



SODIUM CHLORIDE

INJECTABLE;INJECTION

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP FRESENIUS KABI USA 9MG/ML A088911 001 Feb 07, 1985

AP +! HOSPIRA 9MG/ML N018800 001 Oct 29, 1982

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER



AP + B BRAUN 450MG/100ML N019635 001 Mar 09, 1988

AP BAXTER HLTHCARE 450MG/100ML N018016 001



AP FRESENIUS KABI USA 450MG/100ML A208122 001 Jul 23, 2018

AP HOSPIRA 450MG/100ML N019759 001 Jun 08, 1988

AP +! ICU MEDICAL INC 450MG/100ML N018090 001



SODIUM CHLORIDE 0.9%

AP SPECTRA MDCL 9MG/ML A206171 001 Jul 21, 2017

DEVICES

AP WEST-WARD PHARMS 9MG/ML A201850 001 Jan 20, 2012

INT

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

AP +! B BRAUN 900MG/100ML N017464 001

AP +! 900MG/100ML N019635 002 Mar 09, 1988

AP +! BAXTER HLTHCARE 9MG/ML N016677 004 Oct 30, 1985

AP + 9MG/ML N020178 002 Dec 07, 1992

AP +! 900MG/100ML N016677 001



AP +! 900MG/100ML N020178 001 Dec 07, 1992

AP ! FRESENIUS KABI USA 9MG/ML A088912 001 Jan 10, 1985

AP 900MG/100ML A207310 001 Sep 19, 2017

AP FRESENIUS MEDCL 900MG/100ML A078177 001 Apr 12, 2007

AP HAEMONETICS 900MG/100ML A076316 001 Oct 27, 2004

AP +! HOSPIRA 9MG/ML N018803 001 Oct 29, 1982

AP + 9MG/ML N019465 002 Jul 15, 1985

AP +! 900MG/100ML N019465 001 Jul 15, 1985

AP +! 900MG/100ML N019480 001 Sep 17, 1985

AP +! ICU MEDICAL INC 900MG/100ML N016366 001



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-399(of 452)

SODIUM CHLORIDE

INJECTABLE;INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AP JUBILANT 9MG/ML A203352 001 May 18, 2016

HOLLISTRSTR
AP LABORATORIOS 900MG/100ML A207956 001 May 25, 2017

GRIFOLS
AP ! TARO 9MG/ML A077407 001 Aug 11, 2006

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

AP B BRAUN 3GM/100ML
N019635 003 Mar 09, 1988

AP +! BAXTER HLTHCARE 3GM/100ML


N019022 001 Nov 01, 1983

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

AP B BRAUN 5GM/100ML
N019635 004 Mar 09, 1988

AP + BAXTER HLTHCARE 5GM/100ML


N019022 002 Nov 01, 1983

SODIUM CHLORIDE 0.9%

+ B BRAUN 900MG/10ML
N019635 005 Aug 11, 2016

+ MEDEFIL INC 90MG/10ML (9MG/ML)


N202832 006 Jan 06, 2012

WEST-WARD PHARMS 9MG/ML
A201833 001 Sep 24, 2013

INT

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+! LIEBEL-FLARSHEIM 405MG/50ML (9MG/ML)
N021569 001 Jul 27, 2006

+ 1012.5MG/125ML (9MG/ML)
N021569 002 Jul 27, 2006

SODIUM CHLORIDE IN PLASTIC CONTAINER

+ HOSPIRA 2.5MEQ/ML
N018897 001 Jul 20, 1984

SOLUTION;IRRIGATION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



AT +! B BRAUN 900MG/100ML
N016733 001

AT BAXTER HLTHCARE 900MG/100ML
N017427 001

AT 900MG/100ML
N017867 001

AT ICU MEDICAL INC 900MG/100ML
N017514 001

AT 900MG/100ML
N018314 001

SOLUTION FOR SLUSH;IRRIGATION

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

BAXTER HLTHCARE 900MG/100ML
N019319 002 May 17, 1985

SODIUM FERRIC GLUCONATE COMPLEX

INJECTABLE;INJECTION

FERRLECIT

AB +! SANOFI AVENTIS US 62.5MG/5ML
N020955 001 Feb 18, 1999

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

AB WEST-WARD PHARMS
62.5MG/5ML
A078215 001 Mar 31, 2011

INT

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

SODIUM FLUORIDE F-18



AP 3D IMAGING DRUG 10-200mCi/ML
A203777 001 Oct 19, 2015

AP BIOMEDCL RES FDN 10-200mCi/ML


A204351 001 Jan 09, 2015

AP CARDINAL HEALTH 414 10-200mCi/ML


A203780 001 Jul 30, 2015

AP ESSENTIAL ISOTOPES 10-200mCi/ML


A204541 001 Oct 29, 2014

AP GLOBAL ISOTOPES LLC 10-200mCi/ML


A204464 001 Oct 21, 2014

AP HOT SHOTS NM LLC 10-200mCi/ML


A204530 001 Jul 29, 2015

AP ! HOUSTON CYCLOTRON 10-200mCi/ML


A203544 001 Dec 26, 2012

AP JUBILANT DRAXIMAGE 10-200mCi/ML


A203968 001 Oct 23, 2015

AP KREITCHMAN PET CTR 10-200mCi/ML


A203936 001 May 19, 2016

AP MIDWEST MEDCL 10-200mCi/ML


A204440 001 Nov 17, 2015

AP MIPS CRF 10-200mCi/ML


A204517 001 Jul 21, 2015

AP NCM USA BRONX LLC 10-200mCi/ML


A204513 001 Nov 28, 2014

AP PETNET 10-200mCi/ML
A203890 001 Sep 28, 2015

AP PRECISION NUCLEAR 10-200mCi/ML


A204542 001 Feb 27, 2015

AP SHERTECH LABS LLC 10-200mCi/ML


A204315 001 Sep 22, 2014

AP SOFIE 10-200mCi/ML
A203592 001 Aug 18, 2015

AP SPECTRON MRC LLC 10-200mCi/ML


A203912 001 Apr 22, 2015

AP UCSF RODIOPHARM 10-200mCi/ML


A204437 001 Mar 13, 2014

AP UNIV UTAH CYCLOTRON 10-200mCi/ML


A204497 001 Apr 20, 2015

! MCPRF 10-91.5mCi/ML
A203605 001 Jun 28, 2013

THE FEINSTEIN INST 20-600mCi/ML
A204328 001 Nov 19, 2014

SODIUM IODIDE I-123
CAPSULE;ORAL
SODIUM IODIDE I 123
AA +! CARDINAL HEALTH 418 100uCi N018671 001 May 27, 1982
AA +! 200uCi N018671 002 May 27, 1982
AA MALLINKRODT NUCLEAR 100uCi A071909 001 Feb 28, 1989
AA 200uCi A071910 001 Feb 28, 1989
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-400(of 452)

SODIUM IODIDE I-131



CAPSULE;ORAL

SODIUM IODIDE I 131

+ JUBILANT DRAXIMAGE 0.009-0.1mCi N021305 006 May 19, 2005

SOLUTION;ORAL

HICON

+! JUBILANT DRAXIMAGE 250-1000mCi N021305 007 Dec 05, 2011

SODIUM LACTATE

INJECTABLE;INJECTION

SODIUM LACTATE IN PLASTIC CONTAINER

+! HOSPIRA 5MEQ/ML N018947 001 Sep 05, 1984

SODIUM NITRITE

SOLUTION;INTRAVENOUS

SODIUM NITRITE

+! HOPE PHARMS 300MG/10ML (30MG/ML) N203922 001 Feb 14, 2012

SODIUM NITRITE; SODIUM THIOSULFATE

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

NITHIODOTE

+! HOPE PHARMS 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML N201444 001 Jan 14, 2011

(250MG/ML)

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

NITROPRESS

AP ! HOSPIRA 25MG/ML A071961 001 Aug 01, 1988

SODIUM NITROPRUSSIDE

AP AKORN 25MG/ML A208635 001 May 04, 2017

AP AMNEAL PHARMS CO 25MG/ML A209493 001 Nov 07, 2017

AP AMPHASTAR PHARMS 25MG/ML A209832 001 Dec 18, 2017

INC

AP CIPLA 25MG/ML A210855 001 Jul 16, 2018

AP MEDICURE 25MG/ML A209584 001 Aug 10, 2018

AP MICRO LABS 25MG/ML A209352 001 Dec 08, 2017

AP MYLAN LABS LTD 25MG/ML A210763 001 Apr 17, 2018

AP NAMIGEN LLC 25MG/ML A207426 001 Dec 08, 2016

AP NEXUS PHARMS 25MG/ML A207499 001 May 25, 2017

AP RENAISSANCE SSA LLC 25MG/ML A209834 001 Jun 26, 2018

AP SOMERSET THERAPS 25MG/ML A210882 001 Aug 17, 2018

LLC

AP SUN PHARM INDS LTD 25MG/ML A210467 001 Nov 26, 2018

SOLUTION;INTRAVENOUS

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

+! EXELA PHARMA SCS 10MG/50ML (0.2MG/ML) N209387 002 Dec 07, 2017

LLC

+! 20MG/100ML (0.2MG/ML) N209387 003 Jul 13, 2018

+! 50MG/100ML (0.5MG/ML) N209387 001 Mar 08, 2017

SODIUM OXYBATE

SOLUTION;ORAL

SODIUM OXYBATE

AA WEST-WARD PHARMS 500MG/ML A202090 001 Jan 17, 2017

INT

XYREM

AA +! JAZZ PHARMS 500MG/ML N021196 001 Jul 17, 2002

SODIUM PHENYLBUTYRATE

POWDER;ORAL

BUPHENYL

AB +! HORIZON PHARMA INC 3GM/TEASPOONFUL N020573 001 Apr 30, 1996

SODIUM PHENYLBUTYRATE

AB PAR PHARM 3GM/TEASPOONFUL A203918 001 Jun 15, 2016

AB SIGMAPHARM LABS LLC 3GM/TEASPOONFUL A202819 001 Mar 22, 2013



TABLET;ORAL

BUPHENYL

AB +! HORIZON PHARMA INC 500MG N020572 001 May 13, 1996

SODIUM PHENYLBUTYRATE

AB ALVOGEN MALTA 500MG A090910 001 Nov 18, 2011

AB PAR PHARM 500MG A204395 001 Apr 15, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-401(of 452)

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE



TABLET;ORAL

OSMOPREP

+! SALIX PHARMS 0.398GM;1.102GM N021892 001 Mar 16, 2006

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

INJECTABLE;INJECTION

SODIUM PHOSPHATES IN PLASTIC CONTAINER

+! HOSPIRA 142MG/ML;276MG/ML
N018892 001 May 10, 1983

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

KALEXATE
AA ! KVK TECH 454GM/BOT A040905 001 Mar 30, 2009

KIONEX
AA PADDOCK LLC 454GM/BOT A040029 001 Feb 06, 1998

SODIUM POLYSTYRENE SULFONATE

AA APNAR PHARMA LP 454GM/BOT
A206815 001 Feb 18, 2016

AA BELCHER PHARMS LLC 454GM/BOT


A205727 001 Feb 23, 2016

AA CMP PHARMA INC 454GM/BOT


A089910 001 Jan 19, 1989

AA ECI PHARMS LLC 453.6GM/BOT


A090313 001 Dec 21, 2011

AA EPIC PHARMA LLC 453.6GM/BOT


A202333 001 Mar 19, 2014

AA NUVO PHARMS INC 454GM/BOT


A204071 001 Nov 28, 2014

KALEXATE
KVK TECH 15GM/BOT
A040905 002 Apr 03, 2015

SODIUM POLYSTYRENE SULFONATE

NUVO PHARMS INC 15GM/BOT
A204071 002 Nov 28, 2014

SUSPENSION;ORAL, RECTAL

KIONEX

AA PADDOCK LLC 15GM/60ML
A040028 001 Sep 17, 2007

SODIUM POLYSTYRENE SULFONATE

AA PADDOCK LLC 15GM/60ML
A090590 001 May 13, 2011

AA WEST-WARD PHARMS 15GM/60ML


A089049 001 Nov 17, 1986

INT
SPS
AA ! CMP PHARMA INC 15GM/60ML
A087859 001 Dec 08, 1982

SODIUM TETRADECYL SULFATE

INJECTABLE;INJECTION

SOTRADECOL

! MYLAN INSTITUTIONAL
20MG/2ML (10MG/ML)
A040541 001 Nov 12, 2004

!
60MG/2ML (30MG/ML)
A040541 002 Nov 12, 2004

SODIUM THIOSULFATE

SOLUTION;INTRAVENOUS

SODIUM THIOSULFATE

+! HOPE PHARMS
12.5GM/50ML (250MG/ML)
N203923 001 Feb 14, 2012

SODIUM ZIRCONIUM CYCLOSILICATE

FOR SUSPENSION;ORAL

LOKELMA

+ ASTRAZENECA PHARMS
5GM/PACKET
N207078 001 May 18, 2018

+!
10GM/PACKET
N207078 002 May 18, 2018

SOFOSBUVIR

TABLET;ORAL

SOVALDI

+! GILEAD SCIENCES INC
400MG
N204671 001 Dec 06, 2013

SOFOSBUVIR; VELPATASVIR

TABLET;ORAL

EPCLUSA

+! GILEAD SCIENCES INC
400MG;100MG
N208341 001 Jun 28, 2016

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

TABLET;ORAL

VOSEVI

+! GILEAD SCIENCES INC
400MG;100MG;100MG
N209195 001 Jul 18, 2017

SOLIFENACIN SUCCINATE

TABLET;ORAL

SOLIFENACIN SUCCINATE
AB TEVA PHARMS USA 5MG
A091464 001 Apr 02, 2014

AB 10MG
A091464 002 Apr 02, 2014

VESICARE
AB + ASTELLAS 5MG
N021518 001 Nov 19, 2004

AB +! 10MG
N021518 002 Nov 19, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-402(of 452)

SOMATROPIN

INJECTABLE;INJECTION

ZOMACTON

BX +! FERRING 5MG/VIAL N019774 002 Jan 04, 2002

+ 10MG/VIAL N019774 003 Mar 07, 2012

SOMATROPIN RECOMBINANT

INJECTABLE;INJECTION

GENOTROPIN

BX +! PHARMACIA AND 5.8MG/VIAL N020280 006 Aug 24, 1995

UPJOHN

HUMATROPE

BX +! LILLY 5MG/VIAL N019640 004 Mar 08, 1987

BX + 6MG/VIAL N019640 005 Feb 04, 1999

NORDITROPIN FLEXPRO

BX NOVO NORDISK INC 5MG/1.5ML N021148 008 Mar 01, 2010

BX 10MG/1.5ML N021148 009 Mar 01, 2010

OMNITROPE

BX SANDOZ 1.5MG/VIAL N021426 002 May 30, 2006

BX 5MG/1.5ML N021426 003 Jan 16, 2008



BX 5.8MG/VIAL N021426 001 May 30, 2006

BX 10MG/1.5ML N021426 004 Aug 25, 2008

SAIZEN

BX + EMD SERONO 5MG/VIAL N019764 002 Oct 08, 1996

SEROSTIM

BX EMD SERONO 5MG/VIAL N020604 002 Aug 23, 1996

BX 6MG/VIAL N020604 001 Aug 23, 1996

GENOTROPIN

+! PHARMACIA AND 13.8MG/VIAL N020280 007 Oct 23, 1996

UPJOHN

GENOTROPIN PRESERVATIVE FREE

+ PHARMACIA AND 0.2MG/VIAL N020280 001 Jan 27, 1998

UPJOHN

+ 0.4MG/VIAL N020280 002 Jan 27, 1998

+ 0.6MG/VIAL N020280 003 Jan 27, 1998

+ 0.8MG/VIAL N020280 005 Jan 27, 1998

+ 1MG/VIAL N020280 008 Jan 27, 1998

+ 1.2MG/VIAL N020280 009 Jan 27, 1998

+ 1.4MG/VIAL N020280 010 Jan 27, 1998

+ 1.6MG/VIAL N020280 011 Jan 27, 1998

+ 1.8MG/VIAL N020280 012 Jan 27, 1998

+! 2MG/VIAL N020280 013 Jan 27, 1998

HUMATROPE

+! LILLY 12MG/VIAL N019640 006 Feb 04, 1999

+! 24MG/VIAL N019640 007 Feb 04, 1999

NORDITROPIN FLEXPRO

NOVO NORDISK INC 15MG/1.5ML N021148 010 Mar 01, 2010

30MG/3ML N021148 011 Jan 23, 2015

NUTROPIN AQ NUSPIN

+! GENENTECH 5MG/2ML (2.5MG/ML) N020522 003 Jan 03, 2008

+! 10MG/2ML (5MG/ML) N020522 005 Jan 03, 2008

+! 20MG/2ML (10MG/ML) N020522 004 Jan 03, 2008

SAIZEN

+! EMD SERONO 8.8MG/VIAL N019764 003 Aug 29, 2000

SEROSTIM

EMD SERONO 4MG/VIAL N020604 003 Jul 25, 1997

ZORBTIVE

+! EMD SERONO 8.8MG/VIAL N021597 004 Dec 01, 2003

SONIDEGIB PHOSPHATE

CAPSULE;ORAL

ODOMZO

+! SUN PHARMA GLOBAL EQ 200MG BASE N205266 001 Jul 24, 2015

SORAFENIB TOSYLATE

TABLET;ORAL

NEXAVAR

+! BAYER HLTHCARE EQ 200MG BASE N021923 001 Dec 20, 2005

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-403(of 452)

SORBITOL

SOLUTION;IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE 3GM/100ML N017863 001

SORBITOL 3.3% IN PLASTIC CONTAINER

B BRAUN 3.3GM/100ML N016741 001

SOTALOL HYDROCHLORIDE

SOLUTION;INTRAVENOUS

SOTALOL HYDROCHLORIDE

+! ALTATHERA PHARMS 150MG/10ML (15MG/ML) N022306 001 Jul 02, 2009

LLC

SOLUTION;ORAL

SOTYLIZE

+! ARBOR PHARMS LLC 5MG/ML (5MG/ML) N205108 001 Oct 22, 2014

TABLET;ORAL

BETAPACE

AB1 + COVIS PHARMA BV 80MG N019865 001 Oct 30, 1992

AB1 + 120MG N019865 005 Apr 20, 1994

AB1 +! 160MG N019865 002 Oct 30, 1992

AB1 + 240MG N019865 003 Oct 30, 1992

SORINE

AB1 UPSHER SMITH LABS 80MG A075500 001 Apr 27, 2001

AB1 120MG A075500 004 Apr 27, 2001

AB1 160MG A075500 002 Apr 27, 2001

AB1 240MG A075500 003 Apr 27, 2001

SOTALOL HYDROCHLORIDE

AB1 APOTEX INC 80MG A076140 001 Sep 26, 2002

AB1 120MG A076140 002 Sep 26, 2002

AB1 160MG A076140 003 Sep 26, 2002

AB1 240MG A076140 004 Sep 26, 2002

AB1 BEXIMCO PHARMS USA 80MG A207428 001 Oct 21, 2016

AB1 120MG A207428 002 Oct 21, 2016

AB1 160MG A207428 003 Oct 21, 2016

AB1 OXFORD PHARMS 80MG A075563 001 Nov 07, 2003

AB1 120MG A075563 002 Nov 07, 2003

AB1 160MG A075563 003 Nov 07, 2003

AB1 240MG A075563 004 Nov 07, 2003

AB1 TEVA 80MG A075429 001 May 01, 2000

AB1 120MG A075429 002 May 01, 2000

AB1 160MG A075429 003 May 01, 2000

AB1 240MG A075429 004 May 01, 2000

AB1 UPSHER SMITH LABS 80MG A075366 001 May 01, 2000

AB1 120MG A075366 002 May 01, 2000

AB1 160MG A075366 003 May 01, 2000

AB1 240MG A075366 004 May 01, 2000

BETAPACE AF

AB2 + COVIS PHARMA BV 80MG N021151 001 Feb 22, 2000

AB2 + 120MG N021151 002 Feb 22, 2000

AB2 +! 160MG N021151 003 Feb 22, 2000

SOTALOL HYDROCHLORIDE

AB2 APOTEX 80MG A076214 001 Aug 27, 2003

AB2 120MG A076214 002 Aug 27, 2003

AB2 160MG A076214 003 Aug 27, 2003

AB2 BEXIMCO PHARMS USA 80MG A207429 001 Nov 02, 2018

AB2 120MG A207429 002 Nov 02, 2018

AB2 160MG A207429 003 Nov 02, 2018

AB2 EPIC PHARMA INC 80MG A077070 001 Nov 04, 2005

AB2 120MG A077070 002 Nov 04, 2005

AB2 160MG A077070 003 Nov 04, 2005

AB2 MYLAN 80MG A077616 001 Feb 07, 2007

AB2 120MG A077616 002 Feb 07, 2007

AB2 160MG A077616 003 Feb 07, 2007



SOYBEAN OIL

INJECTABLE;INJECTION

INTRALIPID 10%

AP +! FRESENIUS 10% N017643 001

INTRALIPID 20%

AP +! FRESENIUS 20% N018449 001

AP +! 20% N020248 001 Aug 07, 1996

NUTRILIPID 10%

AP +! B BRAUN 10% N019531 001 May 28, 1993

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-404(of 452)

SOYBEAN OIL

INJECTABLE;INJECTION

NUTRILIPID 20%

AP +! B BRAUN 20% N019531 002 May 28, 1993

INTRALIPID 30%

+! FRESENIUS 30% N019942 001 Dec 30, 1993

SPINOSAD

SUSPENSION;TOPICAL

NATROBA

+! PARAPRO LLC 0.9% N022408 001 Jan 18, 2011

SPIRONOLACTONE

SUSPENSION;ORAL

CAROSPIR

+! CMP DEV LLC 25MG/5ML N209478 001 Aug 04, 2017

TABLET;ORAL

ALDACTONE

AB + GD SEARLE LLC 25MG N012151 009 Dec 30, 1983

AB + 50MG N012151 008 Dec 30, 1982

AB +! 100MG N012151 010 Dec 30, 1983

SPIRONOLACTONE

AB ACCORD HLTHCARE 25MG A203512 001 Sep 19, 2016

AB 50MG A203512 002 Sep 19, 2016

AB 100MG A203512 003 Sep 19, 2016

AB ACTAVIS ELIZABETH 25MG A040353 003 Mar 15, 2006

AB 50MG A040353 001 Jul 29, 1999

AB 100MG A040353 002 Jul 29, 1999

AB AMNEAL PHARMS 25MG A091426 001 Jul 02, 2010

AB 50MG A091426 002 Jul 02, 2010

AB 100MG A091426 003 Jul 02, 2010

AB CASI PHARMS INC 25MG A086809 001



AB JUBILANT GENERICS 25MG A203253 001 Apr 23, 2014

AB 50MG A203253 002 Apr 23, 2014

AB 100MG A203253 003 Apr 23, 2014

AB MYLAN 25MG A040424 001 Aug 20, 2001

AB 50MG A040424 002 Aug 20, 2001

AB 100MG A040424 003 Aug 20, 2001

AB OXFORD PHARMS 25MG A040750 001 Aug 29, 2006

AB 50MG A040750 002 Aug 29, 2006

AB 100MG A040750 003 Aug 29, 2006

AB SUN PHARM 25MG A089424 001 Jul 23, 1986

INDUSTRIES

AB 50MG A089424 002 Aug 11, 1999

AB 100MG A089424 003 Aug 11, 1999

AB ZYDUS PHARMS USA 25MG A205936 001 Jul 18, 2018

INC

AB 50MG A205936 002 Jul 18, 2018

AB 100MG A205936 003 Jul 18, 2018



STAVUDINE

CAPSULE;ORAL

STAVUDINE

AB AUROBINDO PHARMA 15MG A077672 003 Dec 29, 2008

AB 20MG A077672 004 Dec 29, 2008

AB 30MG A077672 001 Dec 29, 2008

AB 40MG A077672 002 Dec 29, 2008

AB HETERO LABS LTD III 15MG A078957 001 Dec 29, 2008

AB 20MG A078957 002 Dec 29, 2008

AB 30MG A078957 003 Dec 29, 2008

AB 40MG A078957 004 Dec 29, 2008

AB MYLAN 15MG A079069 001 Dec 29, 2008

AB 20MG A079069 002 Dec 29, 2008

AB 30MG A079069 003 Dec 29, 2008

AB 40MG A079069 004 Dec 29, 2008

ZERIT

AB + BRISTOL MYERS 15MG N020412 002 Jun 24, 1994

SQUIBB

AB + 20MG N020412 003 Jun 24, 1994

AB + 30MG N020412 004 Jun 24, 1994

AB +! 40MG N020412 005 Jun 24, 1994



FOR SOLUTION;ORAL

ZERIT

+! BRISTOL-MYERS 1MG/ML N020413 001 Sep 06, 1996

SQUIBB

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-405(of 452)

STERILE WATER FOR INJECTION



LIQUID;N/A

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER



AP +! HOSPIRA 100% N018802 001 Oct 27, 1982

STERILE WATER FOR INJECTION



AP FRESENIUS KABI USA 100% A209689 001 Nov 24, 2017

AP WEST-WARD PHARMS 100% A206369 001 Sep 02, 2015

INT

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

AP +! B BRAUN 100% N019633 001 Feb 29, 1988

AP +! BAXTER HLTHCARE 100% N018632 001 Jun 30, 1982

AP +! 100% N018632 002 Apr 19, 1988

AP FRESENIUS KABI USA 100% A088400 001 Jan 16, 1984

AP +! HOSPIRA 100% N018801 001 Oct 27, 1982

AP +! ICU MEDICAL INC 100% N018233 001



AP +! 100% N019869 001 Dec 26, 1989

AP TARO 100% A077393 001 Aug 11, 2006



STERILE WATER FOR IRRIGATION

LIQUID;IRRIGATION

STERILE WATER

AT BAXTER HLTHCARE 100% N017428 001

STERILE WATER IN PLASTIC CONTAINER

AT + B BRAUN 100% N016734 001

AT BAXTER HLTHCARE 100% N017866 001

AT ICU MEDICAL INC 100% N017513 001

AT 100% N018313 001

STIRIPENTOL

CAPSULE;ORAL

DIACOMIT

+ BIOCODEX SA 250MG N206709 001 Aug 20, 2018

+! 500MG N206709 002 Aug 20, 2018

FOR SUSPENSION;ORAL

DIACOMIT

+ BIOCODEX SA 250MG/PACKET N207223 001 Aug 20, 2018

+! 500MG/PACKET N207223 002 Aug 20, 2018



STREPTOMYCIN SULFATE

INJECTABLE;INJECTION

STREPTOMYCIN SULFATE

! X GEN PHARMS EQ 1GM BASE/VIAL A064210 001 Jun 30, 1998

STREPTOZOCIN

INJECTABLE;INJECTION

ZANOSAR

+! TEVA PHARMS USA 1GM/VIAL N050577 001 May 07, 1982

STRONTIUM CHLORIDE SR-89

INJECTABLE;INJECTION

METASTRON

AP +! GE HEALTHCARE 1mCi/ML N020134 001 Jun 18, 1993

STRONTIUM CHLORIDE SR-89



AP BIO NUCLEONICS 1mCi/ML A075941 001 Jan 06, 2003

SUCCIMER

CAPSULE;ORAL

CHEMET

+! RECORDATI RARE 100MG N019998 002 Jan 30, 1991

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

ANECTINE

AP +! SANDOZ INC 20MG/ML N008453 002

QUELICIN

AP +! HOSPIRA 20MG/ML N008845 006



SUCCINYLCHOLINE CHLORIDE

AP AMNEAL PHARMS CO 20MG/ML A211432 001 Nov 16, 2018

AP RENAISSANCE SSA LLC 20MG/ML A210231 001 Jun 04, 2018

AP ! ZYDUS PHARMS USA 20MG/ML A209467 001 May 04, 2018

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-406(of 452)

SUCRALFATE

SUSPENSION;ORAL

CARAFATE

+! ALLERGAN SALES LLC 1GM/10ML N019183 001 Dec 16, 1993

TABLET;ORAL

CARAFATE

AB +! ALLERGAN SALES LLC 1GM N018333 001

SUCRALFATE

AB TEVA 1GM A070848 001 Mar 29, 1996

SUCROFERRIC OXYHYDROXIDE

TABLET, CHEWABLE;ORAL

VELPHORO

+! VIFOR FRESENIUS 500MG N205109 001 Nov 27, 2013

SUFENTANIL CITRATE

INJECTABLE;INJECTION

SUFENTA PRESERVATIVE FREE



AP +! AKORN EQ 0.05MG BASE/ML N019050 001 May 04, 1984

SUFENTANIL CITRATE

AP HOSPIRA EQ 0.05MG BASE/ML A074534 001 Dec 11, 1996

AP WEST-WARD PHARMS EQ 0.05MG BASE/ML A074413 001 Dec 15, 1995

INT

TABLET;SUBLINGUAL

DSUVIA

+! ACELRX PHARMS EQ 0.03MG BASE N209128 001 Nov 02, 2018

SUGAMMADEX SODIUM

SOLUTION;INTRAVENOUS

BRIDION

+ ORGANON SUB MERCK EQ 200MG BASE/2ML (EQ 100MG BASE/ML) N022225 002 Dec 15, 2015

+! EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N022225 001 Dec 15, 2015

SULCONAZOLE NITRATE

CREAM;TOPICAL

EXELDERM

+! JOURNEY 1% N018737 001 Feb 28, 1989

SOLUTION;TOPICAL

EXELDERM

+! JOURNEY 1% N018738 001 Aug 30, 1985

SULFACETAMIDE SODIUM

LOTION;TOPICAL

KLARON

AB +! VALEANT PHARMS 10% N019931 001 Dec 23, 1996

NORTH

SULFACETAMIDE SODIUM

AB FOUGERA PHARMS 10% A077015 001 Nov 17, 2006

AB PERRIGO CO 10% A078649 001 Mar 23, 2009

TENNESSEE

AB TARO 10% A078668 001 May 20, 2009

OINTMENT;OPHTHALMIC

SULFACETAMIDE SODIUM

! PERRIGO CO 10% A080029 001

TENNESSEE

SOLUTION/DROPS;OPHTHALMIC

BLEPH-10

AT ! ALLERGAN 10% A080028 001

SULFACETAMIDE SODIUM

AT AKORN 10% A040215 001 May 25, 1999

AT BAUSCH AND LOMB 10% A040066 001 Dec 28, 1994

AT SANDOZ INC 10% A089560 001 Oct 18, 1988



SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

! SANDOZ 500MG A040091 001 Jul 29, 1994

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE;INJECTION

SULFAMETHOXAZOLE AND TRIMETHOPRIM



AP MYLAN LABS LTD 80MG/ML;16MG/ML A206607 001 Aug 30, 2017

AP ! TEVA PHARMS USA 80MG/ML;16MG/ML A073303 001 Oct 31, 1991



SUSPENSION;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM



AB AUROBINDO PHARMA 200MG/5ML;40MG/5ML A091348 001 Jun 08, 2010

AB ! HI TECH PHARMA 200MG/5ML;40MG/5ML A074650 001 Dec 29, 1997



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-407(of 452)

SULFAMETHOXAZOLE; TRIMETHOPRIM

SUSPENSION;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM



AB LANNETT CO INC 200MG/5ML;40MG/5ML A077785 001 Jan 24, 2007

SULFATRIM PEDIATRIC

AB PHARM ASSOC 200MG/5ML;40MG/5ML N018615 001 Jan 07, 1983

TABLET;ORAL

BACTRIM

AB + SUN PHARM 400MG;80MG N017377 001

INDUSTRIES

BACTRIM DS

AB +! SUN PHARM 800MG;160MG N017377 002

INDUSTRIES

SEPTRA

AB MONARCH PHARMS 400MG;80MG N017376 001

SEPTRA DS

AB MONARCH PHARMS 800MG;160MG N017376 002

SULFAMETHOXAZOLE AND TRIMETHOPRIM

AB AMNEAL PHARMS NY 400MG;80MG A076899 001 Jan 27, 2005

AB 800MG;160MG A076899 002 Jan 27, 2005

AB AUROBINDO PHARMA 400MG;80MG A090624 001 Feb 16, 2010

AB 800MG;160MG A090624 002 Feb 16, 2010

AB CHARTWELL MOLECULES 400MG;80MG A078060 002 Jan 25, 2007

AB 800MG;160MG A078060 001 Jan 25, 2007

AB GLENMARK GENERICS 400MG;80MG A090828 002 Dec 22, 2010

AB 800MG;160MG A090828 001 Dec 22, 2010

AB SUN PHARM 400MG;80MG A071017 002 Aug 25, 1986

INDUSTRIES

AB 800MG;160MG A071017 001 Aug 25, 1986

AB VISTA PHARMS 400MG;80MG A076817 001 Oct 07, 2005

AB 800MG;160MG A076817 002 Oct 07, 2005

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH



AB TEVA 800MG;160MG A070037 001 Jun 02, 1987

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH



AB TEVA PHARMS 400MG;80MG A070030 001 Jun 02, 1987

SULFANILAMIDE

CREAM;VAGINAL

AVC

+! MYLAN SPECIALITY LP 15% N006530 003 Jan 27, 1987

SULFASALAZINE

TABLET;ORAL

AZULFIDINE

AB +! PHARMACIA AND 500MG N007073 001

UPJOHN

SULFASALAZINE

AB VINTAGE PHARMS 500MG A040349 001 Jan 11, 2002

AB WATSON LABS 500MG A085828 001



TABLET, DELAYED RELEASE;ORAL

AZULFIDINE EN-TABS

AB +! PHARMACIA AND 500MG N007073 002 Apr 06, 1983

UPJOHN

SULFASALAZINE

AB VINTAGE PHARMS 500MG A075339 001 Jan 11, 2002

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

FOR SUSPENSION;INTRAVENOUS

LUMASON

+! BRACCO 60.7MG/25MG N203684 001 Oct 15, 2014

SULINDAC

TABLET;ORAL

SULINDAC

AB EPIC PHARMA 150MG A072710 001 Mar 25, 1991

AB 200MG A072711 001 Mar 25, 1991

AB MYLAN 150MG A073039 002 Jun 22, 1993

AB 200MG A073039 001 Jun 22, 1993

AB SUN PHARM 150MG A072050 001 Apr 17, 1991

INDUSTRIES

AB 200MG A072051 001 Apr 17, 1991

AB WATSON LABS 150MG A071891 001 Apr 03, 1990

AB ! 200MG A071795 001 Apr 03, 1990



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-408(of 452)

SUMATRIPTAN

SPRAY;NASAL

IMITREX

AB +! GLAXOSMITHKLINE 5MG/SPRAY N020626 001 Aug 26, 1997

AB +! 20MG/SPRAY N020626 003 Aug 26, 1997

SUMATRIPTAN

AB LANNETT CO INC 5MG/SPRAY A204841 001 Feb 19, 2016

AB 20MG/SPRAY A204841 002 Feb 19, 2016



SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS

IMITREX STATDOSE

AB +! GLAXOSMITHKLINE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) N020080 002 Feb 01, 2006

AB +! EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 003 Dec 23, 1996

SUMATRIPTAN SUCCINATE

AB ANTARES PHARMA INC EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) A078319 001 Dec 10, 2015

AB EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078319 002 Dec 10, 2015

AB DR REDDYS LABS INC EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090495 001 Jan 29, 2014

AB SUN PHARMA GLOBAL EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090358 001 Jun 21, 2011

IMITREX

AP +! GLAXOSMITHKLINE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) N020080 001 Dec 28, 1992

SUMATRIPTAN SUCCINATE

AP AUROBINDO PHARMA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A202758 001 Apr 23, 2013

LTD

AP FRESENIUS KABI USA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079242 001 Mar 02, 2009

AP HIKMA FARMACEUTICA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A200183 001 Sep 16, 2013

AP MYLAN ASI EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090314 001 Jun 10, 2010

AP EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A090641 001 Jul 28, 2010

AP MYLAN LABS LTD EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A203322 001 Apr 14, 2014

AP PAR PHARM EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077332 001 Oct 09, 2009

AP PAR STERILE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077871 001 Jul 09, 2009

PRODUCTS

AP TEVA PHARMS USA EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A077907 001 Feb 06, 2009

AP WEST-WARD PHARMS EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A079123 001 Feb 06, 2009

INT

AP WOCKHARDT EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) A078593 001 Feb 06, 2009

POWDER;INHALATION

ONZETRA XSAIL

+! AVANIR PHARMS EQ 11MG BASE N206099 001 Jan 27, 2016

SOLUTION;SUBCUTANEOUS

ZEMBRACE SYMTOUCH

+ DR REDDYS LABS LTD EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) N208223 001 Jan 28, 2016

TABLET;ORAL

IMITREX

AB + GLAXOSMITHKLINE EQ 25MG BASE N020132 002 Jun 01, 1995

AB + EQ 50MG BASE N020132 003 Jun 01, 1995

AB +! EQ 100MG BASE N020132 001 Jun 01, 1995

SUMATRIPTAN SUCCINATE

AB APOTEX INC EQ 25MG BASE A200263 001 Jun 19, 2012

AB EQ 50MG BASE A200263 002 Jun 19, 2012

AB EQ 100MG BASE A200263 003 Jun 19, 2012

AB AUROBINDO PHARMA EQ 25MG BASE A078327 001 Aug 10, 2009

AB EQ 50MG BASE A078327 002 Aug 10, 2009

AB EQ 100MG BASE A078327 003 Aug 10, 2009

AB DR REDDYS LABS INC EQ 25MG BASE A076847 001 Aug 10, 2009

AB EQ 50MG BASE A076847 002 Aug 10, 2009

AB EQ 100MG BASE A076847 003 Aug 10, 2009

AB MYLAN EQ 25MG BASE A077744 001 Aug 10, 2009

AB EQ 50MG BASE A077744 002 Aug 10, 2009

AB EQ 100MG BASE A077744 003 Aug 10, 2009

AB ORCHID HLTHCARE EQ 25MG BASE A078284 001 Aug 10, 2009

AB EQ 50MG BASE A078284 002 Aug 10, 2009

AB EQ 100MG BASE A078284 003 Aug 10, 2009

AB SUN PHARM INDS EQ 25MG BASE A078295 001 Aug 10, 2009

AB EQ 50MG BASE A078295 002 Aug 10, 2009

AB EQ 100MG BASE A078295 003 Aug 10, 2009

AB SUN PHARM INDS LTD EQ 25MG BASE A076554 001 Aug 10, 2009

AB EQ 50MG BASE A076554 002 Aug 10, 2009

AB EQ 100MG BASE A076572 001 Feb 09, 2009

AB WATSON LABS EQ 25MG BASE A076933 001 Aug 10, 2009

AB EQ 50MG BASE A076933 002 Aug 10, 2009

AB EQ 100MG BASE A076933 003 Aug 10, 2009



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-409(of 452)

SUNITINIB MALATE

CAPSULE;ORAL

SUTENT

+ CPPI CV EQ 12.5MG BASE N021938 001 Jan 26, 2006

+ EQ 25MG BASE N021938 002 Jan 26, 2006

+ EQ 37.5MG BASE N021938 004 Mar 31, 2009

+! EQ 50MG BASE N021938 003 Jan 26, 2006

SUVOREXANT

TABLET;ORAL

BELSOMRA

+ MERCK SHARP DOHME 5MG N204569 001 Aug 13, 2014

+ 10MG N204569 002 Aug 13, 2014

+ 15MG N204569 003 Aug 13, 2014

+! 20MG N204569 004 Aug 13, 2014



TACROLIMUS

CAPSULE;ORAL

PROGRAF

AB + ASTELLAS EQ 0.5MG BASE N050708 003 Aug 24, 1998

AB + EQ 1MG BASE N050708 001 Apr 08, 1994

AB +! EQ 5MG BASE N050708 002 Apr 08, 1994

TACROLIMUS

AB ACCORD HLTHCARE EQ 0.5MG BASE A091195 001 Aug 31, 2011

AB EQ 1MG BASE A091195 002 Aug 31, 2011

AB EQ 5MG BASE A091195 003 Aug 31, 2011

AB BELCHER PHARMS LLC EQ 0.5MG BASE A206651 001 Nov 30, 2017

AB EQ 1MG BASE A206651 002 Nov 30, 2017

AB EQ 5MG BASE A206651 003 Nov 30, 2017

AB DR REDDYS LABS LTD EQ 0.5MG BASE A090509 001 May 12, 2010

AB EQ 1MG BASE A090509 002 May 12, 2010

AB EQ 5MG BASE A090509 003 May 12, 2010

AB MYLAN EQ 0.5MG BASE A090596 001 Sep 17, 2010

AB EQ 1MG BASE A090596 002 Sep 17, 2010

AB EQ 5MG BASE A090596 003 Sep 17, 2010

AB PANACEA BIOTEC LTD EQ 0.5MG BASE A090802 001 Sep 28, 2012

AB EQ 1MG BASE A090802 002 Sep 28, 2012

AB EQ 5MG BASE A090802 003 Sep 28, 2012

AB SANDOZ EQ 0.5MG BASE A065461 001 Aug 10, 2009

AB EQ 1MG BASE A065461 002 Aug 10, 2009

AB EQ 5MG BASE A065461 003 Aug 10, 2009

AB STRIDES PHARMA EQ 0.5MG BASE A090687 001 Jul 22, 2014

AB EQ 1MG BASE A090687 002 Jul 22, 2014

AB EQ 5MG BASE A090687 003 Jul 22, 2014



CAPSULE, EXTENDED RELEASE;ORAL

ASTAGRAF XL

+ ASTELLAS EQ 0.5MG BASE N204096 001 Jul 19, 2013

+ EQ 1MG BASE N204096 002 Jul 19, 2013

+! EQ 5MG BASE N204096 003 Jul 19, 2013

FOR SUSPENSION;ORAL

PROGRAF

+ ASTELLAS EQ 0.2MG BASE/PACKET N210115 001 May 24, 2018

+! EQ 1MG BASE/PACKET N210115 002 May 24, 2018

INJECTABLE;INJECTION

PROGRAF

AP +! ASTELLAS EQ 5MG BASE/ML N050709 001 Apr 08, 1994

TACROLIMUS

AP HOSPIRA INC EQ 5MG BASE/ML A203900 001 Aug 25, 2017

OINTMENT;TOPICAL

PROTOPIC

AB +! LEO PHARMA AS 0.03% N050777 001 Dec 08, 2000

AB +! 0.1% N050777 002 Dec 08, 2000

TACROLIMUS

AB FOUGERA PHARMS INC 0.03% A200744 001 Sep 09, 2014

AB 0.1% A200744 002 Sep 09, 2014

AB GLENMARK PHARMS LTD 0.1% A210393 001 Apr 16, 2018

TABLET, EXTENDED RELEASE;ORAL



ENVARSUS XR

+ VELOXIS PHARMS INC EQ 0.75MG BASE N206406 001 Jul 10, 2015

+ EQ 1MG BASE N206406 002 Jul 10, 2015

+! EQ 4MG BASE N206406 003 Jul 10, 2015

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-410(of 452)

TADALAFIL

TABLET;ORAL

CIALIS

AB + LILLY
2.5MG
N021368 004 Jan 07, 2008

AB +
5MG
N021368 001 Nov 21, 2003

AB +
10MG
N021368 002 Nov 21, 2003

TADALAFIL

AB TEVA PHARMS USA
2.5MG
A090141 001 May 22, 2018

AB
5MG
A090141 002 May 22, 2018

AB
10MG
A090141 003 May 22, 2018

CIALIS

AB1 +! LILLY
20MG
N021368 003 Nov 21, 2003

TADALAFIL

AB1 TEVA PHARMS USA
20MG
A090141 004 May 22, 2018

ADCIRCA

AB2 +! ELI LILLY CO
20MG
N022332 001 May 22, 2009

TADALAFIL

AB2 MYLAN PHARMS INC
20MG
A200630 001 Aug 03, 2018

TAFENOQUINE SUCCINATE

TABLET;ORAL

ARAKODA

+! 60 DEGREES PHARMS
EQ 100MG BASE
N210607 001 Aug 08, 2018

KRINTAFEL

+! GLAXOSMITHKLINE
EQ 150MG BASE
N210795 001 Jul 20, 2018

TAFLUPROST

SOLUTION/DROPS;OPHTHALMIC

ZIOPTAN

+! OAK PHARMS INC
0.0015%
N202514 001 Feb 10, 2012

TALAZOPARIB TOSYLATE

CAPSULE;ORAL

TALZENNA

+ PFIZER INC
EQ 0.25MG BASE
N211651 001 Oct 16, 2018

+!
EQ 1MG BASE
N211651 002 Oct 16, 2018

TALC

AEROSOL;INTRAPLEURAL

SCLEROSOL

+! LYMOL MEDCL
4GM/SPRAY
N020587 001 Dec 24, 1997

POWDER;INTRAPLEURAL

STERITALC

+ NOVATECH SA
2GM/VIAL
N205555 001 May 01, 2017

+
3GM/VIAL
N205555 002 May 01, 2017

+!
4GM/VIAL
N205555 003 May 01, 2017

TALC

+! LYMOL MEDCL
5GM/BOT
N021388 001 Dec 15, 2003

TALIGLUCERASE ALFA

POWDER;INTRAVENOUS

ELELYSO

+! PFIZER
200 UNITS/VIAL
N022458 001 May 01, 2012

TAMOXIFEN CITRATE

SOLUTION;ORAL

SOLTAMOX

MIDATECH PHARMA US
EQ 20MG BASE/10ML
N021807 001 Oct 29, 2005

TABLET;ORAL

TAMOXIFEN CITRATE

AB ACTAVIS LABS FL INC
EQ 10MG BASE
A070929 001 Feb 20, 2003

AB
EQ 20MG BASE
A070929 002 Feb 20, 2003

AB APOTEX
EQ 10MG BASE
A090878 001 Sep 23, 2011

AB
EQ 20MG BASE
A090878 002 Sep 23, 2011

AB MAYNE PHARMA
EQ 10MG BASE
A075797 001 Feb 20, 2003

AB !
EQ 20MG BASE
A075797 002 Feb 20, 2003

AB MYLAN
EQ 10MG BASE
A074732 002 Feb 20, 2003

AB
EQ 20MG BASE
A074732 001 Feb 20, 2003

AB ZYDUS PHARMS USA


EQ 10MG BASE
A206694 001 Oct 27, 2017

INC

AB
EQ 20MG BASE
A206694 002 Oct 27, 2017

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-411(of 452)

TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL

FLOMAX

AB +! SANOFI AVENTIS US 0.4MG N020579 001 Apr 15, 1997

TAMSULOSIN HYDROCHLORIDE

AB ALKEM LABS LTD 0.4MG A207405 001 Aug 11, 2017

AB ANCHEN PHARMS 0.4MG A202010 001 Jan 04, 2013

AB AUROBINDO PHARMA 0.4MG A202433 001 Apr 30, 2013

LTD

AB IMPAX LABS 0.4MG A090377 001 Mar 02, 2010

AB MACLEODS PHARMS LTD 0.4MG A204645 001 Jan 20, 2017

AB MYLAN 0.4MG A090408 001 Apr 27, 2010

AB SANDOZ 0.4MG A078015 001 Apr 27, 2010

AB SUN PHARM INDS LTD 0.4MG A090931 001 Jul 15, 2010

AB SYNTHON PHARMS 0.4MG A078801 001 Apr 27, 2010

AB TEVA PHARMS 0.4MG A077630 001 Apr 27, 2010

AB WOCKHARDT 0.4MG A078938 001 Apr 27, 2010

AB ZYDUS PHARMS USA 0.4MG A078225 001 Apr 27, 2010

INC

TAPENTADOL HYDROCHLORIDE

TABLET;ORAL

NUCYNTA

+ DEPO NF EQ 50MG BASE N022304 001 Nov 20, 2008

+ EQ 75MG BASE N022304 002 Nov 20, 2008

+! EQ 100MG BASE N022304 003 Nov 20, 2008

TABLET, EXTENDED RELEASE;ORAL

NUCYNTA ER

+ DEPO NF EQ 50MG BASE N200533 001 Aug 25, 2011

+ EQ 100MG BASE N200533 002 Aug 25, 2011

+ EQ 150MG BASE N200533 003 Aug 25, 2011

+ EQ 200MG BASE N200533 004 Aug 25, 2011

+! EQ 250MG BASE N200533 005 Aug 25, 2011



TASIMELTEON

CAPSULE;ORAL

HETLIOZ

+! VANDA PHARMS INC 20MG N205677 001 Jan 31, 2014

TAVABOROLE

SOLUTION;TOPICAL

KERYDIN

+! ANACOR PHARMS INC 5% N204427 001 Jul 07, 2014

TAZAROTENE

AEROSOL, FOAM;TOPICAL

FABIOR

+! MAYNE PHARMA 0.1% N202428 001 May 11, 2012

CREAM;TOPICAL

AVAGE

AB +! ALLERGAN 0.1% N021184 003 Sep 30, 2002

TAZAROTENE

AB G AND W LABS INC 0.1% A208662 001 Dec 22, 2017

AB TARO PHARMS 0.1% A208258 001 Apr 03, 2017

TAZORAC

AB +! ALLERGAN 0.1% N021184 002 Sep 29, 2000

+! 0.05% N021184 001 Sep 29, 2000

GEL;TOPICAL

TAZORAC

+! ALLERGAN 0.05% N020600 001 Jun 13, 1997

+! 0.1% N020600 002 Jun 13, 1997

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE;INJECTION

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

BS +! DRAXIMAGE N/A N017881 001 Dec 30, 1987

TECHNETIUM TC-99M BICISATE KIT

INJECTABLE;INJECTION

NEUROLITE

+! LANTHEUS MEDCL N/A N020256 001 Nov 23, 1994

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-412(of 452)

TECHNETIUM TC-99M DISOFENIN KIT



INJECTABLE;INJECTION

HEPATOLITE

PHARMALUCENCE N/A N018467 001 Mar 16, 1982

TECHNETIUM TC-99M EXAMETAZIME KIT

INJECTABLE;INJECTION

CERETEC
+! GE HEALTHCARE N/A N019829 001 Dec 30, 1988
POWDER;INTRAVENOUS
DRAX EXAMETAZIME
JUBILANT DRAXIMAGE N/A N208870 001 Aug 17, 2017
TECHNETIUM TC-99M MEBROFENIN KIT

INJECTABLE;INJECTION

CHOLETEC

AP +! BRACCO N/A N018963 001 Jan 21, 1987

TECHNETIUM TC-99M MEBROFENIN



AP PHARMALUCENCE N/A A078242 001 Jan 29, 2008

TECHNETIUM TC-99M MEDRONATE

INJECTABLE;INJECTION

DRAXIMAGE MDP-25

+! JUBILANT DRAXIMAGE N/A N018035 002 Feb 27, 2004

TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE;INJECTION

CIS-MDP

PHARMALUCENCE N/A N018124 001

TECHNETIUM TC-99M MERTIATIDE KIT

INJECTABLE;INJECTION

TECHNESCAN MAG3

+! MALLINKRODT NUCLEAR N/A N019882 001 Jun 15, 1990

TECHNETIUM TC-99M OXIDRONATE KIT

INJECTABLE;INJECTION

TECHNESCAN

+! MALLINKRODT NUCLEAR N/A N018321 001

TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE;INJECTION

DTPA

+! JUBILANT DRAXIMAGE N/A N018511 001 Dec 29, 1989

TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE;INJECTION

CIS-PYRO

AP PHARMALUCENCE N/A N019039 001 Jun 30, 1987

TECHNESCAN PYP KIT



AP MALLINKRODT NUCLEAR N/A N017538 001

TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE;INJECTION

ULTRATAG

+! MALLINKRODT NUCLEAR N/A N019981 001 Jun 10, 1991

TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE;INJECTION

CARDIOLITE

AP +! LANTHEUS MEDCL N/A N019785 001 Dec 21, 1990

TECHNETIUM TC 99M SESTAMIBI



AP CARDINAL HEALTH 414 N/A A078809 001 Apr 28, 2009

AP JUBILANT DRAXIMAGE N/A A078806 001 Apr 29, 2009

AP MALLINKRODT NUCLEAR N/A A078098 001 Sep 22, 2008

AP PHARMALUCENCE 10-30mCi A079157 001 Jul 10, 2009



TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INTRAVENOUS

TECHNELITE

+! LANTHEUS MEDCL 1-20 CI/GENERATOR N017771 002 Feb 12, 2014

ULTRA-TECHNEKOW FM

+! MALLINKRODT NUCLEAR 1-19 CI/GENERATOR N017243 003 Feb 18, 2014

SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC

RADIOGENIX SYSTEM

+ NORTHSTAR MEDICAL 30-1153mCi/GENERATOR N202158 001 Feb 08, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-413(of 452)

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR



SOLUTION;INTRAVENOUS, ORAL

TECHNETIUM TC 99M GENERATOR

+! GE HEALTHCARE 68-2703mCi/GENERATOR N017693 002 Dec 13, 2013

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL

AN-SULFUR COLLOID

+! PHARMALUCENCE N/A N017858 001

TECHNETIUM TC-99M TETROFOSMIN KIT

INJECTABLE;INJECTION

MYOVIEW 30ML

+! GE HEALTHCARE N/A N020372 002 Jul 07, 2005

TECHNETIUM TC-99M TILMANOCEPT

INJECTABLE;INJECTION

LYMPHOSEEK KIT

+! CARDINAL HEALTH 414 N/A N202207 001 Mar 13, 2013

TECOVIRIMAT

CAPSULE;ORAL

TPOXX

+! SIGA TECHNOLOGIES 200MG N208627 001 Jul 13, 2018

TEDIZOLID PHOSPHATE

POWDER;INTRAVENOUS

SIVEXTRO

+! CUBIST PHARMS LLC 200MG/VIAL N205436 001 Jun 20, 2014

TABLET;ORAL

SIVEXTRO

+! CUBIST PHARMS LLC 200MG N205435 001 Jun 20, 2014

TEDUGLUTIDE RECOMBINANT

POWDER;SUBCUTANEOUS

GATTEX KIT

+! NPS PHARMS INC 5MG/VIAL N203441 001 Dec 21, 2012

TELAVANCIN HYDROCHLORIDE

POWDER;INTRAVENOUS

VIBATIV

+! CUMBERLAND PHARMS EQ 750MG BASE/VIAL N022110 002 Sep 11, 2009

TELMISARTAN

TABLET;ORAL

MICARDIS

AB + BOEHRINGER 20MG N020850 003 Apr 04, 2000

INGELHEIM

AB + 40MG N020850 001 Nov 10, 1998

AB +! 80MG N020850 002 Nov 10, 1998

TELMISARTAN

AB ALEMBIC PHARMS LTD 20MG A202130 001 Jul 07, 2014

AB 40MG A202130 002 Jul 07, 2014

AB 80MG A202130 003 Jul 07, 2014

AB AMNEAL PHARMS 20MG A204415 001 Sep 08, 2015

AB 40MG A204415 002 Sep 08, 2015

AB 80MG A204415 003 Sep 08, 2015

AB AUROBINDO PHARMA 20MG A206511 001 Sep 03, 2015

LTD

AB 40MG A206511 002 Sep 03, 2015

AB 80MG A206511 003 Sep 03, 2015

AB CADILA PHARMS LTD 20MG A208605 001 Jul 25, 2017

AB 40MG A208605 002 Jul 25, 2017

AB 80MG A208605 003 Jul 25, 2017

AB GLENMARK PHARMS LTD 20MG A090032 001 Jul 07, 2014

AB 40MG A090032 002 Jul 07, 2014

AB 80MG A090032 003 Jul 07, 2014

AB HETERO LABS LTD V 20MG A205901 001 Apr 22, 2016

AB 40MG A205901 002 Apr 22, 2016

AB 80MG A205901 003 Apr 22, 2016

AB INVENTIA HLTHCARE 20MG A205150 001 Oct 30, 2015

AB 40MG A205150 002 Oct 30, 2015

AB 80MG A205150 003 Oct 30, 2015

AB JUBILANT GENERICS 20MG A204164 001 Aug 22, 2016

AB 40MG A204164 002 Aug 22, 2016

AB 80MG A204164 003 Aug 22, 2016

AB MICRO LABS 20MG A207016 001 Oct 03, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-414(of 452)

TELMISARTAN

TABLET;ORAL

TELMISARTAN

AB 40MG A207016 002 Oct 03, 2017

AB 80MG A207016 003 Oct 03, 2017

AB MYLAN PHARMS INC 20MG A202397 001 Jul 07, 2014

AB 40MG A202397 002 Jul 07, 2014

AB 80MG A202397 003 Jul 07, 2014

AB PRINSTON INC 20MG A207882 001 May 03, 2017

AB 40MG A207882 002 May 03, 2017

AB 80MG A207882 003 May 03, 2017

AB SANDOZ INC 20MG A203867 001 Nov 03, 2014

AB 40MG A203867 002 Nov 03, 2014

AB 80MG A203867 003 Nov 03, 2014

AB TORRENT PHARMS LTD 20MG A203171 001 Jul 07, 2014

AB 40MG A203171 002 Jul 07, 2014

AB 80MG A203171 003 Jul 07, 2014

AB WATSON LABS 20MG A078710 001 Jan 08, 2014

AB 80MG A078710 003 Jan 08, 2014

AB ZYDUS PHARMS USA 20MG A203325 001 Aug 26, 2014

INC

AB 40MG A203325 002 Aug 26, 2014

AB 80MG A203325 003 Aug 26, 2014



TELOTRISTAT ETIPRATE

TABLET;ORAL

XERMELO

+! LEXICON PHARMS INC EQ 250MG BASE N208794 001 Feb 28, 2017

TEMAZEPAM

CAPSULE;ORAL

RESTORIL

AB + SPECGX LLC 7.5MG N018163 003 Oct 25, 1991

AB + 15MG N018163 001



AB + 22.5MG N018163 004 Nov 02, 2004

AB +! 30MG N018163 002



TEMAZEPAM

AB ACTAVIS ELIZABETH 15MG A071620 002 Aug 07, 1987

AB 30MG A071620 001 Aug 07, 1987

AB ALEMBIC PHARMS LTD 7.5MG A211542 001 Nov 23, 2018

AB 15MG A211542 002 Nov 23, 2018

AB 22.5MG A211542 003 Nov 23, 2018

AB 30MG A211542 004 Nov 23, 2018

AB AMNEAL PHARMS 7.5MG A203482 001 May 23, 2016

AB 15MG A203482 002 May 23, 2016

AB 22.5MG A203482 003 May 23, 2016

AB 30MG A203482 004 May 23, 2016

AB MYLAN 7.5MG A070920 002 May 21, 2010

AB 15MG A070920 004 Jul 07, 1986

AB 22.5MG A070920 003 Jun 12, 2009

AB 30MG A070920 001 Jul 10, 1986

AB NOVEL LABS INC 7.5MG A071457 002 Jun 22, 2012

AB 15MG A071456 001 Apr 21, 1987

AB 22.5MG A071457 003 Jun 22, 2012

AB 30MG A071457 001 Apr 21, 1987

AB PRINSTON INC 7.5MG A201781 001 Jun 04, 2015

AB 15MG A201781 002 Jun 04, 2015

AB 22.5MG A201781 003 Jun 04, 2015

AB 30MG A201781 004 Jun 04, 2015

AB SANDOZ 15MG A071427 001 Jan 12, 1988

AB 30MG A071428 001 Jan 12, 1988

AB SUN PHARM 7.5MG A078581 001 Sep 08, 2009

INDUSTRIES

AB 22.5MG A071175 002 Sep 14, 2009

TEMOZOLOMIDE

CAPSULE;ORAL

TEMODAR

AB + MERCK SHARP DOHME 5MG N021029 001 Aug 11, 1999

AB + 20MG N021029 002 Aug 11, 1999

AB + 100MG N021029 003 Aug 11, 1999

AB + 140MG N021029 005 Oct 19, 2006

AB + 180MG N021029 006 Oct 19, 2006

AB +! 250MG N021029 004 Aug 11, 1999



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-415(of 452)

TEMOZOLOMIDE

CAPSULE;ORAL

TEMOZOLOMIDE

AB ACCORD HLTHCARE 5MG A201528 001 Feb 27, 2017

AB 20MG A201528 002 Feb 27, 2017

AB 100MG A201528 003 Feb 27, 2017

AB 140MG A201528 004 Feb 27, 2017

AB 180MG A201528 005 Feb 27, 2017

AB 250MG A201528 006 Feb 27, 2017

AB AMERIGEN PHARMS LTD 5MG A203490 001 Jul 13, 2016

AB 20MG A203490 002 Jul 13, 2016

AB 100MG A203490 003 Jul 13, 2016

AB 140MG A203490 004 Jul 13, 2016

AB 180MG A203490 005 Jul 13, 2016

AB 250MG A203490 006 Jul 13, 2016

AB AMNEAL PHARMS 5MG A203691 001 May 08, 2015

AB 20MG A203691 002 May 08, 2015

AB 100MG A203691 003 May 08, 2015

AB 140MG A203691 004 May 08, 2015

AB 180MG A203691 005 May 08, 2015

AB 250MG A203691 006 May 08, 2015

AB APOTEX INC 5MG A204159 001 Jul 05, 2018

AB 20MG A204159 002 Jul 05, 2018

AB 100MG A204159 003 Jul 05, 2018

AB 140MG A204159 004 Jul 05, 2018

AB 180MG A204159 005 Jul 05, 2018

AB 250MG A204159 006 Jul 05, 2018

AB BARR 5MG A078879 001 Mar 01, 2010

AB 20MG A078879 002 Mar 01, 2010

AB 100MG A078879 003 Mar 01, 2010

AB 140MG A078879 005 Mar 01, 2010

AB 180MG A078879 006 Mar 01, 2010

AB 250MG A078879 004 Mar 01, 2010

AB CHEMI SPA 5MG A204639 001 Nov 23, 2016

AB 20MG A204639 002 Nov 23, 2016

AB 100MG A204639 003 Nov 23, 2016

AB 140MG A204639 004 Nov 23, 2016

AB 180MG A204639 005 Nov 23, 2016

AB 250MG A204639 006 Nov 23, 2016

AB DEVA HOLDING AS 5MG A207658 001 Apr 26, 2017

AB 20MG A207658 002 Apr 26, 2017

AB 100MG A207658 003 Apr 26, 2017

AB 140MG A207658 004 Apr 26, 2017

AB 180MG A207658 005 Apr 26, 2017

AB 250MG A207658 006 Apr 26, 2017

AB IDT AUSTRALIA LTD 5MG A206413 001 Apr 12, 2016

AB 20MG A206413 002 Apr 12, 2016

AB 100MG A206413 003 Apr 12, 2016

AB 140MG A206413 004 Apr 12, 2016

AB 180MG A206413 005 Apr 12, 2016

AB 250MG A206413 006 Apr 12, 2016

AB LANNETT CO INC 5MG A203898 001 Feb 10, 2016

AB 20MG A203898 002 Feb 10, 2016

AB 100MG A203898 003 Feb 10, 2016

AB 140MG A203898 004 Feb 10, 2016

AB 180MG A203898 005 Feb 10, 2016

AB 250MG A203898 006 Feb 10, 2016

AB RISING PHARMS 5MG A206309 001 Apr 27, 2016

AB 20MG A206309 002 Apr 27, 2016

AB 100MG A206309 003 Apr 27, 2016

AB 140MG A206309 004 Apr 27, 2016

AB 180MG A206309 005 Apr 27, 2016

AB 250MG A206309 006 Apr 27, 2016

AB SUN PHARMA GLOBAL 5MG A201742 001 Feb 12, 2014

AB 20MG A201742 002 Feb 12, 2014

AB 100MG A201742 003 Feb 12, 2014

AB 140MG A201742 004 Feb 12, 2014

AB 180MG A201742 005 Feb 12, 2014

AB 250MG A201742 006 Feb 12, 2014

AB WATSON LABS TEVA 5MG A203959 001 Apr 18, 2017

AB 20MG A203959 002 Apr 18, 2017

AB 100MG A203959 003 Apr 18, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-416(of 452)

TEMOZOLOMIDE

CAPSULE;ORAL

TEMOZOLOMIDE

AB 140MG A203959 004 Apr 18, 2017

AB 250MG A203959 005 Apr 18, 2017

AB ZYDUS PHARMS USA 5MG A206750 001 Jul 31, 2017

INC

AB 20MG A206750 002 Jul 31, 2017

AB 100MG A206750 003 Jul 31, 2017

AB 140MG A206750 004 Jul 31, 2017

AB 180MG A206750 005 Jul 31, 2017

AB 250MG A206750 006 Jul 31, 2017



POWDER;INTRAVENOUS

TEMODAR

+! MERCK SHARP DOHME 100MG/VIAL N022277 001 Feb 27, 2009

TEMSIROLIMUS

SOLUTION;INTRAVENOUS

TEMSIROLIMUS

AP ACCORD HLTHCARE 25MG/ML (25MG/ML) A203153 001 Jul 30, 2018

TORISEL

AP +! PF PRISM CV 25MG/ML (25MG/ML) N022088 001 May 30, 2007

TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

VEMLIDY

+! GILEAD SCIENCES INC EQ 25MG BASE N208464 001 Nov 10, 2016

TENOFOVIR DISOPROXIL FUMARATE

POWDER;ORAL

VIREAD

+! GILEAD SCIENCES INC 40MG/SCOOPFUL N022577 001 Jan 18, 2012

TABLET;ORAL

TENOFOVIR DISOPROXIL FUMARATE



AB APOTEX INC 300MG A206481 001 Jul 26, 2018

AB AUROBINDO PHARMA 150MG A090647 001 Jan 26, 2018

LTD

AB 200MG A090647 002 Jan 26, 2018

AB 250MG A090647 003 Jan 26, 2018

AB 300MG A090647 004 Jan 26, 2018

AB CASI PHARMS INC 300MG A209550 001 Feb 26, 2018

AB CIPLA 300MG A078800 001 Jan 26, 2018

AB HETERO LABS LTD III 300MG A090636 001 Jan 26, 2018

AB MACLEODS PHARMS LTD 300MG A203232 001 Jan 26, 2018

AB MYLAN PHARMS INC 150MG A206569 001 Nov 27, 2018

AB 200MG A206569 002 Nov 27, 2018

AB 250MG A206569 003 Nov 27, 2018

AB 300MG A206569 004 Nov 27, 2018

AB QILU PHARM CO LTD 200MG A209498 001 Mar 02, 2018

AB 250MG A209498 002 Mar 02, 2018

AB 300MG A209498 003 Mar 02, 2018

AB STRIDES PHARMA 300MG A090742 001 Jan 26, 2018

AB TEVA PHARMS USA 150MG A091612 002 Jan 26, 2018

AB 200MG A091612 003 Jan 26, 2018

AB 250MG A091612 004 Jan 26, 2018

AB 300MG A091612 001 Mar 18, 2015

VIREAD

AB + GILEAD SCIENCES INC 150MG N021356 002 Jan 18, 2012

AB + 200MG N021356 003 Jan 18, 2012

AB + 250MG N021356 004 Jan 18, 2012

AB +! 300MG N021356 001 Oct 26, 2001



TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
TERAZOSIN HYDROCHLORIDE
AB APOTEX EQ 1MG BASE A075498 001 Apr 12, 2001
AB EQ 2MG BASE A075498 002 Apr 12, 2001
AB EQ 5MG BASE A075498 003 Apr 12, 2001
AB EQ 10MG BASE A075498 004 Apr 12, 2001
AB IVAX SUB TEVA EQ 1MG BASE A075614 002 Jan 30, 2001
PHARMS
AB EQ 2MG BASE A075614 001 Jan 30, 2001
AB EQ 5MG BASE A075614 003 Jan 30, 2001
AB EQ 10MG BASE A075614 004 Jan 30, 2001
AB JUBILANT CADISTA EQ 1MG BASE A075317 001 Dec 20, 2004
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-417(of 452)

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

TERAZOSIN HYDROCHLORIDE

AB EQ 2MG BASE A075317 002 Dec 20, 2004

AB EQ 5MG BASE A075317 003 Dec 20, 2004

AB EQ 10MG BASE A075317 004 Dec 20, 2004

AB MYLAN PHARMS INC EQ 1MG BASE A075140 002 Feb 11, 2000

AB EQ 2MG BASE A075140 003 Feb 11, 2000

AB EQ 5MG BASE A075140 001 Feb 11, 2000

AB EQ 10MG BASE A075140 004 Feb 11, 2000

AB SANDOZ EQ 1MG BASE A074823 001 Mar 30, 1998

AB ! EQ 2MG BASE A074823 002 Mar 30, 1998

AB EQ 5MG BASE A074823 003 Mar 30, 1998

AB EQ 10MG BASE A074823 004 Mar 30, 1998



TERBINAFINE HYDROCHLORIDE

TABLET;ORAL

LAMISIL

AB +! NOVARTIS EQ 250MG BASE N020539 001 May 10, 1996

TERBINAFINE HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 250MG BASE A078297 001 Jul 02, 2007

AB BRECKENRIDGE PHARM EQ 250MG BASE A077714 001 Jun 04, 2010

AB CIPLA EQ 250MG BASE A077137 001 Jul 02, 2007

AB DR REDDYS LABS INC EQ 250MG BASE A076390 001 Jul 02, 2007

AB GLENMARK GENERICS EQ 250MG BASE A078157 001 Jul 02, 2007

AB HARRIS PHARM EQ 250MG BASE A077919 001 Jul 02, 2007

AB INVAGEN PHARMS EQ 250MG BASE A077533 001 Jul 02, 2007

AB ORCHID HLTHCARE EQ 250MG BASE A078163 001 Jul 02, 2007

AB TEVA EQ 250MG BASE A076377 001 Jul 02, 2007



TERBUTALINE SULFATE

INJECTABLE;INJECTION

TERBUTALINE SULFATE

AP AKORN 1MG/ML A078151 001 Jan 07, 2008

AP ! ATHENEX INC 1MG/ML A076770 001 Apr 23, 2004

AP FRESENIUS KABI USA 1MG/ML A076887 001 May 26, 2004

AP HIKMA FARMACEUTICA 1MG/ML A078630 001 May 20, 2009

AP UNITED BIOMEDCL 1MG/ML A200122 001 Nov 08, 2013



TABLET;ORAL

BRETHINE

AB + ANI PHARMS INC 2.5MG N017849 001

AB + 5MG N017849 002

TERBUTALINE SULFATE

AB IMPAX LABS 2.5MG A075877 001 Jun 26, 2001

AB 5MG A075877 002 Jun 26, 2001

AB LANNETT CO INC 2.5MG A077152 001 Mar 25, 2005

AB ! 5MG A077152 002 Mar 25, 2005



TERCONAZOLE

CREAM;VAGINAL

TERCONAZOLE

AB FOUGERA PHARMS 0.4% A076712 001 Feb 18, 2005

AB ! TARO 0.4% A076043 001 Jan 19, 2005



BX +! NYCOMED US 0.8% N021735 001 Oct 01, 2004

BX ! TARO 0.8% A075953 001 Apr 06, 2004

SUPPOSITORY;VAGINAL

TERCONAZOLE

AB ! PERRIGO NEW YORK 80MG A077149 001 Mar 17, 2006

AB TARO 80MG A077553 001 Mar 09, 2007



TERIFLUNOMIDE

TABLET;ORAL

AUBAGIO

AB + SANOFI AVENTIS US 7MG N202992 001 Sep 12, 2012

AB +! 14MG N202992 002 Sep 12, 2012

TERIFLUNOMIDE

AB ACCORD HLTHCARE 7MG A209690 001 Jan 07, 2019

AB 14MG A209690 002 Jan 07, 2019

AB AMNEAL PHARMS CO 7MG A209613 001 Sep 28, 2018

AB 14MG A209613 002 Sep 28, 2018

AB APOTEX INC 7MG A209601 001 Nov 02, 2018

AB 14MG A209601 002 Nov 02, 2018

AB AUROBINDO PHARMA 7MG A209638 001 Oct 26, 2018

LTD

AB 14MG A209638 002 Oct 26, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-418(of 452)

TERIFLUNOMIDE

TABLET;ORAL

TERIFLUNOMIDE

AB GLENMARK PHARMS 7MG A209663 001 Nov 15, 2018

AB 14MG A209663 002 Nov 15, 2018

AB SANDOZ INC 7MG A209710 001 Jan 03, 2019

AB 14MG A209710 002 Jan 03, 2019

AB TEVA PHARMS USA 7MG A209700 001 Sep 04, 2018

AB 14MG A209700 002 Sep 04, 2018

AB WATSON LABS TEVA 7MG A209549 001 Jul 27, 2018

AB 14MG A209549 002 Jul 27, 2018

AB ZYDUS PHARMS USA 7MG A209668 001 Nov 30, 2018

INC

AB 14MG A209668 002 Nov 30, 2018

TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE;SUBCUTANEOUS

FORTEO

+! LILLY 0.6MG/2.4ML (0.25MG/ML) N021318 002 Jun 25, 2008

TESAMORELIN ACETATE

POWDER;SUBCUTANEOUS

EGRIFTA

+! THERATECHNOLOGIES EQ 1MG BASE/VIAL N022505 001 Nov 10, 2010

+! EQ 2MG BASE/VIAL N022505 002 Nov 29, 2011

TESTOSTERONE

FILM, EXTENDED RELEASE;TRANSDERMAL

ANDRODERM

+! ALLERGAN SALES LLC 2MG/24HR N020489 003 Oct 20, 2011

+! 4MG/24HR N020489 004 Oct 20, 2011

GEL;TRANSDERMAL

ANDROGEL

AB1 + ABBVIE 25MG/2.5GM PACKET N021015 001 Feb 28, 2000

AB1 +! 50MG/5GM PACKET N021015 002 Feb 28, 2000

TESTOSTERONE

AB1 ACTAVIS LABS UT INC 25MG/2.5GM PACKET A076737 001 Jan 27, 2006

AB1 50MG/5GM PACKET A076737 002 Jan 27, 2006

AB1 PAR PHARM 25MG/2.5GM PACKET A076744 001 May 23, 2007

AB1 50MG/5GM PACKET A076744 002 May 23, 2007

ANDROGEL

AB2 + ABBVIE 1.62% (20.25MG/1.25GM PACKET) N022309 002 Sep 07, 2012

AB2 +! 1.62% (40.5MG/2.5GM PACKET) N022309 003 Sep 07, 2012

TESTIM

AB2 +! AUXILIUM PHARMS LLC 50MG/5GM PACKET N021454 001 Oct 31, 2002

TESTOSTERONE

AB2 ACTAVIS LABS UT INC 50MG/5GM PACKET A091073 001 Sep 18, 2017

AB2 PERRIGO UK FINCO 1.62% (20.25MG/1.25GM PACKET) A205781 001 Jul 12, 2017

AB2 1.62% (40.5MG/2.5GM PACKET) A205781 002 Jul 12, 2017

VOGELXO

AB2 UPSHER SMITH LABS 50MG/5GM PACKET N204399 002 Jun 04, 2014

GEL, METERED;NASAL

NATESTO

AYTU 5.5MG/0.122GM ACTUATION N205488 001 May 28, 2014

GEL, METERED;TRANSDERMAL

ANDROGEL

AB +! ABBVIE 1.62% (20.25MG/1.25GM ACTUATION) N022309 001 Apr 29, 2011

AB +! 12.5MG/1.25GM ACTUATION N021015 003 Sep 26, 2003

FORTESTA

AB +! ENDO PHARMS 10MG/0.5GM ACTUATION N021463 001 Dec 29, 2010

TESTOSTERONE

AB ACTAVIS LABS UT INC 10MG/0.5GM ACTUATION A204571 001 Aug 05, 2015

AB 12.5MG/1.25GM ACTUATION A076737 003 Mar 09, 2015

AB PERRIGO ISRAEL 1.62% (20.25MG/1.25GM ACTUATION) A204268 001 Aug 04, 2015

VOGELXO

BX UPSHER SMITH LABS 12.5MG/1.25GM ACTUATION N204399 003 Jun 04, 2014

PELLET;IMPLANTATION

TESTOPEL

! AUXILIUM PHARMS INC 75MG A080911 001

SOLUTION, METERED;TRANSDERMAL

TESTOSTERONE

AT ACTAVIS LABS UT INC 30MG/1.5ML ACTUATION A205328 001 Aug 07, 2017

AT CIPLA 30MG/1.5ML ACTUATION A209533 001 Jan 29, 2018

AT LUPIN LTD 30MG/1.5ML ACTUATION A208061 001 Oct 23, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-419(of 452)

TESTOSTERONE

SOLUTION, METERED;TRANSDERMAL

TESTOSTERONE

AT ! PERRIGO ISRAEL 30MG/1.5ML ACTUATION A204255 001 Feb 28, 2017

TABLET, EXTENDED RELEASE;BUCCAL

STRIANT

+! AUXILIUM PHARMS LLC 30MG N021543 001 Jun 19, 2003

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTOSTERONE

AO ! PHARMACIA AND 100MG/ML A085635 002

UPJOHN

AO ! 200MG/ML A085635 003

TESTOSTERONE CYPIONATE

AO CIPLA 100MG/ML A210362 001 Jun 19, 2018

AO 200MG/ML A210362 002 Jun 19, 2018

AO HIKMA FARMACEUTICA 200MG/ML A091244 001 May 01, 2012

AO LUITPOLD 200MG/ML A207742 001 Jun 16, 2017

AO MYLAN INSTITUTIONAL 200MG/ML A040652 001 Dec 11, 2006

AO PADDOCK LLC 200MG/ML A040530 001 Jan 31, 2005

AO SANDOZ INC 100MG/ML A040615 001 Aug 10, 2006

AO 200MG/ML A040615 002 Aug 10, 2006

AO SUN PHARM INDS LTD 100MG/ML A201720 001 Jun 03, 2013

AO 200MG/ML A201720 002 Jun 03, 2013

AO WATSON PHARMS INC 200MG/ML A086030 001



AO WEST-WARD PHARMS 100MG/ML A090387 001 Jul 15, 2010

INT

AO 200MG/ML A090387 002 Jul 15, 2010

TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

TESTOSTERONE ENANTHATE

AO HIKMA FARMACEUTICA 200MG/ML A091120 001 Sep 18, 2012

AO NEXUS PHARMS 200MG/ML A040575 001 Jun 14, 2006

AO ! WATSON PHARMS INC 200MG/ML A085598 001



SOLUTION;SUBCUTANEOUS

XYOSTED (AUTOINJECTOR)

+! ANTARES PHARMA INC 50MG/0.5ML (50MG/0.5ML) N209863 001 Sep 28, 2018

+! 75MG/0.5ML (75MG/0.5ML) N209863 002 Sep 28, 2018

+! 100MG/0.5ML (100MG/0.5ML) N209863 003 Sep 28, 2018



TESTOSTERONE UNDECANOATE

INJECTABLE;INTRAMUSCULAR

AVEED

+! ENDO PHARMS INC 750MG/3ML (250MG/ML) N022219 001 Mar 05, 2014

TETRABENAZINE

TABLET;ORAL

TETRABENAZINE

AB ACTAVIS LABS FL INC 25MG A206686 001 Jul 07, 2017

AB APICORE US 12.5MG A207682 001 Jan 31, 2017

AB 25MG A207682 002 Jan 31, 2017

AB BIONPHARMA INC 12.5MG A208826 001 Dec 18, 2017

AB 25MG A208826 002 Dec 18, 2017

AB DR REDDYS LABS LTD 12.5MG A209284 001 Jan 08, 2018

AB 25MG A209284 002 Jan 08, 2018

AB HETERO LABS LTD V 12.5MG A204574 001 Feb 03, 2016

AB 25MG A204574 002 Feb 03, 2016

AB LUPIN LTD 12.5MG A210544 001 Apr 20, 2018

AB 25MG A210544 002 Apr 20, 2018

AB SUN PHARMA GLOBAL 12.5MG A206129 001 Aug 17, 2015

AB 25MG A206129 002 Aug 17, 2015

XENAZINE

AB + VALEANT PHARMS 12.5MG N021894 001 Aug 15, 2008

NORTH

AB +! 25MG N021894 002 Aug 15, 2008

TETRACAINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC

TETRACAINE HYDROCHLORIDE

+! ALCON LABS 0.5% N208135 001 Feb 29, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-420(of 452)

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

ACHROMYCIN V

AB + HERITAGE PHARMS INC 250MG N050278 003

AB +! 500MG N050278 001

TETRACYCLINE HYDROCHLORIDE

AB AMNEAL PHARMS NY 250MG A210674 001 Sep 18, 2018

AB 500MG A210674 002 Sep 18, 2018

AB BRECKENRIDGE PHARM 250MG A210662 001 Nov 07, 2018

AB 500MG A210662 002 Nov 07, 2018

AB CHARTWELL TETRA 250MG A062752 001 Aug 12, 1988

AB 500MG A062752 002 Aug 12, 1988

AB WATSON LABS 250MG A061837 001



AB 500MG A061837 002

TETRAHYDROZOLINE HYDROCHLORIDE

SOLUTION;NASAL

TYZINE

! FOUGERA PHARMS 0.05% A086576 002

0.1% A086576 001

SPRAY;NASAL

TYZINE

! FOUGERA PHARMS 0.1% A086576 003

THALIDOMIDE

CAPSULE;ORAL

THALOMID

+ CELGENE 50MG N020785 001 Jul 16, 1998

+ 100MG N020785 002 Jan 17, 2003

+ 150MG N020785 004 Jan 10, 2007

+! 200MG N020785 003 Jan 17, 2003

THALLOUS CHLORIDE TL-201

INJECTABLE;INJECTION

THALLOUS CHLORIDE TL 201



AP +! GE HEALTHCARE 1mCi/ML N018110 002 Feb 27, 1996

AP +! LANTHEUS MEDCL 1mCi/ML N017806 001



AP +! MALLINKRODT NUCLEAR 1mCi/ML N018150 001

THEOPHYLLINE

CAPSULE, EXTENDED RELEASE;ORAL

THEO-24

ACTIENT PHARMS 100MG A087942 001 Aug 22, 1983

! AUXILIUM PHARMS INC 400MG A081034 001 Feb 28, 1992



AUXILIUM PHARMS LLC 200MG A087943 001 Aug 22, 1983

300MG A087944 001 Aug 22, 1983

INJECTABLE;INJECTION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

+! B BRAUN 40MG/100ML N019826 001 Aug 14, 1992

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER



+! B BRAUN 80MG/100ML N019826 002 Aug 14, 1992

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER



+! B BRAUN 160MG/100ML N019826 003 Aug 14, 1992

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER



+! B BRAUN 320MG/100ML N019826 006 Aug 14, 1992

SOLUTION;ORAL

THEOPHYLLINE

AA ! LANNETT CO INC 80MG/15ML A091156 001 Apr 13, 2011

AA TRIS PHARMA INC 80MG/15ML A091586 001 Jun 15, 2012



SOLUTION, ELIXIR;ORAL

ELIXOPHYLLIN

AA ! NOSTRUM LABS INC 80MG/15ML A085186 001

THEOPHYLLINE

AA PHARM ASSOC 80MG/15ML A206344 001 Dec 16, 2016

TABLET, EXTENDED RELEASE;ORAL

THEOCHRON

AB NOSTRUM PHARMS LLC 100MG A087400 003 Feb 21, 1985

AB 200MG A087400 004 Feb 21, 1985

THEOPHYLLINE

AB ALEMBIC PHARMS LTD 300MG A090430 001 Oct 27, 2010

AB GLENMARK GENERICS 400MG A090355 001 Jul 13, 2010

AB 600MG A090355 002 Jul 13, 2010

AB MYLAN IRELAND LTD 400MG A040560 003 Apr 21, 2006

AB ! 600MG A040560 002 Apr 21, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-421(of 452)

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL

THEOPHYLLINE

AB ! PLIVA 100MG A089807 001 Apr 30, 1990

AB ! 200MG A089808 001 Apr 30, 1990

AB 300MG A089763 001 Apr 30, 1990

AB RHODES PHARMS 400MG A087571 001 Sep 01, 1982

AB 600MG A040086 001 Apr 15, 1996

! ALEMBIC PHARMS LTD 450MG A090430 002 Oct 27, 2010



THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

THIAMINE HYDROCHLORIDE

AP ! FRESENIUS KABI USA 100MG/ML A080556 001

AP MYLAN INSTITUTIONAL 100MG/ML A091623 001 Jun 25, 2012

AP SAGENT PHARMS 100MG/ML A206106 001 Dec 01, 2017



THIOGUANINE

TABLET;ORAL

THIOGUANINE

+! ASPEN GLOBAL INC 40MG N012429 001

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

THIORIDAZINE HYDROCHLORIDE

AB MYLAN 10MG A088004 002 Mar 15, 1983

AB 25MG A088004 003 Mar 15, 1983

AB 50MG A088004 004 Mar 15, 1983

AB ! 100MG A088004 001 Nov 18, 1983

AB SUN PHARM 10MG A089953 004 Aug 01, 1986

INDUSTRIES

AB 25MG A089953 003 Aug 01, 1986

AB 50MG A089953 002 Aug 01, 1986

AB 100MG A089953 001 Oct 07, 1988



THIOTEPA

INJECTABLE;INJECTION

THIOTEPA

AP DR REDDYS LABS LTD 15MG/VIAL A210337 001 May 04, 2018

AP JIANGSU HENGRUI MED 15MG/VIAL A209150 001 May 04, 2018

AP ! WEST-WARD PHARMS 15MG/VIAL A075547 001 Apr 02, 2001

INT

POWDER;INTRAVENOUS

TEPADINA

+! ADIENNE SA 15MG/VIAL N208264 001 Jan 26, 2017

+! 100MG/VIAL N208264 002 Jan 26, 2017

THIOTHIXENE

CAPSULE;ORAL

THIOTHIXENE

MYLAN 1MG A071093 002 Jun 23, 1987

2MG A071093 003 Jun 23, 1987

! 5MG A071093 004 Jun 23, 1987

10MG A071093 001 Jun 23, 1987

THYROTROPIN ALFA

INJECTABLE;INJECTION

THYROGEN

+! GENZYME 1.1MG/VIAL N020898 001 Nov 30, 1998

TIAGABINE HYDROCHLORIDE

TABLET;ORAL

GABITRIL

AB + CEPHALON 2MG N020646 005 Apr 16, 1999

AB +! 4MG N020646 001 Sep 30, 1997

AB + 12MG N020646 002 Sep 30, 1997

AB + 16MG N020646 003 Sep 30, 1997

TIAGABINE HYDROCHLORIDE

AB AMNEAL PHARMS CO 2MG A208181 001 Dec 08, 2017

AB 4MG A208181 002 Dec 08, 2017

AB 12MG A208181 003 Dec 08, 2017

AB 16MG A208181 004 Dec 08, 2017

AB SUN PHARM INDS 2MG A077555 001 Nov 04, 2011

AB 4MG A077555 002 Nov 04, 2011

AB WILSHIRE PHARMS INC 2MG A206857 001 Oct 13, 2017

AB 4MG A206857 002 Oct 13, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-422(of 452)

TIAGABINE HYDROCHLORIDE

TABLET;ORAL

TIAGABINE HYDROCHLORIDE

AB 12MG A206857 003 Oct 13, 2017

AB 16MG A206857 004 Oct 13, 2017



TICAGRELOR

TABLET;ORAL

BRILINTA

AB + ASTRAZENECA PHARMS 60MG N022433 002 Sep 03, 2015

AB +! 90MG N022433 001 Jul 20, 2011

TICAGRELOR

AB WATSON LABS INC 60MG A208390 001 Sep 04, 2018

AB 90MG A208390 002 Sep 04, 2018



TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLOPIDINE HYDROCHLORIDE

AB APOTEX 250MG A075089 001 Jul 01, 1999

AB SUN PHARM INDS INC 250MG A075526 001 Sep 26, 2002

AB ! TEVA 250MG A075149 001 Aug 20, 1999



TIGECYCLINE

POWDER;INTRAVENOUS

TIGECYCLINE

AP AMNEAL PHARMS LLC 50MG/VIAL N211158 001 Aug 02, 2018

AP APOTEX INC 50MG/VIAL A204439 001 Dec 21, 2018

AP FRESENIUS KABI USA 50MG/VIAL N205645 001 Dec 01, 2016

AP SANDOZ INC 50MG/VIAL A091620 001 May 27, 2015

TYGACIL

AP +! PF PRISM CV 50MG/VIAL N021821 001 Jun 15, 2005

TIGECYCLINE

ACCORD HLTHCARE INC 50MG/VIAL N208744 001 Jan 18, 2018

TIMOLOL

SOLUTION/DROPS;OPHTHALMIC

BETIMOL

AT +! OAK PHARMS INC EQ 0.25% BASE N020439 001 Mar 31, 1995

AT +! EQ 0.5% BASE N020439 002 Mar 31, 1995

TIMOLOL

AT AKORN EQ 0.25% BASE A205309 001 Sep 30, 2016

AT EQ 0.5% BASE A205309 002 Sep 30, 2016



TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AB SANDOZ INC EQ 0.25% BASE N020963 001 Oct 21, 1998

AB EQ 0.5% BASE N020963 002 Oct 21, 1998

TIMOPTIC-XE

AB +! VALEANT PHARMS LLC EQ 0.25% BASE N020330 001 Nov 04, 1993

AB +! EQ 0.5% BASE N020330 002 Nov 04, 1993



SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AT BAUSCH AND LOMB EQ 0.25% BASE A074778 001 Mar 25, 1997

AT FDC LTD EQ 0.25% BASE A077259 001 Apr 30, 2008

AT PACIFIC PHARMA EQ 0.25% BASE A074746 001 Mar 25, 1997

AT ! SANDOZ INC EQ 0.25% BASE A074261 001 Apr 28, 1995

AT WOCKHARDT EQ 0.25% BASE A078771 001 Sep 28, 2009

TIMOPTIC

AT + ATON EQ 0.25% BASE N018086 001

TIMOLOL MALEATE

AT1 AKORN EQ 0.5% BASE A074466 001 Mar 25, 1997

AT1 EQ 0.5% BASE A074516 001 Mar 25, 1997

AT1 BAUSCH AND LOMB EQ 0.5% BASE A074776 001 Mar 25, 1997

AT1 FDC LTD EQ 0.5% BASE A077259 002 Apr 30, 2008

AT1 HI TECH PHARMA EQ 0.5% BASE A075163 001 Sep 10, 2002

AT1 PACIFIC PHARMA EQ 0.5% BASE A074747 001 Mar 25, 1997

AT1 ! SANDOZ INC EQ 0.5% BASE A074262 001 Apr 28, 1995

AT1 WOCKHARDT EQ 0.5% BASE A078771 002 Sep 28, 2009

TIMOPTIC

AT1 + ATON EQ 0.5% BASE N018086 002

ISTALOL

AT2 +! BAUSCH AND LOMB EQ 0.5% BASE N021516 001 Jun 04, 2004

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-423(of 452)

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AT2 APOTEX INC EQ 0.5% BASE A204936 001 Apr 17, 2015

TIMOPTIC IN OCUDOSE

+! ATON EQ 0.25% BASE N019463 001 Nov 05, 1986

+! EQ 0.5% BASE N019463 002 Nov 05, 1986

TABLET;ORAL

TIMOLOL MALEATE

MYLAN 5MG A072668 002 Jun 08, 1990

10MG A072668 003 Jun 08, 1990

! 20MG A072668 001 Jun 08, 1990

TINIDAZOLE

TABLET;ORAL

TINDAMAX

AB + MISSION PHARMA 250MG N021618 001 May 17, 2004

AB +! 500MG N021618 002 May 17, 2004

TINIDAZOLE

AB EDENBRIDGE PHARMS 250MG A203808 001 Aug 04, 2015

AB 500MG A203808 002 Aug 04, 2015

AB NOVEL LABS INC 250MG A202044 001 Apr 30, 2012

AB 500MG A202044 002 Apr 30, 2012

AB UNIQUE PHARM LABS 250MG A202489 001 Oct 09, 2013

AB 500MG A202489 002 Oct 09, 2013

AB WEST-WARD PHARMS 250MG A201172 001 Apr 30, 2012

INT

AB 500MG A201172 002 Apr 30, 2012

TIOPRONIN

TABLET;ORAL

THIOLA

+! MISSION PHARMA 100MG N019569 001 Aug 11, 1988

TIOTROPIUM BROMIDE

POWDER;INHALATION

SPIRIVA

+! BOEHRINGER EQ 0.018MG BASE/INH N021395 001 Jan 30, 2004

INGELHEIM

SPRAY, METERED;INHALATION

SPIRIVA RESPIMAT

+ BOEHRINGER EQ 0.00125MG BASE/INH N021936 002 Sep 15, 2015

INGELHEIM

+! EQ 0.0025MG BASE/INH N021936 001 Sep 24, 2014

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

TABLET;ORAL

LONSURF

+ TAIHO ONCOLOGY EQ 6.14MG BASE;15MG N207981 001 Sep 22, 2015

+! EQ 8.19MG BASE;20MG N207981 002 Sep 22, 2015



TIPRANAVIR

CAPSULE;ORAL

APTIVUS

+! BOEHRINGER 250MG N021814 001 Jun 22, 2005

INGELHEIM

SOLUTION;ORAL

APTIVUS

+! BOEHRINGER 100MG/ML N022292 001 Jun 23, 2008

INGELHEIM

TIROFIBAN HYDROCHLORIDE

INJECTABLE;INJECTION

AGGRASTAT

+ MEDICURE EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) N020913 002 May 17, 2002

+! EQ 12.5MG BASE/250ML (EQ 0.05MG N020913 003 Apr 20, 2000

BASE/ML)

SOLUTION;INJECTION

AGGRASTAT

+! MEDICURE EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) N020912 002 Aug 31, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-424(of 452)

TIZANIDINE HYDROCHLORIDE

CAPSULE;ORAL

TIZANIDINE HYDROCHLORIDE

AB APOTEX INC EQ 2MG BASE A078868 001 Feb 03, 2012

AB EQ 4MG BASE A078868 002 Feb 03, 2012

AB EQ 6MG BASE A078868 003 Feb 03, 2012

AB JUBILANT GENERICS EQ 2MG BASE A209605 001 Aug 04, 2017

AB EQ 4MG BASE A209605 002 Aug 04, 2017

AB EQ 6MG BASE A209605 003 Aug 04, 2017

AB MYLAN PHARMS INC EQ 2MG BASE A091502 001 Nov 09, 2012

AB EQ 4MG BASE A091502 002 Nov 09, 2012

AB EQ 6MG BASE A091502 003 Nov 09, 2012

AB PAR PHARM INC EQ 2MG BASE A207199 001 Mar 14, 2017

AB EQ 4MG BASE A207199 002 Mar 14, 2017

AB EQ 6MG BASE A207199 003 Mar 14, 2017

AB ZYDUS PHARMS USA EQ 2MG BASE A208622 001 Mar 03, 2017

INC

AB EQ 4MG BASE A208622 002 Mar 03, 2017

AB EQ 6MG BASE A208622 003 Mar 03, 2017

ZANAFLEX

AB + COVIS PHARMA BV EQ 2MG BASE N021447 001 Aug 29, 2002

AB + EQ 4MG BASE N021447 002 Aug 29, 2002

AB +! EQ 6MG BASE N021447 003 Aug 29, 2002

TABLET;ORAL

TIZANIDINE HYDROCHLORIDE

AB APOTEX EQ 2MG BASE A076533 001 Jan 16, 2004

AB EQ 4MG BASE A076533 002 Jan 16, 2004

AB CASI PHARMS INC EQ 2MG BASE A076280 001 Nov 26, 2002

AB EQ 4MG BASE A076280 002 Jun 27, 2002

AB DR REDDYS LABS INC EQ 2MG BASE A076286 001 Jul 03, 2002

AB EQ 4MG BASE A076286 002 Jul 03, 2002

AB EPIC PHARMA LLC EQ 2MG BASE A076347 001 Oct 11, 2002

AB EQ 4MG BASE A076347 002 Oct 11, 2002

AB MYLAN EQ 2MG BASE A076354 001 Mar 28, 2003

AB EQ 4MG BASE A076354 002 Mar 28, 2003

AB OXFORD PHARMS EQ 2MG BASE A076281 001 Oct 20, 2003

AB EQ 4MG BASE A076281 002 Oct 20, 2003

AB PAR PHARM INC EQ 2MG BASE A207170 001 Jan 26, 2017

AB EQ 4MG BASE A207170 002 Jan 26, 2017

AB SUN PHARM INDS INC EQ 2MG BASE A076416 001 Sep 29, 2003

AB EQ 4MG BASE A076416 002 Sep 29, 2003

AB TEVA EQ 2MG BASE A076284 001 Jul 03, 2002

AB EQ 4MG BASE A076284 002 Jul 03, 2002

AB UNICHEM LABS LTD EQ 2MG BASE A091283 001 Nov 28, 2012

AB EQ 4MG BASE A091283 002 Nov 28, 2012

AB ZYDUS PHARMS USA EQ 2MG BASE A208187 001 Mar 09, 2018

INC

AB EQ 4MG BASE A208187 002 Mar 09, 2018

ZANAFLEX

AB +! COVIS PHARMA BV EQ 4MG BASE N020397 001 Nov 27, 1996

TOBRAMYCIN

OINTMENT;OPHTHALMIC

TOBREX

+! NOVARTIS PHARMS 0.3% N050555 001

CORP

POWDER;INHALATION

TOBI PODHALER

+! MYLAN SPECIALITY LP 28MG N201688 001 Mar 22, 2013

SOLUTION;INHALATION

KITABIS PAK

AN PULMOFLOW INC 300MG/5ML N205433 001 Dec 02, 2014

TOBI

AN +! MYLAN SPECIALITY LP 300MG/5ML N050753 001 Dec 22, 1997

TOBRAMYCIN

AN AKORN INC 300MG/5ML A201422 001 May 28, 2014

AN AMNEAL PHARMS 300MG/5ML A205501 001 Jul 13, 2015

AN DR REDDYS LABS SA 300MG/5ML A207080 001 Jul 09, 2018

AN LUPIN 300MG/5ML A208964 001 Mar 22, 2017

AN MYLAN PHARMS INC 300MG/5ML A209554 001 Oct 13, 2017

AN TEVA PHARMS USA 300MG/5ML A091589 001 Oct 10, 2013



BETHKIS

+! CHIESI USA INC 300MG/4ML N201820 001 Oct 12, 2012

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-425(of 452)

TOBRAMYCIN

SOLUTION/DROPS;OPHTHALMIC

AKTOB

AT AKORN 0.3% A064096 001 Jan 31, 1996

TOBRAMYCIN

AT BAUSCH AND LOMB 0.3% A064052 001 Nov 29, 1993

AT FERA PHARMS 0.3% A065026 001 Sep 11, 2001

AT SOMERSET THERAPS 0.3% A207444 001 Jun 28, 2017

LLC

TOBREX

AT +! NOVARTIS PHARMS 0.3% N050541 001

CORP

AT SANDOZ INC 0.3% A062535 001 Dec 13, 1984

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

TOBRAMYCIN SULFATE

AP AKORN EQ 40MG BASE/ML A205179 001 Sep 16, 2014

AP BAXTER HLTHCARE EQ 40MG BASE/ML A206965 001 Jul 01, 2016

CORP

AP FRESENIUS KABI USA EQ 10MG BASE/ML A065122 001 Nov 29, 2002

AP ! EQ 40MG BASE/ML A065122 002 Nov 29, 2002

AP EQ 1.2GM BASE/VIAL N050789 001 Jul 13, 2004

AP ! HOSPIRA EQ 10MG BASE/ML A063112 001 Apr 30, 1991

AP EQ 40MG BASE/ML A063111 001 Apr 30, 1991

AP MYLAN LABS LTD EQ 40MG BASE/ML A065407 001 Mar 11, 2008

AP TEVA PHARMS USA EQ 40MG BASE/ML A063100 001 Jan 30, 1992

AP WEST-WARD PHARMS EQ 40MG BASE/ML A063117 001 Apr 26, 1991

INT

AP ! X GEN PHARMS EQ 1.2GM BASE/VIAL A065013 001 Aug 17, 2001

AP XELLIA PHARMS APS EQ 1.2GM BASE/VIAL A205685 001 Sep 16, 2014

TOBRAMYCIN SULFATE (PHARMACY BULK)

! FRESENIUS KABI USA EQ 40MG BASE/ML A065120 001 Nov 29, 2002

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

! HOSPIRA EQ 1.2MG BASE/ML A063081 003 Jul 31, 1990

! EQ 1.6MG BASE/ML A063081 006 Jun 02, 1993

! EQ 80MG BASE/100ML A063081 001 Jul 31, 1990

TOFACITINIB CITRATE

TABLET;ORAL

XELJANZ

+! PF PRISM CV EQ 5MG BASE N203214 001 Nov 06, 2012

+! EQ 10MG BASE N203214 002 May 30, 2018

TABLET, EXTENDED RELEASE;ORAL



XELJANZ XR

+! PFIZER INC EQ 11MG BASE N208246 001 Feb 23, 2016

TOLAZAMIDE

TABLET;ORAL

TOLAZAMIDE

MYLAN PHARMS INC 250MG A070259 001 Jan 02, 1986

! 500MG A070259 003 Mar 17, 1986

TOLBUTAMIDE

TABLET;ORAL

TOLBUTAMIDE

! MYLAN PHARMS INC 500MG A086445 001

TOLCAPONE

TABLET;ORAL

TASMAR

AB +! VALEANT PHARMS LLC 100MG N020697 001 Jan 29, 1998

TOLCAPONE

AB INGENUS PHARMS LLC 100MG A208937 001 Aug 07, 2018

AB PAR PHARM INC 100MG A204584 001 Mar 26, 2015



TOLMETIN SODIUM

CAPSULE;ORAL

TOLMETIN SODIUM

AB MYLAN EQ 400MG BASE A073393 001 May 27, 1993

AB ! TEVA EQ 400MG BASE A073290 001 Nov 27, 1991



TABLET;ORAL

TOLMETIN SODIUM

! MYLAN EQ 600MG BASE A074473 001 Aug 30, 1994

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-426(of 452)

TOLTERODINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

DETROL LA

AB + PHARMACIA AND 2MG N021228 001 Dec 22, 2000

UPJOHN

AB +! 4MG N021228 002 Dec 22, 2000

TOLTERODINE TARTRATE

AB HETERO LABS LTD III 2MG A206419 001 Dec 12, 2017

AB 4MG A206419 002 Dec 12, 2017

AB MYLAN PHARMS INC 2MG A201486 001 Oct 31, 2013

AB 4MG A201486 002 Oct 31, 2013

AB TEVA PHARMS USA 2MG A079141 001 Nov 22, 2016

AB 4MG A079141 002 Nov 22, 2016

AB TORRENT PHARMS LTD 2MG A203016 001 Aug 11, 2015

AB 4MG A203016 002 Aug 11, 2015

TABLET;ORAL

DETROL

AB + PHARMACIA AND 1MG N020771 001 Mar 25, 1998

UPJOHN

AB +! 2MG N020771 002 Mar 25, 1998

TOLTERODINE TARTRATE

AB IVAX SUB TEVA 1MG A077006 001 Feb 23, 2015

PHARMS

AB 2MG A077006 002 Feb 23, 2015

AB MACLEODS PHARMS LTD 1MG A203409 001 Aug 31, 2015

AB 2MG A203409 002 Aug 31, 2015

AB MYLAN PHARMS INC 1MG A202641 001 Nov 27, 2012

AB 2MG A202641 002 Nov 27, 2012



TOLVAPTAN

TABLET;ORAL

JYNARQUE

+ OTSUKA PHARM CO LTD 15MG N204441 001 Apr 23, 2018

+ 30MG N204441 002 Apr 23, 2018

+ 45MG N204441 003 Apr 23, 2018

+ 60MG N204441 004 Apr 23, 2018

+! 90MG N204441 005 Apr 23, 2018

SAMSCA

+ OTSUKA AMERICA 15MG N022275 001 May 19, 2009

PHARM

+! 30MG N022275 002 May 19, 2009

TOPIRAMATE

CAPSULE;ORAL

TOPAMAX

AB + JANSSEN PHARMS 15MG N020844 001 Oct 26, 1998

AB +! 25MG N020844 002 Oct 26, 1998

TOPIRAMATE

AB TEVA 15MG A076575 001 Apr 17, 2009

AB 25MG A076575 002 Apr 17, 2009

AB WATSON LABS 15MG A077868 001 Apr 15, 2009

AB 25MG A077868 002 Apr 15, 2009

AB ZYDUS PHARMS USA 15MG A078877 001 Oct 14, 2009

INC

AB 25MG A078877 002 Oct 14, 2009

CAPSULE, EXTENDED RELEASE;ORAL

TOPIRAMATE

AB ZYDUS PHARMS USA 25MG A207382 001 Nov 24, 2017

INC

AB 50MG A207382 002 Nov 24, 2017

AB 100MG A207382 003 Nov 24, 2017

TROKENDI XR

AB + SUPERNUS PHARMS 25MG N201635 001 Aug 16, 2013

AB + 50MG N201635 002 Aug 16, 2013

AB + 100MG N201635 003 Aug 16, 2013

QUDEXY XR

+ UPSHER SMITH LABS 25MG N205122 001 Mar 11, 2014

+ 50MG N205122 002 Mar 11, 2014

+ 100MG N205122 003 Mar 11, 2014

+ 150MG N205122 004 Mar 11, 2014

+! 200MG N205122 005 Mar 11, 2014

TROKENDI XR

+! SUPERNUS PHARMS 200MG N201635 004 Aug 16, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-427(of 452)

TOPIRAMATE

TABLET;ORAL

TOPAMAX

AB + JANSSEN PHARMS 25MG N020505 004 Dec 24, 1996

AB + 50MG N020505 005 Dec 24, 1996

AB +! 100MG N020505 001 Dec 24, 1996

AB + 200MG N020505 002 Dec 24, 1996

TOPIRAMATE

AB ACCORD HLTHCARE 25MG A076311 001 Mar 27, 2009

AB 50MG A076311 002 Mar 27, 2009

AB 100MG A076311 003 Mar 27, 2009

AB 200MG A076311 004 Mar 27, 2009

AB APOTEX INC 25MG A077733 001 Mar 27, 2009

AB 50MG A077733 002 Mar 27, 2009

AB 100MG A077733 003 Mar 27, 2009

AB 200MG A077733 004 Mar 27, 2009

AB AUROBINDO PHARMA 25MG A078462 001 Mar 27, 2009

AB 50MG A078462 002 Mar 27, 2009

AB 100MG A078462 003 Mar 27, 2009

AB 200MG A078462 004 Mar 27, 2009

AB CIPLA LTD 25MG A076343 001 Mar 27, 2009

AB 50MG A076343 002 Mar 27, 2009

AB 100MG A076343 003 Mar 27, 2009

AB 200MG A076343 004 Mar 27, 2009

AB GLENMARK GENERICS 25MG A077627 001 Mar 27, 2009

AB 50MG A077627 002 Mar 27, 2009

AB 100MG A077627 003 Mar 27, 2009

AB 200MG A077627 004 Mar 27, 2009

AB INVAGEN PHARMS 25MG A079162 001 Mar 27, 2009

AB 50MG A079162 002 Mar 27, 2009

AB 100MG A079162 003 Mar 27, 2009

AB 200MG A079162 004 Mar 27, 2009

AB LUPIN 25MG A078410 001 Sep 11, 2013

AB 50MG A078410 002 Sep 11, 2013

AB 100MG A078410 003 Sep 11, 2013

AB 200MG A078410 004 Sep 11, 2013

AB SUN PHARM INDS LTD 25MG A076327 001 Mar 27, 2009

AB 100MG A076327 002 Mar 27, 2009

AB 200MG A076327 003 Mar 27, 2009

AB SUN PHARMA GLOBAL 25MG A090278 001 Mar 27, 2009

AB 50MG A090278 002 Mar 27, 2009

AB 100MG A090278 003 Mar 27, 2009

AB 200MG A090278 004 Mar 27, 2009

AB TEVA 25MG A076317 001 Mar 27, 2009

AB 50MG A076317 002 Mar 27, 2009

AB 100MG A076317 003 Mar 27, 2009

AB 200MG A076317 004 Mar 27, 2009

AB TORRENT PHARMS 25MG A079153 001 Mar 27, 2009

AB 50MG A079153 002 Mar 27, 2009

AB 100MG A079153 003 Mar 27, 2009

AB 200MG A079153 004 Mar 27, 2009

AB UNICHEM LABS LTD 25MG A090162 001 Mar 27, 2009

AB 50MG A090162 002 Mar 27, 2009

AB 100MG A090162 003 Mar 27, 2009

AB 200MG A090162 004 Feb 19, 2013

AB UPSHER SMITH LABS 25MG A078499 001 Jan 07, 2010

AB 50MG A078499 002 Jan 07, 2010

AB 100MG A078499 003 Jan 07, 2010

AB 200MG A078499 004 Jan 07, 2010

AB ZYDUS PHARMS USA 25MG A078235 001 Mar 27, 2009

INC

AB 50MG A078235 002 Mar 27, 2009

AB 100MG A078235 003 Mar 27, 2009

AB 200MG A078235 004 Mar 27, 2009



TOPOTECAN HYDROCHLORIDE

CAPSULE;ORAL

HYCAMTIN

+ NOVARTIS PHARMS EQ 0.25MG BASE N020981 001 Oct 11, 2007

CORP

+! EQ 1MG BASE N020981 002 Oct 11, 2007

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-428(of 452)

TOPOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

HYCAMTIN

AP +! NOVARTIS PHARMS EQ 4MG BASE/VIAL N020671 001 May 28, 1996

CORP

TOPOTECAN HYDROCHLORIDE

AP ACCORD HLTHCARE EQ 4MG BASE/VIAL A202351 001 Jun 26, 2013

AP ACTAVIS TOTOWA EQ 4MG BASE/VIAL A090620 001 Dec 02, 2010

AP CIPLA EQ 4MG BASE/VIAL A091199 001 Dec 01, 2010

AP DR REDDYS LABS LTD EQ 4MG BASE/VIAL A201191 001 Mar 09, 2011

AP FRESENIUS KABI USA EQ 4MG BASE/VIAL A091089 001 Nov 29, 2010

AP HONG KONG EQ 4MG BASE/VIAL A201166 001 Aug 08, 2012

AP MYLAN LABS LTD EQ 4MG BASE/VIAL A091542 001 Aug 28, 2012

AP NOVAST LABS EQ 4MG BASE/VIAL A206962 001 Nov 30, 2016

AP SAGENT PHARMS EQ 4MG BASE/VIAL A091284 001 Jan 26, 2011



SOLUTION;INTRAVENOUS

TOPOTECAN HYDROCHLORIDE

AP ACCORD HLTHCARE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A204406 002 Jul 06, 2017

AP +! HOSPIRA INC EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N200582 001 Feb 02, 2011

AP MYLAN LABS LTD EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A206074 001 Nov 24, 2017

AP TEVA PHARMS USA EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N022453 001 Dec 20, 2012

ACCORD HLTHCARE EQ 1MG BASE/ML (EQ 1MG BASE/ML) A204406 001 Jul 06, 2017

TOREMIFENE CITRATE

TABLET;ORAL

FARESTON

AB +! KYOWA KIRIN EQ 60MG BASE N020497 001 May 29, 1997

TOREMIFENE CITRATE

AB RISING PHARMS EQ 60MG BASE A208813 001 Dec 04, 2018

TORSEMIDE

TABLET;ORAL

DEMADEX

AB + MYLAN SPECIALITY LP 5MG N020136 001 Aug 23, 1993

AB + 10MG N020136 002 Aug 23, 1993

AB +! 20MG N020136 003 Aug 23, 1993

AB + 100MG N020136 004 Aug 23, 1993

TORSEMIDE

AB APOTEX INC 5MG A076894 001 May 31, 2005

AB 10MG A076894 002 May 31, 2005

AB 20MG A076894 003 May 31, 2005

AB 100MG A076894 004 May 31, 2005

AB AUROBINDO PHARMA 5MG A078249 001 Oct 17, 2007

AB 10MG A078249 002 Oct 17, 2007

AB 20MG A078249 003 Oct 17, 2007

AB 100MG A078249 004 Oct 17, 2007

AB HETERO LABS LTD III 5MG A079234 001 Jan 27, 2009

AB 10MG A079234 002 Jan 27, 2009

AB 20MG A079234 003 Jan 27, 2009

AB 100MG A079234 004 Jan 27, 2009

AB PAR PHARM 5MG A076226 001 May 27, 2003

AB 10MG A076226 002 May 27, 2003

AB 20MG A076226 003 May 27, 2003

AB 100MG A076226 004 May 27, 2003

AB PLIVA PHARM IND 5MG A076346 001 May 30, 2003

AB 10MG A076346 002 May 30, 2003

AB 20MG A076346 003 May 30, 2003

AB 100MG A076346 004 Oct 19, 2004

AB TEVA 5MG A076110 001 May 14, 2002

AB 10MG A076110 002 May 14, 2002

AB 20MG A076110 003 May 14, 2002

AB 100MG A076110 004 May 14, 2002

AB VINTAGE PHARMS 5MG A090613 001 Mar 22, 2011

AB 10MG A090613 002 Mar 22, 2011

AB 20MG A090613 003 Mar 22, 2011

AB 100MG A090613 004 Mar 22, 2011

AB WEST-WARD PHARMS 5MG A076943 001 Mar 01, 2005

INT

AB 10MG A076943 002 Mar 01, 2005

AB 20MG A076943 003 Mar 01, 2005



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-429(of 452)

TRABECTEDIN

POWDER;INTRAVENOUS

YONDELIS

+! JANSSEN PRODS 1MG/VIAL N207953 001 Oct 23, 2015

TRAMADOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CONZIP

+! CIPHER PHARMS INC 100MG N022370 001 May 07, 2010

+ 150MG N022370 004 Aug 01, 2011

+ 200MG N022370 002 May 07, 2010

+ 300MG N022370 003 May 07, 2010

TABLET;ORAL

TRAMADOL HYDROCHLORIDE

AB ACI HEALTHCARE LTD 50MG A202075 001 Nov 28, 2011

AB AMNEAL PHARMS 50MG A076003 001 Jun 20, 2002

AB APOTEX 50MG A075981 001 Jul 10, 2002

AB AUROBINDO PHARMA 50MG A203494 001 Mar 31, 2014

LTD

AB CSPC OUYI PHARM CO 50MG A091498 001 Mar 29, 2013

AB IPCA LABS LTD 50MG A201973 001 Nov 16, 2012

AB MACLEODS PHARMS LTD 50MG A205702 001 Sep 25, 2015

AB MYLAN 50MG A075986 001 Jun 21, 2002

AB PLIVA 50MG A075982 001 Jul 01, 2002

AB SPECGX LLC 50MG A075983 001 Jun 25, 2002

AB SUN PHARM INDS INC 50MG A075964 001 Jun 19, 2002

AB SUN PHARM 50MG A076100 001 Jun 20, 2002

INDUSTRIES

AB TEVA 50MG A075977 001 Jun 19, 2002

AB ZYDUS PHARMS USA 50MG A090404 001 Jan 31, 2011

INC

ULTRAM

AB +! JANSSEN PHARMS 50MG N020281 002 Mar 03, 1995

TABLET, EXTENDED RELEASE;ORAL

TRAMADOL HYDROCHLORIDE

AB1 AUROBINDO PHARMA 100MG A204421 001 Oct 20, 2015

LTD

AB1 200MG A204421 002 Oct 20, 2015

AB1 300MG A204421 003 Oct 20, 2015

AB1 ! LUPIN LTD 100MG A200503 001 Aug 29, 2011

AB1 200MG A200503 002 Aug 29, 2011

AB1 300MG A200503 003 Aug 29, 2011

AB1 MYLAN PHARMS INC 100MG A205257 001 Dec 22, 2015

AB1 200MG A205257 002 Dec 22, 2015

AB1 300MG A205257 003 Dec 22, 2015

AB1 PAR PHARM INC 100MG A078783 001 Nov 13, 2009

AB1 200MG A078783 002 Nov 13, 2009

AB1 300MG A078783 003 Sep 20, 2011

AB1 SUN PHARMA GLOBAL 100MG A201384 001 Dec 07, 2011

AB1 200MG A201384 002 Dec 07, 2011

AB1 300MG A201384 003 Dec 07, 2011

AB2 ACTAVIS ELIZABETH 100MG A091609 001 Jun 27, 2012

AB2 200MG A091609 002 Jun 27, 2012

AB2 300MG A091609 003 Jun 27, 2012

AB2 ANCHEN PHARMS 100MG A200491 001 Jun 27, 2012

AB2 200MG A200491 002 Jun 27, 2012

AB2 300MG A200491 003 Jun 27, 2012

AB2 ! SUN PHARMA GLOBAL 100MG A091607 001 Dec 30, 2011

AB2 200MG A091607 002 Dec 30, 2011

AB2 300MG A091607 003 Dec 30, 2011



TRAMETINIB DIMETHYL SULFOXIDE

TABLET;ORAL

MEKINIST

+ NOVARTIS PHARMS EQ 0.5MG N204114 001 May 29, 2013

CORP

+! EQ 2MG N204114 003 May 29, 2013

TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL

AB AUROBINDO PHARMA 1MG A078438 001 Jun 12, 2007

AB 2MG A078438 002 Jun 12, 2007

AB 4MG A078438 003 Jun 12, 2007

AB EPIC PHARMA 1MG A078508 003 Jun 18, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-430(of 452)

TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL

AB 2MG A078508 001 Jun 18, 2008

AB 4MG A078508 002 Jun 18, 2008

AB LUPIN 1MG A077522 001 Jun 12, 2007

AB 2MG A077522 002 Jun 12, 2007

AB ! 4MG A077522 003 Jun 12, 2007

AB TEVA PHARMS 1MG A077489 001 Dec 12, 2006

AB 2MG A077489 002 Dec 12, 2006

AB 4MG A077489 003 Dec 12, 2006



TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

TARKA

AB + ABBVIE 1MG;240MG N020591 003 Oct 22, 1996

AB + 2MG;180MG N020591 001 Oct 22, 1996

AB + 2MG;240MG N020591 004 Oct 22, 1996

AB +! 4MG;240MG N020591 002 Oct 22, 1996

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE



AB GLENMARK GENERICS 1MG;240MG A079135 004 Aug 30, 2010

AB 2MG;180MG A079135 001 May 26, 2010

AB 2MG;240MG A079135 002 May 26, 2010

AB 4MG;240MG A079135 003 May 05, 2010



TRANEXAMIC ACID

INJECTABLE;INJECTION

CYKLOKAPRON

AP +! PHARMACIA AND 100MG/ML N019281 001 Dec 30, 1986

UPJOHN

TRANEXAMIC ACID

AP ACIC PHARMS 100MG/ML A202436 001 Feb 11, 2014

AP AKORN 100MG/ML A202373 001 Nov 17, 2011

AP 100MG/ML A206594 001 Sep 28, 2017

AP 100MG/ML A206634 001 Jun 09, 2016

AP AMNEAL PHARMS CO 100MG/ML A208840 001 Feb 28, 2017

AP AUROBINDO PHARMA 100MG/ML A205035 001 Jan 14, 2016

LTD

AP EMCURE PHARMS LTD 100MG/ML A203521 001 Aug 12, 2014

AP FRESENIUS KABI USA 100MG/ML A091596 001 Mar 02, 2012

AP GLAND PHARMA LTD 100MG/ML A207239 001 Feb 13, 2017

AP LUITPOLD 100MG/ML A201885 001 Aug 10, 2011

AP MYLAN INSTITUTIONAL 100MG/ML A091657 001 Nov 03, 2011

AP VIRTUS PHARMS 100MG/ML A202755 001 Feb 25, 2016

AP VIVA HLTHCARE 100MG/ML A206713 001 Jun 27, 2017

AP X-GEN PHARMS INC 100MG/ML A201580 001 Jun 14, 2013

AP ZYDUS PHARMS USA 100MG/ML A205228 001 Jul 17, 2017

INC

TABLET;ORAL

LYSTEDA

AB +! FERRING PHARMS INC 650MG N022430 001 Nov 13, 2009

TRANEXAMIC ACID

AB ACTAVIS LABS FL INC 650MG A202093 001 Dec 27, 2012

AB APOTEX INC 650MG A202286 001 Jan 27, 2014

AB MYLAN 650MG A205133 001 Sep 21, 2015



TRANYLCYPROMINE SULFATE

TABLET;ORAL

PARNATE

AB +! CONCORDIA PHARMS EQ 10MG BASE N012342 003 Aug 16, 1985

INC

TRANYLCYPROMINE SULFATE

AB CNTY LINE PHARMS EQ 10MG BASE A206856 001 Apr 17, 2018

AB PAR PHARM EQ 10MG BASE A040640 001 Jun 29, 2006



TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

TRAVATAN Z

AT +! NOVARTIS PHARMS 0.004% N021994 001 Sep 21, 2006

CORP

TRAVOPROST

AT APOTEX INC 0.004% A203431 001 Jul 10, 2015

AT MYLAN PHARMS INC 0.004% A205050 001 Jul 07, 2017



! PAR PHARM 0.004% A091340 001 Mar 01, 2013

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-431(of 452)

TRAZODONE HYDROCHLORIDE

TABLET;ORAL

TRAZODONE HYDROCHLORIDE

AB ACCORD HLTHCARE 50MG A206923 001 Sep 08, 2017

AB 100MG A206923 002 Sep 08, 2017

AB 150MG A206923 003 Sep 08, 2017

AB 300MG A206923 004 Sep 08, 2017

AB ALVOGEN 50MG A071636 001 Apr 18, 1988

AB 100MG A071514 001 Apr 18, 1988

AB APOTEX 50MG A071258 001 Mar 25, 1987

AB ! APOTEX INC 100MG A071196 001 Mar 25, 1987

AB 150MG A071196 002 Apr 26, 1999

AB 300MG A071196 003 Apr 26, 1999

AB OXFORD PHARMS 50MG A072192 001 Feb 02, 1989

AB 100MG A072193 001 Feb 02, 1989

AB PLIVA 150MG A071525 001 Mar 09, 1988

AB SUN PHARM 50MG A073137 002 Mar 24, 1993

INDUSTRIES

AB 100MG A073137 001 Mar 24, 1993

AB 150MG A073137 003 Dec 22, 1995

AB TEVA PHARMS USA 50MG A071523 001 Dec 11, 1987

AB 100MG A071524 001 Dec 11, 1987

AB TORRENT PHARMS LTD 50MG A202180 001 Nov 27, 2013

AB 100MG A202180 002 Nov 27, 2013

AB 150MG A202180 003 Nov 27, 2013

AB 300MG A202180 004 Nov 27, 2013

AB ZYDUS PHARMS USA 50MG A205253 001 Oct 10, 2017

INC

AB 100MG A205253 002 Oct 10, 2017

AB 150MG A205253 003 Oct 10, 2017

AB 300MG A205253 004 Oct 10, 2017



TREPROSTINIL

INJECTABLE;IV (INFUSION), SUBCUTANEOUS

REMODULIN

AP +! UNITED THERAP 1MG/ML N021272 001 May 21, 2002

AP +! 2.5MG/ML N021272 002 May 21, 2002

AP +! 5MG/ML N021272 003 May 21, 2002

AP +! 10MG/ML N021272 004 May 21, 2002

TREPROSTINIL

AP SANDOZ INC 1MG/ML A203649 001 Nov 30, 2017

AP 2.5MG/ML A203649 002 Nov 30, 2017

AP 5MG/ML A203649 003 Nov 30, 2017

AP 10MG/ML A203649 004 Nov 30, 2017



SOLUTION;INHALATION

TYVASO

+! UNITED THERAP 0.6MG/ML N022387 001 Jul 30, 2009

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

REMODULIN

UNITED THERAP 20MG/20ML (1MG/ML) N208276 001 Jul 30, 2018

50MG/20ML (2.5MG/ML) N208276 002 Jul 30, 2018

100MG/20ML (5MG/ML) N208276 003 Jul 30, 2018

200MG/20ML (10MG/ML) N208276 004 Jul 30, 2018

TREPROSTINIL DIOLAMINE

TABLET, EXTENDED RELEASE;ORAL

ORENITRAM

+ UNITED THERAP EQ 0.125MG BASE N203496 001 Dec 20, 2013

+ EQ 0.25MG BASE N203496 002 Dec 20, 2013

+ EQ 1MG BASE N203496 003 Dec 20, 2013

+! EQ 2.5MG BASE N203496 004 Dec 20, 2013

+ EQ 5MG BASE N203496 005 Oct 07, 2016

TRETINOIN

CAPSULE;ORAL

TRETINOIN

AB ANCHEN PHARMS 10MG A201687 001 Oct 24, 2012

AB ! BARR LABS INC 10MG A077684 001 Jun 22, 2007

AB GLENMARK PHARMS LTD 10MG A208279 001 Dec 23, 2016



CREAM;TOPICAL

AVITA

AB MYLAN PHARMS INC 0.025% N020404 003 Jan 14, 1997

RETIN-A

AB +! VALEANT BERMUDA 0.025% N019049 001 Sep 16, 1988

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-432(of 452)

TRETINOIN

CREAM;TOPICAL

RETIN-A

AB +! VALEANT PHARMS 0.1% N017340 001

NORTH

TRETINOIN

AB PERRIGO PHARMA INTL 0.025% A075264 001 Dec 24, 1998

AB 0.1% A075213 001 Dec 24, 1998

RETIN-A

AB1 +! VALEANT BERMUDA 0.05% N017522 001

TRETINOIN

AB1 PERRIGO PHARMA INTL 0.05% A075265 001 Dec 24, 1998

RENOVA

AB2 +! VALEANT PHARMS 0.05% N019963 001 Dec 29, 1995

NORTH

TRETINOIN

AB2 ZO SKIN HEALTH 0.05% A076498 001 Sep 15, 2005

RENOVA

+! VALEANT PHARMS 0.02% N021108 001 Aug 31, 2000

NORTH

GEL;TOPICAL

ATRALIN

AB +! DOW PHARM 0.05% N022070 001 Jul 26, 2007

RETIN-A

AB +! VALEANT INTL 0.01% N017955 001

AB +! 0.025% N017579 002

RETIN-A MICRO

AB +! VALEANT INTL 0.04% N020475 002 May 10, 2002

AB +! 0.1% N020475 001 Feb 07, 1997

TRETINOIN

AB MYLAN PHARMS INC 0.04% A202567 001 Jul 17, 2013

AB 0.05% A207955 001 Aug 13, 2015

AB 0.1% A202026 001 Jul 17, 2013

AB PERRIGO PHARMA INTL 0.01% A075589 001 Jun 11, 2002

AB 0.025% A075529 001 Feb 22, 2000



AVITA

BT MYLAN 0.025% N020400 001 Jan 29, 1998

RETIN-A-MICRO

+! VALEANT INTL 0.06% N020475 004 Oct 23, 2017

+! 0.08% N020475 003 Jan 28, 2014

LOTION;TOPICAL

ALTRENO

+! DOW PHARM 0.05% N209353 001 Aug 23, 2018

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

TRIAMCINOLONE ACETONIDE

AT ALKEM LABS LTD 0.025% A207651 001 Dec 26, 2017

AT 0.1% A207651 002 Dec 26, 2017

AT 0.5% A207651 003 Dec 26, 2017

AT ! FOUGERA PHARMS 0.025% A085692 001



AT ! 0.1% A085692 003

AT ! 0.5% A085692 002

AT G AND W LABS 0.025% A089797 001 May 31, 1991

AT 0.1% A089798 001 May 31, 1991

AT GLENMARK PHARMS LTD 0.1% A207117 001 Aug 05, 2016

AT LANNETT CO INC 0.025% A040671 001 Jun 09, 2006

AT 0.1% A040671 002 Jun 09, 2006

AT LUPIN ATLANTIS 0.025% A208763 001 Feb 01, 2017

AT 0.1% A208763 002 Feb 01, 2017

AT 0.5% A208763 003 Feb 01, 2017

AT MACLEODS PHARMS LTD 0.025% A209535 001 May 18, 2018

AT 0.1% A209535 002 May 18, 2018

AT 0.5% A209535 003 May 18, 2018

AT + MYLAN PHARMS INC 0.025% N011601 003



AT + 0.1% N011601 006

AT PERRIGO NEW YORK 0.025% A086413 002

AT 0.1% A086413 003

AT 0.1% A086414 001

AT 0.5% A086413 001

AT TARO PHARM INDS LTD 0.1% A040039 001 Nov 26, 1997

AT TELIGENT PHARMA INC 0.1% A208848 001 Sep 18, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-433(of 452)

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

TRIDERM

AT CROWN LABS 0.025% A088042 002 Mar 25, 2015

AT 0.1% A088042 001 Mar 19, 1984

AT 0.5% A088042 003 Mar 25, 2015



FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR

ZILRETTA

+! FLEXION THERAPS INC 32MG/VIAL N208845 001 Oct 06, 2017

INJECTABLE;INJECTION

KENALOG-40

AB +! APOTHECON 40MG/ML N014901 001

TRIAMCINOLONE ACETONIDE

AB AMNEAL PHARMS CO 40MG/ML A207550 001 Dec 11, 2017

AB TEVA PHARMS USA 40MG/ML A209852 001 Oct 05, 2018



KENALOG-10

+ APOTHECON 10MG/ML N012041 001

INJECTABLE;INTRAVITREAL

TRIESENCE

+! NOVARTIS PHARMS 40MG/ML (40MG/ML) N022048 001 Nov 29, 2007

CORP

LOTION;TOPICAL

TRIAMCINOLONE ACETONIDE

AT AKORN 0.025% A202374 001 May 08, 2013

AT 0.1% A202374 002 May 08, 2013

AT FOUGERA PHARMS 0.025% A040467 001 Apr 21, 2003

AT 0.1% A040467 002 Apr 21, 2003

AT G AND W LABS INC 0.1% A089129 001 Aug 14, 1986

AT LANNETT CO INC 0.1% A040672 002 Dec 13, 2006

AT TELIGENT PHARMA INC 0.025% A204608 001 Jul 07, 2016

AT 0.1% A204606 001 Jul 07, 2016

AT ! WOCKHARDT BIO AG 0.025% A088450 001 Apr 01, 1985

AT ! 0.1% A088451 001 Apr 03, 1985

OINTMENT;TOPICAL

TRIAMCINOLONE ACETATE

AT MACLEODS PHARMS LTD 0.025% A209828 001 Nov 23, 2018

AT 0.1% A209828 002 Nov 23, 2018

AT 0.5% A209828 003 Nov 23, 2018

TRIAMCINOLONE ACETONIDE

AT FOUGERA PHARMS 0.025% A085691 001

AT 0.1% A085691 003

AT 0.5% A085691 002

AT G AND W LABS 0.025% A089795 001 Dec 23, 1988

AT 0.1% A089796 001 Dec 23, 1988

AT G AND W LABS INC 0.5% A208925 001 Oct 06, 2017

AT GLENMARK PHARMS 0.1% A208320 001 Aug 22, 2017

AT GLENMARK PHARMS LTD 0.5% A206379 001 Jul 22, 2016

AT NOVEL LABS INC 0.1% A207365 001 Oct 12, 2018

AT ! PERRIGO NEW YORK 0.025% A087385 002



AT ! 0.1% A087385 003

AT ! 0.5% A087385 001

AT TARO PHARM INDS LTD 0.1% A040037 001 Sep 30, 1994

AT TELIGENT PHARMA INC 0.1% A205373 001 May 13, 2016

AT 0.5% A208590 001 Mar 03, 2017



TRIAMCINOLONE ACETONIDE IN ABSORBASE

! CMP PHARMA INC 0.05% A089595 001 Mar 23, 1995

PASTE;DENTAL

TRIAMCINOLONE ACETONIDE

AT AKORN 0.1% A206312 001 Aug 11, 2016

AT G AND W LABS INC 0.1% A205592 001 Jan 12, 2017

AT LYNE 0.1% A040771 001 Jul 01, 2010

AT ! TARO 0.1% A070730 001 Oct 01, 1986



SPRAY;TOPICAL

KENALOG

AT +! SUN PHARM INDS INC 0.147MG/GM N012104 001

TRIAMCINOLONE ACETONIDE

AT AKORN 0.147MG/GM A207094 001 Dec 07, 2016

AT PERRIGO UK FINCO 0.147MG/GM A205782 001 Apr 13, 2015

AT RISING PHARMS 0.147MG/GM A206786 001 Sep 08, 2017



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-434(of 452)

TRIAMCINOLONE HEXACETONIDE

INJECTABLE;INJECTION

ARISTOSPAN

+! SANDOZ INC 5MG/ML N016466 001

+! 20MG/ML N016466 002

TRIAMTERENE

CAPSULE;ORAL

DYRENIUM

+ CONCORDIA PHARMS 50MG N013174 001

INC

+! 100MG N013174 002

TRIAZOLAM

TABLET;ORAL

HALCION

AB + PHARMACIA AND 0.125MG N017892 003 Apr 26, 1985

UPJOHN

AB +! 0.25MG N017892 001 Nov 15, 1982

TRIAZOLAM

AB MYLAN PHARMS INC 0.125MG A074031 001 Mar 25, 1994

AB 0.25MG A074031 002 Mar 25, 1994

AB WEST-WARD PHARMS 0.125MG A074224 001 Jun 01, 1994

INT

AB 0.25MG A074224 002 Jun 01, 1994

TRIENTINE HYDROCHLORIDE

CAPSULE;ORAL

SYPRINE

AB +! ATON 250MG N019194 001 Nov 08, 1985

TRIENTINE HYDROCHLORIDE

AB NAVINTA LLC 250MG A211251 001 Jan 16, 2019

AB WATSON LABS TEVA 250MG A207567 001 Feb 07, 2018



TRIFLUOPERAZINE HYDROCHLORIDE

TABLET;ORAL

TRIFLUOPERAZINE HYDROCHLORIDE

AB MYLAN EQ 1MG BASE A040209 001 Jul 07, 1997

AB EQ 2MG BASE A040209 002 Jul 07, 1997

AB EQ 5MG BASE A040209 003 Jul 07, 1997

AB ! EQ 10MG BASE A040209 004 Jul 07, 1997

AB SANDOZ EQ 1MG BASE A085785 001



AB EQ 2MG BASE A085786 001

AB EQ 5MG BASE A085789 001

AB EQ 10MG BASE A085788 001

TRIFLURIDINE

SOLUTION/DROPS;OPHTHALMIC

TRIFLURIDINE

AT HI-TECH PHARMACAL 1% A205438 001 Jul 28, 2017

AT SANDOZ INC 1% A074311 001 Oct 06, 1995

VIROPTIC

AT +! MONARCH PHARMS 1% N018299 001

TRIHEXYPHENIDYL HYDROCHLORIDE

ELIXIR;ORAL

TRIHEXYPHENIDYL HYDROCHLORIDE

AA MIKART 2MG/5ML A040251 001 Sep 27, 1999

AA ! PHARM ASSOC 2MG/5ML A040177 001 Apr 17, 1997

TABLET;ORAL

TRIHEXYPHENIDYL HYDROCHLORIDE

AA NATCO PHARMA LTD 2MG A091630 001 Nov 17, 2010

AA 5MG A091630 002 Nov 17, 2010

AA NOVITIUM PHARMA 2MG A040254 001 Dec 24, 1998

AA 5MG A040254 002 Dec 24, 1998

AA ! WATSON LABS 2MG A084363 001



AA ! 5MG A084364 001

TRIMETHADIONE

TABLET;ORAL

TRIDIONE

+! ABBVIE 150MG N005856 009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-435(of 452)

TRIMETHOBENZAMIDE HYDROCHLORIDE

CAPSULE;ORAL

TIGAN

AB +! KING PHARMS LLC 300MG N017531 006 Dec 13, 2001

TRIMETHOBENZAMIDE HYDROCHLORIDE

AB GAVIS PHARMS 300MG A076546 001 Aug 20, 2003

AB SUN PHARM 300MG A076570 001 Aug 28, 2003

INDUSTRIES

INJECTABLE;INJECTION

TIGAN

AP +! PAR STERILE 100MG/ML N017530 001

PRODUCTS

TRIMETHOBENZAMIDE HYDROCHLORIDE

AP LUITPOLD 100MG/ML A091330 001 Mar 08, 2011

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE



AP LUITPOLD 100MG/ML A091329 001 Mar 08, 2011

TRIMETHOPRIM

TABLET;ORAL

TRIMETHOPRIM

AB +! MAYNE PHARMA 100MG N018679 001 Jul 30, 1982

AB NOVEL LABS INC 100MG A091437 001 Jun 15, 2011

AB WATSON LABS 100MG A070049 001 Jun 06, 1985



TRIMETHOPRIM HYDROCHLORIDE

SOLUTION;ORAL

PRIMSOL

+! ALLEGIS EQ 50MG BASE/5ML N074973 001 Jan 24, 2000

TRIMIPRAMINE MALEATE

CAPSULE;ORAL

SURMONTIL

AB + ODYSSEY PHARMS EQ 25MG BASE N016792 001

AB +! EQ 50MG BASE N016792 002

AB + EQ 100MG BASE N016792 003 Sep 15, 1982

TRIMIPRAMINE MALEATE

AB CROSSMEDIKA SA EQ 25MG BASE A208127 001 Apr 15, 2016

AB EQ 50MG BASE A208127 002 Apr 15, 2016

AB EQ 100MG BASE A208127 003 Apr 15, 2016

AB ELITE LABS INC EQ 25MG BASE A077361 001 Aug 02, 2006

AB EQ 50MG BASE A077361 002 Aug 02, 2006

AB EQ 100MG BASE A077361 003 Aug 02, 2006



TRIPTORELIN PAMOATE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

TRIPTODUR KIT

+! ARBOR PHARMS LLC EQ 22.5MG BASE/VIAL N208956 001 Jun 29, 2017

INJECTABLE;INTRAMUSCULAR

TRELSTAR

+! ALLERGAN SALES LLC EQ 3.75MG BASE/VIAL N020715 001 Jun 15, 2000

+! EQ 11.25MG BASE/VIAL N021288 001 Jun 29, 2001

+! EQ 22.5MG BASE/VIAL N022437 001 Mar 10, 2010

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

MYDRIACYL

AT ! NOVARTIS PHARMS 1% A084306 001

CORP

AT ! SANDOZ INC 0.5% A084305 001

TROPICACYL

AT AKORN 0.5% A040314 001 Sep 29, 2000

AT 1% A040315 001 Sep 29, 2000

TROPICAMIDE

AT BAUSCH AND LOMB 0.5% A040067 001 Jul 27, 1994

AT 1% A040064 001 Jul 27, 1994



TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

TROSPIUM CHLORIDE

AB ! ACTAVIS LABS FL INC 60MG A091289 001 Oct 12, 2012

AB PADDOCK LLC 60MG A201291 001 May 24, 2013

TABLET;ORAL

TROSPIUM CHLORIDE

AB APOTEX 20MG A091513 001 Dec 06, 2011

AB ! GLENMARK GENERICS 20MG A091575 001 Aug 13, 2010

AB HERITAGE PHARMS INC 20MG A204945 001 Aug 30, 2016



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-436(of 452)

TROSPIUM CHLORIDE

TABLET;ORAL

TROSPIUM CHLORIDE

AB INVAGEN PHARMS 20MG A091688 001 Aug 23, 2016

AB PADDOCK LLC 20MG A091573 001 Nov 17, 2010



TRYPAN BLUE

SOLUTION;OPHTHALMIC

MEMBRANEBLUE

+! DORC 0.15% N022278 001 Feb 20, 2009

VISIONBLUE

+! DORC 0.06% N021670 001 Dec 16, 2004

ULIPRISTAL ACETATE

TABLET;ORAL

ELLA

AB +! LAB HRA PHARMA 30MG N022474 001 Aug 13, 2010

LOGILIA

AB TEVA PHARMS USA 30MG A207952 001 Feb 13, 2017

UMECLIDINIUM BROMIDE

POWDER;INHALATION

INCRUSE ELLIPTA

+! GLAXO GRP ENGLAND EQ 62.5MCG BASE/INH N205382 001 Apr 30, 2014

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

POWDER;INHALATION

ANORO ELLIPTA

+! GLAXOSMITHKLINE EQ 0.0625MG BASE/INH;EQ 0.025MG N203975 001 Dec 18, 2013

BASE/INH

UREA, C-14

CAPSULE;ORAL

PYTEST

+! AVENT 1uCi N020617 001 May 09, 1997

PYTEST KIT

+! AVENT 1uCi N020617 002 May 09, 1997

URIDINE TRIACETATE

GRANULE;ORAL

VISTOGARD

+! WELLSTAT THERAP 10GM/PACKET N208159 001 Dec 11, 2015

XURIDEN

+! WELLSTAT THERAP 2GM/PACKET N208169 001 Sep 04, 2015

URSODIOL

CAPSULE;ORAL

ACTIGALL

AB +! ALLERGAN SALES LLC 300MG N019594 002 Dec 31, 1987

URSODIOL

AB ABHAI LLC 300MG A210707 001 May 17, 2018

AB AMNEAL PHARMS CO 300MG A211301 001 Oct 16, 2018

AB EPIC PHARMA 300MG A075517 001 Mar 14, 2000

AB LANNETT CO INC 300MG A079082 001 Dec 15, 2008

AB MYLAN 300MG A090530 001 Feb 17, 2010

AB TEVA PHARMS 300MG A075592 001 May 25, 2000

TABLET;ORAL

URSO 250

AB + ALLERGAN SALES LLC 250MG N020675 001 Dec 10, 1997

URSO FORTE

AB +! ALLERGAN SALES LLC 500MG N020675 002 Jul 21, 2004

URSODIOL

AB GLENMARK GENERICS 250MG A090801 001 Jul 12, 2011

AB 500MG A090801 002 Jul 12, 2011

AB IMPAX LABS INC 250MG A200826 001 Dec 23, 2011

AB 500MG A200826 002 Dec 23, 2011

AB PAR PHARM 250MG A202540 001 Feb 14, 2013

AB 500MG A202540 002 Feb 14, 2013

AB ZYDUS WORLDWIDE 250MG A211145 001 Oct 30, 2018

AB 500MG A211145 002 Oct 30, 2018



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-437(of 452)

VALACYCLOVIR HYDROCHLORIDE

TABLET;ORAL

VALACYCLOVIR HYDROCHLORIDE

AB APOTEX INC EQ 500MG BASE A090500 001 Apr 04, 2014

AB EQ 1GM BASE A090500 002 Apr 04, 2014

AB AUROBINDO PHARMA EQ 500MG BASE A090682 001 May 24, 2010

AB EQ 1GM BASE A090682 002 May 24, 2010

AB CIPLA EQ 500MG BASE A077135 001 May 24, 2010

AB EQ 1GM BASE A077135 002 May 24, 2010

AB HETERO LABS LTD V EQ 500MG BASE A203047 001 Apr 08, 2015

AB EQ 1GM BASE A203047 002 Apr 08, 2015

AB JUBILANT GENERICS EQ 500MG BASE A201506 001 Apr 03, 2012

AB EQ 1GM BASE A201506 002 Apr 03, 2012

AB MYLAN PHARMS INC EQ 500MG BASE A078518 001 May 24, 2010

AB EQ 1GM BASE A078518 002 May 24, 2010

AB SANDOZ EQ 500MG BASE A077478 001 May 24, 2010

AB EQ 1GM BASE A077478 002 May 24, 2010

AB SUN PHARM INDS LTD EQ 500MG BASE A076588 001 Jan 31, 2007

AB EQ 1GM BASE A076588 002 Jan 31, 2007

AB TEVA PHARMS EQ 500MG BASE A077655 001 May 24, 2010

AB EQ 1GM BASE A077655 002 May 24, 2010

AB TIME-CAP LABS INC EQ 500MG BASE A079012 001 May 24, 2010

AB EQ 1GM BASE A079012 002 May 24, 2010

AB WATSON LABS INC EQ 500MG BASE A090370 001 Mar 16, 2011

AB EQ 1GM BASE A090370 002 Mar 16, 2011

AB WEST-WARD PHARMS EQ 500MG BASE A078656 001 May 24, 2010

INT

AB EQ 1GM BASE A078656 002 May 24, 2010

AB WOCKHARDT EQ 500MG BASE A090216 001 May 24, 2010

AB EQ 1GM BASE A090216 002 May 24, 2010

AB ZYDUS PHARMS USA EQ 500MG BASE A079137 001 Dec 29, 2017

INC

AB EQ 1GM BASE A079137 002 Dec 29, 2017

VALTREX

AB + GLAXOSMITHKLINE EQ 500MG BASE N020487 001 Jun 23, 1995

AB +! EQ 1GM BASE N020487 002 Jun 23, 1995



VALBENAZINE TOSYLATE

CAPSULE;ORAL

INGREZZA

+ NEUROCRINE EQ 40MG BASE N209241 001 Apr 11, 2017

+! EQ 80MG BASE N209241 002 Oct 04, 2017



VALGANCICLOVIR HYDROCHLORIDE

FOR SOLUTION;ORAL

VALCYTE

AB +! HOFFMANN LA ROCHE 50MG/ML N022257 001 Aug 28, 2009

VALGANCICLOVIR HYDROCHLORIDE

AB ACTAVIS LABS FL INC 50MG/ML A205220 001 Jul 18, 2016

TABLET;ORAL

VALCYTE

AB +! HOFFMANN LA ROCHE EQ 450MG BASE N021304 001 Mar 29, 2001

VALGANCICLOVIR HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 450MG BASE A204750 001 Mar 31, 2016

LTD

AB CIPLA EQ 450MG BASE A209672 001 Nov 09, 2018

AB DR REDDYS LABS LTD EQ 450MG BASE A203511 001 Nov 04, 2014

AB EQ 450MG BASE A206876 001 Dec 12, 2017

AB ENDO PHARMS INC EQ 450MG BASE A200790 001 Nov 04, 2014

AB HETERO LABS LTD V EQ 450MG BASE A205166 001 Mar 18, 2016

VALPROATE SODIUM

INJECTABLE;INJECTION

DEPACON

AP +! ABBVIE EQ 100MG BASE/ML N020593 001 Dec 30, 1996

VALPROATE SODIUM

AP ATHENEX INC EQ 100MG BASE/ML A076295 001 Nov 14, 2002

AP FRESENIUS KABI USA EQ 100MG BASE/ML A076539 001 Jun 26, 2003

AP HIKMA FARMACEUTICA EQ 100MG BASE/ML A078523 001 Feb 17, 2010



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-438(of 452)

VALPROIC ACID

CAPSULE;ORAL

DEPAKENE

AB +! ABBVIE 250MG N018081 001

VALPROIC ACID

AB BIONPHARMA INC 250MG A073484 001 Jun 29, 1993

AB CATALENT 250MG A073229 001 Oct 29, 1991

AB SUN PHARM INDS LTD 250MG A091037 001 Feb 22, 2013

SYRUP;ORAL

DEPAKENE

AA +! ABBVIE 250MG/5ML N018082 001

VALPROIC ACID

AA ANI PHARMS INC 250MG/5ML A073178 001 Aug 25, 1992

AA ECI PHARMS LLC 250MG/5ML A090517 001 May 28, 2010

AA HIGH TECH PHARMA 250MG/5ML A074060 001 Jan 13, 1995

AA LANNETT CO INC 250MG/5ML A077960 001 Oct 13, 2006

AA PHARM ASSOC 250MG/5ML A075379 001 Dec 15, 2000

AA VISTAPHARM 250MG/5ML A075782 001 Dec 22, 2000

AA WOCKHARDT BIO AG 250MG/5ML A070868 001 Jul 01, 1986



VALRUBICIN

SOLUTION;INTRAVESICAL

VALSTAR PRESERVATIVE FREE

+! ENDO PHARM 40MG/ML N020892 001 Sep 25, 1998

VALSARTAN

TABLET;ORAL

DIOVAN

AB + NOVARTIS 40MG N021283 004 Aug 14, 2002

AB + 80MG N021283 001 Jul 18, 2001

AB + 160MG N021283 002 Jul 18, 2001

AB +! 320MG N021283 003 Jul 18, 2001

VALSARTAN

AB ALEMBIC PHARMS LTD 40MG A091367 001 Jan 05, 2015

AB 80MG A091367 002 Jan 05, 2015

AB 160MG A091367 003 Jan 05, 2015

AB 320MG A091367 004 Jan 05, 2015

AB AMNEAL PHARMS 40MG A204011 001 Jan 11, 2016

AB 80MG A204011 002 Jan 11, 2016

AB 160MG A204011 003 Jan 11, 2016

AB 320MG A204011 004 Jan 11, 2016

AB AUROBINDO PHARMA 40MG A202223 001 Jan 05, 2015

LTD

AB 80MG A202223 002 Jan 05, 2015

AB 160MG A202223 003 Jan 05, 2015

AB 320MG A202223 004 Jan 05, 2015

AB HETERO LABS LTD V 40MG A203311 001 Jan 05, 2015

AB 80MG A203311 002 Jan 05, 2015

AB 160MG A203311 003 Jan 05, 2015

AB 320MG A203311 004 Jan 05, 2015

AB IVAX PHARMS 40MG A077530 001 Jan 04, 2016

AB 80MG A077530 002 Jan 04, 2016

AB 160MG A077530 003 Jan 04, 2016

AB 320MG A077530 004 Jan 04, 2016

AB JUBILANT GENERICS 40MG A203536 001 Jan 05, 2015

AB 80MG A203536 002 Jan 05, 2015

AB 160MG A203536 003 Jan 05, 2015

AB 320MG A203536 004 Jan 05, 2015

AB LUPIN LTD 40MG A201677 001 Jan 05, 2015

AB 80MG A201677 002 Jan 05, 2015

AB 160MG A201677 003 Jan 05, 2015

AB 320MG A201677 004 Jan 05, 2015

AB MACLEODS PHARMS LTD 40MG A202696 001 Sep 16, 2016

AB 80MG A202696 002 Sep 16, 2016

AB 160MG A202696 003 Sep 16, 2016

AB 320MG A202696 004 Sep 16, 2016

AB MYLAN PHARMS INC 40MG A090866 001 Jan 05, 2015

AB 80MG A090866 002 Jan 05, 2015

AB 160MG A090866 003 Jan 05, 2015

AB 320MG A090866 004 Jan 05, 2015

AB OHM LABS INC 40MG A077492 001 Jun 26, 2014

AB 80MG A077492 002 Jun 26, 2014

AB 160MG A077492 003 Jun 26, 2014

AB 320MG A077492 004 Jun 26, 2014



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-439(of 452)

VALSARTAN

TABLET;ORAL

VALSARTAN

AB PRINSTON INC 40MG
A204821 001 Jun 09, 2015

AB 80MG
A204821 002 Jun 09, 2015

AB 160MG
A204821 003 Jun 09, 2015

AB 320MG
A204821 004 Jun 09, 2015

AB SQUARE PHARMS LTD 40MG


A205347 001 Apr 09, 2018

AB 80MG
A205347 002 Apr 09, 2018

AB 160MG
A205347 003 Apr 09, 2018

AB 320MG
A205347 004 Apr 09, 2018

AB TORRENT PHARMS LTD 40MG


A202728 001 Jan 05, 2015

AB 80MG
A202728 002 Jan 05, 2015

AB 160MG
A202728 003 Jan 05, 2015

AB 320MG
A202728 004 Jan 05, 2015

AB UNICHEM LABS LTD 40MG


A209261 001 May 04, 2018

AB 80MG
A209261 002 May 04, 2018

AB 160MG
A209261 003 May 04, 2018

AB 320MG
A209261 004 May 04, 2018

VANCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

VANCOCIN HYDROCHLORIDE

AB + ANI PHARMS INC EQ 125MG BASE
N050606 001 Apr 15, 1986

AB +! EQ 250MG BASE
N050606 002 Apr 15, 1986

VANCOMYCIN HYDROCHLORIDE

AB AKORN EQ 125MG BASE
A065478 001 Apr 09, 2012

AB EQ 250MG BASE
A065478 002 Apr 09, 2012

AB LUPIN LTD EQ 125MG BASE


A090439 001 Jan 28, 2015

AB EQ 250MG BASE
A090439 002 Jan 28, 2015

AB STRIDES PHARMA EQ 125MG BASE


A065490 001 Apr 09, 2012

AB EQ 250MG BASE
A065490 002 Apr 09, 2012

AB WATSON LABS EQ 125MG BASE


A065510 001 Apr 09, 2012

AB EQ 250MG BASE
A065510 002 Apr 09, 2012

FOR SOLUTION;ORAL

FIRVANQ KIT

+! RXMTM THERAPS LLC EQ 25MG BASE/ML
N208910 001 Jan 26, 2018

+! EQ 50MG BASE/ML
N208910 002 Jan 26, 2018

INJECTABLE;INJECTION

VANCOMYCIN HYDROCHLORIDE

AP AUROBINDO PHARMA EQ 500MG BASE/VIAL
A205780 001 Mar 31, 2016

LTD

AP EQ 1GM BASE/VIAL
A205780 002 Mar 31, 2016

AP EQ 5GM BASE/VIAL
A205779 001 Mar 29, 2016

AP EQ 10GM BASE/VIAL
A205779 002 Mar 29, 2016

AP EMCURE PHARMS LTD EQ 500MG BASE/VIAL


A202275 001 Oct 31, 2013

AP EQ 1GM BASE/VIAL
A202275 002 Oct 31, 2013

AP EQ 10GM BASE/VIAL
A202464 001 Oct 09, 2013

AP EQ 5GM BASE/VIAL
A202274 001 Oct 31, 2013

AP ! FRESENIUS KABI USA EQ 500MG BASE/VIAL


A062663 001 Mar 17, 1987

AP EQ 750MG BASE/VIAL
A062663 005 Aug 17, 2016

AP ! EQ 1GM BASE/VIAL
A062663 002 Jul 31, 1987

AP ! EQ 5GM BASE/VIAL
A062663 003 Jun 03, 1988

AP ! EQ 10GM BASE/VIAL
A062663 004 Nov 28, 1997

AP GLAND PHARMA LTD EQ 500MG BASE/VIAL


A205694 001 Jan 21, 2016

AP EQ 1GM BASE/VIAL
A205694 002 Jan 21, 2016

AP HIKMA FARMACEUTICA EQ 5GM BASE/VIAL


A204360 001 Oct 15, 2018

AP EQ 10GM BASE/VIAL
A204360 002 Oct 15, 2018

AP HIKMA PHARMS EQ 750MG BASE/VIAL


A206616 001 Oct 03, 2018

AP ! HOSPIRA EQ 500MG BASE/VIAL


A062911 001 Aug 04, 1988

AP ! EQ 500MG BASE/VIAL
A062931 001 Oct 29, 1992

AP ! EQ 750MG BASE/VIAL
A062912 002 Jan 07, 2009

AP ! EQ 750MG BASE/VIAL
A062933 002 May 27, 2009

AP ! EQ 1GM BASE/VIAL
A062912 001 Aug 04, 1988

AP ! EQ 1GM BASE/VIAL
A062933 001 Oct 29, 1992

AP ! EQ 5GM BASE/VIAL
A063076 001 Dec 21, 1990

AP HOSPIRA INC EQ 10GM BASE/VIAL


A065455 001 Apr 29, 2009

AP MUSTAFA NEVZAT ILAC EQ 500MG BASE/VIAL


A065401 001 Jun 30, 2008

AP EQ 1GM BASE/VIAL
A065401 002 Jun 30, 2008

AP MYLAN LABS LTD EQ 500MG BASE/VIAL


A065397 001 Dec 30, 2008

AP EQ 1GM BASE/VIAL
A065397 002 Dec 30, 2008

AP EQ 5GM BASE/VIAL
A065432 001 Dec 30, 2008

AP EQ 10GM BASE/VIAL
A091554 001 Sep 19, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-440(of 452)

VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

VANCOMYCIN HYDROCHLORIDE

AP SAGENT PHARMS EQ 5GM BASE/VIAL A200837 001 Aug 10, 2012

AP EQ 10GM BASE/VIAL A200837 002 Sep 02, 2014

AP SANDOZ EQ 500MG BASE/VIAL A090250 001 Apr 27, 2010

AP EQ 1GM BASE/VIAL A090250 002 Apr 27, 2010

AP SANDOZ INC EQ 5GM BASE/VIAL A201048 001 Aug 10, 2012

AP EQ 10GM BASE/VIAL A201048 002 Aug 10, 2012

AP XELLIA PHARMS APS EQ 5GM BASE/VIAL A204125 001 Dec 28, 2015

AP EQ 10GM BASE/VIAL A204125 002 Dec 28, 2015

AP EQ 500MG BASE/VIAL A204107 001 Dec 28, 2015

AP EQ 1GM BASE/VIAL A204107 002 Dec 28, 2015



VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER

+! BAXTER HLTHCARE EQ 500MG BASE/100ML N050671 001 Apr 29, 1993

+! EQ 750MG BASE/150ML N050671 002 Dec 20, 2010



+! EQ 1GM BASE/200ML N050671 003 Mar 01, 1999

POWDER;INTRAVENOUS

VANCOMYCIN HYDROCHLORIDE

+! MYLAN LABS LTD EQ 250MG BASE/VIAL N209481 001 Jul 10, 2018

+! EQ 750MG BASE/VIAL N209481 002 Jul 10, 2018

+! EQ 1.25GM BASE/VIAL N209481 003 Jul 10, 2018

+! EQ 1.5GM BASE/VIAL N209481 004 Jul 10, 2018

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

SAMSON MEDCL EQ 100GM BASE A091532 001 Jan 06, 2016

VANDETANIB

TABLET;ORAL

CAPRELSA

+ GENZYME CORP 100MG N022405 001 Apr 06, 2011

+! 300MG N022405 002 Apr 06, 2011



VARDENAFIL HYDROCHLORIDE

TABLET;ORAL

LEVITRA

AB + BAYER HLTHCARE 5MG N021400 001 Aug 19, 2003

AB + 10MG N021400 002 Aug 19, 2003

AB +! 20MG N021400 004 Aug 19, 2003

VARDENAFIL HYDROCHLORIDE

AB AMNEAL PHARMS CO 5MG A210738 001 Oct 31, 2018

AB 10MG A210738 002 Oct 31, 2018

AB 20MG A210738 003 Oct 31, 2018

AB CROSSMEDIKA SA 2.5MG A209057 001 Oct 31, 2018

AB 5MG A209057 002 Oct 31, 2018

AB 10MG A209057 003 Oct 31, 2018

AB 20MG A209057 004 Oct 31, 2018

AB TEVA PHARMS 2.5MG A091347 001 May 03, 2012

AB 5MG A091347 002 May 03, 2012

AB 10MG A091347 003 May 03, 2012

AB 20MG A091347 004 May 03, 2012

AB ZYDUS PHARMS USA 2.5MG A208960 001 Oct 31, 2018

INC

AB 5MG A208960 002 Oct 31, 2018

AB 10MG A208960 003 Oct 31, 2018

AB 20MG A208960 004 Oct 31, 2018



TABLET, ORALLY DISINTEGRATING;ORAL

STAXYN

AB +! BAYER HLTHCARE 10MG N200179 001 Jun 17, 2010

VARDENAFIL HYDROCHLORIDE

AB ALEMBIC PHARMS LTD 10MG A208324 001 Nov 16, 2018

VARENICLINE TARTRATE

TABLET;ORAL

CHANTIX

+ PF PRISM CV EQ 0.5MG BASE N021928 001 May 10, 2006

+! EQ 1MG BASE N021928 002 May 10, 2006



VASOPRESSIN

SOLUTION;IV (INFUSION)

VASOSTRICT

+! PAR STERILE 20UNITS/ML (20UNITS/ML) N204485 001 Apr 17, 2014

PRODUCTS

+! 200UNITS/10ML (20UNITS/ML) N204485 002 Dec 17, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-441(of 452)

VECURONIUM BROMIDE

INJECTABLE;INJECTION

VECURONIUM BROMIDE

AP AUROBINDO PHARMA 10MG/VIAL A206670 001 Dec 20, 2018

LTD

AP 20MG/VIAL A206670 002 Dec 20, 2018

AP GLAND PHARMA LTD 10MG/VIAL A205390 001 May 26, 2016

AP 20MG/VIAL A205390 002 May 26, 2016

AP HOSPIRA 10MG/VIAL A075164 001 Oct 21, 1999

AP 20MG/VIAL A075164 002 Oct 21, 1999

AP MYLAN LABS LTD 10MG/VIAL A090243 001 May 11, 2010

AP 20MG/VIAL A090243 002 May 11, 2010

AP SAGENT PHARMS 10MG/VIAL A078274 001 Dec 29, 2008

AP 20MG/VIAL A078274 002 Dec 29, 2008

AP ! SUN PHARMA GLOBAL 10MG/VIAL A079001 001 Jun 17, 2009

AP ! 20MG/VIAL A079001 002 Jun 17, 2009

AP TEVA PHARMS USA 10MG/VIAL A074688 001 Aug 25, 1999

AP 20MG/VIAL A074688 002 Aug 25, 1999

AP WEST-WARD PHARMS 10MG/VIAL A075549 001 Jun 13, 2000

INT

AP 20MG/VIAL A075549 002 Jun 13, 2000

VELAGLUCERASE ALFA

INJECTABLE;INTRAVENOUS

VPRIV

SHIRE HUMAN GENETIC 400 UNITS/VIAL N022575 001 Feb 26, 2010

VEMURAFENIB

TABLET;ORAL

ZELBORAF

+! HOFFMANN LA ROCHE 240MG N202429 001 Aug 17, 2011

VENETOCLAX

TABLET;ORAL

VENCLEXTA

+ ABBVIE INC 10MG N208573 001 Apr 11, 2016

+ 50MG N208573 002 Apr 11, 2016

+! 100MG N208573 003 Apr 11, 2016



VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EFFEXOR XR

AB + WYETH PHARMS EQ 37.5MG BASE N020699 001 Oct 20, 1997

AB + EQ 75MG BASE N020699 002 Oct 20, 1997

AB +! EQ 150MG BASE N020699 004 Oct 20, 1997

VENLAFAXINE HYDROCHLORIDE

AB AUROBINDO PHARMA EQ 37.5MG BASE A200834 001 Apr 14, 2011

LTD

AB EQ 75MG BASE A200834 002 Apr 14, 2011

AB EQ 150MG BASE A200834 003 Apr 14, 2011

AB DR REDDYS LABS LTD EQ 37.5MG BASE A078421 001 May 06, 2011

AB EQ 75MG BASE A078421 002 May 06, 2011

AB EQ 150MG BASE A078421 003 May 06, 2011

AB INTELLIPHARMACEUTIC EQ 37.5MG BASE A201272 001 Nov 23, 2018

S

AB EQ 75MG BASE A201272 002 Nov 23, 2018

AB EQ 150MG BASE A201272 003 Nov 23, 2018

AB MACLEODS PHARMS LTD EQ 37.5MG BASE A204889 001 Oct 05, 2017

AB EQ 75MG BASE A204889 002 Oct 05, 2017

AB EQ 150MG BASE A204889 003 Oct 05, 2017

AB ORCHID HLTHCARE EQ 37.5MG BASE A091123 001 Jul 11, 2011

AB EQ 75MG BASE A091123 002 Jul 11, 2011

AB EQ 150MG BASE A091123 003 Jul 11, 2011

AB TEVA EQ 37.5MG BASE A076565 001 Jun 28, 2010

AB EQ 75MG BASE A076565 002 Jun 28, 2010

AB EQ 150MG BASE A076565 003 Jun 28, 2010

AB TORRENT PHARMS LLC EQ 37.5MG BASE A090899 001 Jun 01, 2011

AB EQ 75MG BASE A090899 002 Jun 01, 2011

AB EQ 150MG BASE A090899 003 Jun 01, 2011

AB VALEANT PHARMS EQ 37.5MG BASE A090071 001 Apr 15, 2011

NORTH

AB EQ 75MG BASE A090071 002 Apr 15, 2011

AB EQ 150MG BASE A090071 003 Apr 15, 2011

AB WOCKHARDT EQ 37.5MG BASE A078865 001 Apr 14, 2011

AB EQ 75MG BASE A078865 002 Apr 14, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-442(of 452)

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

AB EQ 150MG BASE A078865 003 Apr 14, 2011

AB ZYDUS PHARMS USA EQ 37.5MG BASE A090174 001 Apr 14, 2011

INC

AB EQ 75MG BASE A090174 002 Apr 14, 2011

AB EQ 150MG BASE A090174 003 Apr 14, 2011

TABLET;ORAL

VENLAFAXINE HYDROCHLORIDE

AB ALEMBIC PHARMS LTD EQ 25MG BASE A078932 001 Dec 14, 2010

AB EQ 37.5MG BASE A078932 002 Dec 14, 2010

AB EQ 50MG BASE A078932 003 Dec 14, 2010

AB EQ 75MG BASE A078932 004 Dec 14, 2010

AB EQ 100MG BASE A078932 005 Dec 14, 2010

AB AMNEAL PHARMS EQ 25MG BASE A079098 001 May 11, 2010

AB EQ 37.5MG BASE A079098 002 May 11, 2010

AB EQ 50MG BASE A079098 003 May 11, 2010

AB EQ 75MG BASE A079098 004 May 11, 2010

AB EQ 100MG BASE A079098 005 May 11, 2010

AB AUROBINDO PHARMA EQ 25MG BASE A090555 001 Apr 07, 2010

AB EQ 37.5MG BASE A090555 002 Apr 07, 2010

AB EQ 50MG BASE A090555 003 Apr 07, 2010

AB EQ 75MG BASE A090555 004 Apr 07, 2010

AB EQ 100MG BASE A090555 005 Apr 07, 2010

AB CADILA PHARMS LTD EQ 25MG BASE A206250 001 Nov 21, 2018

AB EQ 37.5MG BASE A206250 002 Nov 21, 2018

AB EQ 50MG BASE A206250 003 Nov 21, 2018

AB EQ 75MG BASE A206250 004 Nov 21, 2018

AB EQ 100MG BASE A206250 005 Nov 21, 2018

AB DR REDDYS LABS LTD EQ 25MG BASE A078301 001 Jun 13, 2008

AB EQ 37.5MG BASE A078301 002 Jun 13, 2008

AB EQ 50MG BASE A078301 003 Jun 13, 2008

AB EQ 75MG BASE A078301 004 Jun 13, 2008

AB EQ 100MG BASE A078301 005 Jun 13, 2008

AB HERITAGE PHARMS INC EQ 25MG BASE A078554 001 Jan 09, 2009

AB EQ 37.5MG BASE A078554 002 Jan 09, 2009

AB EQ 50MG BASE A078554 003 Jan 09, 2009

AB EQ 75MG BASE A078554 004 Jan 09, 2009

AB EQ 100MG BASE A078554 005 Jan 09, 2009

AB MYLAN EQ 25MG BASE A077166 001 Jun 13, 2008

AB EQ 37.5MG BASE A077166 002 Jun 13, 2008

AB EQ 50MG BASE A077166 003 Jun 13, 2008

AB EQ 75MG BASE A077166 004 Jun 13, 2008

AB EQ 100MG BASE A077166 005 Jun 13, 2008

AB PRINSTON INC EQ 25MG BASE A090027 001 Aug 04, 2010

AB EQ 37.5MG BASE A090027 002 Aug 04, 2010

AB EQ 50MG BASE A090027 003 Aug 04, 2010

AB EQ 75MG BASE A090027 004 Aug 04, 2010

AB EQ 100MG BASE A090027 005 Aug 04, 2010

AB SUN PHARM INDS INC EQ 25MG BASE A078627 001 Jun 13, 2008

AB EQ 37.5MG BASE A078627 002 Jun 13, 2008

AB EQ 50MG BASE A078627 003 Jun 13, 2008

AB EQ 75MG BASE A078627 004 Jun 13, 2008

AB EQ 100MG BASE A078627 005 Jun 13, 2008

AB TEVA EQ 25MG BASE A076690 001 Aug 03, 2006

AB EQ 37.5MG BASE A076690 002 Aug 03, 2006

AB ! EQ 50MG BASE A076690 003 Aug 03, 2006

AB EQ 75MG BASE A076690 004 Aug 03, 2006

AB EQ 100MG BASE A076690 005 Aug 03, 2006

AB YAOPHARMA CO LTD EQ 25MG BASE A202036 001 May 28, 2015

AB EQ 37.5MG BASE A202036 002 May 28, 2015

AB EQ 50MG BASE A202036 003 May 28, 2015

AB EQ 75MG BASE A202036 004 May 28, 2015

AB EQ 100MG BASE A202036 005 May 28, 2015

AB ZYDUS PHARMS USA EQ 25MG BASE A077653 001 Jun 13, 2008

AB EQ 37.5MG BASE A077653 002 Jun 13, 2008

AB EQ 50MG BASE A077653 003 Jun 13, 2008

AB EQ 75MG BASE A077653 004 Jun 13, 2008

AB EQ 100MG BASE A077653 005 Jun 13, 2008



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-443(of 452)

VENLAFAXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

AB NOSTRUM LABS INC EQ 150MG BASE A205468 002 Mar 24, 2017

AB EQ 225MG BASE A205468 003 Mar 24, 2017

AB + OSMOTICA PHARM EQ 37.5MG BASE N022104 001 May 20, 2008

AB + EQ 75MG BASE N022104 002 May 20, 2008

AB +! EQ 150MG BASE N022104 003 May 20, 2008

AB + EQ 225MG BASE N022104 004 May 20, 2008

AB SUN PHARMA GLOBAL EQ 37.5MG BASE A091272 001 Aug 18, 2010

AB EQ 75MG BASE A091272 002 Aug 18, 2010

AB EQ 150MG BASE A091272 003 Aug 18, 2010

AB EQ 225MG BASE A091272 004 Jan 08, 2019



VERAPAMIL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE

AB MYLAN 100MG A078306 001 Aug 09, 2007

AB 120MG A075138 001 Apr 20, 1999

AB 180MG A075138 002 Apr 20, 1999

AB 200MG A078306 002 Aug 09, 2007

AB 240MG A075138 003 Apr 20, 1999

AB 300MG A078306 003 Aug 09, 2007

VERELAN

AB + RECRO GAINESVILLE 120MG N019614 001 May 29, 1990

AB + 180MG N019614 003 Jan 09, 1992

AB + 240MG N019614 002 May 29, 1990

VERELAN PM

AB + RECRO GAINESVILLE 100MG N020943 001 Nov 25, 1998

AB + 200MG N020943 002 Nov 25, 1998

AB +! 300MG N020943 003 Nov 25, 1998



VERELAN

+! RECRO GAINESVILLE 360MG N019614 004 May 10, 1996

SOLUTION;INTRAVENOUS

VERAPAMIL HYDROCHLORIDE

AP AMNEAL PHARMS CO 5MG/2ML (2.5MG/ML) A210994 001 Jul 13, 2018

AP 10MG/4ML (2.5MG/ML) A210994 002 Jul 13, 2018

AP EXELA PHARMA SCS 5MG/2ML (2.5MG/ML) N018925 001 Mar 30, 1984

LLC

AP 10MG/4ML (2.5MG/ML) N018925 002 Apr 05, 2018

AP ! HOSPIRA 5MG/2ML (2.5MG/ML) A070738 001 May 06, 1987

AP ! 5MG/2ML (2.5MG/ML) A075136 001 Oct 20, 1998

AP ! 5MG/2ML (2.5MG/ML) A070737 001 May 06, 1987

AP ! 10MG/4ML (2.5MG/ML) A070737 002 May 06, 1987

AP MICRO LABS 5MG/2ML (2.5MG/ML) A211370 001 Dec 28, 2018

AP 10MG/4ML (2.5MG/ML) A211370 002 Dec 28, 2018

AP SOMERSET THERAPS 5MG/2ML (2.5MG/ML) A211015 001 Jun 18, 2018

LLC

AP 5MG/2ML (2.5MG/ML) A211035 001 Jun 18, 2018

AP 10MG/4ML (2.5MG/ML) A211015 002 Jun 18, 2018

AP 10MG/4ML (2.5MG/ML) A211035 002 Jun 18, 2018



TABLET;ORAL

CALAN

AB + GD SEARLE LLC 80MG N018817 001 Sep 10, 1984

AB +! 120MG N018817 002 Sep 10, 1984

VERAPAMIL HYDROCHLORIDE

AB HERITAGE PHARMS INC 40MG A071881 002 Oct 14, 2015

AB 80MG A071881 003 Apr 05, 1988

AB 120MG A071881 001 Apr 05, 1988

AB MYLAN 80MG A071483 002 Feb 15, 1989

AB 120MG A071483 001 Feb 15, 1989

AB WATSON LABS 40MG A072924 001 Jun 29, 1993

AB 80MG A070995 001 Oct 01, 1986

AB 120MG A070994 001 Oct 01, 1986



TABLET, EXTENDED RELEASE;ORAL

CALAN SR

AB +! PFIZER 120MG N019152 003 Mar 06, 1991

AB +! 240MG N019152 001 Dec 16, 1986

VERAPAMIL HYDROCHLORIDE

AB CADILA PHARMS LTD 180MG A206173 001 May 05, 2017

AB 240MG A206173 002 May 05, 2017

AB GLENMARK GENERICS 120MG A090700 001 Aug 03, 2011

AB ! 180MG A090700 002 Aug 03, 2011



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-444(of 452)

VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE
AB 240MG
A078906 001 Sep 17, 2009

AB IVAX SUB TEVA 120MG


A073568 002 Oct 10, 1997

PHARMS
AB 180MG
A074330 001 Jan 31, 1994

AB 240MG
A073568 001 Jul 31, 1992

AB MYLAN 120MG
A074587 002 Feb 21, 1997

AB 180MG
A074587 003 Sep 09, 1997

AB 240MG
A074587 001 Mar 23, 1996

AB PAR PHARM 120MG


A075072 001 May 25, 1999

AB 240MG
A075072 003 May 25, 1999

AB SUN PHARM INDS INC 120MG


A090529 001 Dec 30, 2011

AB 180MG
A090529 002 Dec 30, 2011

AB 240MG
A090529 003 Dec 30, 2011

VERTEPORFIN

INJECTABLE;INJECTION

VISUDYNE

+! VALEANT LUXEMBOURG
15MG/VIAL
N021119 001 Apr 12, 2000

VIGABATRIN

FOR SOLUTION;ORAL

SABRIL

AA +! LUNDBECK PHARMS LLC
500MG/PACKET
N022006 001 Aug 21, 2009

VIGABATRIN

AA AMNEAL PHARMS
500MG/PACKET
A210155 001 Mar 13, 2018

AA DR REDDYS LABS LTD


500MG/PACKET
A211481 001 Nov 20, 2018

AA PAR PHARM INC


500MG/PACKET
A208218 001 Apr 27, 2017

AA TEVA PHARMS USA


500MG/PACKET
A209824 001 Apr 23, 2018

VIGADRONE

AA AUCTA PHARMS
500MG/PACKET
A210196 001 Jun 21, 2018

TABLET;ORAL

SABRIL

AB +! LUNDBECK PHARMS LLC
500MG
N020427 001 Aug 21, 2009

VIGABATRIN

AB TEVA PHARMS USA
500MG
A209822 001 Jan 14, 2019

VILAZODONE HYDROCHLORIDE

TABLET;ORAL

VIIBRYD

+! ALLERGAN SALES LLC
10MG
N022567 001 Jan 21, 2011

+
20MG
N022567 002 Jan 21, 2011

+
40MG
N022567 003 Jan 21, 2011

VINBLASTINE SULFATE

INJECTABLE;INJECTION

VINBLASTINE SULFATE

! FRESENIUS KABI USA
1MG/ML
A089515 001 Apr 29, 1987

! WEST-WARD PHARMS
10MG/VIAL
A089395 001 Apr 09, 1987

INT

VINCRISTINE SULFATE

INJECTABLE;INJECTION

VINCRISTINE SULFATE PFS



AP ! HOSPIRA
1MG/ML
A071484 001 Apr 19, 1988

AP TEVA PHARMS USA


1MG/ML
A075493 001 Sep 01, 1999

INJECTABLE, LIPOSOMAL;INTRAVENOUS

MARQIBO KIT

+! TALON THERAP
5MG/5ML (1MG/ML)
N202497 001 Aug 09, 2012

VINORELBINE TARTRATE

INJECTABLE;INJECTION

NAVELBINE
AP +! PIERRE FABRE EQ 10MG BASE/ML
N020388 001 Dec 23, 1994

VINORELBINE TARTRATE
AP ACTAVIS TOTOWA EQ 10MG BASE/ML
A078011 001 Jul 22, 2009

AP DR REDDYS LABS LTD EQ 10MG BASE/ML


A202017 001 Sep 12, 2013

AP FRESENIUS KABI USA EQ 10MG BASE/ML


A076849 001 Apr 18, 2005

AP HOSPIRA EQ 10MG BASE/ML


A076827 001 Jun 02, 2005

AP JIANGSU HANSOH EQ 10MG BASE/ML


A091106 001 Sep 26, 2012

PHARM
AP TEVA PHARMS USA EQ 10MG BASE/ML
A076028 001 Feb 03, 2003

AP WEST-WARD PHARMS EQ 10MG BASE/ML


A075992 001 Jun 10, 2003

INT
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-445(of 452)

VINORELBINE TARTRATE

INJECTABLE;INJECTION

VINORELBINE TARTRATE

AP EQ 10MG BASE/ML A076461 001 Dec 11, 2003

VISMODEGIB

CAPSULE;ORAL

ERIVEDGE

+! GENENTECH 150MG N203388 001 Jan 30, 2012

VITAMIN A PALMITATE

INJECTABLE;INJECTION

AQUASOL A

+! CASPER PHARMA LLC EQ 50,000 UNITS BASE/ML N006823 001

VORAPAXAR SULFATE

TABLET;ORAL

ZONTIVITY

+! ARALEZ PHARMS EQ 2.08MG BASE N204886 001 May 08, 2014

VORICONAZOLE

FOR SUSPENSION;ORAL

VFEND

AB +! PF PRISM CV 200MG/5ML N021630 001 Dec 19, 2003

VORICONAZOLE

AB AMNEAL PHARMS 200MG/5ML A205034 001 Apr 13, 2016

AB NOVEL LABS INC 200MG/5ML A206799 001 May 31, 2016

INJECTABLE;IV (INFUSION)

VFEND

AP +! PF PRISM CV 200MG/VIAL N021267 001 May 24, 2002

VORICONAZOLE

AP ALVOGEN INC 200MG/VIAL A206398 001 Mar 23, 2016

AP HAINAN POLY PHARM 200MG/VIAL A211661 001 Nov 30, 2018

AP SANDOZ INC 200MG/VIAL A090862 001 May 30, 2012

AP ZYDUS PHARMS USA 200MG/VIAL A208983 001 Jul 16, 2018

INC

POWDER;IV (INFUSION)

VORICONAZOLE

XELLIA PHARMS APS 200MG/VIAL N208562 001 Mar 09, 2017

TABLET;ORAL

VFEND

AB + PF PRISM CV 50MG N021266 001 May 24, 2002

AB +! 200MG N021266 002 May 24, 2002

VORICONAZOLE

AB AJANTA PHARMA LTD 50MG A206181 001 May 24, 2016

AB 200MG A206181 002 May 24, 2016

AB AKORN 50MG A207049 001 Sep 07, 2016

AB 200MG A207049 002 Sep 07, 2016

AB AUROBINDO PHARMA 50MG A206837 001 Jan 22, 2016

LTD

AB 200MG A206837 002 Jan 22, 2016

AB GLENMARK PHARMS LTD 50MG A203503 001 Sep 02, 2015

AB 200MG A203503 002 Sep 02, 2015

AB MYLAN PHARMS INC 50MG A090547 001 Apr 22, 2010

AB 200MG A090547 002 Apr 22, 2010

AB NOVEL LABS INC 50MG A207371 001 May 24, 2016

AB 200MG A207371 002 May 24, 2016

AB PRINSTON INC 50MG A206654 001 Aug 08, 2016

AB 200MG A206654 002 Aug 08, 2016

AB RISING PHARMS 50MG A206762 001 May 24, 2016

AB 200MG A206762 002 May 24, 2016

AB SANDOZ INC 50MG A200265 001 Dec 12, 2011

AB 200MG A200265 002 Dec 12, 2011

AB TEVA PHARMS 50MG A091658 001 Apr 06, 2012

AB 200MG A091658 002 Apr 06, 2012

AB ZYDUS PHARMS USA 50MG A206747 001 May 24, 2016

INC

AB 200MG A206747 002 May 24, 2016

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-446(of 452)

VORINOSTAT

CAPSULE;ORAL

ZOLINZA

+! MERCK 100MG N021991 001 Oct 06, 2006

VORTIOXETINE HYDROBROMIDE

TABLET;ORAL

TRINTELLIX

+ TAKEDA PHARMS USA EQ 5MG BASE N204447 001 Sep 30, 2013

+ EQ 10MG BASE N204447 002 Sep 30, 2013

+! EQ 20MG BASE N204447 004 Sep 30, 2013



WARFARIN SODIUM

TABLET;ORAL

COUMADIN

AB + BRISTOL MYERS 1MG N009218 022 Mar 01, 1990

SQUIBB

AB + 2MG N009218 013



AB + 2.5MG N009218 018

AB + 3MG N009218 025 Nov 18, 1996

AB + 4MG N009218 023 Aug 24, 1993

AB + 5MG N009218 007



AB + 6MG N009218 026 Nov 18, 1996

AB + 7.5MG N009218 016



AB +! 10MG N009218 005

JANTOVEN

AB USL PHARMA 1MG A040416 001 Oct 02, 2003

AB 2MG A040416 002 Oct 02, 2003

AB 2.5MG A040416 003 Oct 02, 2003

AB 3MG A040416 004 Oct 02, 2003

AB 4MG A040416 005 Oct 02, 2003

AB 5MG A040416 006 Oct 02, 2003

AB 6MG A040416 007 Oct 02, 2003

AB 7.5MG A040416 008 Oct 02, 2003

AB 10MG A040416 009 Oct 02, 2003

WARFARIN SODIUM

AB AMNEAL PHARMS 1MG A202202 001 Mar 04, 2013

AB 2MG A202202 002 Mar 04, 2013

AB 2.5MG A202202 003 Mar 04, 2013

AB 3MG A202202 004 Mar 04, 2013

AB 4MG A202202 005 Mar 04, 2013

AB 5MG A202202 006 Mar 04, 2013

AB 6MG A202202 007 Mar 04, 2013

AB 7.5MG A202202 008 Mar 04, 2013

AB 10MG A202202 009 Mar 04, 2013

AB BARR 1MG A040145 001 Mar 26, 1997

AB 2MG A040145 002 Mar 26, 1997

AB 2.5MG A040145 003 Mar 26, 1997

AB 3MG A040145 008 Nov 05, 1998

AB 4MG A040145 004 Mar 26, 1997

AB 5MG A040145 005 Mar 26, 1997

AB 6MG A040145 009 Nov 05, 1998

AB 7.5MG A040145 006 Mar 26, 1997

AB 10MG A040145 007 Mar 26, 1997

AB INVAGEN PHARMS 1MG A090935 001 May 25, 2011

AB 2MG A090935 002 May 25, 2011

AB 2.5MG A090935 003 May 25, 2011

AB 3MG A090935 004 May 25, 2011

AB 4MG A090935 005 May 25, 2011

AB 5MG A090935 006 May 25, 2011

AB 6MG A090935 007 May 25, 2011

AB 7.5MG A090935 008 May 25, 2011

AB 10MG A090935 009 May 25, 2011

AB IPCA LABS LTD 1MG A200104 001 Jun 27, 2013

AB 2MG A200104 002 Jun 27, 2013

AB 2.5MG A200104 003 Jun 27, 2013

AB 3MG A200104 004 Jun 27, 2013

AB 4MG A200104 005 Jun 27, 2013

AB 5MG A200104 006 Jun 27, 2013

AB 6MG A200104 007 Jun 27, 2013

AB 7.5MG A200104 008 Jun 27, 2013

AB 10MG A200104 009 Jun 27, 2013

AB PLIVA 1MG A040616 009 Jul 05, 2006

AB 2MG A040616 001 Jul 05, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-447(of 452)

WARFARIN SODIUM

TABLET;ORAL

WARFARIN SODIUM

AB 2.5MG A040616 002 Jul 05, 2006

AB 3MG A040616 003 Jul 05, 2006

AB 4MG A040616 004 Jul 05, 2006

AB 5MG A040616 005 Jul 05, 2006

AB 6MG A040616 006 Jul 05, 2006

AB 7.5MG A040616 007 Jul 05, 2006

AB 10MG A040616 008 Jul 05, 2006

AB TARO PHARM 1MG A040301 002 Jul 15, 1999

AB 2MG A040301 003 Jul 15, 1999

AB 2.5MG A040301 004 Jul 15, 1999

AB 3MG A040301 005 Jul 15, 1999

AB 4MG A040301 006 Jul 15, 1999

AB 5MG A040301 007 Jul 15, 1999

AB 6MG A040301 008 Jul 15, 1999

AB 7.5MG A040301 009 Jul 15, 1999

AB 10MG A040301 001 Jul 15, 1999

AB ZYDUS PHARMS USA 1MG A040663 001 May 30, 2006

AB 2MG A040663 002 May 30, 2006

AB 2.5MG A040663 003 May 30, 2006

AB 3MG A040663 004 May 30, 2006

AB 4MG A040663 005 May 30, 2006

AB 5MG A040663 006 May 30, 2006

AB 6MG A040663 007 May 30, 2006

AB 7.5MG A040663 008 May 30, 2006

AB 10MG A040663 009 May 30, 2006



XENON XE-133

GAS;INHALATION

XENON XE 133

LANTHEUS MEDCL 10mCi/VIAL N017284 001

20mCi/VIAL N017284 002

MALLINKRODT NUCLEAR 10mCi/VIAL N018327 001 Mar 09, 1982

20mCi/VIAL N018327 002 Mar 09, 1982

ZAFIRLUKAST

TABLET;ORAL

ACCOLATE

AB + PAR PHARM INC 10MG N020547 003 Sep 17, 1999

AB +! 20MG N020547 001 Sep 26, 1996

ZAFIRLUKAST

AB DR REDDYS LABS LTD 10MG A090372 001 Nov 18, 2010

AB 20MG A090372 002 Nov 18, 2010



ZALEPLON

CAPSULE;ORAL

SONATA

AB + PFIZER 5MG N020859 001 Aug 13, 1999

AB +! 10MG N020859 002 Aug 13, 1999

ZALEPLON

AB AUROBINDO PHARMA 5MG A078829 001 Jun 06, 2008

AB 10MG A078829 002 Jun 06, 2008

AB CIPLA LTD 5MG A077505 001 Jun 20, 2008

AB 10MG A077505 002 Jun 20, 2008

AB HIKMA PHARMS 5MG A078147 001 Nov 25, 2008

AB 10MG A078147 002 Nov 25, 2008

AB ORCHID HLTHCARE 5MG A090374 001 Sep 17, 2009

AB 10MG A090374 002 Sep 17, 2009

AB TEVA PHARMS 5MG A077239 001 Jun 06, 2008

AB 10MG A077239 002 Jun 06, 2008

AB UNICHEM 5MG A078989 001 Jun 06, 2008

AB 10MG A078989 002 Jun 06, 2008

AB WEST-WARD PHARMS 5MG A077237 001 Jun 06, 2008

INT

AB 10MG A077237 002 Jun 06, 2008

ZANAMIVIR

POWDER;INHALATION

RELENZA

+! GLAXOSMITHKLINE 5MG N021036 001 Jul 26, 1999

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-448(of 452)

ZICONOTIDE ACETATE

INJECTABLE;INTRATHECAL

PRIALT

+! TERSERA THERAPS LLC 100MCG/1ML (100MCG/ML) N021060 002 Dec 28, 2004

+! 500MCG/20ML (25MCG/ML) N021060 001 Dec 28, 2004

+! 500MCG/5ML (100MCG/ML) N021060 004 Dec 28, 2004

ZIDOVUDINE

CAPSULE;ORAL

RETROVIR

AB +! VIIV HLTHCARE 100MG N019655 001 Mar 19, 1987

ZIDOVUDINE

AB AUROBINDO PHARMA 100MG A078128 001 Mar 27, 2006

LTD

AB CIPLA LTD 100MG A078349 001 May 23, 2007

INJECTABLE;INJECTION

RETROVIR

AP +! VIIV HLTHCARE 10MG/ML N019951 001 Feb 02, 1990

ZIDOVUDINE

AP LUITPOLD 10MG/ML A091457 001 May 06, 2010

SYRUP;ORAL

RETROVIR

AA +! VIIV HLTHCARE 50MG/5ML N019910 001 Sep 28, 1989

ZIDOVUDINE

AA AUROBINDO 50MG/5ML A077268 001 Sep 19, 2005

AA CIPLA LTD 50MG/5ML A077981 001 Jun 26, 2008



TABLET;ORAL

ZIDOVUDINE

AB AUROBINDO 300MG A077267 001 Sep 19, 2005

AB CIPLA 300MG A090561 001 Oct 27, 2010

AB ! HETERO LABS LTD III 300MG A090092 001 Apr 25, 2008

AB MYLAN PHARMS INC 300MG A078922 001 Feb 14, 2008

AB WEST-WARD PHARMS 300MG A076844 001 Sep 19, 2005

INT

ZILEUTON

TABLET;ORAL

ZYFLO

+! CHIESI USA INC 600MG N020471 003 Dec 09, 1996

TABLET, EXTENDED RELEASE;ORAL

ZILEUTON

AB RISING PHARMS 600MG A204929 001 Mar 17, 2017

ZYFLO CR

AB +! CHIESI USA INC 600MG N022052 001 May 30, 2007

ZINC ACETATE

CAPSULE;ORAL

GALZIN

+ TEVA EQ 25MG ZINC N020458 001 Jan 28, 1997

+! EQ 50MG ZINC N020458 002 Jan 28, 1997

ZINC CHLORIDE

INJECTABLE;INJECTION

ZINC CHLORIDE IN PLASTIC CONTAINER

+! HOSPIRA EQ 1MG ZINC/ML N018959 001 Jun 26, 1986

ZIPRASIDONE HYDROCHLORIDE

CAPSULE;ORAL

GEODON

AB +! PFIZER EQ 20MG BASE N020825 001 Feb 05, 2001

AB + EQ 40MG BASE N020825 002 Feb 05, 2001

AB + EQ 60MG BASE N020825 003 Feb 05, 2001

AB + EQ 80MG BASE N020825 004 Feb 05, 2001

ZIPRASIDONE HYDROCHLORIDE

AB APOTEX INC EQ 20MG BASE A077561 001 Mar 02, 2012

AB EQ 40MG BASE A077561 002 Mar 02, 2012

AB EQ 60MG BASE A077561 003 Mar 02, 2012

AB EQ 80MG BASE A077561 004 Mar 02, 2012

AB AUROBINDO PHARMA EQ 20MG BASE A204117 001 Dec 27, 2016

LTD

AB EQ 40MG BASE A204117 002 Dec 27, 2016

AB EQ 60MG BASE A204117 003 Dec 27, 2016

AB EQ 80MG BASE A204117 004 Dec 27, 2016

AB DR REDDYS LABS INC EQ 20MG BASE A077565 001 Mar 02, 2012

AB EQ 40MG BASE A077565 002 Mar 02, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-449(of 452)

ZIPRASIDONE HYDROCHLORIDE

CAPSULE;ORAL

ZIPRASIDONE HYDROCHLORIDE
AB EQ 60MG BASE
A077565 003 Mar 02, 2012

AB EQ 80MG BASE
A077565 004 Mar 02, 2012

AB LUPIN PHARMS EQ 20MG BASE


A077560 001 Mar 02, 2012

AB EQ 40MG BASE
A077560 002 Mar 02, 2012

AB EQ 60MG BASE
A077560 003 Mar 02, 2012

AB EQ 80MG BASE
A077560 004 Mar 02, 2012

AB MACLEODS PHARMS LTD EQ 20MG BASE


A204375 001 Feb 17, 2017

AB EQ 40MG BASE
A204375 002 Feb 17, 2017

AB EQ 60MG BASE
A204375 003 Feb 17, 2017

AB EQ 80MG BASE
A204375 004 Feb 17, 2017

AB SANDOZ INC EQ 20MG BASE


A077562 001 Jun 01, 2012

AB EQ 40MG BASE
A077562 002 Jun 01, 2012

AB EQ 60MG BASE
A077562 003 Jun 01, 2012

AB EQ 80MG BASE
A077562 004 Jun 01, 2012

AB WOCKHARDT LTD EQ 20MG BASE


A090348 001 Sep 05, 2012

AB EQ 40MG BASE
A090348 002 Sep 05, 2012

AB EQ 60MG BASE
A090348 003 Sep 05, 2012

AB EQ 80MG BASE
A090348 004 Sep 05, 2012

AB ZYDUS PHARMS USA EQ 20MG BASE


A208988 001 Aug 22, 2017

INC
AB EQ 40MG BASE
A208988 002 Aug 22, 2017

AB EQ 60MG BASE
A208988 003 Aug 22, 2017

AB EQ 80MG BASE
A208988 004 Aug 22, 2017

ZIPRASIDONE MESYLATE

INJECTABLE;INTRAMUSCULAR

GEODON

+! PFIZER
EQ 20MG BASE/ML
N020919 001 Jun 21, 2002

ZOLEDRONIC ACID

INJECTABLE;IV (INFUSION)

RECLAST

AP +! NOVARTIS
EQ 5MG BASE/100ML
N021817 001 Apr 16, 2007

ZOLEDRONIC

AP GLAND PHARMA LTD
EQ 4MG BASE/100ML
A205749 001 Jun 29, 2018

ZOLEDRONIC ACID

AP ACCORD HLTHCARE
EQ 4MG BASE/5ML
A205279 001 Nov 28, 2016

AP ACTAVIS INC
EQ 4MG BASE/5ML
A202472 001 Mar 04, 2013

AP AKORN
EQ 5MG BASE/100ML
A200918 001 Aug 21, 2014

AP AKORN INC
EQ 4MG BASE/5ML
A202548 001 May 22, 2014

AP APOTEX INC
EQ 5MG BASE/100ML
A204367 001 Dec 24, 2015

AP AUROBINDO PHARMA
EQ 4MG BASE/5ML
A207751 001 Sep 26, 2016

LTD

AP
EQ 5MG BASE/100ML
A209125 001 Dec 08, 2017

AP BPI LABS LLC


EQ 4MG BASE/5ML
A207341 001 Dec 29, 2017

AP BRECKENRIDGE PHARM
EQ 4MG BASE/5ML
A091170 001 Mar 04, 2013

AP
EQ 4MG BASE/5ML
A202571 001 May 07, 2013

AP
EQ 5MG BASE/100ML
A202163 001 Aug 05, 2013

AP CIPLA
EQ 4MG BASE/100ML
A210174 001 Oct 27, 2017

AP DR REDDYS LABS LTD


EQ 4MG BASE/5ML
A091186 001 Mar 04, 2013

AP
EQ 4MG BASE/100ML
A204344 001 Nov 19, 2018

AP
EQ 5MG BASE/100ML
A091363 001 Mar 29, 2013

AP EMCURE PHARMS LTD


EQ 4MG BASE/5ML
A201783 001 Mar 12, 2013

AP
EQ 5MG BASE/100ML
A201801 001 Mar 29, 2013

AP FRESENIUS KABI USA


EQ 4MG BASE/5ML
A091516 001 Apr 23, 2015

AP GLAND PHARMA LTD


EQ 4MG BASE/5ML
A202930 001 Aug 05, 2013

AP
EQ 5MG BASE/100ML
A204217 001 Aug 18, 2016

AP HIKMA FARMACEUTICA
EQ 4MG BASE/5ML
A202182 001 Jun 03, 2013

AP HOSPIRA INC
EQ 4MG BASE/5ML
A090621 001 Mar 19, 2015

AP
EQ 5MG BASE/100ML
A202837 001 Apr 05, 2013

AP INFORLIFE
EQ 4MG BASE/100ML
N203231 001 Aug 02, 2013

AP
EQ 5MG BASE/100ML
A202828 001 Sep 23, 2013

AP MYLAN LABS LTD


EQ 4MG BASE/5ML
A202650 001 Mar 04, 2013

AP
EQ 5MG BASE/100ML
A203841 001 Feb 14, 2017

AP
EQ 5MG BASE/100ML
A205254 001 Oct 27, 2017

AP SAGENT PHARMS
EQ 4MG BASE/5ML
A091493 001 Nov 24, 2014

AP USV NORTH AMERICA


EQ 4MG BASE/5ML
A202923 001 Sep 04, 2014

ZOMETA

AP +! NOVARTIS
EQ 4MG BASE/5ML
N021223 002 Mar 07, 2003

AP +!
EQ 4MG BASE/100ML
N021223 003 Jun 17, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-450(of 452)

ZOLEDRONIC ACID

SOLUTION;IV (INFUSION)

ZOLEDRONIC ACID

HOSPIRA INC EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) N204016 001 Dec 28, 2015

ZOLMITRIPTAN

SPRAY;NASAL

ZOMIG

+ ASTRAZENECA 2.5MG/SPRAY N021450 003 Sep 16, 2013

+! 5MG/SPRAY N021450 004 Sep 30, 2003

TABLET;ORAL

ZOLMITRIPTAN

AB AJANTA PHARMA LTD 2.5MG A204041 001 May 20, 2016

AB 5MG A204041 002 May 20, 2016

AB ALEMBIC PHARMS LTD 2.5MG A204232 001 Sep 30, 2015

AB 5MG A204232 002 Sep 30, 2015

AB AUROBINDO PHARMA 2.5MG A207021 001 May 11, 2016

LTD

AB 5MG A207021 002 May 11, 2016

AB GLENMARK GENERICS 2.5MG A201779 001 May 14, 2013

AB 5MG A201779 002 May 14, 2013

AB INVAGEN PHARMS 2.5MG A204284 001 Apr 09, 2014

AB 5MG A204284 002 Apr 09, 2014

AB JUBILANT GENERICS 2.5MG A202279 001 Nov 20, 2014

AB 5MG A202279 002 Nov 20, 2014

AB MACLEODS PHARMS LTD 2.5MG A203772 001 Sep 30, 2015

AB 5MG A203772 002 Sep 30, 2015

AB PLD ACQUISITIONS 2.5MG A207867 001 Feb 27, 2017

LLC

AB 5MG A207867 002 Feb 27, 2017

AB TEVA PHARMS USA 2.5MG A090861 001 Mar 04, 2014

AB 5MG A090861 002 Mar 04, 2014

AB TWI PHARMS 2.5MG A206973 001 Jun 30, 2017

AB 5MG A206973 002 Jun 30, 2017

AB ZYDUS PHARMS USA 2.5MG A203019 001 Jul 11, 2018

INC

AB 5MG A203019 002 Jul 11, 2018

ZOMIG

AB + IPR 2.5MG N020768 001 Nov 25, 1997

AB +! 5MG N020768 002 Nov 25, 1997



TABLET, ORALLY DISINTEGRATING;ORAL

ZOLMITRIPTAN

AB ALEMBIC PHARMS LTD 2.5MG A205074 001 Dec 01, 2016

AB 5MG A205074 002 Dec 01, 2016

AB GLENMARK GENERICS 2.5MG A202560 001 May 14, 2013

AB 5MG A202560 002 May 14, 2013

AB JUBILANT GENERICS 2.5MG A202956 001 Sep 17, 2015

AB 5MG A202956 002 Sep 17, 2015

AB MACLEODS PHARMS LTD 2.5MG A204336 001 Oct 22, 2015

AB 5MG A204336 002 Oct 22, 2015

AB ZYDUS PHARMS USA 2.5MG A202890 001 May 15, 2013

INC

AB 5MG A202890 002 May 15, 2013

ZOMIG-ZMT

AB + ASTRAZENECA 2.5MG N021231 001 Feb 13, 2001

AB +! 5MG N021231 002 Sep 17, 2001



ZOLPIDEM TARTRATE

SPRAY, METERED;ORAL

ZOLPIMIST

+! MAGNA PHARMS 5MG/SPRAY N022196 001 Dec 19, 2008

TABLET;ORAL

AMBIEN

AB + SANOFI AVENTIS US 5MG N019908 001 Dec 16, 1992

AB +! 10MG N019908 002 Dec 16, 1992

ZOLPIDEM TARTRATE

AB ACME LABS 5MG A077214 001 Apr 23, 2007

AB 10MG A077214 002 Apr 23, 2007

AB APOTEX INC 5MG A077884 001 Apr 23, 2007

AB 10MG A077884 002 Apr 23, 2007

AB AUROBINDO PHARMA 5MG A078413 001 May 04, 2007

AB 10MG A078413 002 May 04, 2007

AB CIPLA LTD 5MG A077388 001 Jul 30, 2012

AB 10MG A077388 002 Jul 30, 2012



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST 3-451(of 452)

ZOLPIDEM TARTRATE

TABLET;ORAL

ZOLPIDEM TARTRATE

AB INVAGEN PHARMS 5MG A078184 001 Sep 07, 2007

AB 10MG A078184 002 Sep 07, 2007

AB MYLAN 5MG A076578 001 Apr 23, 2007

AB 10MG A076578 002 Apr 23, 2007

AB SANDOZ INC 5MG A077322 001 Apr 23, 2007

AB 10MG A077322 002 Apr 23, 2007

AB SUN PHARM INDS INC 5MG A077359 001 Apr 23, 2007

AB 10MG A077359 002 Apr 23, 2007

AB TEVA 5MG A076410 001 Apr 23, 2007

AB 10MG A076410 002 Apr 23, 2007

AB TORRENT PHARMS 5MG A077903 001 Aug 17, 2007

AB 10MG A077903 002 Aug 17, 2007

AB VINTAGE 5MG A078616 001 Nov 21, 2008

AB 10MG A078616 002 Nov 21, 2008

AB WOCKHARDT 5MG A078426 001 May 15, 2007

AB 10MG A078426 002 May 15, 2007

AB YUNG SHIN PHARM 5MG A077990 001 Apr 23, 2007

AB 10MG A077990 002 Apr 23, 2007

TABLET;SUBLINGUAL

EDLUAR

AB + MYLAN SPECIALITY LP 5MG N021997 001 Mar 13, 2009

AB +! 10MG N021997 002 Mar 13, 2009

INTERMEZZO

AB + PURDUE PHARMA 1.75MG N022328 001 Nov 23, 2011

AB +! 3.5MG N022328 002 Nov 23, 2011

ZOLPIDEM TARTRATE

AB DR REDDYS LABS INC 1.75MG A204503 001 Nov 18, 2016

AB 3.5MG A204503 002 Nov 18, 2016

AB MYLAN PHARMS INC 5MG A202657 001 Aug 08, 2016

AB 10MG A202657 002 Aug 08, 2016

AB NOVEL LABS INC 1.75MG A204299 001 Jun 03, 2015

AB 3.5MG A204299 002 Jun 03, 2015

AB PAR FORM 5MG A201509 001 Aug 01, 2016

AB 10MG A201509 002 Aug 01, 2016

AB PAR PHARM INC 1.75MG A204229 001 Sep 11, 2017

AB 3.5MG A204229 002 Sep 11, 2017

TABLET, EXTENDED RELEASE;ORAL

AMBIEN CR

AB + SANOFI AVENTIS US 6.25MG N021774 002 Sep 02, 2005

AB +! 12.5MG N021774 001 Sep 02, 2005

ZOLPIDEM TARTRATE

AB ACTAVIS ELIZABETH 6.25MG A078179 002 Oct 13, 2010

AB 12.5MG A078179 001 Jun 06, 2011

AB ACTAVIS LABS FL INC 6.25MG A090153 001 Mar 25, 2013

AB 12.5MG A090153 002 Mar 25, 2013

AB ANCHEN PHARMS 6.25MG A078148 002 Apr 14, 2011

AB 12.5MG A078148 001 Dec 03, 2010

AB APOTEX INC 6.25MG A200266 001 Sep 10, 2013

AB 12.5MG A200266 002 Sep 10, 2013

AB LUPIN LTD 6.25MG A078970 001 Sep 11, 2013

AB 12.5MG A078970 002 Sep 11, 2013

AB SANDOZ 6.25MG A090107 001 Jul 01, 2011

AB 12.5MG A090107 002 Jul 01, 2011

AB SUN PHARMA GLOBAL 6.25MG A204170 001 Jan 24, 2017

AB 12.5MG A204170 002 Jan 24, 2017



ZONISAMIDE

CAPSULE;ORAL

ZONEGRAN

AB + SUNOVION PHARMS INC 25MG N020789 003 Aug 22, 2003

AB +! 100MG N020789 001 Mar 27, 2000

ZONISAMIDE

AB APOTEX INC 25MG A077642 001 Dec 22, 2005

AB 50MG A077642 002 Dec 22, 2005

AB 100MG A077642 003 Dec 22, 2005

AB BLUEPHARMA 25MG A077813 001 Aug 16, 2006

AB 50MG A077813 002 Aug 16, 2006

AB 100MG A077813 003 Aug 16, 2006

AB GLENMARK GENERICS 25MG A077651 001 Jan 30, 2006

AB 50MG A077651 002 Jan 30, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

PRESCRIPTION DRUG PRODUCT LIST
3-452(of 452)

ZONISAMIDE

CAPSULE;ORAL

ZONISAMIDE
AB 100MG A077651 003 Jan 30, 2006

AB INVAGEN PHARMS 25MG A077869 001 May 31, 2006

AB 50MG A077869 002 May 31, 2006

AB 100MG A077869 003 May 31, 2006

AB MYLAN 25MG A077637 001 Dec 22, 2005

AB 50MG A077637 002 Dec 22, 2005

AB 100MG A077637 003 Dec 22, 2005

AB SUN PHARM INDS (IN) 25MG A077634 001 Mar 17, 2006

AB 50MG A077634 002 Mar 17, 2006

AB 100MG A077634 003 Mar 17, 2006

AB WOCKHARDT 25MG A077636 003 Jul 27, 2006

AB 50MG A077636 002 Jul 27, 2006

AB 100MG A077636 001 Dec 22, 2005

AB ZYDUS PHARMS USA 25MG A077625 001 Oct 16, 2006

AB 50MG A077625 002 Oct 16, 2006

AB 100MG A077625 003 Oct 16, 2006



39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-1(of 20)

ACETAMINOPHEN

SUPPOSITORY;RECTAL

ACEPHEN

G AND W LABS
120MG
N018060 001

325MG
A072344 001
Mar 27, 1992

650MG
A072237 001
Mar 27, 1992

ACETAMINOPHEN

PERRIGO NEW YORK
120MG
A070607 001
Apr 06, 1987

650MG
A070608 001
Dec 01, 1986

+ TARO PHARM INDS LTD
120MG
N018337 003
Sep 12, 1983

+
325MG
N018337 002

+!
650MG
N018337 001

INFANTS' FEVERALL

+ TARO PHARM INDS LTD
80MG
N018337 004
Aug 26, 1992

NEOPAP

POLYMEDICA
120MG
N016401 001

TABLET, EXTENDED RELEASE;ORAL

ACETAMINOPHEN

AUROBINDO PHARMA
650MG
A207229 001
Nov 09, 2016

LTD

HERITAGE PHARMA
650MG
A207035 001
May 31, 2018

OHM LABS
650MG
A076200 001
Mar 19, 2002

PERRIGO
650MG
A075077 001
Feb 25, 2000

SUN PHARM INDS LTD
650MG
A078569 001
Dec 14, 2011

TYLENOL

+! J AND J CONSUMER
650MG
N019872 001
Jun 08, 1994

INC

+!
650MG
N019872 002
Jan 11, 2001

ACETAMINOPHEN; ASPIRIN; CAFFEINE

TABLET;ORAL

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

PERRIGO 250MG;250MG;65MG
A075794 001
Nov 26, 2001

EXCEDRIN (MIGRAINE)

+! GLAXOSMITHKLINE 250MG;250MG;65MG
N020802 001
Jan 14, 1998

CONS

ADAPALENE

GEL;TOPICAL

DIFFERIN

+! GALDERMA LABS LP 0.1%
N020380 002
Jul 08, 2016

ALCOHOL; CHLORHEXIDINE GLUCONATE

SOLUTION;TOPICAL

AVAGARD

+! 3M 61%;1%
N021074 001
Jun 07, 2001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE;ORAL

GAVISCON

+ SANOFI AVENTIS US 80MG;20MG
N018685 001
Dec 09, 1983

ASPIRIN

CAPSULE;ORAL

VAZALORE

+! PLX PHARMA 325MG
N203697 001
Jan 14, 2013

AVOBENZONE; ECAMSULE; OCTOCRYLENE

CREAM;TOPICAL

ANTHELIOS SX

+! LOREAL USA 2%;2%;10%
N021502 001
Jul 21, 2006

CAPITAL SOLEIL 15

+! LOREAL USA 2%;3%;10%
N021501 001
Oct 02, 2006

AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE

CREAM;TOPICAL

ANTHELIOS 20

+! LOREAL USA
2%;2%;10%;2%
N021471 001
Oct 05, 2006

ANTHELIOS 40

+! LOREAL USA
2%;3%;10%;5%
N022009 001
Mar 31, 2008

+!
2%;3%;10%;5%
N022009 002
Oct 29, 2009

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-2(of 20)

BENTOQUATAM

LOTION;TOPICAL

IVY BLOCK

+! STAND HOMEOPATH
5%
N020532 001
Aug 26, 1996

BRIMONIDINE TARTRATE

SOLUTION/DROPS;OPHTHALMIC

LUMIFY

+! BAUSCH AND LOMB INC
0.025%
N208144 001
Dec 22, 2017

BUDESONIDE

SPRAY, METERED;NASAL

BUDESONIDE

APOTEX INC
0.032MG/SPRAY
A078949 002
Nov 20, 2015

RHINOCORT ALLERGY

+! ASTRAZENECA PHARMS
0.032MG/SPRAY
N020746 003
Mar 23, 2015

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

BUTENAFINE HYDROCHLORIDE

TARO PHARMS
1%
A205181 001
Nov 16, 2017

LOTRIMIN ULTRA

+! BAYER HEALTHCARE
1%
N021307 001
Dec 07, 2001

LLC

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE;ORAL

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

PERRIGO R AND D
800MG;10MG;165MG
A077355 001
Feb 06, 2008

800MG;10MG;165MG
A204782 001
Aug 29, 2016

PEPCID COMPLETE

+! J AND J CONSUMER
800MG;10MG;165MG
N020958 001
Oct 16, 2000

INC

CETIRIZINE HYDROCHLORIDE

CAPSULE;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

APOTEX INC 10MG A207235 001
Aug 12, 2016

AUROBINDO PHARMA 10MG A209107 001


Jul 20, 2018

LTD
+ BIONPHARMA INC 5MG N022429 001
Jul 23, 2009

+! 10MG N022429 004
Jul 23, 2009

STRIDES PHARMA 10MG A205291 001
Jul 21, 2017

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

AUROBINDO PHARMA 10MG
A209107 002
Jul 20, 2018

LTD

+ BIONPHARMA INC 5MG
N022429 003
Jul 23, 2009

+! 10MG
N022429 002
Jul 23, 2009

SYRUP;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

AMNEAL PHARMS
5MG/5ML
A090765 002
Oct 07, 2009

APNAR PHARMA LP
5MG/5ML
A091327 001
Oct 17, 2011

AUROBINDO PHARMA
5MG/5ML
A090750 002
Feb 02, 2010

BIO PHARM INC
5MG/5ML
A090474 002
Mar 30, 2009

LANNETT CO INC
5MG/5ML
A091130 001
Apr 22, 2011

PERRIGO R AND D
5MG/5ML
A204226 001
Sep 09, 2013

5MG/5ML
A090254 002
Apr 09, 2008

TARO
5MG/5ML
A090182 002
Apr 22, 2008

5MG/5ML
A201546 001
May 20, 2011

TRIS PHARMA INC


5MG/5ML
A090572 001
Nov 16, 2012

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF

AMNEAL PHARMS
5MG/5ML
A090765 001
Oct 07, 2009

APNAR PHARMA LP
5MG/5ML
A091327 002
Oct 17, 2011

AUROBINDO PHARMA
5MG/5ML
A090750 001
Feb 02, 2010

BIO PHARM INC
5MG/5ML
A090474 001
Mar 30, 2009

LANNETT CO INC
5MG/5ML
A091130 002
Apr 22, 2011

PERRIGO R AND D
5MG/5ML
A090254 001
Apr 09, 2008

TARO
5MG/5ML
A090182 001
Apr 22, 2008

5MG/5ML
A201546 002
May 20, 2011

TRIS PHARMA INC


5MG/5ML
A090572 002
Nov 16, 2012

CHILDREN'S ZYRTEC ALLERGY

+! J AND J CONSUMER 5MG/5ML
N022155 002
Nov 16, 2007

INC

CHILDREN'S ZYRTEC HIVES RELIEF

+! J AND J CONSUMER 5MG/5ML
N022155 001
Nov 16, 2007

INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-3(of 20)

CETIRIZINE HYDROCHLORIDE
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS NY 5MG A078780 001 Jan 21, 2010
10MG A078780 004 Jan 21, 2010
APOTEX INC 5MG A078317 001 Dec 27, 2007
10MG A078317 002 Dec 27, 2007
AUROBINDO PHARMA 5MG A090760 001 Aug 05, 2015
LTD
10MG A090760 003 Aug 05, 2015
CIPLA LTD 5MG A077318 001 Jul 25, 2013
10MG A077318 002 Jul 25, 2013
CONTRACT PHARMACAL 5MG A076047 001 Dec 27, 2007
10MG A076047 002 Dec 27, 2007
DR REDDYS LABS LTD 5MG A078343 004 Jan 15, 2008
10MG A078343 003 Jan 15, 2008
GRANULES INDIA LTD 10MG A209274 001 Dec 22, 2017
IPCA LABS LTD 5MG A202277 002 Mar 11, 2014
10MG A202277 004 Mar 11, 2014
MARKSANS PHARMA 5MG A078933 001 Jun 15, 2010
10MG A078933 002 Jun 15, 2010
MYLAN 5MG A076677 001 Dec 27, 2007
10MG A076677 002 Dec 27, 2007
ORCHID HLTHCARE 5MG A078862 001 Feb 19, 2009
10MG A078862 002 Feb 19, 2009
PERRIGO R AND D 5MG A078336 001 Dec 27, 2007
10MG A078336 002 Dec 27, 2007
PLD ACQUISITIONS 5MG A077946 001 Dec 27, 2007
10MG A077946 002 Dec 27, 2007
SUN PHARM INDS INC 5MG A077499 001 Dec 27, 2007
10MG A077499 002 Dec 27, 2007
SUN PHARM INDS LTD 5MG A077498 001 Dec 27, 2007
10MG A077498 002 Dec 27, 2007
TARO 5MG A078072 001 Jul 22, 2009
5MG A078072 003 Jul 22, 2009
TORRENT PHARMS LLC 5MG A079191 001 Apr 15, 2010
10MG A079191 004 Apr 15, 2010
UNICHEM 5MG A078680 003 Jun 26, 2009
10MG A078680 004 Jun 26, 2009
UNIQUE PHARM LABS 5MG A077829 001 Aug 26, 2009
10MG A077829 004 Aug 26, 2009
WOCKHARDT 5MG A078427 003 Dec 28, 2007
10MG A078427 004 Dec 28, 2007
CETIRIZINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 5MG A078343 001 Jan 15, 2008
10MG A078343 002 Jan 15, 2008
IPCA LABS LTD 5MG A202277 001 Mar 11, 2014
10MG A202277 003 Mar 11, 2014
MARKSANS PHARMA 5MG A078933 003 Jun 15, 2010
10MG A078933 004 Jun 15, 2010
MYLAN 5MG A076677 004 Dec 27, 2007
10MG A076677 003 Dec 27, 2007
ORCHID HLTHCARE 5MG A078862 003 Feb 19, 2009
10MG A078862 004 Feb 19, 2009
PERRIGO R AND D 5MG A078336 003 Dec 27, 2007
10MG A078336 004 Dec 27, 2007
SUN PHARM INDS INC 5MG A077499 003 Dec 27, 2007
10MG A077499 004 Dec 27, 2007
SUN PHARM INDS LTD 5MG A077498 003 Dec 27, 2007
10MG A077498 004 Dec 27, 2007
UNICHEM 5MG A078680 001 Jun 26, 2009
10MG A078680 002 Jun 26, 2009
UNIQUE PHARM LABS 5MG A077829 003 Aug 26, 2009
! 10MG A077829 002 Aug 26, 2009
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS NY 5MG A078780 003 Jan 21, 2010
10MG A078780 002 Jan 21, 2010
AUROBINDO PHARMA 5MG A090760 002 Aug 05, 2015
LTD
10MG A090760 004 Aug 05, 2015
TARO 10MG A078072 002 Jul 22, 2009
10MG A078072 004 Jul 22, 2009
TORRENT PHARMS LLC 5MG A079191 003 Apr 15, 2010
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-4(of 20)

CETIRIZINE HYDROCHLORIDE
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
10MG A079191 002 Apr 15, 2010
ZYRTEC ALLERGY
+! J AND J CONSUMER 10MG N019835 004 Nov 16, 2007
INC
TABLET, CHEWABLE;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
JUBILANT GENERICS 5MG A091116 001 Feb 19, 2015
10MG A091116 002 Feb 19, 2015
NOVEL LABS INC 5MG A206793 001 Mar 08, 2016
10MG A206793 002 Mar 08, 2016
SANDOZ 5MG A078692 001 Feb 14, 2008
! 10MG A078692 002 Feb 14, 2008
SUN PHARMA GLOBAL 5MG A090142 001 Aug 30, 2011
10MG A090142 002 Aug 30, 2011
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
JUBILANT GENERICS 5MG A091116 003 Feb 19, 2015
10MG A091116 004 Feb 19, 2015
SUN PHARMA GLOBAL 5MG A090142 003 Aug 30, 2011
10MG A090142 004 Aug 30, 2011
TABLET, ORALLY DISINTEGRATING;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
PERRIGO R AND D 10MG A205490 001 Sep 02, 2015
ZYRTEC ALLERGY
+! J AND J CONSUMER 10MG N022578 001 Sep 03, 2010
INC
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA 5MG;120MG A077170 001 Feb 25, 2008
PHARMS
PERRIGO R AND D 5MG;120MG A210719 001 Nov 16, 2018
PLD ACQUISITIONS 5MG;120MG A077991 001 Mar 05, 2008
SUN PHARM INDS LTD 5MG;120MG A090922 001 Sep 28, 2012
ZYRTEC-D 12 HOUR
+! J AND J CONSUMER 5MG;120MG N021150 002 Nov 09, 2007
INC
CHLORHEXIDINE GLUCONATE
AEROSOL, METERED;TOPICAL
EXIDINE
+! XTTRIUM 4% N019127 001 Dec 24, 1984
CLOTH;TOPICAL
CHLORHEXIDINE GLUCONATE
+! SAGE PRODS 2% N021669 001 Apr 25, 2005
READYPREP CHG
MEDLINE INDUSTRIES 2% N207964 001 Nov 20, 2018
SOLUTION;TOPICAL
BRIAN CARE
SOAPCO 4% A071419 001 Dec 17, 1987
CHG SCRUB
ECOLAB 4% N019258 002 Jul 22, 1986
CIDA-STAT
ECOLAB 2% N019258 001 Jul 22, 1986
EXIDINE
+! XTTRIUM 2% N019422 001 Dec 17, 1985
4% N019125 001 Dec 24, 1984
HIBICLENS
+! MOLNLYCKE HLTH 4% N017768 001
HIBISTAT
+! MOLNLYCKE HLTH 0.5% N018300 001
SPONGE;TOPICAL
BIOSCRUB
GRIFFEN 4% N019822 001 Mar 31, 1989
CHLORHEXIDINE GLUCONATE
! BECTON DICKINSON 4% A072525 001 Oct 24, 1989
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-5(of 20)

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL



SOLUTION;TOPICAL

SOLUPREP

+! 3M HEALTH CARE 2%;70% N208288 001 Aug 08, 2018

SPONGE;TOPICAL

CHLORAPREP ONE-STEP

+! BECTON DICKINSON CO 2%;70% (3ML) N020832 001 Jul 14, 2000
+! 2%;70% (10.5ML) N020832 004 Aug 20, 2003
+! 2%;70% (26ML) N020832 006 Nov 21, 2006
+! 2%;70% (1ML) N020832 008 Oct 23, 2008
CHLORAPREP ONE-STEP FREPP
+! BECTON DICKINSON CO 2%;70% (1.5ML) N020832 003 Apr 26, 2002
CHLORAPREP WITH TINT
+! BECTON DICKINSON CO 2%;70% (26ML) N020832 002 May 03, 2005
+! 2%;70% (10.5ML) N020832 005 Apr 03, 2006
+! 2%;70% (3ML) N020832 007 Oct 10, 2006
SWAB;TOPICAL
CHLORAPREP ONE-STEP SEPP
+! BECTON DICKINSON CO 2%;70% (0.67ML) N021555 001 Oct 07, 2002
CHLORAPREP SINGLE SWABSTICK
+! BECTON DICKINSON CO 2%;70% (1.75ML) N021555 002 May 10, 2005
CHLORAPREP TRIPLE SWABSTICK
+! BECTON DICKINSON CO 2%;70% (5.25ML) N021555 003 Jun 10, 2009
PREVANTICS MAXI SWABSTICK
+! PROF DSPLS 3.15%;70% (5.1ML) N021524 003 Jun 03, 2005
PREVANTICS SWAB
+! PROF DSPLS 3.15%;70% (1ML) N021524 001 Jun 03, 2005
PREVANTICS SWABSTICK
+! PROF DSPLS 3.15%;70% (1.6ML) N021524 002 Jun 03, 2005
CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+ BAYER HEALTHCARE 12MG N007638 002
LLC
CHLORPHENIRAMINE MALEATE
! AVANTHI INC 12MG A040829 001 May 13, 2009
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET;ORAL

ADVIL ALLERGY AND CONGESTION RELIEF

+! PFIZER 4MG;200MG;10MG N022113 001 Dec 21, 2011

ADVIL MULTI-SYMPTOM COLD & FLU

+! PFIZER 4MG;200MG;10MG N022113 002 Apr 28, 2017

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

SUSPENSION;ORAL

CHILDREN'S ADVIL ALLERGY SINUS

+! PFIZER 1MG/5ML;100MG/5ML;15MG/5ML N021587 001 Feb 24, 2004

TABLET;ORAL

ADVIL ALLERGY SINUS

+! PFIZER 2MG;200MG;30MG N021441 001 Dec 19, 2002

CIMETIDINE

TABLET;ORAL

CIMETIDINE

APOTEX 100MG A074948 001 Jun 19, 1998

200MG A074948 002 Jul 26, 2002

IVAX SUB TEVA 200MG A075345 001 Jun 16, 1999

PHARMS

L PERRIGO CO 200MG A075285 001 Oct 29, 1998

TAGAMET HB

+! MEDTECH PRODUCTS 200MG N020238 002 Aug 21, 1996

CLEMASTINE FUMARATE

TABLET;ORAL

CLEMASTINE FUMARATE

! L PERRIGO CO 1.34MG A074512 001 Nov 22, 1995

CLOTRIMAZOLE

CREAM;VAGINAL

CLOTRIMAZOLE

! ACTAVIS MID 1% A074165 001 Jul 16, 1993

ATLANTIC

TARO 1% A072641 001 Dec 04, 1995

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-6(of 20)

CLOTRIMAZOLE

CREAM;VAGINAL

TRIVAGIZOLE 3

TARO 2% N021143 001 Apr 12, 2000

CROMOLYN SODIUM

SPRAY, METERED;NASAL

CROMOLYN SODIUM

! BAUSCH AND LOMB 5.2MG/SPRAY A075702 001 Jul 03, 2001

PERRIGO 5.2MG/SPRAY A075427 001 Dec 12, 2001

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

ACTAVIS LABS FL 30MG;600MG A091070 001 Aug 31, 2015

60MG;1.2GM A091070 002 Aug 31, 2015

AMNEAL PHARMS 30MG;600MG A209692 001 Nov 01, 2018



60MG;1.2GM A209692 002 Nov 01, 2018

AUROBINDO PHARMA 30MG;600MG A206941 001 Mar 17, 2017

LTD

60MG;1.2GM A206941 002 Mar 17, 2017

PERRIGO R AND D 30MG;600MG A207602 002 Mar 05, 2018

60MG;1.2GM A207602 001 Mar 05, 2018

MUCINEX DM

+ RB HLTH 30MG;600MG N021620 002 Apr 29, 2004

+! 60MG;1.2GM N021620 001 Apr 29, 2004



DEXTROMETHORPHAN POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

DELSYM

+! RB HLTH EQ 30MG HYDROBROMIDE/5ML N018658 001 Oct 08, 1982

DEXTROMETHORPHAN POLISTIREX

AMNEAL PHARMS LLC EQ 30MG HYDROBROMIDE/5ML A203133 001 Jul 28, 2017

TRIS PHARMA INC EQ 30MG HYDROBROMIDE/5ML A091135 001 May 25, 2012

DIPHENHYDRAMINE CITRATE; IBUPROFEN

TABLET;ORAL

ADVIL PM

+! PFIZER 38MG;200MG N021394 001 Dec 21, 2005

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

DR REDDYS LABS LTD 38MG;200MG A090619 001 Jul 08, 2009

PERRIGO R AND D 38MG;200MG A079113 001 Dec 22, 2008

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

CAPSULE;ORAL

ADVIL PM

+! PFIZER 25MG;EQ 200MG FREE ACID AND POTASSIUM N021393 001 Dec 21, 2005

SALT

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

BIONPHARMA INC 25MG;EQ 200MG FREE ACID AND POTASSIUM A090397 001 Nov 22, 2010

SALT

STRIDES PHARMA 25MG;EQ 200MG FREE ACID AND POTASSIUM A200888 001 Mar 05, 2012

SALT

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

TABLET;ORAL

ALEVE PM

+! BAYER HLTHCARE 25MG;220MG N205352 001 Jan 17, 2014

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

AMNEAL PHARMS CO 25MG;220MG A209726 001 Oct 23, 2018

DOCOSANOL

CREAM;TOPICAL

ABREVA

+! GLAXOSMITHKLINE 10% N020941 001 Jul 25, 2000

DOCOSANOL

ACTAVIS LABS UT INC 10% A208754 001 Nov 19, 2018

DOXYLAMINE SUCCINATE

TABLET;ORAL

DOXYLAMINE SUCCINATE

LNK 25MG A040564 001 Aug 27, 2004

PERRIGO 25MG A040167 001 Sep 18, 1996

UNISOM

+! CHATTEM 25MG N018066 001

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-7(of 20)

EPINEPHRINE

AEROSOL, METERED;INHALATION

PRIMATENE MIST

+! ARMSTRONG PHARMS
0.125MG/INH
N205920 001
Nov 07, 2018

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED RELEASE;ORAL

ESOMEPRAZOLE MAGNESIUM

AUROBINDO PHARMA
EQ 20MG BASE
A209339 001
Oct 16, 2017

LTD

DR REDDYS LABS LTD
EQ 20MG BASE
A207673 001
May 15, 2018

PERRIGO R AND D
EQ 20MG BASE
A207193 001
Aug 18, 2017

NEXIUM 24HR

+! ASTRAZENECA LP
EQ 20MG BASE
N204655 001
Mar 28, 2014

TABLET, DELAYED RELEASE;ORAL

NEXIUM 24HR

+! ASTRAZENECA LP
EQ 20MG BASE
N207920 001
Nov 23, 2015

FAMOTIDINE

TABLET;ORAL

FAMOTIDINE

AUROBINDO PHARMA
10MG
A206531 001
Apr 26, 2016

LTD

20MG
A206531 002
Apr 26, 2016

DR REDDYS LABS LTD


10MG
A075758 001
Aug 17, 2001

20MG
A077367 001
Sep 25, 2006

IVAX SUB TEVA


10MG
A075512 001
Jul 26, 2001

PHARMS

MYLAN
10MG
A075674 001
Dec 21, 2001

PERRIGO
10MG
A075400 001
Mar 18, 2005

PERRIGO R AND D
20MG
A077351 001
Sep 25, 2006

SUN PHARM INDS LTD


10MG
A090283 001
Nov 17, 2009

20MG
A090283 002
Nov 17, 2009

TEVA
10MG
A075312 001
May 31, 2001

WOCKHARDT
10MG
A077146 001
Mar 07, 2005

20MG
A090837 001
Aug 04, 2010

PEPCID AC

+ J AND J CONSUMER 10MG
N020325 001
Apr 28, 1995

INC
10MG
N020902 001
Aug 05, 1999

+! 20MG
N020325 002
Sep 23, 2003

TABLET, CHEWABLE;ORAL

FAMOTIDINE

PERRIGO
10MG
A075715 001
Aug 22, 2003

PEPCID AC

+! J AND J CONSUMER
20MG
N020801 002
Dec 17, 2007

INC

FEXOFENADINE HYDROCHLORIDE

SUSPENSION;ORAL

CHILDREN'S ALLEGRA ALLERGY

+! SANOFI AVENTIS US
30MG/5ML
N201373 001
Jan 24, 2011

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

ACTAVIS MID 30MG/5ML
A203330 001
Nov 18, 2014

ATLANTIC

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

! ACTAVIS MID 30MG/5ML
A203330 002
Nov 18, 2014

ATLANTIC

TABLET;ORAL

ALLEGRA ALLERGY

+ SANOFI AVENTIS US 60MG
N020872 007
Jan 24, 2011

+! 180MG
N020872 010
Jan 24, 2011

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

AUROLIFE PHARMA LLC 30MG A202039 001
Nov 19, 2014

DR REDDYS LABS LTD 30MG A076502 004
Apr 12, 2011

HETERO LABS LTD V 30MG A204097 001


Aug 19, 2016

MYLAN 30MG A077081 004


Jul 21, 2011

SUN PHARM INDS 30MG A091567 002
Feb 06, 2012

TEVA 30MG A076447 004
Apr 13, 2011

WOCKHARDT LTD 30MG A079112 002


Feb 08, 2012

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

DR REDDYS LABS LTD 30MG A076502 005
Apr 12, 2011

MYLAN 30MG A077081 005


Jul 21, 2011

SUN PHARM INDS 30MG A091567 001
Feb 06, 2012

TEVA 30MG A076447 005
Apr 13, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-8(of 20)

FEXOFENADINE HYDROCHLORIDE

TABLET;ORAL

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

WOCKHARDT LTD 30MG
A079112 001 Feb 08, 2012

FEXOFENADINE HYDROCHLORIDE ALLERGY

AUROLIFE PHARMA LLC 60MG
A202039 002 Nov 19, 2014

180MG
A202039 003 Nov 19, 2014

DR REDDYS LABS LTD
60MG
A076502 006 Apr 12, 2011

180MG
A076502 008 Apr 12, 2011

HETERO LABS LTD V


60MG
A204097 002 Aug 19, 2016

180MG
A204097 003 Aug 19, 2016

MYLAN
60MG
A077081 006 Jul 21, 2011

180MG
A077081 008 Jul 21, 2011

SCIEGEN PHARMS INC
60MG
A204507 002 Sep 16, 2015

180MG
A204507 003 Sep 16, 2015

SUN PHARM INDS


60MG
A091567 004 Feb 06, 2012

180MG
A091567 006 Feb 06, 2012

TEVA
60MG
A076447 006 Apr 13, 2011

180MG
A076447 008 Apr 13, 2011

UNIQUE PHARM LABS


180MG
A210137 001 Aug 13, 2018

WOCKHARDT LTD
60MG
A079112 004 Feb 08, 2012

180MG
A079112 006 Feb 08, 2012

FEXOFENADINE HYDROCHLORIDE HIVES

DR REDDYS LABS LTD 60MG A076502 007 Apr 12, 2011

180MG A076502 009 Apr 12, 2011

MYLAN 60MG A077081 007 Jul 21, 2011



180MG A077081 009 Jul 21, 2011

SCIEGEN PHARMS INC 60MG A204507 004 Sep 16, 2015

180MG A204507 005 Sep 16, 2015

SUN PHARM INDS 60MG A091567 003 Feb 06, 2012



180MG A091567 005 Feb 06, 2012

TEVA 60MG A076447 007 Apr 13, 2011

WOCKHARDT LTD 60MG A079112 003 Feb 08, 2012



180MG A079112 005 Feb 08, 2012

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

+! SANOFI AVENTIS US 60MG;120MG
N020786 002 Jan 24, 2011

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

+! SANOFI AVENTIS US 180MG;240MG
N021704 002 Jan 24, 2011

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

AUROBINDO PHARMA 60MG;120MG
A209116 001 Oct 30, 2017

LTD

DR REDDYS LABS LTD 60MG;120MG
A076667 001 Nov 18, 2014

180MG;240MG
A079043 002 Jun 22, 2011

SUN PHARMA GLOBAL 60MG;120MG
A090818 001 Jan 29, 2015

FLUTICASONE FUROATE

SPRAY, METERED;NASAL

FLONASE SENSIMIST ALLERGY RELIEF

+! GLAXOSMITHKLINE
0.0275MG/SPRAY
N022051 002 Aug 02, 2016

CONS

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

FLONASE ALLERGY RELIEF

+! GLAXOSMITHKLINE
0.05MG/SPRAY
N205434 001 Jul 23, 2014

CONS

FLUTICASONE PROPIONATE

APOTEX INC
0.05MG/SPRAY
A208150 001 Feb 29, 2016

WEST-WARD PHARMS
0.05MG/SPRAY
A207957 001 May 26, 2016

INT

GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN

ACTAVIS LABS FL
1.2GM
A091009 002 Sep 03, 2015

AMNEAL PHARMS
600MG
A207342 001 Jul 11, 2018

1.2GM
A207342 002 Jul 11, 2018

GUARDIAN DRUG
600MG
A209215 001 Sep 06, 2017

1.2GM
A209215 002 Sep 06, 2017

OHM LABS INC


600MG
A209254 001 Jul 16, 2018

1.2GM
A209254 002 Jul 16, 2018

PERRIGO R AND D
600MG
A078912 001 Nov 23, 2011

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-9(of 20)

GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

MUCINEX

+ RB HLTH 600MG N021282 001 Jul 12, 2002

+! 1.2GM N021282 002 Dec 18, 2002

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

ACTAVIS LABS FL 600MG;60MG A091071 001 May 27, 2015

1.2GM;120MG A091071 002 May 27, 2015

DR REDDYS LABS LTD 600MG;60MG A208369 001 Dec 29, 2017



1.2GM;120MG A208369 002 Dec 29, 2017

MUCINEX D

+ RB HLTH 600MG;60MG N021585 001 Jun 22, 2004
+! 1.2GM;120MG N021585 002 Jun 22, 2004
IBUPROFEN
CAPSULE;ORAL
ADVIL LIQUI-GELS
+! PFIZER EQ 200MG FREE ACID AND POTASSIUM SALT N020402 001 Apr 20, 1995
ADVIL MIGRAINE LIQUI-GELS
+! PFIZER EQ 200MG FREE ACID AND POTASSIUM SALT N020402 002 Mar 16, 2000
IBUPROFEN
AMNEAL PHARMS EQ 200MG FREE ACID AND POTASSIUM SALT A202300 001 Dec 23, 2011
ASCENT PHARMS INC EQ 200MG FREE ACID AND POTASSIUM SALT A206999 001 Dec 21, 2017
AUROBINDO PHARMA EQ 200MG FREE ACID AND POTASSIUM SALT A207753 001 Jun 29, 2018
LTD
BIONPHARMA INC EQ 200MG FREE ACID AND POTASSIUM SALT A078682 001 Mar 24, 2009
HUMANWELL PURACAP EQ 200MG FREE ACID AND POTASSIUM SALT A206568 001 Jun 21, 2016
MARKSANS PHARMA EQ 200MG FREE ACID AND POTASSIUM SALT A079205 001 Jun 26, 2009
P AND L DEV LLC EQ 200MG FREE ACID AND POTASSIUM SALT A077338 001 Jul 10, 2009
SOFGEN PHARMS EQ 200MG FREE ACID AND POTASSIUM SALT A203599 001 Sep 07, 2016
STRIDES PHARMA EQ 200MG FREE ACID AND POTASSIUM SALT A204469 001 Mar 28, 2018
MIDOL LIQUID GELS
+! BIONPHARMA INC 200MG N021472 001 Oct 18, 2002
SUSPENSION;ORAL
CHILDREN'S ADVIL
PFIZER 100MG/5ML N020589 001 Jun 27, 1996
CHILDREN'S ADVIL-FLAVORED
PFIZER 100MG/5ML N020589 002 Nov 07, 1997
CHILDREN'S ELIXSURE
MOBERG PHARMA NORTH 100MG/5ML N021604 001 Jan 07, 2004
CHILDREN'S IBUPROFEN
PERRIGO 100MG/5ML A074937 001 Dec 22, 1998
CHILDREN'S MOTRIN
+! J AND J CONSUMER 100MG/5ML N020516 001 Jun 16, 1995
INC
IBUPROFEN
ACTAVIS MID 100MG/5ML A074916 001 Apr 30, 1999
ATLANTIC
APTAPHARMA INC 100MG/5ML A210602 001 Nov 23, 2018
ARISE PHARMS 100MG/5ML A200457 001 Aug 18, 2011
AUROBINDO PHARMA 100MG/5ML A209179 001 Apr 17, 2018
LTD
GUARDIAN DRUG 100MG/5ML A210149 001 Aug 17, 2018
TARO 100MG/5ML A209207 001 Jun 27, 2017
SUSPENSION/DROPS;ORAL
CHILDREN'S MOTRIN
+! J AND J CONSUMER 40MG/ML N020603 001 Jun 10, 1996
INC
IBUPROFEN
GUARDIAN DRUG 40MG/ML A210755 001 Sep 26, 2018
L PERRIGO CO 40MG/ML A075217 001 Dec 16, 1998
TRIS PHARMA INC 40MG/ML A079058 001 Aug 31, 2009
PEDIATRIC ADVIL
+! PFIZER 100MG/2.5ML N020812 001 Jan 30, 1998
TABLET;ORAL
ADVIL
PFIZER 200MG N018989 001 May 18, 1984
IBU-TAB 200
ALRA 200MG A071057 001 Aug 11, 1988
IBUPROFEN
AMNEAL PHARMS 200MG A079233 001 Mar 18, 2014
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-10(of 20)

IBUPROFEN

TABLET;ORAL

IBUPROFEN

AMNEAL PHARMS NY
200MG
A071333 001
Feb 17, 1987

200MG
A072199 001
May 23, 1988

AUROBINDO PHARMA
200MG
A208865 001
Nov 08, 2017

LTD

AVEMA PHARMA
200MG
A076460 001
Nov 26, 2003

CONTRACT PHARMACAL
200MG
A072299 001
Jul 01, 1988

DR REDDYS LA
200MG
A075661 001
Dec 12, 2001

DR REDDYS LABS INC
200MG
A076117 001
Nov 20, 2001

GRANULES INDIA
200MG
A079174 001
Dec 10, 2010

GRANULES INDIA LTD
200MG
A202312 001
Oct 07, 2016

LNK
200MG
A075010 001
Mar 01, 1999

200MG
A075139 001
Mar 01, 1999

MARKSANS PHARMA
200MG
A091237 001
Feb 08, 2011

200MG
A091239 001
Feb 01, 2011

MCNEIL
200MG
A073019 001
Mar 30, 1994

MERRO PHARM
200MG
A070985 001
Oct 02, 1987

OHM
200MG
A071163 001
Jul 15, 1986

PAR PHARM
200MG
A070481 001
Sep 24, 1986

PERRIGO
200MG
A072096 001
Dec 08, 1987

200MG
A075995 001
Mar 14, 2002

PERRIGO R AND D
200MG
A077349 001
Jun 21, 2005

SHANDONG XINHUA
200MG
A206990 001
Aug 21, 2018

200MG
A207095 001
May 05, 2017

STRIDES PHARMA
200MG
A079129 001
Mar 28, 2011

200MG
A091355 001
Apr 04, 2011

200MG
A206989 001
Jun 29, 2018

200MG
A207052 001
May 30, 2017

VINTAGE PHARMS
200MG
A071229 001
Apr 01, 1987

200MG
A071639 001
Feb 02, 1988

IBUPROHM

OHM LABS
200MG
A071214 001
Dec 01, 1986

JUNIOR STRENGTH ADVIL

PFIZER
100MG
N020267 002
Dec 13, 1996

JUNIOR STRENGTH IBUPROFEN

L PERRIGO CO
100MG
A075367 001
Apr 22, 1999

JUNIOR STRENGTH MOTRIN

J AND J CONSUMER
100MG
N020602 001
Jun 10, 1996

INC

MOTRIN IB

+! J AND J CONSUMER
200MG
N019012 003
Dec 17, 1990

INC

TAB-PROFEN

PERRIGO
200MG
A072095 001
Dec 08, 1987

TABLET, CHEWABLE;ORAL

CHILDREN'S ADVIL

PFIZER
50MG
N020944 001
Dec 18, 1998

IBUPROFEN

! PERRIGO
100MG
A076359 002
Jan 16, 2004

JUNIOR STRENGTH ADVIL

PFIZER
100MG
N020944 002
Dec 18, 1998

IBUPROFEN SODIUM

TABLET;ORAL

ADVIL

+! PFIZER CONS
EQ 200MG BASE
N201803 001
Jun 12, 2012

HLTHCARE

IBUPROFEN SODIUM

PERRIGO R AND D
EQ 200MG BASE
A206581 001
Aug 03, 2015

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

TABLET;ORAL

ADVIL CONGESTION RELIEF

+! PFIZER 200MG;10MG
N022565 001
May 27, 2010

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

PERRIGO R AND D 200MG;10MG
A203200 001
Jul 03, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-11(of 20)

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE



CAPSULE;ORAL

ADVIL COLD AND SINUS

+! PFIZER EQ 200MG FREE ACID AND POTASSIUM N021374 001 May 30, 2002

SALT;30MG
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
AUROBINDO PHARMA EQ 200MG FREE ACID AND POTASSIUM A209235 001 Dec 01, 2017

LTD SALT;30MG
SUSPENSION;ORAL
CHILDREN'S ADVIL COLD
PFIZER 100MG/5ML;15MG/5ML N021373 001 Apr 18, 2002

CHILDREN'S MOTRIN COLD
+! J AND J CONSUMER 100MG/5ML;15MG/5ML N021128 001 Aug 01, 2000

INC
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 100MG/5ML;15MG/5ML A076478 001 Nov 05, 2003

TABLET;ORAL
ADVIL COLD AND SINUS
+! PFIZER 200MG;30MG N019771 001 Sep 19, 1989

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS LTD 200MG;30MG A077628 001 Aug 14, 2006

IBUPROHM COLD AND SINUS
OHM LABS 200MG;30MG A074567 001 Apr 17, 2001

SINE-AID IB
J AND J CONSUMER 200MG;30MG N019899 001 Dec 31, 1992

INC
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R PEN
+! LILLY 100 UNITS/ML N018780 005 Aug 06, 1998

NOVOLIN R
+! NOVO NORDISK INC 100 UNITS/ML N019938 001 Jun 25, 1991

INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R
+! LILLY 100 UNITS/ML N018780 001 Oct 28, 1982

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN 70/30
+! LILLY 30 UNITS/ML;70 UNITS/ML N019717 001 Apr 25, 1989

HUMULIN 70/30 PEN
+! LILLY 30 UNITS/ML;70 UNITS/ML N019717 002 Aug 06, 1998

NOVOLIN 70/30
+! NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML N019991 001 Jun 25, 1991

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN N
+! LILLY 100 UNITS/ML N018781 001 Oct 28, 1982

NOVOLIN N
+! NOVO NORDISK INC 100 UNITS/ML N019959 001 Jul 01, 1991

IODINE POVACRYLEX; ISOPROPYL ALCOHOL
SPONGE;TOPICAL
DURAPREP
+! 3M EQ 0.7% IODINE;74% (6ML) N021586 001 Sep 29, 2006

+! EQ 0.7% IODINE;74% (26ML) N021586 002 Sep 29, 2006



KETOCONAZOLE
SHAMPOO;TOPICAL
NIZORAL A-D
+! JOHNSON AND JOHNSON 1% N020310 001 Oct 10, 1997

KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ALAWAY
+! BAUSCH AND LOMB EQ 0.025% BASE N021996 001 Dec 01, 2006

+ EQ 0.035% BASE N021996 002 Feb 11, 2015

KETOTIFEN FUMARATE
AKORN EQ 0.025% BASE A077958 001 Jul 26, 2007

! ALCON PHARMS LTD EQ 0.025% BASE A077200 001 Sep 02, 2008

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-12(of 20)

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

DR REDDYS LABS LTD 15MG A202194 001 May 18, 2012

LANNETT CO INC 15MG A207157 001 Sep 29, 2017

MYLAN PHARMS INC 15MG A203187 001 Jun 01, 2016



NATCO PHARMA LTD 15MG A203306 001 Jan 13, 2016

PERRIGO R AND D 15MG A202319 001 May 18, 2012

WOCKHARDT LTD 15MG A202727 001 May 18, 2012

PREVACID 24 HR

+! GLAXOSMITHKLINE 15MG N022327 001 May 18, 2009

CONS

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

LANSOPRAZOLE

DEXCEL PHARMA 15MG N208025 001 Jun 07, 2016

LEVOCETIRIZINE DIHYDROCHLORIDE

SOLUTION;ORAL

XYZAL ALLERGY 24HR

+! SANOFI AVENTIS US 2.5MG/5ML N209090 001 Jan 31, 2017

TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

DR REDDYS LABS LTD 5MG A210375 001 Jan 19, 2018

MICRO LABS 5MG A211551 001 Nov 20, 2018

XYZAL ALLERGY 24HR

+! SANOFI AVENTIS US 5MG N209089 001 Jan 31, 2017

LEVONORGESTREL

TABLET;ORAL

ATHENTIA NEXT

AUROBINDO PHARMA 1.5MG A206867 001 Dec 08, 2015

LTD

FALLBACK SOLO

LUPIN LTD 1.5MG A201446 001 Jun 19, 2014

HER STYLE

NOVAST LABS 1.5MG A207976 001 Mar 11, 2016

LEVONORGESTREL

AMNEAL PHARMS 1.5MG A204044 001 Jul 03, 2018
APOTEX INC 1.5MG A205329 001 Sep 18, 2018
FDN CONSUMER 1.5MG A200670 001 Jul 12, 2012
GLENMARK PHARMS LTD 1.5MG A207044 001 Mar 25, 2016
LOTUS PHARM CO LTD 0.75MG A202684 001 Sep 02, 2016
MYLAN LABS LTD 0.75MG A202740 001 Sep 02, 2016
1.5MG A202739 001 Oct 31, 2014
NOVEL LABS INC 1.5MG A202508 001 Feb 22, 2013
OC PHARMA 1.5MG A202380 001 May 29, 2015
! PERRIGO R AND D 0.75MG A090740 001 Dec 30, 2010
1.5MG A202334 001 Aug 20, 2014
RECKITT BENCKISER 1.5MG A202246 001 Jun 05, 2015
OPCICON ONE-STEP
SUN PHARM INDS LTD 1.5MG A202635 001 Sep 11, 2014
PLAN B ONE-STEP
+! FDN CONSUMER 1.5MG N021998 001 Jul 10, 2009
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
+ BIONPHARMA INC 1MG N021855 001 Aug 04, 2005
+! 2MG N021855 002 Aug 04, 2005
SOLUTION;ORAL
IMODIUM A-D
+! J AND J CONSUMER 1MG/5ML N019487 001 Mar 01, 1988
INC
LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA 1MG/5ML A074352 001 Nov 17, 1995
PERRIGO 1MG/5ML A073243 001 Jan 21, 1992
WOCKHARDT BIO AG 1MG/5ML A074730 001 Aug 28, 1997
SUSPENSION;ORAL
IMODIUM A-D
+! J AND J CONSUMER 1MG/7.5ML N019487 002 Jul 08, 2004
INC
LOPERAMIDE HYDROCHLORIDE
PERRIGO R AND D 1MG/7.5ML A091292 001 May 20, 2011
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-13(of 20)

LOPERAMIDE HYDROCHLORIDE
TABLET;ORAL
IMODIUM A-D
+! J AND J CONSUMER 2MG N019860 001 Nov 22, 1989
INC
LOPERAMIDE HYDROCHLORIDE
AUROBINDO PHARMA 2MG A206548 001 Dec 15, 2015
LTD
L PERRIGO CO 2MG A075232 001 Jan 06, 2000
LNK 2MG A076497 001 Jun 10, 2003
OHM LABS 2MG A074091 001 Dec 10, 1992
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET;ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+! J AND J CONSUMER 2MG;125MG N021140 001 Nov 30, 2000

INC

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

PERRIGO R AND D 2MG;125MG A209837 001 Sep 05, 2018

SUN PHARM INDS LTD 2MG;125MG A077500 001 Sep 06, 2006

TABLET, CHEWABLE;ORAL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

! PERRIGO 2MG;125MG A076029 001 Aug 30, 2002

LORATADINE

CAPSULE;ORAL

CLARITIN

+! BAYER HEALTHCARE 10MG N021952 001 Jun 16, 2008

LLC

LORATADINE

BIONPHARMA INC 10MG A202538 001 Dec 21, 2018

MARKSANS PHARMA 10MG A206214 001 Sep 23, 2016

SUSPENSION;ORAL

LORATADINE

+! TARO 1MG/ML N021734 001 Oct 04, 2005

SYRUP;ORAL

CLARITIN

+! BAYER HEALTHCARE 1MG/ML N020641 002 Nov 27, 2002

LLC

LORATADINE

AUROBINDO PHARMA 1MG/ML A208931 001 Jun 29, 2018

LTD

LANNETT CO INC 1MG/ML A077421 001 Jun 29, 2006

PERRIGO 1MG/ML A075728 001 Aug 20, 2004

TARO 1MG/ML A076805 001 Aug 20, 2004

TARO PHARM 1MG/ML A201865 001 Jul 31, 2015



TEVA 1MG/ML A075505 001 Nov 07, 2003

WOCKHARDT BIO AG 1MG/ML A075815 001 Aug 20, 2004

TABLET;ORAL

CLARITIN

+! BAYER HEALTHCARE 10MG N019658 002 Nov 27, 2002

LLC

CLARITIN HIVES RELIEF

+! BAYER HEALTHCARE 10MG N019658 003 Nov 19, 2003

LLC

LORATADINE

APOTEX INC 10MG A076471 001 Feb 14, 2006

AUROBINDO PHARMA 10MG A208314 001 Apr 16, 2018

LTD

MYLAN 10MG A075790 001 Nov 07, 2008

10MG A076154 001 Aug 20, 2003

10MG A078447 001 Aug 12, 2011

PERRIGO 10MG A076301 001 Jun 25, 2004



PLD ACQUISITIONS 10MG A075209 001 Jan 21, 2003

LLC

SUN PHARM INDS LTD 10MG A076134 001 Aug 18, 2003

TABLET, CHEWABLE;ORAL

CHILDREN'S CLARITIN

+! BAYER HEALTHCARE 5MG N021891 001 Aug 23, 2006

LLC

CLARITIN

+ BAYER HEALTHCARE 10MG N021891 002 Nov 21, 2018

LLC

LORATADINE

SUN PHARMA GLOBAL 5MG A210088 001 Apr 16, 2018

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-14(of 20)

LORATADINE

TABLET, ORALLY DISINTEGRATING;ORAL

ALAVERT

PFIZER 10MG N021375 001 Dec 19, 2002

CLARITIN HIVES RELIEF REDITAB

+! BAYER HEALTHCARE 10MG N020704 003 Nov 19, 2003

LLC

CLARITIN REDITABS

+! BAYER HEALTHCARE 5MG N021993 001 Dec 12, 2006
LLC
+! 10MG N020704 002 Nov 27, 2002
LORATADINE
ACTAVIS LABS FL INC 10MG A075990 001 Nov 03, 2003
AUROBINDO PHARMA 10MG A208477 001 Apr 11, 2018
LTD
PERRIGO PHARMA INTL 10MG A076011 001 Sep 29, 2003
PFIZER 10MG A075822 001 Feb 10, 2003
LORATADINE REDIDOSE
SUN PHARM INDS LTD 10MG A077153 001 Apr 11, 2007
LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CLARITIN-D

+! BAYER HEALTHCARE 5MG;120MG N019670 002 Nov 27, 2002

LLC

CLARITIN-D 24 HOUR

+! BAYER HEALTHCARE 10MG;240MG N020470 002 Nov 27, 2002

LLC

LORATADINE AND PSEUDOEPHEDRINE SULFATE

ACTAVIS LABS FL INC 10MG;240MG A075706 001 Feb 21, 2003

PERRIGO PHARMA INTL 5MG;120MG A076050 001 Jan 30, 2003

10MG;240MG A075989 001 Mar 04, 2004

SUN PHARM INDS LTD 10MG;240MG A076557 001 Sep 22, 2004

MENTHOL; METHYL SALICYLATE

PATCH;TOPICAL

SALONPAS

+! HISAMITSU PHARM CO 3%;10% N022029 001 Feb 20, 2008

+ 3%;10% N022029 002 Nov 05, 2012

MICONAZOLE NITRATE

CREAM;TOPICAL, VAGINAL

MICONAZOLE 3 COMBINATION PACK

PERRIGO 2%,4% A076357 001 Mar 30, 2004

MONISTAT 3 COMBINATION PACK

+ MEDTECH PRODUCTS 2%,4% N021261 003 Jun 17, 2003

MONISTAT 3 COMBINATION PACK (PREFILLED)

+! MEDTECH PRODUCTS 2%,4% N021261 001 Feb 02, 2001



CREAM;VAGINAL

MICONAZOLE 3

TARO 4% A076773 001 Mar 02, 2005

MICONAZOLE 7

ACTAVIS MID 2% A074164 001 Mar 29, 1996

ATLANTIC

MICONAZOLE NITRATE

G AND W LABS INC 2% A074366 001 Feb 22, 1996

PERRIGO 2% A074760 001 May 15, 1997

PERRIGO R AND D 4% A091366 001 Jan 15, 2010



TARO PHARMS 2% A074444 001 Jan 13, 1997

MONISTAT 3

+! MEDTECH PRODUCTS 4% N020827 001 Mar 30, 1998

MONISTAT 7

+! MEDTECH PRODUCTS 2% N017450 002 Feb 15, 1991

CREAM, SUPPOSITORY;TOPICAL, VAGINAL

M-ZOLE 3 COMBINATION PACK

ACTAVIS MID 2%,200MG A074926 001 Apr 16, 1999

ATLANTIC

MICONAZOLE NITRATE

PERRIGO R AND D 2%,1.2GM A079114 001 Jun 02, 2010

MICONAZOLE NITRATE COMBINATION PACK

PERRIGO 2%,200MG A075329 001 Apr 20, 1999

MONISTAT 1 COMBINATION PACK



+! MEDTECH PRODUCTS 2%,1.2GM N021308 001 Jun 29, 2001

MONISTAT 3 COMBINATION PACK

+! MEDTECH PRODUCTS 2%,200MG N020670 002 Apr 16, 1996

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-15(of 20)

MICONAZOLE NITRATE
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
MONISTAT 7 COMBINATION PACK
+! MEDTECH PRODUCTS 2%,100MG N020288 002 Apr 26, 1993
SUPPOSITORY;VAGINAL
MICONAZOLE NITRATE
ACTAVIS PHARMA 100MG A073507 001 Nov 19, 1993
G AND W LABS 100MG A074414 001 Apr 30, 1997
! PERRIGO 100MG A074395 001 Mar 20, 1997
MONISTAT 7
+! MEDTECH PRODUCTS 100MG N018520 002 Feb 15, 1991
MINOXIDIL
AEROSOL, FOAM;TOPICAL
MEN'S ROGAINE
+! JOHNSON AND JOHNSON 5% N021812 001 Jan 20, 2006
MINOXIDIL
PERRIGO ISRAEL 5% A091344 001 Apr 28, 2011
MINOXIDIL (FOR MEN)
TARO PHARM 5% A209074 001 Dec 31, 2018
WATSON LABS INC 5% A208092 001 Feb 17, 2017
MINOXIDIL (FOR WOMEN)
WATSON LABS INC 5% A208092 002 Jul 27, 2017
WOMEN'S ROGAINE
+! JOHNSON AND JOHNSON 5% N021812 002 Feb 28, 2014
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID 2% A074588 001 Apr 05, 1996
ATLANTIC
HI TECH PHARMA 2% A074731 001 Dec 24, 1996
L PERRIGO CO 2% A075357 001 Jul 30, 1999
WOCKHARDT BIO AG 2% A074767 001 Feb 28, 1997
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA 2% A074731 002 May 11, 2005
L PERRIGO CO 2% A075357 002 Jul 30, 1999
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID 5% A075518 001 Nov 17, 2000
ATLANTIC
AVACOR PRODS 5% A075619 001 Nov 17, 2000
PERRIGO 5% A075598 001 Jun 13, 2001
PERRIGO NEW YORK 5% A075737 001 Mar 15, 2002
WOCKHARDT BIO AG 5% A075438 001 Feb 27, 2003
ROGAINE (FOR MEN)
+! JOHNSON AND JOHNSON 2% N019501 002 Feb 09, 1996
ROGAINE (FOR WOMEN)
+! JOHNSON AND JOHNSON 2% N019501 003 Feb 09, 1996
ROGAINE EXTRA STRENGTH (FOR MEN)
+! JOHNSON AND JOHNSON 5% N020834 001 Nov 14, 1997
THEROXIDIL
EI INC 2% A078176 001 Nov 09, 2007
5% A076239 001 Aug 24, 2004
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
SOLUTION/DROPS;OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
AKORN INC 0.025%;0.3% A202795 001 Jan 24, 2013
ALTAIRE PHARMS INC 0.02675%;0.315% A078208 001 Sep 27, 2010
NAPHCON-A
+! ALCON 0.025%;0.3% N020226 001 Jun 08, 1994
OPCON-A
+! BAUSCH AND LOMB 0.02675%;0.315% N020065 001 Jun 08, 1994
VISINE
+! JOHNSON AND JOHNSON 0.025%;0.3% N020485 001 Jan 31, 1996
NAPROXEN SODIUM
CAPSULE;ORAL
NAPROXEN SODIUM
+! BIONPHARMA INC EQ 200MG BASE N021920 001 Feb 17, 2006
CATALENT EQ 200MG BASE A202807 001 Jan 04, 2019
PURACAP PHARM LLC EQ 200MG BASE A208363 001 Mar 15, 2018
TABLET;ORAL
ALEVE
+! BAYER EQ 200MG BASE N020204 002 Jan 11, 1994
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-16(of 20)

NAPROXEN SODIUM

TABLET;ORAL

NAPROXEN SODIUM

AMNEAL PHARMS NY EQ 200MG BASE A079096 001 Dec 16, 2008

AUROBINDO PHARMA EQ 200MG BASE A205497 001 Mar 18, 2016

LTD

CONTRACT PHARMACAL EQ 200MG BASE A074635 001 Jan 13, 1997

DR REDDYS LABS INC EQ 200MG BASE A075168 001 Jul 28, 1998

GRANULES INDIA EQ 200MG BASE A091353 001 Sep 20, 2011

LNK INTL INC EQ 200MG BASE A204872 001 Jan 23, 2017

MARKSANS PHARMA EQ 200MG BASE A090545 001 Mar 16, 2011

NOVELGENIX THERAPS EQ 200MG BASE A207612 001 Nov 16, 2018

PERRIGO EQ 200MG BASE A074661 001 Jan 13, 1997

SUN PHARM INDS LTD EQ 200MG BASE A091183 001 May 20, 2011

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALEVE-D SINUS & COLD

+! BAYER 200MG;120MG N021076 001 Nov 29, 1999

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

DR REDDYS LABS INC EQ 220MG BASE;120MG A077381 001 Sep 27, 2006
PERRIGO EQ 200MG BASE;120MG A076518 001 Mar 17, 2004
NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
HABITROL
+ DR REDDYS LABS SA 7MG/24HR N020076 004 Nov 12, 1999
+ 14MG/24HR N020076 005 Nov 12, 1999
+! 21MG/24HR N020076 006 Nov 12, 1999
NICODERM CQ
+ SANOFI AVENTIS US 7MG/24HR N020165 006 Aug 02, 1996
+ 14MG/24HR N020165 005 Aug 02, 1996
+! 21MG/24HR N020165 004 Aug 02, 1996
NICOTINE
AVEVA 7MG/24HR A074612 002 Jul 28, 2003
14MG/24HR A074612 003 Oct 20, 1997
21MG/24HR A074612 001 Oct 20, 1997
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICORETTE
+ GLAXOSMITHKLINE EQ 2MG BASE N018612 002 Feb 09, 1996
+ EQ 2MG BASE N018612 004 Sep 25, 2000
+! EQ 4MG BASE N020066 002 Feb 09, 1996
+ EQ 4MG BASE N020066 004 Sep 25, 2000
NICORETTE (MINT)
+ GLAXOSMITHKLINE EQ 2MG BASE N018612 003 Dec 23, 1998
+ EQ 4MG BASE N020066 003 Dec 23, 1998
NICOTINE POLACRILEX
ACTAVIS LABS NY INC EQ 2MG BASE A074507 001 Mar 15, 1999
EQ 2MG BASE A076569 001 Jul 29, 2004
EQ 2MG BASE A078699 001 Dec 29, 2008
EQ 2MG BASE A079216 001 Jul 08, 2009
EQ 2MG BASE A204794 001 May 10, 2016
EQ 4MG BASE A074707 001 Mar 19, 1999
EQ 4MG BASE A076568 002 Jul 29, 2004
EQ 4MG BASE A078697 001 Dec 29, 2008
EQ 4MG BASE A079038 001 Jul 08, 2009
EQ 4MG BASE A079219 001 Jul 08, 2009
EQ 4MG BASE A204833 001 Feb 26, 2016
L PERRIGO CO EQ 2MG BASE A076775 001 Sep 16, 2004
EQ 2MG BASE A076776 001 Sep 16, 2004
EQ 2MG BASE A076777 001 Sep 16, 2004
EQ 4MG BASE A076778 001 Sep 16, 2004
EQ 4MG BASE A076779 001 Sep 16, 2004
EQ 4MG BASE A076789 001 Sep 16, 2004
PERRIGO R AND D EQ 2MG BASE A078325 001 Oct 30, 2006
EQ 2MG BASE A078547 001 May 24, 2007
EQ 2MG BASE A078967 001 Apr 23, 2008
EQ 2MG BASE A091349 001 Jul 20, 2011
EQ 2MG BASE A206394 001 Dec 15, 2016
EQ 4MG BASE A078326 001 Oct 30, 2006
EQ 4MG BASE A078546 001 May 24, 2007
EQ 4MG BASE A078968 001 Apr 23, 2008
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-17(of 20)

NICOTINE POLACRILEX

GUM, CHEWING;BUCCAL

NICOTINE POLACRILEX

EQ 4MG BASE A091354 001 Jul 20, 2011

EQ 4MG BASE A206393 001 Dec 15, 2016

WATSON LABS EQ 2MG BASE A079044 001 Jul 08, 2009

TROCHE/LOZENGE;ORAL

NICORETTE

+ GLAXOSMITHKLINE EQ 2MG BASE N021330 001 Oct 31, 2002
CONS
+ EQ 2MG BASE N022360 001 May 18, 2009
+! EQ 4MG BASE N021330 002 Oct 31, 2002
+! EQ 4MG BASE N022360 002 May 18, 2009
NICOTINE POLACRILEX
PERRIGO R AND D EQ 2MG BASE A077007 001 Jan 31, 2006
EQ 2MG BASE A090711 001 Jul 10, 2009
EQ 2MG BASE A090821 001 Jul 10, 2009
EQ 2MG BASE A203690 001 Oct 09, 2012
EQ 4MG BASE A077007 002 Jan 31, 2006
EQ 4MG BASE A090711 002 Jul 10, 2009
EQ 4MG BASE A090821 002 Jul 10, 2009
EQ 4MG BASE A203690 002 Oct 09, 2012
WATSON LABS INC EQ 2MG BASE A209206 001 Jun 26, 2018
EQ 4MG BASE A209206 002 Jun 26, 2018
WATSON LABS TEVA EQ 2MG BASE A209519 001 Jul 02, 2018
EQ 4MG BASE A209519 002 Jul 02, 2018
NIZATIDINE
TABLET;ORAL
AXID AR
+! PFIZER 75MG N020555 001 May 09, 1996
NONOXYNOL-9
SPONGE;VAGINAL
TODAY
+! MAYER LABS INC 1GM N018683 001 Apr 01, 1983
OMEPRAZOLE
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE
+! DEXCEL PHARMA 20MG N022032 001 Dec 04, 2007
DR REDDYS LABS LTD 20MG A207740 001 Nov 05, 2018
SUN PHARM INDS LTD 20MG A207891 001 Oct 12, 2018
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL
OMEPRAZOLE
+ DEXCEL PHARMA 20MG N209400 001 Jul 05, 2017
OMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
! DR REDDYS LABS LTD EQ 20MG BASE A078878 001 Jun 05, 2009
SPIL EQ 20MG BASE A210593 001 Jul 20, 2018
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
AUROBINDO PHARMA EQ 20MG BASE A206877 001 Jun 06, 2018
LTD
PERRIGO R AND D EQ 20MG BASE A204152 001 Jul 30, 2015
PRILOSEC OTC
+! ASTRAZENECA PHARMS EQ 20MG BASE N021229 001 Jun 20, 2003
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
ACTAVIS ELIZABETH 20MG;1.1GM A204137 001 Jul 15, 2016
AUROLIFE PHARMA LLC 20MG;1.1GM A204923 001 Nov 07, 2016
PAR PHARM 20MG;1.1GM A201946 001 Jul 15, 2016
PERRIGO R AND D 20MG;1.1GM A201361 001 Jul 15, 2016
ZYDUS PHARMS USA 20MG;1.1GM A203345 001 Mar 16, 2018
INC
ZEGERID OTC
+! BAYER HEALTHCARE 20MG;1.1GM N022281 001 Dec 01, 2009
LLC
FOR SUSPENSION;ORAL
ZEGERID OTC
+! BAYER HEALTHCARE 20MG/PACKET;1.68GM/PACKET N022283 001 Jun 17, 2013
LLC
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST
4-18(of 20)

ORLISTAT

CAPSULE;ORAL

ALLI

+! GLAXOSMITHKLINE 60MG
N021887 001
Feb 07, 2007

CONS

OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYTROL FOR WOMEN

+! ALLERGAN SALES LLC
3.9MG/24HR
N202211 001
Jan 25, 2013

OXYMETAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

VISINE L.R.

+! JOHNSON AND JOHNSON
0.025%
N019407 001
Mar 31, 1989

PERMETHRIN

LOTION;TOPICAL

NIX

+! MEDTECH PRODUCTS
1%
N019918 001
May 02, 1990

PERMETHRIN

ACTAVIS MID
1%
A075014 001
Mar 28, 2000

ATLANTIC

PERRIGO NEW YORK
1%
A076090 001
Dec 20, 2001

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

GLYCOLAX

LANNETT CO INC
17GM/PACKET
A090600 001
Oct 06, 2009

17GM/SCOOPFUL
A090600 002
Oct 06, 2009

MIRALAX

+! BAYER HEALTHCARE
17GM/SCOOPFUL
N022015 001
Oct 06, 2006

LLC

POLYETHYLENE GLYCOL 3350

ANI PHARMS INC
17GM/SCOOPFUL
A202850 001
Dec 15, 2015

APNAR PHARMA LP
17GM/SCOOPFUL
A202071 001
Dec 28, 2012

AUROBINDO PHARMA
17GM/SCOOPFUL
A209017 001
Apr 09, 2018

LTD

MYLAN
17GM/PACKET
A078915 001
Oct 06, 2009

17GM/SCOOPFUL
A078915 002
Oct 06, 2009

NEXGEN PHARMA
17GM/SCOOPFUL
A090812 001
Oct 07, 2009

NOVEL LABS INC
17GM/SCOOPFUL
A091077 001
Oct 06, 2009

NUVO PHARMS INC
17GM/SCOOPFUL
A206105 001
Oct 28, 2016

PAR PHARM
17GM/SCOOPFUL
A079214 001
Jan 31, 2013

PERRIGO R AND D
17GM/PACKET
A090685 001
Oct 06, 2009

17GM/SCOOPFUL
A090685 002
Oct 06, 2009

STRIDES PHARMA
17GM/SCOOPFUL
A203928 001
Aug 24, 2016

17GM/PACKET
A203928 002
Aug 24, 2016

POTASSIUM IODIDE

SOLUTION;ORAL

POTASSIUM IODIDE

MISSION PHARMACAL
65MG/ML
A206211 001
Mar 24, 2016

CO

THYROSHIELD

! ARCO PHARMS LLC
65MG/ML
A077218 001
Jan 12, 2005

TABLET;ORAL

IOSAT

+ ANBEX
65MG
N018664 002
May 12, 2011

+!
130MG
N018664 001
Oct 14, 1982

THYROSAFE

! RECIP
65MG
A076350 001
Sep 10, 2002

POVIDONE-IODINE

SOLUTION;TOPICAL

POVIDONE IODINE

+! ALLEGIANCE HLTHCARE
1%
N019522 001
Mar 31, 1989

SPONGE;TOPICAL

E-Z SCRUB 201

+! BECTON DICKINSON
20%
N019240 001
Nov 29, 1985

E-Z SCRUB 241

+! BECTON DICKINSON
10%
N019476 001
Jan 07, 1987

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-19(of 20)

PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

PSEUDOEPHEDRINE HYDROCHLORIDE

AUROBINDO PHARMA 120MG A209008 001 Jun 09, 2017
LTD
L PERRIGO CO 120MG A075153 001 Feb 26, 1999
SUN PHARM INDS LTD 120MG A077442 001 Sep 28, 2005
SUDAFED 12 HOUR
! MCNEIL CONS 120MG A073585 001 Oct 31, 1991
SUDAFED 24 HOUR
+! J AND J CONSUMER 240MG N020021 002 Dec 15, 1992
INC
PURIFIED WATER
SOLUTION;OPHTHALMIC
PUR-WASH
+! NIAGARA PHARMS 98.3% N022305 001 Sep 01, 2011
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC EQ 75MG BASE A075167 001 May 04, 2000
EQ 150MG BASE A200172 001 May 31, 2012
AUROBINDO PHARMA EQ 75MG BASE A207579 001 Nov 13, 2017
LTD
EQ 150MG BASE A207578 001 Nov 13, 2017
DR REDDYS LABS LTD EQ 75MG BASE A075294 001 Mar 28, 2000
EQ 150MG BASE A078192 001 Aug 31, 2007
GRANULES INDIA LTD EQ 150MG BASE A210243 001 Aug 20, 2018
EQ 150MG BASE A210243 002 Aug 20, 2018
IVAX SUB TEVA EQ 75MG BASE A075296 001 Jan 14, 2000
PHARMS
MYLAN EQ 75MG BASE A075497 001 Jan 14, 2000
PERRIGO EQ 75MG BASE A076195 001 Aug 30, 2002
PERRIGO R AND D EQ 150MG BASE A091429 001 May 11, 2011
EQ 150MG BASE A091429 002 May 11, 2011
STRIDES PHARMA EQ 75MG BASE A201745 001 Feb 29, 2012
EQ 150MG BASE A200536 001 Jun 28, 2011
STRIDES VIVIMED EQ 75MG BASE A209160 001 Mar 05, 2018
EQ 150MG BASE A209161 001 Feb 22, 2018
WOCKHARDT EQ 75MG BASE A076760 001 Feb 24, 2006
ZANTAC 150
+! SANOFI US EQ 150MG BASE N021698 001 Aug 31, 2004
+ EQ 150MG BASE N021698 002 Mar 13, 2007
ZANTAC 75
+ SANOFI US EQ 75MG BASE N020520 001 Dec 19, 1995
SODIUM CHLORIDE
AEROSOL, METERED;INHALATION
BRONCHO SALINE
+! BLAIREX 0.9% N019912 001 Sep 03, 1992
SODIUM FLUORIDE; TRICLOSAN
PASTE;DENTAL
COLGATE TOTAL
+! COLGATE PALMOLIVE 0.24%;0.3% N020231 001 Jul 11, 1997
TERBINAFINE
GEL;TOPICAL
LAMISIL AT
+! GLAXOSMITHKLINE 1% N021958 001 Jul 24, 2006
CONS
TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
+! GLAXOSMITHKLINE 1% N020980 001 Mar 09, 1999
TERBINAFINE HYDROCHLORIDE
TARO 1% A077511 001 Jul 02, 2007
SOLUTION;TOPICAL
LAMISIL AT
+! GLAXOSMITHKLINE 1% N021124 001 Mar 17, 2000
CONS
SPRAY;TOPICAL
LAMISIL AT
+! GLAXOSMITHKLINE 1% N021124 002 Mar 17, 2000
CONS
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

OTC DRUG PRODUCT LIST 4-20(of 20)

TIOCONAZOLE

OINTMENT;VAGINAL

TIOCONAZOLE

PERRIGO 6.5% A075915 001 Nov 21, 2001

VAGISTAT-1

+! COMBE 6.5% N020676 001 Feb 11, 1997

TRIAMCINOLONE ACETONIDE

SPRAY, METERED;NASAL

NASACORT ALLERGY 24 HOUR

+! SANOFI AVENTIS US 0.055MG/SPRAY N020468 002 Oct 11, 2013

TRIAMCINOLONE ACETONIDE

PERRIGO ISRAEL 0.055MG/SPRAY A078104 002 Nov 14, 2014

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST 5 - 1 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP


INJECTABLE; INJECTION
NONE
HAEMONETICS N760305 Jun 30, 1978
MANUFACTURING INC

ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)


INJECTABLE; INJECTION
CITRA LABS LLC N020037 Aug 26, 2003
ACD-A SOLUTION
TERUMO BCT INC A010228 Feb 25, 2002
ADSOL WITH ACD-A
FENWAL INC N000922 Aug 29, 2002
ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A
HAEMONETICS CORP A980728 Feb 06, 2002
AS3 SOLUTION/ACD-A
TERUMO BCT INC N001214 May 29, 2002
NONE
HAEMONETICS A710497 Nov 06, 1987
MANUFACTURING INC

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N160918 Mar 17, 1978

ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD-A)


INJECTABLE; INJECTION
NONE
ARTERIOCYTE MEDICAL N160767 May 11, 2012
SYSTEMS, INC

ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)


INJECTABLE; INJECTION
CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3
HAEMONETICS CORP N000127 Jan 18, 2002

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION


INJECTABLE; INJECTION
NONE
TERUMO MEDICAL CORP N820528 Nov 03, 1982

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)


INJECTABLE; INJECTION
CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS
FENWAL INC N770420 May 12, 1978

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP


INJECTABLE; INJECTION
BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER
FENWAL INC N940404 Jul 28, 1994

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION


INJECTABLE; INJECTION
NONE
HAEMONETICS N800077 Nov 06, 1980
MANUFACTURING INC
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST 5 - 2 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION


INJECTABLE; INJECTION
ADSOL IN PLASTIC CONTAINER
FENWAL INC N900223 Dec 27, 1991

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)


INJECTABLE; INJECTION
CPD ANTICOAGULANT IN PL 2209 PLASTIC CONTAINER
FENWAL INC N900224 Dec 27, 1991
MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1-WB
MACOPRODUCTIONS SAS N040083 Nov 21, 2005
NONE
TERUMO BCT INC A070025 Jan 06, 2008

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N170401 Dec 06, 1977
N811012 Jun 28, 1983
HAEMONETICS N800222 Aug 23, 1982
MANUFACTURING INC
TERUMO MEDICAL CORP N781211 Jun 10, 1981

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1:


DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION
FENWAL INC N811104 May 16, 1983

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5:


DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION
TERUMO MEDICAL CORP N880217 Oct 07, 1988

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-3 NUTRICEL ADDITIVE SYSTEM
HAEMONETICS 0.042GM/100ML;0.276GM/100ML; N820915 Oct 19, 1984
MANUFACTURING INC 0.410GM/100ML;0.30GM/100ML;
1.10GM/100ML;0.588GM/100ML

ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:

AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;

DEXTROSE USP; SODIUM CITRATE USP

INJECTABLE; INJECTION
AS-2 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP 0.042GM/100ML;0.285GM/100ML; N820915 Sep 22, 1983
0.718GM/100ML;0.017GM/100ML;
0.396GM/100ML;0.588GM/100ML
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST 5 - 3 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

ANTICOAGULANT SODIUM CITRATE 4% SOLUTION


INJECTABLE; INJECTION
NONE
HAEMONETICS N980123 Mar 03, 2000
CORPORATION
TERUMO BCT N125608 Jun 26, 2018

ANTICOAGULANT SODIUM CITRATE SOLUTION


INJECTABLE; INJECTION
TRICITRASOL
CYTOSOL N010409 Jul 10, 2003
LABORATORIES INC

ANTICOAGULANT SODIUM CITRATE SOLUTION USP


INJECTABLE; INJECTION
NONE
FENWAL INC N770923 Jan 20, 1978
TERUMO MEDICAL CORP N781214 Feb 08, 1980

CORD BLOOD STERILE COLLECTION BAG, ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION
(CPD)
STERILE CORD BLOOD COLLECTION UNIT
NONE
MACOPHARMA N125552 Dec 21, 2016

DEXTRAN 1 IN SODIUM CHLORIDE 0.6%


INJECTABLE; INJECTION
PROMIT
MEDA AB N830715 Oct 30, 1984

DEXTRAN 40, 10% IN DEXTROSE 5%


INJECTABLE; INJECTION
LMD IN GLASS BOTTLE
HOSPIRA INC 10GM/100ML;5GM/100ML A720563 Oct 30, 1992

DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
LMD IN PLASTIC CONTAINER
HOSPIRA INC 10GM/100ML;0.9GM/100ML A720562 Oct 30, 1992

HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION


INJECTABLE; INJECTION
HEXTEND
BIOTIME INC 6GM/100ML N200952 Mar 31, 1999

HETASTARCH 6% IN SODIUM CHLORIDE 0.9%


INJECTABLE; INJECTION
6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA INC 6GM/100ML;0.9GM/100ML A740193 Jan 30, 1995
HESPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML N890105 Apr 04, 1991
NONE
TEVA PARENTERAL 6GM/100ML;0.9GM/100ML A740592 Nov 12, 1998
MEDICINES INC
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST 5 - 4 of 4

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT


ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST

HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%


STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
NONE
B. BRAUN MEDICAL A110013 Jan 09, 2015
VOLUVEN
FRESENIUS KABI 6GM/100ML;0.9GM/100ML N070012 Dec 27, 2007
DEUTSCHLAND GMBH

ISOPLATE SOLUTION IN THE 500 ML EXCEL CONTAINER


STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
ISOPLATE SOLUTION
HAEMONETICS CORP N90067 Mar 05, 2013

LEUKOCYTE REDUCTION FILTRATION SYSTEM FOR WHOLE BLOOD WITH CPD ANTICOAGULANT AND
SOLX ADDITIVE
INJECTABLE; INJECTION
LEUKOSEP HWB-600-XL
HAEMONETICS CORP N110059 Apr 25, 2013

RED BLOOD CELL PROCESSING SOLUTION


STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
REJUVESOL
CITRA LABS LLC N950522 Feb 26, 1997

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE,


DIABASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
STORAGE/PROCESSING SOLUTION ONLY; SHOULD NEVER BE
INFUSED DIRECTLY TO THE PATIENT.
INTERSOL SOLUTION
FENWAL INC. 2.26G/500ML; 2.21G/500ML; 1.59G/500ML; N080041 Dec 09, 2009
1.53G/500ML; 0.465G/500ML
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST

DISCONTINUED DRUG PRODUCT LIST 6-1(of 393)

** See List Footnote



ABARELIX

INJECTABLE;INTRAMUSCULAR

PLENAXIS

SPECIALITY EUROPEAN 100MG/VIAL N021320 001 Nov 25, 2003

ACAMPROSATE CALCIUM

TABLET, DELAYED RELEASE;ORAL

CAMPRAL

+ FOREST LABS 333MG ** N021431 001 Jul 29, 2004

ACEBUTOLOL HYDROCHLORIDE

CAPSULE;ORAL

ACEBUTOLOL HYDROCHLORIDE

WATSON LABS EQ 200MG BASE A074007 001 Oct 18, 1995

EQ 400MG BASE A074007 002 Oct 18, 1995

SECTRAL

+ PROMIUS PHARMA EQ 200MG BASE N018917 001 Dec 28, 1984

+ EQ 400MG BASE N018917 003 Dec 28, 1984

ACETAMINOPHEN

INJECTABLE;INJECTION

INJECTAPAP

ORTHO MCNEIL PHARM 100MG/ML N017785 001 Mar 07, 1986

SUPPOSITORY;RECTAL

ACEPHEN

G AND W LABS 120MG A072218 001 Mar 27, 1992

325MG N018060 003 Dec 18, 1986

650MG N018060 002

ACETAMINOPHEN

ABLE 120MG A073106 001 Feb 27, 1995

325MG A073107 001 Feb 27, 1995

650MG A073108 001 Feb 27, 1995

ACINO PRODS 120MG A071010 001 May 12, 1987

650MG A071011 001 May 12, 1987

TYLENOL

J AND J CONSUMER INC 120MG N017756 002

650MG N017756 001

TABLET, EXTENDED RELEASE;ORAL

ACETAMINOPHEN

SUN PHARM INDS LTD 650MG A090205 001 Nov 18, 2009

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

CAPSULE;ORAL

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

MIKART 150MG;180MG;15MG A081095 001 Oct 26, 1990

150MG;180MG;30MG A081096 001 Oct 26, 1990

150MG;180MG;60MG A081097 001 Oct 26, 1990

CODEINE, ASPIRIN, APAP FORMULA NO. 2

SCHERER LABS 150MG;180MG;15MG A085640 001

CODEINE, ASPIRIN, APAP FORMULA NO. 3

SCHERER LABS 150MG;180MG;30MG A085639 001

CODEINE, ASPIRIN, APAP FORMULA NO. 4

SCHERER LABS 150MG;180MG;60MG A085638 001

ACETAMINOPHEN; BUTALBITAL

CAPSULE;ORAL

BANCAP

FOREST PHARMS 325MG;50MG A088889 001 Jan 16, 1986
BUCET
MALLINCKRODT 650MG;50MG A088991 001 Jun 28, 1985
PHRENILIN FORTE
VALEANT 650MG;50MG A088831 001 Jun 19, 1985
TENCON
MALLINCKRODT 650MG;50MG A089405 001 May 15, 1990
TRIAPRIN
DUNHALL 325MG;50MG A089268 001 Jul 02, 1987
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
HALSEY 325MG;50MG A089568 001 Oct 05, 1988
WATSON LABS 325MG;50MG A087550 001 Oct 19, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-2(of 393)
** See List Footnote
ACETAMINOPHEN; BUTALBITAL
TABLET;ORAL
BUTAPAP
MIKART 650MG;50MG A089988 001 Oct 26, 1992
PHRENILIN
VALEANT 325MG;50MG ** A087811 001 Jun 19, 1985
SEDAPAP
MAYRAND 650MG;50MG A088944 001 Oct 17, 1985
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
ANOQUAN
SHIRE 325MG;50MG;40MG A087628 001 Oct 01, 1986
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS 325MG;50MG;40MG ** A088825 001 Dec 05, 1984
GRAHAM DM 325MG;50MG;40MG A088743 001 Jul 18, 1985
325MG;50MG;40MG A088765 001 Mar 27, 1985
325MG;50MG;40MG A089067 001 Apr 19, 1985
HIKMA PHARMS 500MG;50MG;40MG A040261 001 Oct 28, 1998
MALLINCKRODT 325MG;50MG;40MG A088758 001 Mar 27, 1985
ESGIC-PLUS
MIKART 500MG;50MG;40MG A040085 001 Mar 28, 1996
FEMCET
MALLINCKRODT 325MG;50MG;40MG A089102 001 Jun 19, 1985
MEDIGESIC PLUS
US CHEM 325MG;50MG;40MG A089115 001 Jan 14, 1986
TRIAD
MALLINCKRODT 325MG;50MG;40MG A089023 001 Jun 19, 1985
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE 325MG;50MG;40MG A040390 001 Jul 23, 2001
500MG;50MG;40MG A040394 001 Jul 23, 2001
GILBERT LABS 325MG;50MG;40MG A087629 001 Nov 13, 1984
HIKMA PHARMS 500MG;50MG;40MG A040336 001 Aug 18, 1999
MIKART 750MG;50MG;40MG A040496 001 Dec 23, 2003
MIRROR PHARMS LLC 500MG;50MG;40MG A040883 001 Dec 23, 2008
NOVAST LABS 325MG;50MG;40MG A040864 001 Dec 01, 2008
SUN PHARM INDUSTRIES 325MG;50MG;40MG A040601 001 Jul 29, 2005
VINTAGE PHARMS 500MG;50MG;40MG A040513 001 Aug 25, 2003
WATSON LABS 325MG;50MG;40MG A089536 001 Feb 16, 1988
500MG;50MG;40MG A040267 001 Jul 30, 1998
ESGIC
FOREST PHARMS 325MG;50MG;40MG A089660 001 Dec 23, 1988
ESGIC-PLUS
MIKART 500MG;50MG;40MG A089451 001 May 23, 1988
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE 325MG;50MG;40MG;30MG A076528 001 Aug 21, 2003
HIKMA INTL PHARMS 325MG;50MG;40MG;30MG A075618 001 Mar 23, 2001
PHRENILIN WITH CAFFEINE AND CODEINE
VALEANT 325MG;50MG;40MG;30MG A074911 001 Aug 22, 2001
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
MIKART 356.4MG;30MG;16MG A040109 001 Aug 26, 1997
WRASER PHARMS LLC 356.4MG;30MG;16MG A040688 001 Apr 03, 2007
DHC PLUS
PHARM RES ASSOC 356.4MG;30MG;16MG A088584 001 Mar 04, 1986
SYNALGOS-DC-A
LEITNER PHARMS 356.4MG;30MG;16MG A089166 001 May 14, 1986
TABLET;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
BOCA PHARMA LLC 712.8MG;60MG;32MG A040701 001 Apr 03, 2007
MIKART 712.8MG;60MG;32MG A040316 001 Apr 28, 1999
WEST-WARD PHARM CORP 712.8MG;60MG;32MG A040637 001 Sep 22, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-3(of 393)

** See List Footnote



ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET;ORAL

TAVIST ALLERGY/SINUS/HEADACHE

NOVARTIS 500MG;EQ 0.25MG BASE;30MG


N021082 001 Mar 01, 2001

ACETAMINOPHEN; CODEINE PHOSPHATE

CAPSULE;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

TEVA
300MG;15MG
A088537 001 Jun 04, 1984

300MG;30MG
A088324 001 Dec 29, 1983

300MG;60MG
A088599 001 Jun 01, 1984

PHENAPHEN W/ CODEINE NO. 2

ROBINS AH
325MG;15MG
A084444 001

PHENAPHEN W/ CODEINE NO. 3

ROBINS AH
325MG;30MG
A084445 001

PHENAPHEN W/ CODEINE NO. 4

ROBINS AH
325MG;60MG
A084446 001

PROVAL #3

SOLVAY
325MG;30MG
A085685 001

TYLENOL W/ CODEINE NO. 3

ORTHO MCNEIL PHARM


300MG;30MG
A087422 001

TYLENOL W/ CODEINE NO. 4

ORTHO MCNEIL PHARM


300MG;60MG
A087421 001

SOLUTION;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACI HEALTHCARE LTD 120MG/5ML;12MG/5ML
A086366 001

ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML
A085861 001

DAVA PHARMS INC 120MG/5ML;12MG/5ML
A040098 001 Sep 20, 1996

TYLENOL W/ CODEINE

ORTHO MCNEIL PHARM 120MG/5ML;12MG/5ML


A085057 001

SUSPENSION;ORAL

CAPITAL AND CODEINE

ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML
A085883 001

VALEANT PHARMS LLC 120MG/5ML;12MG/5ML
A086024 001

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

ABLE
300MG;30MG
A040452 001 Aug 01, 2002

300MG;60MG
A040459 001 Aug 01, 2002

AM THERAP
300MG;15MG
A089478 001 Mar 03, 1987

300MG;15MG
A089481 001 Mar 03, 1987

300MG;30MG
A089479 001 Mar 03, 1987

300MG;30MG
A089482 001 Mar 03, 1987

300MG;60MG
A089480 001 Mar 03, 1987

300MG;60MG
A089483 001 Mar 03, 1987

DURAMED PHARMS BARR
300MG;15MG
A040223 001 Nov 18, 1997

300MG;15MG
A088353 001 Feb 06, 1984

300MG;30MG
A040223 002 Nov 18, 1997

300MG;30MG
A088354 001 Feb 06, 1984

300MG;60MG
A040223 003 Nov 18, 1997

300MG;60MG
A088355 001 Feb 06, 1984

EVERYLIFE
325MG;30MG
A085217 001

FOSUN PHARMA
300MG;30MG
A081250 001 Jul 16, 1992

300MG;60MG
A081249 001 Jul 16, 1992

HALSEY
300MG;15MG
A083871 001

300MG;30MG
A083872 001

300MG;60MG
A086549 001

KV PHARM
300MG;30MG
A085288 001

300MG;60MG
A085365 001

325MG;15MG
A085364 001

325MG;45MG **
A085363 001

LEDERLE
300MG;30MG
A087141 001

MIKART
300MG;30MG
A089238 001 Feb 25, 1986

300MG;60MG
A089244 001 Feb 25, 1986

650MG;30MG
A089231 001 Mar 03, 1986

650MG;60MG
A089363 001 Sep 09, 1991

MUTUAL PHARM
300MG;15MG
A085795 001

300MG;30MG
A085794 001

300MG;60MG
A087653 001 Apr 13, 1982

PURACAP PHARM
300MG;30MG
A087762 001 Dec 10, 1982

PUREPAC PHARM
300MG;30MG
A086681 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-4(of 393)

** See List Footnote



ACETAMINOPHEN; CODEINE PHOSPHATE

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

300MG;30MG
A089080 001 Jul 17, 1986

300MG;60MG
A086683 001

RHODES PHARMS
300MG;15MG
A089673 002 Feb 10, 1988

300MG;30MG
A089673 003 Feb 10, 1988

300MG;60MG
A089673 001 Feb 10, 1988

ROXANE
300MG;15MG
A084659 001

300MG;30MG
A084656 001

300MG;60MG
A084667 001

500MG;15MG
A089511 001 Apr 25, 1989

500MG;30MG
A089512 001 Apr 25, 1989

500MG;60MG
A089513 001 Apr 25, 1989

SANDOZ
300MG;15MG
A087433 001

300MG;30MG
A085291 002

300MG;30MG
A085917 001

300MG;60MG
A085964 001

300MG;60MG
A087423 001

SUPERPHARM
300MG;15MG
A089183 001 Oct 18, 1985

300MG;30MG
A089184 001 Oct 18, 1985

300MG;30MG
A089253 001 May 19, 1986

300MG;60MG
A089185 001 Oct 18, 1985

300MG;60MG
A089254 001 May 19, 1986

USL PHARMA
300MG;30MG
A087919 001 Jun 22, 1982

300MG;60MG
A087920 001 Jun 22, 1982

VALEANT PHARM INTL
300MG;30MG
A085896 001

VITARINE
300MG;30MG
A085676 001

WARNER CHILCOTT
300MG;15MG
A085992 001

300MG;30MG
A085218 002

300MG;60MG
A087306 001

WATSON LABS
300MG;15MG
A087277 001 May 26, 1982

300MG;15MG
A089997 001 Dec 28, 1994

300MG;30MG
A087276 001 May 26, 1982

300MG;30MG
A089998 001 Dec 28, 1994

300MG;60MG
A087275 001 May 26, 1982

300MG;60MG
A089999 001 Dec 28, 1994

WATSON LABS FLORIDA
300MG;15MG
A040443 001 Jan 22, 2003

300MG;30MG
A040443 002 Jan 22, 2003

300MG;60MG
A040443 003 Jan 22, 2003

WHITEWORTH TOWN PLSN 300MG;30MG
A084360 001

300MG;60MG
A085607 001

CAPITAL AND CODEINE

CARNRICK 325MG;30MG
A083643 001

CODRIX

WATSON LABS FLORIDA 500MG;15MG
A040447 001 Feb 26, 2003

500MG;30MG
A040441 001 Mar 27, 2003

500MG;60MG
A040488 001 Mar 28, 2003

EMPRACET W/ CODEINE PHOSPHATE #3

GLAXOSMITHKLINE 300MG;30MG
A083951 001

EMPRACET W/ CODEINE PHOSPHATE #4

GLAXOSMITHKLINE
300MG;60MG
A083951 002

PAPA-DEINE #3

VANGARD
300MG;30MG
A088037 001 Mar 20, 1984

PAPA-DEINE #4

VANGARD
300MG;60MG
A088715 001 Mar 20, 1984

PHENAPHEN-650 W/ CODEINE

ROBINS AH
650MG;30MG
A085856 001

TYLENOL W/ CODEINE

ORTHO MCNEIL PHARM


325MG;7.5MG **
A085056 001

325MG;15MG **
A085056 002

325MG;30MG **
A085056 003

325MG;60MG **
A085056 004

TYLENOL W/ CODEINE NO. 1

JANSSEN PHARMS
300MG;7.5MG
A085055 001

TYLENOL W/ CODEINE NO. 2

JANSSEN PHARMS
300MG;15MG
A085055 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-5(of 393)
** See List Footnote
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DRIXORAL PLUS
SCHERING PLOUGH 500MG;3MG;60MG N019453 001 May 22, 1987
ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS 500MG;5MG A088898 001 Mar 27, 1985
ALLAY
IVAX PHARMS 500MG;5MG A089907 001 Jan 13, 1989
BANCAP HC
FOREST PHARMS 500MG;5MG A087961 001 Mar 17, 1983
CO-GESIC
CENT PHARMS 500MG;5MG A089360 001 Mar 02, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT 500MG;5MG A088956 001 Jul 19, 1985
500MG;5MG A089006 001 Aug 09, 1985
MIKART 500MG;5MG A081067 001 Nov 30, 1989
500MG;5MG A081068 001 Nov 30, 1989
500MG;5MG A081069 001 Nov 30, 1989
500MG;5MG A081070 001 Nov 30, 1989
500MG;5MG A089008 001 Feb 21, 1986
LORCET-HD
MALLINCKRODT 500MG;5MG A087336 001 Jul 08, 1982
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT 500MG/15ML;7.5MG/15ML A040418 001 Jun 27, 2001
MALLINCKRODT INC 500MG/15ML;10MG/15ML A040508 001 Aug 29, 2003
MIKART 500MG/15ML;5MG/15ML A081226 001 Oct 27, 1992
500MG/15ML;5MG/15ML A089557 001 Apr 29, 1992
500MG/15ML;7.5MG/15ML A081051 001 Aug 28, 1992
NESHER PHARMS 500MG/15ML;7.5MG/15ML A040366 001 Jan 23, 2002
PHARM ASSOC 500MG/15ML;7.5MG/15ML A040182 001 Mar 13, 1998
VINTAGE PHARMS 500MG/15ML;7.5MG/15ML A040520 001 Oct 30, 2003
ZYFREL
CYPRESS PHARM INC 325MG/15ML;7.5MG/15ML A090468 001 Apr 14, 2016
TABLET;ORAL
ANEXSIA
MALLINCKRODT 500MG;5MG A089160 001 Apr 23, 1987
750MG;10MG A040468 001 Oct 31, 2002
ANEXSIA 7.5/650
MALLINCKRODT 650MG;7.5MG A089725 001 Sep 30, 1987
CO-GESIC
UCB INC 500MG;5MG A087757 001 May 03, 1982
DURADYNE DHC
FOREST PHARMS 500MG;5MG A087809 001 Mar 17, 1983
HY-PHEN
ASCHER 500MG;5MG A087677 001 May 03, 1982
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ABLE 325MG;5MG A040478 001 Nov 08, 2002
325MG;7.5MG A040464 001 Oct 23, 2002
325MG;10MG A040464 002 Oct 23, 2002
500MG;5MG A040477 001 Nov 06, 2002
500MG;7.5MG A040490 001 May 21, 2003
500MG;10MG A040473 001 Nov 06, 2002
650MG;7.5MG A040474 001 Jan 02, 2003
650MG;10MG A040476 001 Oct 23, 2002
750MG;7.5MG A040469 001 Oct 25, 2002
AMNEAL PHARMS NY 500MG;5MG A040729 001 Aug 25, 2006
500MG;7.5MG A040748 001 Aug 25, 2006
500MG;10MG A040813 001 Feb 23, 2007
650MG;7.5MG A040754 001 Aug 25, 2006
650MG;10MG A040757 001 Aug 25, 2006
750MG;7.5MG A040769 001 Aug 28, 2006
APIL 500MG;10MG A040148 002 Feb 14, 1997
BARR 500MG;2.5MG A040307 001 Jul 26, 2000
500MG;5MG A040308 001 Jul 26, 2000
500MG;5MG A088577 001 Dec 21, 1984
500MG;7.5MG A040307 002 Jul 26, 2000

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-6(of 393)

** See List Footnote



ACETAMINOPHEN; HYDROCODONE BITARTRATE

TABLET;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

500MG;10MG
A040309 001 Jul 26, 2000

650MG;7.5MG
A040307 003 Jul 26, 2000

650MG;10MG
A040307 004 Jul 26, 2000

750MG;7.5MG
A040308 002 Jul 26, 2000

CARACO
500MG;5MG
A090265 001 Dec 23, 2008

500MG;7.5MG
A090265 002 Dec 23, 2008

500MG;10MG
A090265 003 Dec 23, 2008

650MG;7.5MG
A090380 001 Dec 23, 2008

650MG;10MG
A090380 002 Dec 23, 2008

660MG;10MG
A090380 003 Dec 23, 2008

750MG;7.5MG
A090380 004 Dec 23, 2008

HALSEY
500MG;5MG
A089554 001 Jun 12, 1987

IVAX PHARMS
500MG;5MG
A089696 001 Apr 21, 1988

MALLINCKRODT
500MG;5MG
A040084 002 Jun 01, 1995

500MG;7.5MG
A040201 001 Feb 27, 1998

500MG;10MG
A040201 002 Feb 27, 1998

650MG;10MG
A040084 004 Oct 16, 1996

660MG;10MG
A040084 003 Jul 29, 1996

750MG;7.5MG
A040084 001 Jun 01, 1995

MIKART
500MG;2.5MG
A089698 001 Aug 25, 1989

500MG;5MG
A089271 001 Jul 16, 1986

500MG;5MG
A089697 001 Jan 28, 1992

500MG;7.5MG
A089699 001 Aug 25, 1989

650MG;5MG
A040849 001 Jun 09, 2010

650MG;7.5MG
A089689 001 Jun 29, 1988

650MG;10MG
A081223 001 May 29, 1992

MUTUAL PHARM
500MG;5MG
A040236 001 Sep 25, 1997

650MG;7.5MG
A040240 002 Nov 26, 1997

650MG;10MG
A040240 001 Nov 26, 1997

750MG;7.5MG
A040236 002 Sep 25, 1997

RANBAXY
500MG;5MG
A040825 001 Aug 16, 2007

500MG;10MG
A040824 001 Aug 16, 2007

RANBAXY LABS LTD


750MG;7.5MG
A040822 001 Aug 16, 2007

SANDOZ
500MG;5MG
A040149 001 Jan 27, 1997

750MG;7.5MG
A040149 002 Jan 27, 1997

SUN PHARM INDS LTD
325MG;10MG
A040826 001 Aug 16, 2007

UCB INC
500MG;10MG
A040210 001 Aug 13, 1997

650MG;7.5MG
A040134 001 Nov 21, 1996

USL PHARMA
500MG;5MG
A089290 001 May 29, 1987

500MG;5MG
A089291 001 May 29, 1987

VINTAGE PHARMS
500MG;2.5MG
A040144 002 Apr 25, 1997

500MG;5MG
A089831 001 Sep 07, 1988

500MG;5MG
A089971 001 Dec 02, 1988

500MG;7.5MG
A040144 001 Feb 22, 1996

500MG;10MG
A040356 001 May 31, 2000

650MG;7.5MG
A040155 001 Apr 14, 1997

650MG;10MG
A040143 001 Feb 22, 1996

660MG;10MG
A040358 001 May 31, 2000

750MG;7.5MG
A040157 001 Apr 12, 1996

VINTAGE PHARMS LLC


500MG;5MG
A040281 001 Sep 30, 1998

500MG;7.5MG
A040280 001 Sep 30, 1998

650MG;7.5MG
A040280 002 Sep 30, 1998

650MG;10MG
A040280 003 Sep 30, 1998

750MG;7.5MG
A040281 002 Sep 30, 1998

WATSON LABS
325MG;7.5MG
A040248 001 Apr 28, 2000

325MG;10MG
A040248 002 Apr 28, 2000

500MG;2.5MG
A040123 003 Mar 04, 1996

500MG;2.5MG
A081079 001 Aug 30, 1991

500MG;5MG
A040122 001 Mar 04, 1996

500MG;5MG
A089883 001 Dec 01, 1988

500MG;7.5MG
A040123 004 Mar 04, 1996

500MG;7.5MG
A081080 001 Aug 30, 1991

650MG;7.5MG
A040094 001 Sep 29, 1995

650MG;7.5MG
A040123 001 Mar 04, 1996

650MG;10MG
A040094 002 Sep 29, 1995

650MG;10MG
A040123 002 Mar 04, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-7(of 393)
** See List Footnote
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
660MG;10MG A040094 003 Aug 08, 2000
750MG;7.5MG A040122 002 Mar 04, 1996
750MG;7.5MG A081083 001 Aug 30, 1991
750MG;10MG A040094 004 Mar 22, 1999
WATSON LABS FLORIDA 500MG;5MG A040493 001 May 28, 2003
660MG;10MG A040495 001 May 28, 2003
750MG;7.5MG A040494 001 May 28, 2003
LORTAB
UCB INC 500MG;5MG A087722 001 Jul 09, 1982
500MG;10MG A040100 001 Jan 26, 1996
NORCET
ABANA 500MG;5MG A088871 001 May 15, 1986
TYCOLET
ORTHO MCNEIL PHARM 500MG;5MG A089385 001 Aug 27, 1986
VICODIN
ABBOTT 500MG;5MG A085667 001
ABBVIE 500MG;5MG A088058 001 Jan 07, 1983
VICODIN ES
ABBVIE 750MG;7.5MG A089736 001 Dec 09, 1988
VICODIN HP
ABBVIE 660MG;10MG A040117 001 Sep 23, 1996
ZYDONE
VINTAGE PHARMS LLC 400MG;5MG A040288 001 Nov 27, 1998
400MG;7.5MG A040288 002 Nov 27, 1998
400MG;10MG A040288 003 Nov 27, 1998
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH 500MG;5MG A040199 001 Dec 30, 1998
BARR 500MG;5MG A040304 001 Oct 02, 2000
DURAMED PHARMS BARR 500MG;5MG A040289 001 Mar 16, 1999
HALSEY 500MG;5MG A089994 001 May 04, 1989
MALLINCKRODT 500MG;5MG A040257 001 Aug 04, 1998
MUTUAL PHARM 500MG;5MG A040219 001 Jan 22, 1998
VINTAGE PHARMS 500MG;5MG A040106 001 Jul 30, 1996
VINTAGE PHARMS LLC 500MG;5MG A040303 001 Dec 30, 1999
WATSON LABS 500MG;5MG A040234 001 Oct 30, 1997
ROXILOX
ROXANE 500MG;5MG A040061 001 Jul 03, 1995
TYLOX
JANSSEN PHARMS 500MG;5MG A088790 001 Dec 12, 1984
TYLOX-325
ORTHO MCNEIL PHARM 325MG;5MG A088246 001 Nov 08, 1984
SOLUTION;ORAL
OXYCODONE AND ACETAMINOPHEN
SPECGX LLC 325MG/5ML;5MG/5ML A040680 001 Sep 29, 2006
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
VINTAGE PHARMS 325MG/5ML;5MG/5ML A203573 001 Dec 18, 2014
ROXICET
WEST-WARD PHARMS INT 325MG/5ML;5MG/5ML A089351 001 Dec 03, 1986
TABLET;ORAL
OXYCODONE 2.5/APAP 500
BRISTOL MYERS SQUIBB 500MG;2.5MG A085910 001
OXYCODONE 5/APAP 500
BRISTOL MYERS SQUIBB 500MG;5MG A085911 001
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH 325MG;5MG A040203 001 Mar 15, 1999
325MG;7.5MG A040800 001 Apr 03, 2012
325MG;10MG A040800 002 Apr 03, 2012
AMNEAL PHARMS NY 500MG;7.5MG A040789 001 Nov 27, 2007
650MG;10MG A040789 002 Nov 27, 2007
BARR 325MG;5MG A087406 001
DURAMED PHARMS BARR 325MG;5MG A040272 001 Jun 30, 1998
MALLINCKRODT 500MG;7.5MG A040550 001 Jun 30, 2004
650MG;10MG A040550 002 Jun 30, 2004
MAYNE PHARMA INC 500MG;7.5MG A090177 005 Oct 20, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-8(of 393)

** See List Footnote



ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE AND ACETAMINOPHEN

650MG;10MG A090177 006 Oct 20, 2008

MIKART 400MG;2.5MG A040679 001 May 16, 2006

400MG;5MG A040687 001 Apr 27, 2006

400MG;7.5MG A040698 001 Apr 27, 2006

400MG;10MG A040692 001 Apr 27, 2006

500MG;10MG A040676 001 Apr 19, 2006

WATSON LABS 500MG;7.5MG A040371 001 Dec 29, 2000



650MG;10MG A040371 002 Dec 29, 2000

PERCOCET

VINTAGE PHARMS LLC 325MG;5MG A085106 002

500MG;7.5MG A040341 001 Jul 26, 1999

650MG;10MG A040341 002 Jul 26, 1999

ROXICET 5/500

ROXANE 500MG;5MG A089775 001 Jan 12, 1989



TABLET, EXTENDED RELEASE;ORAL

XARTEMIS XR

+ MALLINCKRODT INC 325MG;7.5MG N204031 001 Mar 11, 2014

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

CAPSULE;ORAL

TYLOX

ORTHO MCNEIL PHARM 500MG;4.5MG;0.38MG A085375 001

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE

GAVIS PHARMS 650MG;EQ 25MG BASE A076202 001 Aug 02, 2002

WATSON LABS 650MG;EQ 25MG BASE A074699 001 Mar 24, 2000

TALACEN

SANOFI AVENTIS US 650MG;EQ 25MG BASE N018458 001 Sep 23, 1982

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

TABLET;ORAL

DARVOCET

AAIPHARMA LLC 325MG;32.5MG N016844 001

DOLENE AP-65

LEDERLE 650MG;65MG A085100 001

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

MYLAN 325MG;32MG A083689 001

650MG;65MG A083978 001

SANDOZ 650MG;65MG A089959 001 Jul 18, 1989

VINTAGE PHARMS 650MG;65MG A040507 001 Jul 30, 2003

WATSON LABS 650MG;65MG A040139 001 Dec 16, 1996

WYGESIC

CARACO 650MG;65MG A084999 001

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

TABLET;ORAL

DARVOCET A500

XANODYNE PHARM 500MG;100MG A076429 001 Sep 10, 2003

DARVOCET-N 100

XANODYNE PHARM 650MG;100MG N017122 002

DARVOCET-N 50

XANODYNE PHARM 325MG;50MG N017122 001

PROPACET 100

TEVA 650MG;100MG A070107 001 Jun 12, 1985

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

ABLE 650MG;100MG A075838 001 Jul 11, 2001

ACTAVIS ELIZABETH 650MG;100MG A070910 001 Jan 02, 1987

CORNERSTONE 325MG;100MG A076743 001 May 07, 2004

500MG;100MG A076750 001 Jun 28, 2004



HALSEY 325MG;50MG A072105 001 May 13, 1988

650MG;100MG A072106 001 May 13, 1988

IVAX SUB TEVA PHARMS 650MG;100MG A070146 001 Aug 02, 1985

MALLINCKRODT 650MG;100MG A075738 001 Feb 02, 2001



MIRROR PHARMS 650MG;100MG A077821 001 Feb 11, 2008

MUTUAL PHARM 325MG;50MG A070115 001 Jun 12, 1985

650MG;100MG A070116 001 Jun 12, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-9(of 393)

** See List Footnote



ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

TABLET;ORAL

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

650MG;100MG A070615 001 Mar 21, 1986
650MG;100MG A070771 001 Mar 21, 1986
650MG;100MG A070775 001 Mar 21, 1986
MYLAN 650MG;100MG A072195 001 Feb 16, 1988
MYLAN PHARMS INC 650MG;100MG A070145 001 Jun 12, 1985
SANDOZ 650MG;100MG A070443 001 Jan 23, 1986
SUPERPHARM 650MG;100MG A071319 001 Jan 06, 1987
TEVA 650MG;100MG A070732 001 Jan 03, 1986
650MG;100MG A074119 001 Dec 19, 1994
VINTAGE PHARMS 325MG;50MG A074843 002 Feb 15, 2001
650MG;100MG A074843 001 Feb 12, 1997
WATSON LABS 325MG;50MG A070398 001 Dec 18, 1986
650MG;100MG A070399 001 Dec 18, 1986
WATSON LABS FLORIDA 500MG;100MG A077196 001 Jun 28, 2005
650MG;100MG A076609 001 Nov 16, 2004
WOCKHARDT LTD 325MG;50MG A077677 001 Mar 16, 2007
650MG;100MG A077677 002 Mar 16, 2007
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

TABLET;ORAL

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

CSPC OUYI PHARM CO 325MG;37.5MG A076914 001 Jul 26, 2006

ACETAZOLAMIDE

TABLET;ORAL

ACETAZOLAMIDE

ALRA 250MG A083320 001

ASCOT 250MG A087686 001 Oct 20, 1982

SUN PHARM INDUSTRIES 250MG A089753 001 Jun 22, 1988

VANGARD 250MG A087654 001 Feb 05, 1982

WATSON LABS 250MG A084498 002

250MG A088882 001 Oct 22, 1985

DIAMOX

+ TEVA BRANDED PHARM 125MG ** N008943 001

+ 250MG ** N008943 002

ACETAZOLAMIDE SODIUM

INJECTABLE;INJECTION

ACETAZOLAMIDE SODIUM

HOSPIRA EQ 500MG BASE/VIAL A040108 001 Oct 30, 1995

DIAMOX

+ TEVA WOMENS EQ 500MG BASE/VIAL ** N009388 001

ACETIC ACID, GLACIAL

SOLUTION/DROPS;OTIC

ACETASOL

ACTAVIS MID ATLANTIC 2% A087146 001

ACETIC ACID

KV PHARM 2% A085493 001

ORLEX

WARNER CHILCOTT 2% A086845 001

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

SOLUTION/DROPS;OTIC

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE



BAUSCH AND LOMB 2%;0.79% A040063 001 Feb 25, 1994

BOROFAIR

PHARMAFAIR 2%;0.79% A088606 001 Aug 21, 1985

DOMEBORO

BAYER PHARMS 2%;0.79% A084476 001

ACETIC ACID, GLACIAL; DESONIDE

SOLUTION/DROPS;OTIC

TRIDESILON

BAYER PHARMS 2%;0.05% N017914 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-10(of 393)

** See List Footnote



ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS;OTIC

ACETIC ACID W/ HYDROCORTISONE

KV PHARM 2%;1%
A085492 001

HYDROCORTISONE AND ACETIC ACID

BAUSCH AND LOMB 2%;1%
A040097 001 Oct 31, 1994

WOCKHARDT 2%;1%
A040168 001 Aug 30, 1996

ORLEX HC

WARNER CHILCOTT 2%;1%
A086844 001

ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE

SUSPENSION/DROPS;OTIC

NEO-CORT-DOME

BAYER PHARMS
2%;1%;EQ 0.35% BASE
N050238 001

ACETOHEXAMIDE

TABLET;ORAL

ACETOHEXAMIDE

ANI PHARMS INC
250MG
A070869 001 Feb 09, 1987

500MG
A070870 001 Feb 09, 1987

USL PHARMA
250MG
A070753 001 Nov 03, 1986

500MG
A070754 001 Nov 03, 1986

WATSON LABS TEVA
250MG
A071893 001 Nov 25, 1987

500MG
A071894 001 Nov 25, 1987

DYMELOR

LILLY
250MG
N013378 002

500MG
N013378 001

ACETOPHENAZINE MALEATE

TABLET;ORAL

TINDAL

SCHERING
20MG
N012254 002

ACETRIZOATE SODIUM

SOLUTION;INTRAUTERINE

SALPIX

ORTHO MCNEIL PHARM
53%
N009008 001

ACETYLCHOLINE CHLORIDE

FOR SOLUTION;OPHTHALMIC

MIOCHOL

NOVARTIS
20MG/VIAL
N016211 001

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

HOSPIRA
10%
A071364 001 May 01, 1989

20%
A071365 001 May 01, 1989

ROXANE
10%
A072323 001 Apr 30, 1992

10%
A072621 001 Sep 30, 1992

20%
A072324 001 Apr 30, 1992

20%
A072622 001 Sep 30, 1992

MUCOMYST

+ APOTHECON
10% **
N013601 002

+
20% **
N013601 001

MUCOSIL-10

DEY
10%
A070575 001 Oct 14, 1986

MUCOSIL-20

DEY
20%
A070576 001 Oct 14, 1986

ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE

SOLUTION;INHALATION

MUCOMYST W/ ISOPROTERENOL

MEAD JOHNSON
10%;0.05%
N017366 001

ACETYLDIGITOXIN

TABLET;ORAL

ACYLANID

NOVARTIS
0.1MG
N009436 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-11(of 393)

** See List Footnote



ACITRETIN

CAPSULE;ORAL

ACITRETIN

MYLAN PHARMS INC 17.5MG A203707 001 Sep 10, 2015

22.5MG A203707 002 Sep 10, 2015



ACRISORCIN

CREAM;TOPICAL

AKRINOL

SCHERING 2MG/GM N012470 001

ACYCLOVIR

CAPSULE;ORAL

ACYCLOVIR

ACTAVIS ELIZABETH 200MG A074906 001 Aug 26, 1997

CHARTWELL MOLECULES 200MG A074872 001 Apr 22, 1997

IVAX SUB TEVA PHARMS 200MG A074674 001 Apr 22, 1997

LEK PHARM 200MG A074750 001 Apr 22, 1997

MYLAN 200MG A074727 001 Apr 22, 1997

200MG A074977 001 Apr 13, 1998

RANBAXY 200MG A074975 001 Sep 30, 1998

ROXANE 200MG A074570 002 Apr 22, 1997

TEVA 200MG A074828 001 Apr 22, 1997

TEVA PHARMS 200MG A074914 001 Nov 26, 1997



WATSON LABS 200MG A075101 001 Apr 15, 1998

TABLET;ORAL

ACYCLOVIR

ACTAVIS ELIZABETH 400MG A074870 001 Jun 05, 1997

800MG A074870 002 Jun 05, 1997

CHARTWELL MOLECULES 400MG A074834 001 Apr 24, 1997

800MG A074834 002 Apr 24, 1997

IVAX SUB TEVA PHARMS 400MG A074836 001 Apr 22, 1997

800MG A074836 002 Apr 22, 1997

LEK PHARM 400MG A074658 001 Apr 22, 1997

800MG A074658 002 Apr 22, 1997

MYLAN 400MG A074976 001 Apr 13, 1998

800MG A074976 002 Apr 13, 1998

MYLAN PHARMS INC 400MG A075211 001 Sep 28, 1998

800MG A075211 002 Sep 28, 1998

SUN PHARM INDS LTD 400MG A074980 001 Sep 30, 1998

800MG A074980 002 Sep 30, 1998

TEVA 200MG ** A074556 001 Apr 22, 1997

TEVA PHARMS 400MG A075021 001 Mar 18, 1998



800MG A075021 002 Mar 18, 1998

ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ACYCLOVIR

ABBVIE EQ 50MG BASE/ML A075114 001 Jul 26, 1999

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

EUROHLTH INTL SARL EQ 500MG BASE/VIAL A074885 001 Dec 19, 1997

EQ 1GM BASE/VIAL A074885 002 Dec 19, 1997

ACYCLOVIR SODIUM

APOTHECON EQ 500MG BASE/VIAL A074897 001 Feb 27, 1998

EQ 1GM BASE/VIAL A074897 002 Feb 27, 1998

ATHENEX INC EQ 500MG BASE/VIAL A074596 002 Apr 22, 1997

EQ 1GM BASE/VIAL A074596 001 Apr 22, 1997

EUROHLTH INTL SARL EQ 500MG BASE/VIAL A074913 001 Oct 15, 1997

EQ 1GM BASE/VIAL A074913 002 Oct 15, 1997

FRESENIUS KABI USA EQ 500MG BASE/VIAL A075015 001 Apr 30, 1998

HIKMA PHARMS EQ 500MG BASE/VIAL A205771 001 Feb 29, 2016



EQ 1GM BASE/VIAL A205771 002 Feb 29, 2016

HOSPIRA EQ 25MG BASE/ML A074720 001 Apr 22, 1997

EQ 50MG BASE/ML A075065 001 Feb 25, 1999



EQ 500MG BASE/VIAL A074663 001 Apr 22, 1997

EQ 500MG BASE/VIAL A074758 001 Apr 22, 1997

EQ 1GM BASE/VIAL A074663 002 Apr 22, 1997

EQ 1GM BASE/VIAL A074758 002 Apr 22, 1997

MYLAN LABS LTD EQ 500MG BASE/VIAL A203927 001 Mar 29, 2017

EQ 1GM BASE/VIAL A203927 002 Mar 29, 2017

TEVA PARENTERAL EQ 50MG BASE/ML A075627 001 Mar 28, 2001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-12(of 393)

** See List Footnote



ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ACYCLOVIR SODIUM

EQ 500MG BASE/VIAL
A074969 001 Aug 26, 1997

EQ 1GM BASE/VIAL
A074969 002 Aug 26, 1997

ZYDUS PHARMS USA INC


EQ 500MG BASE/VIAL
A206606 001 Jun 13, 2017

EQ 1GM BASE/VIAL
A206606 002 Jun 13, 2017

ZOVIRAX

+ GLAXOSMITHKLINE
EQ 250MG BASE/VIAL **
N018603 003 Aug 30, 1983

+
EQ 500MG BASE/VIAL **
N018603 001 Oct 22, 1982

+
EQ 1GM BASE/VIAL **
N018603 002 Jun 29, 1989

ADAPALENE

SOLUTION;TOPICAL

DIFFERIN

+ GALDERMA LABS LP
0.1% **
N020338 001 May 31, 1996

ADENOSINE

INJECTABLE;INJECTION

ADENOCARD

+ ASTELLAS
3MG/ML
N019937 002 Oct 30, 1989

ADENOSINE

TEVA PHARMS USA
3MG/ML
A076564 001 Jun 16, 2004

3MG/ML
A078676 001 Jul 31, 2008

WEST-WARD PHARMS INT
3MG/ML
A076501 001 Jun 16, 2004

WOCKHARDT
3MG/ML
A090220 001 Jul 20, 2009

SOLUTION;INTRAVENOUS

ADENOSCAN

+ ASTELLAS
60MG/20ML (3MG/ML) **
N020059 001 May 18, 1995

+
90MG/30ML (3MG/ML) **
N020059 002 May 18, 1995

ALATROFLOXACIN MESYLATE

INJECTABLE;INJECTION

TROVAN PRESERVATIVE FREE

PFIZER
EQ 200MG BASE/VIAL
N020760 001 Dec 18, 1997

EQ 300MG BASE/VIAL
N020760 002 Dec 18, 1997

ALBENDAZOLE

TABLET, CHEWABLE;ORAL

ALBENZA

AMEDRA PHARMS LLC
200MG
N207844 001 Jun 11, 2015

ALBUMIN CHROMATED CR-51 SERUM

INJECTABLE;INJECTION

CHROMALBIN

ISO TEX
100uCi/VIAL
N017835 001

250uCi/VIAL
N017835 002

500uCi/VIAL
N017835 003

ALBUMIN IODINATED I-125 SERUM

INJECTABLE;INJECTION

RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN)

BAYER PHARMS 2.5uCi/AMP


N017846 001

RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125

MALLINCKRODT
6.67uCi/ML
N017844 003

10uCi/ML
N017844 001

100uCi/ML
N017844 002

ALBUMIN IODINATED I-131 SERUM

INJECTABLE;INJECTION

MEGATOPE

ISO TEX
2mCi/VIAL
N017837 003

5uCi/AMP
N017837 004

20uCi/AMP
N017837 005

ALBUTEROL

AEROSOL, METERED;INHALATION

ALBUTEROL

ARMSTRONG PHARMS
0.09MG/INH
A072273 001 Aug 14, 1996

GENPHARM
0.09MG/INH
A073045 001 Aug 19, 1997

IVAX SUB TEVA PHARMS


0.09MG/INH
A073272 001 Dec 28, 1995

PLIVA
0.09MG/INH
A074072 001 Aug 01, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-13(of 393)

** See List Footnote



ALBUTEROL

AEROSOL, METERED;INHALATION

PROVENTIL

SCHERING
0.09MG/INH
N017559 001

VENTOLIN

GLAXOSMITHKLINE
0.09MG/INH
N018473 001

ALBUTEROL SULFATE

CAPSULE;INHALATION

VENTOLIN ROTACAPS

GLAXOSMITHKLINE
EQ 0.2MG BASE
N019489 001 May 04, 1988

SOLUTION;INHALATION

ALBUTEROL SULFATE

ACTAVIS MID ATLANTIC
EQ 0.083% BASE
A073533 001 Sep 26, 1995

APOTEX INC
EQ 0.021% BASE
A078623 001 Apr 05, 2010

EQ 0.042% BASE
A078623 002 Apr 05, 2010

EQ 0.083% BASE
A075717 001 Feb 02, 2007

EQ 0.5% BASE
A076391 001 Apr 01, 2003

BAUSCH AND LOMB


EQ 0.083% BASE
A075358 001 Mar 29, 2000

COPLEY PHARM
EQ 0.083% BASE
A073495 001 May 28, 1993

EQ 0.5% BASE
A073307 001 Nov 27, 1991

HI TECH PHARMA
EQ 0.083% BASE
A075063 001 Feb 09, 1999

LANDELA PHARM
EQ 0.083% BASE
A077569 001 Apr 04, 2006

MYLAN SPECLT
EQ 0.083% BASE **
A072652 001 Feb 21, 1992

ROXANE
EQ 0.083% BASE
A075129 001 Feb 13, 2001

TEVA PHARMS
EQ 0.083% BASE
A075343 001 Nov 09, 1999

WATSON LABS INC
EQ 0.083% BASE
A076370 001 Nov 24, 2003

WOCKHARDT EU OPERATN
EQ 0.083% BASE
A075394 001 Nov 22, 1999

PROVENTIL

+ SCHERING
EQ 0.083% BASE **
N019243 002 Jan 14, 1987

+
EQ 0.5% BASE **
N019243 001 Jan 14, 1987

VENTOLIN

+ GLAXOSMITHKLINE
EQ 0.083% BASE **
N019773 001 Apr 23, 1992

EQ 0.5% BASE **
N019269 002 Jan 16, 1987

SYRUP;ORAL

ALBUTEROL SULFATE

ACTAVIS MID ATLANTIC
EQ 2MG BASE/5ML
A075262 001 Mar 30, 1999

MOVA
EQ 2MG BASE/5ML
A074302 001 Sep 30, 1994

WATSON LABS
EQ 2MG BASE/5ML
A073165 001 Apr 29, 1993

PROVENTIL

+ SCHERING
EQ 2MG BASE/5ML **
N018062 001 Jan 19, 1983

VENTOLIN

GLAXOSMITHKLINE
EQ 2MG BASE/5ML **
N019621 001 Jun 10, 1987

TABLET;ORAL

ALBUTEROL SULFATE

AM THERAP
EQ 2MG BASE
A072449 001 Dec 05, 1989

EQ 4MG BASE
A072450 001 Dec 05, 1989

COPLEY PHARM
EQ 2MG BASE
A072966 001 Nov 22, 1991

EQ 4MG BASE
A072967 001 Nov 22, 1991

DAVA PHARMS INC
EQ 2MG BASE
A072860 002 Dec 20, 1989

EQ 4MG BASE
A072860 001 Dec 20, 1989

PLIVA
EQ 2MG BASE
A072316 001 Dec 05, 1989

EQ 4MG BASE
A072317 001 Dec 05, 1989

TEVA
EQ 2MG BASE
A072619 001 Dec 05, 1989

EQ 2MG BASE
A072779 001 Jun 25, 1993

EQ 2MG BASE
A072938 001 Mar 30, 1990

EQ 4MG BASE
A072620 001 Dec 05, 1989

EQ 4MG BASE
A072780 001 Jun 25, 1993

EQ 4MG BASE
A072939 001 Mar 30, 1990

UCB INC
EQ 2MG BASE
A073120 001 Sep 29, 1992

EQ 4MG BASE
A073121 001 Sep 29, 1992

WARNER CHILCOTT
EQ 2MG BASE
A072817 001 Jan 09, 1990

EQ 4MG BASE
A072818 001 Jan 09, 1990

WATSON LABS
EQ 2MG BASE
A072629 001 Jan 31, 1991

EQ 2MG BASE
A072764 001 Aug 28, 1991

EQ 4MG BASE
A072630 001 Jan 31, 1991

EQ 4MG BASE
A072765 001 Aug 28, 1991

YAOPHARMA CO LTD
EQ 2MG BASE
A072151 001 Dec 05, 1989

EQ 4MG BASE
A072152 001 Dec 05, 1989

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-14(of 393)
** See List Footnote
ALBUTEROL SULFATE
TABLET;ORAL
PROVENTIL
+ SCHERING EQ 2MG BASE ** N017853 001 May 07, 1982
+ EQ 4MG BASE ** N017853 002 May 07, 1982
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE N019112 001 Jul 10, 1986
EQ 4MG BASE N019112 002 Jul 10, 1986
TABLET, EXTENDED RELEASE;ORAL
PROVENTIL
SCHERING EQ 4MG BASE N019383 001 Jul 13, 1987
VOLMAX
MURO EQ 4MG BASE N019604 002 Dec 23, 1992
EQ 8MG BASE N019604 001 Dec 23, 1992
VOSPIRE ER
DAVA PHARMS INC EQ 8MG BASE A076130 003 Sep 26, 2002
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION

COMBIVENT

BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH N020291 001 Oct 24, 1996

SOLUTION;INHALATION

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

APOTEX INC EQ 0.083% BASE;0.017% A077117 001 Dec 31, 2007

FOSUN PHARMA EQ 0.083% BASE;0.017% A076867 001 Dec 21, 2006

TEVA PHARMS EQ 0.083% BASE;0.017% A076724 001 Dec 31, 2007

DUONEB

+ MYLAN SPECIALITY LP EQ 0.083% BASE;0.017% ** N020950 001 Mar 21, 2001

ALCLOMETASONE DIPROPIONATE

CREAM;TOPICAL

ACLOVATE

+ FOUGERA PHARMS 0.05% ** N018707 001 Dec 14, 1982

OINTMENT;TOPICAL

ACLOVATE

+ FOUGERA PHARMS 0.05% ** N018702 001 Dec 14, 1982

ALCOHOL

INJECTABLE;INJECTION

ALCOHOL 5% IN DEXTROSE 5%

MILES 5ML/100ML A083483 001

ALCOHOL; DEXTROSE

INJECTABLE;INJECTION

ALCOHOL 10% AND DEXTROSE 5%

B BRAUN 10ML/100ML;5GM/100ML N004589 006

ALCOHOL 5% AND DEXTROSE 5%

B BRAUN 5ML/100ML;5GM/100ML N004589 004

ALCOHOL 5% IN D5-W

HOSPIRA 5ML/100ML;5GM/100ML A083263 001

ALCOHOL 5% IN DEXTROSE 5% IN WATER

BAXTER HLTHCARE 5ML/100ML;5GM/100ML A083256 001

ALENDRONATE SODIUM

SOLUTION;ORAL

FOSAMAX

+ MERCK EQ 70MG BASE/75ML ** N021575 001 Sep 17, 2003

TABLET;ORAL

ALENDRONATE SODIUM

MYLAN EQ 35MG BASE A076584 003 Aug 04, 2008

EQ 35MG BASE A078638 001 Aug 04, 2008

EQ 70MG BASE A076584 004 Aug 04, 2008

EQ 70MG BASE A078638 002 Aug 04, 2008

TEVA PHARMS EQ 35MG BASE A076184 002 Aug 04, 2008

EQ 70MG BASE A076184 001 Feb 06, 2008



UPSHER SMITH LABS EQ 5MG BASE A075871 001 Apr 22, 2009

EQ 10MG BASE A075871 002 Apr 22, 2009

EQ 35MG BASE A075871 004 Apr 22, 2009

EQ 40MG BASE A075871 003 Apr 22, 2009

EQ 70MG BASE A075871 005 Apr 22, 2009


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-15(of 393)

** See List Footnote



ALENDRONATE SODIUM

TABLET;ORAL

FOSAMAX

+ MERCK AND CO INC EQ 5MG BASE ** N020560 003 Apr 25, 1997

+ EQ 10MG BASE ** N020560 001 Sep 29, 1995

+ EQ 35MG BASE ** N020560 004 Oct 20, 2000



+ EQ 40MG BASE ** N020560 002 Sep 29, 1995

ALFUZOSIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

ALFUZOSIN HYDROCHLORIDE

WOCKHARDT LTD 10MG A090221 001 Aug 10, 2012

ALGLUCERASE

INJECTABLE;INJECTION

CEREDASE

GENZYME 10 UNITS/ML N020057 004 May 08, 1992

80 UNITS/ML N020057 003 Apr 05, 1991



ALISKIREN HEMIFUMARATE

CAPSULE, PELLET;ORAL

TEKTURNA

+ NODEN PHARMA EQ 37.5MG BASE N210709 001 Nov 14, 2017

ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

TABLET;ORAL

TEKAMLO

NOVARTIS EQ 150MG BASE;EQ 5MG BASE N022545 001 Aug 26, 2010

EQ 150MG BASE;EQ 10MG BASE N022545 002 Aug 26, 2010

EQ 300MG BASE;EQ 5MG BASE N022545 003 Aug 26, 2010

EQ 300MG BASE;EQ 10MG BASE N022545 004 Aug 26, 2010



ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

AMTURNIDE

NOVARTIS EQ 150MG BASE;EQ 5MG BASE;12.5MG N200045 001 Dec 21, 2010

EQ 300MG BASE;EQ 5MG BASE;12.5MG N200045 002 Dec 21, 2010

EQ 300MG BASE;EQ 5MG BASE;25MG N200045 003 Dec 21, 2010

EQ 300MG BASE;EQ 10MG BASE;12.5MG N200045 004 Dec 21, 2010

EQ 300MG BASE;EQ 10MG BASE;25MG N200045 005 Dec 21, 2010

ALISKIREN HEMIFUMARATE; VALSARTAN

TABLET;ORAL

VALTURNA

NOVARTIS EQ 150MG BASE;160MG N022217 001 Sep 16, 2009

EQ 300MG BASE;320MG N022217 002 Sep 16, 2009



ALKAVERVIR

TABLET;ORAL

VERILOID

3M 2MG N007336 002

3MG N007336 003

ALLOPURINOL

TABLET;ORAL

ALLOPURINOL

FOSUN PHARMA 100MG A070268 001 Dec 31, 1985

MUTUAL PHARM 100MG A070466 001 Dec 24, 1985

300MG A070467 001 Dec 24, 1985

PURACAP PHARM 100MG A070150 001 Dec 10, 1985

300MG A070147 001 Dec 10, 1985

PUREPAC PHARM 100MG A070579 001 Apr 14, 1986

300MG A070580 001 Apr 14, 1986

SANDOZ 300MG A070269 001 Dec 31, 1985



SUPERPHARM 100MG A070950 001 Nov 30, 1988

300MG A070951 001 Nov 30, 1988

WATSON LABS 100MG N018241 001 Nov 16, 1984

100MG N018785 001 Sep 28, 1984

300MG N018241 002 Nov 16, 1984



300MG N018785 002 Sep 28, 1984

LOPURIN

ABBOTT 100MG N018297 001

300MG N018297 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-16(of 393)

** See List Footnote



ALPRAZOLAM

SOLUTION;ORAL

ALPRAZOLAM

ROXANE
0.5MG/5ML
A074314 001 Oct 31, 1993

TABLET;ORAL

ALPRAZOLAM

ANI PHARMS INC
0.25MG
A074085 001 Feb 16, 1994

0.5MG
A074085 002 Feb 16, 1994

1MG
A074085 003 Feb 16, 1994

2MG
A074085 004 Feb 26, 1996

IVAX SUB TEVA PHARMS
0.25MG
A074294 001 Jul 29, 1994

0.5MG
A074294 002 Jul 29, 1994

1MG
A074294 003 Jul 29, 1994

2MG
A074294 004 Jul 29, 1994

MYLAN PHARMS INC
0.25MG
A074046 001 Oct 19, 1993

0.5MG
A074046 002 Oct 19, 1993

1MG
A074046 003 Oct 19, 1993

2MG
A074046 004 May 07, 1997

ROXANE
0.25MG
A074199 001 Oct 19, 1993

0.5MG
A074199 002 Oct 19, 1993

1MG
A074199 003 Oct 19, 1993

WATSON LABS
0.25MG
A074456 001 Aug 31, 1995

0.25MG
A074479 001 Jan 21, 1997

0.5MG
A074456 002 Aug 31, 1995

0.5MG
A074479 002 Jan 21, 1997

1MG
A074456 003 Aug 31, 1995

1MG
A074479 003 Jan 21, 1997

TABLET, EXTENDED RELEASE;ORAL

ALPRAZOLAM

ACTAVIS LABS FL INC
0.5MG
A077198 001 May 13, 2010

1MG
A077198 002 May 13, 2010

2MG
A077198 003 May 13, 2010

3MG
A077198 004 May 13, 2010

ANI PHARMS INC


0.5MG
A077979 001 Feb 28, 2007

1MG
A077979 002 Feb 28, 2007

2MG
A077979 003 Feb 28, 2007

3MG
A077979 004 Feb 28, 2007

IMPAX LABS
0.5MG
A077968 004 May 24, 2007

1MG
A077968 003 May 24, 2007

2MG
A077968 002 May 24, 2007

3MG
A077968 001 May 24, 2007

IMPAX LABS INC


0.5MG
A077996 001 Jan 31, 2007

1MG
A077996 002 Jan 31, 2007

2MG
A077996 003 Jan 31, 2007

3MG
A077996 004 Jan 31, 2007

MYLAN
0.5MG
A077391 002 Jan 26, 2006

1MG
A077391 003 Jan 26, 2006

2MG
A077391 004 Jan 26, 2006

3MG
A077391 001 Jan 26, 2006

SANDOZ INC
0.5MG
A077777 001 Jun 30, 2006

1MG
A077777 002 Jun 30, 2006

2MG
A077777 003 Jun 30, 2006

3MG
A077777 004 Jun 30, 2006

VINTAGE PHARMS
0.5MG
A078442 001 Oct 15, 2007

1MG
A078442 002 Oct 15, 2007

2MG
A078442 003 Oct 15, 2007

3MG
A078442 004 Oct 15, 2007

TABLET, ORALLY DISINTEGRATING;ORAL

NIRAVAM

+ UCB INC 0.25MG **
N021726 001 Jan 19, 2005

+ 0.5MG **
N021726 002 Jan 19, 2005

+ 1MG **
N021726 003 Jan 19, 2005

+ 2MG **
N021726 004 Jan 19, 2005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-17(of 393)

** See List Footnote



ALPROSTADIL

INJECTABLE;INJECTION

CAVERJECT

PFIZER 0.005MG/ML
N020755 001 Oct 31, 1997

0.01MG/ML
N020755 002 Oct 01, 1997

0.02MG/ML
N020755 003 Oct 01, 1997

+ PHARMACIA AND UPJOHN 0.005MG/VIAL
N020379 003 Jun 27, 1996

EDEX
AUXILIUM PHARMS LLC 0.005MG/VIAL
N020649 001 Jun 12, 1997

ALSEROXYLON

TABLET;ORAL

RAUTENSIN

NOVARTIS
2MG
N009215 001

RAUWILOID

3M
2MG
N008867 001

ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

TABLET, CHEWABLE;ORAL

ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE

PENNEX
80MG;20MG
A089449 001 Nov 27, 1987

FOAMCOAT

GUARDIAN DRUG
80MG;20MG
A071793 001 Sep 04, 1987

FOAMICON

NOVARTIS
80MG;20MG
A072687 001 Jun 28, 1989

GAVISCON

+ SANOFI AVENTIS US
160MG;40MG
N018685 002 Dec 09, 1983

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL

AMANTADINE HYDROCHLORIDE

ACTAVIS ELIZABETH
100MG
A077659 001 Feb 23, 2006

LANNETT CO INC
100MG
A209221 001 Jun 15, 2017

WATSON LABS
100MG
A071382 001 Jan 21, 1987

SYMADINE

SOLVAY
100MG
A071000 001 Sep 04, 1986

SYMMETREL

+ ENDO PHARMS
100MG **
N016020 001

SYRUP;ORAL

AMANTADINE HYDROCHLORIDE

G AND W LABS INC
50MG/5ML
A072655 001 Oct 30, 1990

LANNETT CO INC
50MG/5ML
A076352 001 Sep 10, 2004

TEVA PHARMS
50MG/5ML
A073115 001 Aug 23, 1991

VINTAGE
50MG/5ML
A077992 001 Dec 12, 2006

SYMMETREL

+ ENDO PHARMS
50MG/5ML **
N016023 002

TABLET;ORAL

SYMMETREL

+ ENDO PHARMS
100MG **
N018101 001

AMBENONIUM CHLORIDE

TABLET;ORAL

MYTELASE

SANOFI AVENTIS US
10MG
N010155 002

AMCINONIDE

CREAM;TOPICAL

CYCLOCORT

+ ASTELLAS
0.025%
N018116 001

+
0.1%
N018116 002

LOTION;TOPICAL

CYCLOCORT

+ ASTELLAS
0.1%
N019729 001 Jun 13, 1988

OINTMENT;TOPICAL

CYCLOCORT

+ ASTELLAS
0.1%
N018498 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-18(of 393)

** See List Footnote



AMDINOCILLIN

INJECTABLE;INJECTION

COACTIN

ROCHE 250MG/VIAL N050565 001 Dec 21, 1984

500MG/VIAL N050565 002 Dec 21, 1984

1GM/VIAL N050565 003 Dec 21, 1984

AMIFOSTINE

INJECTABLE;INJECTION

ETHYOL

CLINIGEN HLTHCARE 375MG/VIAL N020221 002 Sep 10, 1999

AMIKACIN SULFATE

INJECTABLE;INJECTION

AMIKACIN SULFATE

ABBOTT EQ 250MG BASE/ML A063265 001 Nov 30, 1994

EQ 250MG BASE/ML A063266 001 Oct 31, 1994

HOSPIRA EQ 50MG BASE/ML A063263 001 Nov 30, 1994

EQ 50MG BASE/ML A063350 001 Jul 30, 1993

EQ 62.5MG BASE/ML A063283 001 Oct 31, 1994

EQ 250MG BASE/ML A063264 001 Nov 30, 1994

EQ 250MG BASE/ML A063350 002 Jul 30, 1993

EQ 250MG BASE/ML A064098 001 Jun 26, 1995

EQ 250MG BASE/ML A064099 001 Jun 20, 1995

IGI LABS INC EQ 50MG BASE/ML A063167 001 Dec 14, 1995

EQ 250MG BASE/ML A063169 001 Dec 14, 1995

TEVA PHARMS USA EQ 50MG BASE/ML A064045 001 Sep 28, 1993

WEST-WARD PHARMS INT EQ 50MG BASE/ML A063274 001 May 18, 1992

EQ 250MG BASE/ML A063275 001 May 18, 1992

AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



HOSPIRA EQ 500MG BASE/100ML A064146 001 Apr 02, 1997

AMIKIN

APOTHECON EQ 50MG BASE/ML A062311 001
EQ 50MG BASE/ML A062562 001 Sep 20, 1984
+ EQ 50MG BASE/ML ** N050495 001
EQ 250MG BASE/ML A062311 002
EQ 250MG BASE/ML A062562 002 Sep 20, 1984
+ EQ 250MG BASE/ML ** N050495 002
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTHECON EQ 5MG BASE/ML N050618 002 Nov 30, 1987
EQ 10MG BASE/ML N050618 001 Nov 30, 1987
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TEVA EQ 5MG ANHYDROUS;50MG A070795 001 Apr 17, 1988
WATSON LABS EQ 5MG ANHYDROUS;50MG A073334 001 Jul 19, 1991
YAOPHARMA CO LTD EQ 5MG ANHYDROUS;50MG A073357 001 Nov 27, 1991
HYDRO-RIDE
PAR PHARM EQ 5MG ANHYDROUS;50MG A070347 001 Dec 25, 1990
MODURETIC 5-50
+ MERCK EQ 5MG ANHYDROUS;50MG ** N018201 001
AMINO ACIDS
INJECTABLE;INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA 5.2% (5.2GM/100ML) N018901 001 Apr 06, 1984
AMINOSYN 10% (PH6)
ICU MEDICAL INC 10% (10GM/100ML) N017673 008 Nov 18, 1985
AMINOSYN 3.5%
ICU MEDICAL INC 3.5% (3.5GM/100ML) N017789 004
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N018804 001 May 15, 1984
3.5% (3.5GM/100ML) N018875 001 Aug 08, 1984
AMINOSYN 5%
ICU MEDICAL INC 5% (5GM/100ML) N017673 001
AMINOSYN 7%
ICU MEDICAL INC 7% (7GM/100ML) N017673 002
AMINOSYN 7% (PH6)
ICU MEDICAL INC 7% (7GM/100ML) N017673 006 Nov 18, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-19(of 393)

** See List Footnote



AMINO ACIDS

INJECTABLE;INJECTION

AMINOSYN 8.5% (PH6)

ICU MEDICAL INC 8.5% (8.5GM/100ML) N017673 007 Nov 18, 1985

AMINOSYN II 10%
ICU MEDICAL INC 10% (10GM/100ML) N019438 005 Apr 03, 1986

AMINOSYN II 3.5%
ICU MEDICAL INC 3.5% (3.5GM/100ML) N019438 001 Apr 03, 1986

AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N019491 001 Oct 10, 1986

AMINOSYN II 5%
ICU MEDICAL INC 5% (5GM/100ML) N019438 002 Apr 03, 1986

AMINOSYN II 7%
ICU MEDICAL INC 7% (7GM/100ML) N019438 003 Apr 03, 1986

AMINOSYN II 8.5%
ICU MEDICAL INC 8.5% (8.5GM/100ML) N019438 004 Apr 03, 1986

AMINOSYN-HBC 7%
ICU MEDICAL INC 7% (7GM/100ML) N019374 001 Jul 12, 1985

AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTT 7% (7GM/100ML) N019400 001 Jul 23, 1986

AMINOSYN-HF 8%
ICU MEDICAL INC 8% (8GM/100ML) A020345 001 Apr 04, 1996

AMINOSYN-RF 5.2%
ICU MEDICAL INC 5.2% (5.2GM/100ML) N018429 001
BRANCHAMIN 4%
BAXTER HLTHCARE 4% (4GM/100ML) N018678 001 Sep 28, 1984

BRANCHAMIN 4% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4% (4GM/100ML) N018684 001 Sep 28, 1984

FREAMINE 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 001
FREAMINE II 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 002
HEPATASOL 8%
BAXTER HLTHCARE 8% (8GM/100ML) A020360 001 Apr 04, 1996

NEOPHAM 6.4%
HOSPIRA 6.4% (6.4GM/100ML) N018792 001 Jan 17, 1984

NOVAMINE 11.4%
HOSPIRA INC 11.4% (11.4GM/100ML) N017957 003 Aug 09, 1982

NOVAMINE 15%
HOSPIRA INC 15% (75GM/500ML) N017957 004 Nov 28, 1986

NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE 15% (15GM/100ML) ** N020107 001 Feb 05, 1993

NOVAMINE 8.5%
HOSPIRA INC 8.5% (8.5GM/100ML) N017957 002 Aug 09, 1982

RENAMIN W/O ELECTROLYTES
BAXTER HLTHCARE 6.5% (6.5GM/100ML) N017493 007 Oct 15, 1982

TRAVASOL 10% W/O ELECTROLYTES
BAXTER HLTHCARE 10% (10GM/100ML) N017493 006
TRAVASOL 5.5% W/O ELECTROLYTES
BAXTER HLTHCARE 5.5% (5.5GM/100ML) N017493 004
TRAVASOL 8.5% W/O ELECTROLYTES
BAXTER HLTHCARE 8.5% (8.5GM/100ML) N017493 005
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM

PHOSPHATE, DIBASIC; SODIUM CHLORIDE



INJECTABLE;INJECTION

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019714 001


Sep 12, 1988

;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001


Nov 07, 1988

;22.4MG/100ML;261MG/100ML;205MG/100ML

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019714 002


Sep 12, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002


Nov 07, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-20(of 393)

** See List Footnote



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

PHOSPHATE, DIBASIC; SODIUM CHLORIDE



INJECTABLE;INJECTION

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019714 004 Sep 12, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003 Nov 07, 1988

L;22.4MG/100ML;261MG/100ML;205MG/100ML

AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

ABBOTT 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2
N019714 003 Sep 12, 1988

2.4MG/100ML;261MG/100ML;205MG/100ML

HOSPIRA INC 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2


N019683 004 Nov 07, 1988

2.4MG/100ML;261MG/100ML;205MG/100ML

AMINO ACIDS; DEXTROSE

INJECTABLE;INJECTION

AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 3.5%;25GM/100ML
N019118 001 Oct 11, 1984

AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT 3.5%;5GM/100ML
N019120 001 Oct 11, 1984

AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 4.25%;25GM/100ML
N019119 001 Oct 11, 1984

AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 3.5%;25GM/100ML
N019505 002 Nov 07, 1986

3.5%;25GM/100ML
N019713 006 Sep 09, 1988

HOSPIRA 3.5%;25GM/100ML
N019681 001 Nov 01, 1988

AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT 3.5%;5GM/100ML
N019506 001 Nov 07, 1986

3.5%;5GM/100ML
N019713 002 Sep 09, 1988

HOSPIRA 3.5%;5GM/100ML
N019681 002 Nov 01, 1988

AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

ABBOTT 4.25%;10GM/100ML
N019713 001 Sep 09, 1988

HOSPIRA 4.25%;10GM/100ML
N019681 004 Nov 01, 1988

AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

ABBOTT 4.25%;20GM/100ML
N019713 004 Sep 09, 1988

HOSPIRA 4.25%;20GM/100ML
N019681 005 Nov 01, 1988

AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 4.25%;25GM/100ML
N019504 002 Nov 07, 1986

4.25%;25GM/100ML
N019713 005 Sep 09, 1988

HOSPIRA 4.25%;25GM/100ML
N019681 003 Nov 01, 1988

AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 5%;25GM/100ML
N019565 001 Dec 17, 1986

5%;25GM/100ML
N019713 003 Sep 09, 1988

HOSPIRA 5%;25GM/100ML
N019681 006 Nov 01, 1988

TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;10GM/100ML
N019520 002 Sep 23, 1988

TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;15GM/100ML
N019520 003 Sep 23, 1988

TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;20GM/100ML
N019520 004 Sep 23, 1988

TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;25GM/100ML
N019520 005 Sep 23, 1988

TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;5GM/100ML
N019520 001 Sep 23, 1988

TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;10GM/100ML
N019520 007 Sep 23, 1988

TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;15GM/100ML
N019520 008 Sep 23, 1988

TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;20GM/100ML
N019520 009 Sep 23, 1988

TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;25GM/100ML
N019520 010 Sep 23, 1988

TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;5GM/100ML
N019520 006 Sep 23, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-21(of 393)

** See List Footnote



AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM

PHOSPHATE, DIBASIC; SODIUM CHLORIDE



INJECTABLE;INJECTION

AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

ABBOTT 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019712 002 Sep 08, 1988

ML;22.4MG/100ML;104.5MG/100ML;205MG/100

ML

HOSPIRA INC 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019682 003 Nov 01, 1988

ML;22.4MG/100ML;104.5MG/100ML;205MG/100

ML

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

SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML N019564 002 Dec 16, 1986

;261MG/100ML;205MG/100ML

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

ABBOTT 4.25%;25GM/100ML;51MG/100ML;22.4MG/100M N019564 004 Dec 16, 1986

L;261MG/100ML;205MG/100ML

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

DIBASIC, HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
N019564 001 Dec 16, 1986

0MG/100ML;49.3MG/100ML

3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
N019712 001 Sep 08, 1988

0MG/100ML;49.3MG/100ML

HOSPIRA INC 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12


N019682 001 Nov 01, 1988

0MG/100ML;49.3MG/100ML

AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER



ABBOTT 4.25%;10GM/100ML;30MG/100ML;97MG/100ML;
N019564 003 Dec 16, 1986

120MG/100ML;49.3MG/100ML

HOSPIRA INC 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1


N019682 002 Nov 01, 1988

20MG/100ML;49.3MG/100ML

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM

CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML N020147 002


Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML N020147 003


Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML N020147 004


Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML N020147 005


Oct 23, 1995

;216MG/100ML;112MG/100ML

TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 001


Oct 23, 1995

216MG/100ML;112MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML N020147 007


Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML N020147 008


Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML N020147 009


Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML N020147 010


Oct 23, 1995

;297MG/100ML;77MG/100ML

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 006


Oct 23, 1995

297MG/100ML;77MG/100ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-22(of 393)

** See List Footnote



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

INJECTABLE;INJECTION

AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018804 002 May 15, 1984
234MG/100ML
3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875 002 Aug 08, 1984
234MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M
ICU MEDICAL INC 3.5%;21MG/100ML;128MG/100ML;234MG/100ML N017789 005
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,

HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M IN PLASTIC CONTAINER

ABBOTT 3.5%;32MG/100ML;128MG/100ML;222MG/100ML N019493 001 Oct 16, 1986

;49MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

INJECTABLE;INJECTION

VEINAMINE 8%

HOSPIRA INC 8%;61MG/100ML;211MG/100ML;56MG/100ML;38 N017957 001

8MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION

AMINOSYN II 10% W/ ELECTROLYTES

ICU MEDICAL INC 10%;102MG/100ML;45MG/100ML;522MG/100ML;


N019437 004 Apr 03, 1986

410MG/100ML

AMINOSYN II 7% W/ ELECTROLYTES

ICU MEDICAL INC 7%;102MG/100ML;45MG/100ML;522MG/100ML;4


N019437 006 Apr 03, 1986

10MG/100ML

AMINOSYN II 8.5% W/ ELECTROLYTES

ICU MEDICAL INC 8.5%;102MG/100ML;45MG/100ML;522MG/100ML


N019437 005 Apr 03, 1986

;410MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC

INJECTABLE;INJECTION

AMINOSYN II 8.5% W/ELECTROLYTES

ICU MEDICAL INC 8.5%;102MG/100ML;492MG/100ML;60MG/100ML N019437 008 Oct 25, 2002

;425MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,

HEPTAHYDRATE

INJECTABLE;INJECTION

AMINOSYN II 3.5% M

ICU MEDICAL INC 3.5%;30MG/100ML;97MG/100ML;120MG/100ML; N019437 007 Apr 03, 1986

49MG/100ML

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML


N020177 001 Oct 23, 1995

;35MG/100ML

TRAVASOL 3.5% W/ ELECTROLYTES

BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML


N017493 003

;35MG/100ML

TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M


N020173 001 Oct 27, 1995

L;224MG/100ML

TRAVASOL 5.5% W/ ELECTROLYTES

BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M


N017493 001

L;224MG/100ML

TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER

BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M


N020173 002 Oct 27, 1995

L;154MG/100ML

TRAVASOL 8.5% W/ ELECTROLYTES

BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M


N017493 002

L;154MG/100ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-23(of 393)

** See List Footnote



AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

INJECTABLE;INJECTION
AMINOSYN 7% W/ ELECTROLYTES
ICU MEDICAL INC 7%;102MG/100ML;522MG/100ML;410MG/100ML N017789 002
AMINOSYN 8.5% W/ ELECTROLYTES
ICU MEDICAL INC 8.5%;102MG/100ML;522MG/100ML;410MG/100M N017673 005
L
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMICAR
+ CLOVER PHARMS 250MG/ML ** N015229 002
AMINOCAPROIC ACID
ABRAXIS PHARM 250MG/ML A070522 001 Jun 17, 1986
BAXTER HLTHCARE 250MG/ML N018590 001 Oct 29, 1982
HOSPIRA 250MG/ML A070888 001 Jun 16, 1988
SYRUP;ORAL
AMINOCAPROIC ACID
AKORN 1.25GM/5ML A074759 001 Sep 02, 1998
TABLET;ORAL
AMINOCAPROIC
AKORN 500MG A075602 001 May 24, 2001
AMINOGLUTETHIMIDE
TABLET;ORAL
CYTADREN
NOVARTIS 250MG N018202 001
AMINOHIPPURATE SODIUM
INJECTABLE;INJECTION
AMINOHIPPURATE SODIUM
MERCK 20% N005619 001
AMINOPHYLLINE
ENEMA;RECTAL
SOMOPHYLLIN
FISONS 300MG/5ML N018232 001 Apr 02, 1982
INJECTABLE;INJECTION
AMINOPHYLLIN
GD SEARLE LLC 25MG/ML A087243 001 May 24, 1982
25MG/ML A087621 001 May 24, 1982
AMINOPHYLLINE
ABRAXIS PHARM 25MG/ML A084568 001
25MG/ML A087200 001
25MG/ML A087250 001 Jan 06, 1982
25MG/ML A087886 001 Aug 30, 1983
25MG/ML A088407 001 Jan 25, 1984
ELKINS SINN 25MG/ML A087239 001
HOSPIRA 25MG/ML A087601 001 Jul 23, 1982
INTL MEDICATION 25MG/ML A087209 001 Feb 01, 1982
25MG/ML A087867 001 Nov 10, 1983
25MG/ML A087868 001 Nov 10, 1983
KING PHARMS 25MG/ML A086606 001
LUITPOLD 25MG/ML A087240 001
LYPHOMED 25MG/ML A087431 001
PHARMA SERVE NY 25MG/ML A087387 001 Jun 03, 1983
25MG/ML A087392 001 Dec 15, 1983
SMITH AND NEPHEW 25MG/ML A088429 001 May 30, 1985
25MG/ML A088749 001 May 30, 1985
TEVA PARENTERAL 25MG/ML A081142 001 Sep 25, 1991
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
HOSPIRA 100MG/100ML A088147 002 May 03, 1983
200MG/100ML A088147 003 May 03, 1983
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 100MG/100ML N018924 001 Dec 12, 1984
200MG/100ML N018924 002 Dec 12, 1984
400MG/100ML N018924 003 Dec 12, 1984
500MG/100ML N018924 004 Dec 12, 1984
SOLUTION;ORAL
AMINOPHYLLINE
MORTON GROVE 105MG/5ML A088156 001 Dec 05, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-24(of 393)

** See List Footnote



AMINOPHYLLINE

SOLUTION;ORAL

AMINOPHYLLINE

ROXANE
105MG/5ML
A088126 001 Aug 19, 1983

AMINOPHYLLINE DYE FREE

ACTAVIS MID ATLANTIC
105MG/5ML
A087727 001 Apr 16, 1982

SOMOPHYLLIN

FISONS
105MG/5ML
A086466 001

SOMOPHYLLIN-DF

FISONS
105MG/5ML
A087045 001

SUPPOSITORY;RECTAL

TRUPHYLLINE

G AND W LABS
250MG
A085498 001 Mar 23, 1983

500MG
A085498 002 Jan 03, 1983

TABLET;ORAL

AMINOPHYLLIN

GD SEARLE LLC
100MG
N002386 002

200MG
N002386 003

AMINOPHYLLINE

ANI PHARMS INC
100MG
A085261 004

200MG
A085261 002

ASCOT
100MG
A087522 001 Feb 12, 1982

200MG
A087523 001 Feb 12, 1982

BARR
100MG
A088297 001 Aug 19, 1983

200MG
A088298 001 Aug 19, 1983

DURAMED PHARMS BARR


100MG
A088182 001 Mar 31, 1983

200MG
A088183 001 Mar 31, 1983

HALSEY
100MG
A084674 001

HIKMA INTL PHARMS
100MG
A084540 001

200MG
A085003 001

IMPAX LABS
100MG
A084574 001

200MG
A084576 001

KV PHARM
100MG
A085284 001

200MG
A085289 001

LANNETT
100MG
A084588 001

200MG
A084588 002

PAL PAK
100MG
A084533 001

PANRAY
100MG
A084552 001

200MG
A084552 002

PUREPAC PHARM
100MG
A084699 001

200MG
A085333 001

ROXANE
100MG
A087500 001 Feb 09, 1982

200MG
A087501 001 Feb 09, 1982

VALEANT PHARM INTL
200MG
A084563 001

VANGARD
100MG
A088314 001 Oct 03, 1983

200MG
A088319 001 Oct 03, 1983

VINTAGE PHARMS
100MG
A085409 001

200MG
A085410 001

WATSON LABS
100MG
A085567 001

200MG
A085564 001

TABLET, DELAYED RELEASE;ORAL

AMINOPHYLLINE

IMPAX LABS
100MG
A084577 001

200MG
A084575 001

TABLICAPS
100MG
A084632 002

VALE
100MG
A084531 001

200MG
A084530 001

TABLET, EXTENDED RELEASE;ORAL

PHYLLOCONTIN

PHARM RES ASSOC
225MG
A086760 001

AMINOSALICYLATE SODIUM

POWDER;ORAL

P.A.S. SODIUM

CENTURY PHARMS
4GM/PACKET
A080947 001

SODIUM AMINOSALICYLATE

HEXCEL
100%
A080097 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-25(of 393)

** See List Footnote



AMINOSALICYLATE SODIUM

TABLET;ORAL

PARASAL SODIUM

PANRAY 500MG
N006811 006

1GM
N006811 011

SODIUM P.A.S.

LANNETT 500MG
A080138 002

TEEBACIN

CONSOLIDATED MIDLAND 500MG
N007320 002

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

TABLET;ORAL

NEOPASALATE

MEDPOINTE PHARM HLC
846MG;112MG
A080059 002

AMINOSALICYLIC ACID

TABLET;ORAL

PARASAL

PANRAY
500MG
N006811 001

1GM
N006811 002

AMINOSALICYLIC ACID RESIN COMPLEX

POWDER;ORAL

REZIPAS

BRISTOL MYERS SQUIBB EQ 500MG BASE/GM
N009052 001

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION

AMIODARONE HYDROCHLORIDE

AKORN
50MG/ML
A076232 001 Jul 05, 2006

BEDFORD
50MG/ML
A076018 001 Oct 15, 2002

BEDFORD LABS
50MG/ML
A076299 001 Oct 24, 2002

BEN VENUE
50MG/ML
A076088 001 Oct 15, 2002

HOSPIRA
50MG/ML
A076108 001 Oct 15, 2002

INTL MEDICATION SYS
50MG/ML
N021594 001 Feb 04, 2004

PAR STERILE PRODUCTS
50MG/ML
A076394 001 Apr 25, 2003

TEVA PHARMS USA


50MG/ML
A076163 001 Sep 05, 2003

CORDARONE

+ WYETH PHARMS INC
50MG/ML **
N020377 001 Aug 03, 1995

NEXTERONE

+ BAXTER HLTHCARE
50MG/ML
N022325 001 Dec 24, 2008

TABLET;ORAL

AMIODARONE HYDROCHLORIDE

MYLAN
200MG
A075188 001 Feb 24, 1999

TEVA
200MG
A074895 001 Apr 16, 1999

CORDARONE

+ WYETH PHARMS
200MG **
N018972 001 Dec 24, 1985

AMITRIPTYLINE HYDROCHLORIDE

CONCENTRATE;ORAL

ENDEP

ROCHE
40MG/ML
A085749 001

INJECTABLE;INJECTION

AMITRIPTYLINE HYDROCHLORIDE

WATSON LABS
10MG/ML
A085594 001

ELAVIL

ASTRAZENECA
10MG/ML
N012704 001

TABLET;ORAL

AMITID

BRISTOL MYERS SQUIBB 10MG
A086454 001

25MG A086454 002

50MG A086454 003

75MG A086454 004

100MG A086454 005

AMITRIL
WARNER CHILCOTT 10MG A083939 001

25MG A083937 001

50MG A083938 002

75MG A084957 001

100MG A085093 001

150MG A086295 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-26(of 393)

** See List Footnote



AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

AM THERAP 25MG A088672 001 Nov 20, 1984

50MG A088673 001 Nov 20, 1984

75MG A088674 001 Nov 20, 1984

100MG A088675 001 Nov 20, 1984

ANI PHARMS INC 10MG A085031 002

25MG A085031 001

50MG A085031 003

75MG A085031 004

COPLEY PHARM 10MG A088421 001 Apr 30, 1984

25MG A088422 001 Apr 30, 1984

50MG A088423 001 Apr 30, 1984

75MG A088424 001 Apr 30, 1984

100MG A088425 001 Apr 30, 1984

150MG A088426 001 Apr 30, 1984

HALSEY 10MG A085923 001



25MG A085922 001

50MG A085925 001

50MG A087557 001 Mar 05, 1982

75MG A085926 001 May 20, 1983

100MG A085927 001 May 20, 1983

LEDERLE 10MG A086744 001



10MG A087366 001 Jan 04, 1982

25MG A086746 001

25MG A087367 001 May 03, 1982

50MG A086743 001



50MG A087181 001 Jan 04, 1982

75MG A086745 001

75MG A087369 001 Jan 04, 1982

100MG A086747 001

100MG A087368 001 May 03, 1982

150MG A087370 001 Jan 04, 1982



MUTUAL PHARM 10MG A085744 001

25MG A085627 001

50MG A085745 001

75MG A085743 001

100MG A085742 002 May 11, 1982

150MG A089423 001 Feb 17, 1987



PAR PHARM 10MG A088697 001 Sep 25, 1984

25MG A088698 001 Sep 25, 1984

50MG A088699 001 Sep 25, 1984

75MG A088700 001 Sep 25, 1984

100MG A088701 001 Sep 25, 1984

150MG A088702 001 Sep 25, 1984

PLIVA 10MG A088883 001 Sep 26, 1984

25MG A088884 001 Sep 26, 1984

50MG A088885 001 Sep 26, 1984

75MG A088886 001 Sep 26, 1984

100MG A088887 001 Sep 26, 1984

150MG A088888 001 Sep 26, 1984

PUREPAC PHARM 10MG A088075 001 Sep 16, 1983

10MG A088084 001 Jul 18, 1983



25MG A088076 001 May 20, 1983

25MG A088085 001 Jul 18, 1983



50MG A088077 001 Sep 16, 1983

50MG A088105 001 Jul 18, 1983



75MG A088078 001 Sep 16, 1983

75MG A088106 001 Jul 18, 1983



100MG A088079 001 Sep 16, 1983

100MG A088107 001 Jul 18, 1983



ROXANE 10MG A086002 001

10MG A086144 001

25MG A085944 001

25MG A086145 001

50MG A085945 001

50MG A086143 001

75MG A086004 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-27(of 393)

** See List Footnote



AMITRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

75MG
A086147 001

100MG
A086003 001

100MG
A086146 001

150MG
A086090 001

150MG
A086148 001

SUN PHARM INDS INC
10MG
A040816 002 Jun 27, 2008

25MG
A040816 001 Jun 27, 2008

50MG
A040816 003 Jun 27, 2008

75MG
A040816 004 Jun 27, 2008

100MG
A040816 005 Jun 27, 2008

150MG
A040816 006 Jun 27, 2008

SUPERPHARM
10MG
A088853 001 Nov 13, 1984

25MG
A088854 001 Nov 13, 1984

50MG
A088855 001 Nov 13, 1984

75MG
A088856 001 Nov 13, 1984

100MG
A088857 001 Nov 13, 1984

TEVA
10MG
A086610 001

25MG
A086859 001

50MG
A086857 001

75MG
A086860 001

100MG
A085836 001

100MG
A086854 001

150MG
A086853 001

UCB INC
10MG
A085864 001

25MG
A085935 001

50MG
A085936 001

75MG
A086337 001

100MG
A086336 001

150MG
A086335 001

USL PHARMA
25MG
A087775 001 Feb 10, 1982

VANGARD
10MG
A087632 001 Feb 01, 1982

50MG
A087616 001 Feb 08, 1982

75MG
A087617 001 Feb 05, 1982

100MG
A087639 001 Feb 08, 1982

WATSON LABS
10MG
A085816 001

10MG
A088620 001 Mar 02, 1984

25MG
A085817 001

25MG
A088621 001 Mar 02, 1984

50MG
A085815 001

50MG
A088622 001 Mar 02, 1984

75MG
A085819 001

75MG
A088633 001 Mar 02, 1984

100MG
A085820 001

100MG
A088634 001 Mar 02, 1984

150MG
A085821 001

150MG
A088635 001 Mar 02, 1984

WEST WARD
10MG
A087647 001 Mar 05, 1982

25MG
A087278 001

ELAVIL

+ ASTRAZENECA
10MG **
N012703 001

+
25MG **
N012703 003

+
50MG **
N012703 004

+
75MG **
N012703 005

+
100MG **
N012703 006

+
150MG **
N012703 007

ENDEP

ROCHE
10MG
A083639 001

25MG
A083639 002

50MG
A083639 003

75MG
A083639 004

100MG
A083639 005

150MG
A085303 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-28(of 393)

** See List Footnote



AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

FRONTIDA BIOPHARM EQ 12.5MG BASE;5MG A070765 001 Dec 10, 1986

EQ 25MG BASE;10MG A070766 001 Dec 10, 1986

PAR PHARM EQ 12.5MG BASE;5MG A072277 001 May 09, 1988

EQ 25MG BASE;10MG A072278 001 May 09, 1988

USL PHARMA EQ 12.5MG BASE;5MG A070477 001 Jan 12, 1988



EQ 25MG BASE;10MG A070478 001 Jan 12, 1988

WATSON LABS EQ 25MG BASE;10MG A072053 001 Dec 16, 1988

WATSON LABS TEVA EQ 12.5MG BASE;5MG A072052 001 Dec 16, 1988

LIMBITROL

+ HERITAGE PHARMS INC EQ 12.5MG BASE;5MG ** N016949 001

LIMBITROL DS

+ HERITAGE PHARMS INC EQ 25MG BASE;10MG ** N016949 002

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET;ORAL

ETRAFON 2-10

SCHERING 10MG;2MG ** N014713 007

ETRAFON 2-25

SCHERING 25MG;2MG ** N014713 004

ETRAFON-A

SCHERING 10MG;4MG ** N014713 002

ETRAFON-FORTE

SCHERING 25MG;4MG ** N014713 006

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

FOSUN PHARMA 10MG;2MG A071062 001 Nov 27, 1987

10MG;4MG A071862 001 Dec 21, 1987

25MG;2MG A071063 001 Nov 27, 1987

25MG;4MG A071064 001 Nov 27, 1987

50MG;4MG A071863 001 Dec 21, 1987

IVAX SUB TEVA PHARMS 10MG;2MG A070935 001 Sep 11, 1986

10MG;4MG A070937 001 Sep 11, 1986

25MG;2MG A070936 001 Sep 11, 1986

25MG;4MG A070938 001 Sep 11, 1986

50MG;4MG A070939 001 Sep 12, 1986

PAR PHARM 10MG;2MG A070565 001 Sep 11, 1986

10MG;4MG A070620 001 Sep 11, 1986

25MG;2MG A070621 001 Sep 11, 1986

25MG;4MG A070595 001 Sep 11, 1986

50MG;4MG A070574 001 Sep 11, 1986

SUN PHARM INDUSTRIES 10MG;2MG A071077 001 Nov 12, 1986



10MG;4MG A071078 001 Nov 12, 1986

25MG;2MG A070297 001 Nov 12, 1986

25MG;4MG A071079 001 Nov 12, 1986

WATSON LABS 10MG;2MG A070373 001 Aug 25, 1986

10MG;2MG A072539 001 Feb 15, 1989



10MG;2MG A073007 001 Oct 17, 1991

10MG;4MG A070375 001 Aug 25, 1986

10MG;4MG A072540 001 Feb 15, 1989



10MG;4MG A073009 001 Oct 17, 1991

25MG;2MG A070374 001 Aug 25, 1986

25MG;2MG A072541 001 Feb 15, 1989



25MG;2MG A073008 001 Oct 17, 1991

25MG;4MG A070376 001 Aug 25, 1986

25MG;4MG A072134 001 Feb 15, 1989



25MG;4MG A073010 001 Oct 17, 1991

50MG;4MG A070377 001 Nov 04, 1986

50MG;4MG A071558 001 Mar 02, 1987

50MG;4MG A072135 001 Feb 15, 1989

TRIAVIL 2-10

NEW RIVER 10MG;2MG ** N014715 004

TRIAVIL 2-25

NEW RIVER 25MG;2MG ** N014715 002

TRIAVIL 4-10

NEW RIVER 10MG;4MG ** N014715 003

TRIAVIL 4-25

NEW RIVER 25MG;4MG ** N014715 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-29(of 393)

** See List Footnote



AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

TABLET;ORAL

TRIAVIL 4-50
NEW RIVER 50MG;4MG ** N014715 006
AMLEXANOX
PASTE;DENTAL
APHTHASOL
ULURU 5% N020511 001 Dec 17, 1996
PATCH;TOPICAL
AMLEXANOX
ULURU 2MG N021727 001 Sep 29, 2004
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AMNEAL PHARMS NY EQ 2.5MG BASE A078477 001 Jan 16, 2008
EQ 5MG BASE A078477 002 Jan 16, 2008
EQ 10MG BASE A078477 003 Jan 16, 2008
GEDEON RICHTER USA EQ 2.5MG BASE A077333 001 Jul 17, 2007
EQ 5MG BASE A077333 002 Jul 17, 2007
EQ 10MG BASE A077333 003 Jul 17, 2007
GENPHARM EQ 2.5MG BASE A077362 001 Jul 09, 2007
EQ 5MG BASE A077362 002 Jul 09, 2007
EQ 10MG BASE A077362 003 Jul 09, 2007
MYLAN PHARMS INC EQ 2.5MG BASE A078224 001 Feb 27, 2008
EQ 5MG BASE A078224 002 Feb 27, 2008
EQ 10MG BASE A078224 003 Feb 27, 2008
PURACAP PHARM EQ 2.5MG BASE A078131 001 Sep 04, 2007
EQ 5MG BASE A078131 002 Sep 04, 2007
EQ 10MG BASE A078131 003 Sep 04, 2007
SOVEREIGN PHARMS EQ 2.5MG BASE A204900 001 Jul 23, 2015
EQ 5MG BASE A204900 002 Jul 23, 2015
EQ 10MG BASE A204900 003 Jul 23, 2015
SUN PHARM INDUSTRIES EQ 2.5MG BASE A078081 001 Jan 31, 2008
EQ 5MG BASE A078081 002 Jan 31, 2008
EQ 10MG BASE A078081 003 Jan 31, 2008
SUNSHINE LAKE EQ 2.5MG BASE A206524 001 May 04, 2018
EQ 5MG BASE A206524 002 May 04, 2018
EQ 10MG BASE A206524 003 May 04, 2018
SYNTHON PHARMS EQ 2.5MG BASE A077080 001 Jun 27, 2007
EQ 5MG BASE A077080 002 Jun 27, 2007
EQ 10MG BASE A077080 003 Jun 27, 2007
YAOPHARMA CO LTD EQ 2.5MG BASE A076859 001 Sep 10, 2007
EQ 5MG BASE A076859 002 Sep 10, 2007
EQ 10MG BASE A076859 003 Sep 10, 2007
TABLET, ORALLY DISINTEGRATING;ORAL
AMLODIPINE BESYLATE
SYNTHON PHARMS EQ 2.5MG BASE N022026 001 Sep 27, 2007
EQ 5MG BASE N022026 002 Sep 27, 2007
EQ 10MG BASE N022026 003 Sep 27, 2007
AMLODIPINE MALEATE
TABLET;ORAL
AMVAZ
DR REDDYS LABS INC 2.5MG N021435 001 Oct 31, 2003
5MG N021435 002 Oct 31, 2003
10MG N021435 003 Oct 31, 2003
AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
CENTRAL RADIOPHARM 3.75-260mCi/ML A204539 001 Jun 23, 2015
UNIV TX MD ANDERSON 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203933 001 Jun 27, 2014
AMMONIUM CHLORIDE
INJECTABLE;INJECTION
AMMONIUM CHLORIDE
ABBOTT 5MEQ/ML A083130 001
GD SEARLE LLC 3MEQ/ML A086205 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-30(of 393)

** See List Footnote



AMMONIUM CHLORIDE

INJECTABLE;INJECTION

AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

MCGAW
900MG/100ML
N006580 001

AMMONIUM CHLORIDE 2.14%

B BRAUN
40MEQ/100ML
A085734 001

AMMONIUM LACTATE

CREAM;TOPICAL

LAC-HYDRIN

SUN PHARM INDS INC
EQ 12% BASE **
N020508 001 Aug 29, 1996

LOTION;TOPICAL

LAC-HYDRIN

+ SUN PHARM INDS INC
EQ 12% BASE **
N019155 001 Apr 24, 1985

AMODIAQUINE HYDROCHLORIDE

TABLET;ORAL

CAMOQUIN HYDROCHLORIDE

PARKE DAVIS
EQ 200MG BASE
N006441 001

AMOXAPINE

TABLET;ORAL

AMOXAPINE

UPSHER SMITH LABS
25MG
A072943 001 Jun 28, 1991

50MG
A072944 001 Jun 28, 1991

100MG
A072878 001 Jun 28, 1991

150MG
A072879 001 Jun 28, 1991

WATSON PHARMS TEVA
25MG
A072418 001 May 11, 1989

50MG
A072419 001 May 11, 1989

100MG
A072420 001 May 11, 1989

150MG
A072421 001 May 11, 1989

ASENDIN

LEDERLE
25MG
N018021 001

50MG
N018021 002

100MG
N018021 003

150MG
N018021 004

AMOXICILLIN

CAPSULE;ORAL

AMOXICILLIN

LABS ATRAL
250MG
A062528 001 Aug 07, 1985

500MG
A062528 002 Aug 07, 1985

MYLAN
250MG
A062067 001

500MG
A062067 002

SUN PHARM INDS LTD
250MG
A065016 001 Apr 08, 1999

500MG
A065016 002 Apr 08, 1999

TEVA
250MG
A062853 001 Dec 22, 1987

250MG
A063030 001 Feb 28, 1989

500MG
A062854 001 Dec 22, 1987

500MG
A063031 001 Feb 28, 1989

AMOXIL

+ GLAXOSMITHKLINE
250MG **
N050459 001

+
500MG **
N050459 002

TRIMOX

APOTHECON
250MG
A061885 001

250MG
A062098 001

250MG
A062152 001

250MG
A063099 001 Mar 20, 1992

500MG
A061885 002

500MG
A062098 002

500MG
A062152 002

500MG
A063099 002 Mar 20, 1992

UTIMOX

PARKE DAVIS
250MG
A062107 001

500MG
A062107 002

WYMOX

WYETH AYERST
250MG
A062120 001

500MG
A062120 002

FOR SUSPENSION;ORAL

AMOXICILLIN

AM ANTIBIOTICS
125MG/5ML
A062059 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-31(of 393)

** See List Footnote



AMOXICILLIN

FOR SUSPENSION;ORAL

AMOXICILLIN

250MG/5ML A062059 002

MYLAN 125MG/5ML A062090 001

250MG/5ML A062090 002

SUN PHARM INDS LTD 200MG/5ML A065113 001 Nov 29, 2002

400MG/5ML A065113 002 Nov 29, 2002

TEVA 125MG/5ML A062946 001 Nov 01, 1988

250MG/5ML A063001 001 Jan 06, 1989

AMOXIL

+ GLAXOSMITHKLINE 50MG/ML ** N050460 005
+ 125MG/5ML ** N050460 001
+ 250MG/5ML ** N050460 002
+ NEOPHARMA 200MG/5ML ** N050760 001 Apr 15, 1999
+ 400MG/5ML ** N050760 002 Apr 15, 1999
LAROTID
+ GLAXOSMITHKLINE 50MG/ML ** N050460 006
POLYMOX
APOTHECON 125MG/5ML A061851 001
125MG/5ML A062323 001
250MG/5ML A061851 002
250MG/5ML A062323 002
TRIMOX
APOTHECON 50MG/ML A061886 001
125MG/5ML A061886 002
125MG/5ML A062099 001
125MG/5ML A062154 001
125MG/5ML A062885 001 Mar 08, 1988
250MG/5ML A061886 003
250MG/5ML A062099 002
250MG/5ML A062154 002
250MG/5ML A062885 002 Mar 08, 1988
UTIMOX
PARKE DAVIS 125MG/5ML A062127 001
250MG/5ML A062127 002
WYMOX
WYETH AYERST 125MG/5ML A062131 001
250MG/5ML A062131 002
TABLET;ORAL
AMOXICILLIN
DAVA PHARMS INC 875MG A065344 001 Jan 15, 2009
SUN PHARM INDS LTD 500MG A065059 001 Nov 24, 2000
875MG A065059 002 Nov 24, 2000
AMOXIL
+ NEOPHARMA 500MG ** N050754 002 Jul 10, 1998
+ 875MG ** N050754 001 Jul 10, 1998
TABLET, CHEWABLE;ORAL
AMOXICILLIN
APOTHECON 125MG A064131 001 May 06, 1996
250MG A064131 002 May 06, 1996
DAVA PHARMS INC 125MG A064139 001 Jan 29, 1996
250MG A064139 002 Jan 29, 1996
SUN PHARM INDS LTD 125MG A065021 001 Dec 23, 1999
200MG A065060 001 Nov 29, 2000
250MG A065021 002 Dec 23, 1999
400MG A065060 002 Nov 29, 2000
TEVA 125MG A064031 001 Dec 19, 1996
250MG A064031 002 Dec 19, 1996
AMOXIL
+ NEOPHARMA 125MG ** N050542 002
200MG N050761 001 Apr 15, 1999
+ 250MG ** N050542 001
400MG N050761 002 Apr 15, 1999
TABLET, EXTENDED RELEASE;ORAL
MOXATAG
+ PRAGMA 775MG N050813 001 Jan 23, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-32(of 393)

** See List Footnote


AMOXICILLIN
TABLET, FOR SUSPENSION;ORAL
AMOXICILLIN
AUROBINDO PHARMA LTD 200MG A065324 001 Jan 17, 2007
400MG A065324 002 Jan 17, 2007
DISPERMOX
RANBAXY LABS LTD 200MG A065080 002 Aug 11, 2003
400MG A065080 001 Aug 11, 2003
600MG A065159 001 Dec 04, 2003
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

TEVA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A200218 001 Aug 30, 2013

G

PREVPAC

+ TAKEDA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M N050757 001 Dec 02, 1997

G

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

SUN PHARM INDS LTD 200MG/5ML;EQ 28.5MG BASE/5ML A065132 001 Mar 19, 2003

400MG/5ML;EQ 57MG BASE/5ML A065132 002 Mar 19, 2003

600MG/5ML;EQ 42.9MG BASE/5ML A065207 002 Jan 30, 2007

AUGMENTIN '200'

+ NEOPHARMA 200MG/5ML;EQ 28.5MG BASE/5ML N050725 001 May 31, 1996

AUGMENTIN '400'

+ NEOPHARMA 400MG/5ML;EQ 57MG BASE/5ML N050725 002 May 31, 1996

AUGMENTIN ES-600

+ NEOPHARMA 600MG/5ML;EQ 42.9MG BASE/5ML N050755 001 Jun 22, 2001

TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

APOTEX INC 250MG;EQ 125MG BASE A065333 001 Feb 24, 2009

500MG;EQ 125MG BASE A065333 002 Feb 24, 2009

875MG;EQ 125MG BASE A065317 003 Oct 20, 2008

SUN PHARM INDS LTD 500MG;EQ 125MG BASE A065109 001 Nov 04, 2002

875MG;EQ 125MG BASE A065102 001 Sep 17, 2002

AUGMENTIN '250'

+ NEOPHARMA 250MG;EQ 125MG BASE ** N050564 001 Aug 06, 1984

AUGMENTIN '500'

+ NEOPHARMA 500MG;EQ 125MG BASE ** N050564 002 Aug 06, 1984

TABLET, CHEWABLE;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

SANDOZ 200MG;EQ 28.5MG BASE A065065 001 Apr 18, 2002

400MG;EQ 57MG BASE A065065 002 Apr 18, 2002

SUN PHARM INDS LTD 200MG;EQ 28.5MG BASE A065161 001 Dec 03, 2003

400MG;EQ 57MG BASE A065161 002 Dec 03, 2003

AUGMENTIN '125'

+ NEOPHARMA 125MG;EQ 31.25MG BASE ** N050597 001 Jul 22, 1985

AUGMENTIN '200'

+ NEOPHARMA 200MG;EQ 28.5MG BASE N050726 001 May 31, 1996

AUGMENTIN '250'

+ NEOPHARMA 250MG;EQ 62.5MG BASE ** N050597 002 Jul 22, 1985

AUGMENTIN '400'

+ NEOPHARMA 400MG;EQ 57MG BASE N050726 002 May 31, 1996

AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE

CAPSULE;ORAL

DELCOBESE

TEVA 1.25MG;1.25MG;1.25MG;1.25MG ** A083564 001

2.5MG;2.5MG;2.5MG;2.5MG ** A083564 002

3.75MG;3.75MG;3.75MG;3.75MG ** A083564 003

5MG;5MG;5MG;5MG ** A083564 004

TABLET;ORAL

DELCOBESE

TEVA 1.25MG;1.25MG;1.25MG;1.25MG A083563 004

2.5MG;2.5MG;2.5MG;2.5MG A083563 003

3.75MG;3.75MG;3.75MG;3.75MG A083563 002

5MG;5MG;5MG;5MG A083563 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-33(of 393)

** See List Footnote



AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE

SULFATE

TABLET;ORAL

ADDERALL 10

+ TEVA WOMENS
2.5MG;2.5MG;2.5MG;2.5MG **
N011522 007 Feb 13, 1996

ADDERALL 12.5

+ TEVA WOMENS
3.125MG;3.125MG;3.125MG;3.125MG **
N011522 012 Aug 31, 2000

ADDERALL 15

+ TEVA WOMENS
3.75MG;3.75MG;3.75MG;3.75MG **
N011522 013 Aug 31, 2000

ADDERALL 20

+ TEVA WOMENS
5MG;5MG;5MG;5MG **
N011522 008 Feb 13, 1996

ADDERALL 30

+ TEVA WOMENS
7.5MG;7.5MG;7.5MG;7.5MG **
N011522 010 May 12, 1997

ADDERALL 5

+ TEVA WOMENS
1.25MG;1.25MG;1.25MG;1.25MG **
N011522 009 May 12, 1997

ADDERALL 7.5

+ TEVA WOMENS
1.875MG;1.875MG;1.875MG;1.875MG **
N011522 011 Aug 31, 2000

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG
A040456 001 May 06, 2003

2.5MG;2.5MG;2.5MG;2.5MG
A040456 002 May 06, 2003

5MG;5MG;5MG;5MG
A040456 003 May 06, 2003

7.5MG;7.5MG;7.5MG;7.5MG
A040456 004 May 06, 2003

TEVA PHARMS 1.25MG;1.25MG;1.25MG;1.25MG


A040472 001 Sep 30, 2003

2.5MG;2.5MG;2.5MG;2.5MG
A040472 002 Sep 30, 2003

5MG;5MG;5MG;5MG
A040472 003 Sep 30, 2003

7.5MG;7.5MG;7.5MG;7.5MG
A040472 004 Sep 30, 2003

AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE;ORAL

BIPHETAMINE 12.5

UCB INC
EQ 6.25MG BASE;EQ 6.25MG BASE
N010093 007

BIPHETAMINE 20

UCB INC
EQ 10MG BASE;EQ 10MG BASE
N010093 003

BIPHETAMINE 7.5

UCB INC
EQ 3.75MG BASE;EQ 3.75MG BASE
N010093 009

AMPHETAMINE SULFATE

TABLET;ORAL

AMPHETAMINE SULFATE

LANNETT
5MG
A083901 001 Aug 31, 1984

10MG
A083901 002 Aug 31, 1984

AMPHOTERICIN B

CREAM;TOPICAL

FUNGIZONE

APOTHECON
3%
N050314 001

INJECTABLE;INJECTION

AMPHOTERICIN B

ABBOTT
50MG/VIAL
A064141 001 Dec 23, 1996

ABRAXIS PHARM
50MG/VIAL
A062728 001 Apr 13, 1987

TEVA PARENTERAL
50MG/VIAL
A064062 001 Mar 31, 1995

FUNGIZONE

APOTHECON
50MG/VIAL
A060517 001

INJECTABLE, LIPID COMPLEX;INJECTION

AMPHOTEC

ALKOPHARMA USA
50MG/VIAL
N050729 001 Nov 22, 1996

100MG/VIAL
N050729 002 Nov 22, 1996

LOTION;TOPICAL

FUNGIZONE

APOTHECON
3%
A060570 001

OINTMENT;TOPICAL

FUNGIZONE

APOTHECON
3%
N050313 001

SUSPENSION;ORAL

FUNGIZONE

BRISTOL MYERS SQUIBB 100MG/ML
N050341 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-34(of 393)

** See List Footnote



AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

ACS DOBFAR SPA
EQ 500MG BASE/VIAL
A090884 001 Apr 03, 2013

EQ 1GM BASE/VIAL
A090884 002 Apr 03, 2013

EQ 2GM BASE/VIAL
A090884 003 Apr 03, 2013

APOTHECON
EQ 125MG BASE/VIAL
A062860 001 Feb 05, 1988

EQ 250MG BASE/VIAL
A062860 002 Feb 05, 1988

EQ 500MG BASE/VIAL
A062860 003 Feb 05, 1988

EQ 1GM BASE/VIAL
A062860 004 Feb 05, 1988

EQ 2GM BASE/VIAL
A062860 005 Feb 05, 1988

AUROBINDO PHARMA
EQ 125MG BASE/VIAL
A065499 001 Aug 17, 2010

CONSOLIDATED PHARM
EQ 125MG BASE/VIAL
A061936 005

EQ 250MG BASE/VIAL
A061936 001

EQ 500MG BASE/VIAL
A061936 002

EQ 1GM BASE/VIAL
A061936 003

EQ 2GM BASE/VIAL
A061936 004

HANFORD GC
EQ 125MG BASE/VIAL
A062772 005 Apr 15, 1993

EQ 500MG BASE/VIAL
A062772 008 Apr 15, 1993

EQ 1GM BASE/VIAL
A062772 002 Apr 15, 1993

EQ 2GM BASE/VIAL
A062772 004 Apr 15, 1993

INTL MEDICATION
EQ 1GM BASE/VIAL
A062634 002 Jan 09, 1987

EQ 2GM BASE/VIAL
A062634 003 Jan 09, 1987

ISTITUTO BIO ITA SPA
EQ 125MG BASE/VIAL
A062797 001 Jul 12, 1993

LILLY
EQ 500MG BASE/VIAL
A062565 001 Apr 04, 1985

EQ 1GM BASE/VIAL
A062565 002 Apr 04, 1985

EQ 2GM BASE/VIAL
A062565 003 Jun 24, 1986

WATSON LABS INC
EQ 125MG BASE/VIAL
A062816 001 Oct 24, 1988

EQ 250MG BASE/VIAL
A062816 002 Oct 24, 1988

EQ 500MG BASE/VIAL
A062816 003 Oct 24, 1988

EQ 1GM BASE/VIAL
A062816 004 Oct 24, 1988

EQ 2GM BASE/VIAL
A062816 005 Oct 24, 1988

EQ 10GM BASE/VIAL
A062994 001 Sep 15, 1988

WEST-WARD PHARMS INT


EQ 125MG BASE/VIAL
A062692 001 Jun 24, 1986

EQ 250MG BASE/VIAL
A062692 002 Jun 24, 1986

EQ 500MG BASE/VIAL
A062692 003 Jun 24, 1986

EQ 1GM BASE/VIAL
A062692 004 Jun 24, 1986

EQ 2GM BASE/VIAL
A062692 005 Jun 24, 1986

EQ 10GM BASE/VIAL
A062692 006 Jun 24, 1986

OMNIPEN-N

WYETH AYERST
EQ 125MG BASE/VIAL
A060626 001

EQ 125MG BASE/VIAL
A062718 001 Dec 16, 1986

EQ 250MG BASE/VIAL
A060626 002

EQ 250MG BASE/VIAL
A062718 002 Dec 16, 1986

EQ 500MG BASE/VIAL
A060626 003

EQ 500MG BASE/VIAL
A062718 003 Dec 16, 1986

EQ 1GM BASE/VIAL
A060626 004

EQ 1GM BASE/VIAL
A062718 004 Dec 16, 1986

EQ 2GM BASE/VIAL
A060626 005

EQ 2GM BASE/VIAL
A062718 005 Dec 16, 1986

PENBRITIN-S

+ WYETH AYERST
EQ 125MG BASE/VIAL **
N050072 001

+
EQ 250MG BASE/VIAL **
N050072 002

+
EQ 500MG BASE/VIAL **
N050072 003

+
EQ 1GM BASE/VIAL **
N050072 004

+
EQ 2GM BASE/VIAL **
N050072 005

+
EQ 4GM BASE/VIAL **
N050072 006

POLYCILLIN-N

BRISTOL
EQ 125MG BASE/VIAL **
N050309 001

EQ 250MG BASE/VIAL **
N050309 002

EQ 500MG BASE/VIAL **
N050309 003

EQ 1GM BASE/VIAL **
N050309 004

EQ 2GM BASE/VIAL **
N050309 005

TOTACILLIN-N

GLAXOSMITHKLINE
EQ 125MG BASE/VIAL
A060677 001

EQ 250MG BASE/VIAL
A060677 002

EQ 500MG BASE/VIAL
A060677 003

EQ 1GM BASE/VIAL
A060677 004

EQ 1GM BASE/VIAL
A062727 001 Dec 19, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-35(of 393)

** See List Footnote



AMPICILLIN SODIUM

INJECTABLE;INJECTION

TOTACILLIN-N

EQ 2GM BASE/VIAL
A060677 005

EQ 2GM BASE/VIAL
A062727 002 Dec 19, 1986

EQ 10GM BASE/VIAL
A060677 006

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

UNASYN

PFIZER EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
N050608 003 Dec 31, 1986

AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMCILL

PARKE DAVIS EQ 250MG BASE
A062041 001

EQ 500MG BASE
A062041 002

AMPICILLIN TRIHYDRATE

AM ANTIBIOTICS EQ 250MG BASE
A061602 001

EQ 500MG BASE
A061602 002

IVAX SUB TEVA PHARMS EQ 250MG BASE
A060765 001

EQ 500MG BASE
A060765 002

LEDERLE
EQ 250MG BASE
A062208 001

EQ 500MG BASE
A062208 002

MYLAN
EQ 250MG BASE
A061755 001

EQ 500MG BASE
A061755 002

PUREPAC PHARM
EQ 250MG BASE
A061853 001

EQ 500MG BASE
A061853 002

TEVA
EQ 250MG BASE
A061502 001

EQ 500MG BASE
A061502 002

VITARINE
EQ 250MG BASE
A061387 001

EQ 500MG BASE
A061387 003

OMNIPEN (AMPICILLIN)

WYETH AYERST
250MG
A060624 001

500MG
A060624 002

PENBRITIN

WYETH AYERST
EQ 250MG BASE
A060908 001

EQ 500MG BASE
A060908 002

PFIZERPEN-A

PFIZER
EQ 250MG BASE
A062050 001

EQ 500MG BASE
A062050 002

POLYCILLIN

BRISTOL
EQ 250MG BASE
N050310 001

EQ 500MG BASE
N050310 002

PRINCIPEN

APOTHECON
EQ 250MG BASE
A062888 001 Mar 04, 1988

EQ 500MG BASE
A062888 002 Mar 04, 1988

BRISTOL MYERS SQUIBB EQ 250MG BASE
A061392 001

EQ 500MG BASE
A061392 002

PRINCIPEN '250'

APOTHECON
EQ 250MG BASE
A062157 002

EQ 250MG BASE
N050056 001

PRINCIPEN '500'

APOTHECON
EQ 500MG BASE
A062157 001

EQ 500MG BASE
N050056 002

TOTACILLIN

GLAXOSMITHKLINE
EQ 250MG BASE
A060060 001

EQ 250MG BASE
A062212 001

EQ 500MG BASE
A060060 002

EQ 500MG BASE
A062212 002

FOR SUSPENSION;ORAL

AMCILL

PARKE DAVIS
EQ 125MG BASE/5ML
A062030 001

EQ 250MG BASE/5ML
A062030 002

AMPICILLIN TRIHYDRATE

AM ANTIBIOTICS
EQ 125MG BASE/5ML
A061601 001

EQ 250MG BASE/5ML
A061601 002

MYLAN
EQ 125MG BASE/5ML
A061829 002

EQ 250MG BASE/5ML
A061829 001

PUREPAC PHARM
EQ 125MG BASE/5ML
A061980 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-36(of 393)

** See List Footnote



AMPICILLIN/AMPICILLIN TRIHYDRATE

FOR SUSPENSION;ORAL

AMPICILLIN TRIHYDRATE

EQ 250MG BASE/5ML
A061980 002

TEVA EQ 125MG BASE/5ML
A061370 001

EQ 250MG BASE/5ML
A061370 002

OMNIPEN (AMPICILLIN)

WYETH AYERST 100MG/ML


A060625 001

125MG/5ML
A060625 002

250MG/5ML
A060625 003

500MG/5ML
A060625 004

PENBRITIN

WYETH AYERST EQ 100MG BASE/ML
N050019 001

EQ 125MG BASE/5ML
N050019 002

EQ 250MG BASE/5ML
N050019 003

PFIZERPEN-A

PFIZER EQ 125MG BASE/5ML
A062049 001

EQ 250MG BASE/5ML
A062049 002

POLYCILLIN

APOTHECON EQ 125MG BASE/5ML
A062297 001

EQ 250MG BASE/5ML
A062297 002

BRISTOL EQ 100MG BASE/ML
N050308 004

EQ 125MG BASE/5ML
N050308 001

EQ 250MG BASE/5ML
N050308 002

EQ 500MG BASE/5ML
N050308 003

PRINCIPEN

APOTHECON EQ 100MG BASE/ML
A061394 001

EQ 125MG BASE/5ML
A061394 002

EQ 250MG BASE/5ML
A061394 003

PRINCIPEN '125'

APOTHECON EQ 125MG BASE/5ML
A060127 002

EQ 125MG BASE/5ML
A062151 001

PRINCIPEN '250'

APOTHECON EQ 250MG BASE/5ML
A060127 001

EQ 250MG BASE/5ML
A062151 002

TOTACILLIN

GLAXOSMITHKLINE EQ 125MG BASE/5ML
A060666 001

EQ 125MG BASE/5ML
A062223 001

EQ 250MG BASE/5ML
A060666 002

EQ 250MG BASE/5ML
A062223 002

TABLET, CHEWABLE;ORAL

POLYCILLIN

BRISTOL EQ 125MG BASE
N050093 001

AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID

CAPSULE;ORAL

PRINCIPEN W/ PROBENECID

APOTHECON EQ 389MG BASE;111MG


A062150 001

EQ 389MG BASE;111MG
N050488 001

FOR SUSPENSION;ORAL

POLYCILLIN-PRB

APOTHECON EQ 3.5GM BASE/BOT;1GM/BOT
A061898 001

BRISTOL EQ 3.5GM BASE/BOT;1GM/BOT
N050457 001

PROBAMPACIN

G AND W LABS INC EQ 3.5GM BASE/BOT;1GM/BOT
A061741 001

AMPRENAVIR

CAPSULE;ORAL

AGENERASE

GLAXOSMITHKLINE 50MG
N021007 001 Apr 15, 1999

150MG
N021007 002 Apr 15, 1999

SOLUTION;ORAL

AGENERASE

+ GLAXOSMITHKLINE 15MG/ML **
N021039 001 Apr 15, 1999

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-37(of 393)
** See List Footnote
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
AGRYLIN
+ SHIRE LLC EQ 1MG BASE ** N020333 002 Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
MYLAN PHARMS INC EQ 0.5MG BASE A076811 001 Apr 18, 2005
EQ 0.5MG BASE A077613 001 Jun 27, 2006
EQ 1MG BASE A076811 002 Apr 18, 2005
EQ 1MG BASE A077613 002 Jun 27, 2006
ROXANE EQ 0.5MG BASE A076489 001 Apr 18, 2005
EQ 1MG BASE A076489 002 Apr 18, 2005
UPSHER SMITH LABS EQ 0.5MG BASE A076683 001 Apr 18, 2005
EQ 1MG BASE A076683 002 Apr 18, 2005
WATSON LABS EQ 0.5MG BASE A076417 001 Apr 18, 2005
EQ 1MG BASE A076417 002 Apr 18, 2005
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
IMPAX LABS INC 1MG A091242 001 May 31, 2012
LANNETT CO INC 1MG A091331 001 Jan 05, 2011
SANDOZ 1MG A079007 001 Jun 28, 2010
SUN PHARM INDS LTD 1MG A091177 001 Jul 15, 2011
SYNTHON PHARMS 1MG A078322 001 Jun 28, 2010
WATSON LABS TEVA 1MG A078984 001 Jun 28, 2010
ANGIOTENSIN II ACETATE
SOLUTION;INTRAVENOUS
GIAPREZA
+ LA JOLLA PHARMA EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML) N209360 002 Dec 21, 2017
ANILERIDINE HYDROCHLORIDE
TABLET;ORAL
LERITINE
MERCK EQ 25MG BASE N010585 002
ANILERIDINE PHOSPHATE
INJECTABLE;INJECTION
LERITINE
MERCK 25MG/ML N010520 003
ANISINDIONE
TABLET;ORAL
MIRADON
SCHERING 50MG N010909 003
ANISOTROPINE METHYLBROMIDE
TABLET;ORAL
ANISOTROPINE METHYLBROMIDE
WATSON LABS 50MG A086046 001
VALPIN 50
ENDO PHARMS 50MG N013428 001
ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
VASOCON-A
NOVARTIS 0.5%;0.05% N018746 002 Jul 11, 1994
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS
APOKYN
US WORLDMEDS 20MG/2ML (10MG/ML) N021264 001 Apr 20, 2004
APROTININ
INJECTABLE;INJECTION
TRASYLOL
BAYER HLTHCARE 10,000KIU/ML N020304 001 Dec 29, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-38(of 393)

** See List Footnote



ARBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

GENESA

GENSIA AUTOMEDICS 0.05MG/ML N020420 001 Sep 12, 1997

ARDEPARIN SODIUM

INJECTABLE;INJECTION

NORMIFLO

+ PHARMACIA AND UPJOHN 5,000 UNITS/0.5ML ** N020227 002 May 23, 1997

+ 10,000 UNITS/0.5ML ** N020227 001 May 23, 1997



ARGATROBAN

SOLUTION;INTRAVENOUS

ARGATROBAN IN DEXTROSE

SANDOZ 125MG/125ML (1MG/ML) N201743 001 May 09, 2011

ARIPIPRAZOLE

INJECTABLE;INTRAMUSCULAR

ABILIFY

OTSUKA 9.75MG/1.3ML (7.5MG/ML) N021866 001 Sep 20, 2006

SOLUTION;ORAL

ABILIFY

+ OTSUKA 1MG/ML ** N021713 001 Dec 10, 2004

TABLET;ORAL

ARIPIPRAZOLE

MYLAN PHARMS INC 2MG A206240 001 Sep 19, 2018

5MG A206240 002 Sep 19, 2018

10MG A206240 003 Sep 19, 2018

15MG A206240 004 Sep 19, 2018

20MG A206240 005 Sep 19, 2018

30MG A206240 006 Sep 19, 2018

TABLET, ORALLY DISINTEGRATING;ORAL



ABILIFY

+ OTSUKA 10MG ** N021729 002 Jun 07, 2006

+ 15MG ** N021729 003 Jun 07, 2006

+ 20MG ** N021729 004 Jun 07, 2006

+ 30MG ** N021729 005 Jun 07, 2006

ARMODAFINIL

TABLET;ORAL

ARMODAFINIL

WATSON LABS INC 100MG A200156 002 Aug 29, 2012

200MG A200156 004 Aug 29, 2012

NUVIGIL

+ CEPHALON 100MG ** N021875 002 Mar 26, 2009

ARSENIC TRIOXIDE

INJECTABLE;INJECTION

TRISENOX

+ CEPHALON 1MG/ML N021248 001 Sep 25, 2000

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A

PALMITATE; VITAMIN E

INJECTABLE;INJECTION

BEROCCA PN

ROCHE 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML; N006071 003 Oct 10, 1985

100

IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;

VITAMIN E

INJECTABLE;INJECTION

M.V.C. 9+3

ABRAXIS PHARM 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440 002 Aug 08, 1985

0

IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/

M.V.I.-12 ADULT

HOSPIRA 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 004 Aug 08, 1985

0

IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/

+ 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML; N008809 006 Sep 09, 2004

0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-39(of 393)

** See List Footnote



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 ADULT
0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
MVC PLUS
WATSON LABS 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018439 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E



INJECTABLE;INJECTION

M.V.I.-12 ADULT

HOSPIRA 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 005 Apr 22, 2004

0

IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;

PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E



INJECTABLE;INJECTION

M.V.I.-12 LYOPHILIZED

TELIGENT PHARMA INC 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N018933 002 Aug 08, 1985

G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4

MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10

MG/VIAL

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID;

PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E



INJECTABLE;INJECTION

VITAPED

HOSPIRA N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001 N020176 001 Dec 29, 1993

MG/VIAL;400

IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI

AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/

VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ

2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A



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

SODIUM SULFATE

FOR SOLUTION;ORAL

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC

NOVEL LABS INC 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
A090145 001 Jan 25, 2012

ASPIRIN

TABLET;ORAL

BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN

BAYER
500MG
N021317 001 Oct 18, 2001

TABLET, EXTENDED RELEASE;ORAL

8-HOUR BAYER

BAYER
650MG
N016030 001

MEASURIN

BAYER
650MG
N016030 002

ASPIRIN; BUTALBITAL

TABLET;ORAL

AXOTAL

SAVAGE LABS
650MG;50MG
A088305 001 Oct 13, 1983

ASPIRIN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

NOSTRUM LABS INC 325MG;50MG;40MG
A078149 001 Jun 13, 2007

WATSON LABS 325MG;50MG;40MG
A086231 002 Feb 12, 1985

TABLET;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

ACTAVIS ELIZABETH
325MG;50MG;40MG
A086710 002 Aug 23, 1983

FOSUN PHARMA
325MG;50MG;40MG
A086398 002 Apr 06, 1984

HALSEY
325MG;50MG;40MG
A089448 001 Dec 01, 1986

IVAX PHARMS
325MG;50MG;40MG
A085441 002 Oct 31, 1984

PURACAP PHARM
325MG;50MG;40MG
A087048 002 Dec 09, 1983

QUANTUM PHARMICS
325MG;50MG;40MG
A088972 001 Jun 18, 1985

WATSON LABS
325MG;50MG;40MG
A086237 002 Mar 23, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-40(of 393)

** See List Footnote



ASPIRIN; BUTALBITAL; CAFFEINE

TABLET;ORAL

FIORINAL

+ ALLERGAN SALES LLC 325MG;50MG;40MG **
N017534 003 Apr 16, 1986

LANORINAL

LANNETT 325MG;50MG;40MG
A086986 002 Oct 18, 1985

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

CAPSULE;ORAL

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

VINTAGE PHARMS LLC 325MG;50MG;40MG;30MG
A075351 001 Mar 05, 1999

WATSON LABS 325MG;50MG;40MG;30MG
A074359 001 Aug 31, 1995

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE

CAPSULE;ORAL

SYNALGOS-DC

+ SUN PHARM INDUSTRIES 356.4MG;30MG;16MG
N011483 004 Sep 06, 1983

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE

TABLET;ORAL

INVAGESIC

SANDOZ 385MG;30MG;25MG
A074817 001 Nov 27, 1996

INVAGESIC FORTE

SANDOZ 770MG;60MG;50MG
A074817 002 Nov 27, 1996

NORGESIC

+ MEDICIS 385MG;30MG;25MG **
N013416 003 Oct 27, 1982

NORGESIC FORTE

+ MEDICIS 770MG;60MG;50MG **
N013416 004 Oct 27, 1982

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

STEVENS J 385MG;30MG;25MG
A074988 001 Apr 30, 1999

770MG;60MG;50MG
A074988 002 Apr 30, 1999

ORPHENGESIC

GALT PHARMS 385MG;30MG;25MG
A075141 001 May 29, 1998

ORPHENGESIC FORTE

GALT PHARMS 770MG;60MG;50MG
A075141 002 May 29, 1998

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL

COMPOUND 65

ALRA
389MG;32.4MG;65MG
A084553 002 Aug 17, 1983

DARVON COMPOUND

XANODYNE PHARM
389MG;32.4MG;32MG
N010996 006 Mar 08, 1983

DARVON COMPOUND-65

XANODYNE PHARM
389MG;32.4MG;65MG
N010996 007 Mar 08, 1983

PROPOXYPHENE COMPOUND 65

IVAX SUB TEVA PHARMS
389MG;32.4MG;65MG
A083077 002 Dec 07, 1984

SANDOZ
389MG;32.4MG;65MG
A080044 002 Sep 16, 1983

TEVA
389MG;32.4MG;65MG
A089025 001 Mar 29, 1985

PROPOXYPHENE COMPOUND-65

SANDOZ
389MG;32.4MG;65MG
A083101 002 Jun 24, 1985

PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE

WATSON LABS 389MG;32.4MG;65MG


A085732 002 Sep 03, 1984

ASPIRIN; CARISOPRODOL

TABLET;ORAL

CARISOPRODOL AND ASPIRIN

OXFORD PHARMS 325MG;200MG
A040252 001 Dec 10, 1997

CARISOPRODOL COMPOUND

WATSON LABS 325MG;200MG
A088809 001 Oct 03, 1985

SOMA COMPOUND

MEDA PHARMS 325MG;200MG **
N012365 005 Jul 11, 1983

ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE

TABLET;ORAL

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

OXFORD PHARMS 325MG;200MG;16MG
A040283 001 Dec 29, 1998

SOMA COMPOUND W/ CODEINE

MEDA PHARMS 325MG;200MG;16MG **


N012366 002 Jul 11, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-41(of 393)

** See List Footnote



ASPIRIN; HYDROCODONE BITARTRATE

TABLET;ORAL

AZDONE

SCHWARZ PHARMA
500MG;5MG **
A089420 001 Jan 25, 1988

VICOPRIN

ABBOTT
500MG;5MG
A086333 001 Sep 14, 1983

ASPIRIN; MEPROBAMATE

TABLET;ORAL

EQUAGESIC

SUN PHARM INDUSTRIES
325MG;200MG
N011702 003 Dec 29, 1983

MEPRO-ASPIRIN

SANDOZ
325MG;200MG
A089127 001 Mar 02, 1987

MEPROBAMATE AND ASPIRIN

PAR PHARM
325MG;200MG
A089126 001 Aug 19, 1986

MICRAININ

MEDPOINTE PHARM HLC
325MG;200MG
A084978 001

Q-GESIC

QUANTUM PHARMICS
325MG;200MG
A088740 001 Jun 01, 1984

ASPIRIN; METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL AND ASPIRIN

IVAX SUB TEVA PHARMS
325MG;400MG
A087211 001 Dec 22, 1982

MCNEIL
325MG;400MG
A089193 001 Feb 12, 1986

PAR PHARM
325MG;400MG
A089657 001 Nov 04, 1988

ROBAXISAL

ROBINS AH
325MG;400MG
N012281 001

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

TABLET;ORAL

CODOXY

HALSEY 325MG;4.5MG;0.38MG
A087464 001 Jul 01, 1982

OXYCODONE AND ASPIRIN

SUN PHARM INDUSTRIES 325MG;4.5MG;0.38MG
A040260 001 Jul 17, 1998

325MG;4.5MG;0.38MG
A087794 001 May 26, 1982

WATSON LABS 325MG;4.5MG;0.38MG


A040255 001 Feb 27, 1998

OXYCODONE AND ASPIRIN (HALF-STRENGTH)

ROXANE 325MG;2.25MG;0.19MG
A087742 001 Jun 04, 1982

PERCODAN

ENDO PHARMS 325MG;4.5MG;0.38MG **
N007337 006

PERCODAN-DEMI

ENDO PHARMS 325MG;2.25MG;0.19MG **
N007337 005

ROXIPRIN

ROXANE 325MG;4.5MG;0.38MG
A087743 001 Jun 04, 1982

ASPIRIN; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN COMPOUND

+ SANOFI AVENTIS US
325MG;EQ 12.5MG BASE **
N016891 001

ASPIRIN; PRAVASTATIN SODIUM

TABLET, TABLET;ORAL

PRAVIGARD PAC (COPACKAGED)

BRISTOL MYERS SQUIBB


325MG,N/A;N/A,80MG
N021387 006 Jun 24, 2003

TABLET, TABLET, TABLET;ORAL

PRAVIGARD PAC (COPACKAGED)

BRISTOL MYERS SQUIBB


81MG,N/A;N/A,20MG
N021387 001 Jun 24, 2003

81MG,N/A;N/A,40MG
N021387 002 Jun 24, 2003

81MG,N/A;N/A,80MG
N021387 003 Jun 24, 2003

325MG,N/A;N/A,20MG
N021387 004 Jun 24, 2003

325MG,N/A;N/A,40MG
N021387 005 Jun 24, 2003

ASPIRIN; PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL

DARVON W/ ASA

XANODYNE PHARM 325MG;65MG


N010996 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-42(of 393)

** See List Footnote



ASPIRIN; PROPOXYPHENE NAPSYLATE

CAPSULE;ORAL

DARVON-N W/ ASA

AAIPHARMA LLC
325MG;100MG
N016829 001

TABLET;ORAL

DARVON-N W/ ASA

AAIPHARMA LLC
325MG;100MG
N016863 001

ATAZANAVIR SULFATE

CAPSULE;ORAL

REYATAZ

+ BRISTOL MYERS SQUIBB
EQ 100MG BASE **
N021567 001 Jun 20, 2003

ATENOLOL

INJECTABLE;INJECTION

TENORMIN

+ ASTRAZENECA
0.5MG/ML **
N019058 001 Sep 13, 1989

TABLET;ORAL

ATENOLOL

ABLE
25MG
A076907 001 Jul 30, 2004

50MG
A076907 002 Jul 30, 2004

100MG
A076907 003 Jul 30, 2004

APOTHECON
50MG
A073317 001 Mar 20, 1992

100MG
A073318 001 Mar 20, 1992

DAVA PHARMS INC
25MG
A074099 001 Apr 28, 1992

MYLAN
25MG
A074126 003 Aug 26, 1998

50MG
A074126 001 Mar 23, 1994

100MG
A074126 002 Mar 23, 1994

NORTHSTAR HLTHCARE
25MG
A078254 001 Sep 25, 2009

50MG
A078254 002 Sep 25, 2009

100MG
A078254 003 Sep 25, 2009

NOSTRUM LABS
50MG
A074127 001 Feb 21, 1995

100MG
A074127 002 Feb 21, 1995

PLIVA
25MG
A074101 001 Jul 17, 1997

50MG
A074101 002 Jul 17, 1997

100MG
A074101 003 Jul 17, 1997

SANDOZ
25MG
A074265 001 Feb 28, 1994

50MG
A074265 002 Feb 28, 1994

100MG
A074265 003 Feb 28, 1994

SCS
50MG
A073676 001 Oct 30, 1992

100MG
A073676 002 Oct 30, 1992

TEVA
50MG
A073315 001 May 28, 1993

100MG
A073316 001 May 28, 1993

TEVA PHARMS
50MG
A074120 001 Feb 24, 1995

100MG
A074120 002 Feb 24, 1995

WATSON LABS
50MG
A073352 001 Dec 27, 1991

WATSON LABS TEVA
100MG
A073353 001 Dec 27, 1991

ATENOLOL; CHLORTHALIDONE

TABLET;ORAL

ATENOLOL AND CHLORTHALIDONE

NOSTRUM LABS
50MG;25MG
A074404 001 May 14, 1998

100MG;25MG
A074404 002 May 14, 1998

PLIVA
50MG;25MG
A074107 001 Sep 24, 1997

100MG;25MG
A074107 002 Sep 24, 1997

ATOMOXETINE HYDROCHLORIDE

CAPSULE;ORAL

ATOMOXETINE HYDROCHLORIDE

ZYDUS PHARMS USA INC
18MG
A079017 001 Sep 17, 2010

25MG
A079017 002 Sep 17, 2010

40MG
A079017 003 Sep 17, 2010

60MG
A079017 004 Sep 17, 2010

80MG
A079017 005 Sep 17, 2010

100MG
A079017 006 Sep 17, 2010

STRATTERA

LILLY
5MG
N021411 001 Nov 26, 2002

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

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DISCONTINUED DRUG PRODUCT LIST 6-43(of 393)

** See List Footnote



ATORVASTATIN CALCIUM

TABLET;ORAL

ATORVASTATIN CALCIUM

TEVA PHARMS EQ 10MG BASE A078773 001 May 29, 2012
EQ 20MG BASE A078773 002 May 29, 2012
EQ 40MG BASE A078773 003 May 29, 2012
EQ 80MG BASE A078773 004 May 29, 2012
ATORVASTATIN CALCIUM; EZETIMIBE
TABLET;ORAL
LIPTRUZET
+ MERCK SHARP DOHME EQ 10MG BASE;10MG ** N200153 001 May 03, 2013
+ EQ 20MG BASE;10MG ** N200153 002 May 03, 2013
+ EQ 40MG BASE;10MG ** N200153 003 May 03, 2013
+ EQ 80MG BASE;10MG ** N200153 004 May 03, 2013
ATOVAQUONE
TABLET;ORAL
MEPRON
+ GLAXOSMITHKLINE LLC 250MG ** N020259 001 Nov 25, 1992
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
BAXTER HLTHCARE 10MG/ML A074824 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074753 001 Jan 23, 1997
HOSPIRA 10MG/ML A074632 001 Dec 23, 1996
10MG/ML A074740 001 Mar 28, 1997
TEVA PARENTERAL 10MG/ML A074784 001 Jun 11, 1997
WATSON PHARMS TEVA 10MG/ML A074945 001 Jul 28, 1998
ATRACURIUM BESYLATE PRESERVATIVE FREE
BAXTER HLTHCARE 10MG/ML A074825 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074768 001 Jan 23, 1997
HOSPIRA 10MG/ML A074633 001 Dec 23, 1996
10MG/ML A074639 001 Mar 25, 1997
10MG/ML A074741 001 Mar 28, 1997
WATSON LABS INC 10MG/ML A074944 001 Jul 28, 1998
TRACRIUM
+ HOSPIRA 10MG/ML ** N018831 002 Jun 20, 1985
TRACRIUM PRESERVATIVE FREE
+ HOSPIRA 10MG/ML ** N018831 001 Nov 23, 1983
ATROPINE
INJECTABLE;INJECTION
ATROPINE
ABBVIE EQ 2MG SULFATE/0.7ML A071295 001 Jan 30, 1987
SOLUTION;INTRAMUSCULAR
ATROPINE (AUTOINJECTOR)
RAFA LABS LTD EQ 2MG SULFATE/0.7ML (EQ 2MG N212319 001 Jul 09, 2018
SULFATE/0.7ML)
ATROPINE SULFATE
AEROSOL, METERED;INHALATION
ATROPINE SULFATE
US ARMY EQ 0.36MG BASE/INH N020056 001 Sep 19, 1990
SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL
ATROPINE SULFATE ANSYR PLASTIC SYRINGE
+ HOSPIRA 0.5MG/5ML (0.1MG/ML) N021146 001 Jul 09, 2001
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN HALF-STRENGTH
SEBELA IRELAND LTD 0.025MG;0.5MG N017744 001
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
SCHERER RP 0.025MG;2.5MG A086440 001
SOLUTION;ORAL
COLONAID
MEDPOINTE PHARM HLC 0.025MG/5ML;2.5MG/5ML A085735 001

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

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DISCONTINUED DRUG PRODUCT LIST 6-44(of 393)
** See List Footnote
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
SOLUTION;ORAL
LOMANATE
ALPHARMA US PHARMS 0.025MG/5ML;2.5MG/5ML A085746 001
LOMOTIL
GD SEARLE LLC 0.025MG/5ML;2.5MG/5ML N012699 001
TABLET;ORAL
COLONAID
MEDPOINTE PHARM HLC 0.025MG;2.5MG A085737 001
DI-ATRO
MD PHARM 0.025MG;2.5MG A085266 001
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ABLE 0.025MG;2.5MG A040395 001 Nov 27, 2000
ASCOT 0.025MG;2.5MG A087934 001 Jul 19, 1983
FOSUN PHARMA 0.025MG;2.5MG A086173 001
HEATHER 0.025MG;2.5MG A086798 001
HIKMA PHARMS 0.025MG;2.5MG A087765 001 Mar 15, 1982
INWOOD LABS 0.025MG;2.5MG A085509 001
KV PHARM 0.025MG;2.5MG A085659 001
LEDERLE 0.025MG;2.5MG A086950 001
PARKE DAVIS 0.025MG;2.5MG A087131 001
PVT FORM 0.025MG;2.5MG A085766 001
R AND S PHARMA 0.025MG;2.5MG A085035 001
ROXANE 0.025MG;2.5MG A086057 001
SUN PHARM INDUSTRIES 0.025MG;2.5MG A085506 001
USL PHARMA 0.025MG;2.5MG A087842 001 Mar 29, 1982
VALEANT PHARM INTL 0.025MG;2.5MG A087195 001 Feb 16, 1982
WATSON LABS 0.025MG;2.5MG A085876 001
LO-TROL
VANGARD 0.025MG;2.5MG A088009 001 Mar 25, 1983
LOGEN
SUPERPHARM 0.025MG;2.5MG A088962 001 May 10, 1985
LONOX
FOSUN PHARMA 0.025MG;2.5MG A085311 002
LOW-QUEL
HALSEY 0.025MG;2.5MG A085211 001
ATROPINE SULFATE; EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON-PLUS
MYLAN INSTITUTIONAL 0.14MG/ML;10MG/ML N019677 001 Nov 06, 1991
+ 0.14MG/ML;10MG/ML N019678 001 Nov 06, 1991
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
ATROPINE AND DEMEROL
ABBVIE 0.4MG/ML;50MG/ML A087853 001 Nov 26, 1982
0.4MG/ML;75MG/ML A087847 001 Nov 26, 1982
0.4MG/ML;100MG/ML A087848 001 Nov 26, 1982
MEPERIDINE AND ATROPINE SULFATE
WYETH AYERST 0.4MG/ML;50MG/ML A085121 001
0.4MG/ML;75MG/ML A085121 002
0.4MG/ML;100MG/ML A085121 003
ATROPINE; PRALIDOXIME CHLORIDE
INJECTABLE;INTRAMUSCULAR
ATNAA
US ARMY 2.1MG/0.7ML;600MG/2ML N021175 001 Jan 17, 2002
AVOBENZONE; OCTINOXATE; OXYBENZONE
LOTION;TOPICAL
SHADE UVAGUARD
+ BAYER HEALTHCARE LLC 3%;7.5%;3% N020045 001 Dec 07, 1992
AZATADINE MALEATE
TABLET;ORAL
OPTIMINE
SCHERING 1MG N017601 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-45(of 393)

** See List Footnote



AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

TRINALIN
SCHERING 1MG;120MG N018506 001 Mar 23, 1982
AZATHIOPRINE
TABLET;ORAL
IMURAN
+ SEBELA IRELAND LTD 25MG ** N016324 002
AZATHIOPRINE SODIUM
INJECTABLE;INJECTION
IMURAN
+ CASPER PHARMA LLC EQ 100MG BASE/VIAL ** N017391 001
AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OPTIVAR
+ MYLAN SPECIALITY LP 0.05% ** N021127 001 May 22, 2000
SPRAY, METERED;NASAL
ASTEPRO
MYLAN SPECIALITY LP EQ 0.125MG BASE/SPRAY N022203 001 Oct 15, 2008
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

APOTEX INC EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY A207712 001 Apr 28, 2017

AZITHROMYCIN

CAPSULE;ORAL

ZITHROMAX

+ PFIZER EQ 250MG BASE ** N050670 001 Nov 01, 1991

FOR SUSPENSION;ORAL

AZITHROMYCIN

SANDOZ EQ 100MG BASE/5ML A065297 001 Sep 18, 2006

EQ 200MG BASE/5ML A065297 002 Sep 18, 2006

FOR SUSPENSION, EXTENDED RELEASE;ORAL



ZMAX

+ PF PRISM CV EQ 2GM BASE/BOT N050797 001 Jun 10, 2005

INJECTABLE;INJECTION

AZITHROMYCIN

CSPC OUYI PHARM CO EQ 500MG BASE/VIAL A065265 001 Jan 18, 2007

TEVA PARENTERAL EQ 500MG BASE/VIAL N050809 001 Dec 19, 2006

EQ 2.5GM BASE/VIAL N050809 002 Dec 19, 2006

TABLET;ORAL

AZITHROMYCIN

APOTEX CORP EQ 250MG BASE A065507 001 Jul 13, 2011

EQ 500MG BASE A065509 001 Jul 13, 2011

EQ 600MG BASE A065508 001 Jul 13, 2011

MYLAN EQ 250MG BASE A065365 001 May 30, 2007

EQ 500MG BASE A065366 001 May 30, 2007



AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE

FOR SUSPENSION, TABLET;ORAL

TROVAN/ZITHROMAX COMPLIANCE PAK

PFIZER EQ 1GM BASE,N/A;N/A,EQ 100MG BASE N050762 001 Dec 18, 1998

AZLOCILLIN SODIUM

INJECTABLE;INJECTION

AZLIN

BAYER PHARMS EQ 2GM BASE/VIAL A062388 001 Sep 08, 1982

EQ 2GM BASE/VIAL A062417 001 Oct 12, 1982



EQ 2GM BASE/VIAL N050562 001 Sep 03, 1982

EQ 3GM BASE/VIAL A062388 002 Sep 08, 1982

EQ 3GM BASE/VIAL A062417 002 Oct 12, 1982



EQ 3GM BASE/VIAL N050562 002 Sep 03, 1982

EQ 4GM BASE/VIAL A062388 003 Sep 08, 1982

EQ 4GM BASE/VIAL A062417 003 Oct 12, 1982



EQ 4GM BASE/VIAL N050562 003 Sep 03, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-46(of 393)

** See List Footnote



AZTREONAM

INJECTABLE;INJECTION

AZACTAM

BRISTOL MYERS SQUIBB 500MG/VIAL
N050580 001
Dec 31, 1986

AZACTAM IN PLASTIC CONTAINER

BRISTOL MYERS SQUIBB
10MG/ML
N050632 003
May 24, 1989

AZTREONAM

WEST-WARD PHARMS INT
1GM/VIAL
A065286 001
Mar 23, 2011

2GM/VIAL
A065286 002
Mar 23, 2011

BACAMPICILLIN HYDROCHLORIDE

FOR SUSPENSION;ORAL

SPECTROBID

PFIZER
125MG/5ML
N050556 001
Mar 23, 1982

TABLET;ORAL

SPECTROBID

PFIZER
400MG
N050520 001

800MG
N050520 002
Sep 12, 1983

BACITRACIN

INJECTABLE;INJECTION

BACITRACIN

MYLAN ASI
50,000 UNITS/VIAL
A090211 001
May 11, 2010

PFIZER
50,000 UNITS/VIAL
A060282 001

PHARMACIA AND UPJOHN 10,000 UNITS/VIAL
A060733 001

OINTMENT;OPHTHALMIC

BACIGUENT

PHARMACIA AND UPJOHN 500 UNITS/GM
A060734 001

BACITRACIN

LILLY
500 UNITS/GM
A060687 001

PHARMADERM
500 UNITS/GM
A062158 001

PHARMAFAIR
500 UNITS/GM
A062453 001
Mar 28, 1984

OINTMENT;TOPICAL

BACITRACIN

COMBE
500 UNITS/GM
A062799 001
May 14, 1987

NASKA
500 UNITS/GM
A062857 001
Nov 13, 1987

POWDER;FOR RX COMPOUNDING

BACI-RX

X GEN PHARMS
5,000,000 UNITS/BOT
A061580 001

BACITRACIN

APOTHEKERNES
5,000,000 UNITS/BOT
A061699 001

PADDOCK LLC
5,000,000 UNITS/BOT
A062456 001
Jul 27, 1983

BACITRACIN ZINC

POWDER;FOR RX COMPOUNDING

ZIBA-RX

X GEN PHARMS
500,000 UNITS/BOT
A061737 001

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

CORTISPORIN

+ CASPER PHARMA LLC 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
N050416 002

UNITS/GM **

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE



PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A062389 001
Jul 02, 1982

UNITS/GM

OINTMENT;TOPICAL

NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE

PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000
A062381 001
Sep 06, 1985

UNITS/GM

BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;TOPICAL

LANABIOTIC

COMBE 400 UNITS/GM;40MG/GM;EQ 5MG
A062499 001
Jun 03, 1985

BASE/GM;5,000 UNITS/GM

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-47(of 393)

** See List Footnote



BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

PHARMAFAIR 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A062386 001
Sep 09, 1982

UNITS/GM

BACITRACIN-NEOMYCIN-POLYMYXIN

PHARMADERM 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
A062167 001

UNITS/GM

NEO-POLYCIN

DOW PHARM 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A060647 001

UNITS/GM

OINTMENT;TOPICAL

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

NASKA 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
A062833 001
Nov 09, 1987

UNITS/GM

BACITRACIN ZINC; POLYMYXIN B SULFATE

AEROSOL;TOPICAL

POLYSPORIN

GLAXOSMITHKLINE 10,000 UNITS/GM;2,000,000 UNITS/GM
N050167 002
Mar 01, 1985

OINTMENT;OPHTHALMIC

OCUMYCIN

PHARMAFAIR 500 UNITS/GM;10,000 UNITS/GM
A062430 001
Apr 08, 1983

POLYSPORIN

MONARCH PHARMS 500 UNITS/GM;10,000 UNITS/GM **
A061229 001

OINTMENT;TOPICAL

BACITRACIN ZINC-POLYMYXIN B SULFATE

NASKA 500 UNITS/GM;10,000 UNITS/GM
A062849 001
Nov 13, 1987

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE

ALTANA 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000


A060731 002

UNITS/GM

BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

MYCITRACIN

PHARMACIA AND UPJOHN 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A061048 001

UNITS/GM

BACITRACIN; POLYMYXIN B SULFATE

DISC;TOPICAL

LANABIOTIC

COMBE 500 UNITS/GM;5,000 UNITS/GM
N050598 001
Sep 22, 1986

BACLOFEN

TABLET;ORAL

BACLOFEN

MYLAN 10MG
A077181 001
Jul 29, 2005

TEVA 10MG
A073043 001
Feb 27, 1992

20MG
A073044 001
Feb 27, 1992

USL PHARMA 10MG
A071260 001
May 06, 1988

20MG
A071261 001
May 06, 1988

WATSON LABS 10MG


A072824 001
Sep 18, 1991

10MG
A073092 001
Jan 28, 1994

10MG
A074698 001
Aug 20, 1996

20MG
A072825 001
Sep 18, 1991

20MG
A073093 001
Jan 28, 1994

20MG
A074698 002
Aug 20, 1996

LIORESAL

+ NOVARTIS 10MG **
N017851 001

+ 20MG **
N017851 003
Jan 20, 1982

TABLET, ORALLY DISINTEGRATING;ORAL

KEMSTRO

UCB INC 10MG
N021589 001
Oct 30, 2003

20MG
N021589 002
Oct 30, 2003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-48(of 393)

** See List Footnote


BARIUM SULFATE
FOR SUSPENSION;ORAL
E-Z-CAT DRY
+ BRACCO 40% (9GM/POUCH) N208036 003 Jan 03, 2017
BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED;INHALATION
BECLOVENT
GLAXOSMITHKLINE 0.042MG/INH N018153 001
QVAR 40
+ TEVA BRANDED PHARM 0.04MG/INH N020911 002 Sep 15, 2000
QVAR 80
+ TEVA BRANDED PHARM 0.08MG/INH N020911 001 Sep 15, 2000
VANCERIL
SCHERING 0.042MG/INH N017573 001
VANCERIL DOUBLE STRENGTH
SCHERING 0.084MG/INH N020486 001 Dec 24, 1996
AEROSOL, METERED;NASAL
BECONASE
GLAXOSMITHKLINE 0.042MG/INH N018584 001
VANCENASE
SCHERING 0.042MG/INH N018521 001
BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED;NASAL

VANCENASE AQ

SCHERING EQ 0.042MG DIPROP/SPRAY N019589 001 Dec 23, 1987

EQ 0.084MG DIPROP/SPRAY N020469 001 Jun 26, 1996

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE

ACTAVIS LABS FL INC 5MG A076267 001 Feb 11, 2004

10MG A076267 002 Feb 11, 2004

20MG A076267 003 Feb 11, 2004

40MG A076267 004 Feb 11, 2004

GENPHARM 5MG A076476 001 Feb 11, 2004

10MG A076476 002 Feb 11, 2004

20MG A076476 003 Feb 11, 2004

40MG A076476 004 Feb 11, 2004

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

ACTAVIS LABS FL INC 5MG;6.25MG A076342 001 Feb 11, 2004

10MG;12.5MG A076342 002 Feb 11, 2004

20MG;12.5MG A076342 003 Feb 11, 2004

20MG;25MG A076342 004 Feb 11, 2004

IVAX SUB TEVA PHARMS 5MG;6.25MG A076348 001 Feb 11, 2004

10MG;12.5MG A076348 002 Feb 11, 2004

20MG;12.5MG A076348 003 Feb 11, 2004

20MG;25MG A076348 004 Feb 11, 2004

MYLAN PHARMS INC 5MG;6.25MG A076612 001 Feb 11, 2004

10MG;12.5MG A076612 002 Feb 11, 2004

20MG;12.5MG A076612 003 Feb 11, 2004

20MG;25MG A076612 004 Feb 11, 2004

SUN PHARM INDS LTD 5MG;6.25MG A077483 001 Sep 08, 2005

10MG;12.5MG A077483 002 Sep 08, 2005

20MG;12.5MG A077483 003 Sep 08, 2005

20MG;25MG A077483 004 Sep 08, 2005

LOTENSIN HCT

+ US PHARMS HOLDINGS I 5MG;6.25MG ** N020033 001 May 19, 1992

BENDAMUSTINE HYDROCHLORIDE

SOLUTION;IV (INFUSION)

TREANDA

+ CEPHALON 45MG/0.5ML (90MG/ML) N022249 003 Sep 13, 2013

+ 180MG/2ML (90MG/ML) N022249 004 Sep 13, 2013


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-49(of 393)

** See List Footnote



BENDROFLUMETHIAZIDE

TABLET;ORAL

NATURETIN-10

APOTHECON 10MG
N012164 003

NATURETIN-2.5

APOTHECON 2.5MG
N012164 001

NATURETIN-5

APOTHECON 5MG
N012164 002

BENDROFLUMETHIAZIDE; NADOLOL

TABLET;ORAL

NADOLOL AND BENDROFLUMETHIAZIDE

MYLAN
5MG;40MG
A078688 001 Feb 15, 2008

5MG;80MG
A078688 002 Feb 15, 2008

BENOXINATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

BENOXINATE HYDROCHLORIDE

SOLA BARNES HIND
0.4%
A084149 001

BENTIROMIDE

SOLUTION;ORAL

CHYMEX

SAVAGE LABS
500MG/7.5ML
N018366 001 Dec 29, 1983

BENZONATATE

CAPSULE;ORAL

BENZONATATE

NESHER PHARMS
100MG
A040795 001 Oct 31, 2007

200MG
A040795 002 Oct 31, 2007

TESSALON

+ PFIZER
200MG **
N011210 003 Jun 25, 1999

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

BENZACLIN

VALEANT BERMUDA
5%;EQ 1% BASE
N050756 002 Apr 20, 2007

BENZPHETAMINE HYDROCHLORIDE

TABLET;ORAL

BENZPHETAMINE HYDROCHLORIDE

EPIC PHARMA LLC
50MG
A040714 001 Oct 29, 2007

IMPAX LABS
50MG
A040845 001 Nov 18, 2008

TEDOR PHARM
25MG
A040747 002 Nov 20, 2015

50MG
A040747 001 Mar 30, 2007

DIDREX

+ PHARMACIA AND UPJOHN 25MG **
N012427 003

+ 50MG **
N012427 002

BENZQUINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

EMETE-CON

PFIZER EQ 50MG BASE/VIAL
N016820 001

SUPPOSITORY;RECTAL

EMETE-CON

ROERIG EQ 100MG BASE
N016818 006

BENZTHIAZIDE

TABLET;ORAL

AQUATAG

SOLVAY 25MG
N016001 001

50MG
N016001 002

BENZTHIAZIDE

PVT FORM 50MG A083206 001

EXNA
AH ROBINS INC 50MG N012489 001

FOVANE

PFIZER 50MG
N012128 002

URESE

PFIZER 25MG
N012128 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-50(of 393)

** See List Footnote



BENZTROPINE MESYLATE

TABLET;ORAL

BENZTROPINE MESYLATE

CHARTWELL RX
1MG
A081265 002 Jan 23, 1992

2MG
A081265 001 Jan 23, 1992

LANNETT CO INC
0.5MG **
A088877 001 Apr 11, 1985

1MG **
A088894 001 Apr 11, 1985

2MG **
A088895 001 Apr 11, 1985

OXFORD PHARMS
2MG
A040706 001 Feb 14, 2008

QUANTUM PHARMICS
0.5MG
A088514 001 Jan 31, 1984

1MG
A088510 001 Jan 31, 1984

2MG
A088511 001 Jan 31, 1984

USL PHARMA
0.5MG
A089211 001 Jun 14, 1988

1MG
A089212 001 Jun 14, 1988

2MG
A089213 001 Jun 14, 1988

COGENTIN

+ MERCK
0.5MG **
N009193 004

+
1MG **
N009193 003

+
2MG **
N009193 002

BENZYL BENZOATE

EMULSION;TOPICAL

BENZYL BENZOATE

LANNETT
50%
A084535 001

BEPRIDIL HYDROCHLORIDE

TABLET;ORAL

BEPADIN

MEDPOINTE PHARM HLC
200MG
N019001 001 Dec 28, 1990

300MG
N019001 002 Dec 28, 1990

400MG
N019001 003 Dec 28, 1990

VASCOR

JOHNSON AND JOHNSON
200MG
N019002 001 Dec 28, 1990

300MG
N019002 002 Dec 28, 1990

400MG
N019002 003 Dec 28, 1990

BETA CAROTENE

CAPSULE;ORAL

SOLATENE

ROCHE
30MG
N017589 001

BETAMETHASONE

CREAM;TOPICAL

CELESTONE

SCHERING
0.2%
N014762 001

SYRUP;ORAL

CELESTONE

MERCK SHARP DOHME
0.6MG/5ML
N014215 002

TABLET;ORAL

CELESTONE

SCHERING
0.6MG
N012657 003

BETAMETHASONE BENZOATE

CREAM;TOPICAL

UTICORT

PARKE DAVIS
0.025%
N016998 002

GEL;TOPICAL

UTICORT

PARKE DAVIS
0.025%
N017244 001

LOTION;TOPICAL

UTICORT

PARKE DAVIS
0.025%
N017528 001

OINTMENT;TOPICAL

UTICORT

PARKE DAVIS
0.025%
N018089 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-51(of 393)

** See List Footnote



BETAMETHASONE DIPROPIONATE

CREAM;TOPICAL

ALPHATREX

SAVAGE LABS
EQ 0.05% BASE
N019138 001 Jun 26, 1984

BETAMETHASONE DIPROPIONATE

PERRIGO NEW YORK
EQ 0.05% BASE
A072536 001 Jan 31, 1990

EQ 0.05% BASE
A074579 001 Nov 26, 1997

PHARMADERM
EQ 0.05% BASE
N019136 001 Jun 26, 1984

TARO
EQ 0.05% BASE
A071143 001 Jun 17, 1987

TEVA
EQ 0.05% BASE
A071476 001 Aug 10, 1987

DIPROSONE

SCHERING
EQ 0.05% BASE
N017536 001

CREAM, AUGMENTED;TOPICAL

DIPROLENE

SCHERING
EQ 0.05% BASE
N019408 001 Jan 31, 1986

DISC;TOPICAL

DIPROSONE

SCHERING
EQ 0.1% BASE
N017829 001

GEL, AUGMENTED;TOPICAL

DIPROLENE

SCHERING
EQ 0.05% BASE
N019408 002 Nov 22, 1991

LOTION;TOPICAL

ALPHATREX

SAVAGE LABS
EQ 0.05% BASE
A070273 001 Aug 12, 1985

BETAMETHASONE DIPROPIONATE

ALPHARMA US PHARMS
EQ 0.05% BASE
A071085 001 Feb 03, 1987

G AND W LABS INC
EQ 0.05% BASE
A071882 001 Jun 06, 1988

PHARMADERM
EQ 0.05% BASE
A070274 001 Aug 12, 1985

TARO
EQ 0.05% BASE
A072276 001 Aug 24, 1988

EQ 0.05% BASE
A074272 001 Sep 30, 1994

DIPROSONE

+ SCHERING
EQ 0.05% BASE **
N017781 001

LOTION, AUGMENTED;TOPICAL

DIPROLENE

+ MERCK SHARP DOHME
EQ 0.05% BASE
N019716 001 Aug 01, 1988

OINTMENT;TOPICAL

ALPHATREX

SAVAGE LABS
EQ 0.05% BASE
N019143 001 Sep 04, 1984

BETAMETHASONE DIPROPIONATE

PERRIGO NEW YORK
EQ 0.05% BASE
A072526 001 Jan 31, 1990

PHARMADERM
EQ 0.05% BASE
N019140 001 Sep 04, 1984

TEVA
EQ 0.05% BASE
A071477 001 Aug 10, 1987

DIPROSONE

SCHERING
EQ 0.05% BASE
N017691 001

BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

BETAMETHASONE SODIUM PHOSPHATE

WATSON LABS
EQ 3MG BASE/ML
A085738 001

CELESTONE

+ SCHERING
EQ 3MG BASE/ML **
N017561 001

BETAMETHASONE VALERATE

CREAM;TOPICAL

BETADERM

ROACO
EQ 0.1% BASE
N018839 001 Jun 30, 1983

BETAMETHASONE VALERATE

PERRIGO NEW YORK
EQ 0.1% BASE
A070053 001 Jun 10, 1986

PHARMADERM
EQ 0.1% BASE
N018860 002 Aug 31, 1983

PHARMAFAIR
EQ 0.1% BASE
A070485 001 May 29, 1987

TARO
EQ 0.1% BASE
A070062 001 May 14, 1985

BETATREX

SAVAGE LABS
EQ 0.1% BASE
N018862 001 Aug 31, 1983

VALISONE

SCHERING
EQ 0.01% BASE
N016322 002

EQ 0.1% BASE
N016322 001

LOTION;TOPICAL

BETA-VAL

G AND W LABS INC
EQ 0.1% BASE
A070072 001 Jun 27, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-52(of 393)
** See List Footnote
BETAMETHASONE VALERATE
LOTION;TOPICAL
BETAMETHASONE VALERATE
PHARMADERM EQ 0.1% BASE N018870 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070484 001 May 29, 1987
TEVA PHARMS EQ 0.1% BASE A071883 001 Apr 22, 1988
BETATREX
SAVAGE LABS EQ 0.1% BASE N018867 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.1% BASE N016932 001
OINTMENT;TOPICAL
BETAMETHASONE VALERATE
PERRIGO NEW YORK EQ 0.1% BASE A071478 001 Dec 23, 1987
PHARMADERM EQ 0.1% BASE N018864 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070486 001 May 29, 1987
BETATREX
SAVAGE LABS EQ 0.1% BASE N018863 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.1% BASE N016740 001
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
APOTEX INC EQ 0.5% BASE A075446 001 Sep 28, 2000
TABLET;ORAL
KERLONE
SANOFI AVENTIS US 10MG N019507 001 Oct 27, 1989
20MG N019507 002 Oct 27, 1989
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

TABLET;ORAL

KERLEDEX

SANOFI AVENTIS US 5MG;12.5MG N019807 001 Oct 30, 1992

10MG;12.5MG N019807 002 Oct 30, 1992

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

BETOPTIC PILO

ALCON EQ 0.25% BASE;1.75% N020619 001 Apr 17, 1997

BETAZOLE HYDROCHLORIDE

INJECTABLE;INJECTION

HISTALOG

LILLY 50MG/ML N009344 001

BETHANECHOL CHLORIDE

INJECTABLE;INJECTION

URECHOLINE

+ ODYSSEY PHARMS 5MG/ML ** N006536 001

TABLET;ORAL

BETHANECHOL CHLORIDE

ABLE 5MG A040492 001 Jul 27, 2004

10MG A040483 001 Jul 27, 2004

25MG A040485 001 Jul 27, 2004

50MG A040509 001 Jul 27, 2004

ACTAVIS ELIZABETH 5MG A040552 001 Oct 28, 2004

10MG A040553 001 Oct 28, 2004

25MG A040554 001 Oct 28, 2004

50MG A040551 001 Oct 28, 2004

ASCOT 10MG A088288 001 Jun 08, 1983

25MG A088289 001 Jun 08, 1983

IMPAX LABS 5MG A040721 001 Nov 01, 2006

10MG A040721 002 Nov 01, 2006

25MG A040721 003 Nov 01, 2016

50MG A040721 004 Nov 01, 2006

IVAX SUB TEVA PHARMS 25MG A084689 001

LANNETT 5MG A084702 001

10MG A084712 001

25MG A084074 001

SANDOZ 5MG A084353 001

10MG A084378 001

10MG A084379 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-53(of 393)

** See List Footnote



BETHANECHOL CHLORIDE

TABLET;ORAL

BETHANECHOL CHLORIDE

25MG
A084383 001

25MG
A084384 001

SUN PHARM INDS INC
5MG
A040897 001
Apr 22, 2009

10MG
A040897 002
Apr 22, 2009

25MG
A040897 003
Apr 22, 2009

50MG
A040897 004
Apr 22, 2009

WATSON LABS
5MG
A084402 001

5MG
A085230 002

5MG
A085841 001

10MG
A084408 001

10MG
A085228 001

10MG
A085842 001

25MG
A084441 001

25MG
A085229 001

25MG
A085839 001

50MG
A087397 001

50MG
A087444 001

MYOTONACHOL

GLENWOOD
5MG
A084188 001

10MG
A084188 003

25MG
A084188 004

URECHOLINE

+ ODYSSEY PHARMS
5MG **
N006536 003

+
10MG **
N006536 002

+
25MG **
N006536 004

+
50MG **
N006536 005

BETHANIDINE SULFATE

TABLET;ORAL

TENATHAN

ROBINS AH
10MG
N017675 001

25MG
N017675 002

BICALUTAMIDE

TABLET;ORAL

BICALUTAMIDE

KUDCO IRELAND
50MG
A077995 001
Jul 06, 2009

ROXANE
50MG
A078285 001
Mar 24, 2011

SYNTHON PHARMS
50MG
A077973 001
Jul 06, 2009

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC

LUMIGAN

+ ALLERGAN
0.03% **
N021275 001
Mar 16, 2001

BIPERIDEN HYDROCHLORIDE

TABLET;ORAL

AKINETON

ABBVIE
2MG
N012003 001

BIPERIDEN LACTATE

INJECTABLE;INJECTION

AKINETON

ABBVIE
5MG/ML
N012418 002

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

FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL

HALFLYTELY

+ BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM N021551 003 Jul 16, 2010

;N/A,5.6GM **

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL



NOVEL LABS INC 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM A202217 001 Aug 20, 2014

;N/A,5.6GM

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-54(of 393)

** See List Footnote



BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

HELIDAC
+ CASPER PHARMA LLC 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5 N050719 001 Aug 15, 1996
00MG **
BISOPROLOL FUMARATE
TABLET;ORAL
BISOPROLOL FUMARATE
ANDA REPOSITORY 5MG A075474 001 Oct 25, 2002
10MG A075474 002 Oct 25, 2002
ZEBETA
+ TEVA WOMENS 5MG ** N019982 002 Jul 31, 1992
+ 10MG ** N019982 001 Jul 31, 1992
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

ACTAVIS ELIZABETH 2.5MG;6.25MG A075672 001 Sep 25, 2000

5MG;6.25MG A075672 002 Sep 25, 2000

10MG;6.25MG A075672 003 Sep 25, 2000

APOTHECON 2.5MG;6.25MG A075642 002 Dec 27, 2000



5MG;6.25MG A075642 001 Dec 27, 2000

10MG;6.25MG A075642 003 Dec 27, 2000

IVAX SUB TEVA PHARMS 2.5MG;6.25MG A075632 001 Sep 27, 2000

5MG;6.25MG A075632 002 Sep 27, 2000

10MG;6.25MG A075632 003 Sep 27, 2000

SANDOZ 2.5MG;6.25MG A075527 001 Sep 25, 2000

5MG;6.25MG A075527 003 Sep 25, 2000

10MG;6.25MG A075527 002 Sep 25, 2000

TEVA 2.5MG;6.25MG A075686 001 Jan 19, 2001



5MG;6.25MG A075686 002 Jan 19, 2001

10MG;6.25MG A075686 003 Jan 19, 2001

WATSON LABS TEVA 2.5MG;6.25MG A075469 001 Sep 25, 2000

5MG;6.25MG A075469 002 Sep 25, 2000

10MG;6.25MG A075469 003 Sep 25, 2000



BITOLTEROL MESYLATE

AEROSOL, METERED;INHALATION

TORNALATE

SANOFI AVENTIS US 0.37MG/INH N018770 001 Dec 28, 1984

SOLUTION;INHALATION

TORNALATE

SANOFI AVENTIS US 0.2% N019548 001 Feb 19, 1992

BLEOMYCIN SULFATE

INJECTABLE;INJECTION

BLENOXANE

+ BRISTOL MYERS SQUIBB EQ 15 UNITS BASE/VIAL ** N050443 001

+ EQ 30 UNITS BASE/VIAL ** N050443 002 Sep 07, 1995

BLEOMYCIN SULFATE

PHARMACHEMIE BV EQ 15 UNITS BASE/VIAL A065201 001 Dec 13, 2007

TEVA PARENTERAL EQ 15 UNITS BASE/VIAL A064084 001 Jun 01, 1996

EQ 30 UNITS BASE/VIAL A064084 002 Jun 01, 1996

BOCEPREVIR

CAPSULE;ORAL

VICTRELIS

MERCK SHARP DOHME 200MG N202258 001 May 13, 2011

BORTEZOMIB

POWDER;INTRAVENOUS, SUBCUTANEOUS

BORTEZOMIB

+ HOSPIRA INC 2.5MG/VIAL N209191 001 Jul 12, 2018

BRETYLIUM TOSYLATE

INJECTABLE;INJECTION

BRETYLIUM TOSYLATE

ABRAXIS PHARM 50MG/ML A070134 001 Apr 29, 1986

100MG/ML A071298 001 Feb 13, 1987



ASTRAZENECA 50MG/ML A071151 001 Aug 10, 1987

50MG/ML A071152 001 Aug 10, 1987

50MG/ML A071153 001 Aug 10, 1987


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-55(of 393)

** See List Footnote



BRETYLIUM TOSYLATE

INJECTABLE;INJECTION

BRETYLIUM TOSYLATE

EUROHLTH INTL SARL 50MG/ML A070546 001 May 14, 1986
+ HOSPIRA 50MG/ML ** N019030 001 Apr 29, 1986
50MG/ML N019033 001 Apr 29, 1986
INTL MEDICATION 50MG/ML A070119 001 Apr 29, 1986
LUITPOLD 50MG/ML A070891 001 Jul 26, 1988
WEST-WARD PHARMS INT 50MG/ML A070545 001 May 14, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5%
ABBOTT 200MG/100ML N019005 002 Apr 29, 1986
400MG/100ML N019005 003 Apr 29, 1986
800MG/100ML N019005 001 Apr 29, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 100MG/100ML N019121 001 Apr 29, 1986
200MG/100ML N019121 002 Apr 29, 1986
400MG/100ML N019121 003 Apr 29, 1986
BAXTER HLTHCARE 200MG/100ML N019837 002 Apr 12, 1989
400MG/100ML N019837 001 Apr 12, 1989
HOSPIRA INC 200MG/100ML N019008 002 Apr 29, 1986
400MG/100ML N019008 003 Apr 29, 1986
800MG/100ML N019008 001 Apr 29, 1986
BRETYLOL
HOSPIRA 50MG/ML N017954 001
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN
+ ALLERGAN 0.2% ** N020613 001 Sep 06, 1996
0.5% N020490 001 Mar 13, 1997
BRIMONIDINE TARTRATE
TEVA PARENTERAL 0.2% A076372 001 Sep 10, 2004
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMDAY
+ BAUSCH AND LOMB INC EQ 0.09% ACID ** N021664 002 Oct 16, 2010
BROMFENAC SODIUM
AMRING PHARMS EQ 0.09% ACID A202030 001 Jan 09, 2013
APOTEX INC EQ 0.09% ACID A202435 001 Jun 19, 2014
EQ 0.09% ACID A202620 001 Jun 23, 2014
COASTAL PHARMS EQ 0.09% ACID A201211 001 May 11, 2011
PADDOCK LLC EQ 0.09% ACID A201941 001 Feb 10, 2015
XIBROM
+ BAUSCH AND LOMB INC EQ 0.09% ACID ** N021664 001 Mar 24, 2005
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM EQ 5MG BASE A075100 001 Dec 10, 1998
BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
AMBODRYL
PARKE DAVIS 25MG N007984 001
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
SYRUP;ORAL
AMBENYL
FOREST LABS 12.5MG/5ML;10MG/5ML N009319 006 Jan 10, 1984
BROMANYL
ALPHARMA US PHARMS 12.5MG/5ML;10MG/5ML A088343 001 Aug 15, 1984
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
WOCKHARDT 12.5MG/5ML;10MG/5ML A088626 001 Oct 12, 1984
BROMPHENIRAMINE MALEATE
ELIXIR;ORAL
BROMPHENIRAMINE MALEATE
ALPHARMA US PHARMS 2MG/5ML A086936 001
KV PHARM 2MG/5ML A085466 001
PHARM ASSOC 2MG/5ML A087517 001
USL PHARMA 2MG/5ML A087964 001 Jan 25, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-56(of 393)

** See List Footnote



BROMPHENIRAMINE MALEATE

INJECTABLE;INJECTION

BROMPHENIRAMINE MALEATE

WATSON LABS
10MG/ML
A083821 001

100MG/ML
A083820 001

DIMETANE-TEN

WYETH AYERST
10MG/ML
N011418 002

TABLET;ORAL

BROMPHENIRAMINE MALEATE

BARR
4MG
A084468 001

IVAX SUB TEVA PHARMS 4MG
A084351 001

NEWTRON PHARMS 4MG A086987 001

NEXGEN PHARMA INC 4MG A086187 001

PAR PHARM 4MG A087009 001

PIONEER PHARMS 4MG A088604 001 Jul 13, 1984

UPSHER SMITH LABS 4MG A083215 001

VITARINE 4MG A085850 001

WATSON LABS 4MG A083123 001

4MG A085769 001

DIMETANE
WYETH CONS 4MG N010799 003

TABLET, EXTENDED RELEASE;ORAL

DIMETANE

WYETH CONS 8MG
N010799 010 Jun 10, 1983

12MG
N010799 011 Jun 10, 1983

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMANATE DM

ALPHARMA US PHARMS 2MG/5ML;10MG/5ML;30MG/5ML
A088722 001 Mar 07, 1985

BROMFED-DM

WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML
A089681 001 Dec 22, 1988

DIMETANE-DX

+ ROBINS AH 2MG/5ML;10MG/5ML;30MG/5ML **
N019279 001 Aug 24, 1984

BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

ALZA
16MG;240MG
N019672 001 Mar 29, 1996

BUCLIZINE HYDROCHLORIDE

TABLET;ORAL

BUCLADIN-S

STUART PHARMS
50MG
N010911 006

BUDESONIDE

AEROSOL, METERED;NASAL

RHINOCORT

ASTRAZENECA
0.032MG/INH
N020233 001 Feb 14, 1994

POWDER, METERED;INHALATION

PULMICORT

ASTRAZENECA
0.16MG/INH
N020441 002 Jun 24, 1997

0.32MG/INH
N020441 003 Jun 24, 1997

BUMETANIDE

INJECTABLE;INJECTION

BUMETANIDE

ATHENEX INC
0.25MG/ML
A074441 001 Jan 27, 1995

HOSPIRA
0.25MG/ML
A074160 001 Oct 30, 1997

TEVA PARENTERAL
0.25MG/ML
A074613 001 Nov 18, 1997

BUMEX

+ VALIDUS PHARMS
0.25MG/ML **
N018226 001 Feb 28, 1983

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE

HOSPIRA
0.75%
A070587 001 Mar 03, 1987

BUPIVACAINE HYDROCHLORIDE KIT

HOSPIRA 0.075%
N019978 001 Sep 03, 1992

0.114%
N019978 002 Sep 03, 1992

0.23%
N019978 003 Sep 03, 1992

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-57(of 393)

** See List Footnote



BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

INTL MEDICATED 0.25% A076012 001 Jan 09, 2002

0.5% A076012 002 Jan 09, 2002

0.75% A076012 003 Jan 09, 2002

INJECTABLE;SPINAL

SENSORCAINE

FRESENIUS KABI USA 0.75% A071202 001 Apr 15, 1987

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

HOSPIRA 0.25%;0.005MG/ML A071166 001 Jun 16, 1988

0.5%;0.005MG/ML A071169 001 Jun 16, 1988

0.75%;0.005MG/ML A071171 001 Jun 16, 1988

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DUOCAINE

AMPHASTAR PHARMS INC EQ 0.375% (37.5MG/10ML);EQ 1% N021496 001 May 23, 2003

(100MG/10ML)

BUPRENORPHINE HYDROCHLORIDE

TABLET;SUBLINGUAL

SUBUTEX

+ INDIVIOR INC EQ 2MG BASE ** N020732 002 Oct 08, 2002

+ EQ 8MG BASE ** N020732 003 Oct 08, 2002

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

TABLET;SUBLINGUAL

SUBOXONE
+ INDIVIOR INC EQ 2MG BASE;EQ 0.5MG BASE ** N020733 001 Oct 08, 2002
+ EQ 8MG BASE;EQ 2MG BASE N020733 002 Oct 08, 2002
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
SANDOZ 75MG A075613 002 Oct 10, 2000
100MG A075613 001 Oct 10, 2000
TEVA 75MG A075310 001 Nov 29, 1999
100MG A075310 002 Nov 29, 1999
WELLBUTRIN
+ GLAXOSMITHKLINE 50MG ** N018644 001 Dec 30, 1985
+ 75MG ** N018644 002 Dec 30, 1985
+ 100MG ** N018644 003 Dec 30, 1985
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
ACTAVIS LABS FL INC 300MG A077715 002 Jun 13, 2007
IMPAX LABS 300MG A077415 002 Dec 15, 2006
SANDOZ 100MG A076845 001 Jul 14, 2005
150MG A076834 001 Jul 14, 2005
150MG A076845 002 Jul 14, 2005
WOCKHARDT LTD 100MG A201331 001 Aug 30, 2012
150MG A201331 002 Aug 30, 2012
200MG A201331 003 Aug 30, 2012
WELLBUTRIN SR
GLAXOSMITHKLINE 50MG N020358 001 Oct 04, 1996
ZYBAN
GLAXOSMITHKLINE 100MG N020711 002 May 14, 1997
BUSPIRONE HYDROCHLORIDE
CAPSULE;ORAL
BUSPAR
BRISTOL MYERS SQUIBB 5MG N021190 001 Dec 20, 2000
7.5MG N021190 002 Dec 20, 2000
10MG N021190 003 Dec 20, 2000
15MG N021190 004 Dec 20, 2000
TABLET;ORAL
BUSPAR
+ BRISTOL MYERS SQUIBB 5MG ** N018731 001 Sep 29, 1986
+ 10MG ** N018731 002 Sep 29, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-58(of 393)

** See List Footnote


BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPAR
+ 15MG ** N018731 003 Apr 22, 1996
+ 30MG ** N018731 004 Apr 22, 1996
BUSPIRONE HYDROCHLORIDE
APOTEX 5MG A075521 001 Apr 05, 2002
10MG A075521 002 Apr 05, 2002
15MG A075521 003 Apr 05, 2002
EGIS 5MG A075119 001 Mar 14, 2002
10MG A075119 002 Mar 14, 2002
15MG A075119 003 Jan 23, 2003
FOSUN PHARMA 5MG A075413 001 Mar 19, 2002
10MG A075413 002 Mar 19, 2002
15MG A075413 003 Mar 19, 2002
IVAX SUB TEVA PHARMS 5MG ** A075385 001 Mar 01, 2002
10MG ** A075385 002 Mar 01, 2002
15MG ** A075385 003 Mar 01, 2002
MYLAN 5MG A075467 001 Feb 28, 2002
10MG A075467 003 Feb 28, 2002
15MG A075467 004 Feb 28, 2002
NESHER PHARMS 5MG A075572 001 Feb 27, 2002
10MG A075572 002 Feb 27, 2002
15MG A075572 003 Feb 27, 2002
OXFORD PHARMS 5MG A075388 001 May 09, 2002
10MG A075388 002 May 09, 2002
15MG A075388 003 May 09, 2002
BUTABARBITAL SODIUM
CAPSULE;ORAL
BUTICAPS
MEDPOINTE PHARM HLC 15MG A085381 001
30MG A085381 002
50MG A085381 003
100MG A085381 004
ELIXIR;ORAL
BUTABARB
ALPHARMA US PHARMS 30MG/5ML A085873 001
BUTABARBITAL SODIUM
WOCKHARDT 30MG/5ML A085383 001
BUTALAN
LANNETT 33.3MG/5ML A085880 001
BUTISOL SODIUM
MEDA PHARMS 30MG/5ML A085380 001
SARISOL
HALSEY 30MG/5ML A084723 001
TABLET;ORAL
BUTABARBITAL
BUNDY 30MG A085550 001
BUTABARBITAL SODIUM
SANDOZ 15MG A084292 003 Feb 09, 1982
15MG A085938 001
30MG A084272 002
30MG A085934 001
SOLVAY 16.2MG A083606 001
32.4MG A083898 001
48.6MG A083897 001
97.2MG A083896 001
TEVA 15MG A088632 001 May 18, 1985
30MG A088631 001 May 01, 1985
WATSON LABS 15MG A085764 001
30MG A085772 001
WHITEWORTH TOWN PLSN 15MG A083325 002
30MG A083337 001
BUTISOL SODIUM
MYLAN SPECIALITY LP 15MG N000793 002
50MG N000793 003
100MG N000793 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-59(of 393)

** See List Footnote



BUTABARBITAL SODIUM

TABLET;ORAL

SARISOL NO. 1

HALSEY
15MG
A084719 001

SARISOL NO. 2

HALSEY
30MG
A084719 002

SODIUM BUTABARBITAL

HIKMA PHARMS
15MG
A085418 001

30MG
A085432 001

IVAX SUB TEVA PHARMS 15MG
A083484 001

30MG
A084040 001

LANNETT
15MG
A085849 001

30MG
A085866 001

100MG
A085881 001

MARSHALL PHARMA
16.2MG
A083524 001

32.4MG
A083858 001

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

MENTAX-TC

MYLAN
1%
N021408 001 Oct 17, 2002

BUTOCONAZOLE NITRATE

CREAM;VAGINAL

BUTOCONAZOLE NITRATE

PERRIGO PHARMA INTL
2%
N019881 001 Feb 07, 1997

FEMSTAT

ROCHE PALO
2%
N019215 001 Nov 25, 1985

FEMSTAT 3

+ BAYER
2%
N020421 001 Dec 21, 1995

SUPPOSITORY;VAGINAL

FEMSTAT

ROCHE PALO
100MG
N019359 001 Nov 25, 1985

BUTORPHANOL TARTRATE

INJECTABLE;INJECTION

BUTORPHANOL TARTRATE

BAXTER HLTHCARE CORP
2MG/ML
A075697 001 Oct 23, 2001

HIKMA FARMACEUTICA
2MG/ML
A078247 001 Apr 29, 2009

HOSPIRA
1MG/ML
A075342 001 Nov 04, 1999

1MG/ML
A075559 001 Mar 20, 2000

2MG/ML
A075342 002 Nov 04, 1999

2MG/ML
A075559 002 Mar 20, 2000

BUTORPHANOL TARTRATE PRESERVATIVE FREE

BAXTER HLTHCARE CORP
1MG/ML
A075695 001 Oct 23, 2001

2MG/ML
A075695 002 Oct 23, 2001

HOSPIRA
1MG/ML
A074620 001 Jan 22, 1997

1MG/ML
A075170 001 Sep 28, 1998

2MG/ML
A074620 002 Jan 22, 1997

2MG/ML
A075170 002 Sep 28, 1998

STADOL

+ APOTHECON
2MG/ML **
N017857 004

STADOL PRESERVATIVE FREE

+ APOTHECON
1MG/ML **
N017857 001

+
2MG/ML **
N017857 002

SPRAY, METERED;NASAL

STADOL

BRISTOL MYERS SQUIBB
1MG/SPRAY **
N019890 001 Dec 12, 1991

CABERGOLINE

TABLET;ORAL

CABERGOLINE

APOTEX CORP
0.5MG
A201503 001 Mar 08, 2013

IMPAX LABS INC
0.5MG
A077843 001 Jul 03, 2007

DOSTINEX

+ PHARMACIA AND UPJOHN
0.5MG **
N020664 001 Dec 23, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-60(of 393)

** See List Footnote



CAFFEINE; ERGOTAMINE TARTRATE

SUPPOSITORY;RECTAL

CAFERGOT

+ NOVARTIS
100MG;2MG **
N009000 002

TABLET;ORAL

CAFERGOT

NOVARTIS
100MG;1MG
N006620 001

WIGRAINE

ORGANON USA INC
100MG;1MG
A086562 001

CALCIFEDIOL

CAPSULE;ORAL

CALDEROL

ORGANON USA INC
0.02MG
N018312 001

0.05MG
N018312 002

CALCIPOTRIENE

OINTMENT;TOPICAL

DOVONEX

+ LEO PHARMA AS
0.005% **
N020273 001 Dec 29, 1993

SOLUTION;TOPICAL

DOVONEX

+ LEO PHARM
0.005% **
N020611 001 Mar 03, 1997

CALCITONIN HUMAN

INJECTABLE;INJECTION

CIBACALCIN

NOVARTIS
0.5MG/VIAL
N018470 001 Oct 31, 1986

CALCITONIN SALMON

INJECTABLE;INJECTION

CALCIMAR

SANOFI AVENTIS US
200 IU/ML
N017769 001

400 IU/VIAL
N017497 001

CALCITONIN-SALMON

IGI LABS INC
200 IU/ML
A073690 001 Apr 14, 1995

MIACALCIN

MYLAN IRELAND LTD
100 IU/ML
N017808 001 Jul 03, 1986

SPRAY, METERED;NASAL

MIACALCIN

+ MYLAN IRELAND LTD
200 IU/SPRAY
N020313 002 Aug 17, 1995

CALCITONIN SALMON RECOMBINANT

SPRAY, METERED;NASAL

FORTICAL

UPSHER SMITH LABS
200 IU/SPRAY **
N021406 001 Aug 12, 2005

CALCITRIOL

INJECTABLE;INJECTION

CALCIJEX

+ ABBVIE
0.001MG/ML **
N018874 001 Sep 25, 1986

+
0.002MG/ML **
N018874 002 Sep 25, 1986

CALCITRIOL

AKORN
0.002MG/ML
A078066 002 Jan 29, 2008

FRESENIUS KABI USA
0.001MG/ML
A075836 001 Dec 31, 2002

0.002MG/ML
A075836 002 Dec 31, 2002

FRESENIUS MEDCL
0.001MG/ML
A075766 001 Feb 20, 2003

0.002MG/ML
A075766 002 Feb 20, 2003

HOSPIRA
0.001MG/ML
A075816 001 Jan 16, 2004

0.002MG/ML
A075816 002 Jan 16, 2004

LUITPOLD
0.001MG/ML
A075746 001 Sep 26, 2003

0.002MG/ML
A075746 002 Sep 26, 2003

ROCKWELL MEDCL
0.001MG/ML
A076206 001 Sep 17, 2003

SAGENT PHARMS
0.001MG/ML
A077102 001 Feb 08, 2006

TEVA PARENTERAL
0.001MG/ML
A075823 001 Mar 31, 2003

0.002MG/ML
A075823 002 Mar 31, 2003

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

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6-61(of 393)

** See List Footnote



CALCIUM ACETATE

CAPSULE;ORAL

PHOSLO

FRESENIUS MEDCL 333.5MG
N021160 001 Apr 02, 2001

667MG
N021160 002 Apr 02, 2001

TABLET;ORAL

CALCIUM ACETATE

WEST-WARD PHARMS INT 667MG
A077693 001 Jan 30, 2008

ELIPHOS

CYPRESS PHARM 667MG
A078502 001 Nov 25, 2008

PHOSLO

+ FRESENIUS MEDCL 667MG **
N019976 001 Dec 10, 1990

CALCIUM CARBONATE; RISEDRONATE SODIUM

TABLET, TABLET;ORAL

ACTONEL WITH CALCIUM (COPACKAGED)

+ WARNER CHILCOTT EQ 500MG BASE,N/A;N/A,35MG ** N021823 001 Aug 12, 2005



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

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE



SOLUTION;IRRIGATION
METHOTREXATE SODIUM
AKORN 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N020079 001 Feb 26, 1999
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

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

BICARBONATE; SODIUM CHLORIDE



INJECTABLE;INJECTION

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE CORP N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0


N021703 010 Oct 10, 2008

5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML

;7.07GM/1000ML (5000ML)

PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE CORP 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;


N021703 012 Oct 10, 2008

3.05GM/1000ML;0.157GM/1000ML;2.21GM/100

0ML;7.07GM/1000ML (5000ML)

PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE CORP 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;


N021703 013 Oct 10, 2008

3.05GM/1000ML;0.314GM/1000ML;2.21GM/100

0ML;7.07GM/1000ML (5000ML)

PRISMASOL BGK 4/0 IN PLASTIC CONTAINER

BAXTER HLTHCARE CORP N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0


N021703 005 Oct 25, 2006

5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML

;6.46GM/1000ML (5000ML)

PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE CORP 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;


N021703 008 Oct 25, 2006

2.03GM/1000ML;0.314GM/1000ML;3.09GM/100

0ML;6.46GM/1000ML (5000ML)

PRISMASOL BK 0/0 IN PLASTIC CONTAINER

BAXTER HLTHCARE CORP N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05


N021703 007 Oct 25, 2006

GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46

GM/1000ML (5000ML)

PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER

+ BAXTER HLTHCARE CORP 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2


N021703 001 Oct 25, 2006

.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6

.46GM/1000ML (5000ML)

PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER

BAXTER HLTHCARE CORP 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3


N021703 009 Oct 25, 2006

.05GM/1000ML;0.314GM/1000ML;3.09GM/1000

ML;6.46GM/1000ML (5000ML)

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM

BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE



SOLUTION;IRRIGATION
NAVSTEL
ALCON PHARMS LTD 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M N022193 001 Jul 24, 2008
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-62(of 393)

** See List Footnote



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

CHLORIDE
INJECTABLE;INJECTION
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N019864 001 Jun 10, 1993
00ML;330MG/100ML;88MG/100ML
ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N018271 001
00ML;330MG/100ML;88MG/100ML

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

CHLORIDE; SODIUM CITRATE



INJECTABLE;INJECTION

ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10
N019867 001 Dec 20, 1993

0ML;640MG/100ML;500MG/100ML;74MG/100ML

ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10
N018269 002 Jan 17, 1983

0ML;640MG/100ML;500MG/100ML;74MG/100ML

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

CHLORIDE; SODIUM LACTATE



INJECTABLE;INJECTION

PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE 37MG/100ML;5GM/100ML;30MG/100ML;119MG/1 N017390 001

00ML;161MG/100ML;94MG/100ML;138MG/100ML

**

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

SOLUTION;INTRAPERITONEAL

DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER

B BRAUN 510MG/100ML;30GM/100ML;200MG/100ML;9.2G
N018807 001 Aug 26, 1983

M/100ML;9.6GM/100ML

510MG/100ML;30GM/100ML;200MG/100ML;9.4G
N018807 003 Aug 26, 1983

M/100ML;11GM/100ML

DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER

B BRAUN 510MG/100ML;50GM/100ML;200MG/100ML;9.2G
N018807 002 Aug 26, 1983

M/100ML;9.6GM/100ML

510MG/100ML;50GM/100ML;200MG/100ML;9.4G
N018807 004 Aug 26, 1983

M/100ML;11GM/100ML

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG
N018460 006 Jan 29, 1986

/100ML;560MG/100ML

DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG
N018460 001

/100ML;560MG/100ML

DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

B BRAUN 29MG/100ML;4.25GM/100ML;15MG/100ML;610M
N018460 003

G/100ML;560MG/100ML

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

SOLUTION;INTRAPERITONEAL

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5


N018379 002

67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5


N018379 003

67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5


N018379 007 Jun 24, 1988

67MG/100ML;392MG/100ML

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;


N018379 001

567MG/100ML;392MG/100ML

DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5


N018379 004 Jul 07, 1982

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 005 Jul 07, 1982

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 008 Jun 24, 1988

38MG/100ML;448MG/100ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-63(of 393)

** See List Footnote



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

SOLUTION;INTRAPERITONEAL

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;


N018379 006
Jul 07, 1982

538MG/100ML;448MG/100ML

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER

B BRAUN 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/
N018460 007
Jan 29, 1986

100ML;450MG/100ML

26MG/100ML;1.5GM/100ML;15MG/100ML;560MG
N018460 002

/100ML;390MG/100ML

DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/
N018460 005
Nov 02, 1983

100ML;450MG/100ML

26MG/100ML;5GM/100ML;5MG/100ML;530MG/10
N018460 008
Jan 29, 1986

0ML;450MG/100ML

DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER

B BRAUN 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG
N018460 009
Jan 29, 1986

/100ML;450MG/100ML

26MG/100ML;4.25GM/100ML;15MG/100ML;560M
N018460 004

G/100ML;390MG/100ML

DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5


N017512 001

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 003

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 002

567MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5


N017512 007
Jul 09, 1984

67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5


N017512 008
Jul 09, 1984

67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5


N017512 010
Nov 18, 1985

67MG/100ML;392MG/100ML

DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;


N017512 009
Jul 09, 1984

567MG/100ML;392MG/100ML

DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5


N017512 011
Nov 18, 1985

38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5
A020374 001
Jun 13, 1994

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
A020374 002
Jun 13, 1994

38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5
A020374 003
Jun 13, 1994

38MG/100ML;448MG/100ML

INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
A020374 004
Jun 13, 1994

538MG/100ML;448MG/100ML

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

INJECTABLE;INJECTION

DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER

B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;380MG/1
N018258 001

00ML;600MG/100ML

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER

HOSPIRA 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
N018254 001

00ML

DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER

B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018256 001

00ML
33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N020000 001
Apr 17, 1992

00ML
BAXTER HLTHCARE 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N016695 001

00ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-64(of 393)

** See List Footnote



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

INJECTABLE;INJECTION

DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER

B BRAUN 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100 N019634 002
Feb 24, 1988

ML;62MG/100ML

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER



B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017510 001

00ML;310MG/100ML

MILES 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N018499 001



00ML;310MG/100ML

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 005
Oct 17, 1988

100ML;310MG/100ML

+ 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 006


Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 007
Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008
Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 003
Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004
Oct 17, 1988

100ML;310MG/100ML

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER



+ ICU MEDICAL INC 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 001
Oct 17, 1988

100ML;310MG/100ML

CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE

SOLUTION;INTRAPERITONEAL

INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;44 N019395 001


Mar 26, 1986

8MG/100ML

INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;44 N019395 002


Mar 26, 1986

8MG/100ML

INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER

FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;4 N019395 003


Mar 26, 1986

48MG/100ML

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

INJECTABLE;INJECTION

TPN ELECTROLYTES IN PLASTIC CONTAINER

ABBOTT 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N019399 001 Jun 16, 1986

16.1MG/ML

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

CITRATE

INJECTABLE;INJECTION

ISOLYTE E IN PLASTIC CONTAINER

B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N018899 001 Oct 31, 1983

100ML;500MG/100ML;74MG/100ML

35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N019718 001 Sep 29, 1989

100ML;500MG/100ML;74MG/100ML

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

LACTATE

INJECTABLE;INJECTION

PLASMA-LYTE R IN PLASTIC CONTAINER

BAXTER HLTHCARE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML; N017438 001

640MG/100ML;496MG/100ML;89.6MG/100ML

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ACETATED RINGER'S IN PLASTIC CONTAINER

B BRAUN 20MG/100ML;30MG/100ML;380MG/100ML;600MG N018725 001 Nov 29, 1982

/100ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-65(of 393)

** See List Footnote



CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

RINGER'S IN PLASTIC CONTAINER

B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML
N018721 001 Nov 09, 1982

SOLUTION;IRRIGATION

RINGER'S IN PLASTIC CONTAINER

ABBOTT 33MG/100ML;30MG/100ML;860MG/100ML
N018462 001

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

INJECTABLE;INJECTION

LACTATED RINGER'S IN PLASTIC CONTAINER

ABBOTT 20MG/100ML;30MG/100ML;600MG/100ML;310MG
N019485 001 Oct 24, 1985

/100ML

B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG
N018023 001

/100ML

MILES 20MG/100ML;30MG/100ML;600MG/100ML;310MG
N018417 001

/100ML

SOLUTION;IRRIGATION

LACTATED RINGER'S IN PLASTIC CONTAINER

BAXTER HLTHCARE
20MG/100ML;30MG/100ML;600MG/100ML;310MG
N019933 001 Aug 29, 1989

/100ML

CALCIUM GLUCEPTATE

INJECTABLE;INJECTION

CALCIUM GLUCEPTATE

ABBOTT
EQ 90MG CALCIUM/5ML
A080001 001

EQ 90MG CALCIUM/5ML
A083159 001

ABRAXIS PHARM
EQ 90MG CALCIUM/5ML
A089373 001 Apr 30, 1987

LILLY
EQ 90MG CALCIUM/5ML
N006470 001

CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

INJECTABLE;INJECTION

ISOPAQUE 440

GE HEALTHCARE 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML
N016847 001

CALCIUM; MEGLUMINE; METRIZOIC ACID

INJECTABLE;INJECTION

ISOPAQUE 280

GE HEALTHCARE
0.35MG/ML;140.1MG/ML;461.8MG/ML
N017506 001

CANDESARTAN CILEXETIL

TABLET;ORAL

CANDESARTAN CILEXETIL

APOTEX INC
4MG
A202079 001
Jan 10, 2014

8MG
A202079 002
Jan 10, 2014

16MG
A202079 003
Jan 10, 2014

32MG
A202079 004
Jan 10, 2014

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

APOTEX INC
16MG;12.5MG
A202884 001
Dec 04, 2012

32MG;12.5MG
A202884 002
Dec 04, 2012

32MG;25MG
A202884 003
Jun 03, 2013

CANDICIDIN

OINTMENT;VAGINAL

VANOBID

SANOFI AVENTIS US
0.6MG/GM
A061596 001

TABLET;VAGINAL

VANOBID

SANOFI AVENTIS US
3MG
A061613 001

CAPTOPRIL

TABLET;ORAL

CAPOTEN

+ PAR PHARM
12.5MG **
N018343 005
Jan 17, 1985

+
25MG **
N018343 002

+
37.5MG **
N018343 006
Sep 17, 1986

+
50MG **
N018343 001

+
75MG **
N018343 007
Jun 13, 1995

+
100MG **
N018343 003

+
150MG **
N018343 004
Jun 13, 1995

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-66(of 393)

** See List Footnote



CAPTOPRIL

TABLET;ORAL

CAPTOPRIL

APOTEX
12.5MG
A074737 001 Oct 28, 1998

25MG
A074737 002 Oct 28, 1998

50MG
A074737 003 Oct 28, 1998

100MG
A074737 004 Oct 28, 1998

APOTHECON
12.5MG
A074472 001 Mar 31, 1995

25MG
A074472 002 Mar 31, 1995

50MG
A074472 003 Mar 31, 1995

100MG
A074472 004 Mar 31, 1995

BOSCOGEN
12.5MG
A074677 004 May 30, 1997

25MG
A074677 002 May 30, 1997

50MG
A074677 001 May 30, 1997

100MG
A074677 003 May 30, 1997

DAVA PHARMS INC


12.5MG
A074423 001 Feb 13, 1996

25MG
A074423 002 Feb 13, 1996

50MG
A074423 003 Feb 13, 1996

100MG
A074423 004 Feb 13, 1996

EGIS PHARMS
12.5MG
A074748 004 May 29, 1997

25MG
A074748 002 May 29, 1997

50MG
A074748 001 May 29, 1997

100MG
A074748 003 May 29, 1997

G AND W LABS INC


12.5MG
A074433 001 Feb 13, 1996

12.5MG
A074462 001 Feb 13, 1996

12.5MG
A074483 001 Feb 13, 1996

12.5MG
A074590 004 Aug 30, 1996

25MG
A074433 002 Feb 13, 1996

25MG
A074462 002 Feb 13, 1996

25MG
A074483 002 Feb 13, 1996

25MG
A074590 002 Aug 30, 1996

50MG
A074433 003 Feb 13, 1996

50MG
A074462 003 Feb 13, 1996

50MG
A074483 003 Feb 13, 1996

50MG
A074590 001 Aug 30, 1996

100MG
A074433 004 Feb 13, 1996

100MG
A074462 004 Feb 13, 1996

100MG
A074483 004 Feb 13, 1996

100MG
A074590 003 Aug 30, 1996

OXFORD PHARMS
12.5MG
A074418 001 Feb 13, 1996

25MG
A074418 002 Feb 13, 1996

50MG
A074418 003 Feb 13, 1996

100MG
A074418 004 Feb 13, 1996

PAR PHARM
12.5MG
A074493 001 Feb 13, 1996

25MG
A074493 002 Feb 13, 1996

50MG
A074493 003 Feb 13, 1996

100MG
A074493 004 Feb 13, 1996

PUREPAC PHARM
12.5MG
A074640 001 Mar 31, 1997

25MG
A074640 002 Mar 31, 1997

50MG
A074640 003 Mar 31, 1997

100MG
A074640 004 Mar 31, 1997

SANDOZ
12.5MG
A074481 001 Feb 13, 1996

25MG
A074481 002 Feb 13, 1996

50MG
A074481 003 Feb 13, 1996

100MG
A074481 004 Feb 13, 1996

WATSON LABS
12.5MG
A074451 001 Feb 13, 1996

12.5MG
A074576 001 Apr 23, 1996

25MG
A074451 002 Feb 13, 1996

25MG
A074576 002 Apr 23, 1996

50MG
A074451 003 Feb 13, 1996

50MG
A074576 003 Apr 23, 1996

100MG
A074451 004 Feb 13, 1996

100MG
A074576 004 Apr 23, 1996

YAOPHARMA CO LTD
12.5MG
A074363 001 Nov 09, 1995

12.5MG
A074519 001 Feb 13, 1996

25MG
A074363 002 Nov 09, 1995

25MG
A074519 002 Feb 13, 1996

50MG
A074363 003 Nov 09, 1995

50MG
A074519 003 Feb 13, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-67(of 393)

** See List Footnote



CAPTOPRIL

TABLET;ORAL

CAPTOPRIL

100MG A074363 004 Nov 09, 1995

100MG A074519 004 Feb 13, 1996

CAPTOPRIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CAPOZIDE 25/15

+ APOTHECON 25MG;15MG ** N018709 001 Oct 12, 1984



CAPOZIDE 25/25

+ APOTHECON 25MG;25MG ** N018709 002 Oct 12, 1984



CAPOZIDE 50/15

+ APOTHECON 50MG;15MG ** N018709 004 Oct 12, 1984



CAPOZIDE 50/25

+ APOTHECON 50MG;25MG ** N018709 003 Oct 12, 1984



CAPTOPRIL AND HYDROCHLOROTHIAZIDE

G AND W LABS INC 25MG;15MG A074827 001 Dec 29, 1997

25MG;25MG A074827 002 Dec 29, 1997

50MG;15MG A074827 004 Dec 29, 1997

50MG;25MG A074827 003 Dec 29, 1997

IVAX SUB TEVA PHARMS 25MG;15MG A075055 001 Jun 18, 1998

25MG;25MG A075055 002 Jun 18, 1998

50MG;15MG A075055 004 Jun 18, 1998

50MG;25MG A075055 003 Jun 18, 1998

VINTAGE PHARMS LLC 25MG;15MG A074788 001 Dec 29, 1997

25MG;25MG A074788 002 Dec 29, 1997

50MG;15MG A074788 004 Dec 29, 1997

50MG;25MG A074788 003 Dec 29, 1997

WATSON LABS 50MG;25MG A074832 001 Dec 29, 1997

CARBACHOL

SOLUTION;INTRAOCULAR

CARBACHOL

PHARMAFAIR 0.01% A070292 001 May 21, 1986

CARBASTAT

NOVARTIS 0.01% A073677 001 Apr 28, 1995

CARBAMAZEPINE

SOLUTION;INTRAVENOUS

CARNEXIV

+ LUNDBECK PHARMS LLC 200MG/20ML (10MG/ML) N206030 001 Oct 07, 2016

SUSPENSION;ORAL

CARBAMAZEPINE

TARO 100MG/5ML A075875 001 Dec 21, 2000

TABLET;ORAL

CARBAMAZEPINE

ACTAVIS ELIZABETH 200MG A071696 001 Nov 09, 1987
INWOOD LABS 200MG A070231 001 Aug 14, 1986
PLIVA 200MG A071479 001 Jul 24, 1987
USL PHARMA 200MG A070300 001 May 15, 1986
WARNER CHILCOTT 200MG A070429 001 Jan 02, 1987
TERIL
TARO 200MG A076525 001 Sep 26, 2003
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
JUBILANT CADISTA 100MG A071940 001 Feb 01, 1988
CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
GEOPEN
ROERIG EQ 1GM BASE/VIAL N050306 001
EQ 2GM BASE/VIAL N050306 004
EQ 5GM BASE/VIAL N050306 002
EQ 10GM BASE/VIAL N050306 006
EQ 30GM BASE/VIAL N050306 007
PYOPEN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050298 001
EQ 2GM BASE/VIAL N050298 002
EQ 5GM BASE/VIAL N050298 003
EQ 10GM BASE/VIAL N050298 006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-68(of 393)

** See List Footnote


CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
PYOPEN
EQ 20GM BASE/VIAL N050298 007
CARBENICILLIN INDANYL SODIUM
TABLET;ORAL
GEOCILLIN
PFIZER EQ 382MG BASE N050435 001
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
ANI PHARMS INC 10MG;100MG A073587 002 Jun 29, 1995
25MG;100MG A073587 001 Jun 29, 1995
25MG;250MG A073587 003 Jun 29, 1995
SCS 10MG;100MG A074080 001 Mar 25, 1994
25MG;100MG A074080 002 Mar 25, 1994
25MG;250MG A074080 003 Mar 25, 1994
WATSON LABS 10MG;100MG A073381 001 Sep 28, 1993
25MG;100MG A073382 001 Sep 28, 1993
25MG;250MG A073383 001 Sep 28, 1993
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
KV PHARM 50MG;200MG A076663 001 Jun 24, 2004
TABLET, FOR SUSPENSION;ORAL
CARBILEV
RANBAXY 10MG;100MG A076643 001 Jun 10, 2005
25MG;100MG A076643 002 Jun 10, 2005
25MG;250MG A076643 003 Jun 10, 2005
TABLET, ORALLY DISINTEGRATING;ORAL
CARBIDOPA AND LEVODOPA
IMPAX LABS 10MG;100MG A090631 001 Jun 08, 2010
25MG;100MG A090631 002 Jun 08, 2010
25MG;250MG A090631 003 Jun 08, 2010
PARCOPA
UCB INC 10MG;100MG ** A076699 001 Aug 27, 2004
25MG;100MG ** A076699 002 Aug 27, 2004
25MG;250MG ** A076699 003 Aug 27, 2004
CARBINOXAMINE MALEATE
ELIXIR;ORAL
CLISTIN
+ MCNEIL 4MG/5ML ** N008955 001
SOLUTION;ORAL
CARBINOXAMINE MALEATE
CYPRESS PHARM 4MG/5ML A090418 001 May 04, 2010
TABLET;ORAL
CARBINOXAMINE MALEATE
CYPRESS PHARM 4MG A090417 001 Aug 23, 2010
CLISTIN
+ ORTHO MCNEIL PHARM 4MG ** N008915 001
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
CIPLA LTD 50MG/VIAL A077383 001 Jan 27, 2006
150MG/VIAL A077383 002 Jan 27, 2006
450MG/VIAL A077383 003 Jan 27, 2006
FRESENIUS KABI USA 50MG/VIAL A076235 001 Oct 14, 2004
150MG/VIAL A076235 002 Oct 14, 2004
450MG/VIAL A076235 003 Oct 14, 2004
HOSPIRA 50MG/VIAL A076473 001 Oct 27, 2004
150MG/VIAL A076473 002 Oct 27, 2004
450MG/VIAL A076473 003 Oct 27, 2004
MYLAN LABS LTD 50MG/VIAL A091510 001 May 29, 2012
150MG/VIAL A091510 002 May 29, 2012
450MG/VIAL A091510 003 May 29, 2012
PLIVA 50MG/VIAL A076602 001 Nov 16, 2004
150MG/VIAL A076602 002 Nov 16, 2004
450MG/VIAL A076602 003 Nov 16, 2004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-69(of 393)

** See List Footnote



CARBOPLATIN

INJECTABLE;INJECTION

CARBOPLATIN

SANDOZ 50MG/VIAL A076959 001 Mar 18, 2005

150MG/VIAL A076959 002 Mar 18, 2005

450MG/VIAL A076959 003 Mar 18, 2005

WATSON LABS TEVA 50MG/VIAL A076162 001 Oct 14, 2004

150MG/VIAL A076162 002 Oct 14, 2004

450MG/VIAL A076162 003 Oct 14, 2004

WEST-WARD PHARMS INT 50MG/VIAL A076099 001 Oct 14, 2004

150MG/VIAL A076099 002 Oct 14, 2004

450MG/VIAL A076099 003 Oct 14, 2004

PARAPLATIN

+ CORDEN PHARMA 50MG/VIAL ** N019880 001 Mar 03, 1989
+ 150MG/VIAL ** N019880 002 Mar 03, 1989
+ 450MG/VIAL ** N019880 003 Mar 03, 1989
INJECTABLE;IV (INFUSION)
CARBOPLATIN
ACTAVIS TOTOWA 50MG/5ML (10MG/ML) A078732 001 Feb 06, 2012
150MG/15ML (10MG/ML) A078732 002 Feb 06, 2012
450MG/45ML (10MG/ML) A078732 003 Feb 06, 2012
600MG/60ML (10MG/ML) A078732 004 Feb 06, 2012
FRESENIUS KABI USA 50MG/5ML (10MG/ML) A077247 001 Oct 21, 2004
50MG/5ML (10MG/ML) A077266 001 Feb 15, 2006
150MG/15ML (10MG/ML) A077247 002 Oct 21, 2004
150MG/15ML (10MG/ML) A077266 002 Feb 15, 2006
MYLAN LABS LTD 1GM/100ML (10MG/ML) A091478 001 Nov 23, 2011
PHARMACHEMIE BV 50MG/5ML (10MG/ML) A077679 001 Feb 25, 2009
150MG/15ML (10MG/ML) A077679 002 Feb 25, 2009
450MG/45ML (10MG/ML) A077679 003 Feb 25, 2009
TEVA PARENTERAL 50MG/5ML (10MG/ML) A077389 001 Mar 30, 2007
150MG/15ML (10MG/ML) A077389 002 Mar 30, 2007
450MG/45ML (10MG/ML) A077389 003 Mar 30, 2007
PARAPLATIN
+ CORDENPHARMA 50MG/5ML (10MG/ML) ** N020452 001 Jul 14, 2003
+ 150MG/15ML (10MG/ML) ** N020452 002 Jul 14, 2003
+ 450MG/45ML (10MG/ML) ** N020452 003 Jul 14, 2003
+ 600MG/60ML (10MG/ML) ** N020452 004 Jan 15, 2004
CARISOPRODOL
CAPSULE;ORAL
SOMA
+ MYLAN SPECIALITY LP 250MG N011792 003
TABLET;ORAL
CARISOPRODOL
ABLE 350MG A040421 001 Jun 21, 2001
EPIC PHARMA LLC 350MG A040397 001 Sep 21, 2000
FOSUN PHARMA 350MG A081025 001 Apr 13, 1989
OXFORD PHARMS 350MG A040188 001 Mar 07, 1997
PIONEER PHARMS 350MG A089390 001 Oct 13, 1988
SANDOZ 350MG A089566 001 Aug 30, 1988
SUN PHARM INDS LTD 350MG A040755 001 Feb 27, 2007
WATSON LABS 350MG A040152 001 Dec 03, 1996
350MG A085433 001
WATSON LABS TEVA 350MG A086179 001
RELA
SCHERING 350MG N012155 001
CARPHENAZINE MALEATE
CONCENTRATE;ORAL
PROKETAZINE
WYETH AYERST 50MG/ML N014173 001
TABLET;ORAL
PROKETAZINE
WYETH AYERST 12.5MG N012768 001
25MG N012768 002
50MG N012768 004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-70(of 393)

** See List Footnote



CARPROFEN

TABLET;ORAL

RIMADYL

ROCHE 100MG N018550 002 Dec 31, 1987

150MG N018550 003 Dec 31, 1987

CARTEOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CARTEOLOL HYDROCHLORIDE

APOTEX INC 1% A076097 001 Feb 06, 2002

OCUPRESS

+ NOVARTIS 1% ** N019972 001 May 23, 1990

TABLET;ORAL

CARTROL

ABBVIE 2.5MG N019204 001 Dec 28, 1988

5MG N019204 002 Dec 28, 1988

10MG N019204 003 Dec 28, 1988

CARVEDILOL

TABLET;ORAL

CARVEDILOL

HIKMA 3.125MG A077887 001 Sep 07, 2007

6.25MG A077887 002 Sep 07, 2007

12.5MG A077887 003 Sep 07, 2007

25MG A077887 004 Sep 07, 2007

PLIVA HRVATSKA DOO 3.125MG A078240 001 Oct 30, 2007



6.25MG A078240 002 Oct 30, 2007

12.5MG A078240 003 Oct 30, 2007

25MG A078240 004 Oct 30, 2007

WOCKHARDT LTD 3.125MG A078786 001 Dec 22, 2009

6.25MG A078786 002 Dec 22, 2009

12.5MG A078786 003 Dec 22, 2009

25MG A078786 004 Dec 22, 2009

CEFACLOR

CAPSULE;ORAL

CECLOR

+ LILLY EQ 250MG BASE ** N050521 001

+ EQ 500MG BASE ** N050521 002

CEFACLOR

CEPH INTL EQ 250MG BASE A062205 001

EQ 500MG BASE A062205 002

DAVA PHARMS INC EQ 250MG BASE A064107 001 Apr 27, 1995

EQ 500MG BASE A064107 002 Apr 27, 1995

IVAX SUB TEVA PHARMS EQ 250MG BASE A064061 001 Apr 27, 1995

EQ 500MG BASE A064061 002 Apr 27, 1995

RANBAXY EQ 250MG BASE A064156 001 Aug 28, 1997

EQ 500MG BASE A064156 002 Aug 28, 1997

TEVA EQ 250MG BASE A064081 001 Sep 16, 1996

EQ 250MG BASE A064145 001 Jun 24, 1996



EQ 500MG BASE A064081 002 Sep 16, 1996

EQ 500MG BASE A064145 002 Jun 24, 1996



WATSON LABS INC EQ 250MG BASE A064148 001 May 23, 1996

EQ 500MG BASE A064148 002 May 23, 1996

FOR SUSPENSION;ORAL

CECLOR

+ LILLY EQ 125MG BASE/5ML ** N050522 001

+ EQ 250MG BASE/5ML ** N050522 002

CEFACLOR

DAVA PHARMS INC EQ 125MG BASE/5ML A064114 001 Apr 28, 1995

EQ 187MG BASE/5ML A064115 001 Apr 28, 1995

EQ 250MG BASE/5ML A064116 001 Apr 28, 1995

EQ 375MG BASE/5ML A064110 001 Apr 28, 1995

FACTA FARMA EQ 125MG BASE/5ML A062206 001



EQ 187MG BASE/5ML A062206 003 Apr 20, 1988

EQ 250MG BASE/5ML A062206 002



EQ 375MG BASE/5ML A062206 004 Apr 20, 1988

IVAX SUB TEVA PHARMS EQ 125MG BASE/5ML A064087 001 Apr 28, 1995

EQ 187MG BASE/5ML A064086 001 Apr 28, 1995

EQ 250MG BASE/5ML A064085 001 Apr 28, 1995

EQ 375MG BASE/5ML A064070 001 Apr 28, 1995


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-71(of 393)
** See List Footnote
CEFACLOR
FOR SUSPENSION;ORAL
CEFACLOR
RANBAXY EQ 125MG BASE/5ML A064166 001 Oct 02, 1997
EQ 187MG BASE/5ML A064165 001 Oct 02, 1997
EQ 250MG BASE/5ML A064164 001 Oct 02, 1997
EQ 375MG BASE/5ML A064155 001 Oct 02, 1997
WATSON LABS INC EQ 125MG BASE/5ML A064204 001 Feb 18, 1998
EQ 187MG BASE/5ML A064205 001 Feb 18, 1998
EQ 250MG BASE/5ML A064206 001 Feb 18, 1998
EQ 375MG BASE/5ML A064207 001 Feb 18, 1998
TABLET, CHEWABLE;ORAL
RANICLOR
RANBAXY LABS LTD EQ 125MG BASE A065092 001 Dec 22, 2003
EQ 187MG BASE A065092 002 Dec 22, 2003
EQ 250MG BASE A065092 003 Dec 22, 2003
EQ 375MG BASE A065092 004 Dec 22, 2003
TABLET, EXTENDED RELEASE;ORAL
CECLOR CD
LILLY EQ 375MG BASE N050673 001 Jun 28, 1996
EQ 500MG BASE N050673 002 Jun 28, 1996
CEFACLOR
WORLD GEN EQ 500MG BASE A065057 001 Jan 05, 2001
CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

CEFADROXIL

CSPC OUYI PHARM CO EQ 500MG BASE A205072 001 Jul 28, 2017

IVAX SUB TEVA PHARMS EQ 500MG BASE A062766 001 Mar 03, 1987

PUREPAC PHARM EQ 500MG BASE A063017 001 Jan 05, 1989

RANBAXY LABS LTD EQ 500MG BASE A065015 001 Jun 22, 1999

SANDOZ EQ 500MG BASE A062291 001

TEVA EQ 500MG BASE A062695 001 Feb 10, 1989

DURICEF

WARNER CHILCOTT EQ 250MG BASE N050512 002

+ EQ 500MG BASE ** N050512 001

ULTRACEF

BRISTOL EQ 500MG BASE A062378 001 Mar 16, 1982

FOR SUSPENSION;ORAL

CEFADROXIL

ANI PHARMS INC EQ 125MG BASE/5ML A062698 001 Mar 01, 1989

EQ 250MG BASE/5ML A062698 002 Mar 01, 1989

EQ 250MG BASE/5ML A065278 001 Jan 20, 2006

EQ 500MG BASE/5ML A062698 003 Mar 01, 1989

EQ 500MG BASE/5ML A065278 002 Jan 20, 2006

APOTHECON EQ 125MG BASE/5ML A062334 001

EQ 250MG BASE/5ML A062334 002

EQ 500MG BASE/5ML A062334 003

SUN PHARM INDS LTD EQ 125MG BASE/5ML A065115 001 Mar 26, 2003

EQ 250MG BASE/5ML A065115 002 Mar 26, 2003

EQ 500MG BASE/5ML A065115 003 Mar 26, 2003

DURICEF

+ WARNER CHILCOTT EQ 125MG BASE/5ML ** N050527 002

+ EQ 250MG BASE/5ML ** N050527 003

+ EQ 500MG BASE/5ML ** N050527 001

ULTRACEF

BRISTOL EQ 125MG BASE/5ML A062376 001 Mar 16, 1982

EQ 250MG BASE/5ML A062376 002 Mar 16, 1982

EQ 500MG BASE/5ML A062376 003 Mar 16, 1982

TABLET;ORAL

CEFADROXIL

RANBAXY EQ 1GM BASE A065018 001 Apr 23, 1999

DURICEF

+ WARNER CHILCOTT EQ 1GM BASE ** N050528 001

ULTRACEF

APOTHECON EQ 1GM BASE A062390 001 Jun 10, 1982

BRISTOL EQ 1GM BASE A062408 001 Aug 31, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-72(of 393)

** See List Footnote



CEFAMANDOLE NAFATE

INJECTABLE;INJECTION

MANDOL

LILLY
EQ 500MG BASE/VIAL
N050504 001

EQ 1GM BASE/VIAL
A062560 001 Sep 10, 1985

EQ 1GM BASE/VIAL
N050504 002

EQ 2GM BASE/VIAL
A062560 002 Sep 10, 1985

EQ 2GM BASE/VIAL
N050504 003

EQ 10GM BASE/VIAL
N050504 004

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

ANCEF

+ GLAXOSMITHKLINE
EQ 250MG BASE/VIAL **
N050461 001

+
EQ 500MG BASE/VIAL
N050461 002

+
EQ 1GM BASE/VIAL **
N050461 003

+
EQ 5GM BASE/VIAL **
N050461 004

+
EQ 10GM BASE/VIAL **
N050461 005

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE EQ 10MG BASE/ML
N050566 003 Jun 08, 1983

EQ 20MG BASE/ML
N050566 004 Jun 08, 1983

ANCEF IN PLASTIC CONTAINER

BAXTER HLTHCARE EQ 10MG BASE/ML
A063002 001 Mar 28, 1991

ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE
EQ 10MG BASE/ML
N050566 001 Jun 08, 1983

EQ 20MG BASE/ML
N050566 002 Jun 08, 1983

CEFAZOLIN AND DEXTROSE

B BRAUN
EQ 500MG BASE/VIAL
N050779 001 Jul 27, 2000

CEFAZOLIN SODIUM

ABRAXIS PHARM
EQ 500MG BASE/VIAL
A062688 002 Nov 17, 1986

EQ 1GM BASE/VIAL
A062688 003 Nov 17, 1986

EQ 10GM BASE/VIAL
A062688 004 Nov 17, 1986

EQ 20GM BASE/VIAL
A062688 005 Aug 03, 1987

AUROBINDO PHARMA
EQ 500MG BASE/VIAL
A065395 001 Aug 08, 2008

EQ 1GM BASE/VIAL
A065395 002 Aug 08, 2008

BEDFORD
EQ 250MG BASE/VIAL
A062894 001 Jul 21, 1988

EQ 500MG BASE/VIAL
A062894 002 Jul 21, 1988

EQ 1GM BASE/VIAL
A062894 003 Jul 21, 1988

EQ 5GM BASE/VIAL
A062894 004 Jul 21, 1988

EQ 10GM BASE/VIAL
A062894 005 Jul 21, 1988

CEPHAZONE PHARMA
EQ 500MG BASE/VIAL
A065280 001 Mar 18, 2009

EQ 1GM BASE/VIAL
A065280 002 Mar 18, 2009

EQ 10GM BASE/VIAL
A065295 001 Mar 18, 2009

EQ 20GM BASE/VIAL
A065296 001 Mar 18, 2009

FACTA FARMA
EQ 500MG BASE/VIAL
A063214 001 Dec 27, 1991

EQ 1GM BASE/VIAL
A063207 001 Dec 27, 1991

EQ 10GM BASE/VIAL
A063209 001 Dec 27, 1991

EQ 20GM BASE/VIAL
A063209 002 Apr 30, 1999

FRESENIUS KABI USA


EQ 500MG BASE/VIAL **
A064169 001 Aug 14, 1998

EQ 1GM BASE/VIAL **
A064169 002 Aug 14, 1998

EQ 10GM BASE/VIAL
A064170 001 Mar 18, 1998

EQ 20GM BASE/VIAL
A064170 002 Mar 18, 1998

GLAXOSMITHKLINE
EQ 1GM BASE/VIAL
A064033 001 Oct 31, 1993

STERI PHARMA
EQ 500MG BASE/VIAL
A063216 001 Dec 27, 1991

EQ 1GM BASE/VIAL
A063208 001 Dec 27, 1991

TEVA PHARMS
EQ 250MG BASE/VIAL
A063016 001 Mar 14, 1989

EQ 500MG BASE/VIAL
A063016 002 Mar 14, 1989

EQ 1GM BASE/VIAL
A063016 003 Mar 14, 1989

EQ 5GM BASE/VIAL
A063018 001 Mar 05, 1990

EQ 10GM BASE/VIAL
A063018 002 Mar 05, 1990

WATSON LABS INC
EQ 250MG BASE/VIAL
A062988 001 Dec 29, 1989

EQ 500MG BASE/VIAL
A062988 002 Dec 29, 1989

EQ 1GM BASE/VIAL
A062988 003 Dec 29, 1989

EQ 5GM BASE/VIAL
A062989 001 Dec 29, 1989

EQ 10GM BASE/VIAL
A062989 002 Dec 29, 1989

EQ 20GM BASE/VIAL
A062989 003 Dec 29, 1989

WEST-WARD PHARMS INT
EQ 250MG BASE/VIAL
A062807 001 Jan 12, 1988

EQ 500MG BASE/VIAL
A062807 002 Jan 12, 1988

EQ 1GM BASE/VIAL
A062807 003 Jan 12, 1988

EQ 5GM BASE/VIAL
A062807 004 Jan 12, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-73(of 393)

** See List Footnote



CEFAZOLIN SODIUM

INJECTABLE;INJECTION

CEFAZOLIN SODIUM

EQ 10GM BASE/VIAL
A062807 005 Jan 12, 1988

EQ 20GM BASE/VIAL
A062807 006 Jan 12, 1988

KEFZOL

ACS DOBFAR EQ 250MG BASE/VIAL
A061773 001

EQ 500MG BASE/VIAL
A061773 002

EQ 1GM BASE/VIAL
A061773 003

EQ 10GM BASE/VIAL
A061773 004

EQ 20GM BASE/VIAL
A061773 005 Sep 08, 1987

LILLY EQ 500MG BASE/VIAL


A062557 001 Sep 10, 1985

EQ 1GM BASE/VIAL
A062557 002 Sep 10, 1985

CEFDINIR

CAPSULE;ORAL

OMNICEF

+ ABBVIE 300MG **
N050739 001 Dec 04, 1997

FOR SUSPENSION;ORAL

OMNICEF

+ ABBVIE 125MG/5ML **
N050749 001 Dec 04, 1997

+ 250MG/5ML **
N050749 002 Jul 29, 2004

CEFDITOREN PIVOXIL

TABLET;ORAL

SPECTRACEF

VANSEN PHARMA 200MG
N021222 001 Aug 29, 2001

400MG
N021222 002 Jul 21, 2008

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

FOSUN PHARMA EQ 500MG BASE/VIAL
A090291 001 Dec 21, 2010

EQ 1GM BASE/VIAL
A090291 002 Dec 21, 2010

EQ 2GM BASE/VIAL
A090291 003 Dec 21, 2010

CEFIXIME

FOR SUSPENSION;ORAL

SUPRAX

+ LEDERLE 100MG/5ML **
N050622 001 Apr 28, 1989

TABLET;ORAL

SUPRAX

+ LEDERLE 200MG **
N050621 001 Apr 28, 1989

+ 400MG **
N050621 002 Apr 28, 1989

CEFMENOXIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFMAX

TAP PHARM EQ 500MG BASE/VIAL
N050571 001 Dec 30, 1987

EQ 1GM BASE/VIAL
N050571 002 Dec 30, 1987

EQ 2GM BASE/VIAL
N050571 003 Dec 30, 1987

CEFMETAZOLE SODIUM

INJECTABLE;INJECTION

ZEFAZONE

+ PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL **
N050637 001 Dec 11, 1989

+ EQ 2GM BASE/VIAL **
N050637 002 Dec 11, 1989

ZEFAZONE IN PLASTIC CONTAINER

+ PHARMACIA AND UPJOHN EQ 20MG BASE/ML **
N050683 001 Dec 29, 1992

+ EQ 40MG BASE/ML **
N050683 002 Dec 29, 1992

CEFONICID SODIUM

INJECTABLE;INJECTION

MONOCID

GLAXOSMITHKLINE EQ 500MG BASE/VIAL
N050579 001 May 23, 1984

EQ 1GM BASE/VIAL
A063295 001 Jul 26, 1993

EQ 1GM BASE/VIAL
N050579 002 May 23, 1984

EQ 2GM BASE/VIAL
N050579 003 May 23, 1984

EQ 10GM BASE/VIAL
N050579 004 May 23, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-74(of 393)

** See List Footnote



CEFOPERAZONE SODIUM

INJECTABLE;INJECTION

CEFOBID

PFIZER EQ 1GM BASE/VIAL A063333 001 Mar 31, 1995

EQ 1GM BASE/VIAL N050551 001 Nov 18, 1982

EQ 2GM BASE/VIAL A063333 002 Mar 31, 1995

EQ 2GM BASE/VIAL N050551 002 Nov 18, 1982

EQ 10GM BASE/VIAL N050551 003 Mar 05, 1990

CEFOBID IN PLASTIC CONTAINER

PFIZER EQ 20MG BASE/ML N050613 002 Jul 31, 1987

EQ 40MG BASE/ML N050613 001 Jul 23, 1986

CEFORANIDE

INJECTABLE;INJECTION

PRECEF

APOTHECON 500MG/VIAL A062579 001 Nov 26, 1984

1GM/VIAL A062579 002 Nov 26, 1984

2GM/VIAL A062579 003 Nov 26, 1984

10GM/VIAL A062579 004 Nov 26, 1984

20GM/VIAL A062579 005 Nov 26, 1984

BRISTOL 500MG/VIAL N050554 001 May 24, 1984

1GM/VIAL N050554 002 May 24, 1984

2GM/VIAL N050554 003 May 24, 1984

10GM/VIAL N050554 004 May 24, 1984

20GM/VIAL N050554 005 May 24, 1984



CEFOTAXIME SODIUM

INJECTABLE;INJECTION

CEFOTAXIME

FRESENIUS KABI USA EQ 500MG BASE/VIAL A064200 001 Mar 24, 2000

EQ 1GM BASE/VIAL A064200 002 Mar 24, 2000

EQ 2GM BASE/VIAL A064200 003 Mar 24, 2000

EQ 10GM BASE/VIAL A064201 001 Mar 24, 2000

EQ 20GM BASE/VIAL A064201 002 Mar 24, 2000

CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

B BRAUN EQ 2GM BASE N050792 001 Jul 29, 2004

CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER

B BRAUN EQ 1GM BASE N050792 002 Jul 29, 2004

CEFOTAXIME SODIUM

AUROBINDO PHARMA EQ 500MG BASE/VIAL A065517 001 Nov 06, 2009

EQ 1GM BASE/VIAL A065517 002 Nov 06, 2009

EQ 2GM BASE/VIAL A065517 003 Nov 06, 2009

AUROBINDO PHARMA LTD EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009

CEPHAZONE PHARMA EQ 10GM BASE/VIAL A065348 001 Jan 25, 2010

LUPIN EQ 500MG BASE/VIAL A065124 001 Sep 24, 2003

EQ 1GM BASE/VIAL A065124 002 Sep 24, 2003

EQ 2GM BASE/VIAL A065124 003 Sep 24, 2003

CLAFORAN

SANOFI AVENTIS US EQ 1GM BASE/VIAL A062659 001 Jan 13, 1987

EQ 2GM BASE/VIAL A062659 002 Jan 13, 1987

+ US PHARM HOLDINGS EQ 500MG BASE/VIAL N050547 001

+ EQ 1GM BASE/VIAL N050547 002

+ EQ 2GM BASE/VIAL N050547 003

+ EQ 10GM BASE/VIAL N050547 004 Dec 29, 1983

CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER

US PHARM HOLDINGS EQ 20MG BASE/ML N050596 002 May 20, 1985

EQ 40MG BASE/ML N050596 004 May 20, 1985

CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



US PHARM HOLDINGS EQ 20MG BASE/ML N050596 001 May 20, 1985

EQ 40MG BASE/ML N050596 003 May 20, 1985



CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTAN

TELIGENT EQ 10GM BASE/VIAL N050588 003 Apr 25, 1988

TELIGENT PHARMA INC EQ 1GM BASE/VIAL A063293 001 Apr 29, 1993

EQ 2GM BASE/VIAL A063293 002 Apr 29, 1993

CEFOTAN IN PLASTIC CONTAINER



TELIGENT EQ 20MG BASE/ML N050694 002 Jul 30, 1993

EQ 40MG BASE/ML N050694 001 Jul 30, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-75(of 393)

** See List Footnote



CEFOTIAM HYDROCHLORIDE

INJECTABLE;INJECTION

CERADON

TAKEDA EQ 1GM BASE/VIAL N050601 001 Dec 30, 1988

CEFOXITIN SODIUM

INJECTABLE;INJECTION

CEFOXITIN

ACS DOBFAR SPA EQ 1GM BASE/VIAL A065467 001 Aug 31, 2011

EQ 2GM BASE/VIAL A065467 002 Aug 31, 2011

EQ 10GM BASE/VIAL A065464 001 Aug 31, 2011

FRESENIUS KABI USA EQ 1GM BASE/VIAL ** A065012 001 Jul 03, 2000

EQ 2GM BASE/VIAL ** A065012 002 Jul 03, 2000

EQ 10GM BASE/VIAL A065011 001 Jul 03, 2000

MEFOXIN

MYLAN INSTITUTIONAL EQ 1GM BASE/VIAL A062757 001 Jan 08, 1987

+ EQ 1GM BASE/VIAL ** N050517 001

EQ 2GM BASE/VIAL A062757 002 Jan 08, 1987

+ EQ 2GM BASE/VIAL ** N050517 002

+ EQ 10GM BASE/VIAL ** N050517 003

MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

+ MERCK EQ 20MG BASE/ML ** N050581 003 Sep 20, 1984

+ EQ 40MG BASE/ML ** N050581 004 Sep 20, 1984

MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



+ MERCK EQ 20MG BASE/ML ** N050581 002 Sep 20, 1984

+ EQ 40MG BASE/ML ** N050581 001 Sep 20, 1984



CEFPIRAMIDE SODIUM

INJECTABLE;INJECTION

CEFPIRAMIDE SODIUM

WYETH AYERST EQ 1GM BASE/VIAL N050633 002 Jan 31, 1989

EQ 2GM BASE/VIAL N050633 003 Jan 31, 1989

EQ 10GM BASE/VIAL N050633 005 Jan 31, 1989

CEFPODOXIME PROXETIL

FOR SUSPENSION;ORAL

BANAN

SANKYO EQ 50MG BASE/5ML N050688 002 Aug 07, 1992

EQ 100MG BASE/5ML N050688 001 Aug 07, 1992

CEFPODOXIME PROXETIL

SUN PHARM INDS LTD EQ 50MG BASE/5ML A065082 001 May 31, 2002

EQ 100MG BASE/5ML A065082 002 May 31, 2002

VANTIN

+ PHARMACIA AND UPJOHN EQ 50MG BASE/5ML ** N050675 001 Aug 07, 1992

+ EQ 100MG BASE/5ML ** N050675 002 Aug 07, 1992

TABLET;ORAL

BANAN

SANKYO EQ 100MG BASE N050687 001 Aug 07, 1992

EQ 200MG BASE N050687 002 Aug 07, 1992

CEFPODOXIME PROXETIL

SUN PHARM INDS LTD EQ 100MG BASE A065083 001 Aug 20, 2003

EQ 200MG BASE A065083 002 Aug 20, 2003

VANTIN

+ PHARMACIA AND UPJOHN EQ 100MG BASE ** N050674 001 Aug 07, 1992

+ EQ 200MG BASE ** N050674 002 Aug 07, 1992



CEFPROZIL

FOR SUSPENSION;ORAL

CEFPROZIL

RANBAXY LABS LTD 125MG/5ML A065202 001 Jun 30, 2006

250MG/5ML A065202 002 Jun 30, 2006

CEFZIL

+ CORDEN PHARMA 125MG/5ML N050665 001 Dec 23, 1991

+ 250MG/5ML N050665 002 Dec 23, 1991

TABLET;ORAL

CEFPROZIL

RANBAXY LABS LTD 250MG A065198 001 Dec 13, 2006

500MG A065198 002 Dec 13, 2006

CEFZIL

+ CORDEN PHARMA 250MG N050664 001 Dec 23, 1991

+ 500MG N050664 002 Dec 23, 1991

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-76(of 393)

** See List Footnote



CEFTAZIDIME

INJECTABLE;INJECTION

CEFTAZIDIME

ACS DOBFAR 500MG/VIAL A062640 001 Nov 20, 1985

AUROBINDO PHARMA LTD 500MG/VIAL A065481 001 May 28, 2010

1GM/VIAL A065481 002 May 28, 2010

2GM/VIAL A065481 003 May 28, 2010

6GM/VIAL A065482 001 May 28, 2010

CEPTAZ

GLAXOSMITHKLINE 500MG/VIAL N050646 001 Sep 27, 1990

1GM/VIAL N050646 002 Sep 27, 1990

2GM/VIAL N050646 003 Sep 27, 1990

10GM/VIAL N050646 004 Sep 27, 1990

PENTACEF

GLAXOSMITHKLINE 1GM/VIAL A063322 001 Nov 07, 1995

1GM/VIAL A064006 001 Mar 31, 1992

2GM/VIAL A063322 002 Nov 07, 1995

2GM/VIAL A064006 002 Mar 31, 1992

6GM/VIAL A064008 001 Mar 31, 1992

10GM/VIAL A064008 002 Mar 31, 1992

TAZIDIME

LILLY 1GM/VIAL A062655 001 Nov 20, 1985

2GM/VIAL A062655 002 Nov 20, 1985

TAZIDIME IN PLASTIC CONTAINER

LILLY 1GM/VIAL A062739 001 Jul 10, 1986

2GM/VIAL A062739 002 Jul 10, 1986

CEFTAZIDIME SODIUM

INJECTABLE;INJECTION

CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

BAXTER HLTHCARE EQ 10MG BASE/ML A063221 001 Apr 29, 1993

EQ 20MG BASE/ML A063221 002 Apr 29, 1993

EQ 40MG BASE/ML A063221 003 Apr 29, 1993

FORTAZ IN PLASTIC CONTAINER



TELIGENT EQ 10MG BASE/ML N050634 001 Apr 28, 1989

+ EQ 20MG BASE/ML N050634 002 Apr 28, 1989

+ EQ 40MG BASE/ML N050634 003 Apr 28, 1989



CEFTIBUTEN DIHYDRATE

CAPSULE;ORAL

CEDAX

SI PHARMS EQ 400MG BASE N050685 002 Dec 20, 1995

FOR SUSPENSION;ORAL

CEDAX

+ SI PHARMS EQ 90MG BASE/5ML ** N050686 001 Dec 20, 1995

+ EQ 180MG BASE/5ML ** N050686 002 Dec 20, 1995

CEFTIZOXIME SODIUM

INJECTABLE;INJECTION

CEFIZOX

ASTELLAS EQ 500MG BASE/VIAL N050560 001 Sep 15, 1983

EQ 1GM BASE/VIAL A063294 002 Mar 31, 1994



EQ 1GM BASE/VIAL N050560 002 Sep 15, 1983

EQ 2GM BASE/VIAL A063294 003 Mar 31, 1994



EQ 2GM BASE/VIAL N050560 003 Sep 15, 1983

EQ 10GM BASE/VIAL N050560 005 Mar 19, 1993



CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER

ASTELLAS EQ 20MG BASE/ML N050589 001 Oct 03, 1984

EQ 40MG BASE/ML N050589 002 Oct 03, 1984

CEFIZOX IN PLASTIC CONTAINER

ASTELLAS EQ 20MG BASE/ML N050589 003 Apr 13, 1995

EQ 40MG BASE/ML N050589 004 Apr 13, 1995



CEFTRIAXONE SODIUM

INJECTABLE;INJECTION

CEFTRIAXONE

AGILA SPECLTS EQ 10GM BASE/VIAL A091068 001 Jan 07, 2013

AUROBINDO PHARMA LTD EQ 10GM BASE/VIAL A065504 001 Jul 31, 2008

BEDFORD EQ 10GM BASE/VIAL A065475 001 Aug 18, 2008

FACTA FARMA EQ 10GM BASE/VIAL A065269 001 Feb 28, 2007



FRESENIUS KABI USA EQ 10GM BASE/VIAL A065252 001 Feb 15, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-77(of 393)

** See List Footnote



CEFTRIAXONE SODIUM

INJECTABLE;INJECTION

CEFTRIAXONE

HOSPIRA INC EQ 1GM BASE/VIAL A065231 001 Aug 02, 2005

EQ 1GM BASE/VIAL A202563 001 Aug 20, 2012

EQ 2GM BASE/VIAL A065231 002 Aug 02, 2005

EQ 2GM BASE/VIAL A202563 002 Aug 20, 2012

LUPIN EQ 10GM BASE/VIAL A065263 001 Sep 12, 2006

TEVA EQ 10GM BASE/VIAL A065274 001 May 01, 2006

ROCEPHIN

HOFFMANN LA ROCHE EQ 250MG BASE/VIAL A063239 001 Aug 13, 1993

EQ 500MG BASE/VIAL A062654 001 Apr 30, 1987

EQ 500MG BASE/VIAL A063239 002 Aug 13, 1993

EQ 1GM BASE/VIAL A062654 002 Apr 30, 1987

EQ 1GM BASE/VIAL A063239 003 Aug 13, 1993

EQ 2GM BASE/VIAL A062654 003 Apr 30, 1987

+ EQ 10GM BASE/VIAL N050585 005 Dec 21, 1984



ROCHE EQ 250MG BASE/VIAL A062510 001 Mar 12, 1985

EQ 500MG BASE/VIAL A062510 002 Mar 12, 1985

EQ 1GM BASE/VIAL A062510 003 Mar 12, 1985

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

+ HOFFMANN LA ROCHE EQ 10MG BASE/ML ** N050624 001 Feb 11, 1987



+ EQ 20MG BASE/ML ** N050624 002 Feb 11, 1987

+ EQ 40MG BASE/ML ** N050624 003 Feb 11, 1987

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFTRIAXONE

AUROBINDO PHARMA LTD EQ 250MG BASE/VIAL A065505 001 Jul 31, 2008

EQ 500MG BASE/VIAL A065505 002 Jul 31, 2008

EQ 1GM BASE/VIAL A065505 003 Jul 31, 2008

EQ 2GM BASE/VIAL A065505 004 Jul 31, 2008

BEDFORD EQ 250MG BASE/VIAL A065465 001 Aug 18, 2008

EQ 500MG BASE/VIAL A065465 002 Aug 18, 2008

EQ 1GM BASE/VIAL A065465 003 Aug 18, 2008

EQ 2GM BASE/VIAL A065465 004 Aug 18, 2008

CEPHAZONE PHARMA EQ 250MG BASE/VIAL A065294 001 Mar 26, 2007



EQ 500MG BASE/VIAL A065294 002 Mar 26, 2007

EQ 1GM BASE/VIAL A065294 003 Mar 26, 2007

EQ 2GM BASE/VIAL A065294 004 Mar 26, 2007

FACTA FARMA EQ 1GM BASE/VIAL A065268 001 Feb 28, 2007

EQ 2GM BASE/VIAL A065268 002 Feb 28, 2007

FRESENIUS KABI USA EQ 250MG BASE/VIAL A065245 001 Feb 15, 2006

EQ 500MG BASE/VIAL A065245 002 Feb 15, 2006

EQ 1GM BASE/VIAL A065245 003 Feb 15, 2006

EQ 2GM BASE/VIAL A065245 004 Feb 15, 2006

TEVA EQ 1GM BASE/VIAL A065262 001 Jun 29, 2006

EQ 2GM BASE/VIAL A065262 002 Jun 29, 2006

TEVA PHARMS USA EQ 250MG BASE/VIAL A065227 001 Mar 15, 2007

EQ 500MG BASE/VIAL A065227 002 Mar 15, 2007

EQ 1GM BASE/VIAL A065227 003 Mar 15, 2007

EQ 2GM BASE/VIAL A065227 004 Mar 15, 2007

ROCEPHIN

+ HOFFMANN LA ROCHE EQ 250MG BASE/VIAL N050585 001 Dec 21, 1984

+ EQ 500MG BASE/VIAL N050585 002 Dec 21, 1984

+ EQ 1GM BASE/VIAL N050585 003 Dec 21, 1984

+ EQ 2GM BASE/VIAL N050585 004 Dec 21, 1984

CEFTRIAXONE SODIUM; LIDOCAINE

INJECTABLE;INJECTION

ROCEPHIN KIT

HOFFMANN LA ROCHE EQ 500MG BASE/VIAL,N/A;N/A,1% N050585 007 May 08, 1996

EQ 1GM BASE/VIAL,N/A;N/A,1% N050585 006 May 08, 1996



CEFUROXIME AXETIL

FOR SUSPENSION;ORAL

CEFTIN

+ GLAXOSMITHKLINE EQ 125MG BASE/5ML N050672 001 Jun 30, 1994

+ EQ 250MG BASE/5ML N050672 002 Apr 29, 1997

CEFUROXIME AXETIL

SUN PHARM INDS LTD EQ 125MG BASE/5ML A065323 001 Feb 05, 2008

EQ 250MG BASE/5ML A065323 002 Feb 05, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-78(of 393)

** See List Footnote



CEFUROXIME AXETIL

TABLET;ORAL

CEFTIN

+ GLAXOSMITHKLINE EQ 125MG BASE N050605 001 Dec 28, 1987
+ EQ 250MG BASE N050605 002 Dec 28, 1987
+ EQ 500MG BASE N050605 003 Dec 28, 1987
CEFUROXIME AXETIL
FOSUN PHARMA EQ 250MG BASE A065126 001 Oct 28, 2003
EQ 500MG BASE A065126 002 Oct 28, 2003
RANBAXY LABS LTD EQ 125MG BASE A065043 003 Feb 15, 2002
EQ 250MG BASE A065043 002 Feb 15, 2002
EQ 500MG BASE A065043 001 Feb 15, 2002
SUN PHARM INDS LTD EQ 125MG BASE A065118 001 Apr 25, 2003
EQ 250MG BASE A065118 002 Apr 25, 2003
EQ 500MG BASE A065118 003 Apr 25, 2003
CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
FRESENIUS KABI USA EQ 1.5GM BASE/VIAL A065001 002 May 30, 2001
EQ 7.5GM BASE/VIAL A065002 001 Sep 28, 1998
TEVA PHARMS EQ 7.5GM BASE/VIAL A064191 001 Apr 16, 1998
WATSON LABS INC EQ 1.5GM BASE/VIAL A064035 002 Feb 26, 1993
EQ 7.5GM BASE/VIAL A064036 001 Feb 26, 1993
CEFUROXIME SODIUM IN PLASTIC CONTAINER
SAMSON MEDCL EQ 75GM BASE/VIAL A065251 001 Dec 30, 2009
EQ 225GM BASE/VIAL A065251 002 Dec 30, 2009
KEFUROX
ACS DOBFAR EQ 1.5GM BASE/VIAL A062591 002 Jan 10, 1986
EQ 7.5GM BASE/VIAL A062591 003 Dec 17, 1987
LILLY EQ 1.5GM BASE/VIAL A062592 002 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 1.5GM BASE/VIAL A062590 002 Jan 10, 1986
ZINACEF IN PLASTIC CONTAINER
TELIGENT EQ 15MG BASE/ML N050643 001 Apr 28, 1989
+ EQ 30MG BASE/ML N050643 002 Apr 28, 1989
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
FRESENIUS KABI USA EQ 750MG BASE/VIAL A065001 001 May 30, 2001
TEVA PHARMS EQ 750MG BASE/VIAL A064192 002 Apr 16, 1998
EQ 1.5GM BASE/VIAL A064192 001 Apr 16, 1998
WATSON LABS INC EQ 750MG BASE/VIAL A064035 001 Feb 26, 1993
KEFUROX
ACS DOBFAR EQ 750MG BASE/VIAL A062591 001 Jan 10, 1986
INJECTABLE;INTRAVENOUS
KEFUROX
LILLY EQ 750MG BASE/VIAL A062592 001 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 750MG BASE/VIAL A062590 001 Jan 10, 1986
CELLULOSE SODIUM PHOSPHATE
POWDER;ORAL
CALCIBIND
MISSION PHARMA 2.5GM/PACKET N018757 002 Dec 28, 1982
300GM/BOT N018757 003 Oct 16, 1984
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
APOTHECON EQ 250MG BASE A062973 001 Nov 08, 1988
EQ 250MG BASE A063063 001 Sep 29, 1989
EQ 250MG BASE A063186 001 Dec 30, 1994
EQ 500MG BASE A062974 001 Nov 23, 1988
EQ 500MG BASE A063063 002 Sep 29, 1989
EQ 500MG BASE A063186 002 Dec 30, 1994
BARR EQ 250MG BASE A062773 001 Jun 26, 1987
EQ 500MG BASE A062775 001 Apr 22, 1987
FACTA FARMA EQ 250MG BASE A062118 001
EQ 500MG BASE A062118 002
IVAX SUB TEVA PHARMS EQ 250MG BASE A061969 001
EQ 500MG BASE A061969 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-79(of 393)

** See List Footnote



CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

PUREPAC PHARM EQ 250MG BASE A062809 001 Apr 22, 1987

EQ 500MG BASE A062809 002 Apr 22, 1987

STEVENS J EQ 250MG BASE A062870 001 Mar 17, 1988



EQ 500MG BASE A062869 001 Mar 17, 1988

SUN PHARM INDS LTD EQ 250MG BASE A065007 001 Sep 16, 1999

EQ 500MG BASE A065007 002 Sep 16, 1999

TEVA EQ 250MG BASE A062760 001 Apr 24, 1987

EQ 250MG BASE A062821 001 Feb 05, 1988



EQ 500MG BASE A062761 001 Apr 24, 1987

EQ 500MG BASE A062823 001 Feb 05, 1988



YOSHITOMI EQ 250MG BASE A062872 001 Jun 20, 1988

EQ 500MG BASE A062871 001 Jul 05, 1988

KEFLEX

+ PRAGMA EQ 333MG BASE ** N050405 004 May 12, 2006

FOR SUSPENSION;ORAL

CEPHALEXIN

APOTHECON EQ 125MG BASE/5ML A062986 001 Apr 18, 1991

EQ 250MG BASE/5ML A062987 001 Jul 25, 1989



BARR EQ 125MG BASE/5ML A062778 001 Aug 06, 1987

EQ 250MG BASE/5ML A062777 001 Aug 06, 1987

FACTA FARMA EQ 100MG BASE/ML ** A062117 001



EQ 125MG BASE/5ML ** A062117 002

EQ 250MG BASE/5ML ** A062117 003

HIKMA PHARMS EQ 125MG BASE/5ML A065444 001 Aug 28, 2009

EQ 250MG BASE/5ML A065444 002 Aug 28, 2009

SUN PHARM INDS LTD EQ 125MG BASE/5ML A065081 001 Jul 27, 2001

EQ 250MG BASE/5ML A065081 002 Jul 27, 2001

TEVA EQ 125MG BASE/5ML A062767 001 Jun 16, 1987

EQ 125MG BASE/5ML A062873 001 May 23, 1988

EQ 250MG BASE/5ML A062768 001 Jun 16, 1987



EQ 250MG BASE/5ML A062867 001 Apr 15, 1988

VITARINE EQ 125MG BASE/5ML A062779 001 Dec 22, 1987



EQ 250MG BASE/5ML A062781 001 Dec 22, 1987

KEFLEX

+ PRAGMA EQ 100MG BASE/ML ** N050406 003

+ EQ 125MG BASE/5ML ** N050406 001

+ EQ 250MG BASE/5ML ** N050406 002

TABLET;ORAL

CEPHALEXIN

BARR EQ 250MG BASE A062826 001 Aug 17, 1987

EQ 500MG BASE A062827 001 Aug 17, 1987

VITARINE EQ 250MG BASE A062863 001 Aug 11, 1988

EQ 500MG BASE A062863 002 Aug 11, 1988

EQ 1GM BASE A062863 003 Aug 11, 1988

KEFLET

LILLY EQ 250MG BASE A062745 001 Dec 01, 1986

EQ 250MG BASE N050440 003 Feb 26, 1987

EQ 500MG BASE A062745 002 Dec 01, 1986

EQ 500MG BASE N050440 001

EQ 1GM BASE N050440 002

TABLET, FOR SUSPENSION;ORAL

PANIXINE DISPERDOSE

RANBAXY LABS LTD EQ 125MG BASE A065100 002 Sep 11, 2003

EQ 250MG BASE A065100 001 Sep 11, 2003



CEPHALEXIN HYDROCHLORIDE

TABLET;ORAL

KEFTAB

LILLY EQ 250MG BASE N050614 001 Oct 29, 1987

EQ 333MG BASE N050614 003 May 16, 1988

EQ 500MG BASE N050614 002 Oct 29, 1987


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-80(of 393)

** See List Footnote



CEPHALOGLYCIN

CAPSULE;ORAL

KAFOCIN

LILLY
250MG
N050219 001

CEPHALOTHIN SODIUM

INJECTABLE;INJECTION

CEPHALOTHIN

INTL MEDICATION
EQ 500MG BASE/VIAL
A062426 001 May 03, 1985

EQ 1GM BASE/VIAL
A062426 002 May 03, 1985

EQ 2GM BASE/VIAL
A062426 003 May 03, 1985

EQ 4GM BASE/VIAL
A062426 004 May 03, 1985

CEPHALOTHIN SODIUM

ABBOTT
EQ 1GM BASE/VIAL
A062547 001 Sep 11, 1985

EQ 1GM BASE/VIAL
A062548 001 Sep 11, 1985

EQ 2GM BASE/VIAL
A062547 002 Sep 11, 1985

EQ 2GM BASE/VIAL
A062548 002 Sep 11, 1985

ABRAXIS PHARM
EQ 1GM BASE/VIAL
A062666 002 Jun 10, 1987

EQ 2GM BASE/VIAL
A062666 001 Jun 10, 1987

BRISTOL
EQ 1GM BASE/VIAL
A062464 001 May 07, 1984

EQ 2GM BASE/VIAL
A062464 002 May 07, 1984

EQ 4GM BASE/VIAL
A062464 003 May 07, 1984

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

BAXTER HLTHCARE EQ 20MG BASE/ML


A062422 003 Jan 31, 1984

EQ 20MG BASE/ML
A062422 005 Jul 16, 1991

EQ 20MG BASE/ML
A062730 001 Mar 05, 1987

EQ 40MG BASE/ML
A062422 004 Jan 31, 1984

EQ 40MG BASE/ML
A062422 006 Jul 16, 1991

EQ 40MG BASE/ML
A062730 002 Mar 05, 1987

CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER

BAXTER HLTHCARE
EQ 20MG BASE/ML
A062422 001 Jan 31, 1984

EQ 40MG BASE/ML
A062422 002 Jan 31, 1984

KEFLIN

LILLY
EQ 1GM BASE/VIAL
N050482 001

EQ 2GM BASE/VIAL
N050482 002

EQ 4GM BASE/VIAL
N050482 003

EQ 20GM BASE/VIAL
N050482 007

KEFLIN IN PLASTIC CONTAINER

LILLY
EQ 1GM BASE/VIAL
A062549 001 Sep 10, 1985

EQ 2GM BASE/VIAL
A062549 002 Sep 10, 1985

SEFFIN

GLAXOSMITHKLINE
EQ 1GM BASE/VIAL
A062435 001 Nov 15, 1983

EQ 2GM BASE/VIAL
A062435 002 Nov 15, 1983

EQ 10GM BASE/VIAL
A062435 003 Nov 15, 1983

CEPHAPIRIN SODIUM

INJECTABLE;INJECTION

CEFADYL

APOTHECON
EQ 500MG BASE/VIAL
A062961 001 Sep 20, 1988

EQ 500MG BASE/VIAL
N050446 005

EQ 1GM BASE/VIAL
A061769 001

EQ 1GM BASE/VIAL
A062724 001 Dec 23, 1986

EQ 1GM BASE/VIAL
A062961 002 Sep 20, 1988

EQ 1GM BASE/VIAL
N050446 001

EQ 2GM BASE/VIAL
A061769 002

EQ 2GM BASE/VIAL
A062724 002 Dec 23, 1986

EQ 2GM BASE/VIAL
A062961 003 Sep 20, 1988

EQ 2GM BASE/VIAL
N050446 002

EQ 4GM BASE/VIAL
A061769 003

EQ 4GM BASE/VIAL
A062961 004 Sep 20, 1988

EQ 4GM BASE/VIAL
N050446 003

EQ 20GM BASE/VIAL
N050446 004

CEPHAPIRIN SODIUM

ABRAXIS PHARM
EQ 500MG BASE/VIAL
A062723 001 Nov 17, 1986

EQ 1GM BASE/VIAL
A062723 002 Nov 17, 1986

EQ 2GM BASE/VIAL
A062723 003 Nov 17, 1986

EQ 4GM BASE/VIAL
A062723 004 Nov 17, 1986

EQ 20GM BASE/VIAL
A062723 005 Nov 17, 1986

WEST-WARD PHARMS INT
EQ 500MG BASE/VIAL
A062720 001 Jul 02, 1987

EQ 1GM BASE/VIAL
A062720 002 Jul 02, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-81(of 393)

** See List Footnote



CEPHAPIRIN SODIUM

INJECTABLE;INJECTION

CEPHAPIRIN SODIUM

EQ 2GM BASE/VIAL
A062720 003 Jul 02, 1987

EQ 20GM BASE/VIAL
A062720 004 Jul 02, 1987

CEPHRADINE

CAPSULE;ORAL

ANSPOR

GLAXOSMITHKLINE 250MG
A061859 001

500MG
A061859 002

CEPHRADINE

BARR 250MG
A062850 001 Apr 22, 1988

500MG
A062851 001 Apr 22, 1988

IVAX SUB TEVA PHARMS 250MG


A062762 001 Mar 06, 1987

500MG
A062762 002 Mar 06, 1987

TEVA 250MG
A062683 001 Jan 09, 1987

500MG
A062683 002 Jan 09, 1987

VITARINE 250MG
A062813 001 Feb 25, 1988

500MG
A062813 002 Feb 25, 1988

VELOSEF

APOTHECON 250MG
A061764 001

500MG
A061764 002

VELOSEF '250'

ERSANA 250MG
N050548 001

VELOSEF '500'

ERSANA 500MG
N050548 002

FOR SUSPENSION;ORAL

ANSPOR

GLAXOSMITHKLINE 125MG/5ML
A061866 001

250MG/5ML
A061866 002

CEPHRADINE

BARR 125MG/5ML
A062858 001 May 19, 1988

250MG/5ML
A062859 001 May 19, 1988

TEVA 125MG/5ML
A062693 001 Jan 09, 1987

250MG/5ML
A062693 002 Jan 09, 1987

VELOSEF '125'

APOTHECON 125MG/5ML
A061763 001

VELOSEF '250'

APOTHECON 250MG/5ML
A061763 002

INJECTABLE;INJECTION

VELOSEF

APOTHECON 250MG/VIAL
A061976 001

500MG/VIAL
A061976 002

1GM/VIAL
A061976 004

2GM/VIAL
A061976 003

4GM/VIAL
A061976 005

TABLET;ORAL

VELOSEF

BRISTOL MYERS SQUIBB 1GM
N050530 001

CERIVASTATIN SODIUM

TABLET;ORAL

BAYCOL

BAYER PHARMS 0.05MG
N020740 001 Jun 26, 1997

0.1MG
N020740 002 Jun 26, 1997

0.2MG
N020740 003 Jun 26, 1997

0.3MG
N020740 004 Jun 26, 1997

0.4MG
N020740 005 May 24, 1999

0.8MG
N020740 006 Jul 24, 2000

CERULETIDE DIETHYLAMINE

INJECTABLE;INJECTION

TYMTRAN

PHARMACIA AND UPJOHN 0.02MG/ML
N018296 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-82(of 393)

** See List Footnote


CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 5MG/5ML A078617 001 Feb 02, 2010
APOTEX INC 5MG/5ML A078412 001 Jun 18, 2008
AUROBINDO PHARMA LTD 5MG/5ML A090751 001 Dec 16, 2009
RANBAXY LABS LTD 5MG/5ML A077472 001 Jun 18, 2008
WOCKHARDT 5MG/5ML A078757 001 Aug 28, 2009
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 5MG/5ML A090378 002 May 09, 2008
APOTEX INC 5MG/5ML A090188 002 Apr 22, 2008
CYPRESS PHARM 5MG/5ML A090300 001 Oct 10, 2008
RANBAXY LABS LTD 5MG/5ML A090183 002 Apr 24, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC 5MG/5ML A090378 001 May 09, 2008
APOTEX INC 5MG/5ML A090188 001 Apr 22, 2008
CYPRESS PHARM 5MG/5ML A090300 002 Oct 10, 2008
RANBAXY LABS LTD 5MG/5ML A090183 001 Apr 24, 2008
ZYRTEC
J AND J CONSUMER INC 5MG/5ML ** N020346 001 Sep 27, 1996
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH 5MG A078615 003 Dec 28, 2007
10MG A078615 004 Dec 28, 2007
ZYRTEC ALLERGY
+ J AND J CONSUMER INC 5MG N019835 003 Nov 16, 2007
ZYRTEC HIVES RELIEF
+ J AND J CONSUMER INC 5MG N019835 005 Nov 16, 2007
+ 10MG N019835 006 Nov 16, 2007
TABLET, CHEWABLE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
SUN PHARM INDS INC 5MG A077631 004 Jan 11, 2008
10MG A077631 003 Jan 11, 2008
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARM INDS INC 5MG A077631 001 Jan 11, 2008
10MG A077631 002 Jan 11, 2008
CHILDREN'S ZYRTEC ALLERGY
+ J AND J CONSUMER INC 5MG ** N021621 003 Nov 16, 2007
+ 10MG ** N021621 004 Nov 16, 2007
CHILDREN'S ZYRTEC HIVES RELIEF
+ J AND J CONSUMER INC 5MG ** N021621 005 Nov 16, 2007
+ 10MG ** N021621 006 Nov 16, 2007
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
EMD SERONO INC EQ 3MG BASE/ML N021197 002 Aug 11, 2000
CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
FOR SUSPENSION;INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE 12MG/VIAL;108MG/VIAL;8MG/VIAL N020044 001 Aug 02, 1990
CEVIMELINE HYDROCHLORIDE
CAPSULE;ORAL
CEVIMELINE HYDROCHLORIDE
APOTEX INC 30MG A091260 001 Aug 25, 2011
CHENODIOL
TABLET;ORAL
CHENIX
+ LEADIANT BIOSCI INC 250MG ** N018513 002 Jul 28, 1983
CHLOPHEDIANOL HYDROCHLORIDE
SYRUP;ORAL
ULO
3M 25MG/5ML N012126 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-83(of 393)

** See List Footnote



CHLORAMPHENICOL

CREAM;TOPICAL

CHLOROMYCETIN

PARKE DAVIS
1%
N050183 001

FOR SOLUTION;OPHTHALMIC

CHLOROMYCETIN

PARKEDALE
25MG/VIAL
N050143 001

INJECTABLE;INJECTION

CHLOROMYCETIN

PARKE DAVIS
250MG/ML
N050153 001

OINTMENT;OPHTHALMIC

CHLORAMPHENICOL

ALTANA
1%
A060133 001

CHLOROFAIR

PHARMAFAIR
1%
A062439 001 Apr 21, 1983

CHLOROMYCETIN

PARKEDALE
1%
N050156 001

CHLOROPTIC S.O.P.

ALLERGAN
1%
A061187 001

ECONOCHLOR

ALCON
1%
A061648 001

SOLUTION/DROPS;OPHTHALMIC

CHLORAMPHENICOL

AKORN
0.5%
A062042 001

ALCON
0.5%
A062628 001 Sep 25, 1985

CHLOROFAIR

PHARMAFAIR
0.5%
A062437 001 Apr 14, 1983

CHLOROPTIC

ALLERGAN
0.5%
N050091 001

ECONOCHLOR

ALCON
0.5%
A061645 001

OPHTHOCHLOR

PARKEDALE
0.5%
A061220 001

OPTOMYCIN

OPTOPICS
0.5%
A062171 001 Mar 31, 1982

SOLUTION/DROPS;OTIC

CHLOROMYCETIN

PARKEDALE
0.5%
N050205 001

CHLORAMPHENICOL SODIUM SUCCINATE

INJECTABLE;INJECTION

CHLORAMPHENICOL

ELKINS SINN EQ 1GM BASE/VIAL
A062406 001 Nov 09, 1982

CHLORAMPHENICOL SODIUM SUCCINATE

GRUPPO LEPETIT EQ 1GM BASE/VIAL
A062278 001

CHLOROMYCETIN

+ PARKEDALE EQ 1GM BASE/VIAL
N050155 001

MYCHEL-S

ANGUS EQ 1GM BASE/VIAL
A060132 001

CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN

OINTMENT;TOPICAL

ELASE-CHLOROMYCETIN

PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM
N050294 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE

FOR SUSPENSION;OPHTHALMIC

CHLOROMYCETIN HYDROCORTISONE

PARKEDALE 12.5MG/VIAL;25MG/VIAL
N050202 001

CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

OPHTHOCORT

PARKEDALE 10MG/GM;5MG/GM;10,000 UNITS/GM
N050201 002

CHLORAMPHENICOL; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

CHLOROMYXIN

PARKE DAVIS 1%;10,000 UNITS/GM
N050203 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-84(of 393)

** See List Footnote



CHLORAMPHENICOL; PREDNISOLONE

OINTMENT;OPHTHALMIC

CHLOROPTIC-P S.O.P.

ALLERGAN 1%;0.5% A061188 001

CHLORDIAZEPOXIDE

CAPSULE, EXTENDED RELEASE;ORAL

LIBRELEASE

VALEANT PHARM INTL 30MG N017813 001 Sep 12, 1983

TABLET;ORAL

LIBRITABS

VALEANT PHARM INTL 5MG A085482 001

10MG A085481 001

25MG A085488 001

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

A-POXIDE

ABBOTT 5MG A085447 001

5MG A085517 001

10MG A085447 002

10MG A085518 001

25MG A085447 003

25MG A085513 001

CHLORDIAZACHEL

RACHELLE 5MG A085086 001

10MG A084639 001

25MG A085087 001

CHLORDIAZEPOXIDE HYDROCHLORIDE

ASCOT 5MG A087525 001 Jan 07, 1982

10MG A087524 001 Jan 07, 1982

25MG A087512 001 Jan 07, 1982

FERRANTE 5MG A085118 001

10MG A085119 001

25MG A085120 001

HALSEY 5MG A085340 001

10MG A085339 001

25MG A084685 001

IMPAX LABS 5MG A086213 001

10MG A085113 001

25MG A086212 001

IVAX SUB TEVA PHARMS 5MG A083741 001

10MG A083742 001

25MG A083570 001

LEDERLE 5MG A086892 001

5MG A087234 001

10MG A086876 001

10MG A087037 001

25MG A086893 001

25MG A087231 001

MAST MM 10MG A086217 001

MYLAN 5MG A084886 001

10MG A084601 001

25MG A084887 001

PARKE DAVIS 5MG A085163 001

10MG A084598 001

25MG A085164 001

PIONEER PHARMS 10MG A089533 001 Jul 15, 1988

25MG A089558 001 Jul 15, 1988

PUREPAC PHARM 5MG A085155 001

10MG A084939 002

25MG A085144 001

ROXANE 5MG A084706 001

10MG A084700 001

25MG A084705 001

SUPERPHARM 5MG A088987 001 Apr 25, 1985

10MG A088986 001 Apr 25, 1985

25MG A088988 001 Apr 25, 1985

TEVA 5MG A088705 001 Jan 18, 1985



10MG A088706 001 Jan 18, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-85(of 393)

** See List Footnote



CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL

CHLORDIAZEPOXIDE HYDROCHLORIDE

25MG
A086494 001

25MG
A088707 001 Jan 18, 1985

UPSHER SMITH LABS
5MG
A084678 001

10MG
A084041 001

25MG
A084679 002

UPSHER-SMITH LABS
5MG
A084919 001

10MG
A084920 001

25MG
A084823 001

USL PHARMA
5MG
A084644 001

10MG
A084623 001

25MG
A084645 001

VANGARD
5MG
A088129 001 Mar 28, 1983

10MG
A088010 001 Mar 28, 1983

25MG
A088130 001 Mar 28, 1983

WATSON LABS
5MG
A086383 001

10MG
A086294 001

25MG
A086382 001

WEST WARD
5MG
A085014 001

10MG
A085000 001

25MG
A085294 001

LIBRIUM

+ VALEANT PHARM INTL 5MG **
N012249 002

+ 10MG **
N012249 001

+ 25MG **
N012249 003

LYGEN
ALRA 5MG
A085107 001

10MG
A085009 001

25MG
A085108 001

INJECTABLE;INJECTION

LIBRIUM

VALEANT PHARMS LLC
100MG/AMP
N012301 001

CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED

TABLET;ORAL

MENRIUM 10-4

ROCHE
10MG;0.4MG
N014740 006

MENRIUM 5-2

ROCHE
5MG;0.2MG
N014740 002

MENRIUM 5-4

ROCHE
5MG;0.4MG
N014740 004

CHLORHEXIDINE GLUCONATE

SOLUTION;DENTAL

CHLORHEXIDINE GLUCONATE

BAJAJ
0.12%
A075561 001 Nov 14, 2000

SOLUTION;TOPICAL

DYNA-HEX

BAJAJ
0.75%
N020111 001 Sep 11, 1997

EXIDINE

XTTRIUM
2.5%
N019421 001 Dec 17, 1985

MICRODERM

J AND J
4%
A072255 001 Apr 15, 1991

PREVACARE R

J AND J
0.5%
A072292 001 Jan 28, 1992

STERI-STAT

MATRIX MEDCL
4%
A070104 001 Jul 24, 1986

SPONGE;TOPICAL

CHLORHEXIDINE GLUCONATE

KENDALL IL
4%
N019490 001 Mar 27, 1987

E-Z SCRUB

BECTON DICKINSON
4%
A073416 001 Mar 14, 2000

HIBICLENS

+ MOLNLYCKE HLTH
4% **
N018423 001

MICRODERM

J AND J
4%
A072295 001 Feb 28, 1991

PHARMASEAL SCRUB CARE

CAREFUSION 2200
4%
N019793 001 Dec 02, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-86(of 393)

** See List Footnote



CHLORMERODRIN HG-197

INJECTABLE;INJECTION

CHLORMERODRIN HG 197

BRACCO
0.6-1.4mCi/ML
N017269 001

CHLORMEZANONE

TABLET;ORAL

TRANCOPAL

SANOFI AVENTIS US
100MG
N011467 003

200MG
N011467 005

CHLOROPROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

NESACAINE-MPF

FRESENIUS KABI USA
2%
N009435 003

3%
N009435 004

CHLOROQUINE HYDROCHLORIDE

INJECTABLE;INJECTION

ARALEN HYDROCHLORIDE

SANOFI AVENTIS US
EQ 40MG BASE/ML
N006002 002

CHLOROQUINE PHOSPHATE

TABLET;ORAL

ARALEN

+ SANOFI AVENTIS US
EQ 300MG BASE
N006002 001

CHLOROQUINE PHOSPHATE

IMPAX LABS
EQ 150MG BASE
A080880 001

EQ 300MG BASE
A040516 001 Aug 29, 2003

MD PHARM
EQ 150MG BASE
A087228 001

PUREPAC PHARM
EQ 150MG BASE
A080886 001

TEVA
EQ 150MG BASE
A087504 001 Jan 13, 1982

WATSON LABS
EQ 150MG BASE
A087979 001 Dec 21, 1982

EQ 300MG BASE
A088030 001 Dec 21, 1982

CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE

TABLET;ORAL

ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE

SANOFI AVENTIS US
EQ 300MG BASE;EQ 45MG BASE
N014860 002

CHLOROTHIAZIDE

TABLET;ORAL

CHLOROTHIAZIDE

ABC HOLDING
250MG
A085569 001

HIKMA INTL PHARMS
250MG
A086028 001 Jul 14, 1982

500MG
A087736 001 Jul 14, 1982

LEDERLE
250MG
A086940 001

500MG
A086938 001

SANDOZ
250MG
A085485 001

WATSON LABS
250MG
A085165 001

250MG
A085173 001

250MG
A086795 001 Aug 15, 1983

500MG
A084026 001 Sep 01, 1982

500MG
A086796 001 Aug 15, 1983

DIURIL

+ OAK PHARMS AKORN
250MG **
N011145 004

+
500MG **
N011145 002

CHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

ALDOCLOR-150

MERCK
150MG;250MG
N016016 001

ALDOCLOR-250

MERCK
250MG;250MG
N016016 002

METHYLDOPA AND CHLOROTHIAZIDE

PAR PHARM 150MG;250MG
A070783 001 Nov 06, 1987

250MG;250MG
A070654 001 Nov 06, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-87(of 393)

** See List Footnote



CHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

CHLOROTHIAZIDE AND RESERPINE

HIKMA PHARMS 250MG;0.125MG
A088557 001 Dec 22, 1983

500MG;0.125MG
A088365 001 Dec 22, 1983

CHLOROTHIAZIDE W/ RESERPINE

WATSON LABS
250MG;0.125MG
A084853 001

500MG;0.125MG
A088151 001 Jun 09, 1983

CHLOROTHIAZIDE-RESERPINE

MYLAN
250MG;0.125MG
A087744 001 May 06, 1982

500MG;0.125MG
A087745 001 May 06, 1982

DIUPRES-250

MERCK
250MG;0.125MG
N011635 003 Aug 26, 1987

DIUPRES-500

MERCK
500MG;0.125MG
N011635 006 Aug 26, 1987

CHLOROTRIANISENE

CAPSULE;ORAL

CHLOROTRIANISENE

BANNER PHARMACAPS
12MG
A084652 001

TACE

SANOFI AVENTIS US
12MG
N008102 004

25MG
N011444 001

72MG
N016235 001

CHLOROXINE

SHAMPOO;TOPICAL

CAPITROL

WESTWOOD SQUIBB
2%
N017594 001

CHLORPHENESIN CARBAMATE

TABLET;ORAL

MAOLATE

PAMLAB LLC
400MG
N014217 002

CHLORPHENIRAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

CHLORPHENIRAMINE MALEATE

AUROLIFE PHARMA LLC
12MG
A070797 001 Aug 12, 1988

TELDRIN

GLAXOSMITHKLINE
8MG
N017369 001

12MG
N017369 002

INJECTABLE;INJECTION

CHLOR-TRIMETON

SCHERING PLOUGH
10MG/ML
N008826 001

100MG/ML
N008794 001

CHLORPHENIRAMINE MALEATE

BEL MAR
10MG/ML
A080821 001

ELKINS SINN
10MG/ML
A080797 001

WATSON LABS
10MG/ML
A083593 001

10MG/ML
A086096 001

100MG/ML
A086095 001

PYRIDAMAL 100

BEL MAR
100MG/ML
A083733 001

SYRUP;ORAL

CHLOR-TRIMETON

SCHERING
2MG/5ML
N006921 006

CHLORPHENIRAMINE MALEATE

PHARM ASSOC
2MG/5ML
A087520 001 Feb 10, 1982

TABLET;ORAL

ANTAGONATE

BAYER PHARMS
4MG
A083381 001

CHLOR-TRIMETON

SCHERING
4MG
N006921 002

CHLORPHENIRAMINE MALEATE

ANABOLIC
4MG
A083078 001

AUROLIFE PHARMA LLC
4MG
A080961 001

BELL PHARMA
4MG
A083062 001

ELKINS SINN
4MG
A080938 001

IMPAX LABS
4MG
A080809 001

IVAX SUB TEVA PHARMS 4MG
A080779 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-88(of 393)

** See List Footnote



CHLORPHENIRAMINE MALEATE

TABLET;ORAL

CHLORPHENIRAMINE MALEATE

KV PHARM 4MG A087164 001

LEDERLE 4MG A086941 001

NEWTRON PHARMS 4MG A086519 001

PANRAY 4MG A083243 001

PHARMAVITE 4MG A085104 001

PHARMERAL 4MG A083753 001

PIONEER PHARMS 4MG A088556 001 Jul 13, 1984

PUREPAC PHARM 4MG A086306 001

PVT FORM 4MG A080786 001

ROXANE 4MG A080626 001

SUN PHARM INDUSTRIES 4MG A080700 001

VITARINE 4MG A085837 001

WATSON LABS 4MG A080696 001

4MG A080791 001

4MG A085139 001

WEST WARD 4MG A083787 001

KLOROMIN

HALSEY 4MG A083629 001

PHENETRON

LANNETT 4MG A080846 001

TABLET, EXTENDED RELEASE;ORAL

CHLOR-TRIMETON

BAYER HEALTHCARE LLC 8MG N007638 001

EFIDAC 24 CHLORPHENIRAMINE MALEATE

ALZA 16MG N019746 002 Nov 18, 1994

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE

TRIS PHARMA INC 4MG/5ML;5MG/5ML A206438 001 Jan 27, 2015

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

BIO-PHARM INC 4MG/5ML;5MG/5ML;60MG/5ML A206660 001 May 15, 2017

TRIS PHARMA INC 4MG/5ML;5MG/5ML;60MG/5ML A203838 001 Nov 26, 2014



CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

COLD CAPSULE IV

GRAHAM DM 12MG;75MG N018793 001 Apr 25, 1985

COLD CAPSULE V

GRAHAM DM 8MG;75MG N018794 001 Apr 23, 1985

TABLET, EXTENDED RELEASE;ORAL



TRIAMINIC-12

NOVARTIS 12MG;75MG N018115 001

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CODIMAL-L.A. 12

SCHWARZ PHARMA 12MG;120MG N018935 001 Apr 15, 1985

ISOCLOR

FISONS 8MG;120MG N018747 001 Mar 06, 1986

PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

CENT PHARMS 8MG;120MG N019428 001 Aug 02, 1988

GRAHAM DM 8MG;120MG N018844 001 Mar 20, 1985



12MG;120MG N018843 001 Mar 18, 1985

KV PHARM 12MG;120MG A071455 001 Mar 01, 1989

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

CHLOR-TRIMETON

+ BAYER HEALTHCARE LLC 8MG;120MG N018397 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-89(of 393)

** See List Footnote



CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

CODEPREX
LANNETT CO INC EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML N021369 001 Jun 21, 2004
PENNTUSS
FISONS EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML N018928 001 Aug 14, 1985
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

TUSSIONEX PENNKINETIC

+ UCB INC EQ 8MG MALEATE/5ML;EQ 10MG N019111 001 Dec 31, 1987

BITARTRATE/5ML

CHLORPHENTERMINE HYDROCHLORIDE

TABLET;ORAL

PRE-SATE

PARKE DAVIS EQ 65MG BASE N014696 001

CHLORPROMAZINE

SUPPOSITORY;RECTAL

THORAZINE

+ GLAXOSMITHKLINE 25MG ** N009149 024

+ 100MG ** N009149 033

CHLORPROMAZINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

THORAZINE

GLAXOSMITHKLINE 30MG N011120 016

75MG N011120 017

150MG N011120 018

200MG N011120 019

300MG N011120 020

CONCENTRATE;ORAL

CHLORPROMAZINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC 100MG/ML A086863 001

PHARM ASSOC 30MG/ML A040231 001 Dec 30, 1999

100MG/ML A040224 001 Jan 26, 1999

WOCKHARDT 30MG/ML A087032 001 Jul 08, 1982

100MG/ML A087053 001

CHLORPROMAZINE HYDROCHLORIDE INTENSOL

CYCLE PHARMS LTD 30MG/ML A088157 001 Apr 27, 1983

100MG/ML A088158 001 Apr 27, 1983

SONAZINE

FOSUN PHARMA 30MG/ML A080983 004

100MG/ML A080983 005

THORAZINE

+ GLAXOSMITHKLINE 30MG/ML ** N009149 032

+ 100MG/ML ** N009149 043

INJECTABLE;INJECTION

CHLORPROMAZINE HYDROCHLORIDE

ABRAXIS PHARM 25MG/ML A084911 001

MARSAM PHARMS LLC 25MG/ML A089563 001 Apr 15, 1988

WATSON LABS 25MG/ML A080365 001



25MG/ML A085591 001

WYETH AYERST 25MG/ML A080370 001

THORAZINE

+ GLAXOSMITHKLINE 25MG/ML ** N009149 011

SYRUP;ORAL

CHLORPROMAZINE HYDROCHLORIDE

ALPHARMA US PHARMS 10MG/5ML A086712 001

SONAZINE

FOSUN PHARMA 10MG/5ML A083040 001

THORAZINE

+ GLAXOSMITHKLINE 10MG/5ML ** N009149 022

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

ABBOTT 10MG A084414 001

25MG A084415 001

50MG A084411 001

100MG A084412 001

200MG A084413 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-90(of 393)

** See List Footnote



CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

CYCLE PHARMS LTD 10MG
A085331 001

25MG
A085331 002

50MG
A085331 003

100MG
A085331 004

200MG
A085331 005

IVAX SUB TEVA PHARMS 10MG
A083549 001

25MG
A083549 002

50MG
A083549 003

100MG
A083574 001

200MG
A083575 001

KV PHARM 10MG
A085750 002 Jan 04, 1982

25MG
A085751 001

50MG
A085484 001

100MG
A085752 001

200MG
A085748 002 Jan 04, 1982

LEDERLE 10MG
A084803 001

25MG
A084801 001

50MG
A084800 001

100MG
A084789 001

200MG
A084802 001

PUREPAC PHARM 10MG
A080403 004

25MG
A080403 001

50MG
A080403 002

100MG
A080403 003

200MG
A080403 005

PVT FORM 25MG
A080340 001

50MG
A080340 002

200MG
A080340 003

SANDOZ 10MG **
A080439 001

25MG **
A080439 002

50MG **
A080439 003

100MG **
A080439 004

200MG **
A080439 005

VANGARD 10MG
A088038 001 Aug 16, 1982

25MG
A087645 001

50MG
A087646 001

WATSON LABS 10MG
A085959 001

25MG
A085956 001

50MG
A085960 001

100MG
A085957 001

200MG
A085958 001

WEST WARD 10MG
A087783 001 Sep 16, 1982

25MG
A087865 001 Sep 16, 1982

50MG
A087878 001 Sep 15, 1982

100MG
A087884 001 Sep 15, 1982

200MG
A087880 001 Sep 16, 1982

PROMAPAR

PARKE DAVIS 10MG
A086886 001

25MG
A084423 001

50MG
A086887 001

100MG
A086888 001

200MG
A086885 001

THORAZINE

GLAXOSMITHKLINE 10MG **
N009149 002

25MG **
N009149 007

50MG **
N009149 013

100MG **
N009149 018

200MG **
N009149 020

CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

ANI PHARMS INC 100MG
A088768 001 Oct 11, 1984

100MG
A088812 001 Oct 19, 1984

100MG
A088840 001 Oct 25, 1984

100MG
A088918 001 Oct 16, 1984

100MG
A088921 001 Apr 12, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-91(of 393)

** See List Footnote



CHLORPROPAMIDE

TABLET;ORAL

CHLORPROPAMIDE

100MG
A089446 001 Nov 17, 1986

250MG
A087353 001

250MG
A088813 001 Oct 19, 1984

250MG
A088919 001 Oct 16, 1984

250MG
A088922 001 Apr 12, 1985

250MG
A089447 001 Nov 17, 1986

AUROLIFE PHARMA LLC 100MG
A088725 001 Aug 31, 1984

250MG
A088726 001 Aug 31, 1984

DAVA PHARMS INC 100MG


A089561 001 Sep 04, 1987

250MG
A089562 001 Sep 04, 1987

HALSEY 100MG
A089321 001 Jan 16, 1986

250MG
A088662 001 Jan 09, 1986

PAR PHARM 100MG
A088175 001 Feb 27, 1984

250MG
A088176 001 Feb 27, 1984

SANDOZ 250MG
A084669 001

SUPERPHARM 100MG
A088694 001 Sep 17, 1984

250MG
A088695 001 Sep 17, 1984

USL PHARMA 100MG


A088708 001 Aug 30, 1984

250MG
A088709 001 Aug 30, 1984

WATSON LABS 100MG


A086865 001 Sep 24, 1984

100MG
A088608 001 Apr 12, 1984

250MG
A086866 001

250MG
A088568 001 Apr 12, 1984

WATSON LABS TEVA 100MG


A088852 001 Sep 26, 1984

250MG
A088826 001 Sep 26, 1984

DIABINESE

+ PFIZER 100MG
N011641 003

+ 250MG
N011641 006

GLUCAMIDE

ANI PHARMS INC 250MG
A088641 001 Oct 11, 1984

CHLORPROTHIXENE

CONCENTRATE;ORAL

TARACTAN

ROCHE 100MG/5ML
N016149 002

INJECTABLE;INJECTION

TARACTAN

ROCHE 12.5MG/ML
N012487 001

TABLET;ORAL

TARACTAN

ROCHE 10MG
N012486 005

25MG
N012486 004

50MG
N012486 003

100MG
N012486 001

CHLORTETRACYCLINE HYDROCHLORIDE

OINTMENT;OPHTHALMIC

AUREOMYCIN

LEDERLE 1%
N050404 001

CHLORTHALIDONE

TABLET;ORAL

CHLORTHALIDONE

ABBOTT 25MG
A087364 001

50MG
A087384 001

ASCOT 25MG
A087698 001 Oct 20, 1982

50MG
A087699 001 Oct 20, 1982

BARR LABS INC 25MG
A088902 001 Sep 19, 1985

50MG
A088903 001 Sep 19, 1985

DAVA PHARMS INC 25MG


A087451 001

50MG
A087450 001

G AND W LABS INC 50MG
A088651 001 May 30, 1985

IVAX PHARMS 25MG


A087555 001

25MG
A088164 001 Jan 09, 1984

50MG
A087176 001

50MG
A087947 001 Feb 27, 1984

KV PHARM 25MG
A087311 001

50MG
A087312 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-92(of 393)

** See List Footnote



CHLORTHALIDONE

TABLET;ORAL

CHLORTHALIDONE

MUTUAL PHARM
25MG
A087292 001

25MG
A089738 001 Sep 19, 1988

50MG
A087293 001

50MG
A089739 001 Sep 19, 1988

PIONEER PHARMS
50MG
A089591 001 Jul 21, 1988

PUREPAC PHARM
25MG
A088139 001 Jul 16, 1986

50MG
A088140 001 Aug 11, 1983

SANDOZ
25MG
A087380 001

50MG
A087118 001

50MG
A087381 001

SUPERPHARM
25MG
A087473 001 Feb 09, 1983

50MG
A087247 001 Feb 09, 1983

USL PHARMA
25MG
A089051 001 Jun 01, 1987

50MG
A089052 001 Jun 01, 1987

VANGARD
25MG
A088012 001 Jul 14, 1982

50MG
A088073 001 Mar 25, 1983

WARNER CHILCOTT
25MG
A087515 001 Jan 24, 1983

50MG
A087516 001 Feb 09, 1983

WATSON LABS
25MG
A087050 001

25MG
A087100 001

25MG
A087296 001

25MG
A087706 001

50MG
A087029 001

50MG
A087082 001

50MG
A087521 001

50MG
A087689 001

HYGROTON

+ SANOFI AVENTIS US
25MG **
N012283 004

+
50MG **
N012283 003

THALITONE

+ CASPER PHARMA LLC
15MG **
N019574 001 Dec 20, 1988

25MG
N019574 002 Feb 12, 1992

MONARCH PHARMS
25MG
A088051 001 Nov 12, 1982

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

TABLET;ORAL

CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE

PAR PHARM 15MG;0.1MG
A071179 001 Dec 16, 1987

15MG;0.2MG
A071178 001 Dec 16, 1987

15MG;0.3MG
A071142 001 Dec 16, 1987

CLORPRES

MYLAN 15MG;0.1MG
A071325 003 Feb 09, 1987

15MG;0.2MG
A071325 002 Feb 09, 1987

15MG;0.3MG
A071325 001 Feb 09, 1987

COMBIPRES

+ BOEHRINGER INGELHEIM 15MG;0.1MG **
N017503 001

+ 15MG;0.2MG **
N017503 002

+ 15MG;0.3MG **
N017503 003 Apr 10, 1984

CHLORTHALIDONE; METOPROLOL TARTRATE

CAPSULE;ORAL

LOPRESSIDONE

NOVARTIS
25MG;100MG
N019451 001 Dec 31, 1987

25MG;200MG
N019451 002 Dec 31, 1987

CHLORTHALIDONE; RESERPINE

TABLET;ORAL

DEMI-REGROTON

SANOFI AVENTIS US
25MG;0.125MG
N015103 002

REGROTON

SANOFI AVENTIS US
50MG;0.25MG
N015103 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-93(of 393)

** See List Footnote



CHLORZOXAZONE

TABLET;ORAL

CHLORZOXAZONE

ACTAVIS ELIZABETH
250MG
A088928 001 May 08, 1987

500MG
A040113 001 Sep 29, 1995

AUROLIFE PHARMA LLC


250MG
A089852 001 May 04, 1988

500MG
A089853 001 May 04, 1988

BARR
500MG
A089895 001 May 04, 1988

OHM LABS
250MG
A081298 001 Dec 29, 1993

500MG
A081299 001 Dec 29, 1993

PAR PHARM
250MG
A087981 001 Sep 20, 1983

PIONEER PHARMS
250MG
A089592 001 Jan 06, 1989

500MG
A089948 001 Jan 06, 1989

SUN PHARM INDUSTRIES
500MG
A089970 001 Sep 27, 1990

WATSON LABS
250MG
A086901 001

250MG
A086948 001 Aug 09, 1982

500MG
A040137 001 Aug 09, 1996

500MG
A081019 001 Jul 29, 1991

500MG
A081040 001 Aug 22, 1989

PARAFLEX

+ ORTHO MCNEIL PHARM
250MG **
N011300 003

PARAFON FORTE DSC

+ JANSSEN R AND D
500MG **
N011529 002 Jun 15, 1987

STRIFON FORTE DSC

FERNDALE LABS
500MG
A081008 001 Dec 23, 1988

CHOLESTYRAMINE

BAR, CHEWABLE;ORAL

CHOLYBAR

PARKE DAVIS
EQ 4GM RESIN/BAR
A071621 001 May 26, 1988

EQ 4GM RESIN/BAR
A071739 001 May 26, 1988

POWDER;ORAL

CHOLESTYRAMINE

IVAX SUB TEVA PHARMS
EQ 4GM RESIN/PACKET
A074771 001 Jul 09, 1997

EQ 4GM RESIN/SCOOPFUL
A074771 002 Jul 09, 1997

TEVA
EQ 4GM RESIN/PACKET
A074347 001 May 28, 1998

EQ 4GM RESIN/SCOOPFUL
A074347 002 May 28, 1998

CHOLESTYRAMINE LIGHT

TEVA
EQ 4GM RESIN/PACKET
A074348 001 May 28, 1998

EQ 4GM RESIN/SCOOPFUL
A074348 002 May 28, 1998

TEVA PHARMS
EQ 4GM RESIN/PACKET
A074555 001 Sep 30, 1998

EQ 4GM RESIN/SCOOPFUL
A074555 002 Sep 30, 1998

LOCHOLEST

SANDOZ
EQ 4GM RESIN/PACKET
A074561 001 Aug 15, 1996

EQ 4GM RESIN/SCOOPFUL
A074561 002 Aug 15, 1996

LOCHOLEST LIGHT

SANDOZ
EQ 4GM RESIN/PACKET
A074562 001 Aug 15, 1996

EQ 4GM RESIN/SCOOPFUL
A074562 002 Aug 15, 1996

QUESTRAN

+ BRISTOL MYERS
EQ 4GM RESIN/PACKET **
N016640 001

+
EQ 4GM RESIN/SCOOPFUL **
N016640 003

QUESTRAN LIGHT

+ BRISTOL MYERS
EQ 4GM RESIN/PACKET **
N019669 001 Dec 05, 1988

+
EQ 4GM RESIN/SCOOPFUL **
N019669 003 Dec 05, 1988

TABLET;ORAL

QUESTRAN

APOTHECON
EQ 800MG RESIN
A073403 002 Dec 27, 1999

EQ 1GM RESIN
A073403 001 Apr 28, 1994

CHORIOGONADOTROPIN ALFA

INJECTABLE;INJECTION

OVIDREL

EMD SERONO
0.25MG/VIAL
N021149 001 Sep 20, 2000

CHROMIC CHLORIDE

INJECTABLE;INJECTION

CHROMIC CHLORIDE

ABRAXIS PHARM
EQ 0.004MG CHROMIUM/ML
N019271 001 May 05, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-94(of 393)

** See List Footnote



CHROMIC PHOSPHATE P-32

INJECTABLE;INJECTION

PHOSPHOCOL P32

MALLINKRODT NUCLEAR
5mCi/ML
N017084 001

CHYMOPAPAIN

INJECTABLE;INJECTION

CHYMODIACTIN

CHART MEDCL
4,000 UNITS/VIAL
N018663 002 Aug 21, 1984

+
10,000 UNITS/VIAL **
N018663 001 Nov 10, 1982

DISCASE

ABBOTT
12,500 UNITS/VIAL
N018625 001 Jan 18, 1984

CHYMOTRYPSIN

FOR SOLUTION;OPHTHALMIC

ALPHA CHYMAR

SOLA BARNES HIND
750 UNITS/VIAL
N011837 001

CATARASE

CIBA
300 UNITS/VIAL
N016938 001

NOVARTIS
150 UNITS/VIAL
N018121 001

ZOLYSE

ALCON
750 UNITS/VIAL
N011903 001

CICLOPIROX

SOLUTION;TOPICAL

CICLOPIROX

MYLAN PHARMS INC
8%
A078567 001 Sep 18, 2007

TEVA PHARMS
8%
A078079 001 Sep 18, 2007

CIDOFOVIR

INJECTABLE;INJECTION

VISTIDE

+ GILEAD SCIENCES INC
EQ 75MG BASE/ML **
N020638 001 Jun 26, 1996

CILASTATIN SODIUM; IMIPENEM

INJECTABLE;INJECTION

PRIMAXIN

MERCK
EQ 250MG BASE/VIAL;250MG/VIAL
A062756 001 Jan 08, 1987

EQ 500MG BASE/VIAL;500MG/VIAL
A062756 002 Jan 08, 1987

POWDER;INTRAMUSCULAR

PRIMAXIN

MERCK
EQ 500MG BASE/VIAL;500MG/VIAL
N050630 001 Dec 14, 1990

EQ 750MG BASE/VIAL;750MG/VIAL
N050630 002 Dec 14, 1990

POWDER;INTRAVENOUS

IMIPENEM AND CILASTATIN

HOSPIRA INC
EQ 250MG BASE/VIAL;250MG/VIAL
A090825 001 Nov 16, 2011

PRIMAXIN

+ MERCK
EQ 250MG BASE/VIAL;250MG/VIAL
N050587 001 Nov 26, 1985

CILOSTAZOL

TABLET;ORAL

CILOSTAZOL

ACTAVIS ELIZABETH
100MG
A077028 002 Nov 26, 2004

EPIC PHARMA LLC
50MG
A077150 001 Mar 11, 2005

100MG
A077022 001 Nov 23, 2004

IVAX SUB TEVA PHARMS
100MG
A077020 002 Mar 01, 2005

MYLAN
50MG
A077323 002 Apr 20, 2006

100MG
A077323 001 Apr 20, 2006

MYLAN PHARMS INC


50MG
A077019 001 Nov 23, 2004

100MG
A077019 002 Nov 23, 2004

PLIVA HRVATSKA DOO
50MG
A077898 001 Oct 29, 2007

100MG
A077898 002 Oct 29, 2007

PLETAL

+ OTSUKA
50MG **
N020863 001 Jan 15, 1999

+
100MG **
N020863 002 Jan 15, 1999

CIMETIDINE

SUSPENSION;ORAL

TAGAMET HB 200

GLAXOSMITHKLINE
200MG/20ML
N020951 001 Jul 09, 1999

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-95(of 393)

** See List Footnote



CIMETIDINE

TABLET;ORAL

CIMETIDINE

CHARTWELL MOLECULES
200MG
A074329 002 May 17, 1994

300MG
A074329 003 May 17, 1994

400MG
A074329 004 May 17, 1994

800MG
A074329 001 May 17, 1994

CONTRACT PHARMACAL
200MG
A074961 001 Jun 19, 1998

200MG
A074963 001 Jun 19, 1998

CYCLE PHARMS LTD
300MG
A074361 001 Dec 23, 1994

400MG
A074361 002 Dec 23, 1994

800MG
A074371 001 Dec 23, 1994

DAVA PHARMS INC
300MG
A074340 001 Jun 23, 1995

400MG
A074340 002 Jun 23, 1995

800MG
A074339 001 Jun 23, 1995

IVAX SUB TEVA PHARMS
200MG
A074401 001 May 30, 1995

200MG
A074424 001 Jul 28, 1995

300MG
A074401 002 May 30, 1995

300MG
A074424 002 Jul 28, 1995

400MG
A074401 003 May 30, 1995

400MG
A074424 003 Jul 28, 1995

800MG
A074402 001 May 30, 1995

800MG
A074424 004 Jul 28, 1995

PERRIGO
100MG
A074972 001 Jun 19, 1998

PLIVA
200MG
A074568 001 Feb 27, 1997

300MG
A074568 002 Feb 27, 1997

400MG
A074568 003 Feb 27, 1997

SANDOZ INC
100MG
A075122 001 Jun 19, 1998

200MG
A074250 001 Jun 29, 1995

200MG
A075122 002 Jun 19, 1998

300MG
A074250 002 Jun 29, 1995

400MG
A074250 003 Jun 29, 1995

800MG
A074250 004 Jun 29, 1995

TEVA
200MG
A074365 001 Feb 28, 1995

300MG
A074365 002 Feb 28, 1995

400MG
A074365 003 Feb 28, 1995

800MG
A074365 004 Feb 28, 1995

UPSHER SMITH LABS
200MG
A074506 001 Jan 24, 1996

300MG
A074506 002 Jan 24, 1996

400MG
A074506 003 Jan 24, 1996

800MG
A074506 004 Jan 24, 1996

WATSON LABS INC
200MG
A074349 001 Aug 30, 1996

300MG
A074349 002 Aug 30, 1996

400MG
A074349 003 Aug 30, 1996

800MG
A074316 001 Feb 28, 1996

WATSON LABS TEVA
200MG
A075425 001 Jul 29, 1999

YAOPHARMA CO LTD
200MG
A074100 001 Jan 31, 1995

300MG
A074100 002 Jan 31, 1995

400MG
A074100 003 Jan 31, 1995

800MG
A074100 004 Jan 31, 1995

TAGAMET

GLAXOSMITHKLINE
200MG **
N017920 002

300MG **
N017920 003

400MG **
N017920 004 Dec 14, 1983

800MG **
N017920 005 Apr 30, 1986

TAGAMET HB

+ MEDTECH PRODUCTS
100MG **
N020238 001 Jun 19, 1995

CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CIMETIDINE HYDROCHLORIDE

HOSPIRA
EQ 300MG BASE/2ML
A074296 001 Mar 28, 1997

EQ 300MG BASE/2ML
A074344 001 Jan 31, 1995

EQ 300MG BASE/2ML
A074345 001 Jan 31, 1995

EQ 300MG BASE/2ML
A074412 001 Mar 28, 1997

EQ 300MG BASE/2ML
A074422 001 Jan 31, 1995

LUITPOLD
EQ 300MG BASE/2ML
A074353 001 Dec 20, 1994

TEVA PARENTERAL
EQ 300MG BASE/2ML
A074252 001 Nov 26, 1997

VINTAGE PHARMS LLC
EQ 300MG BASE/2ML
A074005 001 Aug 31, 1994

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-96(of 393)

** See List Footnote



CIMETIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

HOSPIRA EQ 6MG BASE/ML A074269 001 Dec 27, 1994

EQ 90MG BASE/100ML A074468 005 Dec 29, 1994

EQ 120MG BASE/100ML A074468 006 Dec 29, 1994

EQ 180MG BASE/100ML A074468 003 Dec 29, 1994

EQ 240MG BASE/100ML A074468 004 Dec 29, 1994

EQ 360MG BASE/100ML A074468 001 Dec 29, 1994

EQ 480MG BASE/100ML A074468 002 Dec 29, 1994

TAGAMET

GLAXOSMITHKLINE EQ 300MG BASE/2ML ** N017939 002

TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ GLAXOSMITHKLINE EQ 6MG BASE/ML ** N019434 001 Oct 31, 1985

SOLUTION;ORAL

CIMETIDINE HYDROCHLORIDE

ANI PHARMS INC EQ 300MG BASE/5ML A074859 001 Jul 09, 1998

EQ 300MG BASE/5ML A075110 001 Jun 18, 1998

APOTEX INC EQ 300MG BASE/5ML A075560 001 Mar 15, 2000

CYCLE PHARMS LTD EQ 300MG BASE/5ML A074541 001 Aug 05, 1997

G AND W LABS INC EQ 300MG BASE/5ML A074176 001 Jun 01, 1994

LANNETT CO INC EQ 300MG BASE/5ML A074251 001 Dec 22, 1994

TAGAMET

GLAXOSMITHKLINE EQ 300MG BASE/5ML ** N017924 001

CINOXACIN

CAPSULE;ORAL

CINOBAC

LILLY 250MG N018067 001

500MG N018067 002

CINOXACIN

TEVA 250MG A073005 001 Feb 28, 1992

500MG A073006 001 Feb 28, 1992

CIPROFLOXACIN

INJECTABLE;INJECTION

CIPRO

+ BAYER HLTHCARE 400MG/40ML (10MG/ML) ** N019847 001 Dec 26, 1990

+ 200MG/20ML (10MG/ML) ** N019847 002 Dec 26, 1990

1200MG/120ML (10MG/ML) ** N019847 003 Dec 26, 1990

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER

+ BAYER HLTHCARE 200MG/100ML ** N019857 001 Dec 26, 1990

+ 400MG/200ML ** N019857 002 Dec 26, 1990

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAYER PHARMS 200MG/100ML N019858 001 Dec 26, 1990

CIPROFLOXACIN

BEDFORD LABS 200MG/20ML (10MG/ML) A076992 001 Aug 28, 2006

400MG/40ML (10MG/ML) A076992 002 Aug 28, 2006

1200MG/120ML (10MG/ML) A076993 001 Aug 28, 2006

FRESENIUS KABI USA 200MG/20ML (10MG/ML) A076484 001 Aug 28, 2006

400MG/40ML (10MG/ML) A076484 002 Aug 28, 2006

TEVA PHARMS USA 200MG/20ML (10MG/ML) A077782 001 Aug 28, 2006

400MG/40ML (10MG/ML) A077782 002 Aug 28, 2006

CIPROFLOXACIN IN DEXTROSE 5%

HIKMA FARMACEUTICA 200MG/100ML A076757 001 Apr 21, 2008

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER



BAXTER HLTHCARE 200MG/100ML A077888 001 Mar 18, 2008

400MG/200ML A077888 002 Mar 18, 2008

BEDFORD 200MG/100ML A078114 001 Mar 18, 2008

400MG/200ML A078114 002 Mar 18, 2008

TEVA PHARMS 200MG/100ML A077138 001 Mar 18, 2008

400MG/200ML A077138 002 Mar 18, 2008

CIPROFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CIPROFLOXACIN HYDROCHLORIDE

AMRING PHARMS EQ 0.3% BASE A078598 001 Jan 16, 2008

APOTEX INC EQ 0.3% BASE A075928 001 Jun 09, 2004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-97(of 393)

** See List Footnote



CIPROFLOXACIN HYDROCHLORIDE

TABLET;ORAL

CIPRO

+ BAYER HLTHCARE
EQ 100MG BASE
N019537 001 Apr 08, 1996

+
EQ 750MG BASE
N019537 004 Oct 22, 1987

CIPROFLOXACIN HYDROCHLORIDE

ANI PHARMS INC
EQ 100MG BASE
A075939 001 Mar 03, 2005

EQ 250MG BASE
A075939 002 Jun 09, 2004

EQ 500MG BASE
A075939 003 Jun 09, 2004

EQ 750MG BASE
A075939 004 Jun 09, 2004

BARR
EQ 250MG BASE
A074124 001 Jun 09, 2004

EQ 500MG BASE
A074124 002 Jun 09, 2004

EQ 750MG BASE
A074124 003 Jun 09, 2004

FOSUN PHARMA
EQ 250MG BASE
A076593 002 Jun 09, 2004

EQ 500MG BASE
A076593 003 Jun 09, 2004

EQ 750MG BASE
A076593 004 Jun 09, 2004

MYLAN
EQ 100MG BASE
A075817 001 Jun 25, 2007

EQ 250MG BASE
A075685 002 Jun 09, 2004

EQ 250MG BASE
A075817 002 Jun 09, 2004

EQ 500MG BASE
A075685 003 Jun 09, 2004

EQ 750MG BASE
A075685 001 Jun 09, 2004

EQ 750MG BASE
A075817 004 Jun 09, 2004

NOSTRUM LABS
EQ 250MG BASE
A076138 001 Jun 09, 2004

EQ 500MG BASE
A076138 002 Jun 09, 2004

EQ 750MG BASE
A076138 003 Jun 09, 2004

PLIVA
EQ 100MG BASE
A076426 001 Jun 15, 2005

EQ 250MG BASE
A076426 002 Jun 15, 2005

EQ 500MG BASE
A076426 003 Jun 15, 2005

EQ 750MG BASE
A076426 004 Jun 15, 2005

SUN PHARM INDS LTD
EQ 250MG BASE
A075747 001 Jun 09, 2004

EQ 500MG BASE
A075747 002 Jun 09, 2004

EQ 750MG BASE
A075747 003 Jun 09, 2004

TEVA
EQ 250MG BASE
A076136 001 Jun 09, 2004

EQ 500MG BASE
A076136 002 Jun 09, 2004

EQ 750MG BASE
A076136 003 Jun 09, 2004

TABLET, EXTENDED RELEASE;ORAL

PROQUIN XR

DEPOMED INC
EQ 500MG BASE
N021744 001 May 19, 2005

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CIPRO XR

BAYER HLTHCARE 212.6MG;EQ 287.5MG BASE **
N021473 001 Dec 13, 2002

425.2MG;EQ 574.9MG BASE **
N021473 002 Aug 28, 2003

CIPROFLOXACIN EXTENDED RELEASE

ACTAVIS LABS FL INC 212.6MG;EQ 287.5MG BASE
A077417 001 Nov 30, 2010

425.2MG;EQ 574.9MG BASE
A077809 001 Nov 30, 2010

DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE
A077701 002 Oct 31, 2007

FOSUN PHARMA 212.6MG;EQ 287.5MG BASE
A078712 001 Dec 11, 2007

CISAPRIDE MONOHYDRATE

SUSPENSION;ORAL

PROPULSID

JANSSEN PHARMS EQ 1MG BASE/ML
N020398 001 Sep 15, 1995

TABLET;ORAL

PROPULSID

JANSSEN PHARMS EQ 10MG BASE
N020210 001 Jul 29, 1993

EQ 20MG BASE
N020210 002 Dec 23, 1993

TABLET, ORALLY DISINTEGRATING;ORAL

PROPULSID QUICKSOLV

JANSSEN PHARMA EQ 20MG BASE
N020767 001 Nov 07, 1997

CISATRACURIUM BESYLATE

INJECTABLE;INJECTION

CISATRACURIUM BESYLATE

HOSPIRA INC EQ 2MG BASE/ML
A203236 001 Mar 30, 2018

EQ 2MG BASE/ML
A203238 001 Mar 30, 2018

EQ 10MG BASE/ML
A203236 002 Mar 30, 2018

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-98(of 393)

** See List Footnote



CISPLATIN

INJECTABLE;INJECTION

CISPLATIN

BEDFORD 10MG/VIAL A074713 001 Nov 14, 2000

50MG/VIAL A074713 002 Nov 14, 2000

TEVA PHARMS USA 1MG/ML A074814 001 May 16, 2000

PLATINOL

+ HQ SPCLT PHARMA 10MG/VIAL N018057 001

+ 50MG/VIAL N018057 002

PLATINOL-AQ

+ HQ SPCLT PHARMA 0.5MG/ML N018057 003 Jul 18, 1984

CITALOPRAM HYDROBROMIDE

CAPSULE;ORAL

CITALOPRAM HYDROBROMIDE

MYLAN PHARMS INC EQ 10MG BASE A077668 001 Feb 28, 2007

EQ 20MG BASE A077668 002 Feb 28, 2007

EQ 40MG BASE A077668 003 Feb 28, 2007

SOLUTION;ORAL

CELEXA

+ FOREST LABS EQ 10MG BASE/5ML ** N021046 001 Dec 22, 1999

CITALOPRAM HYDROBROMIDE

APOTEX INC EQ 10MG BASE/5ML A077601 001 Nov 15, 2005

TABLET;ORAL

CELEXA

ALLERGAN SALES LLC EQ 60MG BASE N020822 004 Jul 17, 1998

CITALOPRAM HYDROBROMIDE

ACTAVIS ELIZABETH EQ 10MG BASE A077033 001 Oct 28, 2004

EQ 20MG BASE A077033 002 Oct 28, 2004

EQ 40MG BASE A077033 003 Oct 28, 2004

EPIC PHARMA LLC EQ 10MG BASE A077036 001 Oct 28, 2004

EQ 20MG BASE A077036 002 Oct 28, 2004

EQ 40MG BASE A077036 003 Oct 28, 2004

FOSUN PHARMA EQ 10MG BASE A077035 001 Oct 28, 2004

EQ 10MG BASE A077040 001 Aug 17, 2005

EQ 20MG BASE A077035 002 Oct 28, 2004



EQ 20MG BASE A077040 002 Aug 17, 2005

EQ 40MG BASE A077035 003 Oct 28, 2004



EQ 40MG BASE A077040 003 Aug 17, 2005

MYLAN EQ 10MG BASE A077039 001 Feb 03, 2005



EQ 20MG BASE A077039 002 Feb 03, 2005

EQ 40MG BASE A077039 003 Feb 03, 2005

MYLAN PHARMS INC EQ 10MG BASE A077037 001 Nov 05, 2004

EQ 20MG BASE A077037 002 Nov 05, 2004

EQ 40MG BASE A077037 003 Nov 05, 2004

NATCO PHARMA LTD EQ 20MG BASE A077141 002 Apr 10, 2008

EQ 40MG BASE A077141 001 Apr 10, 2008

ROXANE EQ 10MG BASE A077041 001 Nov 23, 2004



EQ 20MG BASE A077041 002 Nov 23, 2004

EQ 40MG BASE A077041 003 Nov 23, 2004

SUN PHARM INDUSTRIES EQ 10MG BASE A077052 001 Jul 03, 2006

EQ 20MG BASE A077052 002 Jul 03, 2006

EQ 40MG BASE A077052 003 Jul 03, 2006

TARO EQ 10MG BASE A077278 001 Mar 22, 2006

EQ 20MG BASE A077278 002 Mar 22, 2006

EQ 40MG BASE A077278 003 Mar 22, 2006

TEVA PHARMS EQ 10MG BASE A077213 001 Mar 31, 2006

EQ 20MG BASE A077213 002 Mar 31, 2006

EQ 40MG BASE A077213 003 Mar 31, 2006

WATSON LABS EQ 10MG BASE A077034 001 Jun 30, 2005

EQ 20MG BASE A077034 002 Jun 30, 2005

EQ 40MG BASE A077034 003 Jun 30, 2005

TABLET, ORALLY DISINTEGRATING;ORAL

CITALOPRAM HYDROBROMIDE

BIOVAIL LABS INTL EQ 10MG BASE N021763 001 Dec 20, 2005

EQ 20MG BASE N021763 002 Dec 20, 2005

EQ 40MG BASE N021763 003 Dec 20, 2005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-99(of 393)

** See List Footnote



CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE

SOLUTION;IRRIGATION

IRRIGATING SOLUTION G IN PLASTIC CONTAINER

BAXTER HLTHCARE 3.24GM/100ML;380MG/100ML;430MG/100ML N018519 001 Jun 22, 1982

UROLOGIC G IN PLASTIC CONTAINER

HOSPIRA 3.24GM/100ML;380MG/100ML;430MG/100ML N018904 001 May 27, 1983

CLADRIBINE

INJECTABLE;INJECTION

LEUSTATIN

+ JANSSEN PHARMS 1MG/ML ** N020229 001 Feb 26, 1993

CLARITHROMYCIN

FOR SUSPENSION;ORAL

BIAXIN

+ ABBVIE 125MG/5ML N050698 001 Dec 23, 1993
187MG/5ML N050698 003 Sep 30, 1998
+ 250MG/5ML N050698 002 Dec 23, 1993
CLARITHROMYCIN
SUN PHARM INDS LTD 125MG/5ML A065382 001 Aug 30, 2007
250MG/5ML A065382 002 Aug 30, 2007
TABLET;ORAL
BIAXIN
+ ABBVIE 250MG ** N050662 001 Oct 31, 1991
+ 500MG ** N050662 002 Oct 31, 1991
CLARITHROMYCIN
IVAX SUB TEVA PHARMS 250MG A065137 001 May 31, 2005
500MG A065137 002 May 31, 2005
MYLAN 250MG A065195 001 Mar 11, 2005
500MG A065195 002 Mar 11, 2005
SUN PHARM INDS LTD 250MG A065174 001 Sep 24, 2004
500MG A065174 002 Sep 24, 2004
TABLET, EXTENDED RELEASE;ORAL
BIAXIN XL
+ ABBVIE 500MG ** N050775 001 Mar 03, 2000
CLARITHROMYCIN
ANI PHARMS INC 500MG A065250 001 Aug 25, 2005
RANBAXY 1GM A065210 001 Jan 26, 2005
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

INJECTABLE;INJECTION

TIMENTIN

GLAXOSMITHKLINE EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL A062691 001 Dec 19, 1986

EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 001 Apr 01, 1985

EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 002 Apr 01, 1985

EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL N050590 003 Aug 18, 1987

TIMENTIN IN PLASTIC CONTAINER



GLAXOSMITHKLINE EQ 100MG BASE/100ML;EQ 3GM BASE/100ML N050658 001 Dec 15, 1989

CLEMASTINE FUMARATE

SYRUP;ORAL

CLEMASTINE FUMARATE

ACTAVIS MID ATLANTIC EQ 0.5MG BASE/5ML A074075 001 Oct 31, 1993

APOTEX INC EQ 0.5MG BASE/5ML A075703 001 Nov 27, 2000

LANNETT CO INC EQ 0.5MG BASE/5ML A074884 001 Dec 17, 1997

TEVA PHARMS EQ 0.5MG BASE/5ML A073095 001 Apr 21, 1992

WOCKHARDT BIO AG EQ 0.5MG BASE/5ML A074863 001 Mar 13, 1998



TAVIST

+ NOVARTIS EQ 0.5MG BASE/5ML ** N018675 001 Jun 28, 1985

TABLET;ORAL

CLEMASTINE FUMARATE

ANI PHARMS INC 1.34MG A073282 001 Jan 31, 1992

1.34MG A073282 002 Dec 03, 1992

PLD ACQUISITIONS LLC 1.34MG A073458 001 Oct 31, 1993

SANDOZ 2.68MG A073459 001 Oct 31, 1993

TAVIST

+ NOVARTIS 2.68MG N017661 001

TAVIST-1

+ GLAXOSMITHKLINE CONS 1.34MG N020925 001 Aug 21, 1992

NOVARTIS 1.34MG N017661 002



1.34MG N017661 003 Aug 21, 1992

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-100(of 393)
** See List Footnote
CLEVIDIPINE
EMULSION;INTRAVENOUS
CLEVIPREX
+ CHIESI USA INC 125MG/250ML (0.5MG/ML) N022156 003 Nov 08, 2013
CLIDINIUM BROMIDE
CAPSULE;ORAL
QUARZAN
ROCHE 2.5MG N010355 001
5MG N010355 002
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN

PHARMACIA AND UPJOHN EQ 75MG BASE A061809 001

EQ 150MG BASE A061809 002

CLINDAMYCIN HYDROCHLORIDE

MYLAN PHARMS INC EQ 75MG BASE A091225 001 May 31, 2011

EQ 150MG BASE A091225 002 May 31, 2011

EQ 300MG BASE A091225 003 May 31, 2011

TEVA EQ 75MG BASE A063027 001 Sep 20, 1989

WATSON LABS EQ 75MG BASE A063082 001 Jul 31, 1991



CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION;ORAL

CLEOCIN

PHARMACIA AND UPJOHN EQ 75MG BASE/5ML ** A061827 001

CLINDAMYCIN PHOSPHATE

CREAM;VAGINAL

CLEOCIN

PHARMACIA AND UPJOHN EQ 2% BASE N050680 001 Aug 11, 1992

INJECTABLE;INJECTION

CLEOCIN PHOSPHATE

PHARMACIA AND UPJOHN EQ 150MG BASE/ML A061839 001

CLINDAMYCIN PHOSPHATE

ABRAXIS PHARM EQ 150MG BASE/ML A062747 001 Jun 03, 1988

BEDFORD EQ 150MG BASE/ML A063163 001 Jun 30, 1994

BRISTOL MYERS SQUIBB EQ 150MG BASE/ML A062908 001 Feb 01, 1989

IGI LABS INC EQ 150MG BASE/ML A062928 001 Feb 13, 1989

LOCH EQ 150MG BASE/ML A062905 001 May 09, 1988

MARSAM PHARMS LLC EQ 150MG BASE/ML A062913 001 Oct 20, 1988

SOLOPAK EQ 150MG BASE/ML A062819 001 Mar 15, 1988

EQ 150MG BASE/ML A062852 001 Mar 17, 1988

TEVA PARENTERAL EQ 150MG BASE/ML A063041 001 Dec 29, 1989

EQ 150MG BASE/ML A063282 001 May 29, 1992

WATSON LABS EQ 150MG BASE/ML A062900 001 Jun 08, 1988



EQ 150MG BASE/ML A063079 001 Mar 05, 1990

WEST-WARD PHARMS INT EQ 150MG BASE/ML A062806 001 Oct 15, 1987

EQ 150MG BASE/ML A062953 001 Apr 21, 1988

EQ 150MG BASE/ML A063068 001 Aug 28, 1989

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%



ABRAXIS PHARM EQ 12MG BASE/ML N050636 001 Dec 22, 1989

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT LABS EQ 6MG BASE/ML A065027 001 Jun 29, 2001

EQ 12MG BASE/ML A065027 002 Jun 29, 2001

EQ 18MG BASE/ML A065027 003 Jun 29, 2001

BAXTER HLTHCARE EQ 6MG BASE/ML N050648 001 Dec 29, 1989

EQ 12MG BASE/ML N050648 002 Dec 29, 1989

EQ 900MG BASE/100ML N050648 003 Dec 29, 1989

SOLUTION;TOPICAL

CLEOCIN T

PHARMACIA AND UPJOHN EQ 1% BASE A062363 001 Feb 08, 1982

CLINDAMYCIN PHOSPHATE

BOCA PHARMA LLC EQ 1% BASE A062944 001 Jan 11, 1989

NOVAST LABS EQ 1% BASE A064108 001 Sep 27, 1996

VINTAGE PHARMS EQ 1% BASE A062930 001 Jun 28, 1989



WOCKHARDT BIO AG EQ 1% BASE A063304 001 Jul 15, 1997

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-101(of 393)

** See List Footnote



CLIOQUINOL; NYSTATIN

OINTMENT;TOPICAL

NYSTAFORM

BAYER PHARMS
10MG/GM;100,000 UNITS/GM
N050235 001

CLOBAZAM

TABLET;ORAL

ONFI

LUNDBECK PHARMS LLC 5MG
N202067 001 Oct 21, 2011

CLOBETASOL PROPIONATE

CREAM;TOPICAL

CLOBETASOL PROPIONATE

TEVA PHARMS USA 0.05%
A074087 001 Feb 16, 1994

CLOBETASOL PROPIONATE (EMOLLIENT)

NOVAST LABS
0.05%
A075733 001 Aug 22, 2001

TEMOVATE

+ FOUGERA PHARMS
0.05% **
N019322 001 Dec 27, 1985

TEMOVATE E

+ FOUGERA PHARMS
0.05% **
N020340 001 Jun 17, 1994

GEL;TOPICAL

TEMOVATE

+ FOUGERA PHARMS
0.05% **
N020337 001 Apr 29, 1994

OINTMENT;TOPICAL

CLOBETASOL PROPIONATE

ACTAVIS MID ATLANTIC
0.05%
A074128 001 Aug 03, 1994

TEMOVATE

+ FOUGERA PHARMS
0.05% **
N019323 001 Dec 27, 1985

SOLUTION;TOPICAL

TEMOVATE

+ FOUGERA PHARMS
0.05% **
N019966 001 Feb 22, 1990

SPRAY;TOPICAL

CLOBETASOL PROPIONATE

APOTEX INC
0.05%
A210446 001 Apr 17, 2018

CLOFAZIMINE

CAPSULE;ORAL

LAMPRENE

+ NOVARTIS
50MG
N019500 002 Dec 15, 1986

100MG
N019500 001 Dec 15, 1986

CLOFIBRATE

CAPSULE;ORAL

ATROMID-S

WYETH AYERST
500MG
N016099 002

CLOFIBRATE

BANNER PHARMACAPS
500MG
A073396 001 Mar 20, 1992

SANDOZ
500MG
A072191 001 May 02, 1988

TEVA
500MG
A072600 001 Jul 25, 1991

USL PHARMA
500MG
A070531 001 Jun 16, 1986

WATSON LABS
500MG
A071603 001 Sep 18, 1987

CLOMIPHENE CITRATE

TABLET;ORAL

CLOMID

+ SANOFI AVENTIS US
50MG
N016131 002

MILOPHENE

MILEX
50MG
A072196 001 Dec 20, 1988

SEROPHENE

EMD SERONO
50MG
N018361 001 Mar 22, 1982

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

TEVA
25MG
A074849 001 Apr 04, 1997

50MG
A074849 002 Apr 04, 1997

75MG
A074849 003 Apr 04, 1997

WATSON LABS
25MG
A074600 001 Nov 27, 1996

25MG
A074751 001 Sep 30, 1998

50MG
A074600 002 Nov 27, 1996

50MG
A074751 002 Sep 30, 1998

75MG
A074600 003 Nov 27, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-102(of 393)

** See List Footnote



CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

75MG
A074751 003 Sep 30, 1998

CLONAZEPAM

TABLET;ORAL

CLONAZEPAM

APOTEX INC
0.5MG
A075468 001 Oct 06, 2000

1MG
A075468 002 Oct 06, 2000

2MG
A075468 003 Oct 06, 2000

MYLAN PHARMS INC
0.5MG
A074940 001 Oct 30, 1997

1MG
A074940 002 Oct 30, 1997

2MG
A074940 003 Oct 30, 1997

SANDOZ
0.5MG
A074925 001 Sep 30, 1997

1MG
A074925 002 Sep 30, 1997

2MG
A074925 003 Sep 30, 1997

TEVA
0.5MG
A074920 001 Aug 04, 1998

1MG
A074920 002 Aug 04, 1998

2MG
A074920 003 Aug 04, 1998

KLONOPIN

ROCHE
0.125MG
N017533 005 Apr 09, 1997

0.25MG
N017533 006 Apr 09, 1997

TABLET, ORALLY DISINTEGRATING;ORAL

KLONOPIN RAPIDLY DISINTEGRATING

+ ROCHE 0.125MG **
N020813 001 Dec 23, 1997

+ 0.25MG **
N020813 002 Dec 23, 1997

+ 0.5MG **
N020813 003 Dec 23, 1997

+ 1MG **
N020813 004 Dec 23, 1997

+ 2MG **
N020813 005 Dec 23, 1997

CLONIDINE

SUSPENSION, EXTENDED RELEASE;ORAL

CLONIDINE

TRIS PHARMA INC
EQ 0.09MG BASE/ML
N022499 001 Dec 03, 2009

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE

TRIS PHARMA INC
EQ 0.17MG BASE
N022500 001 Dec 03, 2009

EQ 0.26MG BASE
N022500 002 Dec 03, 2009

CLONIDINE HYDROCHLORIDE

TABLET;ORAL

CLONIDINE HYDROCHLORIDE

AM THERAP
0.1MG
A070881 001 Jul 08, 1986

0.2MG
A070882 001 Jul 08, 1986

0.3MG
A070883 001 Jul 08, 1986

AUROLIFE PHARMA LLC
0.1MG
A070886 002 Aug 31, 1988

0.2MG
A070886 001 Aug 31, 1988

0.3MG
A070886 003 Aug 31, 1988

CHARTWELL MOLECULES
0.1MG
A071785 002 Apr 05, 1988

0.2MG
A071785 003 Apr 05, 1988

0.3MG
A071785 001 Apr 05, 1988

DURAMED PHARMS BARR


0.1MG
A071103 001 Aug 14, 1986

0.2MG
A071102 001 Aug 14, 1986

0.3MG
A071101 001 Aug 14, 1986

INTERPHARM
0.1MG
A071252 001 Oct 01, 1986

0.2MG
A071253 001 Oct 01, 1986

0.3MG
A071254 001 Oct 01, 1986

PAR PHARM
0.1MG
A070461 001 Jul 08, 1986

0.2MG
A070460 001 Jul 08, 1986

0.3MG
A070459 001 Jul 08, 1986

TEVA
0.1MG
A070747 001 Jul 08, 1986

0.2MG
A070702 001 Jul 08, 1986

0.3MG
A070659 001 Jul 08, 1986

WARNER CHILCOTT
0.1MG
A072138 001 Jun 13, 1988

0.2MG
A072139 001 Jun 13, 1988

0.3MG
A072140 001 Jun 13, 1988

WATSON LABS
0.1MG
A070395 001 Mar 23, 1987

0.1MG
A070965 001 Jul 08, 1986

0.2MG
A070396 001 Mar 23, 1987

0.2MG
A070964 001 Jul 08, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-103(of 393)

** See List Footnote



CLONIDINE HYDROCHLORIDE

TABLET;ORAL

CLONIDINE HYDROCHLORIDE

0.3MG A070397 001 Mar 23, 1987

0.3MG A070963 001 Jul 08, 1986

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE

ACTAVIS ELIZABETH 0.2MG A202792 002 May 15, 2015

0.2MG A203320 002 May 15, 2015

ANCHEN PHARMS 0.1MG A202983 001 Apr 02, 2014

0.2MG A202983 002 Apr 02, 2014

0.2MG A202984 002 Sep 30, 2013

JENLOGA

+ CONCORDIA PHARMS INC 0.1MG ** N022331 001 Sep 30, 2009

+ 0.2MG ** N022331 002 May 25, 2010

KAPVAY

+ CONCORDIA PHARMS INC 0.2MG ** N022331 004 Sep 28, 2010

CLOPIDOGREL BISULFATE

TABLET;ORAL

CLOPIDOGREL BISULFATE

ACTAVIS TOTOWA EQ 75MG BASE A090307 001 May 28, 2013

CLORAZEPATE DIPOTASSIUM

CAPSULE;ORAL

CLORAZEPATE DIPOTASSIUM

ABLE 3.75MG A071777 001 Jul 14, 1987

7.5MG A071778 001 Jul 14, 1987

15MG A071779 001 Jul 14, 1987

AM THERAP 3.75MG A071429 001 Jun 23, 1987

7.5MG A071430 001 Jun 23, 1987

15MG A071431 001 Jun 23, 1987

AUROLIFE PHARMA LLC 3.75MG A072112 002 Aug 11, 2017

7.5MG A072112 003 Aug 11, 2017

15MG A072112 001 Aug 26, 1988

DAVA PHARMS INC 3.75MG A071742 001 Dec 14, 1987



7.5MG A071743 001 Dec 14, 1987

15MG A071744 001 Dec 14, 1987

GD SEARLE LLC 3.75MG A071727 001 Dec 18, 1987

7.5MG A071728 001 Dec 18, 1987

15MG A071729 001 Dec 18, 1987

MYLAN 3.75MG A071509 001 Oct 19, 1987

7.5MG A071510 001 Oct 19, 1987

15MG A071511 001 Oct 19, 1987

PUREPAC PHARM 3.75MG A071924 001 Apr 25, 1988

7.5MG A071925 001 Apr 25, 1988

15MG A071926 001 Apr 25, 1988

QUANTUM PHARMICS 3.75MG A071549 001 Sep 12, 1988

7.5MG A071550 001 Sep 12, 1988

15MG A071522 001 Sep 12, 1988

USL PHARMA 3.75MG A071242 001 Jun 23, 1987



7.5MG A071243 001 Jun 23, 1987

15MG A071244 001 Jun 23, 1987

WARNER CHILCOTT 3.75MG A071774 001 Mar 01, 1988

7.5MG A071775 001 Mar 01, 1988

15MG A071776 001 Mar 01, 1988

WATSON LABS 3.75MG A071878 001 Mar 15, 1988

7.5MG A071879 001 Mar 15, 1988

15MG A071860 001 Mar 15, 1988

TRANXENE

RECORDATI RARE 3.75MG ** N017105 001

7.5MG ** N017105 002

15MG ** N017105 003

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

ABLE 3.75MG A071780 001 Jun 26, 1987

7.5MG A071781 001 Jun 26, 1987

15MG A071782 001 Jun 26, 1987

AM THERAP 3.75MG A071747 001 Jun 23, 1987

7.5MG A071748 001 Jun 23, 1987

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

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** See List Footnote



CLORAZEPATE DIPOTASSIUM

TABLET;ORAL

CLORAZEPATE DIPOTASSIUM

15MG A071749 001 Jun 23, 1987

AUROLIFE PHARMA LLC 3.75MG A072512 001 May 11, 1990

7.5MG A072513 001 May 11, 1990

15MG A072514 001 May 11, 1990

LEDERLE 3.75MG A072013 001 Dec 15, 1987



7.5MG A072014 001 Dec 15, 1987

15MG A072015 001 Dec 15, 1987

PUREPAC PHARM 3.75MG A072330 001 Aug 08, 1988

7.5MG A072331 001 Aug 08, 1988

15MG A072332 001 Aug 08, 1988

QUANTUM PHARMICS 3.75MG A071730 001 Oct 26, 1987



7.5MG A071731 001 Oct 26, 1987

15MG A071702 001 Oct 26, 1987

SUN PHARM INDS LTD 3.75MG A076911 001 Sep 29, 2004

7.5MG A076911 002 Sep 29, 2004

15MG A076911 003 Sep 29, 2004

WARNER CHILCOTT 3.75MG A071828 001 Mar 03, 1988



7.5MG A071829 001 Mar 03, 1988

15MG A071830 001 Mar 03, 1988

WATSON LABS 3.75MG A071852 001 Feb 09, 1988

7.5MG A071853 001 Feb 09, 1988

15MG A071854 001 Feb 09, 1988

TRANXENE

RECORDATI RARE 3.75MG ** N017105 006

+ 15MG ** N017105 008

TRANXENE SD

RECORDATI RARE 11.25MG ** N017105 005

22.5MG ** N017105 004

CLOTRIMAZOLE

CREAM;TOPICAL

LOTRIMIN

SCHERING PLOUGH 1% ** N017619 001

MYCELEX

BAYER HEALTHCARE LLC 1% N018183 001

CREAM;VAGINAL

GYNE-LOTRIMIN

+ BAYER HEALTHCARE LLC 1% ** N018052 002 Nov 30, 1990

GYNE-LOTRIMIN 3

+ BAYER HEALTHCARE LLC 2% N020574 001 Nov 24, 1998

MYCELEX-7

BAYER HEALTHCARE LLC 1% N018230 002 Dec 26, 1991

CREAM, TABLET;TOPICAL, VAGINAL

GYNE-LOTRIMIN 3 COMBINATION PACK

+ BAYER HEALTHCARE LLC 1%,200MG N020526 002 Jul 29, 1996

GYNE-LOTRIMIN COMBINATION PACK

+ BAYER HEALTHCARE LLC 1%,100MG N020289 002 Apr 26, 1993

MYCELEX-7 COMBINATION PACK



BAYER HEALTHCARE LLC 1%,100MG N020389 002 Jun 23, 1994

LOTION;TOPICAL

LOTRIMIN

SCHERING 1% N018813 001 Feb 17, 1984

SOLUTION;TOPICAL

LOTRIMIN

+ SCHERING PLOUGH 1% N017613 001

MYCELEX

+ BAYER HLTHCARE 1% ** N018181 001

TABLET;VAGINAL

GYNE-LOTRIMIN

+ BAYER HEALTHCARE LLC 100MG N017717 002 Nov 30, 1990

GYNE-LOTRIMIN 3

+ BAYER HEALTHCARE LLC 200MG N020525 001 Jul 29, 1996
GYNIX
TEVA PHARMS 100MG A073249 001 Feb 13, 1998
MYCELEX-7

BAYER HEALTHCARE LLC 100MG N018182 002 Dec 26, 1991

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

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6-105(of 393)

** See List Footnote



CLOTRIMAZOLE

TABLET;VAGINAL

MYCELEX-G

BAYER PHARMS
500MG
N019069 001 Apr 19, 1985

TROCHE/LOZENGE;ORAL

MYCELEX

+ BAYER HLTHCARE
10MG **
N018713 001 Jun 17, 1983

CLOXACILLIN SODIUM

CAPSULE;ORAL

CLOXACILLIN SODIUM

APOTHECON
EQ 250MG BASE
A061452 001

EQ 500MG BASE
A061452 002

TEVA
EQ 250MG BASE
A062240 001

EQ 500MG BASE
A062240 002

CLOXAPEN

GLAXOSMITHKLINE
EQ 250MG BASE
A061806 001

EQ 250MG BASE
A062233 001

EQ 500MG BASE
A061806 002

EQ 500MG BASE
A062233 002

FOR SOLUTION;ORAL

CLOXACILLIN SODIUM

TEVA
EQ 125MG BASE/5ML
A062268 001

EQ 125MG BASE/5ML
A062978 001 Apr 06, 1989

TEGOPEN

APOTHECON
EQ 125MG BASE/5ML
A061453 001

EQ 125MG BASE/5ML
N050192 001

CLOZAPINE

TABLET;ORAL

CLOZAPINE

MYLAN
12.5MG
A075417 003 Apr 15, 2010

PAR PHARM
25MG
A075162 001 Apr 26, 2005

100MG
A075162 002 Apr 26, 2005

SANDOZ
25MG
A074546 001 Aug 30, 1996

100MG
A074546 002 Aug 30, 1996

ZYDUS PHARMS USA INC


25MG
A209480 001 Dec 06, 2017

50MG
A209480 002 Dec 06, 2017

100MG
A209480 003 Dec 06, 2017

200MG
A209480 004 Dec 06, 2017

TABLET, ORALLY DISINTEGRATING;ORAL

FAZACLO ODT

JAZZ PHARMS III 50MG
N021590 003 Jun 03, 2005

COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A;N/A

RUBRATOPE-57 KIT

BRACCO N/A;N/A;N/A;N/A N016089 001

COBALT CHLORIDE CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN CO-60; INTRINSIC FACTOR

N/A;N/A

RUBRATOPE-60 KIT

BRACCO N/A;N/A;N/A;N/A N016090 001

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN VC W/ CODEINE

+ ANI PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML **
N008306 005 Apr 02, 1984

PHERAZINE VC W/ CODEINE

HALSEY
10MG/5ML;5MG/5ML;6.25MG/5ML
A088870 001 Mar 02, 1987

PROMETHAZINE VC W/ CODEINE

CENCI
10MG/5ML;5MG/5ML;6.25MG/5ML
A088816 001 Nov 22, 1985

WOCKHARDT
10MG/5ML;5MG/5ML;6.25MG/5ML
A088896 001 Jan 04, 1985

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN W/ CODEINE

+ ANI PHARMS 10MG/5ML;6.25MG/5ML **


N008306 004 Apr 02, 1984

PHERAZINE W/ CODEINE

HALSEY 10MG/5ML;6.25MG/5ML
A088739 001 Dec 23, 1988

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

PHARM ASSOC 10MG/5ML;6.25MG/5ML
A089647 001 Dec 22, 1988

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

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DISCONTINUED DRUG PRODUCT LIST 6-106(of 393)

** See List Footnote



CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE W/ CODEINE

CENCI 10MG/5ML;6.25MG/5ML A088814 001 Nov 22, 1985



CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

ACTIFED W/ CODEINE

GLAXOSMITHKLINE 10MG/5ML;30MG/5ML;1.25MG/5ML N012575 003 Apr 04, 1984

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE

CENCI 10MG/5ML;30MG/5ML;1.25MG/5ML A089018 001 Jul 23, 1986



TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE

WOCKHARDT
10MG/5ML;30MG/5ML;1.25MG/5ML
A088833 001 Nov 16, 1984

CODEINE SULFATE

SOLUTION;ORAL

CODEINE SULFATE

WEST-WARD PHARMS INT
30MG/5ML
N202245 001 Jun 30, 2011

COLCHICINE; PROBENECID

TABLET;ORAL

COLBENEMID

+ MERCK
0.5MG;500MG **
N012383 001

PROBEN-C

WATSON LABS
0.5MG;500MG
A085552 001

PROBENECID AND COLCHICINE

ANI PHARMS INC
0.5MG;500MG
A083734 001

BEECHAM
0.5MG;500MG
A084321 001

IMPAX LABS
0.5MG;500MG
A083720 002

SANDOZ
0.5MG;500MG
A086130 001

PROBENECID W/ COLCHICINE

LEDERLE
0.5MG;500MG
A086954 001

WATSON LABS
0.5MG;500MG
A083221 001

COLESEVELAM HYDROCHLORIDE

CAPSULE;ORAL

WELCHOL

DAIICHI SANKYO
375MG
N021141 001 May 26, 2000

COLISTIN SULFATE

SUSPENSION;ORAL

COLY-MYCIN S

PARKE DAVIS
EQ 25MG BASE/5ML
N050355 001

CONIVAPTAN HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

VAPRISOL

CUMBERLAND PHARMS
20MG/4ML (5MG/ML)
N021697 001 Dec 29, 2005

COPPER

INTRAUTERINE DEVICE;INTRAUTERINE

CU-7

GD SEARLE LLC
89MG
N017408 001

TATUM-T

GD SEARLE LLC
120MG
N018205 001

CORTICOTROPIN

INJECTABLE;INJECTION

ACTH

PARKEDALE
25 UNITS/VIAL
N008317 002

40 UNITS/VIAL
N008317 004

ACTHAR

SANOFI AVENTIS US
25 UNITS/VIAL
N007504 002

40 UNITS/VIAL
N007504 003

CORTICOTROPIN

ORGANICS LAGRANGE
40 UNITS/ML
N010831 001

80 UNITS/ML
N010831 002

WATSON LABS
40 UNITS/VIAL
A088772 001 Nov 21, 1984

H.P. ACTHAR GEL

MALLINCKRODT ARD
40 UNITS/ML
N008372 006

PURIFIED CORTROPHIN GEL

ANI PHARMS INC
40 UNITS/ML
N008975 001

80 UNITS/ML
N008975 002

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

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6-107(of 393)

** See List Footnote



CORTICOTROPIN-ZINC HYDROXIDE

INJECTABLE;INJECTION

CORTROPHIN-ZINC

ANI PHARMS INC 40 UNITS/ML
N009854 001

CORTISONE ACETATE

INJECTABLE;INJECTION

CORTISONE ACETATE

PHARMACIA AND UPJOHN 25MG/ML
N008126 002

WATSON LABS
25MG/ML
A083147 003

25MG/ML
A085677 001

50MG/ML
A083147 004

50MG/ML
A085677 002

CORTONE

MERCK
25MG/ML
N007110 002

50MG/ML
N007110 003

TABLET;ORAL

CORTISONE ACETATE

BARR
25MG
A083471 001

ELKINS SINN
25MG
A080836 001

EVERYLIFE
25MG
A084246 001

HEATHER
25MG
A085736 001

IMPAX LABS
25MG
N009458 001

INWOOD LABS
25MG
A080731 001

IVAX SUB TEVA PHARMS 25MG
A080630 001

25MG
A083536 001

LANNETT 25MG
A080694 001

PANRAY 5MG
N008284 002

25MG
N008284 001

PHARMACIA AND UPJOHN 5MG
N008126 003

10MG
N008126 004

25MG
N008126 001

PUREPAC PHARM 25MG
A080493 001

VITARINE 25MG
A080333 001

WATSON LABS 25MG
A085884 001

WHITEWORTH TOWN PLSN 25MG
A080341 001

CORTONE

+ MERCK
25MG **
N007750 003

COSYNTROPIN

SOLUTION;INTRAVENOUS

COSYNTROPIN

SANDOZ INC
0.25MG/ML (0.25MG/ML)
N022028 001 Feb 21, 2008

CROMOLYN SODIUM

AEROSOL, METERED;INHALATION

INTAL

KING PHARMS LLC
0.8MG/INH
N018887 001 Dec 05, 1985

CAPSULE;INHALATION

INTAL

+ SANOFI AVENTIS US
20MG **
N016990 001

CAPSULE;ORAL

GASTROCROM

UCB INC
100MG
N019188 001 Dec 22, 1989

CONCENTRATE;ORAL

CROMOLYN SODIUM

GENERA PHARMS
100MG/5ML
A090954 001 Dec 18, 2009

SOLUTION;INHALATION

CROMOLYN SODIUM

ACTAVIS MID ATLANTIC
10MG/ML
A075067 001 Jul 19, 1999

APOTEX INC
10MG/ML
A075333 001 Apr 30, 2002

BAUSCH AND LOMB


10MG/ML
A075585 001 Dec 21, 2000

FERA PHARMS LLC
10MG/ML
A075437 001 Apr 21, 2000

ROXANE
10MG/ML
A075175 001 Sep 30, 1999

WATSON LABS
10MG/ML
A076469 001 Jun 17, 2005

INTAL

+ KING PHARMS LLC
10MG/ML **
N018596 001 May 28, 1982

SOLUTION/DROPS;OPHTHALMIC

CROLOM

BAUSCH AND LOMB
4%
A074443 001 Jan 30, 1995

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

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6-108(of 393)

** See List Footnote



CROMOLYN SODIUM

SOLUTION/DROPS;OPHTHALMIC

CROMOLYN SODIUM

APOTEX INC
4%
A075615 001 Jan 26, 2001

CROMOPTIC

KING PHARMS
4%
A075088 001 Apr 27, 1999

OPTICROM

+ ALLERGAN
4% **
N018155 001 Oct 03, 1984

SPRAY, METERED;NASAL

CROMOLYN SODIUM

ACTAVIS MID ATLANTIC
5.2MG/SPRAY
A074800 001 Jul 26, 2001

HH AND P
5.2MG/SPRAY
A077976 001 Sep 07, 2007

NASALCROM

+ BLACKSMITH BRANDS
5.2MG/SPRAY **
N020463 001 Jan 03, 1997

CRYPTENAMINE ACETATES

INJECTABLE;INJECTION

UNITENSEN

MEDPOINTE PHARM HLC
260CSR UNIT/ML
N008814 001

CRYPTENAMINE TANNATES

TABLET;ORAL

UNITENSEN

MEDPOINTE PHARM HLC
260CSR UNIT
N009217 001

CUPRIC SULFATE

INJECTABLE;INJECTION

CUPRIC SULFATE

ABRAXIS PHARM
EQ 0.4MG COPPER/ML
N019350 001 May 05, 1987

CYANOCOBALAMIN

GEL, METERED;NASAL

NASCOBAL

PAR PHARM
0.5MG/INH
N019722 001 Nov 05, 1996

INJECTABLE;INJECTION

BERUBIGEN

PHARMACIA AND UPJOHN 1MG/ML
N006798 001

BETALIN 12

LILLY
0.1MG/ML
A080855 001

1MG/ML
A080855 002

COBAVITE

WATSON LABS
0.1MG/ML
A083013 001

1MG/ML
A083064 001

CYANOCOBALAMIN

ABRAXIS PHARM
0.03MG/ML
A080510 003

0.1MG/ML
A080510 001

1MG/ML
A080510 002

AKORN
1MG/ML
A087969 001 Nov 10, 1983

DELL LABS
0.03MG/ML
A080689 001

0.1MG/ML
A080689 002

1MG/ML
A080689 003

FRESENIUS KABI USA
0.1MG/ML
A080557 002

LUITPOLD
0.03MG/ML
A080668 001

LYPHOMED
1MG/ML
A083075 001

MYLAN INSTITUTIONAL
1MG/ML
A040451 001 Sep 23, 2003

SANOFI AVENTIS US
1MG/ML
A080564 001

SOLOPAK
1MG/ML
A087551 001 Feb 29, 1984

WARNER CHILCOTT
1MG/ML
N007085 002

WATSON LABS
0.1MG/ML
A080573 002

0.1MG/ML
A083120 001

1MG/ML
A080573 001

1MG/ML
A083120 002

WYETH AYERST
0.1MG/ML
A080554 001

1MG/ML
A080554 002

DODEX

ACCORD HLTHCARE
1MG/ML
A083022 001

REDISOL

MERCK
1MG/ML
N006668 010

RUBIVITE

BEL MAR
0.03MG/ML
N010791 004

0.05MG/ML
N010791 001

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

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6-109(of 393)

** See List Footnote



CYANOCOBALAMIN

INJECTABLE;INJECTION

RUBIVITE

0.1MG/ML
N010791 002

0.12MG/ML
N010791 005

1MG/ML
N010791 003

RUBRAMIN PC

BRISTOL MYERS SQUIBB 0.1MG/ML
N006799 002

+
1MG/ML **
N006799 004

+
1MG/ML **
N006799 010 Apr 28, 1988

RUVITE

SAVAGE LABS
1MG/ML
A080570 002

VI-TWEL

BAYER HLTHCARE
1MG/ML
N007012 002

SPRAY, METERED;NASAL

CALOMIST

PAR PHARM
25MCG/SPRAY
N022102 001 Jul 27, 2007

TABLET;ORAL

CYANOCOBALAMIN

WEST WARD
1MG
A084264 001

CYANOCOBALAMIN CO-57

CAPSULE;ORAL

RUBRATOPE-57

BRACCO
0.5-1uCi
N016089 002

CYANOCOBALAMIN CO-60

CAPSULE;ORAL

RUBRATOPE-60

BRACCO
0.5-1uCi
N016090 002

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

N/A;N/A

DICOPAC KIT

GE HEALTHCARE N/A;N/A;N/A
N017406 001

CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR

N/A;N/A

CYANOCOBALAMIN CO 57 SCHILLING TEST KIT



MALLINCKRODT 0.1MG;0.5uCi;60MG
N016635 001

CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE

INJECTABLE;INJECTION

DEPINAR

ARMOUR PHARM
0.5MG/ML;2.3MG/ML;1MG/ML
N011208 001

CYCLACILLIN

FOR SUSPENSION;ORAL

CYCLAPEN-W

WYETH AYERST
125MG/5ML
N050508 001

250MG/5ML
N050508 002

500MG/5ML
N050508 003

TABLET;ORAL

CYCLACILLIN

TEVA
250MG
A062895 001 Aug 04, 1988

500MG
A062895 002 Aug 04, 1988

CYCLAPEN-W

WYETH AYERST
250MG
N050509 001

500MG
N050509 002

CYCLIZINE LACTATE

INJECTABLE;INJECTION

MAREZINE

GLAXOSMITHKLINE
50MG/ML
N009495 001

CYCLOBENZAPRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

TWI PHARMS INC 15MG A091281 001 Jan 31, 2013

30MG A091281 002 Jan 31, 2013

TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE

SANDOZ 10MG
A073683 001 Feb 26, 1993

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

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** See List Footnote



CYCLOBENZAPRINE HYDROCHLORIDE

TABLET;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

UPSHER SMITH LABS 5MG A072854 002 Feb 03, 2006

10MG A072854 001 Nov 19, 1991

WATSON LABS 10MG A073143 001 Nov 27, 1991

10MG A074436 001 Nov 30, 1994

FLEXERIL

+ JANSSEN RES AND DEV 5MG ** N017821 001

+ 10MG ** N017821 002

CYCLOPENTOLATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AK-PENTOLATE

AKORN 1% A085555 001

AKPENTOLATE

AKORN 2% A040165 001 Jan 13, 1997

CYCLOPENTOLATE HYDROCHLORIDE

ALCON PHARMS LTD 1% A089162 001 Jan 24, 1991

SOLA BARNES HIND 1% A084150 001

1% A084863 001

PENTOLAIR

PHARMAFAIR 0.5% A088643 001 Feb 09, 1987

1% A088150 001 Feb 25, 1983

CYCLOPHOSPHAMIDE

INJECTABLE;INJECTION

CYCLOPHOSPHAMIDE

BAXTER HLTHCARE 100MG/VIAL A088371 001 Jul 03, 1986

200MG/VIAL A088372 001 Jul 03, 1986

500MG/VIAL A088373 001 Jul 03, 1986

1GM/VIAL A088374 001 Sep 24, 1986

CYTOXAN

+ BAXTER HLTHCARE 100MG/VIAL ** N012142 001

+ 200MG/VIAL ** N012142 002

CYTOXAN (LYOPHILIZED)

+ BAXTER HLTHCARE 500MG/VIAL N012142 003



+ 500MG/VIAL ** N012142 008 Jan 04, 1984

+ 1GM/VIAL N012142 004 Aug 30, 1982

+ 1GM/VIAL ** N012142 010 Sep 24, 1985

+ 2GM/VIAL N012142 005 Aug 30, 1982

+ 2GM/VIAL ** N012142 009 Dec 10, 1985



LYOPHILIZED CYTOXAN

+ BAXTER HLTHCARE 100MG/VIAL ** N012142 006 Dec 05, 1985

+ 200MG/VIAL ** N012142 007 Dec 10, 1985

NEOSAR

BEDFORD 100MG/VIAL A087442 001 Feb 16, 1982

200MG/VIAL A087442 002 Feb 16, 1982

500MG/VIAL A087442 003 Feb 16, 1982

1GM/VIAL A087442 004 Jul 08, 1983

2GM/VIAL A087442 005 Mar 30, 1989

TEVA PARENTERAL 100MG/VIAL A040015 001 Apr 29, 1993

200MG/VIAL A040015 002 Apr 29, 1993

500MG/VIAL A040015 003 Apr 29, 1993

1GM/VIAL A040015 004 Apr 29, 1993

2GM/VIAL A040015 005 Apr 29, 1993

TABLET;ORAL

CYCLOPHOSPHAMIDE

ROXANE 25MG A040032 001 Aug 17, 1999

50MG A040032 002 Aug 17, 1999

CYTOXAN

+ BAXTER HLTHCARE 25MG ** N012141 002

+ 50MG ** N012141 001

CYCLOSPORINE

CAPSULE;ORAL

GENGRAF

ABBVIE 50MG A065003 002 May 12, 2000

NEORAL

+ NOVARTIS 50MG ** N050715 003 Jul 14, 1995

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

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6-111(of 393)

** See List Footnote



CYCLOSPORINE

SOLUTION;ORAL

CYCLOSPORINE

APOTEX INC 100MG/ML
A065167 001 Jan 05, 2005

CYCLOTHIAZIDE

TABLET;ORAL

ANHYDRON

LILLY 2MG
N013157 002

FLUIDIL

PHARMACIA AND UPJOHN 2MG
N018173 001

CYCRIMINE HYDROCHLORIDE

TABLET;ORAL

PAGITANE

LILLY 1.25MG
N008951 001

2.5MG
N008951 002

CYPROHEPTADINE HYDROCHLORIDE

SYRUP;ORAL

CYPROHEPTADINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC 2MG/5ML **
A086833 001

HALSEY 2MG/5ML
A089199 001 Jul 03, 1986

MORTON GROVE 2MG/5ML
A087001 001 Nov 04, 1982

NASKA 2MG/5ML
A089021 001 Dec 21, 1987

PERIACTIN

+ MERCK 2MG/5ML **
N013220 002

TABLET;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AM THERAP
4MG
A088798 001 Feb 15, 1985

ASCOT
4MG
A087685 001 Oct 25, 1982

CHARTWELL RX
4MG
A088212 001 May 26, 1983

DURAMED PHARMS BARR


4MG
A088232 001 Oct 25, 1983

FOSUN PHARMA
4MG
A086808 001

HALSEY
4MG
A089057 001 Jul 03, 1986

KV PHARM
4MG
A086737 001

MD PHARM
4MG
A087566 001 Nov 10, 1982

MYLAN
4MG
A086678 001

PIONEER PHARMS
4MG
A087839 001 Feb 08, 1984

PLIVA
4MG
A088205 001 Jul 26, 1983

SUPERPHARM
4MG
A087405 001

VITARINE
4MG
A087284 001

WATSON LABS
4MG
A085245 001

4MG
A086165 001

4MG
A086580 001

PERIACTIN

+ MERCK
4MG **
N012649 001

CYSTEINE HYDROCHLORIDE

INJECTABLE;INJECTION

CYSTEINE HYDROCHLORIDE

+ HOSPIRA
7.25% **
N019523 001 Oct 22, 1986

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

+ TEVA PARENTERAL
100MG/VIAL **
N016793 001

+
500MG/VIAL **
N016793 002

+
1GM/VIAL **
N016793 003 Dec 21, 1987

+
2GM/VIAL **
N016793 004 Dec 21, 1987

CYTOSAR-U

TEVA PHARMS USA
100MG/VIAL
A075206 001 Dec 30, 1998

500MG/VIAL
A075206 002 Dec 30, 1998

1GM/VIAL
A075206 004 Dec 30, 1998

2GM/VIAL
A075206 003 Dec 30, 1998

INJECTABLE, LIPOSOMAL;INJECTION

DEPOCYT

+ PACIRA PHARMS INC 10MG/ML
N021041 001 Apr 01, 1999

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

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6-112(of 393)

** See List Footnote



DACARBAZINE

INJECTABLE;INJECTION

DACARBAZINE

ABRAXIS PHARM
100MG/VIAL
A070962 001 Aug 28, 1986

200MG/VIAL
A070990 001 Aug 28, 1986

DTIC-DOME

+ BAYER HLTHCARE
100MG/VIAL **
N017575 001

+
200MG/VIAL **
N017575 002

DACTINOMYCIN

INJECTABLE;INJECTION

DACTINOMYCIN

WEST-WARD PHARMS INT
0.5MG/VIAL
A090304 001 Mar 16, 2010

DALFOPRISTIN; QUINUPRISTIN

INJECTABLE;INTRAVENOUS

SYNERCID

KING PHARMS
420MG/VIAL;180MG/VIAL
N050748 002 Aug 24, 2000

DALTEPARIN SODIUM

INJECTABLE;INJECTION

FRAGMIN

PFIZER INC
7,500 IU/0.75ML
N020287 008 Apr 04, 2002

INJECTABLE;SUBCUTANEOUS

FRAGMIN

PFIZER INC
10,000IU/0.4ML (25,000IU/ML)
N020287 002 May 01, 2007

95,000IU/9.5ML (10,000IU/ML)
N020287 007 Apr 04, 2002

DANAPAROID SODIUM

INJECTABLE;INJECTION

ORGARAN

ASPEN GLOBAL INC
750 UNITS/0.6ML
N020430 001 Dec 24, 1996

DANAZOL

CAPSULE;ORAL

DANAZOL

AM THERAP
200MG
A071569 001 Dec 30, 1987

DANOCRINE

SANOFI AVENTIS US
50MG **
N017557 003

100MG **
N017557 004

200MG **
N017557 002

DAPIPRAZOLE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DAPIPRAZOLE HYDROCHLORIDE

+ FERA PHARMS
0.5% **
N019849 001 Dec 31, 1990

DAPTOMYCIN

POWDER;IV (INFUSION)

CUBICIN

CUBIST PHARMS LLC
250MG/VIAL
N021572 001 Sep 12, 2003

DARUNAVIR ETHANOLATE

TABLET;ORAL

PREZISTA

+ JANSSEN PRODS
EQ 300MG BASE **
N021976 001 Jun 23, 2006

+
EQ 400MG BASE **
N021976 003 Oct 21, 2008

DASATINIB

TABLET;ORAL

DASATINIB

APOTEX INC
20MG
A202103 001 Jun 10, 2016

50MG
A202103 002 Jun 10, 2016

70MG
A202103 003 Jun 10, 2016

100MG
A202103 004 Jun 10, 2016

DAUNORUBICIN CITRATE

INJECTABLE, LIPOSOMAL;INJECTION

DAUNOXOME

GALEN (UK) EQ 2MG BASE/ML
N050704 002 Apr 08, 1996

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

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6-113(of 393)

** See List Footnote



DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

CERUBIDINE

SANOFI AVENTIS US
EQ 20MG BASE/VIAL
A061876 001

WYETH AYERST
EQ 20MG BASE/VIAL **
N050484 001

DAUNORUBICIN HYDROCHLORIDE

TEVA PARENTERAL
EQ 20MG BASE/VIAL
A064212 001 Jun 23, 1998

EQ 50MG BASE/VIAL
A064212 002 May 03, 1999

DECAMETHONIUM BROMIDE

INJECTABLE;INJECTION

SYNCURINE

GLAXOSMITHKLINE
1MG/ML
N006931 002

DEFEROXAMINE MESYLATE

INJECTABLE;INJECTION

DEFEROXAMINE MESYLATE

WATSON LABS
500MG/VIAL
A076806 001 Mar 31, 2006

2GM/VIAL
A076806 002 Mar 31, 2006

DEMECARIUM BROMIDE

SOLUTION/DROPS;OPHTHALMIC

HUMORSOL

MERCK
0.125%
N011860 002

0.25%
N011860 001

DEMECLOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DECLOMYCIN

LEDERLE
150MG
N050262 001

SYRUP;ORAL

DECLOMYCIN

LEDERLE
75MG/5ML
N050257 001

TABLET;ORAL

DECLOMYCIN

COREPHARMA
75MG
N050261 001

150MG
N050261 002

300MG
N050261 003

DEMECLOCYCLINE HYDROCHLORIDE

IMPAX LABS 150MG
A065094 001 Mar 22, 2004

300MG
A065094 002 Mar 22, 2004

DESERPIDINE

TABLET;ORAL

HARMONYL

ABBVIE 0.1MG
N010796 001

0.25MG
N010796 002

DESERPIDINE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ORETICYL 25

ABBVIE
0.125MG;25MG
N012148 001

ORETICYL 50

ABBVIE
0.125MG;50MG
N012148 003

ORETICYL FORTE

ABBVIE
0.25MG;25MG
N012148 002

DESERPIDINE; METHYCLOTHIAZIDE

TABLET;ORAL

ENDURONYL

ABBOTT
0.25MG;5MG
N012775 001

ENDURONYL FORTE

ABBOTT
0.5MG;5MG
N012775 002

METHYCLOTHIAZIDE AND DESERPIDINE

WATSON LABS 0.25MG;5MG
A088486 001 Aug 10, 1984

0.5MG;5MG
A088452 001 Aug 10, 1984

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

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6-114(of 393)

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DESIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

PERTOFRANE

SANOFI AVENTIS US
25MG
N013621 001

50MG
N013621 002

TABLET;ORAL

DESIPRAMINE HYDROCHLORIDE

ANI PHARMS INC
25MG
A071803 002 Dec 08, 1987

50MG
A071803 003 Dec 08, 1987

75MG
A071803 004 Dec 08, 1987

100MG
A071803 001 May 29, 1997

150MG
A071803 005 May 29, 1997

USL PHARMA
25MG
A071864 001 Sep 09, 1987

50MG
A071865 001 Sep 09, 1987

75MG
A071866 001 Sep 09, 1987

100MG
A071867 001 Sep 09, 1987

DESIRUDIN RECOMBINANT

INJECTABLE;SUBCUTANEOUS

IPRIVASK

+ VALEANT PHARMS NORTH
15MG/VIAL
N021271 001 Apr 04, 2003

DESLANOSIDE

INJECTABLE;INJECTION

CEDILANID-D

NOVARTIS
0.2MG/ML
N009282 002

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION

DDAVP

FERRING PHARMS INC
0.015MG/ML
N018938 002 Apr 25, 1995

DESMOPRESSIN ACETATE

BEDFORD
0.004MG/ML
A074575 001 Feb 18, 2000

HOSPIRA
0.004MG/ML
A075220 001 Aug 28, 2000

TEVA PHARMS USA


0.004MG/ML
A074888 001 Oct 15, 1997

DESMOPRESSIN ACETATE PRESERVATIVE FREE

BEDFORD
0.004MG/ML
A074574 001 Feb 18, 2000

SOLUTION;NASAL

CONCENTRAID

FERRING
0.01%
N019776 001 Dec 26, 1990

SPRAY, METERED;NASAL

DDAVP

+ FERRING PHARMS INC
0.01MG/SPRAY **
N017922 002 Feb 06, 1989

STIMATE

FERRING PHARMS INC
0.15MG/SPRAY
N020355 001 Mar 07, 1994

TABLET;ORAL

DESMOPRESSIN ACETATE

FERRING
0.1MG
N021795 001 May 08, 2008

0.2MG
N021795 002 May 08, 2008

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-21

DESOGEN

ORGANON USA INC
0.15MG;0.03MG
N020071 001 Dec 10, 1992

DESOGESTREL AND ETHINYL ESTRADIOL

DURAMED PHARMS BARR
0.15MG;0.03MG
A075256 001 Aug 12, 1999

ORTHO-CEPT

JANSSEN PHARMS
0.15MG;0.03MG
N020301 001 Dec 14, 1992

TABLET;ORAL-28

MIRCETTE

+ TEVA BRANDED PHARM
0.15MG,N/A;0.02MG,0.01MG **
N020713 001 Apr 22, 1998

ORTHO-CEPT

JANSSEN PHARMS
0.15MG;0.03MG
N020301 002 Dec 14, 1992

DESOXIMETASONE

CREAM;TOPICAL

TOPICORT

+ TARO PHARM INDS LTD
0.25% **
N017856 001

TOPICORT LP

+ TARO PHARM INDS LTD
0.05% **
N018309 001

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

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6-115(of 393)

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DESOXIMETASONE

GEL;TOPICAL

TOPICORT

+ TARO PHARM INDS LTD
0.05% **
N018586 001 Mar 29, 1982

OINTMENT;TOPICAL

DESOXIMETASONE

ALTANA
0.25%
A073440 001 Apr 01, 1998

TOPICORT

+ TARO PHARM INDS LTD
0.25% **
N018763 001 Sep 30, 1983

DESOXYCORTICOSTERONE ACETATE

INJECTABLE;INJECTION

DOCA

ORGANON USA INC
5MG/ML
N001104 001

PELLET;IMPLANTATION

PERCORTEN

NOVARTIS
125MG
N005151 001

DESOXYCORTICOSTERONE PIVALATE

INJECTABLE;INJECTION

PERCORTEN

NOVARTIS
25MG/ML
N008822 001

DESVENLAFAXINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE

+ SUN PHARMA GLOBAL EQ 50MG BASE
N205583 001 Jan 28, 2014

+ EQ 100MG BASE
N205583 002 Jan 28, 2014

TEVA PHARMS USA EQ 50MG BASE
N205208 001 Oct 11, 2013

EQ 100MG BASE
N205208 002 Oct 11, 2013

DEXAMETHASONE

AEROSOL;TOPICAL

AEROSEB-DEX

ALLERGAN HERBERT
0.01% **
A083296 002

DECASPRAY

+ MERCK
0.04% **
N012731 002

ELIXIR;ORAL

DECADRON

MERCK
0.5MG/5ML
N012376 002

DEXAMETHASONE

ALPHARMA US PHARMS
0.5MG/5ML
A088997 001 Oct 10, 1986

HEXADROL

ASPEN GLOBAL INC
0.5MG/5ML
N012674 001

GEL;TOPICAL

DECADERM

MERCK
0.1%
N013538 001

SUSPENSION/DROPS;OPHTHALMIC

DEXAMETHASONE

WATSON LABS
0.1%
A089170 001 May 09, 1989

TABLET;ORAL

DECADRON

+ MERCK
0.25MG **
N011664 004

+
0.5MG **
N011664 001

+
0.75MG **
N011664 002

+
1.5MG **
N011664 003

+
4MG **
N011664 005

+
6MG **
N011664 006 Jul 30, 1982

DEXAMETHASONE

ANI PHARMS INC
0.75MG
A080399 001

IMPAX LABS
0.75MG
A085376 001

PAR PHARM
0.25MG
A088149 001 Apr 28, 1983

PHOENIX LABS NY
0.75MG
A083806 001

PVT FORM
0.75MG
A083420 001

ROXANE
0.25MG
A084614 001

SUN PHARM INDUSTRIES 0.25MG
A084013 001

0.25MG
A084764 001

0.5MG
A084084 001

0.5MG
A084766 001

0.75MG
A084081 001

0.75MG
A084765 001

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

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6-116(of 393)

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DEXAMETHASONE

TABLET;ORAL

DEXAMETHASONE

1.5MG
A084086 001

1.5MG
A084763 001

UPSHER SMITH
0.75MG
A087534 001

1.5MG
A087533 001

WATSON LABS
0.25MG
A085455 001

0.5MG
A085458 001

0.75MG
A080968 001

0.75MG
A084457 001

0.75MG
A085818 001

1.5MG
A085456 001

1.5MG
A085840 001

WHITEWORTH TOWN PLSN 0.75MG
A084327 001

DEXONE 0.5

SOLVAY
0.5MG
A084991 001

DEXONE 0.75

SOLVAY
0.75MG
A084993 001

DEXONE 1.5

SOLVAY
1.5MG
A084990 001

DEXONE 4

SOLVAY
4MG
A084992 001

HEXADROL

ASPEN GLOBAL INC
0.5MG
N012675 004

0.75MG
N012675 007

1.5MG
N012675 009

4MG
N012675 010

DEXAMETHASONE ACETATE

INJECTABLE;INJECTION

DECADRON-LA

+ MERCK
EQ 8MG BASE/ML **
N016675 001

DEXAMETHASONE ACETATE

WATSON LABS
EQ 8MG BASE/ML
A084315 001

WATSON LABS TEVA
EQ 16MG BASE/ML
A087711 001 May 24, 1982

DEXAMETHASONE SODIUM PHOSPHATE

AEROSOL;NASAL

DEXACORT

UCB INC
EQ 0.1MG PHOSPHATE/INH
N014242 001

AEROSOL, METERED;INHALATION

DEXACORT

UCB INC
EQ 0.1MG PHOSPHATE/INH
N013413 001

CREAM;TOPICAL

DECADRON

MERCK
EQ 0.1% PHOSPHATE
N011983 002

INJECTABLE;INJECTION

DECADRON

+ MERCK
EQ 4MG PHOSPHATE/ML **
N012071 002

+
EQ 24MG PHOSPHATE/ML **
N012071 004

DEXACEN-4

CENT PHARMS
EQ 4MG PHOSPHATE/ML
A084342 001

DEXAMETHASONE

ABRAXIS PHARM
EQ 4MG PHOSPHATE/ML
A088448 001 Jan 25, 1984

FRESENIUS KABI USA
EQ 10MG PHOSPHATE/ML
A088469 001 Jan 25, 1984

DEXAMETHASONE SODIUM PHOSPHATE

AKORN
EQ 4MG PHOSPHATE/ML
A084493 001

BEL MAR
EQ 4MG PHOSPHATE/ML
A084752 001

DELL LABS
EQ 4MG PHOSPHATE/ML
A083161 001

INTL MEDICATION
EQ 20MG PHOSPHATE/ML
A088522 001 Feb 17, 1984

LYPHOMED
EQ 4MG PHOSPHATE/ML
A087065 001

TEVA PARENTERAL
EQ 4MG PHOSPHATE/ML
A081125 001 Aug 31, 1990

EQ 10MG PHOSPHATE/ML
A081126 001 Aug 31, 1990

WATSON LABS
EQ 4MG PHOSPHATE/ML
A083702 001

EQ 4MG PHOSPHATE/ML
A084355 001

EQ 4MG PHOSPHATE/ML
A089169 001 Apr 09, 1986

EQ 10MG PHOSPHATE/ML
A087668 001 Jul 01, 1982

EQ 24MG PHOSPHATE/ML
A085606 001

WYETH AYERST
EQ 4MG PHOSPHATE/ML
A085641 001

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

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6-117(of 393)

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DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

HEXADROL

+ ASPEN GLOBAL INC
EQ 4MG PHOSPHATE/ML **
N014694 002

+
EQ 10MG PHOSPHATE/ML **
N014694 003

EQ 20MG PHOSPHATE/ML
N014694 004

OINTMENT;OPHTHALMIC

DECADRON

MERCK
EQ 0.05% PHOSPHATE
N011977 001

DEXAIR

PHARMAFAIR
EQ 0.05% PHOSPHATE
A088071 001 Dec 28, 1982

MAXIDEX

ALCON
EQ 0.05% PHOSPHATE
A083342 001

SOLUTION/DROPS;OPHTHALMIC

DEXAIR

PHARMAFAIR
EQ 0.1% PHOSPHATE
A088433 001 Dec 15, 1983

DEXAMETHASONE SODIUM PHOSPHATE

SOLA BARNES HIND EQ 0.1% PHOSPHATE
A084170 001

EQ 0.1% PHOSPHATE
A084173 001

SOLUTION/DROPS;OPHTHALMIC, OTIC

DECADRON

MERCK EQ 0.1% PHOSPHATE
N011984 001

SOLUTION/DROPS;OTIC

DEXAMETHASONE SODIUM PHOSPHATE



AKORN EQ 0.1% PHOSPHATE
A084855 001

DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DECADRON W/ XYLOCAINE

MERCK EQ 4MG PHOSPHATE/ML;10MG/ML


N013334 002

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

OINTMENT;OPHTHALMIC

NEODECADRON
MERCK EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM N050324 001

SOLUTION/DROPS;OPHTHALMIC
NEODECADRON
MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML N050322 001

NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

BAUSCH AND LOMB EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A064055 001 Oct 30, 1995

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

ALCON PHARMS LTD EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A062714 001 Jul 21, 1986

PHARMAFAIR EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A062539 001 Jan 10, 1985

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

DEXACIDIN

NOVARTIS
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062566 001 Feb 22, 1985

DEXASPORIN

PHARMAFAIR
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062411 001 May 16, 1983

SUSPENSION/DROPS;OPHTHALMIC

DEXACIDIN

NOVARTIS
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062544 001 Oct 29, 1984

DEXASPORIN

PHARMAFAIR
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062428 001 May 18, 1983

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

ALCON PHARMS LTD 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062721 001 Nov 17, 1986

DEXBROMPHENIRAMINE MALEATE

SYRUP;ORAL

DISOMER

SCHERING 2MG/5ML
N011814 002

TABLET;ORAL

DISOMER

SCHERING 2MG
N011814 001

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

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6-118(of 393)

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DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE

TABLET;ORAL

DISOPHROL

SCHERING 2MG;60MG
N012394 002

TABLET, EXTENDED RELEASE;ORAL

BROMPHERIL

COPLEY PHARM 6MG;120MG
A089116 001 Jan 22, 1987

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

AVANTHI INC
6MG;120MG
A078648 001 Feb 27, 2013

DISOBROM

SANDOZ
6MG;120MG
A070770 001 Sep 30, 1991

DISOPHROL

SCHERING PLOUGH
6MG;120MG
N013483 004 Sep 13, 1982

DRIXORAL

+ SCHERING PLOUGH
6MG;120MG **
N013483 003 Sep 13, 1982

RESPORAL

PIONEER PHARMS
6MG;120MG
A089139 001 Jun 16, 1988

DEXCHLORPHENIRAMINE MALEATE

SYRUP;ORAL

POLARAMINE

SCHERING
2MG/5ML
A086837 001 Jul 19, 1982

TABLET;ORAL

DEXCHLORPHENIRAMINE MALEATE

ANI PHARMS INC
2MG
A088682 001 Jan 17, 1986

POLARAMINE

SCHERING
2MG
A086835 001

DEXLANSOPRAZOLE

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

DEXILANT SOLUTAB

+ TAKEDA PHARMS USA
30MG
N208056 001 Jan 26, 2016

DEXTROAMPHETAMINE SULFATE

CAPSULE;ORAL

DEXAMPEX

TEVA
15MG
A085355 001

CAPSULE, EXTENDED RELEASE;ORAL

DEXTROAMPHETAMINE SULFATE

ABLE
5MG
A076814 001 Aug 25, 2004

10MG
A076814 002 Aug 25, 2004

15MG
A076814 003 Aug 25, 2004

ELIXIR;ORAL

DEXEDRINE

GLAXOSMITHKLINE
5MG/5ML **
A083902 001

TABLET;ORAL

DEXAMPEX

TEVA
5MG
A083735 001

10MG
A083735 002

DEXEDRINE

GLAXOSMITHKLINE
5MG
A084935 001

DEXTROAMPHETAMINE SULFATE

ANI PHARMS INC
5MG
A085370 001

EPIC PHARMA LLC
5MG
A090652 001 Mar 07, 2014

10MG
A090652 002 Mar 07, 2014

HALSEY
10MG
A083930 001

LANNETT
5MG
A083903 001

10MG
A083903 003

15MG
A085652 001

MAST MM
5MG
A086521 001

NESHER PHARMS
5MG
A040365 001 Oct 31, 2002

10MG
A040367 001 Oct 31, 2002

PUREPAC PHARM
5MG
A084125 001

SANDOZ
10MG
A085371 001

VINTAGE PHARMS LLC
5MG
A040299 001 May 13, 1999

VITARINE
5MG
A084986 001

10MG
A085892 001

DEXTROSTAT

SHIRE
5MG **
A084051 001

10MG **
A084051 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-119(of 393)

** See List Footnote



DEXTROAMPHETAMINE SULFATE

TABLET;ORAL

FERNDEX

FERNDALE LABS 5MG
A084001 001

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHERAZINE DM

HALSEY 15MG/5ML;6.25MG/5ML
A088913 001 Mar 02, 1987

PROMETH W/ DEXTROMETHORPHAN

G AND W LABS INC 15MG/5ML;6.25MG/5ML **


A088762 001 Oct 31, 1984

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

AMNEAL PHARMS 15MG/5ML;6.25MG/5ML
A090575 001 Feb 08, 2011

+ ANI PHARMS 15MG/5ML;6.25MG/5ML **
N011265 002 Apr 02, 1984

TRIS PHARMA INC 15MG/5ML;6.25MG/5ML


A091687 001 Jun 28, 2012

DEXTROSE

INJECTABLE;INJECTION

DEXTROSE 10% IN PLASTIC CONTAINER

B BRAUN 10GM/100ML
N018046 001

MILES 10GM/100ML
N018504 001

DEXTROSE 2.5% IN PLASTIC CONTAINER

B BRAUN 2.5GM/100ML
N018358 001

2.5GM/100ML
N019626 001 Feb 02, 1988

DEXTROSE 20% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE 20GM/100ML
N017521 004

DEXTROSE 30% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE 30GM/100ML
N017521 003

DEXTROSE 38.5% IN PLASTIC CONTAINER

ABBOTT 38.5GM/100ML
N018923 001 Sep 19, 1984

DEXTROSE 40% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE 40GM/100ML
N017521 002

DEXTROSE 5% IN PLASTIC CONTAINER

DHL 5GM/100ML
N019971 001 Sep 28, 1995

+ ICU MEDICAL INC 50MG/ML


N019222 001 Jul 13, 1984

DEXTROSE 50% IN PLASTIC CONTAINER

+ BAXTER HLTHCARE 50GM/100ML
N017521 001

ICU MEDICAL INC 50GM/100ML
N019894 001 Dec 26, 1989

DEXTROSE 60%

B BRAUN 60GM/100ML
N017995 002 Sep 22, 1982

DEXTROSE 60% IN PLASTIC CONTAINER

B BRAUN 60GM/100ML
N017995 001

+ BAXTER HLTHCARE 60GM/100ML
N017521 005 Mar 26, 1982

60GM/100ML
N020047 002 Jul 02, 1991

HOSPIRA 60GM/100ML
N019346 001 Jan 25, 1985

DEXTROSE 7.7% IN PLASTIC CONTAINER

B BRAUN 7.7GM/100ML
N019626 003 Feb 02, 1988

DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/ N017385 001

100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

INJECTABLE;INJECTION

ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019025 001 Dec 27, 1984

00ML;320MG/100ML

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE;

SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS



INJECTABLE;INJECTION

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA 5GM/100ML;53MG/100ML;100MG/100ML;100MG/ N019515 001 May 08, 1986

100ML;180MG/100ML;280MG/100ML;16MG/100M

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-120(of 393)

** See List Footnote



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

INJECTABLE;INJECTION

ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N019844 001 Jun 10, 1993

00ML;140MG/100ML

ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N018273 001



00ML;140MG/100ML

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

GLUCONATE

INJECTABLE;INJECTION

ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1
N019843 001 Aug 09, 1993

00ML;530MG/100ML;500MG/100ML

ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1
N018274 001

00ML;530MG/100ML;500MG/100ML

PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER



+ BAXTER HLTHCARE 5GM/100ML;30MG/100ML;37MG/100ML;368MG/1
N017451 001

00ML;526MG/100ML;502MG/100ML

DEXTROSE; POTASSIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;37MG/100ML
N019699 001 Sep 29, 1989

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;75MG/100ML
N018744 001 Nov 09, 1982

5GM/100ML;75MG/100ML
N019699 002 Sep 29, 1989

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;110MG/100ML
N019699 003 Sep 29, 1989

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML
N018744 002 Nov 09, 1982

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML
N018744 003 Nov 09, 1982

5GM/100ML;220MG/100ML
N019699 005 Sep 29, 1989

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;300MG/100ML
N018744 004 Nov 09, 1982

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC

ANHYDROUS

INJECTABLE;INJECTION

IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA 5GM/100ML;111MG/100ML;256MG/100ML;146MG N019514 001 May 08, 1986

/100ML;207MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG
N019870 001 Jun 10, 1993

/100ML;91MG/100ML

ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG
N018270 001

/100ML;91MG/100ML

DEXTROSE; POTASSIUM CHLORIDE; 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 N018840 001 Jun 29, 1983
/100ML;220MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N018268 009
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N018268 004

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N018268 005

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N018268 006

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N018268 011 Jan 18, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-121(of 393)

** See List Footnote



DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N018268 012 Jan 18, 1986

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N018268 013 Jan 18, 1986

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N018268 014 Jan 18, 1986

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%

B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N018268 010

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N018268 001

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N018268 002

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N018268 003

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 003

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 001



DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 002

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 002 Mar 24, 1988

+ 5GM/100ML;149MG/100ML;900MG/100ML N019691 004 Mar 24, 1988

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;224MG/100ML;450MG/100ML N018362 006 Mar 28, 1988

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;224MG/100ML;900MG/100ML N019691 006 Mar 24, 1988

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;298MG/100ML;450MG/100ML N018362 007 Mar 28, 1988

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;298MG/100ML;900MG/100ML N019691 008 Mar 24, 1988

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;224MG/100ML;900MG/100ML N019691 007 Mar 24, 1988

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 008 Mar 28, 1988

+ 5GM/100ML;149MG/100ML;450MG/100ML N018362 004 Mar 28, 1988

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ ICU MEDICAL INC 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 001 Mar 24, 1988
+ 5GM/100ML;149MG/100ML;900MG/100ML N019691 003 Mar 24, 1988
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML N018386 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;450MG/100ML N018229 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;900MG/100ML N018047 001
BAXTER HLTHCARE 10GM/100ML;900MG/100ML N016696 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;450MG/100ML N018030 001
HOSPIRA 2.5GM/100ML;450MG/100ML N018096 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;900MG/100ML N018376 001
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 3.3GM/100ML;300MG/100ML N018055 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML N018030 005
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;200MG/100ML N018030 004
MILES 5GM/100ML;200MG/100ML N018399 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;225MG/100ML N019482 001 Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;300MG/100ML N019486 001 Oct 04, 1985
MILES 5GM/100ML;300MG/100ML N018501 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-122(of 393)

** See List Footnote



DEXTROSE; SODIUM CHLORIDE

INJECTABLE;INJECTION

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

B BRAUN 5GM/100ML;330MG/100ML
N018030 003

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

ABBOTT 5GM/100ML;450MG/100ML
N019484 001 Oct 04, 1985

B BRAUN 5GM/100ML;450MG/100ML
N018030 002

MILES 5GM/100ML;450MG/100ML
N018400 001

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABBOTT
5GM/100ML;900MG/100ML
N019483 001 Oct 04, 1985

B BRAUN
5GM/100ML;900MG/100ML
N018026 001

MILES
5GM/100ML;900MG/100ML
N018500 001

DEXTROTHYROXINE SODIUM

TABLET;ORAL

CHOLOXIN

ABBVIE
1MG
N012302 005

2MG
N012302 002

4MG
N012302 004

6MG
N012302 006

DEZOCINE

INJECTABLE;INJECTION

DALGAN

ASTRAZENECA
5MG/ML
N019082 001 Dec 29, 1989

10MG/ML
N019082 002 Dec 29, 1989

15MG/ML
N019082 003 Dec 29, 1989

DIATRIZOATE MEGLUMINE

INJECTABLE;INJECTION

ANGIOVIST 282

BAYER HLTHCARE
60%
A087726 001 Sep 23, 1982

CARDIOGRAFIN

BRACCO
85%
N011620 002

DIATRIZOATE MEGLUMINE

BRACCO
76%
N010040 017

HYPAQUE

GE HEALTHCARE
30%
N016403 002

60%
N016403 001

RENO-60

BRACCO
60%
N010040 016

RENO-DIP

BRACCO
30%
N010040 012

UROVIST MEGLUMINE DIU/CT

BAYER HLTHCARE
30%
A087739 001 Sep 23, 1982

SOLUTION;URETERAL

RENO-30

BRACCO
30%
N010040 021

UROVIST CYSTO

BAYER HLTHCARE
30%
A087729 001 Sep 23, 1982

UROVIST CYSTO PEDIATRIC

BAYER HLTHCARE
30%
A087731 001 Sep 23, 1982

SOLUTION;URETHRAL

HYPAQUE-CYSTO

GE HEALTHCARE
30%
N016403 003

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE;INJECTION

ANGIOVIST 292

BAYER HLTHCARE
52%;8%
A087724 001 Sep 23, 1982

ANGIOVIST 370

BAYER HLTHCARE
66%;10%
A087723 001 Sep 23, 1982

DIATRIZOATE-60

INTL MEDICATION
52%;8%
A088166 001 Jun 17, 1983

HYPAQUE-76

GE HEALTHCARE
66%;10%
A086505 001

HYPAQUE-M,75%

GE HEALTHCARE
50%;25%
N010220 003

HYPAQUE-M,90%

GE HEALTHCARE
60%;30%
N010220 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-123(of 393)

** See List Footnote



DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

INJECTABLE;INJECTION

MD-60

MALLINCKRODT
52%;8%
A087074 001

MD-76

MALLINCKRODT
66%;10%
A087073 001

MD-76R

+ LIEBEL-FLARSHEIM
66%;10%
N019292 001 Sep 29, 1989

RENOCAL-76

BRACCO
66%;10%
A089347 001 Jun 01, 1988

RENOGRAFIN-60

BRACCO
52%;8%
N010040 006

RENOGRAFIN-76

+ BRACCO
66%;10%
N010040 001

RENOVIST

BRACCO
34.3%;35%
N010040 020

RENOVIST II

BRACCO
28.5%;29.1%
N010040 019

SOLUTION;ORAL, RECTAL

GASTROVIST

BAYER HLTHCARE
66%;10%
A087728 001 Sep 23, 1982

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

SOLUTION;INTRAUTERINE

SINOGRAFIN

+ BRACCO
52.7%;26.8%
N011324 002

DIATRIZOATE SODIUM

FOR SOLUTION;ORAL, RECTAL

HYPAQUE

GE HEALTHCARE
100%
N011386 001

INJECTABLE;INJECTION

HYPAQUE

GE HEALTHCARE
25%
N009561 003

50%
N009561 001

MD-50

MALLINCKRODT
50%
A087075 001

UROVIST SODIUM 300

BAYER HLTHCARE
50%
A087725 001 Sep 23, 1982

SOLUTION;ORAL, RECTAL

HYPAQUE

GE HEALTHCARE
40%
N011386 003

SOLUTION;URETERAL

HYPAQUE SODIUM 20%

GE HEALTHCARE
20%
N009561 002

DIAZEPAM

CAPSULE, EXTENDED RELEASE;ORAL

VALRELEASE

ROCHE
15MG
N018179 001

GEL;RECTAL

DIASTAT

+ VALEANT PHARMS NORTH
5MG/ML (5MG/ML) **
N020648 002 Jul 29, 1997

+
10MG/2ML (5MG/ML) **
N020648 003 Jul 29, 1997

+
15MG/3ML (5MG/ML) **
N020648 004 Jul 29, 1997

+
20MG/4ML (5MG/ML) **
N020648 005 Jul 29, 1997

INJECTABLE;INJECTION

DIAZEPAM

ABRAXIS PHARM
5MG/ML
A070662 001 Jun 25, 1986

HOSPIRA
5MG/ML
A071584 001 Oct 13, 1987

MARSAM PHARMS LLC
5MG/ML
A072371 001 Jan 29, 1993

PARENTA PHARMS
5MG/ML
A076815 001 Apr 15, 2004

US ARMY
5MG/ML **
N020124 001 Dec 05, 1990

WARNER CHILCOTT
5MG/ML
A071613 001 Oct 22, 1987

5MG/ML
A071614 001 Oct 22, 1987

WATSON LABS
5MG/ML
A070296 001 Feb 12, 1986

5MG/ML
A070911 001 Aug 28, 1986

5MG/ML
A070912 001 Aug 28, 1986

5MG/ML
A070930 001 Dec 01, 1986

WATSON LABS INC
5MG/ML
A072370 001 Jan 29, 1993

5MG/ML
A072397 001 Jan 29, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-124(of 393)

** See List Footnote



DIAZEPAM

INJECTABLE;INJECTION

DIAZEPAM

WEST-WARD PHARMS INT
5MG/ML A070311 001 Dec 16, 1985

5MG/ML A070312 001 Dec 16, 1985

5MG/ML A070313 001 Dec 16, 1985

5MG/ML A071308 001 Jul 17, 1987

5MG/ML A071309 001 Jul 17, 1987

5MG/ML A071310 001 Jul 17, 1987

DIZAC

PHARMACIA AND UPJOHN
5MG/ML ** N019287 001 Jun 18, 1993

VALIUM

+ ROCHE
5MG/ML ** N016087 001

TABLET;ORAL

DIAZEPAM

ACTAVIS ELIZABETH
2MG A070781 001 Mar 19, 1986

5MG A070706 001 Mar 19, 1986

10MG A070707 001 Mar 19, 1986

DAVA PHARMS INC
2MG A070228 002 Sep 26, 1985

5MG A070228 003 Sep 26, 1985

10MG A070228 001 Sep 26, 1985

DURAMED PHARMS BARR


2MG A070894 001 Aug 27, 1986

5MG A070895 001 Aug 27, 1986

10MG A070896 001 Aug 27, 1986

FERNDALE LABS
2MG A070903 001 Apr 01, 1987

5MG A070904 001 Apr 01, 1987

10MG A070905 001 Apr 01, 1987

HALSEY
2MG A070987 001 Aug 15, 1986

5MG A070996 001 Aug 15, 1986

10MG A070956 001 Aug 15, 1986

IVAX SUB TEVA PHARMS


2MG A070360 001 Sep 04, 1985

5MG A070361 001 Sep 04, 1985

10MG A070362 001 Sep 04, 1985

MARTEC USA LLC


10MG A072402 001 Apr 25, 1989

PIONEER PHARMS
2MG A070787 001 Aug 02, 1988

5MG A070788 001 Aug 02, 1988

10MG A070776 001 Aug 02, 1988

ROXANE
2MG A070356 001 Jun 17, 1986

5MG A070357 001 Jun 17, 1986

10MG A070358 001 Jun 17, 1986

TEVA PHARMS
5MG A070153 001 Nov 01, 1985

UPSHER SMITH LABS
2MG A070302 001 Dec 20, 1985

5MG A070303 001 Dec 20, 1985

10MG A070304 001 Dec 20, 1985

VIRTUS PHARMS
2MG A070462 001 Feb 25, 1986

5MG A070463 001 Feb 25, 1986

10MG A070464 001 Feb 25, 1986

WARNER CHILCOTT
2MG A070209 001 Sep 04, 1985

5MG A070210 001 Sep 04, 1985

10MG A070222 001 Sep 04, 1985

WATSON LABS
2MG A070456 001 Nov 01, 1985

5MG A070457 001 Nov 01, 1985

10MG A070458 001 Nov 01, 1985

Q-PAM

QUANTUM PHARMICS
2MG A070423 001 Dec 12, 1985

2MG A072431 001 Apr 29, 1988

5MG A070424 001 Dec 12, 1985



5MG A072432 001 Apr 29, 1988

10MG A070425 001 Dec 12, 1985



10MG A072433 001 Apr 29, 1988

DIAZOXIDE

CAPSULE;ORAL

PROGLYCEM

TEVA BRANDED PHARM
50MG N017425 001

100MG N017425 002

INJECTABLE;INJECTION

DIAZOXIDE

ABRAXIS PHARM
15MG/ML A071519 001 Aug 26, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-125(of 393)

** See List Footnote



DIAZOXIDE

INJECTABLE;INJECTION

HYPERSTAT

SCHERING 15MG/ML N016996 001

DIBUCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

HEAVY SOLUTION NUPERCAINE

NOVARTIS 2.5MG/ML N006203 001

DICHLORPHENAMIDE

TABLET;ORAL

DARANIDE

+ STRONGBRIDGE US 50MG ** N011366 001

DICLOFENAC POTASSIUM

TABLET;ORAL

CATAFLAM

+ NOVARTIS 25MG ** N020142 001 Nov 24, 1993

50MG ** N020142 002 Nov 24, 1993

DICLOFENAC POTASSIUM

SANDOZ 50MG A075582 001 Feb 23, 2001

SUN PHARM INDUSTRIES 50MG A075470 001 Feb 21, 2002

WATSON LABS TEVA 50MG A075152 001 Nov 27, 1998

DICLOFENAC SODIUM

SOLUTION;INTRAVENOUS

DYLOJECT

+ JAVELIN PHARMS INC 37.5MG/ML (37.5MG/ML) N022396 001 Dec 23, 2014

SOLUTION;TOPICAL

PENNSAID

+ NUVO PHARMS INC 1.5% ** N020947 001 Nov 04, 2009

SOLUTION/DROPS;OPHTHALMIC

DICLOFENAC SODIUM

APOTEX INC 0.1% A077600 001 Nov 13, 2008

FALCON PHARMS 0.1% N020809 001 May 04, 1998

TABLET, DELAYED RELEASE;ORAL



DICLOFENAC SODIUM

ALLIED 50MG A074986 001 Feb 26, 1999

75MG A074986 002 Feb 26, 1999

PLIVA 50MG A074432 002 Jul 29, 1999

75MG A074432 003 Jul 29, 1999

ROXANE 25MG A074391 001 Jun 29, 1995

50MG A074391 002 Jun 29, 1995

75MG A074391 003 Jun 29, 1995

TEVA 50MG A074723 001 Mar 30, 1999

75MG A074390 001 Aug 15, 1996

TEVA PHARMS 25MG A074459 001 Jun 25, 1997



50MG A074459 002 Jun 25, 1997

75MG A074459 003 Jun 25, 1997

VOLTAREN

+ NOVARTIS 25MG ** N019201 001 Jul 28, 1988
+ 50MG ** N019201 002 Jul 28, 1988
+ 75MG ** N019201 003 Jul 28, 1988
TABLET, EXTENDED RELEASE;ORAL
DICLOFENAC SODIUM
ACTAVIS ELIZABETH 100MG A075910 001 Jan 07, 2002
VOLTAREN-XR
+ NOVARTIS 100MG ** N020254 001 Mar 08, 1996
DICLOXACILLIN SODIUM
CAPSULE;ORAL
DYCILL
GLAXOSMITHKLINE EQ 250MG BASE A060254 002
EQ 250MG BASE A062238 001
EQ 500MG BASE A060254 003
EQ 500MG BASE A062238 002
PATHOCIL
WYETH AYERST EQ 250MG BASE N050011 002
EQ 500MG BASE N050011 003 Mar 28, 1983

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

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DISCONTINUED DRUG PRODUCT LIST 6-126(of 393)

** See List Footnote



DICLOXACILLIN SODIUM

FOR SUSPENSION;ORAL

DICLOXACILLIN SODIUM

APOTHECON EQ 62.5MG BASE/5ML A061455 001

DYNAPEN

APOTHECON EQ 62.5MG BASE/5ML N050337 002

PATHOCIL

WYETH AYERST EQ 62.5MG BASE/5ML N050092 001

DICUMAROL

CAPSULE;ORAL

DICUMAROL

LILLY 25MG N005509 003

50MG N005509 001

TABLET;ORAL

DICUMAROL

ABBVIE 25MG N005545 003

50MG N005545 004

100MG N005545 005

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL

DICYCLOMINE HYDROCHLORIDE

PIONEER PHARMS 10MG A089361 001 Jan 10, 1989

SUN PHARM INDUSTRIES 10MG A084505 001 Oct 21, 1986

WATSON LABS 10MG A083179 001 Feb 12, 1986

INJECTABLE;INJECTION

DICYCLOMINE HYDROCHLORIDE

WATSON LABS 10MG/ML A080614 001 Feb 11, 1986

SYRUP;ORAL

BENTYL

+ APTALIS PHARMA US 10MG/5ML ** N007961 002 Oct 15, 1984

DICYCLOMINE HYDROCHLORIDE

ALPHARMA US PHARMS 10MG/5ML A084479 001

TABLET;ORAL

DICYCLOMINE HYDROCHLORIDE

PIONEER PHARMS 20MG A088585 001 Aug 20, 1986

SUN PHARM INDUSTRIES 20MG A084600 001 Jul 29, 1985



WATSON LABS 20MG A084361 001 Feb 06, 1986

DIDANOSINE

CAPSULE, DELAYED REL PELLETS;ORAL

DIDANOSINE

BARR 200MG A077167 001 Dec 03, 2004

250MG A077167 002 Dec 03, 2004

400MG A077167 003 Dec 03, 2004

MYLAN PHARMS INC 125MG A090788 001 Apr 08, 2010

200MG A090788 002 Apr 08, 2010

250MG A090788 003 Apr 08, 2010

400MG A090788 004 Apr 08, 2010

FOR SOLUTION;ORAL

DIDANOSINE

AUROBINDO PHARMA 10MG/ML A078112 001 Mar 08, 2007
VIDEX
BRISTOL MYERS SQUIBB 100MG/PACKET N020155 003 Oct 09, 1991
167MG/PACKET N020155 004 Oct 09, 1991
250MG/PACKET N020155 005 Oct 09, 1991
375MG/PACKET N020155 006 Oct 09, 1991
TABLET, CHEWABLE;ORAL
VIDEX
+ BRISTOL MYERS SQUIBB 25MG ** N020154 002 Oct 09, 1991
+ 50MG ** N020154 003 Oct 09, 1991
+ 100MG ** N020154 004 Oct 09, 1991
+ 150MG ** N020154 005 Oct 09, 1991
+ 200MG ** N020154 006 Oct 28, 1999
TABLET, FOR SUSPENSION;ORAL
DIDANOSINE
AUROBINDO 100MG A077275 001 Aug 14, 2012
150MG A077275 002 Aug 14, 2012
200MG A077275 003 Aug 14, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-127(of 393)

** See List Footnote



DIENESTROL

CREAM;VAGINAL

DIENESTROL

ORTHO MCNEIL PHARM
0.01%
N006110 005

DV

SANOFI AVENTIS US
0.01%
A083518 001

ESTRAGUARD

SOLVAY
0.01%
A084436 001

SUPPOSITORY;VAGINAL

DV

SANOFI AVENTIS US
0.7MG
A083517 001

DIETHYLCARBAMAZINE CITRATE

TABLET;ORAL

HETRAZAN

LEDERLE
50MG
N006459 001

DIETHYLPROPION HYDROCHLORIDE

TABLET;ORAL

DIETHYLPROPION HYDROCHLORIDE

CHARTWELL RX
25MG
A088267 001 Aug 25, 1983

25MG
A088268 001 Aug 25, 1983

EPIC PHARMA LLC


25MG
A040828 001 Nov 05, 2008

SANDOZ
25MG
A085916 001

TEVA
25MG
A088642 001 Sep 20, 1984

UCB INC
25MG
A085544 001

WATSON LABS
25MG
A085741 001

TENUATE

SANOFI AVENTIS US
25MG
N017668 001

TEPANIL

3M
25MG
N011673 001

TABLET, EXTENDED RELEASE;ORAL

TENUATE

SANOFI AVENTIS US
75MG
N017669 001

TEPANIL TEN-TAB

3M
75MG
N017956 001

DIETHYLSTILBESTROL

INJECTABLE;INJECTION

STILBESTROL

BRISTOL MYERS SQUIBB 0.2MG/ML
N004056 003

0.5MG/ML
N004056 004

1MG/ML
N004056 005

5MG/ML
N004056 006

SUPPOSITORY;VAGINAL

DIETHYLSTILBESTROL

LILLY
0.1MG
N004040 001

0.5MG
N004040 002

STILBESTROL

BRISTOL MYERS SQUIBB 0.1MG
N004056 001

0.5MG
N004056 002

TABLET;ORAL

DIETHYLSTILBESTROL

LILLY 0.1MG
N004041 002

0.5MG
N004041 003

1MG
N004041 004

5MG
N004041 005

STILBESTROL

TABLICAPS 0.5MG
A083004 001

1MG
A083002 001

5MG
A083006 001

STILBETIN

BRISTOL MYERS SQUIBB 0.1MG
N004056 007

0.25MG
N004056 017

0.5MG
N004056 008

1MG
N004056 009

5MG
N004056 010

TABLET, DELAYED RELEASE;ORAL

DIETHYLSTILBESTROL

LILLY 0.1MG
N004039 002

0.25MG
N004039 005

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

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6-128(of 393)

** See List Footnote


DIETHYLSTILBESTROL
TABLET, DELAYED RELEASE;ORAL
DIETHYLSTILBESTROL
0.5MG N004039 003

1MG N004039 004

5MG N004039 006

STILBESTROL
TABLICAPS 0.5MG A083003 001

1MG A083005 001

5MG A083007 001

STILBETIN
BRISTOL MYERS SQUIBB 0.1MG
N004056 011

0.5MG
N004056 012

1MG
N004056 013

5MG
N004056 014

DIETHYLSTILBESTROL DIPHOSPHATE

INJECTABLE;INJECTION

STILPHOSTROL

BAYER PHARMS
250MG/5ML
N010010 001

TABLET;ORAL

STILPHOSTROL

BAYER PHARMS
50MG
N010010 002

DIFLORASONE DIACETATE

CREAM;TOPICAL

DIFLORASONE DIACETATE

FOUGERA PHARMS
0.05%
A075187 001 Mar 30, 1998

FLORONE

PHARMACIA AND UPJOHN 0.05% **
N017741 001

FLORONE E

PHARMACIA AND UPJOHN
0.05%
N019259 001 Aug 28, 1985

PSORCON

+ TARO PHARMS NORTH
0.05% **
N020205 001 Nov 20, 1992

OINTMENT;TOPICAL

PSORCON

+ PHARMACIA AND UPJOHN
0.05%
N019260 001 Aug 28, 1985

PSORCON E

PHARMACIA AND UPJOHN 0.05%
N017994 001

DIFLUNISAL

TABLET;ORAL

DIFLUNISAL

ANI PHARMS INC
500MG
A074604 001 Jun 10, 1996

PUREPAC PHARM
250MG
A074285 001 May 07, 1996

500MG
A074285 002 May 07, 1996

SOCORRO
250MG
A073562 001 Nov 27, 1992

500MG
A073563 001 Nov 27, 1992

TEVA
250MG
A073679 001 Jul 31, 1992

WATSON LABS
250MG
A074400 001 Jul 17, 1997

500MG
A074400 002 Jul 17, 1997

DOLOBID

+ MERCK
250MG **
N018445 001 Apr 19, 1982

+
500MG **
N018445 002 Apr 19, 1982

DIGITOXIN

INJECTABLE;INJECTION

CRYSTODIGIN

LILLY
0.2MG/ML
A084100 005

DIGOXIN

CAPSULE;ORAL

LANOXICAPS

GLAXOSMITHKLINE LLC
0.05MG
N018118 002 Jul 26, 1982

0.1MG
N018118 003 Jul 26, 1982

0.15MG
N018118 004 Sep 24, 1984

0.2MG
N018118 001 Jul 26, 1982

INJECTABLE;INJECTION

DIGOXIN

ABRAXIS PHARM
0.25MG/ML
A083217 001

HOSPIRA
0.25MG/ML
A040093 001 May 16, 1996

0.25MG/ML
A040206 001 Aug 28, 1998

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

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DISCONTINUED DRUG PRODUCT LIST 6-129(of 393)

** See List Footnote



DIGOXIN

INJECTABLE;INJECTION

DIGOXIN

WYETH AYERST 0.25MG/ML A084386 001

DIGOXIN PEDIATRIC

HOSPIRA 0.1MG/ML A040092 001 Apr 25, 1996

TABLET;ORAL

LANOXIN

+ CONCORDIA PHARMS INC 0.1875MG N020405 003 Sep 30, 1997

0.375MG N020405 005 Sep 30, 1997

0.5MG N020405 006 Sep 30, 1997



DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

EMBOLEX

NOVARTIS 0.5MG/0.5ML;2,500 N018885 001 Nov 30, 1984

UNITS/0.5ML;5.33MG/0.5ML

0.5MG/0.7ML;5,000 N018885 002 Nov 30, 1984

UNITS/0.7ML;7.46MG/0.7ML

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CARDIZEM SR

+ BIOVAIL 60MG ** N019471 001 Jan 23, 1989

+ 90MG ** N019471 002 Jan 23, 1989

+ 120MG ** N019471 003 Jan 23, 1989

+ 180MG ** N019471 004 Jan 23, 1989

DILACOR XR

+ ALLERGAN SALES LLC 120MG ** N020092 001 May 29, 1992

+ 180MG ** N020092 002 May 29, 1992

+ 240MG ** N020092 003 May 29, 1992

DILT-CD

APOTEX 120MG A076151 001 May 20, 2004

180MG A076151 002 May 20, 2004

240MG A076151 003 May 20, 2004

300MG A076151 004 May 20, 2004

DILTIAZEM HYDROCHLORIDE

ACTAVIS LABS FL INC 120MG A074852 001 Oct 10, 1997

180MG A074852 002 Oct 10, 1997

240MG A074852 003 Oct 10, 1997

BIOVAIL 60MG A074845 001 Sep 15, 1999

90MG A074845 002 Sep 15, 1999

120MG A074845 003 Sep 15, 1999

120MG N020939 001 Jan 28, 2000



180MG N020939 002 Jan 28, 2000

240MG N020939 003 Jan 28, 2000

300MG N020939 004 Jan 28, 2000

360MG N020939 005 Sep 14, 2001

420MG N020939 006 Sep 14, 2001

NESHER PHARMS 120MG A076563 002 Sep 12, 2006

180MG A076563 003 Sep 12, 2006

240MG A076563 004 Sep 12, 2006

300MG A076563 005 Sep 12, 2006

360MG A076563 006 Sep 12, 2006

420MG A076563 001 Sep 12, 2006

TEVA 60MG A074079 001 Nov 30, 1993



90MG A074079 002 Nov 30, 1993

120MG A074079 003 Nov 30, 1993

INJECTABLE;INJECTION

CARDIZEM

BIOVAIL 100MG/VIAL ** N020792 001 Sep 05, 1997

+ BIOVAIL LABS INTL 5MG/ML ** N020027 001 Oct 24, 1991



+ 25MG/VIAL ** N020027 003 Aug 18, 1995

DILTIAZEM HYDROCHLORIDE

HOSPIRA 5MG/ML A075004 001 Feb 16, 2000

5MG/ML A075106 001 Apr 29, 1999

MYLAN LABS LTD 5MG/ML A075375 001 Sep 30, 1999

TEVA PHARMS USA 5MG/ML A074894 001 Aug 26, 1997


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

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6-130(of 393)

** See List Footnote



DILTIAZEM HYDROCHLORIDE

TABLET;ORAL

DILTIAZEM HYDROCHLORIDE

APOTHECON
30MG
A074051 001 Mar 31, 1993

60MG
A074051 002 Mar 31, 1993

90MG
A074051 003 Mar 31, 1993

120MG
A074051 004 Mar 31, 1993

CHARTWELL MOLECULES
30MG
A074093 001 Nov 05, 1992

60MG
A074093 002 Nov 05, 1992

90MG
A074093 003 Nov 05, 1992

120MG
A074093 004 Nov 05, 1992

IVAX SUB TEVA PHARMS
30MG
A074168 001 Mar 03, 1995

60MG
A074168 002 Mar 03, 1995

90MG
A074168 003 Mar 03, 1995

120MG
A074168 004 Mar 03, 1995

TEVA
30MG
A074084 001 Feb 25, 1994

60MG
A074084 002 Feb 25, 1994

TEVA PHARMS
30MG
A074067 001 Nov 05, 1992

60MG
A074067 002 Nov 05, 1992

90MG
A074067 003 Nov 05, 1992

120MG
A074067 004 Nov 05, 1992

DILTIAZEM MALATE

TABLET, EXTENDED RELEASE;ORAL

TIAMATE

MERCK
EQ 120MG HYDROCHLORIDE
N020506 001 Oct 04, 1996

EQ 180MG HYDROCHLORIDE
N020506 002 Oct 04, 1996

EQ 240MG HYDROCHLORIDE
N020506 003 Oct 04, 1996

DILTIAZEM MALATE; ENALAPRIL MALEATE

TABLET, EXTENDED RELEASE;ORAL

TECZEM

BIOVAIL
EQ 180MG HYDROCHLORIDE;5MG
N020507 001 Oct 04, 1996

DIMENHYDRINATE

INJECTABLE;INJECTION

DIMENHYDRINATE

BAXTER HLTHCARE
50MG/ML
A084767 001

WATSON LABS
50MG/ML
A083531 001

WATSON LABS TEVA
50MG/ML
A080615 001

WYETH AYERST
50MG/ML
A084316 001

LIQUID;ORAL

DIMENHYDRINATE

ALRA
12.5MG/4ML
A080715 001

TABLET;ORAL

DIMENHYDRINATE

HEATHER
50MG
A080841 001

NEXGEN PHARMA INC
50MG
A085985 001

WATSON LABS
50MG
A085166 001

DIMYRISTOYL LECITHIN; PERFLEXANE

INJECTABLE;INTRAVENOUS

IMAGENT

VESSELON SPV LLC 0.92MG/VIAL;0.092MG/VIAL
N021191 001 May 31, 2002

DINOPROST TROMETHAMINE

INJECTABLE;INJECTION

PROSTIN F2 ALPHA

PHARMACIA AND UPJOHN EQ 5MG BASE/ML
N017434 001

DIPHEMANIL METHYLSULFATE

TABLET;ORAL

PRANTAL

SCHERING 100MG
N008114 004

DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

BENADRYL

MCNEIL CONS 25MG
N005845 007

50MG
N005845 001

DIPHENHYDRAMINE HYDROCHLORIDE

ALRA 25MG
A080519 004

50MG
A080519 003

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

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DISCONTINUED DRUG PRODUCT LIST
6-131(of 393)

** See List Footnote



DIPHENHYDRAMINE HYDROCHLORIDE

CAPSULE;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

ANABOLIC 50MG A083275 001

ELKINS SINN 25MG A085701 001

50MG A085701 002

FOSUN PHARMA 25MG A080832 001

25MG A080845 002

50MG A080832 002

50MG A080845 001

HALSEY 50MG A087914 001 Jun 04, 1984

HEATHER 25MG A084524 001

50MG A083953 001

HIKMA INTL PHARMS 50MG A083567 001

IMPAX LABS 25MG A080807 001

50MG A080807 002

IVAX SUB TEVA PHARMS 25MG
A080762 001

50MG A080762 002

LANNETT 25MG A080868 001

50MG A080868 002

LEDERLE 25MG A086874 001

50MG A086875 001

LNK 25MG A087977 001 Jan 27, 1983

50MG A087978 001 Jan 27, 1983

MK LABS 25MG A083087 001

50MG A083087 002

MUTUAL PHARM 25MG A084506 001

NEWTRON PHARMS 25MG A086543 001

50MG A086544 001

NEXGEN PHARMA INC 25MG A083634 001

PERRIGO 25MG A083061 001

50MG A083061 002

PIONEER PHARMS 25MG A089101 001 Dec 20, 1985

50MG A088880 001 Dec 20, 1985

PUREPAC PHARM 25MG A085156 001

50MG A085150 001

PVT FORM 25MG A083027 001

50MG A083027 002

ROXANE 50MG A080635 001

SUN PHARM INDUSTRIES 25MG A089488 001 Jan 02, 1987

50MG A089489 001 Jan 02, 1987

SUPERPHARM 25MG A089040 001 May 15, 1985

50MG A089041 001 May 15, 1985

TEVA 25MG A085874 001



50MG A085874 002

VALEANT PHARM INTL 25MG A080596 001

50MG A080592 001

VANGARD 25MG A088034 001 Oct 27, 1982

50MG A087630 001

WATSON LABS 25MG A080728 001

25MG A083797 001

25MG A085138 001

50MG A080727 001

50MG A083797 002

50MG A085083 001

WHITEWORTH TOWN PLSN 25MG
A083441 001

50MG
A080800 001

ELIXIR;ORAL

BELIX

HALSEY
12.5MG/5ML
A086586 001 Oct 03, 1983

BENADRYL

MCNEIL CONS
12.5MG/5ML
N005845 004

DIBENIL

CENCI
12.5MG/5ML
A088304 001 Dec 16, 1983

DIPHEN

USL PHARMA
12.5MG/5ML
A084640 001

DIPHENHYDRAMINE HYDROCHLORIDE

BUNDY 12.5MG/5ML
A083674 001

CENCI 12.5MG/5ML
A087941 001 Dec 17, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-132(of 393)

** See List Footnote



DIPHENHYDRAMINE HYDROCHLORIDE

ELIXIR;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

KV PHARM
12.5MG/5ML
A085621 001

LANNETT
12.5MG/5ML
A080939 002

LEDERLE
12.5MG/5ML
A086937 001

MK LABS
12.5MG/5ML
A083088 002

NASKA
12.5MG/5ML
A088680 001 May 31, 1985

PERRIGO
12.5MG/5ML
A083063 001

PUREPAC PHARM
12.5MG/5ML
A083237 001 Jan 25, 1982

PVT FORM
12.5MG/5ML
A085287 001

ROXANE
12.5MG/5ML
A080643 001

HYDRAMINE

ALPHARMA US PHARMS
12.5MG/5ML
A080763 002

INJECTABLE;INJECTION

BENADRYL

MCNEIL CONS
10MG/ML
N006146 001

+
50MG/ML **
N006146 002

BENADRYL PRESERVATIVE FREE

+ MCNEIL CONS
50MG/ML **
N009486 001

DIPHENHYDRAMINE HYDROCHLORIDE

BEL MAR 10MG/ML
A080822 001

EUROHLTH INTL SARL 50MG/ML
A083183 001

LYPHOMED 10MG/ML
A087066 001

WATSON LABS 10MG/ML
A083533 001

WATSON LABS TEVA 10MG/ML
A080873 001

50MG/ML
A080873 002

WYETH AYERST 50MG/ML
A080577 001

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

ABRAXIS PHARM
50MG/ML
A080586 002

INTL MEDICATION
50MG/ML
A084094 001

WATSON LABS TEVA
50MG/ML
A080873 003

SYRUP;ORAL

ANTITUSSIVE

PERRIGO
12.5MG/5ML
A071292 001 Apr 10, 1987

BELDIN

HALSEY
12.5MG/5ML
A089179 001 Jun 05, 1986

BENYLIN

PARKE DAVIS
12.5MG/5ML
N006514 004

DIPHEN

MORTON GROVE
12.5MG/5ML
A070118 001 Oct 01, 1985

DIPHENHYDRAMINE HYDROCHLORIDE

ALPHARMA US PHARMS 12.5MG/5ML A070497 001 Apr 25, 1989

CUMBERLAND SWAN 12.5MG/5ML A073611 001 Aug 20, 1992

HI TECH PHARMA 12.5MG/5ML A072416 001 Sep 28, 1990



HYDRAMINE
ALPHARMA US PHARMS 12.5MG/5ML A070205 001 Jan 28, 1986

SILPHEN
LANNETT CO INC 12.5MG/5ML A072646 001 Feb 27, 1992

VICKS FORMULA 44
WARNER CHILCOTT 12.5MG/5ML A070524 001 Jan 14, 1987

DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

BENYLIN

PARKE DAVIS 12.5MG/5ML;30MG/5ML
N019014 001 Jun 11, 1985

DIPHENIDOL HYDROCHLORIDE

TABLET;ORAL

VONTROL

GLAXOSMITHKLINE EQ 25MG BASE
N016033 001

DIPHENYLPYRALINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

HISPRIL

GLAXOSMITHKLINE 5MG
N011945 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-133(of 393)

** See List Footnote



DIPIVEFRIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKPRO

AKORN 0.1% A074382 001 Sep 29, 1995

DIPIVEFRIN HYDROCHLORIDE

BAUSCH AND LOMB 0.1% A074188 001 May 19, 1995

FALCON PHARMS 0.1% A073636 001 Jun 30, 1994



PROPINE

ALLERGAN 0.1% N018239 001

DIPYRIDAMOLE

INJECTABLE;INJECTION

DIPYRIDAMOLE

HOSPIRA 5MG/ML A074601 001 Dec 19, 1997

MYLAN LABS LTD 5MG/ML A075769 001 Nov 27, 2002

TEVA PHARMS USA 5MG/ML A074952 001 Nov 26, 1997

IV PERSANTINE

+ BOEHRINGER INGELHEIM 5MG/ML ** N019817 001 Dec 13, 1990

TABLET;ORAL

DIPYRIDAMOLE

ANI PHARMS INC 25MG A086944 002 Apr 16, 1991

50MG A086944 001 Feb 25, 1992



75MG A086944 003 Feb 25, 1992

GLENMARK GENERICS 25MG A088999 001 Feb 05, 1991

50MG A089000 001 Feb 05, 1991

75MG A089001 001 Feb 05, 1991

LANNETT CO INC 25MG A040898 001 Apr 23, 2008

50MG A040898 002 Apr 23, 2008

75MG A040898 003 Apr 23, 2008

OXFORD PHARMS 25MG A040542 001 Apr 21, 2006

50MG A040542 002 Apr 21, 2006

75MG A040542 003 Apr 21, 2006

PUREPAC PHARM 25MG A089425 001 Jul 12, 1990



50MG A089426 001 Jul 12, 1990

75MG A089427 001 Jul 12, 1990

WATSON LABS 50MG A087160 001 Jun 07, 1996

DIRITHROMYCIN

TABLET, DELAYED RELEASE;ORAL

DYNABAC

LILLY RES LABS 250MG N050678 001 Jun 19, 1995

DISOPYRAMIDE PHOSPHATE

CAPSULE;ORAL

DISOPYRAMIDE PHOSPHATE

AUROLIFE PHARMA LLC EQ 100MG BASE A070470 001 Dec 10, 1985

EQ 150MG BASE A070471 001 Dec 10, 1985

INTERPHARM EQ 100MG BASE A071190 001 Jan 15, 1987

EQ 150MG BASE A071191 001 Jan 15, 1987

IVAX SUB TEVA PHARMS EQ 100MG BASE A070186 001 Nov 18, 1985

EQ 150MG BASE A070187 001 Nov 18, 1985

MYLAN EQ 100MG BASE A070138 001 Jun 14, 1985

EQ 150MG BASE A070139 001 Jun 14, 1985

SUN PHARM INDUSTRIES EQ 100MG BASE A070351 001 Dec 17, 1985

EQ 150MG BASE A070352 001 Dec 17, 1985

SUPERPHARM EQ 100MG BASE A070940 001 Feb 09, 1987

EQ 150MG BASE A070941 001 Feb 09, 1987

WATSON LABS EQ 100MG BASE A070240 001 Feb 02, 1986

EQ 150MG BASE A070241 001 Feb 02, 1986

CAPSULE, EXTENDED RELEASE;ORAL

DISOPYRAMIDE PHOSPHATE

NESHER PHARMS EQ 150MG BASE A071200 001 Dec 15, 1987

DISULFIRAM

TABLET;ORAL

ANTABUSE

+ TEVA WOMENS 250MG ** N007883 003

+ 500MG ** N007883 002

DISULFIRAM

PAR PHARM 250MG A088792 001 Aug 14, 1984

500MG A088793 001 Aug 14, 1984


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-134(of 393)

** See List Footnote



DISULFIRAM

TABLET;ORAL

DISULFIRAM

WATSON LABS 250MG A086889 001

250MG A087973 001 Aug 05, 1983

500MG A087974 001 Aug 05, 1983

WATSON LABS TEVA 500MG A086890 001



DIVALPROEX SODIUM

TABLET, DELAYED RELEASE;ORAL

DEPAKOTE CP

ABBOTT EQ 250MG BASE N019794 001 Jul 11, 1990

EQ 500MG BASE N019794 002 Jul 11, 1990

DIVALPROEX SODIUM

MYLAN EQ 125MG VALPROIC ACID A077254 001 Jul 29, 2008

EQ 250MG VALPROIC ACID A077254 002 Jul 29, 2008

EQ 500MG VALPROIC ACID A077254 003 Jul 29, 2008

TABLET, EXTENDED RELEASE;ORAL

DIVALPROEX SODIUM

G AND W LABS INC EQ 500MG VALPROIC ACID A078700 001 Aug 03, 2009

DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOBUTAMINE HYDROCHLORIDE

BAXTER HLTHCARE EQ 12.5MG BASE/ML A074381 001 Sep 26, 1996

HOSPIRA EQ 1.25GM BASE/100ML A074634 001 Sep 27, 1996

LUITPOLD EQ 12.5MG BASE/ML A074545 001 Jun 25, 1998



TELIGENT PHARMA INC EQ 12.5MG BASE/ML A074098 001 Feb 21, 1995

TEVA PARENTERAL EQ 12.5MG BASE/ML A074206 001 Oct 19, 1993

WATSON LABS EQ 12.5MG BASE/ML A074114 001 Nov 30, 1993

WATSON LABS INC EQ 12.5MG BASE/ML A074279 001 Feb 18, 1998

EQ 12.5MG BASE/ML A074995 001 Mar 31, 1998

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

HOSPIRA EQ 50MG BASE/100ML N020269 001 Oct 19, 1993

EQ 100MG BASE/100ML N020269 002 Oct 19, 1993

EQ 200MG BASE/100ML N020269 003 Oct 19, 1993

DOBUTREX

+ LILLY EQ 12.5MG BASE/ML N017820 002

DOCETAXEL

INJECTABLE;INJECTION

DOCEFREZ

+ SUN PHARMA GLOBAL 20MG/VIAL N022534 001 May 03, 2011

+ 80MG/VIAL N022534 002 May 03, 2011

DOCETAXEL

+ ACCORD HLTHCARE 20MG/0.5ML (40MG/ML) N201195 001 Jun 08, 2011

+ 80MG/2ML (40MG/ML) N201195 002 Jun 08, 2011

APOTEX INC 20MG/0.5ML (40MG/ML) N022312 001 Jan 11, 2012

80MG/2ML (40MG/ML) N022312 002 Jan 11, 2012

+ HOSPIRA INC 120MG/6ML (20MG/ML) N022234 006 Jun 23, 2016

PFIZER LABS 20MG/2ML (10MG/ML) N202356 001 Mar 13, 2014

80MG/8ML (10MG/ML) N202356 002 Mar 13, 2014

130MG/13ML (10MG/ML) N202356 003 Mar 13, 2014

200MG/20ML (10MG/ML) N202356 004 Mar 13, 2014

TAXOTERE

+ SANOFI AVENTIS US 40MG/ML ** N020449 001 May 14, 1996

DOLASETRON MESYLATE

INJECTABLE;INJECTION

ANZEMET

+ US PHARM HOLDINGS 12.5MG/0.625ML (20MG/ML) N020624 002 Sep 11, 1997

+ 100MG/5ML (20MG/ML) N020624 001 Sep 11, 1997

500MG/25ML (20MG/ML) N020624 003 Dec 11, 2001



TABLET;ORAL

ANZEMET

+ US PHARM HOLDINGS 50MG N020623 001 Sep 11, 1997

+ 100MG N020623 002 Sep 11, 1997


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-135(of 393)

** See List Footnote



DONEPEZIL HYDROCHLORIDE

SOLUTION;ORAL

ARICEPT

EISAI INC 5MG/5ML N021719 001 Oct 18, 2004

TABLET;ORAL

DONEPEZIL HYDROCHLORIDE

ACCORD HLTHCARE 5MG A201335 001 Aug 29, 2011

10MG A201335 002 Aug 29, 2011

APOTEX 5MG A078841 001 Jun 02, 2011



10MG A078841 002 Jun 02, 2011

HIKMA PHARMS 5MG A090247 001 May 31, 2011

10MG A090247 002 May 31, 2011

SUN PHARM INDS LTD 5MG A076786 001 Nov 26, 2010

10MG A076786 002 Nov 26, 2010

TABLET, ORALLY DISINTEGRATING;ORAL

ARICEPT ODT

+ EISAI INC 5MG N021720 001 Oct 18, 2004

+ 10MG N021720 002 Oct 18, 2004

DONEPEZIL HYDROCHLORIDE

BARR 5MG A078388 002 Nov 26, 2010

10MG A078388 001 Nov 26, 2010

SUN PHARM INDUSTRIES 5MG A077975 002 Dec 11, 2009

10MG A077975 001 Dec 11, 2009

ZYDUS PHARMS USA INC 5MG A090175 001 May 10, 2011

10MG A090175 002 May 10, 2011



DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

AMNEAL PHARMS 10MG;14MG A208328 001 Jan 27, 2017

10MG;28MG A208328 002 Jan 27, 2017

DOPAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

DOPAMINE HYDROCHLORIDE

ABBOTT 40MG/ML A070656 001 Jan 24, 1989

80MG/ML A070657 001 Jan 24, 1989

ABRAXIS PHARM 40MG/ML A070012 001 Jun 12, 1985

40MG/ML A070058 001 Mar 20, 1985

80MG/ML A070013 001 Jun 12, 1985

80MG/ML A070059 001 Mar 20, 1985

160MG/ML A070364 001 Dec 04, 1985

BAXTER HLTHCARE 40MG/ML N018398 001

80MG/ML N018398 002 Mar 22, 1982

HOSPIRA 40MG/ML A074403 001 May 23, 1996

IGI LABS INC 40MG/ML A070087 001 Oct 23, 1985



80MG/ML A070089 001 Oct 23, 1985

80MG/ML A070090 001 Oct 23, 1985

80MG/ML A070091 001 Oct 23, 1985

160MG/ML A070092 001 Oct 23, 1985

160MG/ML A070093 001 Oct 23, 1985

160MG/ML A070094 001 Oct 23, 1985

INTL MEDICATION 40MG/ML N018014 001

LUITPOLD 160MG/ML A070826 001 Feb 11, 1987

LYPHOMED 40MG/ML N018549 001 Mar 11, 1983

SMITH AND NEPHEW 40MG/ML A070011 001 Aug 29, 1985

40MG/ML A070046 001 Aug 29, 1985

80MG/ML A070047 001 Aug 29, 1985

TELIGENT 40MG/ML N018656 001 Jun 28, 1983



TEVA PARENTERAL 40MG/ML A072999 001 Oct 23, 1991

80MG/ML A073000 001 Oct 23, 1991

WARNER CHILCOTT 40MG/ML A070558 001 Sep 20, 1985

40MG/ML N018138 001



80MG/ML A070559 001 Sep 20, 1985

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%



HOSPIRA 1.6MG/ML N020542 001 Aug 30, 1995

INTROPIN

HOSPIRA 40MG/ML N017395 001

80MG/ML N017395 002

160MG/ML N017395 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-136(of 393)

** See List Footnote



DORIPENEM

INJECTABLE;INTRAVENOUS

DORIBAX

+ SHIONOGI INC 250MG/VIAL
N022106 002 Oct 05, 2010

+ 500MG/VIAL
N022106 001 Oct 12, 2007

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

APOTEX INC EQ 2% BASE
A078395 001 Oct 28, 2008

TEVA PHARMS EQ 2% BASE
A078756 001 Dec 04, 2008

WATSON LABS INC EQ 2% BASE
A202053 001 Sep 11, 2014

ZAMBON SPA EQ 2% BASE


A091034 001 Dec 04, 2013

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE



APOTEX INC
EQ 2% BASE;EQ 0.5% BASE
A078201 001 Oct 28, 2008

LANNETT CO INC
EQ 2% BASE;EQ 0.5% BASE
A201998 001 Dec 17, 2014

WATSON LABS INC
EQ 2% BASE;EQ 0.5% BASE
A202054 001 Sep 03, 2014

ZAMBON SPA
EQ 2% BASE;EQ 0.5% BASE
A091180 001 Dec 04, 2013

DOXACURIUM CHLORIDE

INJECTABLE;INJECTION

NUROMAX

ABBVIE
EQ 1MG BASE/ML
N019946 001 Mar 07, 1991

DOXAPRAM HYDROCHLORIDE

INJECTABLE;INJECTION

DOXAPRAM HYDROCHLORIDE

WATSON LABS
20MG/ML
A073529 001 Jan 30, 1992

DOXAZOSIN MESYLATE

TABLET;ORAL

DOXAZOSIN MESYLATE

ACTAVIS ELIZABETH
EQ 1MG BASE
A075574 001 Oct 18, 2000

EQ 2MG BASE
A075574 002 Oct 18, 2000

EQ 4MG BASE
A075574 003 Oct 18, 2000

EQ 8MG BASE
A075574 004 Oct 18, 2000

GENPHARM
EQ 1MG BASE
A075466 001 Oct 18, 2000

EQ 2MG BASE
A075466 002 Oct 18, 2000

EQ 4MG BASE
A075466 003 Oct 18, 2000

EQ 8MG BASE
A075466 004 Oct 18, 2000

IVAX SUB TEVA PHARMS
EQ 1MG BASE
A075453 001 Oct 18, 2000

EQ 2MG BASE
A075453 002 Oct 18, 2000

EQ 4MG BASE
A075453 003 Oct 18, 2000

EQ 8MG BASE
A075453 004 Oct 18, 2000

NESHER PHARMS
EQ 1MG BASE
A075609 001 Oct 18, 2000

EQ 2MG BASE
A075609 002 Oct 18, 2000

EQ 4MG BASE
A075609 003 Oct 18, 2000

EQ 8MG BASE
A075609 004 Oct 18, 2000

TEVA
EQ 1MG BASE
A075353 001 Jan 12, 2001

EQ 2MG BASE
A075353 002 Jan 12, 2001

EQ 4MG BASE
A075353 003 Jan 12, 2001

EQ 8MG BASE
A075353 004 Jan 12, 2001

WATSON LABS INC
EQ 1MG BASE
A075426 001 Oct 18, 2000

EQ 2MG BASE
A075426 002 Oct 18, 2000

EQ 4MG BASE
A075426 003 Oct 18, 2000

EQ 8MG BASE
A075426 004 Oct 18, 2000

YAOPHARMA CO LTD
EQ 1MG BASE
A075646 001 Oct 18, 2000

EQ 2MG BASE
A075646 002 Oct 18, 2000

EQ 4MG BASE
A075646 003 Oct 18, 2000

EQ 8MG BASE
A075646 004 Oct 18, 2000

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

DAVA PHARMS INC
EQ 10MG BASE
A071685 001 Jan 05, 1988

EQ 25MG BASE
A071686 001 Jan 05, 1988

EQ 50MG BASE
A071673 001 Jan 05, 1988

EQ 75MG BASE
A071674 001 Jan 05, 1988

EQ 100MG BASE
A071675 001 Jan 05, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-137(of 393)

** See List Footnote



DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

EQ 150MG BASE
A071676 001 Jan 05, 1988

NEW RIVER
EQ 10MG BASE
N016987 001

EQ 25MG BASE
N016987 002

EQ 50MG BASE
N016987 003

EQ 75MG BASE
N016987 006

EQ 100MG BASE
N016987 004

EQ 150MG BASE
N016987 007 Apr 13, 1987

PAR PHARM
EQ 10MG BASE
A071697 001 Nov 09, 1987

EQ 25MG BASE
A071437 001 Nov 09, 1987

EQ 75MG BASE
A071608 001 Nov 09, 1987

PUREPAC PHARM
EQ 10MG BASE
A073054 001 Dec 28, 1990

EQ 25MG BASE
A072109 001 Dec 28, 1990

EQ 50MG BASE
A073055 001 Dec 28, 1990

EQ 75MG BASE
A072386 001 Sep 08, 1988

EQ 100MG BASE
A072110 001 Sep 08, 1988

EQ 150MG BASE
A072387 001 Sep 08, 1988

QUANTUM PHARMICS
EQ 10MG BASE
A070972 001 Sep 29, 1987

EQ 25MG BASE
A070973 001 Sep 29, 1987

EQ 50MG BASE
A070931 001 Sep 29, 1987

EQ 75MG BASE
A070932 001 Sep 29, 1987

EQ 100MG BASE
A072375 001 Mar 15, 1989

EQ 150MG BASE
A072376 001 Mar 15, 1989

SANDOZ
EQ 10MG BASE
A071487 001 Mar 02, 1987

EQ 25MG BASE
A070827 001 May 15, 1986

EQ 50MG BASE
A070828 001 May 15, 1986

EQ 75MG BASE
A070825 001 May 15, 1986

EQ 100MG BASE
A071562 001 Mar 02, 1987

SUN PHARM INDUSTRIES
EQ 25MG BASE
A071502 001 Feb 18, 1988

EQ 50MG BASE
A071653 001 Feb 18, 1988

EQ 75MG BASE
A071654 001 Feb 18, 1988

EQ 100MG BASE
A071521 001 Feb 18, 1988

WATSON LABS
EQ 10MG BASE
A070952 001 Mar 04, 1987

EQ 10MG BASE
A071485 001 Apr 30, 1987

EQ 10MG BASE
A072985 001 Mar 29, 1991

EQ 25MG BASE
A070953 001 May 15, 1986

EQ 25MG BASE
A071486 001 Apr 30, 1987

EQ 25MG BASE
A072986 001 Mar 29, 1991

EQ 50MG BASE
A070954 001 May 15, 1986

EQ 50MG BASE
A071238 001 Apr 30, 1987

EQ 75MG BASE
A071326 001 Apr 30, 1987

EQ 75MG BASE
A071763 001 Feb 09, 1988

EQ 100MG BASE
A070955 001 May 15, 1986

EQ 100MG BASE
A071239 001 Apr 30, 1987

EQ 150MG BASE
A071764 001 Feb 09, 1988

WATSON LABS TEVA
EQ 50MG BASE
A072987 001 Mar 29, 1991

SINEQUAN

+ PFIZER
EQ 10MG BASE **
N016798 003

+
EQ 25MG BASE **
N016798 001

+
EQ 50MG BASE **
N016798 002

+
EQ 75MG BASE **
N016798 006

+
EQ 100MG BASE **
N016798 005

+
EQ 150MG BASE **
N016798 007

CONCENTRATE;ORAL

DOXEPIN HYDROCHLORIDE

PHARM ASSOC
EQ 10MG BASE/ML
A075924 001 Jan 15, 2004

SINEQUAN

+ PFIZER
EQ 10MG BASE/ML **
N017516 001

TABLET;ORAL

DOXEPIN HYDROCHLORIDE

ACTAVIS ELIZABETH
EQ 3MG BASE
A201951 001 Jul 26, 2013

EQ 6MG BASE
A201951 002 Jul 26, 2013

MYLAN PHARMS INC
EQ 3MG BASE
A202337 001 Jan 20, 2016

EQ 6MG BASE
A202337 002 Jan 20, 2016

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-138(of 393)

** See List Footnote



DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

ADRIAMYCIN PFS

PHARMACIA AND UPJOHN 2MG/ML A063165 001 Jan 30, 1991

200MG/100ML A063165 002 Jan 30, 1991

DOXORUBICIN HYDROCHLORIDE

ALVOGEN INC 2MG/ML A065515 001 Nov 08, 2012

MYLAN LABS LTD 10MG/VIAL A200170 001 Oct 28, 2011

PHARMACIA AND UPJOHN 10MG/VIAL N050467 001

20MG/VIAL N050467 003 May 20, 1985

50MG/VIAL N050467 002



150MG/VIAL N050467 004 Jul 22, 1987

SANDOZ INC 2MG/ML A200146 001 Jul 18, 2012

RUBEX

BRISTOL MYERS SQUIBB 10MG/VIAL A062926 001 Apr 13, 1989

50MG/VIAL A062926 002 Apr 13, 1989

100MG/VIAL A062926 003 Apr 13, 1989



DOXYCYCLINE

CAPSULE;ORAL

DOXYCYCLINE

PAR PHARM EQ 75MG BASE A065055 004 Apr 18, 2005

SANDOZ INC EQ 50MG BASE A065032 001 Jun 30, 2000



EQ 100MG BASE A065032 002 Jun 30, 2000

WATSON LABS EQ 50MG BASE A065041 001 Apr 28, 2000

EQ 100MG BASE A065041 002 Apr 28, 2000

FOR SUSPENSION;ORAL

DOXYCHEL

RACHELLE EQ 25MG BASE/5ML A061720 001

TABLET;ORAL

DOXYCYCLINE

SANDOZ INC EQ 50MG BASE A065353 001 Nov 27, 2006

EQ 75MG BASE A065353 002 Nov 27, 2006

EQ 100MG BASE A065353 003 Nov 27, 2006

SUN PHARM INDUSTRIES EQ 50MG BASE A065471 001 Apr 17, 2009

EQ 75MG BASE A065471 002 Apr 17, 2009

EQ 100MG BASE A065471 003 Apr 17, 2009



DOXYCYCLINE HYCLATE

CAPSULE;ORAL

ACTICLATE CAP

+ AQUA PHARMS EQ 75MG BASE N208253 001 Apr 26, 2016

DOXY-LEMMON

TEVA EQ 50MG BASE A062497 001 Aug 23, 1984

EQ 100MG BASE A062497 002 Jun 15, 1984



DOXYCYCLINE HYCLATE

HALSEY EQ 50MG BASE A062119 002 May 24, 1985

EQ 100MG BASE A062119 001 May 24, 1985

HEATHER EQ 50MG BASE A062463 001 Dec 07, 1983



EQ 100MG BASE A062463 002 Dec 07, 1983

HIKMA INTL PHARMS EQ 20MG BASE A065103 001 May 13, 2005

INTERPHARM EQ 50MG BASE A062763 001 Sep 02, 1988

EQ 100MG BASE A062763 002 Sep 02, 1988

MUTUAL PHARM EQ 50MG BASE A062418 001 Jan 28, 1983



EQ 100MG BASE A062418 002 Jan 28, 1983

PAR PHARM EQ 50MG BASE A062434 001 Oct 19, 1984

EQ 100MG BASE A062442 001 Dec 22, 1983

PVT FORM EQ 50MG BASE A062631 001 Jul 24, 1986

EQ 100MG BASE A062631 002 Jul 24, 1986

RANBAXY EQ 50MG BASE A062479 001 Dec 23, 1983

EQ 100MG BASE A062479 002 Dec 23, 1983

SUPERPHARM EQ 50MG BASE A062469 001 Oct 31, 1984

EQ 100MG BASE A062469 002 Oct 31, 1984

WARNER CHILCOTT EQ 50MG BASE A062594 001 Dec 05, 1985

EQ 100MG BASE A062594 002 Dec 05, 1985

WATSON LABS EQ 50MG BASE A061717 001

EQ 50MG BASE A062142 001

EQ 100MG BASE A061717 002

EQ 100MG BASE A062142 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-139(of 393)

** See List Footnote



DOXYCYCLINE HYCLATE

CAPSULE;ORAL

PERIOSTAT

+ COLLAGENEX EQ 20MG BASE ** N050744 001 Sep 30, 1998

VIBRAMYCIN

+ PFIZER EQ 50MG BASE ** N050007 001

CAPSULE, COATED PELLETS;ORAL

DOXYCYCLINE HYCLATE

PLIVA EQ 100MG BASE A063187 001 Jun 30, 1992

CAPSULE, DELAYED RELEASE;ORAL

DORYX
+ MAYNE PHARMA INTL EQ 75MG BASE N050582 002 Aug 13, 2001
+ EQ 100MG BASE N050582 001 Jul 22, 1985
WARNER CHILCOTT EQ 100MG BASE A062653 001 Oct 30, 1985
DOXYCYCLINE HYCLATE
MEDICIS EQ 75MG BASE A065281 001 Dec 21, 2005
EQ 100MG BASE A065281 002 Dec 21, 2005
INJECTABLE;INJECTION
DOXYCHEL HYCLATE
RACHELLE EQ 100MG BASE/VIAL A061953 001
DOXYCYCLINE
WEST-WARD PHARMS INT EQ 100MG BASE/VIAL A062450 001 Oct 27, 1983
EQ 200MG BASE/VIAL A062450 002 Oct 27, 1983
EQ 200MG BASE/VIAL A062569 002 Mar 09, 1988
DOXYCYCLINE HYCLATE
WEST-WARD PHARMS INT EQ 100MG BASE/VIAL A062992 001 Feb 16, 1989
EQ 200MG BASE/VIAL A062992 002 Feb 16, 1989
VIBRAMYCIN
+ PFIZER EQ 100MG BASE/VIAL ** N050442 002
+ EQ 200MG BASE/VIAL ** N050442 001
TABLET;ORAL
DOXY-LEMMON
TEVA EQ 100MG BASE A062581 001 Mar 15, 1985
DOXYCYCLINE HYCLATE
EPIC PHARMA LLC EQ 20MG BASE A065182 001 May 13, 2005
HEATHER EQ 100MG BASE A062462 001 May 11, 1983
INTERPHARM EQ 100MG BASE A062764 001 Sep 02, 1988
MUTUAL PHARM EQ 100MG BASE A062391 001 Sep 30, 1982
SUPERPHARM EQ 100MG BASE A062494 001 Feb 20, 1985
VINTAGE PHARMS EQ 100MG BASE A062538 001 Apr 07, 1986
WARNER CHILCOTT EQ 100MG BASE A062593 001 Aug 28, 1985
WATSON LABS EQ 50MG BASE A062392 001 Mar 31, 1983
EQ 100MG BASE A062392 002 Mar 31, 1983
LYMEPAK
+ CHARTWELL PHARMA EQ 100MG BASE N209844 001 Jun 15, 2018
PERIOSTAT
+ GALDERMA LABS LP EQ 20MG BASE ** N050783 001 Feb 02, 2001
VIBRA-TABS
+ PFIZER EQ 100MG BASE ** N050533 001
TABLET, DELAYED RELEASE;ORAL
DORYX
+ MAYNE PHARMA EQ 80MG BASE N050795 004 Apr 11, 2013
DORYX MPC
+ MAYNE PHARMA EQ 60MG BASE ** N050795 007 May 20, 2016
DOXYCYCLINE HYCLATE
IMPAX LABS INC EQ 75MG BASE A090505 001 Dec 28, 2010
EQ 100MG BASE A090505 002 Dec 28, 2010
MYLAN EQ 80MG BASE A090431 004 Apr 29, 2016
DOXYLAMINE SUCCINATE
CAPSULE;ORAL
UNISOM
PFIZER 25MG N019440 001 Feb 05, 1986
TABLET;ORAL
DECAPRYN
SANOFI AVENTIS US 12.5MG N006412 015
25MG N006412 014
DOXY-SLEEP-AID
PAR PHARM 25MG A070156 001 Jul 02, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-140(of 393)

** See List Footnote



DOXYLAMINE SUCCINATE

TABLET;ORAL

DOXYLAMINE SUCCINATE

COPLEY PHARM 25MG A088900 002 Feb 12, 1988

QUANTUM PHARMICS 25MG A088603 001 Aug 07, 1984

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BENDECTIN
SANOFI AVENTIS US 10MG;10MG ** N010598 002
DROMOSTANOLONE PROPIONATE
INJECTABLE;INJECTION
DROLBAN
LILLY 50MG/ML N012936 001
DRONABINOL
CAPSULE;ORAL
DRONABINOL
INSYS THERAP 2.5MG A078501 001 Aug 19, 2011
5MG A078501 002 Aug 19, 2011
10MG A078501 003 Aug 19, 2011
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
ABRAXIS PHARM 2.5MG/ML A070992 001 Nov 17, 1986
2.5MG/ML A070993 001 Nov 17, 1986
ASTRAZENECA 2.5MG/ML A072018 001 Oct 20, 1988
HOSPIRA 2.5MG/ML A071645 001 Apr 07, 1988
2.5MG/ML A072272 001 Aug 31, 1995
IGI LABS INC 2.5MG/ML A072019 001 Oct 19, 1988
2.5MG/ML A072020 001 Oct 19, 1988
2.5MG/ML A072021 001 Oct 19, 1988
LUITPOLD 2.5MG/ML A072335 001 Oct 24, 1988
SMITH AND NEPHEW 2.5MG/ML A071750 001 Sep 06, 1988
SOLOPAK 2.5MG/ML A071754 001 Sep 06, 1988
2.5MG/ML A071755 001 Sep 06, 1988
WATSON LABS 2.5MG/ML A073520 001 Nov 27, 1991
2.5MG/ML A073521 001 Nov 27, 1991
2.5MG/ML A073523 001 Nov 27, 1991
DROPERIDOL; FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA 2.5MG/ML;EQ 0.05MG BASE/ML A072026 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072027 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072028 001 Apr 13, 1989
HOSPIRA 2.5MG/ML;EQ 0.05MG BASE/ML A071982 001 May 04, 1988
INNOVAR
AKORN MFG 2.5MG/ML;EQ 0.05MG BASE/ML N016049 001
DUTASTERIDE
CAPSULE;ORAL
DUTASTERIDE
MYLAN PHARMS INC 0.5MG A203241 001 Jun 14, 2016
DYCLONINE HYDROCHLORIDE
SOLUTION;TOPICAL
DYCLONE
+ ASTRAZENECA 0.5% ** N009925 002
+ 1% ** N009925 001
DYDROGESTERONE
TABLET;ORAL
GYNOREST
SOLVAY 5MG ** N017388 001
10MG ** N017388 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-141(of 393)

** See List Footnote



DYPHYLLINE

ELIXIR;ORAL

NEOTHYLLINE

TEVA
160MG/15ML
N007794 003

INJECTABLE;INJECTION

NEOTHYLLINE

TEVA
250MG/ML
N009088 001

TABLET;ORAL

DILOR

SAVAGE LABS
200MG
A084514 001

DILOR-400

SAVAGE LABS
400MG
A084751 001

LUFYLLIN

MYLAN SPECIALITY LP
200MG
A084566 001

400MG
A084566 002

NEOTHYLLINE

TEVA
200MG
N007794 001

400MG
N007794 002

ECHOTHIOPHATE IODIDE

FOR SOLUTION;OPHTHALMIC

PHOSPHOLINE IODIDE

WYETH PHARMS
0.03%
N011963 002

0.06%
N011963 004

0.25%
N011963 003

EDETATE CALCIUM DISODIUM

TABLET;ORAL

CALCIUM DISODIUM VERSENATE

MEDICIS
500MG
N008922 002

EDROPHONIUM CHLORIDE

INJECTABLE;INJECTION

EDROPHONIUM CHLORIDE

HOSPIRA
10MG/ML
A040131 001 Feb 24, 1998

WATSON LABS
10MG/ML
A040044 001 Mar 20, 1996

EDROPHONIUM CHLORIDE PRESERVATIVE FREE

WATSON LABS
10MG/ML
A040043 001 Mar 20, 1996

ENLON

MYLAN INSTITUTIONAL
10MG/ML
A088873 001 Aug 06, 1985

REVERSOL

ORGANON USA INC
10MG/ML
A089624 001 May 13, 1988

TENSILON

+ TELIGENT
10MG/ML **
N007959 001

TENSILON PRESERVATIVE FREE

+ TELIGENT
10MG/ML **
N007959 002

EFAVIRENZ

CAPSULE;ORAL

SUSTIVA

+ BRISTOL MYERS SQUIBB
100MG **
N020972 002 Sep 17, 1998

TABLET;ORAL

SUSTIVA

+ BRISTOL MYERS SQUIBB
300MG **
N021360 001 Feb 01, 2002

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

AUROBINDO PHARMA LTD 600MG;300MG;300MG
N022343 001 Aug 15, 2018

EFLORNITHINE HYDROCHLORIDE

INJECTABLE;INJECTION

ORNIDYL

SANOFI AVENTIS US 200MG/ML
N019879 002 Nov 28, 1990

ELVITEGRAVIR

TABLET;ORAL

VITEKTA

+ GILEAD SCIENCES INC 85MG
N203093 001 Sep 24, 2014

+ 150MG
N203093 002 Sep 24, 2014

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-142(of 393)

** See List Footnote



ENALAPRIL MALEATE

TABLET;ORAL

ENALAPRIL MALEATE

APOTHECON 2.5MG A075583 001 Aug 22, 2000

5MG A075583 002 Aug 22, 2000

10MG A075583 003 Aug 22, 2000

20MG A075583 004 Aug 22, 2000

IVAX SUB TEVA PHARMS 2.5MG A075482 001 Aug 22, 2000

5MG A075482 002 Aug 22, 2000

10MG A075482 003 Aug 22, 2000

20MG A075482 004 Aug 22, 2000

KRKA DD NOVO MESTO 2.5MG A075370 001 Aug 22, 2000

5MG A075370 002 Aug 22, 2000

10MG A075369 001 Aug 22, 2000

20MG A075369 002 Aug 22, 2000

MYLAN 2.5MG A075472 001 Aug 22, 2000

2.5MG A075480 001 Aug 22, 2000

5MG A075472 002 Aug 22, 2000

10MG A075472 003 Aug 22, 2000

20MG A075472 004 Aug 22, 2000

20MG A075480 004 Aug 22, 2000

SANDOZ 2.5MG A075048 001 Aug 22, 2000

5MG A075048 002 Aug 22, 2000

10MG A075048 003 Aug 22, 2000

20MG A075048 004 Aug 22, 2000

SANDOZ INC 2.5MG A075621 001 Aug 22, 2000

5MG A075621 002 Aug 22, 2000

10MG A075621 003 Aug 22, 2000

20MG A075621 004 Aug 22, 2000

SUN PHARM INDS LTD 2.5MG A075556 001 Aug 22, 2000

5MG A075556 002 Aug 22, 2000

10MG A075556 003 Aug 22, 2000

20MG A075556 004 Aug 22, 2000

WATSON LABS 2.5MG A075501 001 Aug 22, 2000

5MG A075501 002 Aug 22, 2000

10MG A075501 003 Aug 22, 2000

20MG A075501 004 Aug 22, 2000



ENALAPRIL MALEATE; FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

LEXXEL

ASTRAZENECA 5MG;2.5MG N020668 002 Oct 28, 1998

5MG;5MG N020668 001 Dec 27, 1996

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

IVAX SUB TEVA PHARMS 5MG;12.5MG A075736 001 Mar 25, 2003

10MG;25MG A075736 002 Mar 25, 2003

UPSHER SMITH LABS 5MG;12.5MG A076116 001 Sep 19, 2001

10MG;25MG A076116 002 Sep 19, 2001



ENALAPRILAT

INJECTABLE;INJECTION

ENALAPRILAT

HOSPIRA 1.25MG/ML A075456 001 Aug 22, 2000

1.25MG/ML A075571 001 Aug 22, 2000

VASOTEC

+ BIOVAIL LABS INTL 1.25MG/ML ** N019309 001 Feb 09, 1988

ENFLURANE

LIQUID;INHALATION

ENFLURANE

ABBOTT 99.9% A070803 001 Sep 08, 1987

PIRAMAL CRITICAL 99.9% A074396 001 Jul 29, 1994



ETHRANE

BAXTER HLTHCARE 99.9% N017087 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-143(of 393)

** See List Footnote



ENOXACIN

TABLET;ORAL

PENETREX

SANOFI AVENTIS US
200MG
N019616 004 Dec 31, 1991

400MG
N019616 005 Dec 31, 1991

ENOXAPARIN SODIUM

INJECTABLE;SUBCUTANEOUS

LOVENOX (PRESERVATIVE FREE)

+ SANOFI AVENTIS US
90MG/0.6ML (150MG/ML) **
N020164 006 Jun 02, 2000

ENTACAPONE

TABLET;ORAL

ENTACAPONE

MYLAN PHARMS INC
200MG
A202394 001 May 13, 2013

EPINEPHRINE

AEROSOL, METERED;INHALATION

BRONKAID MIST

STERLING
0.25MG/INH
N016803 001

EPINEPHRINE

ARMSTRONG PHARMS
0.2MG/INH
A087907 001 May 23, 1984

PRIMATENE MIST

WYETH CONS
0.2MG/INH
N016126 001

INJECTABLE;INJECTION

SUS-PHRINE SULFITE FREE

FOREST LABS
1.5MG/AMP
N007942 003 Feb 05, 1999

5MG/ML
N007942 001

INJECTABLE;INTRAMUSCULAR

EPI E Z PEN JR

MYLAN SPECIALITY LP
0.15MG/DELIVERY
N019430 004 Aug 03, 1995

EPIPEN E Z PEN

MYLAN SPECIALITY LP
0.3MG/DELIVERY
N019430 003 Aug 03, 1995

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

TWINJECT 0.15

IMPAX
EQ 0.15MG/DELIVERY
N020800 002 May 28, 2004

TWINJECT 0.3

IMPAX
EQ 0.3MG/DELIVERY
N020800 001 May 30, 2003

EPINEPHRINE BITARTRATE

AEROSOL, METERED;INHALATION

BRONITIN MIST

WYETH CONS
0.3MG/INH
N016126 002

MEDIHALER-EPI

3M
0.3MG/INH
N010374 003

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

+ ASTRAZENECA 0.005MG/ML;1% **
N017751 006

+ 0.005MG/ML;1.5% **
N017751 007

+ DENTSPLY PHARM 0.005MG/ML;1.5% **
N021384 001

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST FORTE

ASTRAZENECA 0.005MG/ML;4%
N014763 008

EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

+ ASTRAZENECA 0.005MG/ML;0.5% **
N017751 004

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE

CARLISLE 0.01MG/ML;2%
A084720 001

0.02MG/ML;2%
A084732 001

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

BELMORA LLC 0.01MG/ML;2%
A080504 004 Oct 19, 1983

0.02MG/ML;2%
A080504 005 Oct 19, 1983

EASTMAN KODAK 0.01MG/ML;2%
A040057 002 Feb 26, 1993

0.02MG/ML;2%
A040057 001 Feb 26, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-144(of 393)

** See List Footnote



EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

HOSPIRA 0.005MG/ML;1%
A089649 001 Jun 21, 1988

0.005MG/ML;1.5%
A089650 001 Jun 21, 1988

0.01MG/ML;2%
A078772 001 May 12, 2008

0.02MG/ML;2%
A078772 002 May 12, 2008

WEST-WARD PHARMS INT 0.01MG/ML;1%


A080406 001

0.01MG/ML;2%
A080406 002

LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE

ABBOTT
0.01MG/ML;1%
A083154 001

BEL MAR
0.01MG/ML;1%
A080820 001

0.01MG/ML;2%
A080757 001

DELL LABS
0.01MG/ML;1%
A083389 001

0.01MG/ML;2%
A083390 001

INTL MEDICATION
0.01MG/ML;1%
A086402 001

WATSON LABS
0.01MG/ML;1%
A080377 003

0.01MG/ML;1%
A085463 001

0.01MG/ML;2%
A080377 004

LIDOCATON

PHARMATON
0.01MG/ML;2%
A084729 001 Aug 17, 1983

0.02MG/ML;2%
A084728 001 Aug 17, 1983

OCTOCAINE

SEPTODONT
0.01MG/ML;2%
A084048 001

0.02MG/ML;2%
A084048 002

XYLOCAINE DENTAL WITH EPINEPHRINE

DENTSPLY PHARM
0.01MG/ML;2%
N021381 001

0.02MG/ML;2%
N021381 002

XYLOCAINE W/ EPINEPHRINE

ASTRAZENECA
0.005MG/ML;1%
N010418 006

0.005MG/ML;1.5%
N010418 010

0.005MG/ML;2%
N010418 008

FRESENIUS KABI USA
0.01MG/ML;2%
N006488 003

PATCH;IONTOPHORESIS, TOPICAL

LIDOSITE TOPICAL SYSTEM KIT

VYTERIS
1.05MG/PATCH;100MG/PATCH
N021504 001 May 06, 2004

SOLUTION;IONTOPHORESIS

IONTOCAINE

IOMED
0.01MG/ML;2%
N020530 001 Dec 21, 1995

SOLUTION;IONTOPHORESIS, TOPICAL

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

EMPI 0.01MG/ML;2%
N021486 001 Oct 26, 2004

EPINEPHRINE; PROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

PROCAINE HYDROCHLORIDE W/ EPINEPHRINE

BEL MAR
0.02MG/ML;1%
A080758 001

0.02MG/ML;2%
A080759 001

EPIRUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

EPIRUBICIN HYDROCHLORIDE

EBEWE PHARMA
50MG/25ML (2MG/ML)
A065339 001 Dec 22, 2009

200MG/100ML (2MG/ML)
A065339 002 Dec 22, 2009

HOSPIRA
50MG/25ML (2MG/ML)
A065343 002 Apr 19, 2007

MUSTAFA NEVSAT
50MG/25ML (2MG/ML)
A090266 001 Apr 15, 2011

200MG/100ML (2MG/ML)
A090266 002 Apr 15, 2011

MYLAN INSTITUTIONAL
50MG/25ML (2MG/ML)
A065371 001 Nov 28, 2007

200MG/100ML (2MG/ML)
A065371 002 Nov 28, 2007

POWDER;INTRAVENOUS

EPIRUBICIN HYDROCHLORIDE

HOSPIRA
50MG/VIAL
N050807 001 Sep 15, 2006

200MG/VIAL
N050807 002 Sep 15, 2006

EPLERENONE

TABLET;ORAL

INSPRA

GD SEARLE LLC
100MG
N021437 003 Sep 27, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-145(of 393)

** See List Footnote



EPROSARTAN MESYLATE

TABLET;ORAL

TEVETEN

ABBVIE EQ 300MG BASE N020738 004 Dec 22, 1997
+ EQ 400MG BASE N020738 005 Dec 22, 1997
+ EQ 600MG BASE N020738 006 May 27, 1999
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

TEVETEN HCT

ABBVIE 600MG;12.5MG N021268 001 Nov 01, 2001

600MG;25MG N021268 002 Nov 01, 2001

EPTIFIBATIDE

INJECTABLE;INJECTION

EPTIFIBATIDE

TEVA PHARMS USA 75MG/100ML A091555 001 Jun 05, 2015

ERGOCALCIFEROL

CAPSULE;ORAL

DELTALIN

LILLY 50,000 IU A080884 001

VITAMIN D

CHASE CHEM 50,000 IU A080747 001

EVERYLIFE 50,000 IU A080956 001

IMPAX LABS 50,000 IU A080951 001

LANNETT 50,000 IU A080825 001

VITARINE 50,000 IU A084053 001

WEST WARD 50,000 IU A083102 001

ERGOLOID MESYLATES

CAPSULE;ORAL

HYDERGINE LC

NOVARTIS 1MG N018706 001 Jan 18, 1983

SOLUTION;ORAL

HYDERGINE

NOVARTIS 1MG/ML N018418 001

TABLET;ORAL

ERGOLOID MESYLATES

MUTUAL PHARM 1MG A088891 001 Nov 01, 1985

WATSON LABS 1MG A086433 001 May 27, 1982

1MG A087244 001 Aug 16, 1982

GERIMAL

WATSON LABS 1MG A088207 001 Mar 22, 1984

HYDERGINE

NOVARTIS 0.5MG N017993 003

+ 1MG N017993 001

TABLET;SUBLINGUAL

ALKERGOT

SANDOZ 0.5MG A085153 001

1MG A087417 001

CIRCANOL

3M 0.5MG A084868 001

1MG A085809 001

DEAPRIL-ST

BRISTOL MYERS SQUIBB 1MG A085020 002

ERGOLOID MESYLATES

KV PHARM 0.5MG A085899 001

0.5MG A086265 001

1MG A085900 001

1MG A086264 001

LEDERLE 0.5MG A086984 001

1MG A086985 001

SUN PHARM INDUSTRIES 0.5MG A087407 001

1MG A087552 001

SUPERPHARM 0.5MG A089233 001 Sep 23, 1986

1MG A089234 001 Sep 23, 1986

VANGARD 0.5MG A088013 001 Sep 20, 1982

1MG A088014 001 Sep 20, 1982

WATSON LABS 0.5MG A084930 001



0.5MG A087233 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-146(of 393)
** See List Footnote
ERGOLOID MESYLATES

TABLET;SUBLINGUAL

ERGOLOID MESYLATES

1MG A085177 001
1MG A087183 001
GERIMAL

WATSON LABS
0.5MG A086189 001
1MG A086188 001
HYDERGINE

NOVARTIS
0.5MG N009087 002
1MG N009087 001
HYDROGENATED ERGOT ALKALOIDS

IVAX PHARMS
0.5MG A087186 001
1MG A087185 001
ERGOTAMINE TARTRATE

AEROSOL, METERED;INHALATION

MEDIHALER ERGOTAMINE

3M
0.36MG/INH N012102 001
TABLET;SUBLINGUAL

ERGOSTAT

WATSON LABS INC
2MG A088337 001 Jun 08, 1984
WIGRETTES

ORGANON USA INC
2MG A086750 001 Jul 29, 1982
ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

ERLOTINIB HYDROCHLORIDE

MYLAN PHARMS INC
EQ 25MG BASE A091002 001 Jun 11, 2014
EQ 100MG BASE A091002 002 Jun 11, 2014
EQ 150MG BASE A091002 003 Jun 11, 2014
TEVA PHARMS USA
EQ 100MG BASE A091059 002 Aug 28, 2015
EQ 150MG BASE A091059 003 Aug 28, 2015
ERYTHROMYCIN

CAPSULE, DELAYED REL PELLETS;ORAL

ERYC

PARKE DAVIS
250MG A062546 001 Jul 25, 1985
250MG A062618 001 Sep 25, 1985
WARNER CHILCOTT LLC
250MG A062338 001
ERYC 125

PARKE DAVIS
125MG A062648 001 Oct 24, 1985
ERYC SPRINKLES

HOSPIRA
125MG N050593 001 Jul 22, 1985
ERYTHROMYCIN

BARR
250MG A063098 001 May 04, 1989
GEL;TOPICAL

E-GLADES

MYLAN PHARMS INC
2% A065009 001 Mar 18, 2002
EMGEL

ALTANA
2% A063107 001 Aug 23, 1991
LOTION;TOPICAL

E-SOLVE 2

SYOSSET
2% A062467 001 Jul 03, 1985
OINTMENT;OPHTHALMIC

ERYTHROMYCIN

PHARMADERM
5MG/GM A062446 001 Sep 26, 1983
PHARMAFAIR
5MG/GM A062481 001 Apr 05, 1984
ILOTYCIN

DISTA
0.5% N050368 001
OINTMENT;TOPICAL

AKNE-MYCIN

+ DOW PHARM
2% N050584 001 Jan 10, 1985
POWDER;FOR RX COMPOUNDING

ERYTHROMYCIN

PADDOCK LLC
100% N050610 001 Nov 07, 1986
SOLUTION;TOPICAL

A/T/S

TARO
2% A062405 001 Nov 18, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-147(of 393)

** See List Footnote



ERYTHROMYCIN

SOLUTION;TOPICAL

C-SOLVE-2

FOUGERA PHARMS 2% A062468 001 Jul 03, 1985

ERYDERM

ARBOR PHARMS INC 2% A062290 001

ERYMAX

MERZ PHARMS 2% A062508 002 Jul 11, 1985

ERYTHRA-DERM

ANDA REPOSITORY 2% A062687 001 Feb 05, 1988

ERYTHRO-STATIN

HI TECH PHARMA 2% A064101 001 Oct 22, 1996

ERYTHROMYCIN

ALPHARMA US PHARMS 1.5% A062328 001 Apr 19, 1982

2% A062326 001 Apr 19, 1982

2% A062327 001 Apr 19, 1982

2% A062342 001 Feb 25, 1982



2% A062957 001 Jul 21, 1988

BAUSCH AND LOMB 2% A064039 001 Jan 27, 1994

FOUGERA PHARMS 2% A064187 001 Sep 30, 1997

LILLY 2% N050532 001



PHARMAFAIR 1.5% A062485 001 Jul 11, 1984

2% A062616 001 Jul 25, 1985

RENAISSANCE PHARMA 2% A064127 001 Feb 14, 1997

SANSAC

DOW PHARM 2% A062522 001 Jan 24, 1985

STATICIN

+ WESTWOOD SQUIBB 1.5% ** N050526 001

T-STAT

WESTWOOD SQUIBB 2% ** A062436 001 Mar 09, 1983

SWAB;TOPICAL

C-SOLVE-2

IVAX SUB TEVA PHARMS 2% A062751 001 Jul 30, 1993

ERYCETTE

+ JOHNSON AND JOHNSON 2% ** N050594 001 Feb 15, 1985

ERYTHROMYCIN

FOUGERA PHARMS 2% A065320 001 Jul 25, 2006

MYLAN PHARMS INC 2% A064128 001 Jul 03, 1996

T-STAT

WESTWOOD SQUIBB 2% A062748 001 Jul 23, 1987

TABLET, COATED PARTICLES;ORAL

PCE

+ ARBOR PHARMS LLC 333MG N050611 001 Sep 09, 1986

+ 500MG N050611 002 Aug 22, 1990

TABLET, DELAYED RELEASE;ORAL



E-BASE

BARR 333MG A063028 001 May 15, 1990

333MG A063086 001 May 15, 1990

500MG A062999 001 Nov 25, 1988



E-MYCIN

ARBOR PHARMS INC 250MG A060272 001

333MG A060272 002

ILOTYCIN

DISTA 250MG A061910 001

R-P MYCIN

SOLVAY 250MG A061659 001

ROBIMYCIN

ROBINS AH 250MG A061633 001

ERYTHROMYCIN ESTOLATE

CAPSULE;ORAL

ERYTHROMYCIN ESTOLATE

BARR EQ 125MG BASE A062162 001

EQ 250MG BASE A062162 002

IVAX SUB TEVA PHARMS EQ 250MG BASE A062237 001

WATSON LABS EQ 250MG BASE A062087 001

ILOSONE

LILLY EQ 125MG BASE A061897 001

EQ 250MG BASE A061897 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-148(of 393)

** See List Footnote



ERYTHROMYCIN ESTOLATE

FOR SUSPENSION;ORAL

ILOSONE

DISTA
EQ 125MG BASE/5ML
A061893 001

SUSPENSION;ORAL

ERYTHROMYCIN ESTOLATE

ALPHARMA US PHARMS
EQ 125MG BASE/5ML
A062353 001 Nov 18, 1982

EQ 250MG BASE/5ML
A062409 001 Dec 16, 1982

G AND W LABS INC
EQ 125MG BASE/5ML
A062169 001 Oct 17, 1990

EQ 250MG BASE/5ML
A062169 002 Oct 17, 1990

LIFE LABS
EQ 250MG BASE/5ML
A062362 001 Dec 17, 1982

ILOSONE

LILLY
EQ 125MG BASE/5ML
A061894 001

EQ 125MG BASE/5ML
N050010 001

EQ 250MG BASE/5ML
A061894 002

EQ 250MG BASE/5ML
N050010 002

SUSPENSION/DROPS;ORAL

ILOSONE

LILLY
EQ 100MG BASE/ML
A061894 003

TABLET;ORAL

ILOSONE

LILLY
EQ 500MG BASE
A061896 001

TABLET, CHEWABLE;ORAL

ILOSONE

DISTA
EQ 125MG BASE
A061895 001

EQ 250MG BASE
A061895 002

ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL

SUSPENSION;ORAL

ILOSONE SULFA

LILLY
EQ 125MG BASE/5ML;EQ 600MG BASE/5ML
N050599 001 Sep 29, 1989

ERYTHROMYCIN ETHYLSUCCINATE

GRANULE;ORAL

PEDIAMYCIN

ROSS LABS
EQ 200MG BASE/5ML
A062305 001

SUSPENSION;ORAL

E-MYCIN E

PHARMACIA AND UPJOHN EQ 200MG BASE/5ML
A062198 001

EQ 400MG BASE/5ML
A062198 002

E.E.S. 200

ARBOR PHARMS LLC
EQ 200MG BASE/5ML **
A061639 001

E.E.S. 400

ARBOR PHARMS LLC
EQ 400MG BASE/5ML **
A061639 002

ERYTHROMYCIN ETHYLSUCCINATE

ALPHARMA US PHARMS
EQ 200MG BASE/5ML
A062200 001

EQ 400MG BASE/5ML
A062200 002

DISTA
EQ 200MG BASE/5ML
A062177 001

EQ 400MG BASE/5ML
A062177 002

NASKA
EQ 400MG BASE/5ML
A062674 001 Mar 10, 1987

PARKE DAVIS
EQ 200MG BASE/5ML
A062231 001

EQ 400MG BASE/5ML
A062231 002

PHARMAFAIR
EQ 200MG BASE/5ML
A062559 001 Mar 15, 1985

EQ 400MG BASE/5ML
A062558 001 Mar 15, 1985

PEDIAMYCIN

ARBOR PHARMS LLC
EQ 200MG BASE/5ML
A062304 001

PEDIAMYCIN 400

ARBOR PHARMS LLC
EQ 400MG BASE/5ML
A062304 002

WYAMYCIN E

WYETH AYERST
EQ 200MG BASE/5ML
A062123 002

EQ 400MG BASE/5ML
A062123 001

SUSPENSION/DROPS;ORAL

PEDIAMYCIN

ROSS LABS
EQ 100MG BASE/2.5ML
A062305 002

TABLET;ORAL

E.E.S. 400

ARBOR PHARMS LLC
EQ 400MG BASE
A061905 001

ERYTHROMYCIN ETHYLSUCCINATE

BARR
EQ 400MG BASE
A062256 001

MYLAN
EQ 400MG BASE
A062847 001 Sep 14, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-149(of 393)

** See List Footnote



ERYTHROMYCIN ETHYLSUCCINATE

TABLET, CHEWABLE;ORAL

E.E.S.

ARBOR PHARMS INC EQ 200MG BASE
N050297 002

ERYPED

ARBOR PHARMS INC EQ 200MG BASE
N050297 003 Jul 05, 1988

PEDIAMYCIN

ROSS LABS EQ 200MG BASE
A062306 001

ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL

GRANULE;ORAL

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

BARR
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
A062759 001 May 20, 1988

ERYZOLE

ALRA
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
A062758 001 Jun 15, 1988

PEDIAZOLE

ROSS LABS
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
N050529 001

ERYTHROMYCIN GLUCEPTATE

INJECTABLE;INJECTION

ILOTYCIN GLUCEPTATE

DISTA
EQ 250MG BASE/VIAL
N050370 001

EQ 500MG BASE/VIAL
N050370 002

EQ 1GM BASE/VIAL
N050370 003

ERYTHROMYCIN LACTOBIONATE

INJECTABLE;INJECTION

ERYTHROCIN

ABBOTT
EQ 500MG BASE/VIAL
A062586 001 Jan 04, 1988

EQ 1GM BASE/VIAL
A062586 002 Jan 04, 1988

HOSPIRA
EQ 500MG BASE/VIAL
N050182 002

EQ 1GM BASE/VIAL
A062638 002 Oct 31, 1986

EQ 1GM BASE/VIAL
N050182 003

+
EQ 1GM BASE/VIAL
N050609 002 Sep 24, 1986

ERYTHROMYCIN

ELKINS SINN
EQ 500MG BASE/VIAL
A062563 001 Mar 28, 1985

EQ 1GM BASE/VIAL
A062563 002 Mar 28, 1985

ERYTHROMYCIN LACTOBIONATE

ABRAXIS PHARM
EQ 500MG BASE/VIAL
A062604 001 Nov 24, 1986

EQ 1GM BASE/VIAL
A062604 002 Nov 24, 1986

BAXTER HLTHCARE
EQ 500MG BASE/VIAL
A062993 001 May 09, 1989

EQ 1GM BASE/VIAL
A062993 002 May 09, 1989

TEVA PARENTERAL
EQ 500MG BASE/VIAL
A063253 001 Jul 30, 1993

EQ 1GM BASE/VIAL
A063253 002 Jul 30, 1993

ERYTHROMYCIN STEARATE

TABLET;ORAL

BRISTAMYCIN

BRISTOL
EQ 250MG BASE
A061304 001

EQ 250MG BASE
A061887 001

ERYPAR

PARKE DAVIS
EQ 250MG BASE
A062032 001

EQ 500MG BASE
A062032 002

WARNER CHILCOTT
EQ 250MG BASE
A062322 001

ERYTHROCIN STEARATE

ARBOR PHARMS LLC
EQ 125MG BASE
A060359 002

EQ 500MG BASE
A060359 003

ERYTHROMYCIN STEARATE

ANI PHARMS INC
EQ 250MG BASE
A061461 001

EQ 250MG BASE
A061591 001

EQ 500MG BASE
A061461 002

EQ 500MG BASE
A063179 001 May 15, 1990

LEDERLE
EQ 250MG BASE
A062089 001

EQ 500MG BASE
A062089 002

MYLAN
EQ 250MG BASE
A061505 001

EQ 500MG BASE
A061505 002

PUREPAC PHARM
EQ 250MG BASE
A061743 001

WATSON LABS
EQ 250MG BASE
A062121 002

EQ 500MG BASE
A062121 001

ETHRIL 250

BRISTOL MYERS SQUIBB EQ 250MG BASE
A061605 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-150(of 393)

** See List Footnote



ERYTHROMYCIN STEARATE

TABLET;ORAL

ETHRIL 500

BRISTOL MYERS SQUIBB EQ 500MG BASE A061605 002

PFIZER-E
PFIZER EQ 250MG BASE A061791 001
EQ 500MG BASE A061791 002
WYAMYCIN S
WYETH AYERST EQ 250MG BASE A061675 001
EQ 500MG BASE A061675 002
ESCITALOPRAM OXALATE
CAPSULE;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC EQ 5MG BASE A077660 001 Jul 31, 2007
EQ 10MG BASE A077660 002 Jul 31, 2007
EQ 20MG BASE A077660 003 Jul 31, 2007
TABLET;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC EQ 5MG BASE A077550 001 May 14, 2015
EQ 10MG BASE A077550 002 May 14, 2015
EQ 20MG BASE A077550 003 May 14, 2015
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
BREVIBLOC
BAXTER HLTHCARE 10MG/ML N019386 003 Aug 15, 1988
20MG/ML N019386 007 May 28, 2003
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS
ESOMEPRAZOLE SODIUM
AUROBINDO PHARMA LTD EQ 20MG BASE/VIAL A204657 001 Aug 10, 2016
MYLAN LABS LTD EQ 20MG BASE/VIAL A202686 001 May 17, 2017
SUN PHARMA GLOBAL EQ 20MG BASE/VIAL A200882 001 Mar 18, 2013
NEXIUM IV
+ ASTRAZENECA PHARMS EQ 20MG BASE/VIAL ** N021689 001 Mar 31, 2005
ESOMEPRAZOLE STRONTIUM
CAPSULE, DELAYED RELEASE;ORAL
ESOMEPRAZOLE STRONTIUM
+ R2 PHARMA LLC 24.65MG N202342 001 Aug 06, 2013
ESTAZOLAM
TABLET;ORAL
PROSOM
+ ABBOTT 1MG ** N019080 001 Dec 26, 1990
+ 2MG ** N019080 002 Dec 26, 1990
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
ESCLIM
WOMEN FIRST HLTHCARE 0.025MG/24HR N020847 001 Aug 04, 1998
0.0375MG/24HR N020847 002 Aug 04, 1998
0.05MG/24HR N020847 003 Aug 04, 1998
0.075MG/24HR N020847 004 Aug 04, 1998
0.1MG/24HR N020847 005 Aug 04, 1998
ESTRADERM
+ NOVARTIS 0.05MG/24HR N019081 002 Sep 10, 1986
+ 0.1MG/24HR N019081 003 Sep 10, 1986
ESTRADIOL
ORTHO MCNEIL PHARM 0.05MG/24HR N021048 001 Sep 20, 1999
0.075MG/24HR N021048 002 Sep 20, 1999
0.1MG/24HR N021048 003 Sep 20, 1999
FEMPATCH
PARKE DAVIS 0.025MG/24HR N020417 001 Dec 03, 1996
VIVELLE
NOVARTIS 0.025MG/24HR N020323 005 Aug 16, 2000
0.0375MG/24HR N020323 001 Oct 28, 1994
0.05MG/24HR N020323 002 Oct 28, 1994
0.075MG/24HR N020323 003 Oct 28, 1994
0.1MG/24HR N020323 004 Oct 28, 1994

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-151(of 393)

** See List Footnote



ESTRADIOL

GEL;TOPICAL

ESTROGEL

ASCEND THERAPS US 0.06% N021166 001 Feb 09, 2004

TABLET;ORAL

ESTRACE

BRISTOL MYERS SQUIBB 0.5MG A081295 001 Jun 30, 1993

1MG A084499 001

2MG A084500 001

ESTRADIOL

LANNETT HOLDINGS INC 0.5MG A040138 001 Jan 30, 1998

1MG A040138 002 Jan 30, 1998

2MG A040138 003 Jan 30, 1998

USL PHARMA 0.5MG A040297 001 Apr 17, 2002

1MG A040297 002 Apr 17, 2002

2MG A040297 003 Apr 17, 2002

GYNODIOL

DURAMED PHARMS BARR 0.5MG A040212 001 Dec 29, 1997

1MG A040212 002 Dec 29, 1997

1.5MG A040212 003 Dec 29, 1997

2MG A040212 004 Dec 29, 1997

INNOFEM

NOVO NORDISK INC 0.5MG A040312 001 Nov 19, 1999

1MG A040312 002 Nov 19, 1999

2MG A040312 003 Nov 19, 1999

TABLET;VAGINAL

VAGIFEM

+ NOVO NORDISK INC 25MCG ** N020908 001 Mar 26, 1999

ESTRADIOL ACETATE

TABLET;ORAL

FEMTRACE

+ APIL 0.45MG N021633 001 Aug 20, 2004

+ 0.9MG N021633 002 Aug 20, 2004

+ 1.8MG N021633 003 Aug 20, 2004



ESTRADIOL CYPIONATE

INJECTABLE;INJECTION

DEPO-ESTRADIOL

PHARMACIA AND UPJOHN 1MG/ML A085470 001

3MG/ML A085470 002

ESTRADIOL CYPIONATE

WATSON LABS 5MG/ML A085620 001

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE

INJECTABLE;INTRAMUSCULAR

LUNELLE

PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML N020874 001 Oct 05, 2000

ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTADIOL

PHARMACIA AND UPJOHN 2MG/ML;50MG/ML N017968 001

TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE

WATSON LABS 2MG/ML;50MG/ML A085603 001 Mar 13, 1986

ESTRADIOL HEMIHYDRATE

EMULSION;TOPICAL

ESTRASORB

+ EXELTIS USA INC 0.25% N021371 001 Oct 09, 2003

ESTRADIOL VALERATE

INJECTABLE;INJECTION

ESTRADIOL VALERATE

FOSUN PHARMA 10MG/ML A040628 001 Oct 04, 2007

20MG/ML A040628 002 Oct 04, 2007

40MG/ML A040628 003 Oct 04, 2007

WATSON LABS 10MG/ML A083546 001

40MG/ML A083714 001

WATSON LABS INC 20MG/ML A083547 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-152(of 393)

** See List Footnote



ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

DITATE-DS

SAVAGE LABS 8MG/ML;180MG/ML
A086423 001

TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE

WATSON LABS 4MG/ML;90MG/ML
A085865 001

8MG/ML;180MG/ML
A085860 001

ESTRADIOL; NORGESTIMATE

TABLET;ORAL

PREFEST

+ TEVA WOMENS 1MG,1MG;N/A,0.09MG **
N021040 001 Oct 22, 1999

ESTROGENS, CONJUGATED

TABLET;ORAL

PREMARIN

WYETH PHARMS 2.5MG
N004782 002

ESTROGENS, CONJUGATED SYNTHETIC A

CREAM;VAGINAL

SYNTHETIC CONJUGATED ESTROGENS A

TEVA WOMENS 0.625MG/GM
N021788 001 Nov 28, 2008

TABLET;ORAL

CENESTIN

+ TEVA BRANDED PHARM 0.3MG **
N020992 001 Jun 21, 2002

+ 0.45MG **
N020992 005 Feb 05, 2004

+ 0.625MG **
N020992 002 Mar 24, 1999

+ 0.9MG **
N020992 003 Mar 24, 1999

+ 1.25MG **
N020992 004 Mar 13, 2000

ESTROGENS, CONJUGATED SYNTHETIC B

TABLET;ORAL

ENJUVIA

TEVA BRANDED PHARM 0.3MG
N021443 001 Dec 20, 2004

0.45MG
N021443 002 Dec 20, 2004

0.625MG **
N021443 003 May 10, 2004

0.9MG
N021443 005 Apr 27, 2007

1.25MG **
N021443 004 May 10, 2004

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

TABLET;ORAL-28

PREMPHASE (PREMARIN;CYCRIN 14/14)

WYETH PHARMS INC 0.625MG,0.625MG;N/A,5MG


N020303 002 Dec 30, 1994

PREMPRO (PREMARIN;CYCRIN)

WYETH PHARMS INC 0.625MG,0.625MG;2.5MG,2.5MG


N020303 001 Dec 30, 1994

ESTROGENS, CONJUGATED; MEPROBAMATE

TABLET;ORAL

MILPREM-200

MEDPOINTE PHARM HLC
0.45MG;200MG
N011045 002

MILPREM-400

MEDPOINTE PHARM HLC
0.45MG;400MG
N011045 001

PMB 200

WYETH AYERST
0.45MG;200MG
N010971 005

PMB 400

WYETH AYERST
0.45MG;400MG
N010971 003

ESTROGENS, ESTERIFIED

TABLET;ORAL

AMNESTROGEN

BRISTOL MYERS SQUIBB 0.3MG
A083266 001

0.625MG A083266 002

1.25MG A083266 003

2.5MG A083266 004

ESTERIFIED ESTROGENS
PVT FORM 0.625MG A083414 001

1.25MG A083765 001

2.5MG A085907 001

SANDOZ 1.25MG A085302 001

ESTRATAB
SOLVAY 0.3MG A086715 001

0.625MG A083209 001

1.25MG A083856 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-153(of 393)
** See List Footnote
ESTROGENS, ESTERIFIED
TABLET;ORAL
ESTRATAB
2.5MG A083857 001
EVEX
ROCHE PALO 0.625MG A084215 001
1.25MG A083376 002
FEMOGEN
PVT FORM 0.625MG A085076 001
1.25MG A085008 001
2.5MG A085007 001
ESTRONE
INJECTABLE;INJECTION
ESTROGENIC SUBSTANCE
WYETH AYERST 2MG/ML A083488 001
ESTRONE
WATSON LABS 2MG/ML A083397 001
WATSON LABS TEVA 5MG/ML A085239 001
NATURAL ESTROGENIC SUBSTANCE-ESTRONE
WATSON LABS 2MG/ML A085237 001 Nov 23, 1982
THEELIN
PARKEDALE 1MG/ML N003977 001
2MG/ML N003977 002
5MG/ML N003977 003
ESTROPIPATE
CREAM;VAGINAL
OGEN
PHARMACIA AND UPJOHN 1.5MG/GM A084710 001
TABLET;ORAL
ESTROPIPATE
BARR 0.75MG A040135 001 Nov 27, 1996
1.5MG A040135 002 Nov 27, 1996
3MG A040135 003 Nov 27, 1996
DURAMED PHARMS BARR 0.75MG A040296 001 Nov 01, 1999
1.5MG A040296 002 Nov 01, 1999
3MG A040296 003 Nov 01, 1999
MYLAN 3MG A040359 003 Aug 26, 1999
WATSON LABS 0.75MG A081213 001 Sep 23, 1993
1.5MG A081214 001 Sep 23, 1993
6MG A081216 001 Sep 23, 1993
WATSON LABS TEVA 3MG A081215 001 Sep 23, 1993
OGEN .625
PHARMACIA AND UPJOHN 0.75MG A083220 001
OGEN 1.25
PHARMACIA AND UPJOHN 1.5MG A083220 002
OGEN 2.5
PHARMACIA AND UPJOHN 3MG A083220 003
ORTHO-EST
SUN PHARM INDS INC 0.75MG A089567 001 Feb 27, 1991
1.5MG A089582 001 Jul 17, 1991
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
WOCKHARDT LTD 1MG A091165 001 Jul 14, 2011
2MG A091165 002 Jul 14, 2011
3MG A091165 003 Jul 14, 2011
ETHACRYNIC ACID
TABLET;ORAL
EDECRIN
ATON 50MG N016092 002
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
MYAMBUTOL
STI PHARMA LLC 200MG N016320 002
500MG N016320 004

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

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** See List Footnote



ETHCHLORVYNOL

CAPSULE;ORAL

ETHCHLORVYNOL

BANNER PHARMACAPS 100MG A084463 001

200MG A084463 002

500MG A084463 003

750MG A084463 004

PLACIDYL

ABBVIE 100MG N010021 004

200MG N010021 007

500MG N010021 002

750MG N010021 010

ETHINAMATE

CAPSULE;ORAL

VALMID

DISTA 500MG N009750 001

ETHINYL ESTRADIOL

TABLET;ORAL

ESTINYL

SCHERING 0.02MG N005292 001

0.05MG N005292 002

0.5MG N005292 003

FEMINONE

PHARMACIA AND UPJOHN 0.05MG N016649 001

LYNORAL

ORGANON USA INC 0.01MG N005490 003

0.05MG N005490 002

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

TABLET;ORAL-21

DEMULEN 1/35-21
GD SEARLE LLC 0.035MG;1MG ** N018168 001
DEMULEN 1/50-21
GD SEARLE LLC 0.05MG;1MG N016927 001
ZOVIA 1/35E-21
WATSON PHARMS TEVA 0.035MG;1MG A072720 001 Dec 30, 1991
ZOVIA 1/50E-21
WATSON LABS 0.05MG;1MG A072722 001 Dec 30, 1991
TABLET;ORAL-28
DEMULEN 1/35-28
GD SEARLE LLC 0.035MG;1MG ** N018160 001
DEMULEN 1/50-28
GD SEARLE LLC 0.05MG;1MG ** N016936 001
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

TABLET;ORAL-28

NORQUEST FE

GD SEARLE LLC 0.035MG;75MG;1MG N018926 001 Jul 18, 1986

ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE

TABLET;ORAL-28

NORLESTRIN FE 1/50

PARKE DAVIS 0.05MG;75MG;1MG N016766 001



NORLESTRIN FE 2.5/50

PARKE DAVIS 0.05MG;75MG;2.5MG N016854 001



ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

LYBREL

+ WYETH PHARMS INC 0.02MG;0.09MG ** N021864 001 May 22, 2007

PREVEN EMERGENCY CONTRACEPTIVE KIT



TEVA BRANDED PHARM 0.05MG;0.25MG N020946 001 Sep 01, 1998

TABLET;ORAL-21

ALESSE

+ CADENCE HEALTH 0.02MG;0.1MG ** N020683 001 Mar 27, 1997

AVIANE-21

DURAMED PHARMS BARR 0.02MG;0.1MG A075796 002 Apr 30, 2001

ENPRESSE-21

DURAMED PHARMS BARR 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A075809 001 Jul 16, 2001

25MG

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-155(of 393)

** See List Footnote



ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL-21

LESSINA-21

BARR 0.02MG;0.1MG A075803 001 Mar 20, 2002

LEVLITE

+ BAYER HLTHCARE 0.02MG;0.1MG ** N020860 001 Jul 13, 1998

LEVONORGESTREL AND ETHINYL ESTRADIOL

BARR 0.02MG;0.1MG A075862 001 Apr 29, 2003

LEVORA 0.15/30-21

WATSON LABS 0.03MG;0.15MG A073592 001 Dec 13, 1993



NORDETTE-21

TEVA BRANDED PHARM 0.03MG;0.15MG N018668 001 May 10, 1982

PORTIA-21

BARR 0.03MG;0.15MG A075866 001 May 23, 2002

TRIPHASIL-21

+ WYETH PHARMS 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019192 001 Nov 01, 1984

25MG **

TRIVORA-21

MAYNE PHARMA 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A074538 001 Dec 18, 1997

25MG

TABLET;ORAL-28

ALESSE

+ CADENCE HEALTH 0.02MG;0.1MG ** N020683 002 Mar 27, 1997

LEVLITE

+ BAYER HLTHCARE 0.02MG;0.1MG ** N020860 002 Jul 13, 1998

LEVONORGESTREL AND ETHINYL ESTRADIOL

BARR 0.02MG;0.1MG A075862 002 Apr 29, 2003

NORDETTE-28

+ TEVA BRANDED PHARM 0.03MG;0.15MG ** N018782 001 Jul 21, 1982

TRIPHASIL-28

+ WYETH PHARMS INC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 N019190 001 Nov 01, 1984

25MG **

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE;TRANSDERMAL

ORTHO EVRA

+ JANSSEN PHARMS 0.035MG/24HR;0.15MG/24HR ** N021180 001 Nov 20, 2001

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-21

BALZIVA-21

BARR 0.035MG;0.4MG A076198 001 Apr 22, 2004

BREVICON 21-DAY

ALLERGAN SALES LLC 0.035MG;0.5MG N017566 001

GENCEPT 10/11-21

BARR 0.035MG,0.035MG;0.5MG,1MG A072694 001 Feb 28, 1992



MODICON 21

ORTHO MCNEIL PHARM 0.035MG;0.5MG ** N017488 001

N.E.E. 1/35 21

LPI 0.035MG;1MG A071541 001 Dec 14, 1987



NORCEPT-E 1/35 21

ORTHO MCNEIL PHARM 0.035MG;1MG A071545 001 Feb 09, 1989



NORETHIN 1/35E-21

WATSON PHARMS TEVA 0.035MG;1MG A071480 001 Apr 12, 1988

NORETHINDRONE AND ETHINYL ESTRADIOL



WATSON LABS 0.035MG;0.4MG A078379 001 Feb 23, 2010

0.035MG;0.5MG A070684 001 Jan 29, 1987

WATSON PHARMS TEVA 0.035MG;1MG A070685 001 Jan 29, 1987

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)

WATSON LABS 0.035MG,0.035MG;0.5MG,1MG A071043 001 Apr 01, 1988

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

WATSON LABS TEVA 0.035MG,0.035MG;0.5MG,1MG A071041 001 Sep 24, 1991

NORTREL 0.5/35-21

BARR 0.035MG;0.5MG A072692 001 Feb 28, 1992



ORTHO-NOVUM 1/35-21

ORTHO MCNEIL PHARM 0.035MG;1MG ** N017489 002



ORTHO-NOVUM 10/11-21

+ ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG ** N018354 001 Jan 11, 1982



ORTHO-NOVUM 7/14-21

ORTHO MCNEIL PHARM 0.035MG,0.035MG;0.5MG,1MG ** N019004 001 Apr 04, 1984


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-156(of 393)

** See List Footnote



ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-21

ORTHO-NOVUM 7/7/7-21

JANSSEN PHARMS
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
N018985 001 Apr 04, 1984

G

OVCON-35

+ WARNER CHILCOTT
0.035MG;0.4MG **
N018127 001

OVCON-50

WARNER CHILCOTT
0.05MG;1MG
N018128 001

TRI-NORINYL 21-DAY

MAYNE PHARMA
0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
N018977 001 Apr 13, 1984

TABLET;ORAL-28

GENCEPT 10/11-28

BARR
0.035MG,0.035MG;0.5MG,1MG
A072697 001 Feb 28, 1992

MODICON 28

+ JANSSEN PHARMS
0.035MG;0.5MG
N017735 001

N.E.E. 1/35 28

LPI
0.035MG;1MG
A071542 001 Dec 14, 1987

NORCEPT-E 1/35 28

ORTHO MCNEIL PHARM 0.035MG;1MG


A071546 001 Feb 09, 1989

NORETHIN 1/35E-28

WATSON LABS 0.035MG;1MG


A071481 001 Apr 12, 1988

NORETHINDRONE AND ETHINYL ESTRADIOL

MYLAN LABS LTD 0.035MG;0.4MG
A200897 001 May 11, 2015

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
A200486 001 Dec 28, 2015

G

0.035MG;0.5MG
A200488 001 Oct 21, 2015

0.035MG;1MG
A200489 001 Oct 21, 2015

WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
A076393 001 Feb 04, 2010

G

NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)

WATSON LABS 0.035MG,0.035MG;0.5MG,1MG


A071042 001 Sep 24, 1991

ORTHO-NOVUM 10/11-28

+ ORTHO MCNEIL JANSSEN 0.035MG,0.035MG;0.5MG,1MG


N018354 002 Jan 11, 1982

ORTHO-NOVUM 7/14-28

ORTHO MCNEIL PHARM 0.035MG,0.035MG;0.5MG,1MG **


N019004 002 Apr 04, 1984

OVCON-35

+ WARNER CHILCOTT LLC 0.035MG;0.4MG **
N017716 001

OVCON-50

WARNER CHILCOTT LLC 0.05MG;1MG **
N017576 001

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL

FEMHRT

+ APIL 0.005MG;1MG **
N021065 002 Oct 15, 1999

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

MYLAN LABS LTD 0.01MG,0.01MG;1MG,N/A
A205049 001 May 31, 2016

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

APOTEX INC
0.02MG;1MG
A208639 001 Mar 21, 2018

TABLET;ORAL-21

ESTROSTEP 21

+ APIL
0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **
N020130 001 Oct 09, 1996

NORLESTRIN 21 1/50

PARKE DAVIS
0.05MG;1MG
N016749 001

NORLESTRIN 21 2.5/50

PARKE DAVIS
0.05MG;2.5MG
N016852 001

TABLET;ORAL-28

NORLESTRIN 28 1/50

PARKE DAVIS
0.05MG;1MG
N016723 001

TABLET, CHEWABLE, TABLET;ORAL

LO MINASTRIN FE

+ APIL
0.01MG,0.01MG,N/A;1MG,N/A,N/A
N204654 001 Jul 24, 2013

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-21

ORTHO CYCLEN-21

JANSSEN PHARMS
0.035MG;0.25MG
N019653 001 Dec 29, 1989

ORTHO TRI-CYCLEN

JANSSEN PHARMS
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
N019697 002 Jul 03, 1992

0.25MG

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-157(of 393)

** See List Footnote



ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

NORGESTIMATE AND ETHINYL ESTRADIOL

WATSON LABS
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
A090479 001 Mar 09, 2011

0.25MG

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
A076626 001 Aug 17, 2006

0.25MG

0.035MG;0.25MG
A076627 001 Aug 17, 2006

ETHINYL ESTRADIOL; NORGESTREL

TABLET;ORAL-21

LO/OVRAL

CADENCE HEALTH
0.03MG;0.3MG
N017612 001

LOW-OGESTREL-21

MAYNE PHARMA
0.03MG;0.3MG
A075288 001 Jul 28, 1999

OGESTREL 0.5/50-21

WATSON LABS
0.05MG;0.5MG
A075406 001 Dec 15, 1999

OVRAL

WYETH PHARMS
0.05MG;0.5MG
N016672 001

TABLET;ORAL-28

LO/OVRAL-28

WYETH PHARMS
0.03MG;0.3MG **
N017802 001

NORGESTREL AND ETHINYL ESTRADIOL

MYLAN LABS LTD
0.03MG;0.3MG
A201828 001 Jun 21, 2016

0.05MG;0.5MG
A202875 001 May 08, 2017

OVRAL-28

WYETH PHARMS
0.05MG;0.5MG
N016806 001

ETHOPROPAZINE HYDROCHLORIDE

TABLET;ORAL

PARSIDOL

PARKE DAVIS
10MG
N009078 003

50MG
N009078 006

100MG
N009078 008

ETHOTOIN

TABLET;ORAL

PEGANONE

RECORDATI RARE
500MG
N010841 003

ETHOXZOLAMIDE

TABLET;ORAL

CARDRASE

PHARMACIA AND UPJOHN 62.5MG
N011047 002

125MG
N011047 001

ETHAMIDE

ALLERGAN
125MG
N016144 001

ETHYLESTRENOL

ELIXIR;ORAL

MAXIBOLIN

ORGANON USA INC
2MG/5ML
N014006 002

TABLET;ORAL

MAXIBOLIN

ORGANON USA INC
2MG
N014005 002

ETHYNODIOL DIACETATE; MESTRANOL

TABLET;ORAL-20

OVULEN

GD SEARLE LLC
1MG;0.1MG
N016029 002

TABLET;ORAL-21

OVULEN-21

GD SEARLE LLC
1MG;0.1MG
N016029 003

TABLET;ORAL-28

OVULEN-28

GD SEARLE LLC
1MG;0.1MG
N016705 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-158(of 393)

** See List Footnote



ETIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

DURANEST

+ ASTRAZENECA 0.5% ** N017751 003

+ 1% ** N017751 005

ETIDRONATE DISODIUM

INJECTABLE;INJECTION

DIDRONEL

MGI PHARMA INC 50MG/ML N019545 001 Apr 20, 1987

TABLET;ORAL

DIDRONEL

+ APIL 200MG ** N017831 001

+ 400MG ** N017831 002

ETODOLAC

CAPSULE;ORAL

ETODOLAC

ANI PHARMS INC 200MG A074840 001 Aug 29, 1997

200MG A074899 001 Jul 08, 1997



300MG A074840 002 Aug 29, 1997

300MG A074899 002 Jul 08, 1997



CHARTWELL MOLECULES 200MG A074842 001 Jul 17, 1997

300MG A074842 002 Jul 17, 1997

ECI PHARMS LLC 300MG A074929 001 Jan 30, 1998

MYLAN 200MG A074932 001 May 16, 1997

200MG A075071 001 Sep 30, 1998

300MG A074932 002 May 16, 1997

300MG A075071 002 Sep 30, 1998

SANDOZ 200MG A074942 001 Sep 30, 1997

300MG A074942 002 Sep 30, 1997

WATSON LABS 200MG A074844 001 Dec 23, 1997



300MG A074844 002 Dec 23, 1997

LODINE

+ WYETH PHARMS INC 200MG ** N018922 002 Jan 31, 1991

+ 300MG N018922 003 Jan 31, 1991

TABLET;ORAL

ETODOLAC

CHARTWELL MOLECULES 400MG A074841 001 Jun 27, 1997

ECI PHARMS LLC 400MG A074927 001 Oct 30, 1997

IVAX SUB TEVA PHARMS 400MG A074883 001 Feb 28, 1997

500MG A074883 002 Nov 20, 1998

MYLAN 400MG A075012 001 Sep 30, 1998

500MG A075012 002 Sep 30, 1998

MYLAN PHARMS INC 400MG A075104 001 Feb 06, 1998



500MG A075104 002 Nov 20, 1998

OXFORD PHARMS 400MG A074819 001 Feb 28, 1997

500MG A074819 002 Apr 28, 1998

RANBAXY LABS LTD 400MG A075226 001 Nov 24, 1998



500MG A075226 002 Nov 24, 1998

SANDOZ 400MG A074839 001 Jul 11, 1997

400MG A074846 001 Feb 28, 1997

TEVA 400MG A074847 001 Apr 23, 1999

500MG A074847 002 Apr 23, 1999

WATSON LABS 400MG A074892 001 Apr 16, 1997

400MG A075069 001 Apr 16, 1998

500MG A074892 002 Oct 29, 1998



LODINE

+ WYETH PHARMS INC 400MG ** N018922 004 Jul 29, 1993

+ 500MG ** N018922 005 Jun 28, 1996

TABLET, EXTENDED RELEASE;ORAL

ETODOLAC

ACTAVIS ELIZABETH 400MG A075696 001 Jul 31, 2000

ANI PHARMS INC 400MG A075943 001 Jul 26, 2002

500MG A075943 002 Jul 26, 2002

600MG A075943 003 Jul 26, 2002

WATSON LABS FLORIDA 400MG A075829 001 Nov 30, 2001

500MG A075829 002 Nov 30, 2001

LODINE XL

WYETH PHARMS INC 400MG ** N020584 001 Oct 25, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-159(of 393)

** See List Footnote



ETODOLAC

TABLET, EXTENDED RELEASE;ORAL

LODINE XL

500MG ** N020584 003 Jan 20, 1998

+ 600MG ** N020584 002 Oct 25, 1996

ETONOGESTREL

IMPLANT;IMPLANTATION

IMPLANON

ORGANON USA INC 68MG/IMPLANT N021529 001 Jul 17, 2006

ETOPOSIDE

CAPSULE;ORAL

VEPESID

+ DAVA PHARMS INC 50MG N019557 001 Dec 30, 1986

+ 100MG N019557 002 Dec 30, 1986

INJECTABLE;INJECTION

ETOPOSIDE

HOSPIRA 20MG/ML A074320 001 Aug 30, 1995

20MG/ML A074351 001 Aug 30, 1995

PHARMACHEMIE BV 20MG/ML A074227 001 Feb 22, 1996



PIERRE FABRE 20MG/ML A074813 001 Jul 09, 1997

TEVA PARENTERAL 20MG/ML A074510 001 Jun 29, 1995

TEVA PHARMS USA 20MG/ML A074284 001 Feb 10, 1994

WATSON LABS 20MG/ML A074228 001 Oct 15, 1996

WATSON LABS INC 20MG/ML A074968 001 Jan 09, 1998

TOPOSAR

TEVA PARENTERAL 20MG/ML A074166 001 Feb 27, 1995

VEPESID

+ CORDEN PHARMA 20MG/ML ** N018768 001 Nov 10, 1983

ETOPOSIDE PHOSPHATE

INJECTABLE;INJECTION

ETOPOPHOS PRESERVATIVE FREE

BRISTOL MYERS SQUIBB EQ 500MG BASE/VIAL N020906 001 Feb 27, 1998

EQ 1GM BASE/VIAL N020906 002 Feb 27, 1998

ETRETINATE

CAPSULE;ORAL

TEGISON

ROCHE 10MG N019369 001 Sep 30, 1986

25MG N019369 002 Sep 30, 1986



EVANS BLUE

INJECTABLE;INJECTION

EVANS BLUE

PARKE DAVIS 0.5% ** N008041 001

EZOGABINE

TABLET;ORAL

POTIGA

+ GLAXOSMITHKLINE 50MG N022345 001 Jun 10, 2011

+ 200MG N022345 002 Jun 10, 2011

+ 300MG N022345 003 Jun 10, 2011

+ 400MG N022345 004 Jun 10, 2011

FAMCICLOVIR

TABLET;ORAL

FAMVIR

+ NOVARTIS 125MG ** N020363 003 Dec 11, 1995

+ 250MG ** N020363 001 Apr 26, 1996

+ 500MG ** N020363 002 Jun 29, 1994



FAMOTIDINE

INJECTABLE;INJECTION

FAMOTIDINE

APOTEX INC 10MG/ML A075942 001 Aug 02, 2002

APOTHECON 10MG/ML A075707 001 Apr 16, 2001

HOSPIRA 10MG/ML A075705 001 Apr 16, 2001

10MG/ML A075870 001 Nov 23, 2001



10MG/ML A075905 001 Nov 23, 2001

WEST-WARD PHARMS INT 10MG/ML A075799 001 Apr 30, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-160(of 393)

** See List Footnote



FAMOTIDINE

INJECTABLE;INJECTION

FAMOTIDINE PRESERVATIVE FREE

APOTEX INC 10MG/ML A076324 001 Nov 27, 2002

APOTHECON 10MG/ML A075708 001 Apr 16, 2001

HOSPIRA 10MG/ML A075669 001 Apr 16, 2001

WEST-WARD PHARMS INT 10MG/ML A075789 001 Apr 30, 2002

FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)

APOTEX INC 10MG/ML A076322 001 Nov 27, 2002



FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER

ABBVIE 0.4MG/ML A075729 001 Dec 17, 2001

PEPCID

+ MERCK 10MG/ML ** N019510 001 Nov 04, 1986

PEPCID PRESERVATIVE FREE

+ MERCK 10MG/ML ** N019510 004 Nov 04, 1986

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

+ MERCK SHARP DOHME 0.4MG/ML ** N020249 001 Feb 18, 1994

TABLET;ORAL

FAMOTIDINE

ACTAVIS ELIZABETH 20MG A075650 001 Sep 14, 2001

40MG A075650 002 Sep 14, 2001

APOTEX 10MG A075610 001 Mar 12, 2002



MYLAN PHARMS INC 20MG A075457 001 Apr 18, 2001

40MG A075457 002 Apr 18, 2001

PLD ACQUISITIONS 20MG A075302 001 Apr 16, 2001

40MG A075302 002 Apr 16, 2001

SANDOZ 10MG A076101 001 Oct 21, 2002



20MG A075607 001 May 10, 2001

20MG A075793 001 Apr 16, 2001

40MG A075607 002 May 10, 2001

40MG A075793 002 Apr 16, 2001

SUN PHARM INDUSTRIES 20MG A075639 002 Dec 12, 2001



40MG A075639 001 Dec 12, 2001

WATSON LABS 10MG A075404 001 Nov 28, 2001

20MG A075062 002 Apr 16, 2001

40MG A075062 001 Apr 16, 2001

TABLET, CHEWABLE;ORAL

PEPCID AC

+ J AND J CONSUMER INC 10MG ** N020801 001 Sep 24, 1998

TABLET, ORALLY DISINTEGRATING;ORAL



FLUXID

UCB INC 20MG N021712 001 Sep 24, 2004

40MG N021712 002 Sep 24, 2004

PEPCID RPD

MERCK 20MG N020752 001 May 28, 1998

40MG N020752 002 May 28, 1998



FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

WOCKHARDT LTD 2.5MG A091484 001 Aug 15, 2012

5MG A091484 002 Aug 15, 2012

10MG A091484 003 Aug 15, 2012

PLENDIL

+ ASTRAZENECA 2.5MG ** N019834 004 Sep 22, 1994

+ 5MG ** N019834 001 Jul 25, 1991



+ 10MG ** N019834 002 Jul 25, 1991

FENOFIBRATE

CAPSULE;ORAL

ANTARA (MICRONIZED)

LUPIN ATLANTIS 87MG N021695 002 Nov 30, 2004



LIPIDIL

ABBVIE 100MG N019304 001 Dec 31, 1993

LIPOFEN

CIPHER PHARMS INC 100MG N021612 002 Jan 11, 2006

TRICOR (MICRONIZED)

+ ABBVIE 67MG ** N019304 002 Feb 09, 1998



+ 134MG ** N019304 003 Jun 30, 1999

+ 200MG ** N019304 004 Jun 30, 1999

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-161(of 393)

** See List Footnote



FENOFIBRATE

TABLET;ORAL

FENOFIBRATE

MYLAN 107MG A076520 002 Dec 29, 2005

TRICOR

+ ABBVIE INC 54MG ** N021203 001 Sep 04, 2001

+ 160MG ** N021203 003 Sep 04, 2001

TRIGLIDE

SKYEPHARMA AG 50MG N021350 001 May 07, 2005

FENOLDOPAM MESYLATE

INJECTABLE;INJECTION

FENOLDOPAM MESYLATE

LUITPOLD EQ 10MG BASE/ML A076656 001 Dec 01, 2003

TEVA PARENTERAL EQ 10MG BASE/ML A077826 001 Mar 07, 2007

FENOPROFEN CALCIUM

CAPSULE;ORAL

FENOPROFEN CALCIUM

AM THERAP EQ 200MG BASE A072307 001 Aug 22, 1988

EQ 300MG BASE A072308 001 Aug 22, 1988

AUROLIFE PHARMA LLC EQ 200MG BASE A072394 001 Oct 17, 1988

EQ 300MG BASE A072395 001 Oct 17, 1988

HALSEY EQ 200MG BASE A072355 001 Aug 17, 1988

EQ 300MG BASE A072356 001 Aug 17, 1988

PAR PHARM EQ 200MG BASE A072437 001 Aug 22, 1988

EQ 300MG BASE A072438 001 Aug 22, 1988

QUANTUM PHARMICS EQ 200MG BASE A072214 001 Aug 17, 1988

EQ 300MG BASE A071738 001 Aug 17, 1988

WARNER CHILCOTT EQ 200MG BASE A072946 001 Apr 30, 1991

EQ 300MG BASE A072472 001 Apr 30, 1991

WATSON LABS EQ 200MG BASE A072294 001 Aug 17, 1988

EQ 200MG BASE A072981 001 Aug 19, 1991

EQ 300MG BASE A072293 001 Aug 17, 1988

EQ 300MG BASE A072982 001 Aug 19, 1991

NALFON

XSPIRE PHARMA EQ 300MG BASE N017604 002

TABLET;ORAL

FENOPROFEN CALCIUM

ACTAVIS ELIZABETH EQ 600MG BASE A072274 001 May 02, 1988

AM THERAP EQ 600MG BASE A072309 001 Aug 17, 1988

AUROLIFE PHARMA LLC EQ 600MG BASE A072396 001 Oct 17, 1988

DAVA PHARMS INC EQ 600MG BASE A072326 001 Aug 17, 1988

HALSEY EQ 600MG BASE A072357 001 Aug 17, 1988

IVAX SUB TEVA PHARMS EQ 600MG BASE A072557 001 Aug 29, 1988

PAR PHARM EQ 600MG BASE A072429 001 Aug 17, 1988

QUANTUM PHARMICS EQ 600MG BASE A072194 001 Aug 17, 1988

SUN PHARM INDUSTRIES EQ 600MG BASE A072902 001 Dec 21, 1990

USL PHARMA EQ 600MG BASE A072362 001 Aug 17, 1988

WATSON LABS EQ 600MG BASE A072165 001 Aug 17, 1988

EQ 600MG BASE A072602 001 Oct 11, 1988



WATSON LABS TEVA EQ 600MG BASE A072407 001 Aug 17, 1988

NALFON

DISTA EQ 600MG BASE N017710 001

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-100

ACTAVIS LABS UT INC 100MCG/HR A076709 004 Aug 20, 2007

NOVEN 100MCG/HR A077775 004 Oct 16, 2009



FENTANYL-25

ACTAVIS LABS UT INC 25MCG/HR A076709 001 Aug 20, 2007

NOVEN 25MCG/HR A077775 001 Oct 16, 2009



FENTANYL-50

ACTAVIS LABS UT INC 50MCG/HR A076709 002 Aug 20, 2007

NOVEN 50MCG/HR A077775 002 Oct 16, 2009



FENTANYL-75

ACTAVIS LABS UT INC 75MCG/HR A076709 003 Aug 20, 2007

NOVEN 75MCG/HR A077775 003 Oct 16, 2009


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-162(of 393)

** See List Footnote



FENTANYL CITRATE

FILM;BUCCAL

ONSOLIS

BDSI EQ 0.2MG BASE N022266 001 Jul 16, 2009

EQ 0.4MG BASE N022266 002 Jul 16, 2009

EQ 0.6MG BASE N022266 003 Jul 16, 2009

EQ 0.8MG BASE N022266 004 Jul 16, 2009

EQ 1.2MG BASE N022266 005 Jul 16, 2009

INJECTABLE;INJECTION

FENTANYL CITRATE

ABBOTT EQ 0.05MG BASE/ML A070636 001 Apr 30, 1990

EQ 0.05MG BASE/ML A070637 001 Apr 30, 1990

WATSON LABS EQ 0.05MG BASE/ML A073488 001 Jun 30, 1992



FENTANYL CITRATE PRESERVATIVE FREE

WATSON LABS INC EQ 0.05MG BASE/ML A074917 001 Feb 03, 1998

TABLET;BUCCAL, SUBLINGUAL

FENTANYL CITRATE

WATSON LABS EQ 0.1MG BASE A079075 001 Jan 07, 2011

EQ 0.2MG BASE A079075 002 Jan 07, 2011

EQ 0.4MG BASE A079075 003 Jan 07, 2011

EQ 0.6MG BASE A079075 004 Jan 07, 2011

EQ 0.8MG BASE A079075 005 Jan 07, 2011

FENTORA

+ CEPHALON EQ 0.3MG BASE ** N021947 006 Mar 02, 2007

TROCHE/LOZENGE;ORAL

FENTANYL

CEPHALON EQ 0.1MG BASE N020195 007 Oct 30, 1995

EQ 0.2MG BASE N020195 001 Oct 04, 1993

EQ 0.3MG BASE N020195 002 Oct 04, 1993

EQ 0.4MG BASE N020195 003 Oct 04, 1993

TROCHE/LOZENGE;TRANSMUCOSAL

FENTANYL CITRATE

PAR PHARM EQ 0.2MG BASE A077312 001 Oct 30, 2009

EQ 0.4MG BASE A077312 002 Oct 30, 2009

EQ 0.6MG BASE A077312 003 Oct 30, 2009

EQ 0.8MG BASE A077312 004 Oct 30, 2009

EQ 1.2MG BASE A077312 005 Oct 30, 2009

EQ 1.6MG BASE A077312 006 Oct 30, 2009

FENTANYL HYDROCHLORIDE

SYSTEM;IONTOPHORESIS, TRANSDERMAL

IONSYS

+ THE MEDICINES CO EQ 40MCG BASE/ACTIVATION N021338 001 May 22, 2006

FERRIC AMMONIUM CITRATE

FOR SOLUTION;ORAL

FERRISELTZ

OTSUKA 600MG/PACKET N020292 001 Oct 14, 1997

FERRIC PYROPHOSPHATE CITRATE

SOLUTION;INTRAVENOUS

TRIFERIC

+ ROCKWELL MEDICAL INC 272MG IRON/50ML (5.44MG IRON/ML) N206317 002 Sep 04, 2015

FERROUS CITRATE, FE-59

INJECTABLE;INJECTION

FERROUS CITRATE FE 59

MALLINCKRODT 25uCi/ML N016729 001

FERROUS SULFATE; FOLIC ACID

CAPSULE;ORAL

FOLVRON

LEDERLE 182MG;0.33MG N006012 003

FERUMOXIDES

INJECTABLE;INJECTION

FERIDEX I.V.

AMAG PHARMS INC EQ 11.2MG IRON/ML N020416 001 Aug 30, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-163(of 393)

** See List Footnote



FERUMOXSIL

SUSPENSION;ORAL

GASTROMARK

AMAG PHARMS INC
EQ 0.175MG IRON/ML
N020410 001 Dec 06, 1996

FESOTERODINE FUMARATE

TABLET, EXTENDED RELEASE;ORAL

FESOTERODINE FUMARATE

ALKEM LABS LTD
4MG
A204827 001 Dec 10, 2015

8MG
A204827 002 Dec 10, 2015

FEXOFENADINE HYDROCHLORIDE

CAPSULE;ORAL

ALLEGRA

SANOFI AVENTIS US
60MG **
N020625 001 Jul 25, 1996

FEXOFENADINE HYDROCHLORIDE

BARR
60MG
A076169 001 Jul 13, 2005

SUSPENSION;ORAL

ALLEGRA

+ SANOFI AVENTIS US
30MG/5ML
N021963 001 Oct 16, 2006

CHILDREN'S ALLEGRA HIVES

+ SANOFI AVENTIS US
30MG/5ML
N201373 002 Jan 24, 2011

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

TARO PHARM 30MG/5ML
A208123 001 Nov 09, 2017

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

TARO PHARM
30MG/5ML
A208123 002 Nov 09, 2017

FEXOFENADINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC
30MG/5ML
A201311 001 Jul 25, 2012

TABLET;ORAL

ALLEGRA HIVES

+ SANOFI AVENTIS US
60MG
N020872 008 Jan 24, 2011

+
180MG
N020872 009 Jan 24, 2011

CHILDREN'S ALLEGRA ALLERGY

+ SANOFI AVENTIS US
30MG
N020872 005 Jan 24, 2011

CHILDREN'S ALLEGRA HIVES

+ SANOFI AVENTIS US
30MG
N020872 006 Jan 24, 2011

TABLET, ORALLY DISINTEGRATING;ORAL

CHILDREN'S ALLEGRA ALLERGY
+ SANOFI AVENTIS US 30MG N021909 002 Jan 24, 2011

CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US 30MG N021909 003 Jan 24, 2011

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

DR REDDYS LABS LTD 30MG
A202978 001 Jan 18, 2013

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES

DR REDDYS LABS LTD 30MG
A202978 002 Jan 18, 2013

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

BARR 60MG;120MG
A076236 001 Apr 14, 2005

IMPAX PHARMS 60MG;120MG


A076298 001 Nov 12, 2010

FIBRINOGEN, I-125

INJECTABLE;INJECTION

IBRIN

GE HEALTHCARE 154uCi/VIAL
N017879 001

RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR

ABBOTT 140uCi/ML
N017787 001

FINASTERIDE

TABLET;ORAL

FINASTERIDE

GEDEON RICHTER USA 5MG
A077251 001 Dec 22, 2006

IVAX SUB TEVA PHARMS 5MG
A076340 001 Jun 19, 2006

MYLAN PHARMS INC 1MG
A078161 001 Nov 05, 2013

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-164(of 393)

** See List Footnote



FLAVOXATE HYDROCHLORIDE

TABLET;ORAL

FLAVOXATE HYDROCHLORIDE

IMPAX PHARMS 100MG A076234 001 Aug 28, 2003

URISPAS

ORTHO MCNEIL JANSSEN 100MG N016769 001

FLECAINIDE ACETATE

TABLET;ORAL

FLECAINIDE ACETATE

ANI PHARMS INC 50MG A076030 001 Oct 28, 2002

100MG A076030 002 Oct 28, 2002

150MG A076030 003 Oct 28, 2002

APOTEX INC 50MG A079164 001 Jul 09, 2009

100MG A079164 002 Jul 09, 2009

150MG A079164 003 Jul 09, 2009

TAMBOCOR

CNTY LINE PHARMS 200MG N018830 002 Oct 31, 1985

FLORBETAPIR F-18

SOLUTION;INTRAVENOUS

AMYVID

AVID RADIOPHARMS INC 10ML (13.5-51mCi/ML) N202008 001 Apr 06, 2012

FLOXURIDINE

INJECTABLE;INJECTION

FUDR

+ HOSPIRA 500MG/VIAL ** N016929 001

FLUCONAZOLE

FOR SUSPENSION;ORAL

FLUCONAZOLE

SUN PHARM INDS LTD 50MG/5ML A076332 001 Jul 29, 2004

200MG/5ML A076332 002 Jul 29, 2004

TARO PHARM INDS 50MG/5ML A076918 001 Dec 18, 2006

200MG/5ML A076918 002 Dec 18, 2006

INJECTABLE;INJECTION

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

+ PFIZER 200MG/100ML (2MG/ML) N019950 003 Sep 29, 1992

+ 400MG/200ML (2MG/ML) N019950 005 Jul 08, 1994



DIFLUCAN IN SODIUM CHLORIDE 0.9%

+ PFIZER 200MG/100ML (2MG/ML) N019950 001 Jan 29, 1990

+ 400MG/200ML (2MG/ML) N019950 006 Jan 29, 1990

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+ PFIZER 200MG/100ML (2MG/ML) N019950 002 Jan 29, 1990

+ 400MG/200ML (2MG/ML) N019950 004 Jan 29, 1990

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

MYLAN LABS LTD 200MG/100ML (2MG/ML) A076888 001 Mar 25, 2005

400MG/200ML (2MG/ML) A076888 002 Mar 25, 2005

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

TEVA PHARMS USA 200MG/100ML (2MG/ML) A076653 001 Jul 29, 2004

400MG/200ML (2MG/ML) A076653 002 Jul 29, 2004

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

HOSPIRA 200MG/100ML (2MG/ML) A076617 001 Jul 29, 2004

400MG/200ML (2MG/ML) A076617 002 Jul 29, 2004

MYLAN LABS LTD 200MG/100ML (2MG/ML) A076889 001 Mar 25, 2005

400MG/200ML (2MG/ML) A076889 002 Mar 25, 2005

TEVA PHARMS 200MG/100ML (2MG/ML) A076837 001 Jan 13, 2005

400MG/200ML (2MG/ML) A076837 002 Jan 13, 2005

TABLET;ORAL

FLUCONAZOLE

ANI PHARMS INC 50MG A076086 001 Jul 29, 2004

100MG A076086 002 Jul 29, 2004

150MG A076086 003 Jul 29, 2004

200MG A076086 004 Jul 29, 2004

GEDEON RICHTER USA 50MG A076432 001 Jul 29, 2004

100MG A076432 002 Jul 29, 2004

150MG A076432 003 Jul 29, 2004

200MG A076432 004 Jul 29, 2004

MYLAN PHARMS INC 50MG A076042 001 Jul 29, 2004

100MG A076042 002 Jul 29, 2004

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

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** See List Footnote



FLUCONAZOLE

TABLET;ORAL

FLUCONAZOLE

150MG A076042 003 Jul 29, 2004

200MG A076042 004 Jul 29, 2004

PLIVA 50MG A076424 001 Jul 29, 2004

100MG A076424 002 Jul 29, 2004

150MG A076424 003 Jul 29, 2004

200MG A076424 004 Jul 29, 2004

RANBAXY LABS LTD 50MG A076386 001 Jul 29, 2004

100MG A076386 002 Jul 29, 2004

150MG A076386 003 Jul 29, 2004

200MG A076386 004 Jul 29, 2004

ROXANE 50MG A076213 001 Jul 29, 2004

100MG A076213 002 Jul 29, 2004

150MG A076213 003 Jul 29, 2004

200MG A076213 004 Jul 29, 2004

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARA

+ GENZYME CORP 50MG/VIAL ** N020038 001 Apr 18, 1991

TABLET;ORAL

OFORTA

SANOFI AVENTIS US 10MG N022273 001 Dec 18, 2008

FLUDEOXYGLUCOSE F-18

INJECTABLE;INJECTION

FLUDEOXYGLUCOSE F18

+ DOWNSTATE CLINCL 4-40mCi/ML ** N020306 001 Aug 19, 1994

+ 4-90mCi/ML ** N020306 002 Sep 25, 2001

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

+ FEINSTEIN 20-200mCi/ML N021870 001 Aug 19, 2005

MIDWEST MEDCL 20-200mCi/ML A203736 001 Nov 19, 2015



WEILL MEDCL COLL 10-100mCi/ML ** N021768 001 Aug 05, 2004

FLUDROCORTISONE ACETATE

TABLET;ORAL

FLORINEF

+ CASPER PHARMA LLC 0.1MG ** N010060 001

FLUMAZENIL

INJECTABLE;INJECTION

FLUMAZENIL

BAXTER HLTHCARE CORP 0.5MG/5ML (0.1MG/ML) A076755 002 Oct 12, 2004

1MG/10ML (0.1MG/ML) A076755 001 Oct 12, 2004

TEVA PHARMS USA 0.5MG/5ML (0.1MG/ML) A076589 002 Oct 12, 2004

1MG/10ML (0.1MG/ML) A076589 001 Oct 12, 2004

ROMAZICON

+ HOFFMANN LA ROCHE 1MG/10ML (0.1MG/ML) ** N020073 001 Dec 20, 1991

+ 0.5MG/5ML (0.1MG/ML) ** N020073 002 Dec 20, 1991

FLUMETHASONE PIVALATE

CREAM;TOPICAL

LOCORTEN

NOVARTIS 0.03% N016379 001

FLUNISOLIDE

AEROSOL, METERED;INHALATION

AEROBID

ROCHE PALO 0.25MG/INH N018340 001 Aug 17, 1984

SPRAY, METERED;NASAL

FLUNISOLIDE

APOTEX INC 0.029MG/SPRAY A077436 001 Aug 09, 2007

NASALIDE

IVAX RES 0.025MG/SPRAY ** N018148 001

NASAREL

TEVA BRANDED PHARM 0.029MG/SPRAY N020409 001 Mar 08, 1995

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-166(of 393)

** See List Footnote



FLUOCINOLONE ACETONIDE

CREAM;TOPICAL

FLUOCET

ALPHARMA US PHARMS
0.025%
A088360 001 Jan 16, 1984

FLUOCINOLONE ACETONIDE

ALPHARMA US PHARMS
0.01%
A088361 001 Jan 16, 1984

G AND W LABS
0.025%
A089525 001 Jul 26, 1988

PERRIGO NEW YORK
0.01%
A086810 001 Mar 04, 1982

0.025%
A086811 001 Mar 04, 1982

PHARMADERM
0.01%
A088047 001 Dec 16, 1982

0.025%
A088045 001 Dec 16, 1982

PHARMAFAIR
0.01%
A088499 001 Aug 02, 1984

0.025%
A088506 001 Aug 02, 1984

TARO
0.01%
A040035 001 Oct 31, 1994

0.01%
A087102 001 Apr 27, 1982

0.025%
A040042 001 Oct 31, 1994

USL PHARMA
0.01%
A088757 001 Feb 11, 1985

0.025%
A088756 001 Mar 28, 1985

FLUONID

ALLERGAN HERBERT
0.025%
A087156 002 Sep 06, 1984

FLUOTREX

SAVAGE LABS
0.01%
A088174 001 May 06, 1983

0.025%
A088173 001 Mar 09, 1983

SYNALAR-HP

MEDIMETRIKS PHARMS
0.2%
N016161 002

GEL;TOPICAL

FLUONID

ALLERGAN HERBERT
0.025%
A087300 001 May 27, 1982

OINTMENT;TOPICAL

FLUOCINOLONE ACETONIDE

PHARMADERM
0.025%
A088046 001 Dec 16, 1982

PHARMAFAIR
0.025%
A088507 001 Feb 27, 1984

USL PHARMA
0.025%
A088742 001 Feb 08, 1985

FLUONID

ALLERGAN HERBERT
0.025%
A087157 001 Sep 06, 1984

FLUOTREX

SAVAGE LABS
0.025%
A088172 001 Mar 09, 1983

SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

ALPHARMA US PHARMS
0.01%
A087159 001 Jun 16, 1982

BAUSCH AND LOMB
0.01%
A040059 001 Dec 20, 1993

G AND W LABS INC
0.01%
A207441 001 Sep 28, 2016

GLASSHOUSE PHARMS
0.01%
A209596 001 Dec 26, 2017

MORTON GROVE
0.01%
A088312 001 Jan 27, 1984

PHARMADERM
0.01%
A088048 001 Dec 16, 1982

PHARMAFAIR
0.01%
A088449 001 Feb 08, 1984

FLUONID

ALLERGAN HERBERT
0.01%
A087158 001 Mar 17, 1983

FLUOTREX

SAVAGE LABS
0.01%
A088171 001 Mar 09, 1983

FLUOCINONIDE

CREAM;TOPICAL

FLUOCINONIDE

PERRIGO NEW YORK
0.05%
A071790 001 Jul 13, 1988

LIDEX

+ CNTY LINE PHARMS
0.05%
N016908 002

SOLUTION;TOPICAL

FLUOCINONIDE

TARO
0.05%
A072857 001 Aug 02, 1989

TEVA PHARMS
0.05%
A072522 001 Sep 28, 1990

FLUORESCEIN SODIUM

INJECTABLE;INJECTION

FUNDUSCEIN-25

+ NOVARTIS
25% **
N017869 001

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

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6-167(of 393)

** See List Footnote



FLUOROMETHOLONE

CREAM;TOPICAL

OXYLONE

PHARMACIA AND UPJOHN 0.025%
N011748 001

SUSPENSION/DROPS;OPHTHALMIC

FLUOR-OP

NOVARTIS 0.1%
A070185 001 Feb 27, 1986

FLUOROMETHOLONE ACETATE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

TOBRASONE

ALCON 0.1%;0.3%
N050628 001 Jul 21, 1989

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

SUSPENSION/DROPS;OPHTHALMIC

FML-S

ALLERGAN
0.1%;10%
N019525 001 Sep 29, 1989

FLUOROURACIL

INJECTABLE;INJECTION

ADRUCIL

PHARMACIA AND UPJOHN
50MG/ML
A081222 001 Jun 28, 1991

50MG/ML
N017959 001

TEVA PARENTERAL
50MG/ML
A040023 001 Oct 18, 1991

50MG/ML
A081225 001 Aug 28, 1991

FLUOROURACIL

ABIC
50MG/ML
A088929 001 Mar 04, 1986

ABRAXIS PHARM
50MG/ML
A089152 001 Mar 21, 1986

50MG/ML
A089428 001 Jan 12, 1987

50MG/ML
A089519 001 Mar 12, 1987

BEDFORD
50MG/ML
A089508 001 Jan 26, 1988

EBEWE PHARMA
500MG/10ML (50MG/ML)
A040772 001 Aug 11, 2008

FRESENIUS KABI USA


50MG/ML
A040291 001 Mar 24, 1999

50MG/ML
A040379 001 Nov 15, 2000

MARCHAR
50MG/ML
A087791 001 Jan 18, 1983

SANDOZ
2.5GM/50ML (50MG/ML)
A091299 001 May 02, 2011

5GM/100ML (50MG/ML)
A091299 002 May 02, 2011

SMITH AND NEPHEW


50MG/ML
A088766 001 Dec 28, 1984

50MG/ML
A088767 001 Dec 28, 1984

50MG/ML
A089434 001 Mar 26, 1987

SPECTRUM PHARMS
50MG/ML
A087792 001 Oct 13, 1982

+
500MG/10ML (50MG/ML) **
N012209 001

+
2.5GM/50ML (50MG/ML)
N012209 002 Jul 29, 2016

SOLUTION;TOPICAL

FLUOROPLEX

ELORAC
1%
N016765 001

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE

SUN PHARM INDUSTRIES
EQ 10MG BASE
A075787 001 Jan 29, 2002

EQ 20MG BASE
A075787 002 Jan 29, 2002

WATSON LABS
EQ 10MG BASE
A075662 001 Jan 29, 2002

EQ 20MG BASE
A075662 002 Jan 29, 2002

FLUOXETINE HYDROCHLORIDE

ANI PHARMS INC
EQ 10MG BASE
A076287 001 May 20, 2008

EQ 20MG BASE
A076287 002 May 20, 2008

BARR
EQ 40MG BASE
A076251 001 May 18, 2005

CARLSBAD
EQ 10MG BASE
A076022 001 Jan 30, 2002

EQ 20MG BASE
A076022 002 Jan 30, 2002

CR DOUBLE CRANE
EQ 10MG BASE
A076165 001 Feb 01, 2002

EQ 20MG BASE
A076165 002 Feb 01, 2002

MYLAN
EQ 10MG BASE
A075207 001 Jan 30, 2002

EQ 20MG BASE
A075207 002 Jan 30, 2002

EQ 40MG BASE
A075207 003 May 25, 2007

MYLAN PHARMS INC


EQ 10MG BASE
A075577 001 Jan 29, 2002

EQ 20MG BASE
A075577 002 Jan 29, 2002

PAR PHARM
EQ 10MG BASE
A076922 001 Dec 16, 2004

EQ 20MG BASE
A076922 002 Dec 16, 2004

SANDOZ
EQ 10MG BASE
A075807 001 Jan 29, 2002

EQ 10MG BASE
A077469 001 Nov 17, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-168(of 393)

** See List Footnote



FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE

EQ 20MG BASE A075807 002 Jan 29, 2002

EQ 20MG BASE A077469 002 Nov 17, 2008

WOCKHARDT LTD EQ 10MG BASE A078143 001 Jan 16, 2008

EQ 20MG BASE A078143 002 Jan 16, 2008

EQ 40MG BASE A078143 003 Jan 16, 2008

PROZAC

ELI LILLY AND CO EQ 60MG BASE N018936 004 Jun 15, 1999

SARAFEM

+ ELI LILLY AND CO EQ 10MG BASE ** N018936 007 Jul 06, 2000

+ EQ 20MG BASE ** N018936 008 Jul 06, 2000

SOLUTION;ORAL

FLUOXETINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC EQ 20MG BASE/5ML A075690 001 Jan 31, 2002

APOTEX INC EQ 20MG BASE/5ML A075292 001 Feb 07, 2002

AUROBINDO PHARMA LTD EQ 20MG BASE/5ML A079209 001 Mar 20, 2009

HI TECH PHARMA EQ 20MG BASE/5ML A075525 001 Jun 27, 2002

LANNETT CO INC EQ 20MG BASE/5ML A076458 001 May 14, 2004

PROZAC

+ LILLY EQ 20MG BASE/5ML ** N020101 001 Apr 24, 1991

TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

BARR EQ 10MG BASE A075810 001 Feb 01, 2002

FOSUN PHARMA EQ 10MG BASE A076024 001 Jan 29, 2002

IVAX SUB TEVA PHARMS EQ 10MG BASE A075865 001 Feb 28, 2002

EQ 40MG BASE A075865 003 Aug 30, 2004

PROZAC

+ LILLY EQ 10MG BASE ** N020974 001 Mar 09, 1999

+ EQ 20MG BASE ** N020974 002 Mar 09, 1999

FLUOXYMESTERONE

TABLET;ORAL

ANDROID-F

VALEANT PHARM INTL 10MG A087196 001

FLUOXYMESTERONE

VALEANT PHARM INTL 10MG A088221 001 May 05, 1983

WATSON LABS 2MG A088260 001 Dec 06, 1983



5MG A088265 001 Dec 06, 1983

10MG A088309 001 Dec 06, 1983

HALOTESTIN

PHARMACIA AND UPJOHN 2MG N010611 002

5MG N010611 006

10MG N010611 010

ORA-TESTRYL

BRISTOL MYERS SQUIBB 2MG N011359 001

5MG N011359 002

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION

FLUPHENAZINE DECANOATE

HOSPIRA 25MG/ML A074966 001 Apr 16, 1998

TEVA PARENTERAL 25MG/ML A074795 001 Sep 10, 1996

PROLIXIN DECANOATE

+ BRISTOL MYERS SQUIBB 25MG/ML ** N016727 001

FLUPHENAZINE ENANTHATE

INJECTABLE;INJECTION

PROLIXIN ENANTHATE

APOTHECON 25MG/ML ** N016110 001

FLUPHENAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

FLUPHENAZINE HYDROCHLORIDE

ANI PHARMS INC 5MG/ML A073058 001 Aug 30, 1991

PERMITIL

SCHERING 5MG/ML ** N016008 001

PROLIXIN

APOTHECON 5MG/ML A070533 001 Nov 07, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-169(of 393)

** See List Footnote



FLUPHENAZINE HYDROCHLORIDE

ELIXIR;ORAL

FLUPHENAZINE HYDROCHLORIDE

ANI PHARMS INC
2.5MG/5ML
A081310 001 Apr 29, 1993

PROLIXIN

+ APOTHECON
2.5MG/5ML **
N012145 003

INJECTABLE;INJECTION

PROLIXIN

APOTHECON
2.5MG/ML **
N011751 005

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

WATSON LABS
1MG
A088555 001 Dec 18, 1987

2.5MG
A088544 001 Dec 18, 1987

5MG
A088527 001 Dec 18, 1987

10MG
A088550 001 Dec 18, 1987

PERMITIL

SCHERING
0.25MG
N012034 001

2.5MG
N012034 004

5MG
N012034 005

10MG
N012034 006

PROLIXIN

+ APOTHECON
1MG **
N011751 004

+
2.5MG **
N011751 001

+
5MG **
N011751 003

+
10MG **
N011751 002

TABLET, EXTENDED RELEASE;ORAL

PERMITIL

SCHERING
1MG
N012419 004

FLUPREDNISOLONE

TABLET;ORAL

ALPHADROL

PHARMACIA AND UPJOHN 1.5MG
N012259 002

FLURANDRENOLIDE

LOTION;TOPICAL

FLURANDRENOLIDE

ALPHARMA US PHARMS 0.05%
A087203 001 Apr 29, 1982

OINTMENT;TOPICAL

CORDRAN

+ AQUA PHARMS 0.025% **
N012806 004

FLURANDRENOLIDE; NEOMYCIN SULFATE

CREAM;TOPICAL

CORDRAN N

LILLY
0.05%;EQ 3.5MG BASE/GM
N050346 001

OINTMENT;TOPICAL

CORDRAN N

LILLY
0.05%;EQ 3.5MG BASE/GM
N050345 001

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

DALMANE

VALEANT PHARM INTL
15MG **
N016721 001

+
30MG **
N016721 002

FLURAZEPAM HYDROCHLORIDE

AUROLIFE PHARMA LLC
15MG
A071717 002 Jul 31, 1991

30MG
A071717 001 Jul 31, 1991

HALSEY
15MG
A071808 001 Jan 07, 1988

30MG
A071809 001 Jan 07, 1988

HIKMA INTL PHARMS
15MG
A071107 001 Dec 08, 1986

HIKMA PHARMS
30MG
A071108 001 Dec 08, 1986

PAR PHARM
15MG
A070444 001 Mar 20, 1986

30MG
A070445 001 Mar 20, 1986

PUREPAC PHARM
15MG
A071927 001 Sep 09, 1987

30MG
A071551 001 Sep 09, 1987

SUN PHARM INDUSTRIES


15MG
A070454 001 Aug 04, 1986

30MG
A070455 001 Aug 04, 1986

SUPERPHARM
15MG
A071659 001 Aug 04, 1988

30MG
A071660 001 Aug 04, 1988

USL PHARMA
15MG
A070562 001 Jul 09, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-170(of 393)

** See List Footnote



FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

FLURAZEPAM HYDROCHLORIDE

30MG A070563 001 Jul 09, 1987

WARNER CHILCOTT 15MG A071767 001 Dec 04, 1987

30MG A071768 001 Dec 04, 1987

WATSON LABS 15MG A071205 001 Nov 25, 1986

15MG A072368 001 Mar 30, 1989

30MG A071068 001 Nov 25, 1986

30MG A072369 001 Mar 30, 1989

FLURBIPROFEN

TABLET;ORAL

ANSAID

PHARMACIA AND UPJOHN 50MG N018766 002 Oct 31, 1988

100MG N018766 003 Oct 31, 1988

FLURBIPROFEN

AUROLIFE PHARMA LLC 50MG A074448 001 Jul 28, 1995

100MG A074448 002 Jul 28, 1995

IVAX SUB TEVA PHARMS 50MG A074411 001 May 31, 1995

100MG A074411 002 May 31, 1995

PLIVA 50MG A074647 001 Apr 01, 1997

100MG A074647 002 Apr 01, 1997

TEVA 50MG A074405 002 May 24, 1995

100MG A074405 001 May 24, 1995

THERAGEN 100MG A074560 002 May 16, 1997



FLUTAMIDE

CAPSULE;ORAL

EULEXIN

+ SCHERING 125MG N018554 001 Jan 27, 1989

FLUTAMIDE

MYLAN 125MG A076224 001 May 09, 2003

YAOPHARMA CO LTD 125MG A075818 001 Sep 18, 2001



FLUTEMETAMOL F-18

INJECTABLE;INTRAVENOUS

VIZAMYL

+ GE HEALTHCARE 40.5mCi/10ML (4.05mCi/ML) N203137 001 Oct 25, 2013

FLUTICASONE PROPIONATE

AEROSOL, METERED;INHALATION

FLOVENT

GLAXOSMITHKLINE 0.044MG/INH N020548 001 Mar 27, 1996

0.11MG/INH N020548 002 Mar 27, 1996

0.22MG/INH N020548 003 Mar 27, 1996

CREAM;TOPICAL

CUTIVATE

+ FOUGERA PHARMS 0.05% ** N019958 001 Dec 18, 1990

FLUTICASONE PROPIONATE

NESHER PHARMS 0.05% A076865 001 Sep 10, 2004

OINTMENT;TOPICAL

CUTIVATE

+ FOUGERA PHARMS 0.005% N019957 001 Dec 14, 1990

FLUTICASONE PROPIONATE

FOUGERA PHARMS 0.005% A076300 001 May 14, 2004

TARO PHARM INDS 0.005% A077145 001 Jun 14, 2005



POWDER;INHALATION

FLOVENT

GLAXOSMITHKLINE 0.044MG/INH N020549 001 Nov 07, 1997

0.088MG/INH N020549 002 Nov 07, 1997

0.22MG/INH N020549 003 Nov 07, 1997

SPRAY, METERED;NASAL

FLONASE

+ GLAXOSMITHKLINE 0.05MG/SPRAY ** N020121 001 Oct 19, 1994

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-171(of 393)

** See List Footnote



FLUVASTATIN SODIUM

CAPSULE;ORAL

LESCOL

+ NOVARTIS EQ 20MG BASE ** N020261 001 Dec 31, 1993

+ EQ 40MG BASE ** N020261 002 Dec 31, 1993

FLUVOXAMINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

LUVOX CR

+ JAZZ PHARMS 100MG ** N022033 001 Feb 28, 2008

+ 150MG ** N022033 002 Feb 28, 2008

TABLET;ORAL

FLUVOXAMINE MALEATE

ACTAVIS ELIZABETH 25MG A075901 001 Dec 28, 2000
50MG A075901 002 Dec 28, 2000
100MG A075901 003 Dec 28, 2000
ANI PHARMS INC 25MG A075898 001 Mar 12, 2001
50MG A075898 002 Mar 12, 2001
100MG A075898 003 Mar 12, 2001
ECI PHARMS LLC 25MG A075900 001 Feb 23, 2006
50MG A075900 002 Feb 23, 2006
100MG A075900 003 Feb 23, 2006
MYLAN 50MG A075950 001 Oct 15, 2001
100MG A075950 002 Oct 15, 2001
SUN PHARM INDUSTRIES 25MG A076125 001 Apr 29, 2002
50MG A076125 002 Apr 29, 2002
100MG A076125 003 Apr 29, 2002
SYNTHON PHARMS 25MG A075899 001 Jan 17, 2001
50MG A075899 002 Jan 17, 2001
100MG A075899 003 Jan 17, 2001
UPSHER SMITH LABS 25MG A075887 001 Jan 05, 2001
50MG A075887 002 Jan 05, 2001
100MG A075887 003 Jan 05, 2001
WATSON LABS 25MG A075894 001 Apr 18, 2001
50MG A075894 002 Apr 18, 2001
100MG A075894 003 Apr 18, 2001
LUVOX
+ SOLVAY 25MG ** N020243 001 Dec 05, 1994
+ 50MG ** N020243 002 Dec 05, 1994
+ 100MG ** N020243 003 Dec 05, 1994
+ 150MG ** N020243 004 Dec 05, 1994
FOLIC ACID

INJECTABLE;INJECTION

FOLIC ACID

BEN VENUE 5MG/ML A081066 001 Dec 29, 1993

FOLVITE

WYETH PHARMS INC 5MG/ML N005897 008

TABLET;ORAL

FOLIC ACID

BARR 1MG A089177 001 Jan 08, 1986

CONTRACT PHARMACAL 1MG A085061 001

EVERYLIFE 1MG A080755 001

HALSEY 1MG A083598 001

IMPAX LABS 1MG A080686 001

IVAX SUB TEVA PHARMS 1MG A083000 001

JUBILANT CADISTA 1MG A040514 001 Jun 14, 2005

LANNETT 1MG A080816 001

LILLY 1MG N006135 003

MK LABS 1MG A083526 001

NEXGEN PHARMA INC 1MG A084915 001

PHARMERAL 1MG A084158 001

PIONEER PHARMS 1MG A088949 001 Sep 13, 1985

PUREPAC PHARM 1MG A080784 001



SANDOZ 1MG A084472 001

SUN PHARM INDUSTRIES 1MG A040582 001 Jul 18, 2005

TABLICAPS 1MG A083133 002

UDL 1MG A088199 001 Mar 29, 1983

USL PHARMA 1MG A087828 001 May 13, 1982

VALEANT PHARM INTL 1MG A080903 001


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-172(of 393)

** See List Footnote



FOLIC ACID

TABLET;ORAL

FOLIC ACID

VANGARD 1MG A088730 001 Mar 23, 1984

VINTAGE PHARMS 1MG A086296 001

WATSON LABS 1MG A083141 001

1MG A085141 002

WHITEWORTH TOWN PLSN 1MG A080691 002

FOLICET

MISSION PHARMA 1MG A087438 001

FOLVITE

WYETH PHARMS INC 1MG N005897 004

FOLLITROPIN ALFA/BETA

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

FOLLISTIM

ORGANON USA INC 75 IU/VIAL N020582 001 Sep 29, 1997

150 IU/VIAL N020582 002 Sep 29, 1997

INJECTABLE;SUBCUTANEOUS

FOLLISTIM AQ

ORGANON USA INC 75 IU/0.5ML N021273 001 Aug 26, 2005

150 IU/0.18ML N021211 003 Feb 11, 2004



150 IU/0.5ML N021273 002 Aug 26, 2005

GONAL-F

EMD SERONO 37.5 IU/VIAL N020378 003 May 25, 2000

37.5 IU/VIAL N021765 001 Mar 25, 2004



75 IU/VIAL N020378 001 Sep 29, 1997

150 IU/VIAL N020378 002 Sep 29, 1997

150 IU/VIAL N021765 003 Mar 25, 2004



FOMEPIZOLE

INJECTABLE;INJECTION

FOMEPIZOLE

MYLAN INSTITUTIONAL 1.5GM/1.5ML (1GM/ML) A079033 001 Apr 07, 2009

FOMIVIRSEN SODIUM

INJECTABLE;INJECTION

VITRAVENE PRESERVATIVE FREE

NOVARTIS 6.6MG/ML N020961 001 Aug 26, 1998

FORMOTEROL FUMARATE

POWDER;INHALATION

FORADIL

+ NOVARTIS 0.012MG/INH N020831 001 Feb 16, 2001

FORADIL CERTIHALER

NOVARTIS 0.0085MG/INH N021592 001 Dec 15, 2006

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

EMEND

+ MERCK AND CO INC EQ 115MG BASE/VIAL ** N022023 001 Jan 25, 2008

FOSCARNET SODIUM

INJECTABLE;INJECTION

FOSCARNET SODIUM

HOSPIRA 2.4GM/100ML A077174 001 May 31, 2005

FOSINOPRIL SODIUM

TABLET;ORAL

FOSINOPRIL SODIUM

ACTAVIS LABS FL INC 10MG A076620 001 Oct 15, 2004

20MG A076620 002 Oct 15, 2004

40MG A076620 003 Oct 15, 2004

RANBAXY LABS LTD 10MG A076580 001 Apr 23, 2004

20MG A076580 002 Apr 23, 2004

40MG A076580 003 Apr 23, 2004

UPSHER SMITH LABS 10MG A076188 001 Oct 08, 2004



20MG A076188 002 Oct 08, 2004

40MG A076188 003 Oct 08, 2004

WATSON LABS 10MG A076987 001 Dec 23, 2004

10MG A077531 001 Aug 31, 2006

20MG A076987 002 Dec 23, 2004



20MG A077531 002 Aug 31, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-173(of 393)

** See List Footnote



FOSINOPRIL SODIUM

TABLET;ORAL

FOSINOPRIL SODIUM

40MG A076987 003 Dec 23, 2004

40MG A077531 003 Aug 31, 2006

MONOPRIL

+ BRISTOL MYERS SQUIBB 10MG ** N019915 002 May 16, 1991

+ 20MG ** N019915 003 May 16, 1991

+ 40MG ** N019915 004 Mar 28, 1995



FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

TABLET;ORAL

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

ACTAVIS LABS FL INC 10MG;12.5MG A076608 001 Dec 03, 2004

20MG;12.5MG A076608 002 Dec 03, 2004

MYLAN 10MG;12.5MG A077705 001 Aug 14, 2006

20MG;12.5MG A077705 002 Aug 14, 2006

SUN PHARM INDS LTD 10MG;12.5MG A076739 001 Dec 17, 2004

20MG;12.5MG A076739 002 Dec 17, 2004

TEVA 10MG;12.5MG A076945 001 Jul 05, 2006

20MG;12.5MG A076945 002 Jul 05, 2006

WATSON LABS 10MG;12.5MG A077144 001 Aug 16, 2005

20MG;12.5MG A077144 002 Aug 16, 2005

MONOPRIL-HCT

+ BRISTOL MYERS SQUIBB 10MG;12.5MG ** N020286 002 Nov 30, 1994

+ 20MG;12.5MG ** N020286 001 Nov 30, 1994

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

FOSPHENYTOIN SODIUM

APOTEX INC EQ 50MG PHENYTOIN NA/ML A078126 001 Aug 06, 2007

HOSPIRA EQ 50MG PHENYTOIN NA/ML A078158 001 Aug 06, 2007

TEVA PHARMS USA EQ 50MG PHENYTOIN NA/ML A076886 001 Aug 06, 2007

FOSPROPOFOL DISODIUM

SOLUTION;INTRAVENOUS

LUSEDRA

EISAI INC 1050MG/30ML (35MG/ML) N022244 001 Dec 12, 2008

FURAZOLIDONE

SUSPENSION;ORAL

FUROXONE

SHIRE 50MG/15ML N011323 002

TABLET;ORAL

FUROXONE

SHIRE 100MG N011270 002

FUROSEMIDE

INJECTABLE;INJECTION

FUROSEMIDE

ABRAXIS PHARM 10MG/ML N018507 001 Jul 30, 1982

10MG/ML N019036 001 Aug 13, 1984

ACCORD HLTHCARE 10MG/ML A070017 001 Dec 15, 1986



ASTRAZENECA 10MG/ML A070014 001 Sep 09, 1985

HOSPIRA 10MG/ML A070578 001 Jul 08, 1987



10MG/ML A072080 001 Aug 13, 1991

10MG/ML A074337 001 Oct 31, 1994



IGI LABS INC 10MG/ML A070095 001 Sep 09, 1985

10MG/ML A070096 001 Sep 09, 1985

INTL MEDICATION 10MG/ML N018025 001



+ LUITPOLD 10MG/ML ** N018579 001 Nov 30, 1983

MARSAM PHARMS LLC 10MG/ML A074017 001 Jun 30, 1994

SMITH AND NEPHEW 10MG/ML A070023 001 Feb 05, 1986

10MG/ML A070078 001 Feb 05, 1986

WARNER CHILCOTT 10MG/ML N018420 001 Feb 26, 1982

WATSON LABS 10MG/ML A070019 001 Sep 22, 1986

10MG/ML A070604 001 Jan 02, 1987



WEST-WARD PHARMS INT 10MG/ML A071439 001 Sep 14, 1990

10MG/ML N018267 001



WYETH AYERST 10MG/ML N018670 001 Jul 20, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-174(of 393)

** See List Footnote



FUROSEMIDE

INJECTABLE;INJECTION

LASIX

+ SANOFI AVENTIS US
10MG/ML ** N016363 001

SOLUTION;ORAL

LASIX

SANOFI AVENTIS US
10MG/ML N017688 001

TABLET;ORAL

FUROSEMIDE

DAVA PHARMS INC
20MG N018415 001 Jul 27, 1982

40MG N018415 002 Jul 27, 1982

80MG N018415 003 Nov 26, 1984

INTL MEDICATION
20MG N018753 001 Feb 28, 1984

40MG N018753 002 Feb 28, 1984

KALAPHARM
20MG N018868 001 Jun 28, 1983

40MG N018868 002 Jun 28, 1983

SANDOZ
40MG N018750 002 Jul 30, 1984

SUN PHARM INDS INC
20MG A091258 001 Apr 01, 2014

40MG A091258 002 Apr 01, 2014

40MG N018790 001 Nov 29, 1983



80MG A091258 003 Apr 01, 2014

SUN PHARM INDUSTRIES


20MG A070043 001 Sep 26, 1985

80MG A070100 001 Jan 26, 1988



SUPERPHARM
20MG N018370 002 Jun 26, 1984

40MG N018370 001 Feb 10, 1983

WARNER CHILCOTT
20MG N018419 001 Jan 31, 1983

40MG N018419 002 Jan 31, 1983

80MG N018419 003 Nov 13, 1984

WATSON LABS
20MG A070412 001 Feb 26, 1986

20MG A071379 001 Jan 02, 1987

20MG N018369 001 May 14, 1982

40MG A070413 001 Feb 26, 1986



40MG A070450 001 Nov 22, 1985

40MG N018369 002 May 14, 1982

80MG A071594 001 Feb 09, 1988



WATSON LABS TEVA
20MG A070449 001 Nov 22, 1985

80MG A070528 001 Jan 07, 1986

GABAPENTIN

CAPSULE;ORAL

GABAPENTIN

CSPC OUYI PHARM CO
100MG A075477 001 Mar 23, 2005

300MG A075477 002 Mar 23, 2005

400MG A075477 003 Mar 23, 2005

HIKMA
100MG A078150 001 Sep 25, 2007

300MG A078150 002 Sep 25, 2007

400MG A078150 003 Sep 25, 2007

SANDOZ
100MG A075428 001 Jan 24, 2006

100MG A075539 001 Apr 06, 2005

300MG A075428 002 Jan 24, 2006



300MG A075539 002 Apr 06, 2005

400MG A075428 003 Jan 24, 2006



400MG A075539 003 Apr 06, 2005

SUN PHARM INDS LTD


100MG A076606 001 Oct 07, 2005

300MG A076606 002 Oct 07, 2005

400MG A076606 003 Oct 07, 2005

SUN PHARM INDUSTRIES
100MG A076537 001 Jun 30, 2005

300MG A076537 002 Jun 30, 2005

400MG A076537 003 Jun 30, 2005

WATSON LABS
100MG A075485 003 May 11, 2007

300MG A075485 002 May 11, 2007

400MG A075485 001 May 11, 2007



TABLET;ORAL

GABAPENTIN

HIKMA PHARMS
600MG A078782 001 Jul 21, 2011

800MG A078782 002 Jul 21, 2011

RANBAXY
600MG A076605 001 Sep 14, 2005

800MG A076605 002 Sep 14, 2005

SANDOZ
600MG A076120 001 Jan 27, 2006

600MG A076877 001 Jul 06, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-175(of 393)

** See List Footnote



GABAPENTIN

TABLET;ORAL

GABAPENTIN

800MG A076120 002 Jan 27, 2006

800MG A076877 002 Jul 06, 2006

TEVA 600MG A075827 001 Dec 15, 2004

800MG A075827 002 Dec 15, 2004

GADODIAMIDE

INJECTABLE;INJECTION

OMNISCAN

GE HEALTHCARE 14.35GM/50ML (287MG/ML) N022066 001 Sep 05, 2007

GADOFOSVESET TRISODIUM

SOLUTION;INTRAVENOUS

ABLAVAR

LANTHEUS MEDCL 2440MG/10ML (244MG/ML) N021711 001 Dec 22, 2008

3660MG/15ML (244MG/ML) N021711 002 Dec 22, 2008

GADOVERSETAMIDE

INJECTABLE;INJECTION

OPTIMARK

+ LIEBEL-FLARSHEIM 1654.5MG/5ML (330.9MG/ML) N020937 001 Dec 08, 1999
+ 3309MG/10ML (330.9MG/ML) N020937 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020937 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020937 004 Dec 08, 1999
+ 16.545GM/50ML (330.9MG/ML) N020975 001 Dec 08, 1999
OPTIMARK IN PLASTIC CONTAINER
+ LIEBEL-FLARSHEIM 3309MG/10ML (330.9MG/ML) N020976 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020976 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020976 004 Dec 08, 1999
+ 9927MG/30ML (330.9MG/ML) N020976 001 Dec 08, 1999
GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE;ORAL
GALANTAMINE HYDROBROMIDE
IMPAX LABS EQ 8MG BASE A078484 001 May 27, 2009
EQ 16MG BASE A078484 002 May 27, 2009
EQ 24MG BASE A078484 003 May 27, 2009
MYLAN EQ 8MG BASE A090900 001 Jan 24, 2011
EQ 16MG BASE A090900 002 Jan 24, 2011
EQ 24MG BASE A090900 003 Jan 24, 2011
SOLUTION;ORAL
RAZADYNE
JANSSEN PHARMS 4MG/ML ** N021224 001 Jun 22, 2001
TABLET;ORAL
GALANTAMINE HYDROBROMIDE
ACTAVIS ELIZABETH EQ 4MG BASE A077585 001 Sep 15, 2009
EQ 8MG BASE A077585 002 Sep 15, 2009
EQ 12MG BASE A077585 003 Sep 15, 2009
MYLAN EQ 4MG BASE A077603 001 Aug 28, 2008
EQ 8MG BASE A077603 002 Aug 28, 2008
EQ 12MG BASE A077603 003 Aug 28, 2008
GALLAMINE TRIETHIODIDE
INJECTABLE;INJECTION
FLAXEDIL
DAVIS AND GECK 20MG/ML N007842 001
100MG/ML N007842 002
GALLIUM CITRATE GA-67
INJECTABLE;INJECTION
GALLIUM CITRATE GA 67
GE HEALTHCARE 1mCi/ML N017700 001
NEOSCAN
GE HEALTHCARE 2mCi/ML N017655 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-176(of 393)

** See List Footnote



GALLIUM NITRATE

INJECTABLE;INJECTION

GANITE

CHAPTER 7 TRUSTEE
25MG/ML **
N019961 002 Jan 17, 1991

GANCICLOVIR

CAPSULE;ORAL

CYTOVENE

+ ROCHE PALO
250MG **
N020460 001 Dec 22, 1994

+
500MG **
N020460 002 Dec 12, 1997

GANCICLOVIR

RANBAXY LABS LTD
250MG
A076457 001 Jun 27, 2003

500MG
A076457 002 Jun 27, 2003

IMPLANT;IMPLANTATION

VITRASERT

BAUSCH AND LOMB
4.5MG
N020569 001 Mar 04, 1996

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

GANCICLOVIR SODIUM

WEST-WARD PHARMS INT
EQ 500MG BASE/VIAL
A076222 001 Jul 16, 2003

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

GATIFLOXACIN

APOTEX INC
0.3%
A079084 001 Aug 19, 2011

GEFITINIB

TABLET;ORAL

IRESSA

ASTRAZENECA
250MG
N021399 001 May 05, 2003

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION

GEMCITABINE HYDROCHLORIDE

HAMELN RDS GMBH
EQ 200MG BASE/VIAL
A090663 001 Sep 10, 2012

EQ 1GM BASE/VIAL
A090663 002 Sep 10, 2012

SAGENT PHARMS
EQ 200MG BASE/VIAL
A091597 001 May 07, 2013

EQ 1GM BASE/VIAL
A091597 002 May 07, 2013

GEMFIBROZIL

CAPSULE;ORAL

GEMFIBROZIL

MYLAN
300MG
A073466 001 Jan 25, 1993

PUREPAC PHARM
300MG
A072929 001 Jan 29, 1993

LOPID

PFIZER PHARMS
200MG
N018422 001

300MG
N018422 002

TABLET;ORAL

GEMFIBROZIL

MYLAN
600MG
A074452 001 Feb 16, 1995

PUREPAC PHARM
600MG
A074360 001 Aug 31, 1994

WATSON LABS
600MG
A074156 001 Oct 24, 1994

600MG
A074442 001 Apr 28, 1995

YAOPHARMA CO LTD
600MG
A074615 001 Sep 29, 1995

GEMTUZUMAB OZOGAMICIN

INJECTABLE;INJECTION

MYLOTARG

WYETH PHARMS INC
5MG/VIAL
N021174 001 May 17, 2000

GENTAMICIN SULFATE

CREAM;TOPICAL

GARAMYCIN

SCHERING
EQ 0.1% BASE ** A060462 001
GENTAFAIR

PHARMAFAIR
EQ 0.1% BASE A062458 001 Sep 01, 1983
GENTAMICIN SULFATE

ALPHARMA US PHARMS
EQ 0.1% BASE A062471 001 Sep 27, 1983
FOUGERA PHARMS INC
EQ 0.1% BASE A062531 001 Jul 05, 1984
PHARMADERM
EQ 1MG BASE/GM A062530 001 Jul 05, 1984
TARO
EQ 0.1% BASE A062427 001 May 26, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-177(of 393)

** See List Footnote



GENTAMICIN SULFATE

INJECTABLE;INJECTION

APOGEN

KING PHARMS
EQ 10MG BASE/ML
A062289 001

EQ 40MG BASE/ML
A062289 002

BRISTAGEN

BRISTOL
EQ 40MG BASE/ML
A062288 001

GARAMYCIN

SCHERING
EQ 1MG BASE/ML **
A061716 002

EQ 10MG BASE/ML **
A061739 001

EQ 40MG BASE/ML **
A061716 001

GENTAFAIR

PHARMAFAIR
EQ 40MG BASE/ML
A062493 001 Aug 28, 1985

GENTAMICIN

INTL MEDICATION
EQ 1MG BASE/ML
A062325 003 Jun 23, 1982

EQ 40MG BASE/ML
A062325 001

EQ 100MG BASE/100ML
A062325 004 Jun 23, 1982

GENTAMICIN SULFATE

ABBOTT
EQ 1.2MG BASE/ML
A062413 001 Aug 11, 1983

EQ 1.4MG BASE/ML
A062413 002 Aug 11, 1983

EQ 1.6MG BASE/ML
A062413 003 Aug 11, 1983

EQ 1.8MG BASE/ML
A062413 004 Aug 11, 1983

EQ 2MG BASE/ML
A062413 005 Aug 11, 1983

EQ 60MG BASE/100ML
A062413 006 Aug 11, 1983

EQ 70MG BASE/100ML
A062413 007 Aug 11, 1983

EQ 80MG BASE/100ML
A062413 008 Aug 11, 1983

EQ 90MG BASE/100ML
A062413 009 Aug 11, 1983

EQ 100MG BASE/100ML
A062413 010 Aug 11, 1983

FRESENIUS KABI USA


EQ 10MG BASE/ML
A062356 001 Mar 04, 1982

EQ 40MG BASE/ML
A062356 002 Mar 04, 1982

KALAPHARM
EQ 40MG BASE/ML
A062354 001 Apr 05, 1982

PHARM SPEC
EQ 40MG BASE/ML
A062340 001 Mar 28, 1983

SOLOPAK
EQ 10MG BASE/ML
A062507 001 Jun 06, 1985

EQ 40MG BASE/ML
A062507 002 Jun 06, 1985

TEVA PARENTERAL
EQ 10MG BASE/ML
A063149 001 Nov 21, 1991

EQ 40MG BASE/ML
A063106 002 Nov 21, 1991

WATSON LABS
EQ 10MG BASE/ML
A062318 002

EQ 40MG BASE/ML
A062318 001

WEST-WARD PHARMS INT EQ 10MG BASE/ML
A062251 002

EQ 40MG BASE/ML
A062251 001

WYETH AYERST EQ 10MG BASE/ML
A062264 001

EQ 40MG BASE/ML
A062264 002

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN
EQ 0.8MG BASE/ML
A062814 001 Aug 28, 1987

EQ 1.2MG BASE/ML
A062814 002 Aug 28, 1987

EQ 1.4MG BASE/ML
A062814 003 Aug 28, 1987

EQ 1.6MG BASE/ML
A062814 004 Aug 28, 1987

EQ 1.8MG BASE/ML
A062814 005 Aug 28, 1987

EQ 2MG BASE/ML
A062814 006 Aug 28, 1987

EQ 2.4MG BASE/ML
A062814 007 Aug 28, 1987

EQ 40MG BASE/100ML
A062814 008 Aug 28, 1987

EQ 60MG BASE/100ML
A062814 009 Aug 28, 1987

EQ 70MG BASE/100ML
A062814 010 Aug 28, 1987

EQ 80MG BASE/100ML
A062814 011 Aug 28, 1987

EQ 90MG BASE/100ML
A062814 012 Aug 28, 1987

EQ 100MG BASE/100ML
A062814 013 Aug 28, 1987

EQ 120MG BASE/100ML
A062814 014 Aug 28, 1987

BAXTER HLTHCARE
EQ 0.8MG BASE/ML
A062373 001 Sep 07, 1982

EQ 2.4MG BASE/ML
A062373 010 Sep 07, 1982

EQ 40MG BASE/100ML
A062373 003 Sep 07, 1982

EQ 60MG BASE/100ML
A062373 004 Sep 07, 1982

HOSPIRA
EQ 1.2MG BASE/ML
A062588 001 Jan 06, 1986

EQ 1.4MG BASE/ML
A062414 002 Aug 15, 1983

EQ 1.4MG BASE/ML
A062588 002 Jan 06, 1986

EQ 1.6MG BASE/ML
A062588 003 Jan 06, 1986

EQ 1.8MG BASE/ML
A062414 004 Aug 15, 1983

EQ 1.8MG BASE/ML
A062588 004 Jan 06, 1986

EQ 2MG BASE/ML
A062414 005 Aug 15, 1983

EQ 2MG BASE/ML
A062588 005 Jan 06, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-178(of 393)

** See List Footnote



GENTAMICIN SULFATE

INJECTABLE;INJECTION

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

EQ 60MG BASE/100ML A062414 006 Aug 15, 1983

EQ 60MG BASE/100ML A062588 006 Jan 06, 1986



EQ 70MG BASE/100ML A062414 007 Aug 15, 1983

EQ 70MG BASE/100ML A062588 007 Jan 06, 1986



EQ 80MG BASE/100ML A062588 008 Jan 06, 1986

EQ 90MG BASE/100ML A062414 009 Aug 15, 1983

EQ 90MG BASE/100ML A062588 009 Jan 06, 1986



EQ 100MG BASE/100ML A062588 010 Jan 06, 1986

U-GENCIN

PHARMACIA AND UPJOHN EQ 10MG BASE/ML A062248 001

EQ 40MG BASE/ML A062248 002

INJECTABLE;INTRATHECAL

GARAMYCIN

+ SCHERING EQ 2MG BASE/ML ** N050505 001

OINTMENT;OPHTHALMIC

GARAMYCIN

SCHERING EQ 0.3% BASE N050425 001

GENTACIDIN

NOVARTIS EQ 0.3% BASE A062501 001 Jul 26, 1984

GENTAFAIR

PHARMAFAIR EQ 3MG BASE/GM A062443 001 May 26, 1983

OINTMENT;TOPICAL

GARAMYCIN

SCHERING EQ 0.1% BASE ** A060463 001

GENTAFAIR

PHARMAFAIR EQ 0.1% BASE A062444 001 May 26, 1983

GENTAMICIN SULFATE

ALPHARMA US PHARMS EQ 0.1% BASE A062496 001 Mar 14, 1984

PHARMADERM EQ 0.1% BASE A062534 001 Oct 10, 1984

SOLUTION/DROPS;OPHTHALMIC

GARAMYCIN

+ SCHERING EQ 0.3% BASE ** N050039 002

GENTACIDIN

NOVARTIS EQ 0.3% BASE A062480 001 Mar 30, 1984

GENTAFAIR

PHARMAFAIR EQ 0.3% BASE A062440 001 May 03, 1983

GENTAMICIN SULFATE

ALCON PHARMS LTD EQ 0.3% BASE A062523 001 Nov 25, 1985

PACO EQ 3MG BASE/ML A062932 001 Nov 07, 1988

GENTIAN VIOLET

SUPPOSITORY;VAGINAL

GVS

SAVAGE LABS 0.4% A083513 001

TAMPON;VAGINAL

GENAPAX

KEY PHARMS 5MG A085017 001

GLATIRAMER ACETATE

FOR SOLUTION;SUBCUTANEOUS

COPAXONE

TEVA PHARMS USA 20MG/VIAL N020622 001 Dec 20, 1996

GLIMEPIRIDE

TABLET;ORAL

GLIMEPIRIDE

ACTAVIS LABS FL INC 1MG A076995 001 Apr 27, 2010

2MG A076995 002 Apr 27, 2010

4MG A076995 003 Apr 27, 2010

EPIC PHARMA LLC 1MG A077274 001 Oct 06, 2005



2MG A077274 002 Oct 06, 2005

4MG A077274 003 Oct 06, 2005

HIKMA PHARMS 1MG A078952 001 Aug 01, 2013

2MG A078952 002 Aug 01, 2013

4MG A078952 003 Aug 01, 2013

MYLAN 1MG A077486 001 Feb 10, 2006



2MG A077486 002 Feb 10, 2006

4MG A077486 003 Feb 10, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-179(of 393)

** See List Footnote



GLIMEPIRIDE

TABLET;ORAL

GLIMEPIRIDE

RANBAXY 3MG A077366 001 Oct 06, 2005

6MG A077366 002 Oct 06, 2005

RANBAXY LABS LTD 1MG A076875 001 Oct 06, 2005

2MG A076875 002 Oct 06, 2005

4MG A076875 003 Oct 06, 2005

8MG A076875 004 Oct 06, 2005

WATSON LABS 1MG A077280 001 Feb 03, 2006

2MG A077280 002 Feb 03, 2006

4MG A077280 003 Feb 03, 2006

GLIMEPIRIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDARYL

+ SB PHARMCO 1MG;4MG ** N021700 001 Nov 23, 2005
+ 2MG;4MG ** N021700 002 Nov 23, 2005
+ 2MG;8MG ** N021700 004 Mar 30, 2007
+ 4MG;4MG ** N021700 003 Nov 23, 2005
+ 4MG;8MG ** N021700 005 Mar 30, 2007
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
TEVA PHARMS USA 1MG;4MG A078709 001 Apr 01, 2016
2MG;4MG A078709 002 Apr 01, 2016
2MG;8MG A078709 004 Apr 01, 2016
4MG;4MG A078709 003 Apr 01, 2016
4MG;8MG A078709 005 Apr 01, 2016
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
ANI PHARMS INC 5MG A074387 001 Mar 04, 1996
10MG A074387 002 Mar 04, 1996
BARR LABS INC 5MG A074619 001 Apr 04, 1997
10MG A074619 002 Apr 04, 1997
MYLAN 5MG A074438 001 Jun 20, 1995
10MG A074438 002 Jun 20, 1995
OXFORD PHARMS 5MG A074378 001 Nov 28, 1994
10MG A074378 002 Nov 28, 1994
SANDOZ 5MG A074542 001 Jun 20, 1995
10MG A074542 002 Jun 20, 1995
WATSON LABS 5MG A074370 001 Nov 22, 1994
10MG A074370 002 Nov 22, 1994
GLUCOTROL
PFIZER 2.5MG N017783 003 May 11, 1993
GLIPIZIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
METAGLIP
+ BRISTOL MYERS SQUIBB 2.5MG;250MG ** N021460 001 Oct 21, 2002
+ 2.5MG;500MG ** N021460 002 Oct 21, 2002
+ 5MG;500MG ** N021460 003 Oct 21, 2002
GLUCAGON HYDROCHLORIDE
INJECTABLE;INJECTION
GLUCAGON
+ LILLY EQ 1MG BASE/VIAL ** N012122 001
+ EQ 10MG BASE/VIAL ** N012122 002
GLUTETHIMIDE
CAPSULE;ORAL
DORIDEN
SANOFI AVENTIS US 500MG N009519 008
TABLET;ORAL
DORIDEN
SANOFI AVENTIS US 250MG N009519 002
500MG N009519 005
GLUTETHIMIDE
HALSEY 250MG A089458 001 Oct 10, 1986
500MG A089459 001 Oct 10, 1986
LANNETT 250MG A083475 001
500MG A085571 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-180(of 393)

** See List Footnote



GLUTETHIMIDE

TABLET;ORAL

GLUTETHIMIDE

UCB INC 500MG A085171 001

UPSHER SMITH LABS 500MG A083234 002

VITARINE 500MG A087297 001

WATSON LABS 500MG A084362 001

500MG A085763 001

GLYBURIDE

TABLET;ORAL

GLYBURIDE

ACTAVIS ELIZABETH 1.5MG A075947 001 Nov 14, 2002

3MG A075947 002 Nov 14, 2002

6MG A075947 003 Nov 14, 2002

GLYBURIDE (MICRONIZED)

SANOFI AVENTIS US 1.5MG N020055 001 Apr 17, 1992

3MG N020055 002 Apr 17, 1992

6MG N020055 003 Mar 08, 2000



YAOPHARMA CO LTD 1.5MG A075174 001 Jun 22, 1998

3MG A075174 002 Jun 22, 1998

GLYNASE

+ PHARMACIA AND UPJOHN 4.5MG ** N020051 003 Sep 24, 1993

MICRONASE

+ PHARMACIA AND UPJOHN 1.25MG ** N017498 001 May 01, 1984

2.5MG N017498 002 May 01, 1984

+ 5MG ** N017498 003 May 01, 1984



GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOVANCE

+ BRISTOL MYERS SQUIBB 1.25MG;250MG ** N021178 001 Jul 31, 2000

+ 2.5MG;500MG ** N021178 002 Jul 31, 2000

+ 5MG;500MG ** N021178 003 Jul 31, 2000

GLYBURIDE AND METFORMIN HYDROCHLORIDE

IMPAX LABS INC 1.25MG;250MG A076731 001 Nov 19, 2004

2.5MG;500MG A076731 002 Nov 19, 2004

5MG;500MG A076731 003 Nov 19, 2004

TEVA 1.25MG;250MG A076821 001 Jan 27, 2005

2.5MG;500MG A076821 002 Jan 27, 2005

5MG;500MG A076821 003 Jan 27, 2005

GLYCINE

SOLUTION;IRRIGATION

GLYCINE 1.5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 1.5GM/100ML N018522 001 Feb 19, 1982

HOSPIRA 1.5GM/100ML N017633 001

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

ABRAXIS PHARM 0.2MG/ML A088475 001 Jun 12, 1984

HOSPIRA 0.2MG/ML A089393 001 Jun 15, 1988

TEVA PARENTERAL 0.2MG/ML A081169 001 Sep 10, 1991

WATSON LABS 0.2MG/ML A086947 001 Jun 24, 1983



ROBINUL

ROBINS AH 0.2MG/ML N014764 001

+ WEST-WARD PHARMS INT 0.2MG/ML ** N017558 001

TABLET;ORAL

GLYCOPYRROLATE

HIKMA INTL PHARMS 1MG A040836 001 Mar 05, 2009

2MG A040836 002 Mar 05, 2009

RENATA 1MG A040568 001 Dec 22, 2004

2MG A040568 002 Dec 22, 2004

WATSON LABS 1MG A085562 001

1MG A086902 001

2MG A085563 001

2MG A086178 001

2MG A086900 001

ROBINUL

+ CASPER PHARMA LLC 1MG N012827 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-181(of 393)

** See List Footnote



GLYCOPYRROLATE

TABLET;ORAL

ROBINUL FORTE

+ CASPER PHARMA LLC 2MG N012827 002

GONADORELIN ACETATE

INJECTABLE;INJECTION

LUTREPULSE KIT

FERRING 0.8MG/VIAL N019687 001 Oct 10, 1989

3.2MG/VIAL N019687 002 Oct 10, 1989

GONADORELIN HYDROCHLORIDE

INJECTABLE;INJECTION

FACTREL

WEST-WARD PHARMS INT EQ 0.1MG BASE/VIAL N018123 001 Sep 30, 1982

EQ 0.2MG BASE/VIAL N018123 002 Sep 30, 1982

EQ 0.5MG BASE/VIAL N018123 003 Sep 30, 1982



GONADOTROPIN, CHORIONIC

INJECTABLE;INJECTION

A.P.L.

FERRING 5,000 UNITS/VIAL N017055 001

10,000 UNITS/VIAL N017055 002

20,000 UNITS/VIAL N017055 003

CHORIONIC GONADOTROPIN

BEL MAR 5,000 UNITS/VIAL N017054 001

10,000 UNITS/VIAL N017054 002

FERRING 2,000 UNITS/VIAL N017016 009 Dec 27, 1984

2,000 UNITS/VIAL N017016 011 Feb 16, 1990

15,000 UNITS/VIAL N017016 010 Feb 15, 1985

20,000 UNITS/VIAL N017016 004

FRESENIUS KABI USA 5,000 UNITS/VIAL N017067 001

15,000 UNITS/VIAL N017067 004

20,000 UNITS/VIAL N017067 003

FOLLUTEIN

BRISTOL MYERS SQUIBB 10,000 UNITS/VIAL N017056 001

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OPHTHALMIC

NEO-POLYCIN

DOW PHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060427 001

UNITS/ML

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN



IPHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062818 001 Oct 11, 1988

UNITS/ML

WATSON LABS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062788 001 Jun 11, 1987

UNITS/ML

NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN



PHARMAFAIR 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A062383 001 Aug 31, 1982

UNITS/ML

GRANISETRON HYDROCHLORIDE

INJECTABLE;INJECTION

GRANISETRON HYDROCHLORIDE

BAXTER HLTHCARE CORP EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078197 001 Dec 31, 2007

EQ 1MG BASE/ML (EQ 1MG BASE/ML) A078198 001 Jun 30, 2008

EQ 4MG BASE/4ML (EQ 1MG BASE/ML) A078198 002 Jun 30, 2008

SANDOZ INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) A078808 001 Apr 29, 2008

TEVA PHARMS USA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077963 001 Jan 03, 2008

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

TEVA PHARMS USA EQ 1MG BASE/ML (EQ 1MG BASE/ML) A077165 001 Dec 31, 2007

KYTRIL

+ ROCHE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) ** N020239 003 Sep 17, 2004

+ EQ 1MG BASE/ML (EQ 1MG BASE/ML) ** N020239 004 Mar 11, 1994

+ EQ 3MG BASE/ML ** N020239 001 Dec 29, 1993

+ EQ 4MG BASE/4ML (EQ 1MG BASE/ML) ** N020239 002 Mar 11, 1994

SOLUTION;ORAL

GRANISOL

PEDIATRX EQ 2MG BASE/10ML A078334 001 Feb 28, 2008

KYTRIL

+ ROCHE EQ 2MG BASE/10ML ** N021238 001 Jun 27, 2001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-182(of 393)

** See List Footnote



GRANISETRON HYDROCHLORIDE

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

BARR
EQ 1MG BASE
A078221 001 Dec 31, 2007

EPIC PHARMA LLC
EQ 1MG BASE
A078260 001 Dec 31, 2007

KYTRIL

+ ROCHE
EQ 1MG BASE **
N020305 001 Mar 16, 1995

+
EQ 2MG BASE **
N020305 002 Jun 15, 1998

GREPAFLOXACIN HYDROCHLORIDE

TABLET;ORAL

RAXAR

OTSUKA
EQ 200MG BASE
N020695 001 Nov 06, 1997

EQ 400MG BASE
N020695 002 May 14, 1998

EQ 600MG BASE
N020695 003 May 14, 1998

GRISEOFULVIN, MICROCRYSTALLINE

CAPSULE;ORAL

GRISACTIN

WYETH AYERST
125MG
N050051 002

250MG
N050051 001

SUSPENSION;ORAL

GRIFULVIN V

+ JOHNSON AND JOHNSON
125MG/5ML **
N050448 001

TABLET;ORAL

FULVICIN-U/F

CHARTWELL RX
250MG
A060569 002

500MG
A060569 001

GRIFULVIN V

J AND J
125MG
A060618 001

250MG
A060618 002

500MG
A060618 003

VALEANT LUXEMBOURG
125MG
A062279 001

250MG **
A062279 002

GRISACTIN

WYETH AYERST
500MG
A060212 001

GRISEOFULVIN, MICROSIZE

SUSPENSION;ORAL

GRIFULVIN V

VALEANT LUXEMBOURG
125MG/5ML **
A062483 001 Jan 26, 1984

TABLET;ORAL

GRIFULVIN V

VALEANT LUXEMBOURG
500MG
A062279 003

GRISEOFULVIN, ULTRAMICROCRYSTALLINE

TABLET;ORAL

FULVICIN P/G

CHARTWELL RX
125MG
A061996 001

250MG
A061996 002

FULVICIN P/G 165

CHARTWELL RX
165MG
A061996 003 Apr 06, 1982

FULVICIN P/G 330

CHARTWELL RX
330MG
A061996 004 Apr 06, 1982

GRISACTIN ULTRA

WYETH AYERST
125MG
A062178 001

165MG
A062438 001 Nov 17, 1983

250MG
A062178 002

330MG
A062438 002 Nov 17, 1983

ULTRAGRIS-165

PLIVA
165MG
A062645 001 Jun 30, 1992

ULTRAGRIS-330

PLIVA
330MG
A062646 001 Jun 30, 1992

GUAIFENESIN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

FLOWTUSS

BKK PHARMS 200MG/5ML;2.5MG/5ML
N022424 001 May 14, 2015

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-183(of 393)

** See List Footnote



GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYCOFENIX

+ BKK PHARMS 200MG/5ML;2.5MG/5ML;30MG/5ML N022279 001 May 14, 2015

GUANABENZ ACETATE

TABLET;ORAL

GUANABENZ ACETATE

ANI PHARMS INC EQ 4MG BASE A074267 001 Jun 01, 1994

EQ 8MG BASE A074267 002 Jun 01, 1994

WATSON LABS EQ 4MG BASE A074025 001 Feb 28, 1994

EQ 8MG BASE A074025 002 Feb 28, 1994

YAOPHARMA CO LTD EQ 4MG BASE A074517 001 Sep 30, 1998

EQ 8MG BASE A074517 002 Sep 30, 1998

WYTENSIN

WYETH AYERST EQ 4MG BASE N018587 001 Sep 07, 1982

EQ 8MG BASE N018587 002 Sep 07, 1982

EQ 16MG BASE N018587 003 Sep 07, 1982



GUANADREL SULFATE

TABLET;ORAL

HYLOREL

PHARMACIA AND UPJOHN 10MG N018104 001 Dec 29, 1982

25MG N018104 002 Dec 29, 1982

GUANETHIDINE MONOSULFATE

TABLET;ORAL

GUANETHIDINE MONOSULFATE

WATSON LABS EQ 10MG SULFATE A086113 001 Mar 26, 1985

EQ 25MG SULFATE A086114 001 Mar 26, 1985

ISMELIN

NOVARTIS EQ 10MG SULFATE N012329 001

EQ 25MG SULFATE N012329 002

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

ESIMIL

NOVARTIS 10MG;25MG N013553 001

GUANFACINE HYDROCHLORIDE

TABLET;ORAL

GUANFACINE HYDROCHLORIDE

EPIC PHARMA LLC EQ 1MG BASE A074673 001 Feb 28, 1997
EQ 2MG BASE A074673 002 Feb 28, 1997
WATSON LABS EQ 1MG BASE A074762 001 Jun 25, 1997
EQ 2MG BASE A074762 002 Jun 25, 1997
TENEX
+ PROMIUS PHARMA EQ 1MG BASE N019032 001 Oct 27, 1986
+ EQ 2MG BASE N019032 002 Nov 07, 1988
EQ 3MG BASE N019032 003 Nov 07, 1988
TABLET, EXTENDED RELEASE;ORAL
GUANFACINE HYDROCHLORIDE
IMPAX LABS INC EQ 1MG BASE A202238 001 Oct 20, 2015
EQ 2MG BASE A202238 002 Oct 20, 2015
EQ 3MG BASE A202238 003 Oct 20, 2015
EQ 4MG BASE A202238 004 Oct 20, 2015
HALAZEPAM
TABLET;ORAL
PAXIPAM
SCHERING 20MG N017736 003
40MG N017736 004
HALCINONIDE
CREAM;TOPICAL
HALOG
WESTWOOD SQUIBB 0.025% N017818 001
HALOG-E
SUN PHARM INDS INC 0.1% N018234 001
OINTMENT;TOPICAL
HALOG
BRISTOL MYERS SQUIBB 0.025% N018125 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-184(of 393)

** See List Footnote



HALCINONIDE

SOLUTION;TOPICAL

HALOG

SUN PHARM INDS INC
0.1%
N017823 001

HALOBETASOL PROPIONATE

OINTMENT;TOPICAL

HALOBETASOL PROPIONATE

FOUGERA PHARMS
0.05%
A076903 001 Dec 16, 2004

HALOFANTRINE HYDROCHLORIDE

TABLET;ORAL

HALFAN

GLAXOSMITHKLINE
250MG
N020250 001 Jul 24, 1992

HALOPERIDOL

TABLET;ORAL

HALDOL

+ ORTHO MCNEIL
0.5MG **
N015921 001

+
1MG **
N015921 002

+
2MG **
N015921 003

+
5MG **
N015921 004

+
10MG **
N015921 005

+
20MG **
N015921 006 Feb 02, 1982

HALDOL SOLUTAB

ORTHO MCNEIL PHARM
1MG
N017079 001

HALOPERIDOL

ANDA REPOSITORY
0.5MG
A071156 001 Jan 02, 1987

1MG
A071157 001 Jan 02, 1987

2MG
A071172 001 Jan 02, 1987

5MG
A071212 001 Jan 07, 1988

10MG
A071173 001 Jan 07, 1988

20MG
A071177 001 Jan 07, 1988

CYCLE PHARMS LTD
0.5MG
A071128 001 Feb 17, 1987

1MG
A071129 001 Feb 17, 1987

2MG
A071130 001 Feb 17, 1987

5MG
A071131 001 Feb 17, 1987

10MG
A071132 001 May 12, 1987

20MG
A071133 001 May 12, 1987

DURAMED PHARMS BARR


0.5MG
A071216 001 Dec 04, 1986

1MG
A071217 001 Dec 04, 1986

2MG
A071218 001 Dec 04, 1986

5MG
A071219 001 Dec 04, 1986

10MG
A071220 001 Jul 07, 1987

20MG
A071221 001 Jul 07, 1987

LEDERLE
0.5MG
A072727 001 Sep 19, 1989

1MG
A072728 001 Sep 19, 1989

2MG
A072729 001 Sep 19, 1989

5MG
A072730 001 Sep 19, 1989

10MG
A072731 001 Sep 19, 1989

20MG
A072732 001 Sep 19, 1989

PAR PHARM
20MG
A071328 001 Jul 20, 1987

PUREPAC PHARM
0.5MG
A071071 001 Nov 03, 1986

1MG
A071072 001 Nov 03, 1986

2MG
A071073 001 Nov 03, 1986

5MG
A071074 001 Nov 03, 1986

10MG
A071075 001 Aug 04, 1987

20MG
A071076 001 Aug 04, 1987

QUANTUM PHARMICS
0.5MG
A071255 001 Feb 17, 1987

1MG
A071269 001 Feb 17, 1987

2MG
A071256 001 Feb 17, 1987

5MG
A071257 001 Feb 17, 1987

ROYCE LABS
0.5MG
A071722 001 Dec 24, 1987

1MG
A071723 001 Dec 24, 1987

2MG
A071724 001 Dec 24, 1987

5MG
A071725 001 Dec 24, 1987

10MG
A072121 001 Dec 24, 1987

20MG
A072122 001 Dec 24, 1987

SCS
0.5MG
A070720 001 Jun 10, 1986

1MG
A070721 001 Jun 10, 1986

2MG
A070722 001 Jun 10, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-185(of 393)

** See List Footnote



HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

5MG A070723 001 Jun 10, 1986

10MG A070724 001 Jun 10, 1986

20MG A070725 001 Sep 24, 1986

VINTAGE 0.5MG A071235 002 Nov 03, 1986



1MG A071235 003 Nov 03, 1986

2MG A071235 001 Nov 03, 1986

5MG A071235 004 Nov 03, 1986

10MG A071235 005 Jul 20, 1987

WATSON LABS 0.5MG A070981 001 Mar 06, 1987

0.5MG A071571 001 Jun 03, 1988

1MG A070982 001 Mar 06, 1987

1MG A071572 001 Jun 03, 1988

2MG A070983 001 Mar 06, 1987

2MG A071573 001 Jun 03, 1988

5MG A070984 001 Mar 06, 1987

5MG A071374 001 Jun 03, 1988

10MG A071375 001 Jun 03, 1988

10MG A072113 001 Aug 27, 1991

20MG A071376 001 Jun 03, 1988



20MG A072353 001 Aug 27, 1991

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION

HALOPERIDOL DECANOATE

HOSPIRA EQ 50MG BASE/ML A075176 001 Feb 09, 2000

EQ 100MG BASE/ML A075176 002 Feb 09, 2000

SANDOZ INC EQ 50MG BASE/ML A076463 001 Jun 24, 2005

EQ 100MG BASE/ML A076463 002 Jun 24, 2005

HALOPERIDOL LACTATE

CONCENTRATE;ORAL

HALDOL

ORTHO MCNEIL EQ 2MG BASE/ML ** N015922 001

HALOPERIDOL

ALPHARMA EQ 2MG BASE/ML A070318 001 Apr 11, 1986

MORTON GROVE EQ 2MG BASE/ML A070710 001 Mar 07, 1986



SCS EQ 2MG BASE/ML A070726 001 Jun 10, 1986

TEVA EQ 2MG BASE/ML A071015 001 Aug 25, 1987

HALOPERIDOL INTENSOL

CYCLE PHARMS LTD EQ 2MG BASE/ML A072045 001 Apr 12, 1988

INJECTABLE;INJECTION

HALOPERIDOL

ABRAXIS PHARM EQ 5MG BASE/ML A071187 001 Jan 20, 1987

BAXTER HLTHCARE CORP EQ 5MG BASE/ML A076791 001 Aug 25, 2004

EQ 5MG BASE/ML A076828 001 Aug 25, 2004

FOSUN PHARMA EQ 5MG BASE/ML A076464 001 Sep 29, 2004

MARSAM PHARMS LLC EQ 5MG BASE/ML A072516 001 Feb 25, 1993

EQ 5MG BASE/ML A072517 001 Feb 25, 1993

SMITH AND NEPHEW EQ 5MG BASE/ML A070802 001 Dec 14, 1987

SOLOPAK EQ 5MG BASE/ML A070800 001 Dec 14, 1987

EQ 5MG BASE/ML A070801 001 Dec 14, 1987

EQ 5MG BASE/ML A070864 001 Dec 14, 1987

WATSON LABS EQ 5MG BASE/ML A070713 001 May 17, 1988

EQ 5MG BASE/ML A070714 001 May 17, 1988

EQ 5MG BASE/ML A070744 001 May 17, 1988

SOLUTION;ORAL

HALOPERIDOL LACTATE

ACTAVIS MID ATLANTIC EQ 1MG BASE/ML A074536 001 Nov 02, 1995

HALOPROGIN

CREAM;TOPICAL

HALOTEX

WESTWOOD SQUIBB 1% N016942 001

SOLUTION;TOPICAL

HALOTEX

WESTWOOD SQUIBB 1% N016943 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-186(of 393)

** See List Footnote



HALOTHANE

LIQUID;INHALATION

FLUOTHANE

WYETH AYERST
99.99%
N011338 001

HALOTHANE

BH
99.99%
A084977 001

HALOCARBON
99.99%
A080810 001

HOSPIRA
99.99%
A083254 001

HEPARIN CALCIUM

INJECTABLE;INJECTION

CALCIPARINE

SANOFI AVENTIS US
25,000 UNITS/ML
N018237 001

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN LOCK FLUSH

HOSPIRA
100 UNITS/ML
N005264 010

INTL MEDICATION
10 UNITS/ML
A086357 001

500 UNITS/ML
A086357 002

LUITPOLD
10 UNITS/ML
A089063 001 Oct 09, 1985

100 UNITS/ML
A089064 001 Oct 09, 1985

PARKE DAVIS
10 UNITS/ML
N017346 006

SMITH AND NEPHEW
10 UNITS/ML
A087904 001 Apr 20, 1983

10 UNITS/ML
A087958 001 Apr 20, 1983

10 UNITS/ML
A088458 001 Jul 26, 1984

10 UNITS/ML
A088580 001 Oct 25, 1984

100 UNITS/ML
A087906 001 Apr 20, 1983

100 UNITS/ML
A087959 001 Apr 20, 1983

100 UNITS/ML
A088460 001 Jul 26, 1984

100 UNITS/ML
A088581 001 Oct 25, 1984

SOLOPAK
10 UNITS/ML
A087903 001 Apr 20, 1983

10 UNITS/ML
A088457 001 Oct 25, 1984

100 UNITS/ML
A087905 001 Apr 20, 1983

100 UNITS/ML
A088459 001 Jul 26, 1984

HEPARIN SODIUM

ABRAXIS PHARM
1,000 UNITS/ML
N017033 001

1,000 UNITS/ML
N017979 001

5,000 UNITS/ML
N017979 003

10,000 UNITS/ML
N017979 002

AKORN
1,000 UNITS/ML
N017486 001

5,000 UNITS/ML
N017486 002

10,000 UNITS/ML
N017486 003

20,000 UNITS/ML
N017486 004

40,000 UNITS/ML
N017486 005

CHAMBERLIN PARENTERL 1,000 UNITS/ML
N017130 001

5,000 UNITS/ML
N017130 002

10,000 UNITS/ML
N017130 003

20,000 UNITS/ML
N017130 004

DELL LABS
1,000 UNITS/ML
N017540 001

5,000 UNITS/ML
N017540 002

10,000 UNITS/ML
N017540 003

20,000 UNITS/ML
N017540 004

40,000 UNITS/ML
N017540 005

FRESENIUS KABI USA
1,000 UNITS/ML
N017651 005

5,000 UNITS/ML
N017029 002

10,000 UNITS/ML
N017651 003

20,000 UNITS/ML
N017651 008

HOSPIRA
2,500 UNITS/ML
A088099 001 Apr 28, 1983

10,000 UNITS/ML
A040095 001 Jul 26, 1996

LILLY
1,000 UNITS/ML
N005521 001

10,000 UNITS/ML
N005521 002

20,000 UNITS/ML
N005521 004

LUITPOLD
1,000 UNITS/ML
A087452 001 Oct 31, 1983

ORGANON USA INC
1,000 UNITS/ML
N000552 008

5,000 UNITS/ML
N000552 009

10,000 UNITS/ML
N000552 010

PARKE DAVIS
1,000 UNITS/ML
N017346 001

5,000 UNITS/ML
N017346 002

7,500 UNITS/ML
N017346 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-187(of 393)

** See List Footnote



HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

10,000 UNITS/ML N017346 004

20,000 UNITS/ML N017346 005

PHARM SPEC 1,000 UNITS/ML N017780 001

5,000 UNITS/ML N017780 002

10,000 UNITS/ML N017780 003

20,000 UNITS/ML N017780 004

40,000 UNITS/ML N017780 005

PHARMACIA AND UPJOHN 1,000 UNITS/ML N004570 001

5,000 UNITS/ML N004570 002

10,000 UNITS/ML N004570 003

SMITH AND NEPHEW 1,000 UNITS/ML A088239 001 Jul 26, 1984

SOLOPAK 1,000 UNITS/ML A087043 001

5,000 UNITS/ML A087077 001

5,000 UNITS/0.5ML A087395 001

10,000 UNITS/ML A087107 001

10,000 UNITS/0.5ML A087363 001

WATSON LABS 1,000 UNITS/ML N017064 002

2,500 UNITS/ML N017064 015

3,000 UNITS/ML N017064 016

4,000 UNITS/ML N017064 017

5,000 UNITS/ML N017064 003

6,000 UNITS/ML N017064 018

7,500 UNITS/ML N017064 019

10,000 UNITS/ML N017064 004

20,000 UNITS/ML N017064 005

40,000 UNITS/ML N017064 006

WATSON LABS INC 1,000 UNITS/ML A040007 001 Jun 07, 1996

1,000 UNITS/ML A040008 001 Oct 10, 1995

+ WEST-WARD PHARMS INT 1,000 UNITS/ML ** N017007 001

+ 2,500 UNITS/ML ** N017007 007

+ 5,000 UNITS/ML ** N017007 002

+ 5,000 UNITS/0.5ML ** N017007 010

5,000 UNITS/0.5ML N017037 013 Apr 07, 1986

+ 7,500 UNITS/ML ** N017007 003



+ 10,000 UNITS/ML ** N017007 004

+ 15,000 UNITS/ML ** N017007 005

+ 20,000 UNITS/ML ** N017007 006

HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAW 200 UNITS/100ML N019130 001 Dec 31, 1984

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 200 UNITS/100ML N019042 001 Mar 29, 1985

HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 2,000 UNITS/100ML N018814 002 Jul 09, 1985

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%

HOSPIRA 10,000 UNITS/100ML N018911 006 Jan 30, 1985

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

HOSPIRA 10,000 UNITS/100ML N018911 001 Jan 30, 1985

10,000 UNITS/100ML N018916 005 Jan 31, 1984

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA 10,000 UNITS/100ML N018911 003 Jan 30, 1985

10,000 UNITS/100ML N018916 002 Jan 31, 1984

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%

HOSPIRA 5,000 UNITS/100ML N018911 007 Jan 30, 1985

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 5,000 UNITS/100ML N019802 001 Jul 20, 1992

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA 5,000 UNITS/100ML N018911 005 Jan 30, 1985

5,000 UNITS/100ML N018916 003 Jan 31, 1984

HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

MCGAW 200 UNITS/100ML N019130 003 Dec 31, 1984

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 200 UNITS/100ML N019042 002 Mar 29, 1985

HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4,000 UNITS/100ML N018814 001 Oct 31, 1983

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 5,000 UNITS/100ML N018814 003 Jul 09, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-188(of 393)

** See List Footnote



HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER

10,000 UNITS/100ML N018814 004 Jul 02, 1987

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

HOSPIRA 5,000 UNITS/100ML N018911 009 Jan 30, 1985

10,000 UNITS/100ML N018911 008 Jan 30, 1985

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 5,000 UNITS/100ML N019134 001 Mar 29, 1985

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN 5,000 UNITS/100ML N019802 005 Jul 20, 1992

10,000 UNITS/100ML N019802 002 Jul 20, 1992

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA 5,000 UNITS/100ML N018911 004 Jan 30, 1985

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 5,000 UNITS/100ML N019135 001 Mar 29, 1985

5,000 UNITS/100ML N019802 003 Jul 20, 1992

HOSPIRA 5,000 UNITS/100ML N018916 009 Jan 31, 1984

HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCARE 500 UNITS/100ML N018609 003 Apr 28, 1982

HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER



MCGAW 1,000 UNITS/100ML N019130 002 Dec 31, 1984

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

HOSPIRA 100 UNITS/ML N018911 002 Jan 30, 1985

100 UNITS/ML N018916 004 Jan 31, 1984

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%

HOSPIRA 1,000 UNITS/100ML N018916 001 Jan 31, 1984

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 1,000 UNITS/100ML
N019042 004 Mar 29, 1985

HEPARIN SODIUM PRESERVATIVE FREE

HOSPIRA
2,000 UNITS/ML
N005264 013 Apr 07, 1986

2,500 UNITS/ML
N005264 014 Apr 07, 1986

PHARMA SERVE NY
1,000 UNITS/ML
A086129 001

WATSON LABS INC
1,000 UNITS/ML
A089464 001 Jun 03, 1986

LIPO-HEPIN

3M
1,000 UNITS/0.5ML
N017027 001

1,000 UNITS/ML
N017027 006

5,000 UNITS/0.5ML
N017027 002

5,000 UNITS/ML
N017027 008

7,500 UNITS/0.5ML
N017027 010

10,000 UNITS/0.5ML
N017027 003

10,000 UNITS/ML
N017027 009

15,000 UNITS/0.5ML
N017027 011

20,000 UNITS/0.5ML
N017027 004

20,000 UNITS/ML
N017027 007

40,000 UNITS/ML
N017027 005

LIQUAEMIN LOCK FLUSH

ORGANON USA INC
100 UNITS/ML
N000552 007

LIQUAEMIN SODIUM

ORGANON USA INC
1,000 UNITS/ML
N000552 004

5,000 UNITS/ML
N000552 003

10,000 UNITS/ML
N000552 005

20,000 UNITS/ML
N000552 001

40,000 UNITS/ML
N000552 002

LIQUAEMIN SODIUM PRESERVATIVE FREE

ORGANON USA INC
1,000 UNITS/ML
N000552 011 Apr 11, 1986

5,000 UNITS/ML
N000552 012 Apr 11, 1986

10,000 UNITS/ML
N000552 013 Apr 11, 1986

PANHEPRIN

HOSPIRA
1,000 UNITS/ML
N005264 004

5,000 UNITS/ML
N005264 006

10,000 UNITS/ML
N005264 007

20,000 UNITS/ML
N005264 008

40,000 UNITS/ML
N005264 009

SODIUM HEPARIN

ABRAXIS PHARM
5,000 UNITS/ML
N017033 002

10,000 UNITS/ML
N017033 003

20,000 UNITS/ML
N017033 004

BAXTER HLTHCARE
1,000 UNITS/ML
N017036 001 Mar 04, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-189(of 393)

** See List Footnote



HETACILLIN

FOR SUSPENSION;ORAL

VERSAPEN

BRISTOL
EQ 112.5MG AMPICIL/ML
A061398 001

EQ 112.5MG AMPICIL/5ML
N050060 001

EQ 112.5MG AMPICIL/ML
N050060 003

EQ 225MG AMPICIL/5ML
A061398 002

HETACILLIN POTASSIUM

CAPSULE;ORAL

VERSAPEN-K

BRISTOL
EQ 225MG AMPICIL
A061396 001

EQ 450MG AMPICIL
A061396 002

HEXACHLOROPHENE

AEROSOL;TOPICAL

SEPTISOL

VESTAL LABS
0.23%
N017424 001

TURGEX

XTTRIUM
3%
N018375 001

EMULSION;TOPICAL

HEXA-GERM

HUNTINGTON LABS
3%
N017411 001

PHISOHEX

SANOFI AVENTIS US
3%
N006882 001

3%
N008402 001

SOY-DOME

BAYER PHARMS
3%
N017405 001

TURGEX

XTTRIUM
3%
N019055 001 Nov 30, 1984

SOAP;TOPICAL

GAMOPHEN

ARBROOK
2%
N006270 003

SOLUTION;TOPICAL

DIAL

DIAL
0.25%
N017421 002

GERMA-MEDICA

HUNTINGTON LABS
1%
N017412 001

GERMA-MEDICA "MG"

HUNTINGTON LABS
0.25%
N017412 002

SEPTI-SOFT

CALGON
0.25%
N017460 001

SEPTISOL

VESTAL LABS
0.25%
N017423 001

SPONGE;TOPICAL

E-Z SCRUB

BECTON DICKINSON
450MG
N017452 001

HEXASCRUB

PROF DSPLS
3%
N018363 001

PHISO-SCRUB

SANOFI AVENTIS US
3%
N017446 001

SCRUBTEAM SURGICAL SPONGEBRUSH

3M
330MG
N017413 001

HEXAFLUORENIUM BROMIDE

INJECTABLE;INJECTION

MYLAXEN

MEDPOINTE PHARM HLC
20MG/ML
N009789 003

HEXOCYCLIUM METHYLSULFATE

TABLET;ORAL

TRAL

ABBVIE
25MG
N010599 001

HEXYLCAINE HYDROCHLORIDE

SOLUTION;TOPICAL

CYCLAINE

MERCK
5%
N008472 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-190(of 393)

** See List Footnote



HISTAMINE PHOSPHATE

INJECTABLE;INJECTION

HISTAMINE PHOSPHATE

LILLY
EQ 0.1MG BASE/ML
N000734 003

EQ 0.2MG BASE/ML
N000734 002

EQ 1MG BASE/ML
N000734 001

HISTRELIN ACETATE

INJECTABLE;INJECTION

SUPPRELIN

SHIRE
EQ 0.2MG BASE/ML
N019836 001 Dec 24, 1991

EQ 0.5MG BASE/ML
N019836 002 Dec 24, 1991

EQ 1MG BASE/ML
N019836 003 Dec 24, 1991

HOMATROPINE METHYLBROMIDE

TABLET;ORAL

HOMAPIN-10

MISSION PHARMA
10MG
A086308 001

HOMAPIN-5

MISSION PHARMA
5MG
A086309 001

TABLET, CHEWABLE;ORAL

EQUIPIN

MISSION PHARMA 3MG
A086310 001

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYCODAN

+ GENUS LIFESCIENCES 1.5MG/5ML;5MG/5ML **
N005213 002 Jul 26, 1988

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

BIO-PHARM INC 1.5MG/5ML;5MG/5ML
A204765 001 Mar 06, 2017

IVAX SUB TEVA PHARMS 1.5MG/5ML;5MG/5ML
A040285 001 Jul 19, 1999

HYDROPANE

HALSEY 1.5MG/5ML;5MG/5ML
A088066 001 Jun 28, 1985

TABLET;ORAL

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

ACTAVIS ELIZABETH
1.5MG;5MG
A040295 001 Dec 01, 2000

HYCODAN

+ GENUS LIFESCIENCES
1.5MG;5MG **
N005213 001 Jul 26, 1988

HYALURONIDASE

INJECTABLE;INJECTION

HYDASE

AKORN INC
150 UNITS/ML
N021716 001 Oct 25, 2005

VITRASE

BAUSCH AND LOMB
6,200 UNITS/VIAL
N021640 001 May 05, 2004

WYDASE

BAXTER HLTHCARE
150 UNITS/ML **
N006343 002

150 UNITS/VIAL **
N006343 006

1,500 UNITS/VIAL **
N006343 005

HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

APRESOLINE

+ NOVARTIS
20MG/ML **
N008303 003

HYDRALAZINE HYDROCHLORIDE

ABRAXIS PHARM
20MG/ML
A089532 001 Aug 11, 1987

SMITH AND NEPHEW


20MG/ML
A088518 001 Apr 20, 1984

SOLOPAK
20MG/ML
A088517 001 Aug 22, 1985

TEVA PARENTERAL
20MG/ML
A040373 001 Feb 23, 2000

TABLET;ORAL

APRESOLINE

+ NOVARTIS
10MG **
N008303 004

+
25MG **
N008303 001

+
50MG **
N008303 002

+
100MG **
N008303 005

DRALZINE

TEVA
25MG
A084301 001

HYDRALAZINE HYDROCHLORIDE

ACTAVIS ELIZABETH
25MG
A088560 001 Oct 04, 1984

50MG
A088649 001 Oct 18, 1984

ACTAVIS GRP PTC
10MG
A091679 001 Mar 04, 2013

25MG
A091679 002 Mar 04, 2013

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-191(of 393)

** See List Footnote



HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

50MG
A091679 003 Mar 04, 2013

100MG
A091679 004 Mar 04, 2013

ANDA REPOSITORY
10MG
A089359 001 Jul 25, 1986

25MG
A089258 001 May 05, 1986

50MG
A089259 001 May 05, 1986

100MG
A088729 001 Apr 11, 1985

ASCOT
25MG
A088310 001 Dec 19, 1984

50MG
A088311 001 Dec 19, 1984

CHARTWELL RX
10MG
A088846 001 Feb 26, 1985

25MG
A088847 001 Feb 26, 1985

50MG
A088848 001 Feb 26, 1985

100MG
A088849 001 Feb 26, 1985

HALSEY
10MG
A089218 001 Jan 22, 1986

25MG
A089130 001 Jan 15, 1986

50MG
A089222 001 Jan 22, 1986

100MG
A089178 001 Jan 15, 1986

HERITAGE PHARMS INC
10MG
A040858 001 Feb 26, 2010

25MG
A040858 002 Feb 26, 2010

50MG
A040858 003 Feb 26, 2010

100MG
A040858 004 Feb 26, 2010

IMPAX LABS
25MG
A084922 001

50MG
A084923 001

IVAX SUB TEVA PHARMS 10MG
A084443 001

25MG
A084437 001

50MG
A084469 002

100MG
A084581 001

MUTUAL PHARM
10MG
A088728 001 Apr 11, 1985

25MG
A084106 002

50MG
A084107 002

MYLAN
10MG
A090413 001 Dec 08, 2010

25MG
A090413 002 Dec 08, 2010

50MG
A090413 003 Dec 08, 2010

100MG
A090413 004 Dec 08, 2010

PUREPAC PHARM
25MG
A088177 001 Jul 29, 1983

50MG
A088178 001 Aug 15, 1983

QUANTUM PHARMICS
10MG
A088671 001 May 01, 1984

25MG
A088657 001 Jun 15, 1984

50MG
A088652 001 May 08, 1984

100MG
A088686 001 May 01, 1984

SUPERPHARM
10MG
A088787 001 Aug 28, 1984

25MG
A088788 001 Aug 28, 1984

50MG
A088789 001 Aug 28, 1984

UPSHER SMITH LABS


10MG
A083241 001

25MG
A083560 001

50MG
A083561 001

UPSHER-SMITH LABS
50MG
A085088 001

USL PHARMA
25MG
A087780 001 Mar 29, 1982

50MG
A087751 001 Mar 29, 1982

VANGARD
25MG
A087712 001

50MG
A087908 001 May 07, 1982

VITARINE
25MG
A086088 001

WATSON LABS
25MG
A084504 001

25MG
A085532 002 May 24, 1982

50MG
A084503 001

50MG
A085533 002 May 25, 1982

WEST WARD
25MG
A088240 001 May 27, 1983

50MG
A088241 001 May 27, 1983

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

APRESAZIDE

NOVARTIS 25MG;25MG
A084735 001

50MG;50MG
A084810 001

100MG;50MG
A084811 001

HYDRA-ZIDE

PAR PHARM 100MG;50MG
A088961 001 Oct 21, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-192(of 393)

** See List Footnote



HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

SOLVAY 25MG;25MG
A087608 001 Feb 08, 1982

50MG;50MG
A087213 001 Feb 08, 1982

100MG;50MG
A087609 001 Feb 08, 1982

SUPERPHARM 25MG;25MG
A089200 001 Feb 09, 1987

50MG;50MG
A089201 001 Feb 09, 1987

WATSON LABS 25MG;25MG
A085457 001 Mar 04, 1982

50MG;50MG
A085446 001 Mar 04, 1982

100MG;50MG
A085440 001 Mar 04, 1982

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50

IVAX PHARMS 100MG;50MG


A088358 001 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25

IVAX PHARMS 25MG;25MG


A088356 001 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50

IVAX PHARMS 50MG;50MG


A088357 001 Apr 10, 1984

TABLET;ORAL

APRESOLINE-ESIDRIX

NOVARTIS 25MG;15MG
N012026 002

HYDRALAZINE AND HYDROCHLOROTHIAZIDE

WATSON LABS 25MG;15MG
A085827 001

HYDROCHLOROTHIAZIDE W/ HYDRALAZINE

WATSON LABS 25MG;15MG


A085373 001

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

CAM-AP-ES

CHARTWELL RX 25MG;15MG;0.1MG
A084897 001

HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE

IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG
A084291 001

HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE

MYLAN 25MG;15MG;0.1MG
A087085 001

HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE

WATSON LABS 25MG;15MG;0.1MG


A085771 001

HYDRAP-ES

SANDOZ 25MG;15MG;0.1MG
A084876 001

HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE

WATSON LABS 25MG;15MG;0.1MG


A083770 001

HYDROSERPINE PLUS (R-H-H)

IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG


A083877 001

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

SOLVAY 25MG;15MG;0.1MG
A088376 001 Oct 28, 1983

SUN PHARM INDUSTRIES 25MG;15MG;0.1MG
A088570 001 Apr 10, 1984

WATSON LABS 25MG;15MG;0.1MG


A085549 001

25MG;15MG;0.1MG
A087556 001

RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE

LEDERLE 25MG;15MG;0.1MG
A087709 001 May 13, 1982

SER-A-GEN

SOLVAY 25MG;15MG;0.1MG
A087210 001

SER-AP-ES

NOVARTIS 25MG;15MG;0.1MG
N012193 005

UNIPRES

SOLVAY 25MG;15MG;0.1MG
A085893 001

25MG;15MG;0.1MG
A086298 001

HYDRALAZINE HYDROCHLORIDE; RESERPINE

TABLET;ORAL

DRALSERP

SANDOZ
25MG;0.1MG
A084617 001

SERPASIL-APRESOLINE

NOVARTIS
25MG;0.1MG
N009296 004

50MG;0.2MG
N009296 002

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDROCHLOROTHIAZIDE

APOTEX
12.5MG
A078389 001 May 16, 2008

HIKMA INTL PHARMS


12.5MG
A077885 001 Nov 26, 2007

LANNETT CO INC
12.5MG
A091662 001 Jan 27, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-193(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE

SOLUTION;ORAL

HYDROCHLOROTHIAZIDE

MORTON GROVE 50MG/5ML
A089661 001 Jun 20, 1988

ROXANE 50MG/5ML
A088587 001 Jul 02, 1984

HYDROCHLOROTHIAZIDE INTENSOL

ROXANE
100MG/ML
A088588 001 Jul 02, 1984

TABLET;ORAL

ESIDRIX

NOVARTIS
25MG
N011793 005

50MG
N011793 008

100MG
N011793 009

HYDRO-D

HALSEY
25MG
A086504 001

50MG
A083891 002

HYDROCHLOROTHIAZIDE

ABC HOLDING
50MG
A085672 001

ACTAVIS ELIZABETH
25MG
A085054 002

50MG
A085208 001

ALRA
25MG
A086369 001

50MG
A083554 001

APOTEX
25MG
A040774 001 Oct 03, 2007

50MG
A040774 002 Oct 03, 2007

ASCOT
25MG
A087539 001 Feb 03, 1982

50MG
A087540 001 Feb 03, 1982

AUROLIFE PHARMA LLC
25MG
A083899 001

50MG
A085219 001

BARR
50MG
A084771 001

CHARTWELL RX
25MG
A085683 001

50MG
A083965 001

DAVA PHARMS INC
100MG
A087060 001

ELKINS SINN
50MG
A085152 002

HEATHER
50MG
A084135 001

HIKMA INTL PHARMS
25MG
A084878 002 Jul 12, 2006

IMPAX LABS
25MG
A084029 001

50MG
A083607 002

100MG
A085098 001

INWOOD LABS
25MG
A084776 001

25MG
A085067 001

50MG
A084776 002

IVAX SUB TEVA PHARMS 50MG
A084658 001

100MG A085022 001

JUBILANT CADISTA 25MG A040809 001 Sep 04, 2007

50MG A040809 002 Sep 04, 2007

LANNETT CO INC 25MG A084325 001



50MG A084324 001

MAST MM 25MG A086192 001

50MG A086192 002

MYLAN 25MG A084880 001

50MG A085112 001

MYLAN PHARMS INC 12.5MG A040770 001 Jan 23, 2007

PVT FORM 50MG A086597 001

ROXANE 25MG A085004 001

50MG A084536 002

50MG A085005 001

SOLVAY 25MG A085323 001

SUN PHARM INDUSTRIES 25MG
A083972 001

50MG A083972 002

100MG A083972 003

SUPERPHARM 25MG A088827 001 Dec 28, 1984

50MG A088828 001 Dec 28, 1984

100MG A088829 001 Dec 28, 1984

TEVA 25MG A088924 001 Feb 07, 1985

50MG A088923 001 Feb 07, 1985

USL PHARMA 25MG A087827 001 Apr 19, 1982

50MG A087752 001 Apr 19, 1982

VANGARD 25MG A087638 001



50MG A087610 001

WARNER CHILCOTT 25MG A087586 001 May 03, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-194(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE

TABLET;ORAL

HYDROCHLOROTHIAZIDE

50MG A087587 001 May 03, 1982

WATSON LABS 25MG A081189 001 Jan 24, 1992



25MG A083458 001

25MG A085232 002

50MG A083456 001

50MG A085233 001

50MG A086087 001

50MG A086594 001

100MG A081190 001 Jan 24, 1992

100MG A085099 001

100MG A087002 001

WATSON LABS TEVA 50MG A083232 001

WEST WARD 25MG A084899 001

WHITEWORTH TOWN PLSN 25MG A083809 002

50MG A083809 001

100MG A085347 001

YAOPHARMA CO LTD 25MG A087565 001 Mar 09, 1982

50MG A084912 001

HYDRODIURIL

+ MERCK 25MG ** N011835 003

+ 50MG ** N011835 006

+ 100MG ** N011835 007

ORETIC

ABBVIE 25MG N011971 001

50MG N011971 002

ZIDE

SOLVAY 50MG A083925 001

HYDROCHLOROTHIAZIDE; IRBESARTAN

TABLET;ORAL

AVALIDE

+ SANOFI AVENTIS US 12.5MG;75MG ** N020758 001 Sep 30, 1997

+ 25MG;300MG ** N020758 004 Mar 15, 2005



IRBESARTAN AND HYDROCHLOROTHIAZIDE

ATLAS PHARMS LLC 12.5MG;150MG A203036 001 Jan 15, 2016

12.5MG;300MG A203036 002 Jan 15, 2016

25MG;300MG A203036 003 Jan 15, 2016

MYLAN PHARMS INC 12.5MG;150MG A077969 001 Sep 27, 2012

12.5MG;300MG A077969 002 Sep 27, 2012

25MG;300MG A077969 003 Jul 20, 2016



TEVA 25MG;300MG A077369 003 Mar 30, 2012

WATSON LABS INC 12.5MG;150MG A091539 001 Oct 22, 2012

12.5MG;300MG A091539 002 Oct 22, 2012

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

TABLET;ORAL

NORMOZIDE

SCHERING 25MG;100MG N019046 001 Apr 06, 1987

25MG;200MG N019046 002 Apr 06, 1987

25MG;300MG N019046 003 Apr 06, 1987

25MG;400MG N019046 004 Apr 06, 1987

TRANDATE HCT

GLAXOSMITHKLINE 25MG;100MG N019174 001 Apr 10, 1987

25MG;200MG N019174 002 Apr 10, 1987

25MG;300MG N019174 003 Apr 10, 1987

25MG;400MG N019174 004 Apr 10, 1987



HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

APOTEX INC 12.5MG;10MG A076674 001 Oct 05, 2004

12.5MG;20MG A076674 002 Oct 05, 2004

25MG;20MG A076674 003 Oct 05, 2004

SANDOZ 12.5MG;10MG A075926 001 Jul 01, 2002

12.5MG;20MG A075926 002 Jul 01, 2002

25MG;20MG A075926 003 Jul 01, 2002

TEVA 12.5MG;10MG A075869 001 Jul 01, 2002

12.5MG;20MG A075869 002 Jul 01, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-195(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

25MG;20MG A075869 003 Jul 01, 2002
PRINZIDE
+ MERCK 12.5MG;10MG ** N019778 003 Nov 18, 1993
+ 12.5MG;20MG ** N019778 001 Feb 16, 1989
+ 25MG;20MG ** N019778 002 Feb 16, 1989
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

HYZAAR

+ MERCK SHARP DOHME 12.5MG;50MG N020387 001 Apr 28, 1995

+ 25MG;100MG N020387 002 Nov 10, 1998



LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

APOTEX 12.5MG;50MG A090150 001 Oct 06, 2010

12.5MG;100MG A090150 002 Aug 11, 2010

25MG;100MG A090150 003 Oct 06, 2010



WATSON LABS 12.5MG;50MG A200180 001 Jan 12, 2011

12.5MG;100MG A200180 002 Jan 12, 2011

25MG;100MG A200180 003 Jan 12, 2011

HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

ALDORIL 15

MERCK 15MG;250MG N013402 001

ALDORIL 25

MERCK 25MG;250MG N013402 002

ALDORIL D30

MERCK 30MG;500MG N013402 003

ALDORIL D50

MERCK 50MG;500MG N013402 004

METHYLDOPA AND HYDROCHLOROTHIAZIDE

DAVA PHARMS INC 15MG;250MG A072507 001 Jun 02, 1989

25MG;250MG A072508 001 Jun 02, 1989

30MG;500MG A072509 001 Jun 02, 1989

50MG;500MG A072510 001 Jun 02, 1989

IVAX SUB TEVA PHARMS 15MG;250MG A071458 001 Mar 08, 1988

25MG;250MG A071459 001 Mar 08, 1988

30MG;500MG A071460 001 Mar 08, 1988

50MG;500MG A071461 001 Mar 08, 1988

PAR PHARM 15MG;250MG A070616 001 Feb 02, 1987

25MG;250MG A070612 001 Feb 02, 1987

30MG;500MG A070613 001 Feb 02, 1987

50MG;500MG A070614 001 Feb 02, 1987

PARKE DAVIS 15MG;250MG A071897 001 Nov 23, 1987

25MG;250MG A071898 001 Nov 23, 1987

30MG;500MG A071899 001 Nov 23, 1987

50MG;500MG A071900 001 Nov 23, 1987

PUREPAC PHARM 15MG;250MG A070853 001 Oct 08, 1986

25MG;250MG A070688 001 Apr 24, 1986

30MG;500MG A070854 001 Oct 08, 1986



50MG;500MG A070689 001 Apr 24, 1986

SANDOZ 15MG;250MG A070829 001 Mar 09, 1987



25MG;250MG A070830 001 Mar 09, 1987

TEVA 15MG;250MG A071819 001 Apr 08, 1988

25MG;250MG A071820 001 Apr 08, 1988

30MG;500MG A071821 001 Apr 08, 1988

50MG;500MG A071822 001 Apr 08, 1988

WATSON LABS 15MG;250MG A070365 001 Mar 19, 1986



15MG;250MG A070958 001 Feb 06, 1989

15MG;250MG A071920 001 Aug 29, 1988

25MG;250MG A070366 001 Apr 16, 1986

25MG;250MG A070959 001 Jan 19, 1989



25MG;250MG A071921 001 Aug 29, 1988

30MG;500MG A070367 001 Mar 19, 1986



30MG;500MG A071069 001 Jan 19, 1989

30MG;500MG A071922 001 Aug 29, 1988

50MG;500MG A070368 001 Apr 16, 1986

50MG;500MG A070960 001 Feb 06, 1989


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-196(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE; METHYLDOPA

TABLET;ORAL

METHYLDOPA AND HYDROCHLOROTHIAZIDE

50MG;500MG A071923 001 Aug 29, 1988

YAOPHARMA CO LTD 15MG;250MG A070182 001 Jan 15, 1986



25MG;250MG A070183 001 Jan 15, 1986

30MG;500MG A070543 001 Jan 15, 1986

50MG;500MG A070544 001 Jan 15, 1986

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

TABLET;ORAL

LOPRESSOR HCT

+ US PHARMS HOLDINGS I 50MG;100MG ** N018303 003 Dec 31, 1984

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

CHARTWELL RX 12.5MG;7.5MG A090096 001 Sep 25, 2008

12.5MG;15MG A090096 002 Sep 25, 2008

25MG;15MG A090096 003 Sep 25, 2008

UNIRETIC

UCB INC 12.5MG;7.5MG ** N020729 001 Jun 27, 1997

12.5MG;15MG ** N020729 003 Feb 14, 2002

25MG;15MG ** N020729 002 Jun 27, 1997

HYDROCHLOROTHIAZIDE; PINDOLOL

TABLET;ORAL

VISKAZIDE

NOVARTIS 25MG;5MG N018872 001 Jul 22, 1987

25MG;10MG N018872 002 Jul 22, 1987

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

INDERIDE LA 120/50

WYETH AYERST 50MG;120MG N019059 002 Jul 03, 1985



INDERIDE LA 160/50

WYETH AYERST 50MG;160MG N019059 003 Jul 03, 1985



INDERIDE LA 80/50

WYETH AYERST 50MG;80MG N019059 001 Jul 03, 1985



TABLET;ORAL

INDERIDE-40/25

+ WYETH PHARMS INC 25MG;40MG ** N018031 001



INDERIDE-80/25

+ WYETH PHARMS INC 25MG;80MG ** N018031 002



PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE

DURAMED PHARMS BARR 25MG;40MG A071126 001 Mar 02, 1987

25MG;80MG A071127 001 Mar 02, 1987

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

ACTAVIS ELIZABETH 25MG;40MG A070851 001 May 15, 1986

25MG;80MG A070852 001 May 15, 1986

ANI PHARMS INC 25MG;40MG A070704 001 Oct 01, 1986



25MG;40MG A072042 001 Mar 14, 1988

25MG;80MG A070705 001 Oct 01, 1986

25MG;80MG A072043 001 Mar 14, 1988

IVAX SUB TEVA PHARMS 25MG;40MG A071552 001 Dec 01, 1988

25MG;80MG A071553 001 Dec 01, 1988

WARNER CHILCOTT 25MG;40MG A071771 001 Jan 26, 1988

25MG;80MG A071772 001 Jan 26, 1988

WATSON LABS 25MG;40MG A070301 001 Apr 18, 1986

25MG;40MG A071498 001 Dec 18, 1991



25MG;80MG A070305 001 Apr 18, 1986

25MG;80MG A071501 001 Dec 18, 1991



YAOPHARMA CO LTD 25MG;40MG A071060 001 Aug 26, 1987

25MG;80MG A071061 001 Aug 26, 1987



HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

SUN PHARM INDS LTD 12.5MG;EQ 10MG BASE A078211 001 Mar 04, 2009

12.5MG;EQ 20MG BASE A078211 002 Mar 04, 2009

25MG;EQ 20MG BASE A078211 003 Mar 04, 2009

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-197(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE; RESERPINE

TABLET;ORAL

H.R.-50

WHITEWORTH TOWN PLSN 50MG;0.125MG
A085338 001

HYDRO-RESERP

ABC HOLDING 50MG;0.125MG
A084714 002 Jun 29, 1982

HYDRO-SERP "25"

SANDOZ 25MG;0.125MG
A084827 001

HYDRO-SERP "50"

SANDOZ 50MG;0.125MG
A085213 001

HYDROCHLOROTHIAZIDE W/ RESERPINE

IVAX SUB TEVA PHARMS 25MG;0.1MG


A083572 001

25MG;0.125MG
A083571 001

50MG;0.1MG
A083568 001

50MG;0.125MG
A083573 001

PHARMERAL
25MG;0.125MG
A085421 001

50MG;0.125MG
A085420 001

ROXANE
50MG;0.125MG
A084603 001

WATSON LABS
25MG;0.125MG
A084466 001

25MG;0.125MG
A085317 001

25MG;0.125MG
A086330 002

50MG;0.125MG
A083666 001

50MG;0.125MG
A084467 001

50MG;0.125MG
A086331 001

HYDROPRES 25

MERCK
25MG;0.125MG
N011958 002

HYDROPRES 50

MERCK
50MG;0.125MG
N011958 003

RESERPINE AND HYDROCHLOROTHIAZIDE

BARR 25MG;0.125MG
A084580 001

50MG;0.125MG
A084579 001

SANDOZ 50MG;0.125MG
A088200 001 Jan 31, 1984

RESERPINE AND HYDROCHLOROTHIAZIDE-50

WEST WARD 50MG;0.125MG
A088189 001 May 10, 1984

SERPASIL-ESIDRIX #1

NOVARTIS 25MG;0.1MG
N011878 003

SERPASIL-ESIDRIX #2

NOVARTIS 50MG;0.1MG
N011878 005

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

ASCOT
25MG;25MG
A088025 001 Nov 23, 1984

MUTUAL PHARM
25MG;25MG
A087267 001

PUREPAC PHARM
25MG;25MG
A087999 001 Nov 06, 1985

SUPERPHARM
25MG;25MG
A089137 001 Aug 26, 1985

WATSON LABS
25MG;25MG
A087398 001

YAOPHARMA CO LTD
25MG;25MG
A086881 001

SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE

IVAX PHARMS 25MG;25MG


A087004 002 May 24, 1982

LEDERLE 25MG;25MG
A087511 001

PARKE DAVIS 25MG;25MG
A087948 001 Feb 22, 1983

PUREPAC PHARM 25MG;25MG
A088054 001 Aug 18, 1983

UPSHER SMITH 25MG;25MG


A087553 001

USL PHARMA 25MG;25MG
A087651 001

VANGARD 25MG;25MG
A087655 001

WATSON LABS 25MG;25MG
A085974 001

25MG;25MG
A086026 001

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE

TABLET;ORAL

TIMOLIDE 10-25

MERCK 25MG;10MG
N018061 001

HYDROCHLOROTHIAZIDE; TRIAMTERENE

CAPSULE;ORAL

DYAZIDE

GLAXOSMITHKLINE LLC 25MG;50MG
N016042 002

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

ANI PHARMS INC 25MG;37.5MG
A074970 001 Jan 06, 1998

NOVARTIS 25MG;37.5MG
A074857 001 Sep 09, 1997

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-198(of 393)

** See List Footnote



HYDROCHLOROTHIAZIDE; TRIAMTERENE

CAPSULE;ORAL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

VITARINE 25MG;50MG A071737 001 Feb 12, 1988

TABLET;ORAL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

AM THERAP 50MG;75MG A072022 001 Apr 17, 1988

QUANTUM PHARMICS 50MG;75MG A071980 001 Apr 17, 1988

WATSON LABS 50MG;75MG A071969 001 Apr 17, 1988



HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

VALSARTAN AND HYDROCHLOROTHIAZIDE

APOTEX INC 12.5MG;80MG A203026 001 Mar 21, 2013

12.5MG;160MG A203026 002 Mar 21, 2013

12.5MG;320MG A203026 003 Mar 21, 2013

25MG;160MG A203026 004 Mar 21, 2013

25MG;320MG A203026 005 Mar 21, 2013

WATSON LABS TEVA 12.5MG;80MG A091519 001 Mar 21, 2013

12.5MG;160MG A091519 002 Mar 21, 2013

12.5MG;320MG A091519 003 Mar 21, 2013

25MG;160MG A091519 004 Mar 21, 2013

25MG;320MG A091519 005 Mar 21, 2013

HYDROCODONE BITARTRATE

TABLET, EXTENDED RELEASE;ORAL

VANTRELA ER

+ TEVA BRANDED PHARM 15MG N207975 001 Jan 17, 2017

+ 30MG N207975 002 Jan 17, 2017

+ 45MG N207975 003 Jan 17, 2017

+ 60MG N207975 004 Jan 17, 2017

+ 90MG N207975 005 Jan 17, 2017

HYDROCODONE BITARTRATE; IBUPROFEN

TABLET;ORAL

HYDROCODONE BITARTRATE AND IBUPROFEN

ACTAVIS LABS FL INC 5MG;200MG A077454 001 Jun 23, 2010

VICOPROFEN

+ ABBVIE 7.5MG;200MG N020716 001 Sep 23, 1997

HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

SYRUP;ORAL

CODAMINE

ALPHARMA US PHARMS 5MG/5ML;25MG/5ML A075103 001 Sep 29, 2000

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

TRIS PHARMA INC 5MG/5ML;60MG/5ML A203839 001 Oct 28, 2014

HYDROCORTAMATE HYDROCHLORIDE

OINTMENT;TOPICAL

MAGNACORT

PFIZER 0.5% N010554 001

HYDROCORTISONE

AEROSOL;TOPICAL

AEROSEB-HC

ALLERGAN HERBERT 0.5% A085805 001

CREAM;TOPICAL

CORT-DOME

BAYER PHARMS 0.5% N009585 003

1% N009585 001

DERMACORT

MONARCH PHARMS 1% A083011 002

ELDECORT

VALEANT PHARM INTL 1% A080459 001

2.5% A084055 001

FLEXICORT

WESTWOOD SQUIBB 0.5% A087136 003 Apr 08, 1982

1% A087136 002 Apr 08, 1982

2.5% A087136 001 Apr 08, 1982


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-199(of 393)

** See List Footnote



HYDROCORTISONE

CREAM;TOPICAL

H-CORT

PHARM ASSOC 0.5% A086823 001

HC #1
BAYER PHARMS 0.5% A080438 001

HC #4
BAYER PHARMS 1% A080438 002

HC (HYDROCORTISONE)

C AND M PHARMA 0.5%


A080482 003

1%
A080482 004

HI-COR

C AND M PHARMA 2.5%
A080483 001

HYDROCORTISONE

ALPHARMA US PHARMS 2.5%
A089754 001 Feb 01, 1989

ALTANA 0.5%
A080848 002

1%
A080848 003

AMBIX 1%
A086080 001

2.5%
A086271 001

EVERYLIFE 0.5%
A080452 001

1%
A080452 002

G AND W LABS 1%
A084059 001

INGRAM PHARM 0.5%
A080456 002

1%
A080456 003

IVAX PHARMS 1%
A085733 001

NASKA 1%
A089706 001 Mar 10, 1988

PERRIGO NEW YORK 0.5%
A084970 002

1%
A085026 001

PHARMADERM 1%
A088845 001 Feb 27, 1986

2.5%
A089413 001 Dec 16, 1986

PHARMAFAIR 1%
A087838 001 Jul 28, 1982

STIEFEL 1%
A086170 001

SYOSSET 0.5%
A085527 001

TARO 0.5%
A086154 001

TARO PHARM INDS LTD 1%
A086155 001

TEVA 0.5%
A080400 002

1%
A080400 003

1%
A085191 001

2.5%
A080400 004

TOPIDERM 1%
A089273 001 Feb 17, 1989

USL PHARMA 1%
A088027 001 Sep 27, 1983

2.5%
A088029 001 Sep 27, 1983

WHITEWORTH TOWN PLSN 1%


A080496 002

HYTONE

VALEANT INTL 1% **
A080472 003

2.5% **
A080472 004

NOGENIC HC

IVAX PHARMS 1%
A087427 001 Apr 04, 1988

NUTRACORT

DOW PHARM 0.5%
A080442 002

1%
A080442 003

PENECORT

ALLERGAN HERBERT 1%
A088216 001 Jun 06, 1984

PROCTOCORT

MONARCH PHARMS 1%
A083011 001

SYNACORT

MEDICIS 0.5%
A087459 001

1%
A087458 001

2.5%
A087457 001

GEL;TOPICAL

NUTRACORT

HEALTHPOINT 1%
A084698 001

PENECORT

ALLERGAN HERBERT 1%
A088215 001 Jun 06, 1984

INJECTABLE;INJECTION

CORTEF

PHARMACIA AND UPJOHN 50MG/ML
N009864 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-200(of 393)

** See List Footnote



HYDROCORTISONE

LOTION;TOPICAL

ACTICORT

BAKER NORTON
1%
A086535 001

ALA-CORT

CROWN LABS
1%
A083201 001

BALNEOL-HC

SOLVAY
1%
A088041 001 Dec 03, 1982

BETA-HC

BETA DERMAC
1%
A089495 001 Jan 25, 1988

CETACORT

DOW PHARM
0.5%
A080426 002

1%
A080426 001

CORT-DOME

BAYER PHARMS
0.5%
N009895 003

1%
N009895 001

DERMACORT

SOLVAY
0.5%
A084573 002

1%
A086462 001

EPICORT

BLULINE
0.5%
A083219 002

GLYCORT

HERAN
1%
A087489 001 Oct 03, 1983

H-CORT

PHARM ASSOC
0.5%
A086824 001

HYDROCORTISONE

ALPHARMA US PHARMS
0.5%
A087317 001 Jun 07, 1982

1%
A087315 001 Jun 07, 1982

MERICON
0.5%
A085282 001

1%
A085282 002 Feb 26, 1987

NASKA
1%
A089705 001 Apr 25, 1988

PERRIGO NEW YORK


0.5%
A085662 001

1%
A085663 001

TARO
1%
A089024 001 Feb 12, 1986

HYTONE

VALEANT INTL
1% **
A080473 003

2.5% **
A080473 004 Nov 30, 1982

NUTRACORT

DOW PHARM
0.5%
A080443 002

1%
A080443 003

2.5%
A087644 001 Aug 24, 1982

STIE-CORT

PERRIGO CO
1%
A089066 001 Nov 25, 1985

OINTMENT;TOPICAL

CORTRIL

PFIZER GLOBAL
1%
N009176 001

2.5%
N009176 002

HC (HYDROCORTISONE)

C AND M PHARMA
0.5%
A080481 001

1%
A080481 002

HYDROCORTISONE

ALTANA
0.5%
A080489 002

1%
A080489 003

AMBIX
1%
A086079 001

2.5%
A086272 001

NASKA
1%
A089704 001 Mar 10, 1988

PERRIGO NEW YORK
0.5%
A084969 003

1%
A085028 001

PHARMADERM
1%
A088842 001 Feb 09, 1987

TARO
0.5%
A086256 001

2.5%
A040310 001 Dec 29, 2000

USL PHARMA
1%
A088061 001 Sep 27, 1983

2.5%
A088039 001 Sep 27, 1983

HYTONE

DERMIK LABS
1% **
A080474 003

2.5% **
A080474 004

PENECORT

ALLERGAN HERBERT
2.5%
A088217 001 Jun 06, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-201(of 393)

** See List Footnote



HYDROCORTISONE

POWDER;FOR RX COMPOUNDING

H-CORT

TORCH
100%
A087834 001 Mar 29, 1982

HYDRO-RX

X GEN PHARMS
100%
A085982 001

HYDROCORTISONE

PADDOCK LLC
100%
A088082 001 Apr 08, 1983

SOLUTION;TOPICAL

PENECORT

ALLERGAN HERBERT
1%
A088214 001 Jun 06, 1984

TEXACORT

MISSION PHARMA
1%
A080425 001

TABLET;ORAL

CORTRIL

PFIZER
10MG
N009127 005

20MG
N009127 003

HYDROCORTISONE

BARR
20MG
A083999 001

ELKINS SINN
20MG
A080624 001

FERRANTE
10MG
A080568 001

20MG
A080568 002

IMPAX LABS
20MG
A080781 001

INWOOD LABS
20MG
A080732 001

LANNETT
20MG
A085070 001

NEXGEN PHARMA INC
20MG
A083140 001

PANRAY
10MG
N009659 001

20MG
N009659 002

PARKE DAVIS
20MG
A084243 001

PUREPAC PHARM
10MG
A084247 003 Aug 31, 1982

20MG
A080395 001

20MG
A084247 002

ROXANE
10MG
A088539 001 Mar 21, 1984

SANDOZ
20MG
A080642 002

WATSON LABS
20MG
A080355 001

WHITEWORTH TOWN PLSN 10MG
A080344 001

20MG
A080344 002

HYDROCORTONE

MERCK
10MG
N008506 007

20MG
N008506 011

TABLET;VAGINAL

CORTRIL

PFIPHARMECS
10MG
N009796 001

HYDROCORTISONE ACETATE

CREAM;TOPICAL

HEMSOL-HC

ABLE
1%
A081274 001 Jun 19, 1992

HYDROCORTISONE ACETATE

CENCI
1%
A080419 001 Jan 25, 1982

FERNDALE LABS
2.5%
A040259 001 Jul 29, 1999

PARKE DAVIS
1%
A089914 001 Jan 03, 1989

PUREPAC PHARM
0.5%
A086050 001

1%
A086052 001

MICORT-HC

SEBELA IRELAND LTD 2%
A040398 001 Mar 29, 2002

INJECTABLE;INJECTION

CORTEF ACETATE

PHARMACIA AND UPJOHN 50MG/ML
N009378 002

CORTRIL

PFIZER 25MG/ML
N009164 001

HYDROCORTISONE ACETATE

AKORN
25MG/ML
N009637 001

50MG/ML
N009637 002

BEL MAR
25MG/ML
A083739 001

50MG/ML
A083739 002

WATSON LABS
25MG/ML
A083128 001

25MG/ML
A083759 001

50MG/ML
A083759 002

50MG/ML
A085214 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-202(of 393)

** See List Footnote



HYDROCORTISONE ACETATE

INJECTABLE;INJECTION

HYDROCORTONE

MERCK
25MG/ML
N008228 001

50MG/ML
N008228 004

LOTION;TOPICAL

DRICORT

INGRAM PHARM
0.5%
A086207 001

OINTMENT;OPHTHALMIC

HYDROCORTISONE ACETATE

FERA PHARMS
0.5%
A080828 001

OINTMENT;OPHTHALMIC, OTIC

HYDROCORTONE

MERCK
1.5%
N009018 003

OINTMENT;TOPICAL

CORTEF ACETATE

PHARMACIA AND UPJOHN 1%
N008917 002

+
2.5% **
N008917 001

PASTE;TOPICAL

ORABASE HCA

COLGATE
0.5%
A083205 001

POWDER;FOR RX COMPOUNDING

HYDROCORTISONE ACETATE

X GEN PHARMS
100%
A085981 001

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-CORTEF

PHARMACIA AND UPJOHN 1%;EQ 3.5MG BASE/GM
A061049 001

2.5%;EQ 3.5MG BASE/GM
A061049 002

OINTMENT;OPHTHALMIC

NEO-CORTEF

PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM
A060610 001

1.5%;EQ 3.5MG BASE/GM
A060610 002

OINTMENT;TOPICAL

NEO-CORTEF

PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/GM
A060751 001

1%;EQ 3.5MG BASE/GM
A060751 002

2.5%;EQ 3.5MG BASE/GM
A060751 003

SUSPENSION/DROPS;OPHTHALMIC

COR-OTICIN

AKORN 1.5%;EQ 3.5MG BASE/ML
A060188 001

NEO-CORTEF

PHARMACIA AND UPJOHN 0.5%;EQ 3.5MG BASE/ML
A060612 002

1.5%;EQ 3.5MG BASE/ML
A060612 001

HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE

SUSPENSION;OPHTHALMIC

TERRA-CORTRIL

PFIZER 1.5%;EQ 5MG BASE/ML
A061016 001

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

AEROSOL, METERED;TOPICAL

HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%

GENUS LIFESCIENCES
1%;1%
A089440 001 May 17, 1988

LOTION;TOPICAL

PRAMOSONE

FERNDALE LABS
0.5%;1%
A083213 002

HYDROCORTISONE ACETATE; UREA

CREAM;TOPICAL

CARMOL HC

FOUGERA PHARMS
1%;10%
A080505 001

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL

LOCOID

YAMANOUCHI
0.1%
N018795 001 Jan 07, 1983

OINTMENT;TOPICAL

LOCOID

YAMANOUCHI
0.1%
N019106 001 Jul 03, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-203(of 393)

** See List Footnote



HYDROCORTISONE BUTYRATE

SOLUTION;TOPICAL

LOCOID

YAMANOUCHI 0.1%
N019819 001 Sep 15, 1988

HYDROCORTISONE CYPIONATE

SUSPENSION;ORAL

CORTEF

PHARMACIA AND UPJOHN EQ 10MG BASE/5ML
N009900 001

HYDROCORTISONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

HYDROCORTONE

MERCK EQ 50MG BASE/ML
N012052 001

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-HYDROCORT

ABBOTT EQ 100MG BASE/VIAL
A085928 001

EQ 100MG BASE/VIAL
A089577 001 Apr 11, 1989

EQ 250MG BASE/VIAL
A089578 001 Apr 11, 1989

EQ 500MG BASE/VIAL
A089579 001 Apr 11, 1989

EQ 1GM BASE/VIAL
A089580 001 Apr 11, 1989

HOSPIRA EQ 100MG BASE/VIAL


A040666 001 Apr 06, 2006

EQ 100MG BASE/VIAL
A085929 001

EQ 250MG BASE/VIAL
A085930 001

EQ 500MG BASE/VIAL
A085931 001

EQ 1GM BASE/VIAL
A085932 001

HYDROCORTISONE SODIUM SUCCINATE

ABRAXIS PHARM
EQ 100MG BASE/VIAL
A088667 001 Jun 08, 1984

EQ 100MG BASE/VIAL
A088712 001 Jun 08, 1984

EQ 250MG BASE/VIAL
A088668 001 Jun 08, 1984

EQ 500MG BASE/VIAL
A088669 001 Jun 08, 1984

EQ 1GM BASE/VIAL
A088670 001 Jun 08, 1984

BAXTER HLTHCARE
EQ 100MG BASE/VIAL
A086619 001

EQ 250MG BASE/VIAL
A087567 001

EQ 500MG BASE/VIAL
A087568 001

EQ 1GM BASE/VIAL
A087569 001

INTL MEDICATION
EQ 100MG BASE/VIAL
A087532 001 Mar 19, 1982

WATSON LABS
EQ 100MG BASE/VIAL
A084737 002

EQ 100MG BASE/VIAL
A084738 001

EQ 250MG BASE/VIAL
A084737 001

EQ 500MG BASE/VIAL
A084747 001

EQ 1GM BASE/VIAL
A084748 001

HYDROCORTISONE VALERATE

CREAM;TOPICAL

HYDROCORTISONE VALERATE

G AND W LABS INC
0.2%
A074489 001 Aug 12, 1998

WESTCORT

+ SUN PHARM INDS INC
0.2% **
N017950 001

OINTMENT;TOPICAL

HYDROCORTISONE VALERATE

FOUGERA PHARMS
0.2%
A075085 001 Jul 31, 2001

WESTCORT

+ SUN PHARM INDS INC
0.2% **
N018726 001 Aug 08, 1983

HYDROCORTISONE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-CORT-DOME

BAYER PHARMS 0.5%;EQ 3.5MG BASE/GM
N050237 006 Jun 05, 1984

1%;EQ 3.5MG BASE/GM
N050237 005 Jun 05, 1984

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

CORTISPORIN

+ MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
N050479 001

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

AMRING PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A065216 001 Oct 31, 2005

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062394 001 Sep 29, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-204(of 393)

** See List Footnote



HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

OTOCORT
WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A060730 002

SUSPENSION/DROPS;OPHTHALMIC
CORTISPORIN
MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050169 001

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062623 001 Sep 24, 1985

SUSPENSION/DROPS;OTIC

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE



PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062617 001 Sep 18, 1985

OTICAIR

PHARMAFAIR
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062399 001 Nov 18, 1982

OTOBIONE

SCHERING
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A061816 001

OTOCORT

ACTAVIS LABS FL INC
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062521 001 Jul 11, 1985

PEDIOTIC

MONARCH PHARMS
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062822 001 Sep 29, 1987

HYDROCORTISONE; POLYMYXIN B SULFATE

SOLUTION/DROPS;OTIC

OTOBIOTIC
SCHERING 5MG/ML;EQ 10,000 UNITS BASE/ML A062302 001

PYOCIDIN
FOREST LABS 5MG/ML;EQ 10,000 UNITS BASE/ML A061606 001

HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE

OINTMENT;OPHTHALMIC

ACHROMYCIN

LEDERLE 1.5%;1%
N050272 001

HYDROCORTISONE; UREA

CREAM;TOPICAL

ALPHADERM

BIOGLAN 1%;10%
A086008 001

CALMURID HC

PHARMACIA AND UPJOHN 1%;10%
A083947 001

HYDROFLUMETHIAZIDE

TABLET;ORAL

DIUCARDIN

WYETH AYERST
50MG
A083383 001

HYDROFLUMETHIAZIDE

PAR PHARM
50MG
A088850 001 May 31, 1985

WATSON LABS
50MG
A088031 001 Apr 06, 1983

50MG
A088528 001 Aug 15, 1984

SALURON

+ SHIRE LLC
50MG
N011949 001

HYDROFLUMETHIAZIDE; RESERPINE

TABLET;ORAL

HYDROFLUMETHIAZIDE AND RESERPINE

USL PHARMA 50MG;0.125MG
A088195 001 Oct 26, 1983

WATSON LABS 25MG;0.125MG
A088127 001 Mar 22, 1983

50MG;0.125MG
A088110 001 Mar 22, 1983

RESERPINE AND HYDROFLUMETHIAZIDE

IVAX PHARMS 50MG;0.125MG
A088932 001 Jan 11, 1985

PAR PHARM 50MG;0.125MG
A088907 001 Sep 20, 1985

SALUTENSIN

SHIRE 50MG;0.125MG
N012359 003

SALUTENSIN-DEMI

SHIRE 25MG;0.125MG
N012359 004

HYDROMORPHONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PALLADONE

PURDUE PHARMA LP 12MG
N021044 001 Sep 24, 2004

16MG
N021044 002 Sep 24, 2004

24MG
N021044 003 Sep 24, 2004

32MG
N021044 004 Sep 24, 2004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-205(of 393)

** See List Footnote



HYDROMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

DILAUDID

+ FRESENIUS KABI USA
4MG/ML
N019034 005 Apr 30, 2009

DILAUDID-HP

+ FRESENIUS KABI USA
10MG/ML
N019034 001 Jan 11, 1984

250MG/VIAL
N019034 002 Aug 04, 1994

HYDROMORPHONE HYDROCHLORIDE

HOSPIRA
10MG/ML
A074598 001 Jun 19, 1997

WATSON LABS
10MG/ML
A074317 001 Aug 23, 1995

TABLET;ORAL

HYDROMORPHONE HYDROCHLORIDE

NESHER PHARMS
2MG
A077311 001 Nov 09, 2005

4MG
A077311 002 Nov 09, 2005

8MG
A077311 003 Nov 09, 2005

TABLET, EXTENDED RELEASE;ORAL

HYDROMORPHONE HYDROCHLORIDE

ACTAVIS LABS FL INC
8MG
A202144 001 May 12, 2014

12MG
A202144 002 May 12, 2014

16MG
A202144 003 May 12, 2014

32MG
A202144 004 Jun 30, 2016

HYDROXOCOBALAMIN

INJECTABLE;INJECTION

ALPHAREDISOL

MERCK
1MG/ML
A080778 001

CYANOKIT

SERB SA
2.5GM/VIAL (5GM/KIT)
N022041 002 Dec 15, 2006

HYDROXOCOBALAMIN

ABRAXIS PHARM
1MG/ML
A084921 001

WATSON LABS
1MG/ML
A085528 001

HYDROXOMIN

BEL MAR
1MG/ML
A084629 001

HYDROXYAMPHETAMINE HYDROBROMIDE

SOLUTION/DROPS;OPHTHALMIC

PAREDRINE

PHARMICS
1%
N000004 004

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

SANDOZ
200MG
A040150 001 Jan 27, 1996

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

HYDROXYPROGESTERONE CAPROATE

AKORN 125MG/ML
N018004 001

ALLERGAN SALES LLC 125MG/ML
N017439 001

250MG/ML
N017439 002

SOLUTION;INTRAMUSCULAR

DELALUTIN

+ BRISTOL MYERS SQUIBB 125MG/ML (125MG/ML) **
N010347 004

+ 125MG/ML (125MG/ML) **
N016911 001

+ 250MG/ML (250MG/ML) **
N010347 002

+ 250MG/ML (250MG/ML) **
N016911 002

HYDROXYSTILBAMIDINE ISETHIONATE

INJECTABLE;INJECTION

HYDROXYSTILBAMIDINE ISETHIONATE

SANOFI AVENTIS US
225MG/AMP
N009166 001

HYDROXYUREA

CAPSULE;ORAL

HYDROXYUREA

BARR
250MG
A075143 002 Sep 21, 2000

BARR LABS INC


250MG
A075020 002 Jun 26, 2000

500MG
A075020 001 Jul 30, 1998

ROXANE
500MG
A074476 001 Aug 18, 1995

TABLET;ORAL

HYDROXYUREA

BARR
1GM
A075734 001 Aug 29, 2000

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-206(of 393)

** See List Footnote



HYDROXYZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDROXYZINE

BAXTER HLTHCARE
50MG/ML A085551 002

HYDROXYZINE HYDROCHLORIDE

ALTANA
25MG/ML A087273 001 Apr 20, 1982

50MG/ML A087273 002 Apr 20, 1982

BAXTER HLTHCARE
25MG/ML A085551 001

FRESENIUS KABI USA
25MG/ML A087329 001

25MG/ML A088184 001 Mar 31, 1983

50MG/ML A087329 002

50MG/ML A088185 001 Mar 31, 1983

HOSPIRA
25MG/ML A087416 001

50MG/ML A086821 001

50MG/ML A087546 001

PHARMAFAIR
25MG/ML A088862 001 Feb 14, 1986

25MG/ML A089106 001 Feb 14, 1986

50MG/ML A088881 001 Feb 14, 1986

50MG/ML A089107 001 Feb 14, 1986

SMITH AND NEPHEW
25MG/ML A087592 001

SOLOPAK
25MG/ML A086822 001

25MG/ML A087591 001

50MG/ML A087310 001

50MG/ML A087593 001

50MG/ML A087595 001

50MG/ML A087596 001

WATSON LABS
25MG/ML A085778 001

25MG/ML A087274 001

50MG/ML A085779 001

50MG/ML A087274 002

WYETH AYERST
25MG/ML A086258 001

50MG/ML A086258 002

ORGATRAX

ORGANON USA INC
25MG/ML A087014 001

50MG/ML A087014 002

VISTARIL

+ PFIZER
25MG/ML ** N011111 001

+
50MG/ML ** N011111 002

SYRUP;ORAL

ATARAX

ROERIG
10MG/5ML ** N010485 001

HYDROXYZINE HYDROCHLORIDE

ALPHARMA US PHARMS
10MG/5ML A088785 001 Feb 03, 1988

KV PHARM
10MG/5ML A087730 001 Jul 01, 1982

STI PHARMA LLC
10MG/5ML A086880 001

TABLET;ORAL

ATARAX

+ PFIZER
10MG ** N010392 001

+
25MG ** N010392 004

+
50MG ** N010392 006

+
100MG ** N010392 005

HYDROXYZINE HYDROCHLORIDE

ABLE
10MG A040559 001 Jul 22, 2004

25MG A040562 001 Jul 22, 2004

50MG A040563 001 Jul 22, 2004

ACTAVIS ELIZABETH
10MG A089071 001 Jul 22, 1986

25MG A089072 001 Jul 22, 1986

50MG A089073 001 Jul 22, 1986

AUROLIFE PHARMA LLC
10MG A087871 002 Dec 20, 1982

25MG A087871 003 Dec 20, 1982

50MG A087871 001 Dec 20, 1982

HALSEY
10MG A089366 001 May 02, 1988

25MG A089117 001 May 02, 1988

50MG A089396 001 May 02, 1988

IVAX PHARMS
10MG A087216 001

25MG A087410 001

50MG A087411 001

KV PHARM
10MG A087819 001 Jun 23, 1982

25MG A087820 001 Jun 23, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-207(of 393)

** See List Footnote



HYDROXYZINE HYDROCHLORIDE

TABLET;ORAL

HYDROXYZINE HYDROCHLORIDE

50MG
A087821 001 Jun 23, 1982

100MG
A087822 001 Jun 23, 1982

MUTUAL PHARM
10MG
A088409 001 Nov 15, 1983

25MG
A087857 001 Apr 18, 1983

50MG
A087860 001 Apr 18, 1983

PLIVA
100MG
A081054 001 Sep 25, 1995

PUREPAC PHARM
10MG
A088120 001 Sep 25, 1984

25MG
A088121 001 Sep 25, 1984

50MG
A088122 001 Sep 25, 1984

QUANTUM PHARMICS
10MG
A088540 001 Oct 22, 1985

25MG
A088551 001 Oct 22, 1985

50MG
A088529 001 Oct 22, 1985

SANDOZ
10MG
A087246 002

25MG
A085247 001

50MG
A087245 001

SUN PHARM INDS INC
10MG
A040899 001 Jun 10, 2008

25MG
A040899 002 Jun 10, 2008

50MG
A040899 003 Jun 10, 2008

SUN PHARM INDUSTRIES
10MG
A089381 001 May 19, 1986

25MG
A089382 001 May 19, 1986

50MG
A089383 001 May 19, 1986

100MG
A087862 001 Apr 18, 1983

SUPERPHARM
10MG
A088794 001 Dec 05, 1984

25MG
A088795 001 Dec 05, 1984

50MG
A088796 001 Dec 05, 1984

USL PHARMA
10MG
A089121 001 Mar 20, 1986

25MG
A089122 001 Mar 20, 1986

50MG
A089123 001 Mar 20, 1986

VINTAGE
10MG
A087602 001 Jan 22, 1982

25MG
A087603 001 Jan 22, 1982

50MG
A087604 001 Jan 22, 1982

WATSON LABS
10MG
A081149 001 Mar 18, 1994

10MG
A086827 001

10MG
A088348 001 Sep 15, 1983

25MG
A081150 001 Mar 18, 1994

25MG
A086829 001

25MG
A088349 001 Sep 15, 1983

50MG
A081151 001 Mar 18, 1994

50MG
A086836 001

50MG
A088350 001 Sep 15, 1983

HYDROXYZINE PAMOATE

CAPSULE;ORAL

HY-PAM "25"

TEVA
EQ 25MG HYDROCHLORIDE
A088713 001 Mar 04, 1985

HYDROXYZINE PAMOATE

DURAMED PHARMS BARR
EQ 25MG HYDROCHLORIDE
A088593 001 Feb 29, 1984

EQ 50MG HYDROCHLORIDE
A088594 001 Feb 29, 1984

EQ 100MG HYDROCHLORIDE
A088595 001 Feb 29, 1984

IVAX SUB TEVA PHARMS
EQ 25MG HYDROCHLORIDE
A087761 001 Mar 05, 1982

EQ 50MG HYDROCHLORIDE
A087760 001 Mar 05, 1982

PAR PHARM
EQ 25MG HYDROCHLORIDE
A087656 001 Jun 11, 1982

EQ 25MG HYDROCHLORIDE
A089145 001 Mar 17, 1986

EQ 50MG HYDROCHLORIDE
A087657 001 Jun 11, 1982

EQ 50MG HYDROCHLORIDE
A089146 001 Mar 17, 1986

EQ 100MG HYDROCHLORIDE
A087658 001 Jun 11, 1982

SANDOZ
EQ 25MG HYDROCHLORIDE
A081127 001 Jun 28, 1991

EQ 50MG HYDROCHLORIDE
A081128 001 Jun 28, 1991

EQ 100MG HYDROCHLORIDE
A081129 001 Jun 28, 1991

SUPERPHARM
EQ 25MG HYDROCHLORIDE
A089031 001 Jan 02, 1987

EQ 50MG HYDROCHLORIDE
A089032 001 Jan 02, 1987

EQ 100MG HYDROCHLORIDE
A089033 001 Jan 02, 1987

VANGARD
EQ 25MG HYDROCHLORIDE
A088392 001 Sep 19, 1983

EQ 50MG HYDROCHLORIDE
A088393 001 Sep 19, 1983

WATSON LABS
EQ 25MG HYDROCHLORIDE
A081165 001 Jul 31, 1991

EQ 25MG HYDROCHLORIDE
A086698 001

EQ 25MG HYDROCHLORIDE
A086840 001 Jul 01, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-208(of 393)

** See List Footnote



HYDROXYZINE PAMOATE

CAPSULE;ORAL

HYDROXYZINE PAMOATE

EQ 50MG HYDROCHLORIDE A086695 001

EQ 50MG HYDROCHLORIDE A086705 001 Jul 01, 1982

EQ 50MG HYDROCHLORIDE A087767 001 Aug 16, 1982

EQ 100MG HYDROCHLORIDE A086697 001



EQ 100MG HYDROCHLORIDE A086728 001 Oct 05, 1982

EQ 100MG HYDROCHLORIDE A087790 001 Aug 16, 1982

VISTARIL

PFIZER EQ 100MG HYDROCHLORIDE ** N011459 006

SUSPENSION;ORAL

VISTARIL

PFIZER EQ 25MG HYDROCHLORIDE/5ML N011795 001

IBANDRONATE SODIUM

TABLET;ORAL

BONIVA

+ HOFFMANN LA ROCHE EQ 2.5MG BASE ** N021455 001 May 16, 2003

IBANDRONATE SODIUM

MYLAN PHARMS INC EQ 150MG BASE A078995 001 Mar 19, 2012

IBUPROFEN

CAPSULE;ORAL

IBUPROFEN

CONTRACT PHARMACAL 200MG A074782 001 Jul 06, 1998
MIDOL
BAYER 200MG ** A070626 001 Sep 02, 1987
200MG ** A071002 001 Sep 02, 1987
SOLUTION;INTRAVENOUS
CALDOLOR
CUMBERLAND PHARMS 400MG/4ML (100MG/ML) N022348 001 Jun 11, 2009
SUSPENSION;ORAL
CHILDREN'S ADVIL
WYETH CONS 100MG/5ML N019833 002 Sep 19, 1989
IBU
ABBOTT 100MG/5ML N019784 001 Dec 18, 1989
MOTRIN
+ MCNEIL CONSUMER 100MG/5ML ** N019842 001 Sep 19, 1989
SUSPENSION/DROPS;ORAL
MOTRIN
MCNEIL 40MG/ML N020476 001 May 25, 1995
TABLET;ORAL
ACHES-N-PAIN
LEDERLE 200MG A071065 001 May 28, 1987
CAP-PROFEN
PERRIGO 200MG A072097 001 Dec 08, 1987
IBU
BASF 400MG A070083 001 Feb 22, 1985
400MG N018197 001
600MG A070088 001 Feb 08, 1985
600MG A070099 001 Mar 29, 1985
800MG A070745 001 Jul 23, 1986
IBU-TAB
ALRA 800MG A071965 001 Aug 11, 1988
IBUPRIN
PLIVA 200MG A071773 001 Jul 16, 1987
IBUPROFEN
ABBOTT 600MG A070556 001 Jun 14, 1985
800MG A071264 001 Jul 25, 1986
ANI PHARMS INC 200MG A071144 001 Jan 20, 1987
200MG A072901 001 Dec 19, 1991
200MG A072903 001 Dec 19, 1991
AUROLIFE PHARMA LLC 300MG A070736 002 Jun 12, 1986
400MG A070736 003 Jun 12, 1986
600MG A070736 001 Jun 12, 1986
800MG A071938 001 Jan 14, 1988
CONTRACT PHARMACAL 200MG A071265 001 Oct 15, 1986
200MG A071265 002 Sep 10, 1987
200MG A071735 001 Sep 10, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-209(of 393)

** See List Footnote



IBUPROFEN

TABLET;ORAL

IBUPROFEN

200MG
A073691 001 Feb 25, 1994

200MG
A074931 001 Jul 20, 1998

HALSEY
200MG
A071027 001 Sep 29, 1987

300MG
A071028 001 Mar 23, 1987

400MG
A071029 001 Mar 23, 1987

600MG
A071030 001 Mar 23, 1987

800MG
A072137 001 Feb 05, 1988

IVAX SUB TEVA PHARMS
200MG
A071154 001 Oct 27, 1987

200MG
A072040 001 Apr 29, 1988

400MG
A071145 001 Sep 23, 1986

600MG
A071146 001 Sep 23, 1986

800MG
A071769 001 May 08, 1987

J AND J CONSUMER INC


400MG
A070081 001 Jun 16, 1986

LEDERLE
400MG
A070629 001 Sep 19, 1986

600MG
A070630 001 Sep 19, 1986

LEINER
300MG
A071266 001 Oct 15, 1986

LNK
100MG
A076741 001 Jun 17, 2004

MCNEIL
600MG
A070476 001 Jun 16, 1986

MYLAN
200MG
A071870 001 May 05, 1988

600MG
A070057 001 Sep 24, 1985

800MG
A071999 001 Dec 03, 1987

MYLAN PHARMS INC
400MG
A070045 001 Sep 24, 1985

NORTHSTAR HLTHCARE
400MG
A078132 001 Sep 10, 2007

600MG
A078132 002 Sep 10, 2007

800MG
A078132 003 Sep 10, 2007

OHM LABS
400MG
A070818 001 Dec 26, 1985

P AND L DEV LLC
200MG
A070733 001 Sep 19, 1986

PAR PHARM
200MG
A071575 001 May 08, 1987

300MG
A070328 001 Aug 06, 1985

400MG
A070329 001 Aug 06, 1985

600MG
A070330 001 Aug 06, 1985

800MG
A070986 001 Jul 25, 1986

PERRIGO
200MG
A072098 001 Dec 08, 1987

PLIVA
400MG
A071666 001 Jun 18, 1987

600MG
A071667 001 Jun 18, 1987

800MG
A071668 001 Jun 18, 1987

PUREPAC PHARM
200MG
A071122 001 Oct 03, 1986

200MG
A071664 001 Feb 03, 1987

300MG
A071123 001 Sep 19, 1986

400MG
A071124 001 Sep 19, 1986

600MG
A071125 001 Sep 19, 1986

800MG
A071964 001 Feb 01, 1988

SANDOZ
200MG
A071807 001 Feb 25, 1988

200MG
A074525 001 Dec 15, 1995

200MG
A074533 001 Dec 15, 1995

400MG
A072064 001 Jan 14, 1988

600MG
A072065 001 Jan 14, 1988

800MG
A072169 001 Dec 11, 1987

SUN PHARM INDUSTRIES
200MG
A070493 001 Dec 24, 1985

200MG
A070908 001 Sep 26, 1986

200MG
A071462 001 Oct 02, 1986

400MG
A070079 001 Jul 24, 1985

600MG
A070080 001 Jul 24, 1985

800MG
A071448 001 Feb 18, 1987

SUPERPHARM
600MG
A070709 001 Apr 25, 1986

TEVA
200MG
A073141 001 May 29, 1992

400MG
A073343 001 Jun 30, 1992

600MG
A073344 001 Jun 30, 1992

800MG
A073345 001 Jun 30, 1992

VINTAGE PHARMS
200MG
A072249 001 Jan 10, 1989

300MG
A071230 001 Oct 22, 1986

400MG
A071231 001 Oct 22, 1986

600MG
A071232 001 Oct 22, 1986

800MG
A072004 001 Nov 18, 1987

WATSON LABS
200MG
A070435 001 Mar 05, 1986

200MG
A071765 001 Sep 04, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-210(of 393)

** See List Footnote



IBUPROFEN

TABLET;ORAL

IBUPROFEN

200MG A071905 001 Mar 08, 1988

300MG A071338 001 Dec 01, 1986

400MG A070038 001 Sep 06, 1985

400MG A070436 001 Aug 21, 1985

600MG A070041 001 Sep 06, 1985

600MG A070437 001 Aug 21, 1985

800MG A071547 001 Jul 02, 1987



800MG A071911 001 Oct 13, 1987

IBUPROHM

OHM LABS 400MG A070469 001 Aug 29, 1985

MEDIPREN

MCNEIL 200MG A070475 001 Feb 06, 1986
200MG A071215 001 Jun 26, 1986
MIDOL
BAYER 200MG A070591 001 Sep 02, 1987
200MG A071001 001 Sep 02, 1987
MOTRIN
+ MCNEIL CONSUMER 300MG ** N017463 003
+ 400MG ** N017463 002
+ 600MG ** N017463 004
+ 800MG ** N017463 005 May 22, 1985
MCNEIL PED 100MG N020418 001 Nov 16, 1994
MOTRIN MIGRAINE PAIN
J AND J CONSUMER INC 200MG N019012 004 Feb 25, 2000
NUPRIN
BRISTOL MYERS 200MG A072035 001 Feb 16, 1988
200MG A072036 001 Feb 16, 1988
J AND J CONSUMER INC 200MG N019012 001 May 18, 1984
200MG N019012 002 Jul 29, 1987
RUFEN
BASF 600MG N018197 002 Mar 05, 1984
TABLET, CHEWABLE;ORAL
CHILDREN'S MOTRIN
+ J AND J CONSUMER INC 50MG N020601 001 Nov 15, 1996
IBUPROFEN
PERRIGO 50MG A076359 001 Jan 16, 2004
JUNIOR STRENGTH MOTRIN
+ J AND J CONSUMER INC 100MG N020601 003 Nov 15, 1996
MOTRIN
MCNEIL PED 50MG N020135 001 Nov 16, 1994
100MG N020135 002 Nov 16, 1994
IBUPROFEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

COMBUNOX

FOREST LABS 400MG;5MG ** N021378 001 Nov 26, 2004

OXYCODONE HYDROCHLORIDE AND IBUPROFEN

WATSON LABS 400MG;5MG A078394 001 Nov 26, 2007

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET;ORAL

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

CONTRACT PHARMACAL 200MG;30MG A075588 001 Apr 08, 2002

IBUTILIDE FUMARATE

INJECTABLE;INJECTION

IBUTILIDE FUMARATE

MYLAN INSTITUTIONAL 0.1MG/ML A090924 001 Jan 11, 2010

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDAMYCIN

PHARMACIA AND UPJOHN 5MG/VIAL N050661 002 Sep 27, 1990

10MG/VIAL N050661 001 Sep 27, 1990

20MG/VIAL N050661 003 Apr 25, 1995

IDARUBICIN HYDROCHLORIDE

SANDOZ 1MG/ML A091293 001 Mar 29, 2011

TEVA PARENTERAL 5MG/VIAL A065037 003 May 01, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-211(of 393)

** See List Footnote



IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDARUBICIN HYDROCHLORIDE

10MG/VIAL
A065037 002 May 01, 2002

20MG/VIAL
A065037 001 May 01, 2002

IDOXURIDINE

OINTMENT;OPHTHALMIC

STOXIL

GLAXOSMITHKLINE
0.5%
N015868 001

SOLUTION/DROPS;OPHTHALMIC

DENDRID

+ ALCON
0.1%
N014169 001

HERPLEX

ALLERGAN
0.1%
N013935 002

STOXIL

GLAXOSMITHKLINE
0.1%
N013934 001

IFOSFAMIDE

INJECTABLE;INJECTION

IFOSFAMIDE

FRESENIUS KABI USA
1GM/20ML (50MG/ML)
A090181 001 Sep 22, 2009

3GM/60ML (50MG/ML)
A090181 002 Sep 22, 2009

IFOSFAMIDE; MESNA

INJECTABLE;INJECTION

IFEX/MESNEX KIT

BAXTER HLTHCARE
1GM/VIAL;100MG/ML
N019763 003 Oct 10, 1992

3GM/VIAL;100MG/ML
N019763 004 Oct 10, 1992

INJECTABLE;INTRAVENOUS

IFOSFAMIDE/MESNA KIT

TEVA PHARMS USA


1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)
A075874 001 Feb 26, 2002

3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)
A075874 002 Feb 26, 2002

ILOPROST

SOLUTION;INHALATION

VENTAVIS

ACTELION PHARMS LTD
20MCG/2ML (10MCG/ML)
N021779 001 Dec 29, 2004

IMATINIB MESYLATE

CAPSULE;ORAL

GLEEVEC

+ NOVARTIS
EQ 50MG BASE **
N021335 001 May 10, 2001

+
EQ 100MG BASE **
N021335 002 May 10, 2001

IMIPRAMINE HYDROCHLORIDE

CONCENTRATE;ORAL

IMIPRAMINE HYDROCHLORIDE

NOVARTIS
25MG/ML
A086765 001

INJECTABLE;INJECTION

TOFRANIL

NOVARTIS
12.5MG/ML
N011838 002

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

LEDERLE
10MG
A086269 001

25MG
A086267 001

50MG
A086268 001

OXFORD PHARMS
50MG
A040751 001 Feb 28, 2008

PAR PHARM
10MG
A089422 001 Jul 14, 1987

25MG
A089497 001 Jul 14, 1987

ROXANE
10MG
A083799 001

25MG
A083799 002

50MG
A083799 003

SANDOZ
10MG
A085200 001

25MG
A084869 002

50MG
A085133 001

TEVA
10MG
A083729 001

25MG
A083729 004

50MG
A083729 003

USL PHARMA
25MG
A087776 001 Feb 10, 1982

VANGARD
10MG
A088036 001 Nov 03, 1982

25MG
A087619 001 Feb 09, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-212(of 393)

** See List Footnote



IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

50MG A087631 001 Jan 04, 1982

WATSON LABS 10MG A085220 001

10MG A085875 001

25MG A084252 002

25MG A085878 001

50MG A085221 001

50MG A085877 001

WEST WARD 25MG A088222 001 May 26, 1983

50MG A088223 001 May 26, 1983

JANIMINE

ABBOTT 10MG N017895 001

25MG N017895 002

50MG N017895 003

PRAMINE

ALRA 10MG A083827 001

25MG A083827 002

50MG A083827 003

PRESAMINE

SANOFI AVENTIS US 10MG N011836 006

25MG N011836 003

50MG N011836 007

IMIPRAMINE PAMOATE

CAPSULE;ORAL

IMIPRAMINE PAMOATE

MYLAN PHARMS INC EQ 75MG HYDROCHLORIDE A202338 001 Jun 28, 2013

EQ 100MG HYDROCHLORIDE A202338 002 Jun 28, 2013

EQ 125MG HYDROCHLORIDE A202338 003 Jun 28, 2013

EQ 150MG HYDROCHLORIDE A202338 004 Jun 28, 2013

TOFRANIL-PM

+ SPECGX LLC EQ 75MG HYDROCHLORIDE ** N017090 001

+ EQ 100MG HYDROCHLORIDE ** N017090 004

+ EQ 125MG HYDROCHLORIDE ** N017090 003

+ EQ 150MG HYDROCHLORIDE ** N017090 002

IMIQUIMOD

CREAM;TOPICAL

IMIQUIMOD

G AND W LABS INC 5% A200481 001 Apr 18, 2011

STRIDES PHARMA 5% A202002 001 Jun 24, 2014



INAMRINONE LACTATE

INJECTABLE;INJECTION

AMRINONE LACTATE

BAXTER HLTHCARE CORP EQ 5MG BASE/ML A075542 001 May 10, 2000

HOSPIRA EQ 5MG BASE/ML A074616 001 Aug 03, 1998

INOCOR

SANOFI AVENTIS US EQ 5MG BASE/ML N018700 001 Jul 31, 1984

INDAPAMIDE

TABLET;ORAL

INDAPAMIDE

ANI PHARMS INC 1.25MG A074498 002 Feb 12, 1998
2.5MG A074498 001 Oct 31, 1996
MYLAN PHARMS INC 1.25MG A075105 001 Jul 23, 1998
2.5MG A075105 002 Jul 23, 1998
TEVA 1.25MG A074665 001 Apr 04, 1997
2.5MG A074665 002 Apr 04, 1997
WATSON LABS 1.25MG A074585 001 Sep 26, 1996
2.5MG A074585 002 Sep 26, 1996
YAOPHARMA CO LTD 1.25MG A074594 001 May 23, 1996
2.5MG A074594 002 May 23, 1996
LOZOL
+ SANOFI AVENTIS US 1.25MG ** N018538 002 Apr 29, 1993
+ 2.5MG ** N018538 001 Jul 06, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-213(of 393)

** See List Footnote



INDECAINIDE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

DECABID

LILLY EQ 50MG BASE N019693 001 Dec 29, 1989

EQ 75MG BASE N019693 002 Dec 29, 1989

EQ 100MG BASE N019693 003 Dec 29, 1989

INDINAVIR SULFATE

CAPSULE;ORAL

CRIXIVAN

MERCK SHARP DOHME EQ 100MG BASE N020685 006 Apr 19, 2000

EQ 333MG BASE N020685 005 Dec 17, 1998



INDIUM IN-111 OXYQUINOLINE

INJECTABLE;INJECTION

INDIUM IN 111 OXYQUINOLINE

BWXT ITG 1mCi/ML A202586 001 Jul 25, 2018

INDOCYANINE GREEN

INJECTABLE;INJECTION

IC-GREEN

AKORN 10MG/VIAL ** N011525 003

40MG/VIAL ** N011525 004

50MG/VIAL ** N011525 002

INDOMETHACIN

CAPSULE;ORAL

INDO-LEMMON

TEVA 25MG A070266 001 Nov 07, 1985

50MG A070267 001 Nov 07, 1985

INDOCIN

+ IROKO PHARMS LLC 25MG ** N016059 001

+ 50MG ** N016059 002

INDOMETHACIN

ABLE 25MG A076666 001 Dec 17, 2003

50MG A076666 002 Dec 17, 2003

CHARTWELL MOLECULES 25MG N018829 002 Aug 06, 1984

50MG A070651 001 Mar 05, 1986



50MG N018829 001 Aug 06, 1984

CYCLE PHARMS LTD 25MG A070353 001 Jun 18, 1985



50MG A070354 001 Jun 18, 1985

DURAMED PHARMS BARR 25MG A070326 001 Oct 18, 1985

50MG A070327 001 Oct 18, 1985

HALSEY 25MG A070782 001 Jun 03, 1987

50MG A070635 001 Jun 03, 1987

IVAX SUB TEVA PHARMS 25MG N018730 001 May 04, 1984

50MG N018730 002 May 04, 1984

MUTUAL PHARM 25MG A070067 001 Oct 03, 1986



50MG A070068 001 Oct 03, 1986

MYLAN 50MG N018858 002 Apr 20, 1984

PARKE DAVIS 25MG N018806 001 Nov 23, 1984



50MG N018806 002 Nov 23, 1984

PIONEER PHARMS 25MG A070813 001 Aug 11, 1986

50MG A070592 001 Aug 11, 1986

PLIVA 25MG A071148 001 Mar 18, 1987



50MG A071149 001 Mar 18, 1987

SUN PHARM INDUSTRIES 25MG A070900 002 Feb 09, 1987

50MG A070900 001 Feb 09, 1987

SUPERPHARM 25MG A070487 001 Oct 10, 1986

50MG A070488 001 Oct 10, 1986

TEVA 25MG A071342 001 Apr 18, 1988

50MG A071343 001 Apr 18, 1988

WATSON LABS 25MG A070529 001 Oct 18, 1985



25MG A070784 001 Aug 20, 1986

25MG A072996 001 Jul 31, 1991



25MG N018690 001 Jul 31, 1984

50MG A070530 001 Oct 18, 1985

50MG A070785 001 Aug 20, 1986

50MG A071635 001 May 18, 1987

50MG A072997 001 Jul 31, 1991



50MG N018690 002 Jul 31, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-214(of 393)

** See List Footnote



INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL

INDOCIN SR
+ IROKO PHARMS 75MG ** N018185 001 Feb 23, 1982
INDOMETHACIN
ABLE 75MG A076114 001 Feb 06, 2002
INWOOD LABS 75MG A072410 001 Mar 15, 1989
WATSON LABS INC 75MG A202572 001 Dec 09, 2013
SUPPOSITORY;RECTAL
INDOCIN
+ IROKO PHARMS 50MG ** N017814 001 Aug 13, 1984
SUSPENSION;ORAL
INDOMETHACIN
CYCLE PHARMS LTD 25MG/5ML A071412 001 Mar 18, 1987
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG MIX 50/50

NOVO NORDISK INC 50 UNITS/ML;50 UNITS/ML N021810 001 Aug 26, 2008

NOVOLOG MIX 70/30 PENFILL

NOVO NORDISK INC 210 UNITS/3ML;90 UNITS/3ML (70 N021172 002 Nov 01, 2001

UNITS/ML; 30 UNITS/ML)

210 UNITS/3ML;90 UNITS/3ML (70 N021172 003 Nov 01, 2001

UNITS/ML; 30 UNITS/ML)

INSULIN ASPART RECOMBINANT

INJECTABLE;SUBCUTANEOUS

NOVOLOG FLEXTOUCH

+ NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 005 Oct 31, 2013

NOVOLOG INNOLET

NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 004 Apr 23, 2004

INSULIN DETEMIR RECOMBINANT

INJECTABLE;SUBCUTANEOUS

LEVEMIR FLEXPEN

NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 002 Jun 16, 2005

LEVEMIR INNOLET

NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 003 Jun 16, 2005

LEVEMIR PENFILL

NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 004 Jun 16, 2005

INSULIN GLULISINE RECOMBINANT

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

APIDRA

+ SANOFI AVENTIS US 300 UNITS/3ML (100 UNITS/ML) N021629 002 Dec 20, 2005

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG MIX 50/50 PEN

LILLY 50 UNITS/ML;50 UNITS/ML N021018 003 Dec 22, 1999



HUMALOG MIX 75/25 PEN

LILLY 75 UNITS/ML;25 UNITS/ML N021017 003 Dec 22, 1999



INSULIN LISPRO RECOMBINANT

INJECTABLE;INJECTION

HUMALOG PEN

LILLY 100 UNITS/ML N020563 002 Aug 06, 1998

INSULIN PORK

INJECTABLE;INJECTION

ILETIN I

LILLY 500 UNITS/ML N017931 001

INSULIN

NOVO NORDISK INC 40 UNITS/ML N017926 001

REGULAR INSULIN

NOVO NORDISK INC 100 UNITS/ML N017926 003

INSULIN PURIFIED BEEF

INJECTABLE;INJECTION

REGULAR ILETIN II

LILLY 100 UNITS/ML N018478 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-215(of 393)

** See List Footnote



INSULIN PURIFIED PORK

INJECTABLE;INJECTION

ILETIN II

LILLY 500 UNITS/ML
N018344 002

REGULAR ILETIN II (PORK)

LILLY 100 UNITS/ML


N018344 001

REGULAR PURIFIED PORK INSULIN

NOVO NORDISK INC 100 UNITS/ML
N018381 001

VELOSULIN

NOVO NORDISK INC 100 UNITS/ML
N018193 001

INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE;INJECTION

INSULIN NORDISK MIXTARD (PORK)

NOVO NORDISK INC


30 UNITS/ML;70 UNITS/ML
N018195 001

INSULIN RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN BR

LILLY
100 UNITS/ML
N019529 001 Apr 28, 1986

VELOSULIN BR

NOVO NORDISK INC
100 UNITS/ML
N021028 001 Jul 19, 1999

POWDER;INHALATION

EXUBERA

PFIZER
1MG/INH
N021868 001 Jan 27, 2006

3MG/INH
N021868 002 Jan 27, 2006

INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN 50/50

LILLY 50 UNITS/ML;50 UNITS/ML


N020100 001 Apr 29, 1992

INSULIN RECOMBINANT PURIFIED HUMAN

INJECTABLE;INJECTION

NOVOLIN R
NOVO NORDISK INC 100 UNITS/ML N018778 001 Aug 30, 1983

VELOSULIN BR HUMAN
NOVO NORDISK INC 100 UNITS/ML N019450 001 May 30, 1986

INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

MIXTARD HUMAN 70/30

BAYER PHARMS 30 UNITS/ML;70 UNITS/ML N019585 001 Mar 11, 1988



NOVOLIN 70/30

NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML N019441 001 Jul 11, 1986

INSULIN SUSP ISOPHANE BEEF

INJECTABLE;INJECTION

NPH INSULIN

NOVO NORDISK INC 40 UNITS/ML
N017929 001

100 UNITS/ML
N017929 003

INSULIN SUSP ISOPHANE BEEF/PORK

INJECTABLE;INJECTION

NPH ILETIN I (BEEF-PORK)

LILLY 40 UNITS/ML
N017936 001

100 UNITS/ML
N017936 002

INSULIN SUSP ISOPHANE PURIFIED BEEF

INJECTABLE;INJECTION

NPH ILETIN II

LILLY 100 UNITS/ML
N018479 001

INSULIN SUSP ISOPHANE PURIFIED PORK

INJECTABLE;INJECTION

INSULIN INSULATARD NPH NORDISK

NOVO NORDISK INC 100 UNITS/ML
N018194 001

NPH ILETIN II (PORK)

LILLY 100 UNITS/ML


N018345 001

NPH PURIFIED PORK ISOPHANE INSULIN

NOVO NORDISK INC 100 UNITS/ML
N018623 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-216(of 393)

** See List Footnote



INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

INSULATARD NPH HUMAN
NOVO NORDISK INC 100 UNITS/ML N019449 001 May 30, 1986

NOVOLIN N
NOVO NORDISK INC 100 UNITS/ML N019065 001 Jan 23, 1985

INSULIN SUSP PROTAMINE ZINC BEEF/PORK

INJECTABLE;INJECTION

PROTAMINE ZINC & ILETIN I (BEEF-PORK)

LILLY 40 UNITS/ML
N017932 001

100 UNITS/ML
N017932 002

INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF

INJECTABLE;INJECTION

PROTAMINE ZINC AND ILETIN II

LILLY 100 UNITS/ML
N018476 001

PROTAMINE ZINC INSULIN

BRISTOL MYERS SQUIBB 40 UNITS/ML
N017928 001

100 UNITS/ML
N017928 003

INSULIN SUSP PROTAMINE ZINC PURIFIED PORK

INJECTABLE;INJECTION

PROTAMINE ZINC AND ILETIN II (PORK)

LILLY 100 UNITS/ML


N018346 001

INSULIN ZINC SUSP BEEF

INJECTABLE;INJECTION

LENTE INSULIN

NOVO NORDISK INC 40 UNITS/ML
N017998 001

100 UNITS/ML
N017998 003

INSULIN ZINC SUSP EXTENDED BEEF

INJECTABLE;INJECTION

ULTRALENTE INSULIN

NOVO NORDISK INC 100 UNITS/ML
N017997 003

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF

INJECTABLE;INJECTION

ULTRALENTE

NOVO NORDISK INC 100 UNITS/ML
N018385 001

INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN U

LILLY 40 UNITS/ML
N019571 001 Jun 10, 1987

100 UNITS/ML
N019571 002 Jun 10, 1987

INSULIN ZINC SUSP PROMPT BEEF

INJECTABLE;INJECTION

SEMILENTE INSULIN

NOVO NORDISK INC 100 UNITS/ML
N017996 003

INSULIN ZINC SUSP PROMPT PURIFIED PORK

INJECTABLE;INJECTION

SEMILENTE

NOVO NORDISK INC 100 UNITS/ML
N018382 001

INSULIN ZINC SUSP PURIFIED BEEF

INJECTABLE;INJECTION

LENTE ILETIN II

LILLY 100 UNITS/ML
N018477 001

INSULIN ZINC SUSP PURIFIED BEEF/PORK

INJECTABLE;INJECTION

LENTARD

NOVO NORDISK INC 100 UNITS/ML
N018384 001

INSULIN ZINC SUSP PURIFIED PORK

INJECTABLE;INJECTION

LENTE

NOVO NORDISK INC 100 UNITS/ML
N018383 001

LENTE ILETIN II (PORK)

LILLY 100 UNITS/ML


N018347 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-217(of 393)

** See List Footnote



INSULIN ZINC SUSP RECOMBINANT HUMAN

INJECTABLE;INJECTION

HUMULIN L
LILLY 100 UNITS/ML N019377 002 Sep 30, 1985

NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML N019965 001 Jun 25, 1991

INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN

INJECTABLE;INJECTION

NOVOLIN L

NOVO NORDISK INC 100 UNITS/ML
N018777 001 Aug 30, 1983

INULIN

INJECTABLE;INJECTION

INULIN AND SODIUM CHLORIDE

ISO TEX 100MG/ML
N002282 001

INVERT SUGAR

INJECTABLE;INJECTION

TRAVERT 10% IN PLASTIC CONTAINER

BAXTER HLTHCARE
10GM/100ML
N016717 001

IOBENGUANE SULFATE I-131

INJECTABLE;INJECTION

IOBENGUANE SULFATE I 131

PHARMALUCENCE
2.3mCi/ML
N020084 001 Mar 25, 1994

IOCETAMIC ACID

TABLET;ORAL

CHOLEBRINE

MALLINCKRODT
750MG
N017129 001

IODAMIDE MEGLUMINE

INJECTABLE;INJECTION

RENOVUE-65

BRACCO
65%
N017902 001

RENOVUE-DIP

BRACCO
24%
N017903 001

IODIPAMIDE MEGLUMINE

INJECTABLE;INJECTION

CHOLOGRAFIN MEGLUMINE

BRACCO
10.3%
N009321 007

+
52%
N009321 003

IODIPAMIDE SODIUM

INJECTABLE;INJECTION

CHOLOGRAFIN SODIUM

BRACCO
20%
N009321 001

IODIXANOL

INJECTABLE;INJECTION

VISIPAQUE 270

GE HEALTHCARE
55%
N020808 001 Aug 29, 1997

IODOHIPPURATE SODIUM I-123

INJECTABLE;INJECTION

NEPHROFLOW

GE HEALTHCARE
1mCi/ML
N018289 001 Dec 28, 1984

IODOHIPPURATE SODIUM I-131

INJECTABLE;INJECTION

HIPPURAN I 131

MALLINCKRODT
0.25mCi/ML
N016666 001

HIPPUTOPE

BRACCO
1-2mCi/VIAL
N015419 002

IODOHIPPURATE SODIUM I 131

PHARMALUCENCE
0.2mCi/ML
N017313 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-218(of 393)

** See List Footnote



IODOXAMATE MEGLUMINE

INJECTABLE;INJECTION

CHOLOVUE

BRACCO 9.9%
N018077 001

40.3%
N018076 001

IOFETAMINE HYDROCHLORIDE I-123

INJECTABLE;INJECTION

SPECTAMINE

IMP 1mCi/ML
N019432 001 Dec 24, 1987

IOHEXOL

INJECTABLE;INJECTION

OMNIPAQUE 210

GE HEALTHCARE 45.3%
N018956 006 Jun 30, 1989

SOLUTION;INJECTION, ORAL, RECTAL

OMNIPAQUE 240

GE HEALTHCARE 51.8%
N020608 001 Oct 24, 1995

SOLUTION;URETHRAL

OMNIPAQUE 70

GE HEALTHCARE 15.1%
N018956 007 Jun 01, 1994

IOPAMIDOL

INJECTABLE;INJECTION

IOPAMIDOL

BAXTER HLTHCARE 41%
A074629 001 Nov 06, 1996

51%
A074629 004 Mar 31, 1998

61%
A074629 002 Nov 06, 1996

76%
A074629 003 Nov 06, 1996

HOSPIRA 61%
A074734 001 Dec 10, 1996

76%
A074734 002 Dec 10, 1996

IOPAMIDOL-200

COOK IMAGING 41%
A074881 001 Jul 28, 2000

HOSPIRA 41%
A074898 001 Dec 30, 1997

IOPAMIDOL-200 IN PLASTIC CONTAINER

HOSPIRA 41%
A074636 001 Dec 30, 1997

IOPAMIDOL-250

COOK IMAGING 51%
A074881 002 Jul 28, 2000

FRESENIUS KABI USA 51%
A074679 001 Apr 02, 1997

HOSPIRA 51%
A074898 002 Dec 30, 1997

51%
A075005 001 Feb 24, 1998

IOPAMIDOL-250 IN PLASTIC CONTAINER

HOSPIRA 51%
A074636 002 Dec 30, 1997

IOPAMIDOL-300

ABBVIE 61%
A074638 001 Apr 30, 1997

COOK IMAGING 61%


A074881 003 Jul 28, 2000

FRESENIUS KABI USA 61%
A074679 002 Apr 02, 1997

HOSPIRA 61%
A074898 003 Dec 30, 1997

61%
A075005 002 Feb 24, 1998

IOPAMIDOL-300 IN PLASTIC CONTAINER

HOSPIRA 61%
A074636 003 Dec 30, 1997

61%
A074637 001 Apr 03, 1997

IOPAMIDOL-370

COOK IMAGING 76%
A074881 004 Jul 28, 2000

FRESENIUS KABI USA 76%
A074679 003 Apr 02, 1997

HOSPIRA 76%
A074898 004 Dec 30, 1997

76%
A075005 003 Feb 24, 1998

IOPAMIDOL-370 IN PLASTIC CONTAINER

HOSPIRA 76%
A074636 004 Dec 30, 1997

ISOVUE-128

BRACCO 26%
N018735 005 Oct 21, 1986

ISOVUE-200

BRACCO 41%
N020327 001 Oct 12, 1994

IOPANOIC ACID

TABLET;ORAL

TELEPAQUE

GE HEALTHCARE 500MG
N008032 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-219(of 393)

** See List Footnote



IOPHENDYLATE

INJECTABLE;INJECTION

PANTOPAQUE

ALCON
100%
N005319 001

IOPROMIDE

INJECTABLE;INJECTION

ULTRAVIST 150

+ BAYER HLTHCARE 31.2%
N020220 004 May 10, 1995

ULTRAVIST 300 IN PLASTIC CONTAINER

+ BAYER HLTHCARE 62.3%
N020220 005 Nov 18, 2008

IOTHALAMATE MEGLUMINE

INJECTABLE;INJECTION

CONRAY 30

+ LIEBEL-FLARSHEIM 30%
N016983 001

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

INJECTABLE;INJECTION

VASCORAY

MALLINCKRODT
52%;26%
N016783 001

IOTHALAMATE SODIUM

INJECTABLE;INJECTION

ANGIO-CONRAY

MALLINCKRODT
80%
N013319 001

CONRAY 325

MALLINCKRODT
54.3%
N017685 001

CONRAY 400

MALLINCKRODT
66.8%
N014295 001

IOTROLAN

INJECTABLE;INTRATHECAL

OSMOVIST 190

BAYER HLTHCARE
40.6%
N019580 001 Dec 07, 1989

OSMOVIST 240

BAYER HLTHCARE
51.3%
N019580 002 Dec 07, 1989

IOVERSOL

INJECTABLE;INJECTION

OPTIRAY 160

LIEBEL-FLARSHEIM
34%
N019710 003 Dec 30, 1988

OPTIRAY 240

LIEBEL-FLARSHEIM
51%
N020923 001 May 28, 1998

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

INJECTABLE;INJECTION

HEXABRIX

GUERBET
39.3%;19.6%
N018905 002 Jul 26, 1985

IOXILAN

INJECTABLE;INJECTION

OXILAN-300

GUERBET
62%
N020316 001 Dec 21, 1995

OXILAN-350

GUERBET
73%
N020316 002 Dec 21, 1995

IPODATE CALCIUM

GRANULE;ORAL

ORAGRAFIN CALCIUM

BRACCO
3GM/PACKET
N012968 001

IPODATE SODIUM

CAPSULE;ORAL

BILIVIST

BAYER HLTHCARE
500MG
A087768 001 Aug 11, 1982

ORAGRAFIN SODIUM

BRACCO
500MG
N012967 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-220(of 393)

** See List Footnote



IPRATROPIUM BROMIDE

AEROSOL, METERED;INHALATION

ATROVENT

BOEHRINGER INGELHEIM 0.018MG/INH N019085 001 Dec 29, 1986

SOLUTION;INHALATION

ATROVENT

+ BOEHRINGER INGELHEIM 0.02% ** N020228 001 Sep 29, 1993

IPRATROPIUM BROMIDE

ACTAVIS MID ATLANTIC 0.02% A075111 001 Apr 22, 1999

APOTEX INC 0.02% A075441 001 Mar 28, 2001



BAUSCH AND LOMB INC 0.02% A075835 001 Oct 15, 2001

MYLAN SPECIALITY LP 0.02% A074755 001 Jan 10, 1997

PHARMASCIENCE INC 0.02% A075507 001 Jan 19, 2001

ROXANE 0.02% A075867 001 Jul 22, 2002

TEVA PHARMS USA 0.02% A075313 001 Feb 07, 2000

SPRAY, METERED;NASAL

ATROVENT

+ BOEHRINGER INGELHEIM 0.021MG/SPRAY N020393 001 Oct 20, 1995

+ 0.042MG/SPRAY N020394 001 Oct 20, 1995

IPRATROPIUM BROMIDE

APOTEX INC 0.021MG/SPRAY A076156 001 Apr 18, 2003

IRBESARTAN

TABLET;ORAL

IRBESARTAN

AJANTA PHARMA LTD 75MG A203685 001 Dec 10, 2015

150MG A203685 002 Dec 10, 2015

300MG A203685 003 Dec 10, 2015

APOTEX INC 75MG A200832 001 Oct 15, 2012

150MG A200832 002 Oct 15, 2012

300MG A200832 003 Oct 15, 2012

MYLAN PHARMS INC 75MG A200461 001 Sep 27, 2012

150MG A200461 002 Sep 27, 2012

300MG A200461 003 Sep 27, 2012

WATSON LABS INC 75MG A090720 001 Oct 12, 2012



150MG A090720 002 Oct 12, 2012

300MG A090720 003 Oct 12, 2012

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

IRINOTECAN HYDROCHLORIDE

SANDOZ 40MG/2ML (20MG/ML) A077994 001 Feb 27, 2008

100MG/5ML (20MG/ML) A077994 002 Feb 27, 2008

SANDOZ INC 40MG/2ML (20MG/ML) A090137 001 Nov 12, 2009

100MG/5ML (20MG/ML) A090137 002 Nov 12, 2009

SUN PHARMA GLOBAL 40MG/2ML (20MG/ML) A078805 001 Apr 21, 2008

100MG/5ML (20MG/ML) A078805 002 Apr 21, 2008



IRON DEXTRAN

INJECTABLE;INJECTION

IRON DEXTRAN

SANOFI AVENTIS US EQ 50MG IRON/ML N010787 002

IRON SUCROSE

INJECTABLE;INTRAVENOUS

VENOFER

LUITPOLD EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML) N021135 005 Mar 29, 2013

EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML) N021135 003 Mar 29, 2005

ISOETHARINE HYDROCHLORIDE

SOLUTION;INHALATION

BETA-2

NEPHRON 1% A086711 001

BRONKOSOL

SANOFI AVENTIS US 0.25% N012339 009

1% N012339 008

ISOETHARINE HYDROCHLORIDE

ALPHARMA US PHARMS 1% A087101 001

ASTRAZENECA 0.062% A087937 001 Nov 15, 1982

0.062% A089614 001 Jun 13, 1991

0.125% A087938 001 Nov 15, 1982

0.125% A089615 001 Jun 13, 1991

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-221(of 393)

** See List Footnote



ISOETHARINE HYDROCHLORIDE

SOLUTION;INHALATION

ISOETHARINE HYDROCHLORIDE

0.167% A088470 001 Mar 14, 1984

0.167% A089616 001 Jun 13, 1991

0.2% A088471 001 Mar 14, 1984

0.2% A089617 001 Jun 13, 1991

0.25% A088472 001 Mar 14, 1984

0.25% A089618 001 Jun 13, 1991

BAXTER HLTHCARE 0.08% A088144 001 Jul 29, 1983

0.14% A088145 001 Mar 26, 1984

0.25% A088146 001 Aug 01, 1983

DEY 0.08% A088187 001 Dec 03, 1982



0.1% A087389 001

0.17% A087390 001

0.25% A088188 001 Dec 03, 1982

1% A086763 001

INTL MEDICATION 0.077% A086651 001

0.08% A086651 002

0.1% A086651 003

0.143% A086651 004

0.167% A086651 005

0.2% A086651 006

0.25% A086651 007

1% A086651 008

PARKE DAVIS 0.5% A085997 001

1% A085889 001

ROXANE 0.1% A087396 001

0.125% A087025 001

0.167% A088226 001 Sep 16, 1983

0.2% A087324 001



0.25% A088275 001 Jun 03, 1983

1% A086899 001

ISOETHARINE HYDROCHLORIDE S/F

DEY 0.08% A089817 001 Nov 22, 1988



0.1% A089818 001 Nov 22, 1988

0.17% A089819 001 Nov 22, 1988

0.25% A089820 001 Nov 22, 1988

1% A089252 001 Sep 15, 1986

ISOETHARINE MESYLATE

AEROSOL, METERED;INHALATION

BRONKOMETER

SANOFI AVENTIS US 0.34MG/INH N012339 007

ISOETHARINE MESYLATE

ALPHARMA US PHARMS 0.34MG/INH A087858 001 Aug 21, 1984

ISOFLURANE

LIQUID;INHALATION

ISOFLURANE

HOSPIRA 99.9% A074097 001 Jan 25, 1993

WATSON LABS INC 99.9% A074393 001 May 12, 1995

ISOFLUROPHATE

OINTMENT;OPHTHALMIC

FLOROPRYL

MERCK 0.025% N010656 001

ISONIAZID

INJECTABLE;INJECTION

NYDRAZID

SANDOZ 100MG/ML ** N008662 001

RIMIFON

ROCHE 25MG/ML N008420 002

100MG/ML N008420 003

SYRUP;ORAL

ISONIAZID

MIKART 50MG/5ML A081118 001 Jul 21, 1997

LANIAZID

LANNETT 50MG/5ML A089243 001 Feb 03, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-222(of 393)

** See List Footnote



ISONIAZID

SYRUP;ORAL

RIMIFON

ROCHE
50MG/5ML
N008420 001

TABLET;ORAL

DOW-ISONIAZID

DOW PHARM
300MG
A080330 002

HYZYD

MEDPOINTE PHARM HLC
100MG
A080134 003

300MG
A080134 004

INH

NOVARTIS
300MG
A080935 001

ISONIAZID

DURAMED PHARMS BARR
100MG
A088231 001 Mar 17, 1983

300MG
A088119 001 Mar 17, 1983

HALSEY
50MG
A083632 001

HIKMA INTL PHARMS
100MG
A080212 001

300MG
A087425 001

IMPAX LABS
100MG
A080153 001

IVAX SUB TEVA PHARMS 100MG
A080270 001

300MG A083610 001

LILLY 100MG N008499 002

300MG N008499 003

MK LABS 100MG A080941 001

NEXGEN PHARMA INC 100MG A084050 001

PANRAY 50MG N008428 001

100MG N008428 002

300MG N008428 003

PERRIGO 100MG A083060 001

PHARMAVITE 100MG A085091 001

PHOENIX LABS NY 50MG A080368 001

100MG A080368 002

PUREPAC PHARM 50MG A080132 003 Jul 14, 1982

100MG A080132 004 Jul 14, 1982

SUN PHARM INDUSTRIES 100MG
A080136 001

300MG
A083633 001

WATSON LABS 50MG
A080522 001

100MG
A080401 001

100MG
A080523 001

100MG
A085790 001

300MG
A080521 001

300MG
A083178 001

300MG
A085784 001

WHITEWORTH TOWN PLSN 100MG
A080120 002

LANIAZID

LANNETT 50MG
A080140 001

100MG
A080140 002

NYDRAZID

BRISTOL MYERS SQUIBB 100MG
N008392 003

STANOZIDE

EVERYLIFE
100MG
A080126 001

300MG
A080126 002

ISONIAZID; RIFAMPIN

CAPSULE;ORAL

RIFAMPIN AND ISONIAZID

HIKMA INTL PHARMS
150MG;300MG
A065221 001 Jul 29, 2005

ISOPROPAMIDE IODIDE

TABLET;ORAL

DARBID

GLAXOSMITHKLINE
EQ 5MG BASE
N010744 001

ISOPROTERENOL HYDROCHLORIDE

AEROSOL, METERED;INHALATION

ISOPROTERENOL HYDROCHLORIDE

3M
0.12MG/INH
N010375 004

ALPHARMA US PHARMS
0.12MG/INH
A085904 001

ISUPREL

SANOFI AVENTIS US
0.103MG/INH
N011178 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-223(of 393)

** See List Footnote



ISOPROTERENOL HYDROCHLORIDE

DISC;INHALATION

NORISODRINE AEROTROL

ABBOTT
0.25%
N016814 001

INJECTABLE;INJECTION

ISOPROTERENOL HYDROCHLORIDE

ABRAXIS PHARM
0.2MG/ML
A083431 001

BAXTER HLTHCARE
0.2MG/ML
A083486 001

HOSPIRA
0.02MG/ML
A083283 001

0.2MG/ML
A083346 001

INTL MEDICATION
0.2MG/ML
A083724 001

SOLUTION;INHALATION

AEROLONE

LILLY
0.25%
N007245 001

ISOPROTERENOL HYDROCHLORIDE

ARMOUR PHARM
0.031%
A087935 001 Nov 18, 1982

0.062%
A087936 001 Nov 18, 1982

DEY
0.5%
A086764 001 Jan 04, 1982

PARKE DAVIS
0.25%
A085994 001

0.5%
A085540 001

ISUPREL

SANOFI AVENTIS US
0.5%
N006327 002

1%
N006327 003

VAPO-ISO

FISONS
0.5%
N016813 001

TABLET;RECTAL, SUBLINGUAL

ISUPREL

SANOFI AVENTIS US
10MG
N006328 001

15MG
N006328 002

ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE

AEROSOL, METERED;INHALATION

DUO-MEDIHALER

3M
0.16MG/INH;0.24MG/INH
N013296 001

ISOPROTERENOL SULFATE

AEROSOL, METERED;INHALATION

MEDIHALER-ISO

3M
0.08MG/INH
N010375 003

POWDER;INHALATION

NORISODRINE

ABBVIE
10%
N006905 003

25%
N006905 002

ISOSORBIDE

SOLUTION;ORAL

ISMOTIC

ALCON
100GM/220ML
N017063 001

ISOSORBIDE DINITRATE

CAPSULE, EXTENDED RELEASE;ORAL

ISORDIL

WYETH AYERST
40MG
N012882 002 Jul 29, 1988

TABLET;ORAL

ISORDIL

+ VALEANT PHARMS NORTH
10MG **
N012093 002 Jul 29, 1988

+
20MG **
N012093 006 Jul 29, 1988

+
30MG **
N012093 005 Jul 29, 1988

ISOSORBIDE DINITRATE

SUN PHARM INDUSTRIES
5MG
A086166 002 Sep 19, 1986

10MG
A086169 001 Sep 19, 1986

20MG
A086167 001 Sep 19, 1986

30MG
A087564 001 Sep 18, 1986

SUPERPHARM
5MG
A089190 001 Feb 17, 1987

10MG
A089191 001 Feb 17, 1987

20MG
A089192 001 Feb 17, 1987

WATSON LABS
5MG
A086034 001 Jan 06, 1988

10MG
A086032 001 Jan 07, 1988

SORBITRATE

ASTRAZENECA
5MG
N016192 001 Apr 01, 1996

10MG
N016192 002 Apr 01, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-224(of 393)

** See List Footnote



ISOSORBIDE DINITRATE

TABLET;ORAL

SORBITRATE

20MG A086405 002 Aug 21, 1990

30MG A088124 001 Aug 21, 1990

40MG A088125 001 Aug 21, 1990

TABLET;SUBLINGUAL

ISORDIL

+ BIOVAIL 2.5MG ** N012940 004 Jul 29, 1988

+ 5MG ** N012940 003 Jul 29, 1988

+ 10MG ** N012940 005 Jul 29, 1988

ISOSORBIDE DINITRATE

HIKMA INTL PHARMS 2.5MG A086054 001 Oct 29, 1987

5MG A086055 001 Nov 02, 1987

SANDOZ 2.5MG A086225 001 Feb 19, 1988

5MG A086222 001 Feb 19, 1988

SUN PHARM INDUSTRIES 2.5MG A084204 001 Sep 18, 1986

5MG A086168 001 Sep 18, 1986

10MG A087545 001 Sep 18, 1986

WATSON LABS 2.5MG ** A086033 001 Feb 26, 1988



WATSON LABS TEVA 5MG ** A086031 001 Sep 29, 1987

SORBITRATE

ASTRAZENECA 2.5MG N016191 002 Apr 01, 1996

5MG N016191 001 Apr 01, 1996

TABLET, CHEWABLE;ORAL

SORBITRATE

ASTRAZENECA 5MG N016776 002 Apr 01, 1996

10MG N016776 003 Apr 01, 1996

TABLET, EXTENDED RELEASE;ORAL



ISORDIL

WYETH AYERST 40MG N012882 001 Jul 29, 1988

ISOSORBIDE DINITRATE

IMPAX LABS INC 40MG A040723 001 Mar 17, 2008

ISOSORBIDE MONONITRATE

TABLET;ORAL

ISMO

PROMIUS PHARMA 20MG N019091 001 Dec 30, 1991

TABLET, EXTENDED RELEASE;ORAL

IMDUR

+ SCHERING PLOUGH 30MG ** N020225 001 Aug 12, 1993

+ 60MG ** N020225 002 Aug 12, 1993

+ 120MG ** N020225 003 Mar 30, 1995



ISOSORBIDE MONONITRATE

ACCORD HLTHCARE 30MG A209684 001 Oct 24, 2017

60MG A209684 002 Oct 24, 2017

120MG A209684 003 Oct 24, 2017

ACTAVIS ELIZABETH 30MG A075306 001 Dec 31, 1998

60MG A075306 002 Dec 31, 1998

ALKERMES GAINESVILLE 60MG A075041 001 Sep 22, 1998

IVAX SUB TEVA PHARMS 30MG A075448 002 Aug 07, 2001

60MG A075448 001 Jun 19, 2000



120MG A075448 003 Aug 07, 2001

SKYEPHARMA AG 60MG A075166 001 Oct 07, 1999



ISOSULFAN BLUE

INJECTABLE;INJECTION

LYMPHAZURIN

+ COVIDIEN 1% ** N018310 001

ISOTRETINOIN

CAPSULE;ORAL

ACCUTANE

+ HOFFMANN LA ROCHE 10MG ** N018662 002 May 07, 1982

+ 20MG ** N018662 004 Mar 28, 1983



+ 40MG ** N018662 003 May 07, 1982

SOTRET

SUN PHARM INDS LTD 10MG A076041 001 Dec 24, 2002

20MG A076041 002 Dec 24, 2002

30MG A076503 001 Jun 20, 2003

40MG A076041 003 Dec 24, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-225(of 393)

** See List Footnote



ISRADIPINE

CAPSULE;ORAL

DYNACIRC

+ SMITHKLINE BEECHAM 2.5MG N019546 001 Dec 20, 1990

+ 5MG N019546 002 Dec 20, 1990

TABLET, EXTENDED RELEASE;ORAL

DYNACIRC CR

+ GLAXOSMITHKLINE LLC 5MG ** N020336 001 Jun 01, 1994

+ 10MG ** N020336 002 Jun 01, 1994

ISRADIPINE

MYLAN PHARMS INC 5MG A201067 001 Nov 27, 2015

10MG A201067 002 Nov 27, 2015

ITRACONAZOLE

INJECTABLE;INJECTION

SPORANOX

JANSSEN PHARMS 10MG/ML N020966 001 Mar 30, 1999

IVERMECTIN

TABLET;ORAL

STROMECTOL

MERCK SHARP DOHME 6MG N050742 001 Nov 22, 1996

KANAMYCIN SULFATE

CAPSULE;ORAL

KANTREX

APOTHECON EQ 500MG BASE A060516 001

EQ 500MG BASE A061911 001

EQ 500MG BASE A062726 001 Mar 06, 1987

INJECTABLE;INJECTION

KANAMYCIN

WEST-WARD PHARMS INT EQ 75MG BASE/2ML A062324 001

EQ 500MG BASE/2ML A062324 002

EQ 1GM BASE/3ML A062324 003

KANAMYCIN SULFATE

ABRAXIS PHARM EQ 75MG BASE/2ML A062504 001 Apr 05, 1984

EQ 500MG BASE/2ML A062504 002 Apr 05, 1984

EQ 1GM BASE/3ML A062504 003 Apr 05, 1984

FRESENIUS KABI USA EQ 500MG BASE/2ML A065111 001 Dec 17, 2002

EQ 1GM BASE/3ML A065111 002 Dec 17, 2002

INTL MEDICATION EQ 500MG BASE/2ML A062466 001 Sep 30, 1983

EQ 1GM BASE/3ML A062466 002 Sep 30, 1983

LOCH EQ 75MG BASE/2ML A063021 001 Jul 31, 1992



EQ 500MG BASE/2ML A063022 001 Jul 31, 1992

EQ 1GM BASE/3ML A063025 001 Jul 31, 1992

PHARMAFAIR EQ 75MG BASE/2ML A062668 001 May 07, 1987

EQ 500MG BASE/2ML A062672 001 May 07, 1987

EQ 1GM BASE/3ML A062669 001 May 07, 1987

SOLOPAK EQ 75MG BASE/2ML A062605 003 Feb 26, 1986



EQ 500MG BASE/2ML A062605 001 Feb 26, 1986

EQ 1GM BASE/3ML A062605 002 Feb 26, 1986

WARNER CHILCOTT EQ 1GM BASE/3ML A063092 001 Oct 11, 1989

WATSON LABS EQ 1GM BASE/3ML A062520 003 May 09, 1985

KANTREX

APOTHECON EQ 75MG BASE/2ML A061655 003

EQ 75MG BASE/2ML A061901 003

EQ 75MG BASE/2ML A062564 001 Sep 21, 1984

EQ 500MG BASE/2ML A061655 001



EQ 500MG BASE/2ML A061901 001

EQ 500MG BASE/2ML A062564 002 Sep 21, 1984

EQ 1GM BASE/3ML A061655 002



EQ 1GM BASE/3ML A061901 002

EQ 1GM BASE/3ML A062564 003 Sep 21, 1984

KLEBCIL

KING PHARMS EQ 75MG BASE/2ML A062170 001

EQ 500MG BASE/2ML A062170 002

EQ 1GM BASE/3ML A062170 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-226(of 393)

** See List Footnote



KETOCONAZOLE

CREAM;TOPICAL

NIZORAL

+ JANSSEN PHARMA 2% N019084 001 Dec 31, 1985

SUSPENSION;ORAL

NIZORAL

JANSSEN PHARMA 100MG/5ML A070767 001 Nov 07, 1986

TABLET;ORAL

KETOCONAZOLE

AAIPHARMA LLC 200MG A075341 001 Jul 27, 1999

APOTEX 200MG A075912 001 Jan 10, 2002

PLIVA 200MG A075362 001 Jun 15, 1999

SUN PHARM INDUSTRIES 200MG A075314 001 Jun 15, 1999

TEVA 200MG A074971 001 Jun 15, 1999

NIZORAL

+ JANSSEN PHARMS 200MG ** N018533 001

KETOPROFEN

CAPSULE;ORAL

KETOPROFEN

AUROLIFE PHARMA LLC 50MG A074024 001 Dec 29, 1995

75MG A074024 002 Dec 29, 1995

MYLAN 50MG A074035 002 Dec 31, 1996

75MG A074035 003 Dec 31, 1996

TEVA 25MG A073515 001 Dec 22, 1992

ORUDIS

+ WYETH AYERST 25MG ** N018754 001 Jul 31, 1987
+ 50MG ** N018754 002 Jan 09, 1986
+ 75MG ** N018754 003 Jan 09, 1986
CAPSULE, EXTENDED RELEASE;ORAL
KETOPROFEN
ACTAVIS LABS FL INC 100MG A075270 002 Mar 24, 1999
150MG A075270 003 Mar 24, 1999
200MG A075270 001 Mar 24, 1999
ALKERMES GAINESVILLE 200MG A074879 001 Dec 10, 1997
MYLAN 100MG A075679 003 Feb 20, 2002
150MG A075679 002 Feb 20, 2002
ORUVAIL
+ WYETH PHARMS INC 100MG ** N019816 003 Feb 08, 1995
+ 150MG ** N019816 002 Feb 08, 1995
+ 200MG ** N019816 001 Sep 24, 1993
FILM;ORAL
NEXCEDE
NOVARTIS 12.5MG N022470 001 Nov 25, 2009
TABLET;ORAL
ACTRON
BAYER 12.5MG N020499 001 Oct 06, 1995
KETOPROFEN
PERRIGO 12.5MG A075364 001 Feb 07, 2002
ORUDIS KT
+ WYETH CONS 12.5MG ** N020429 001 Oct 06, 1995
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
APOTEX INC 30MG/ML A075626 001 Jul 24, 2001
30MG/ML A077201 001 Oct 14, 2005
APOTHECON 15MG/ML A075348 001 Nov 28, 2000
30MG/ML A075348 002 Nov 28, 2000
BAXTER HLTHCARE CORP 15MG/ML A075631 002 Jun 29, 2001
30MG/ML A075631 001 Jun 29, 2001
BEDFORD 15MG/ML A075230 002 Oct 25, 1999
30MG/ML A075230 001 Oct 25, 1999
GLAND PHARMA LTD 15MG/ML A076722 001 Jul 27, 2004
30MG/ML A076722 002 Jul 27, 2004
HOSPIRA 15MG/ML A074801 001 Jun 05, 1997
30MG/ML A074801 002 Jun 05, 1997
LUITPOLD 15MG/ML A078145 001 Jan 14, 2008
30MG/ML A078145 002 Jan 14, 2008
MYLAN LABS LTD 15MG/ML A078299 001 Jul 16, 2007

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-227(of 393)

** See List Footnote



KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

15MG/ML A201155 001 Aug 04, 2014

30MG/ML A078299 002 Jul 16, 2007



30MG/ML A201155 002 Aug 04, 2014

SANDOZ INC 15MG/ML A076271 001 Oct 06, 2004



SUN PHARMA GLOBAL 15MG/ML A078737 001 Oct 06, 2008

30MG/ML A078737 002 Oct 06, 2008

WEST-WARD PHARMS INT 15MG/ML ** A075222 001 Apr 26, 1999

15MG/ML A075299 001 Nov 03, 1999



15MG/ML A075772 001 Jul 21, 2004

30MG/ML ** A075222 002 Apr 26, 1999

30MG/ML ** A075228 001 Apr 26, 1999

30MG/ML A075299 002 Nov 03, 1999



30MG/ML A075772 002 Jul 21, 2004

WOCKHARDT 30MG/ML A077943 001 Mar 27, 2007

TORADOL

+ ROCHE PALO 15MG/ML ** N019698 001 Nov 30, 1989

+ 30MG/ML ** N019698 002 Nov 30, 1989

SOLUTION/DROPS;OPHTHALMIC

ACULAR PRESERVATIVE FREE



ALLERGAN 0.5% N020811 001 Nov 03, 1997

KETOROLAC TROMETHAMINE

AKORN 0.45% A203376 001 Feb 10, 2014

TABLET;ORAL

KETOROLAC TROMETHAMINE

CYCLE PHARMS LTD 10MG A074790 001 Jun 26, 1997

WATSON LABS 10MG A074955 001 Sep 19, 1997

TORADOL

+ ROCHE PALO 10MG ** N019645 001 Dec 20, 1991

KETOTIFEN FUMARATE

SOLUTION/DROPS;OPHTHALMIC

KETOTIFEN FUMARATE

APOTEX INC EQ 0.025% BASE A077354 001 May 09, 2006

ZADITOR

+ ALCON PHARMA EQ 0.025% BASE ** N021066 002 Oct 19, 2006

KRYPTON, KR-81M

GAS;INHALATION

MPI KRYPTON 81M GENERATOR

GE HEALTHCARE N/A N018088 001

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION

LABETALOL HYDROCHLORIDE

AKORN INC 5MG/ML A075524 001 Nov 29, 1999

APOTHECON 5MG/ML A075355 001 Nov 29, 1999

BAXTER HLTHCARE CORP 5MG/ML A076051 001 Jul 05, 2002

HOSPIRA 5MG/ML A075242 001 Sep 30, 1999

NORMODYNE

SCHERING 5MG/ML N018686 001 Aug 01, 1984

TRANDATE

+ SEBELA IRELAND LTD 5MG/ML ** N019425 001 Dec 31, 1985

TABLET;ORAL

LABETALOL HYDROCHLORIDE

APOTHECON 100MG A075223 001 Nov 20, 1998

200MG A075223 002 Nov 20, 1998

300MG A075223 003 Nov 20, 1998

TEVA 100MG A074989 001 Sep 30, 1998

200MG A074989 002 Sep 30, 1998

300MG A074989 003 Sep 30, 1998

NORMODYNE

+ SCHERING 100MG ** N018687 001 Aug 31, 1987

+ 200MG ** N018687 002 Aug 01, 1984

+ 300MG ** N018687 003 Aug 01, 1984

+ 400MG ** N018687 004 Aug 01, 1984

TRANDATE

+ CNTY LINE PHARMS 400MG ** N018716 004 Aug 01, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-228(of 393)

** See List Footnote



LACTULOSE

SOLUTION;ORAL

CHRONULAC

+ SANOFI AVENTIS US 10GM/15ML ** N017884 001

CONSTULOSE

ACTAVIS MID ATLANTIC 10GM/15ML A070288 001 Aug 15, 1988

DUPHALAC

SOLVAY 10GM/15ML A072372 001 Mar 22, 1989

EVALOSE

TEVA PHARMS 10GM/15ML A073497 001 May 28, 1993

LACTULOSE

APOTEX INC 10GM/15ML A075911 001 Feb 21, 2002

MORTON GROVE 10GM/15ML A071841 001 Sep 22, 1988

PACO 10GM/15ML A073160 001 Aug 25, 1992

LAXILOSE

NOSTRUM LABS 10GM/15ML A073686 001 May 28, 1993

SOLUTION;ORAL, RECTAL

ACILAC

NOSTRUM LABS 10GM/15ML A073685 001 May 28, 1993

CEPHULAC

+ SANOFI AVENTIS US 10GM/15ML ** N017657 001

GENERLAC

MORTON GROVE 10GM/15ML A071842 001 Sep 27, 1988

HEPTALAC

TEVA PHARMS 10GM/15ML A073504 001 May 28, 1993

LACTULOSE

APOTEX INC 10GM/15ML A076645 001 Jul 28, 2003

PACO 10GM/15ML A072029 001 Aug 25, 1992

ROXANE 10GM/15ML A073590 001 May 29, 1992

SOLVAY 10GM/15ML N017906 001



PORTALAC

SOLVAY 10GM/15ML A072374 001 Mar 22, 1989

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

TABLET;ORAL

LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE

+ MICRO LABS 150MG;200MG;300MG N205626 001 Aug 13, 2018

LAMIVUDINE; RALTEGRAVIR POTASSIUM

TABLET;ORAL

DUTREBIS

MERCK SHARP DOHME 150MG;EQ 300MG BASE N206510 001 Feb 06, 2015

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

AUROBINDO PHARMA LTD 300MG;300MG N022344 001 May 15, 2018

LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

LAMIVUDINE AND ZIDOVUDINE

PHARMACARE 150MG;300MG N022018 001 Mar 17, 2017

TEVA PHARMS 150MG;300MG A079081 001 May 25, 2011

LAMOTRIGINE

TABLET;ORAL

LAMICTAL

+ GLAXOSMITHKLINE LLC 50MG ** N020241 006 Dec 27, 1994

+ 250MG ** N020241 004 Dec 27, 1994

LAMOTRIGINE

ACTAVIS TOTOWA 25MG A078669 001 Apr 08, 2011

100MG A078669 002 Apr 08, 2011

150MG A078669 003 Apr 08, 2011

200MG A078669 004 Apr 08, 2011

HIKMA PHARMS 25MG A078134 001 Apr 19, 2011

100MG A078134 002 Apr 19, 2011

150MG A078134 003 Apr 19, 2011

200MG A078134 004 Apr 19, 2011

MYLAN 25MG A077428 001 Jan 27, 2009



100MG A077428 002 Jan 27, 2009

150MG A077428 003 Jan 27, 2009

200MG A077428 004 Jan 27, 2009

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-229(of 393)

** See List Footnote



LAMOTRIGINE

TABLET;ORAL

LAMOTRIGINE

MYLAN LABS LTD 25MG A078443 001 Feb 11, 2009

100MG A078443 002 Feb 11, 2009

150MG A078443 003 Feb 11, 2009

200MG A078443 004 Feb 11, 2009

PHARMASCIENCE INC 25MG A078310 001 Feb 04, 2009

100MG A078310 002 Feb 04, 2009

150MG A078310 003 Feb 04, 2009

200MG A078310 004 Feb 04, 2009

ROXANE 25MG A077392 001 Jan 27, 2009

100MG A077392 002 Jan 27, 2009

150MG A077392 003 Jan 27, 2009

200MG A077392 004 Jan 27, 2009

SANDOZ 25MG A078645 001 Jan 27, 2009

100MG A078645 002 Jan 27, 2009

150MG A078645 003 Jan 27, 2009

200MG A078645 004 Jan 27, 2009

WOCKHARDT 25MG A078982 001 Jan 27, 2009

100MG A078982 002 Jan 27, 2009

150MG A078982 003 Jan 27, 2009

200MG A078982 004 Jan 27, 2009

TABLET, CHEWABLE;ORAL

LAMICTAL CD

GLAXOSMITHKLINE LLC 100MG N020764 003 Aug 24, 1998

LAMOTRIGINE

MYLAN 5MG A076630 001 Jan 22, 2009

25MG A076630 002 Jan 22, 2009

SANDOZ 5MG A078409 002 Jan 22, 2009

25MG A078409 003 Jan 22, 2009

TABLET, EXTENDED RELEASE;ORAL

LAMOTRIGINE

HANDA PHARMS LLC 25MG A202887 001 Jun 17, 2013

50MG A202887 002 Jun 17, 2013

LANSOPRAZOLE

FOR SUSPENSION, DELAYED RELEASE;ORAL

PREVACID

TAKEDA PHARMS NA 15MG/PACKET N021281 001 May 03, 2001

30MG/PACKET N021281 002 May 03, 2001

INJECTABLE;INTRAVENOUS

PREVACID IV

+ TAKEDA PHARMS NA 30MG/VIAL ** N021566 001 May 27, 2004

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL



LANSOPRAZOLE

ANI PHARMS INC 15MG A078730 001 Oct 15, 2010

30MG A078730 002 Oct 15, 2010

LANSOPRAZOLE; NAPROXEN

CAPSULE, DELAYED REL PELLETS, TABLET;ORAL

PREVACID NAPRAPAC 250 (COPACKAGED)

+ TAKEDA PHARMS NA 15MG,N/A;N/A,250MG ** N021507 002 Nov 14, 2003



PREVACID NAPRAPAC 375 (COPACKAGED)

TAKEDA PHARMS NA 15MG,N/A;N/A,375MG N021507 003 Nov 14, 2003



PREVACID NAPRAPAC 500 (COPACKAGED)

TAKEDA PHARMS NA 15MG,N/A;N/A,500MG N021507 004 Nov 14, 2003



LANTHANUM CARBONATE

TABLET, CHEWABLE;ORAL

FOSRENOL

SHIRE LLC EQ 250MG BASE N021468 001 Oct 26, 2004

LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX

SOLUTION;TOPICAL

VIRAC REX

CHESEBROUGH PONDS 0.5%;1.8% N011914 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-230(of 393)

** See List Footnote



LATANOPROST

SOLUTION/DROPS;OPHTHALMIC

LATANOPROST

APOTEX INC
0.005%
A077697 001 Mar 22, 2011

LEFLUNOMIDE

TABLET;ORAL

LEFLUNOMIDE

FOSUN PHARMA
10MG
A077087 001 Sep 13, 2005

20MG
A077087 002 Sep 13, 2005

SANDOZ
10MG
A077085 001 Sep 13, 2005

20MG
A077085 002 Sep 13, 2005

LEPIRUDIN RECOMBINANT

INJECTABLE;INJECTION

REFLUDAN

BAYER HLTHCARE
50MG/VIAL
N020807 001 Mar 06, 1998

LETROZOLE

TABLET;ORAL

LETROZOLE

ACTAVIS TOTOWA
2.5MG
A090292 001 Jul 13, 2011

IMPAX LABS
2.5MG
A091638 001 Jun 03, 2011

LANNETT CO INC
2.5MG
A091098 001 Jun 03, 2011

2.5MG
A202048 001 Oct 29, 2014

MYLAN
2.5MG
A078190 001 Dec 24, 2008

SUN PHARM INDS LTD
2.5MG
A091466 001 Jun 03, 2011

SYNTHON PHARMS
2.5MG
A090196 001 Jun 03, 2011

LEUCOVORIN CALCIUM

FOR SOLUTION;ORAL

LEUCOVORIN CALCIUM

HOSPIRA
EQ 60MG BASE/VIAL
N008107 003 Jan 30, 1987

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

ABIC EQ 3MG BASE/ML
A089352 001 Jun 01, 1988

EQ 50MG BASE/VIAL
A089353 001 Jun 01, 1988

ABRAXIS PHARM EQ 50MG BASE/VIAL
A088939 001 Dec 01, 1986

ELKINS SINN EQ 50MG BASE/VIAL
A070480 001 Jan 02, 1987

EQ 100MG BASE/VIAL
A081224 001 Jun 03, 1994

+ HOSPIRA EQ 3MG BASE/ML **
N008107 001

+ EQ 50MG BASE/VIAL **
N008107 002

+ EQ 100MG BASE/VIAL **
N008107 004 May 23, 1988

+ EQ 350MG BASE/VIAL **
N008107 005 Apr 05, 1989

PHARMACHEMIE EQ 350MG BASE/VIAL


A040262 001 Dec 15, 1999

PHARMACHEMIE USA EQ 50MG BASE/VIAL
A089628 001 Apr 17, 1997

EQ 100MG BASE/VIAL
A089915 001 Apr 17, 1997

TEVA PARENTERAL EQ 50MG BASE/VIAL


A081278 001 Sep 28, 1993

LEUCOVORIN CALCIUM PRESERVATIVE FREE

HOSPIRA
EQ 10MG BASE/ML **
A040147 001 Jun 25, 1997

LUITPOLD
EQ 50MG BASE/VIAL
A040338 001 Jan 31, 2001

TEVA PARENTERAL
EQ 10MG BASE/ML
A040332 001 Jun 28, 1999

WELLCOVORIN

GLAXOSMITHKLINE
EQ 5MG BASE/ML
A087439 001 Oct 19, 1982

EQ 25MG BASE/VIAL
A089833 001 Jan 23, 1989

EQ 50MG BASE/VIAL
A089465 001 Jan 23, 1989

EQ 100MG BASE/VIAL
A089834 001 Jan 23, 1989

TABLET;ORAL

LEUCOVORIN CALCIUM

ANI PHARMS INC
EQ 15MG BASE
A075327 001 Mar 24, 1999

EPIC PHARMA LLC
EQ 5MG BASE
A074544 001 Aug 28, 1997

EQ 25MG BASE
A074544 002 Aug 28, 1997

PAR PHARM
EQ 5MG BASE
A071600 001 Oct 14, 1987

EQ 25MG BASE
A071598 001 Oct 14, 1987

PHARMACHEMIE
EQ 5MG BASE
A073099 001 Mar 28, 1997

EQ 25MG BASE
A073101 001 Mar 28, 1997

XANODYNE PHARM
EQ 5MG BASE
N018459 001 Jan 30, 1986

EQ 10MG BASE
A071962 001 Nov 19, 1987

EQ 15MG BASE
A071104 001 Mar 04, 1987

WELLCOVORIN

+ GLAXOSMITHKLINE
EQ 5MG BASE **
N018342 001 Jul 08, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-231(of 393)

** See List Footnote



LEUCOVORIN CALCIUM

TABLET;ORAL

WELLCOVORIN

+ EQ 25MG BASE ** N018342 002 Jul 08, 1983

LEUPROLIDE ACETATE

IMPLANT;IMPLANTATION

VIADUR

ORTHO MCNEIL JANSSEN EQ 65MG BASE N021088 001 Mar 03, 2000

INJECTABLE;INJECTION

LEUPROLIDE ACETATE

GENZYME 1MG/0.2ML A075721 001 Nov 29, 2001

LUPRON

+ ABBVIE ENDOCRINE INC 1MG/0.2ML N019010 001 Apr 09, 1985

LUPRON DEPOT

+ ABBVIE ENDOCRINE INC 3.75MG/VIAL ** N020011 001 Oct 22, 1990

LUPRON DEPOT-PED

+ ABBVIE ENDOCRINE INC 3.75MG/VIAL,7.5MG/VIAL ** N020263 003 Apr 16, 1993

+ 7.5MG/VIAL,7.5MG/VIAL ** N020263 004 Apr 16, 1993



LEVALLORPHAN TARTRATE

INJECTABLE;INJECTION

LORFAN

ROCHE 1MG/ML N010423 001

LEVAMISOLE HYDROCHLORIDE

TABLET;ORAL

ERGAMISOL

JANSSEN PHARMA EQ 50MG BASE N020035 001 Jun 18, 1990

LEVETIRACETAM

SOLUTION;ORAL

LEVETIRACETAM

ACI HEALTHCARE LTD 100MG/ML A078582 001 Jan 15, 2009

APOTEX INC 100MG/ML A090187 001 Aug 05, 2011

TABLET;ORAL

LEVETIRACETAM

ACTAVIS LABS FL INC 250MG A077408 001 Mar 02, 2009

500MG A077408 002 Mar 02, 2009

750MG A077408 003 Mar 02, 2009

FOSUN PHARMA 250MG A077324 001 Jan 15, 2009

500MG A077324 002 Jan 15, 2009

750MG A077324 003 Jan 15, 2009

1GM A077324 004 Jan 15, 2009

MYLAN 250MG A078731 001 Feb 10, 2009

500MG A078731 002 Feb 10, 2009

750MG A078731 003 Feb 10, 2009

1GM A078731 004 Feb 10, 2009

WATSON LABS INC 250MG A078797 002 Jan 15, 2009

500MG A078797 003 Jan 15, 2009

750MG A078797 004 Jan 15, 2009

1GM A078797 001 Jan 15, 2009

TABLET, EXTENDED RELEASE;ORAL

LEVETIRACETAM

MYLAN PHARMS INC 500MG A200475 001 Dec 19, 2011

750MG A200475 002 Dec 19, 2011

1GM A200475 003 Dec 07, 2015

SANDOZ 500MG A091668 001 Nov 01, 2012

750MG A091668 002 Nov 01, 2012

VIRTUS PHARMS 500MG A091291 001 Sep 12, 2011

750MG A091291 002 Sep 12, 2011



LEVOBETAXOLOL HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

BETAXON

ALCON PHARMS LTD EQ 0.5% BASE N021114 001 Feb 23, 2000

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-232(of 393)

** See List Footnote



LEVOBUNOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

LEVOBUNOLOL HYDROCHLORIDE

ALCON LABS INC 0.25% A074851 001 Oct 28, 1996

APOTEX INC 0.25% A075473 001 Aug 03, 2000

0.5% A075475 001 Aug 03, 2000

BAUSCH AND LOMB 0.25% A074307 001 Mar 04, 1994



LEVOBUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CHIROCAINE

PURDUE PHARMA LP EQ 2.5MG BASE/ML N020997 001 Aug 05, 1999

EQ 5MG BASE/ML N020997 002 Aug 05, 1999

EQ 7.5MG BASE/ML N020997 003 Aug 05, 1999



LEVOCABASTINE HYDROCHLORIDE

SUSPENSION/DROPS;OPHTHALMIC

LIVOSTIN

NOVARTIS EQ 0.05% BASE N020219 001 Nov 10, 1993

LEVOCARNITINE

INJECTABLE;INJECTION

LEVOCARNITINE

TEVA PHARMS USA 200MG/ML A075881 001 Mar 29, 2001

SOLUTION;ORAL

CARNITOR

LEADIANT BIOSCI INC 1GM/10ML N018948 002 Apr 27, 1988

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

FOSUN PHARMA 5MG A090486 001 Mar 26, 2013

LEVODOPA

CAPSULE;ORAL

BENDOPA

VALEANT PHARM INTL 100MG N016948 003

250MG N016948 001

500MG N016948 002

DOPAR

SHIRE 100MG N016913 003

250MG N016913 001

500MG N016913 002

LARODOPA

ROCHE 100MG N016912 002

250MG N016912 001

500MG N016912 006

TABLET;ORAL

DOPAR

SHIRE 250MG N016913 004

500MG N016913 005

LARODOPA

ROCHE 100MG N016912 005

250MG N016912 003

500MG N016912 004

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVAQUIN

+ JANSSEN PHARMS EQ 500MG/20ML (EQ 25MG/ML) N020635 001 Dec 20, 1996

+ EQ 750MG/30ML (EQ 25MG/ML) N020635 004 Dec 20, 1996

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

+ JANSSEN PHARMS EQ 250MG/50ML (EQ 5MG/ML) ** N020635 002 Dec 20, 1996

+ EQ 500MG/100ML (EQ 5MG/ML) ** N020635 003 Dec 20, 1996

+ EQ 750MG/150ML (EQ 5MG/ML) ** N020635 005 Dec 20, 1996

LEVOFLOXACIN

AKORN EQ 500MG/20ML (EQ 25MG/ML) A091644 001 Jun 20, 2011

EQ 750MG/30ML (EQ 25MG/ML) A091644 002 Jun 20, 2011

EMCURE PHARMS LTD EQ 500MG/20ML (EQ 25MG/ML) A202590 001 Jan 24, 2013

EQ 750MG/30ML (EQ 25MG/ML) A202590 002 Jan 24, 2013

HOSPIRA INC EQ 500MG/20ML (EQ 25MG/ML) A078577 001 Aug 12, 2015

EQ 750MG/30ML (EQ 25MG/ML) A078577 002 Aug 12, 2015


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-233(of 393)

** See List Footnote



LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN

MYLAN ASI
EQ 500MG/20ML (EQ 25MG/ML)
A200560 001
Jun 20, 2011

EQ 750MG/30ML (EQ 25MG/ML)
A200560 002
Jun 20, 2011

ZYDUS PHARMS USA INC
EQ 500MG/20ML (EQ 25MG/ML)
A205968 001
Jun 01, 2017

EQ 750MG/30ML (EQ 25MG/ML)
A205968 002
Jun 01, 2017

SOLUTION;ORAL

LEVAQUIN

+ JANSSEN PHARMS
250MG/10ML
N021721 001
Oct 21, 2004

SOLUTION/DROPS;OPHTHALMIC

IQUIX

+ SANTEN
1.5% **
N021571 001
Mar 01, 2004

LEVOFLOXACIN

APOTEX INC
0.5%
A078282 001
Dec 20, 2010

QUIXIN

+ SANTEN
0.5% **
N021199 001
Aug 18, 2000

TABLET;ORAL

LEVAQUIN

+ JANSSEN PHARMS
250MG
N020634 001
Dec 20, 1996

+
500MG
N020634 002
Dec 20, 1996

+
750MG
N020634 003
Sep 08, 2000

LEVOFLOXACIN

MYLAN
250MG
A076276 001
Jun 20, 2011

500MG
A076276 002
Jun 20, 2011

750MG
A077097 001
Jun 20, 2011

WATSON LABS INC
250MG
A201484 001
Nov 22, 2013

500MG
A201484 002
Nov 22, 2013

750MG
A201484 003
Nov 22, 2013

LEVOLEUCOVORIN CALCIUM

SOLUTION;INTRAVENOUS

FUSILEV

+ SPECTRUM PHARMS
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
N020140 002
Apr 29, 2011

**

+
EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **
N020140 003
Apr 29, 2011

LEVOMEPROMAZINE

INJECTABLE;INJECTION

LEVOPROME

IMMUNEX
20MG/ML
N015865 001

LEVOMETHADYL ACETATE HYDROCHLORIDE

CONCENTRATE;ORAL

ORLAAM

+ ROXANE 10MG/ML **
N020315 001
Jul 09, 1993

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

SOLVAY 0.05MG/ML;2%
A085010 001

CARBOCAINE W/ NEO-COBEFRIN

EASTMAN KODAK 0.05MG/ML;2%


N012125 002

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

SEPTODONT INC 0.05MG/ML;2%


A084697 001

MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN

BELMORA LLC 0.05MG/ML;2%


A084850 002
Oct 21, 1983

POLOCAINE W/ LEVONORDEFRIN

DENTSPLY PHARM 0.05MG/ML;2%


A089517 001
Apr 14, 1988

LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN

EASTMAN KODAK 0.05MG/ML;2%;0.4%


N008592 007

LEVONORGESTREL

IMPLANT;IMPLANTATION

JADELLE

+ POPULATION COUNCIL 75MG/IMPLANT **
N020544 001
Nov 01, 1996

LEVONORGESTREL

WYETH PHARMS INC 75MG/IMPLANT
N020627 001
Aug 15, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-234(of 393)

** See List Footnote



LEVONORGESTREL

IMPLANT;IMPLANTATION

NORPLANT

POPULATION COUNCIL 36MG/IMPLANT N019897 001 Dec 10, 1990

NORPLANT SYSTEM IN PLASTIC CONTAINER

WYETH PHARMS INC 36MG/IMPLANT N020088 001 Dec 10, 1990

TABLET;ORAL

LEVONORGESTREL

FDN CONSUMER 0.75MG ** A078665 001 Aug 28, 2009

LUPIN LTD 0.75MG A091328 001 Jan 23, 2013



WATSON LABS 0.75MG A078666 001 Jun 24, 2009

PLAN B

+ FDN CONSUMER 0.75MG ** N021045 001 Jul 28, 1999

+ 0.75MG ** N021045 002 Aug 24, 2006

LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS

CAPSULE;ORAL

NOVRAD

LILLY EQ 50MG BASE N012928 006

EQ 100MG BASE N012928 004

SUSPENSION;ORAL

NOVRAD

LILLY EQ 50MG BASE/5ML N012928 002

LEVORPHANOL TARTRATE

INJECTABLE;INJECTION

LEVO-DROMORAN

VALEANT PHARM INTL 2MG/ML N008719 001 Dec 19, 1991

TABLET;ORAL

LEVO-DROMORAN

+ VALEANT PHARM INTL 2MG ** N008720 001 Dec 19, 1991

LEVOTHYROXINE SODIUM

SOLUTION;ORAL

TIROSINT-SOL

+ INSTITUT BIOCHIMIQUE 13MCG/ML N206977 001 Dec 15, 2016
+ 25MCG/ML N206977 002 Dec 15, 2016
+ 50MCG/ML N206977 003 Dec 15, 2016
+ 75MCG/ML N206977 004 Dec 15, 2016
+ 88MCG/ML N206977 005 Dec 15, 2016
+ 100MCG/ML N206977 006 Dec 15, 2016
+ 112MCG/ML N206977 007 Dec 15, 2016
+ 125MCG/ML N206977 008 Dec 15, 2016
+ 137MCG/ML N206977 009 Dec 15, 2016
+ 150MCG/ML N206977 010 Dec 15, 2016
+ 175MCG/ML N206977 011 Dec 15, 2016
+ 200MCG/ML N206977 012 Dec 15, 2016
TABLET;ORAL
EUTHYROX
PROVELL 0.3MG N021292 012 May 31, 2002
LEVOLET
GENUS LIFESCIENCES 0.025MG N021137 001 Jun 06, 2003
0.05MG N021137 002 Jun 06, 2003
0.075MG N021137 003 Jun 06, 2003
0.088MG N021137 004 Jun 06, 2003
0.1MG N021137 005 Jun 06, 2003
0.112MG N021137 006 Jun 06, 2003
0.125MG N021137 007 Jun 06, 2003
0.137MG N021137 008 Jun 06, 2003
0.15MG N021137 009 Jun 06, 2003
0.175MG N021137 010 Jun 06, 2003
0.2MG N021137 011 Jun 06, 2003
0.3MG N021137 012 Jun 06, 2003
LEVOTHYROXINE SODIUM
MERCK KGAA 0.025MG A076752 001 Jun 16, 2005
0.05MG A076752 002 Jun 16, 2005
0.075MG A076752 003 Jun 16, 2005
0.088MG A076752 004 Jun 16, 2005
0.1MG A076752 005 Jun 16, 2005
0.112MG A076752 006 Jun 16, 2005
0.125MG A076752 007 Jun 16, 2005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-235(of 393)

** See List Footnote



LEVOTHYROXINE SODIUM

TABLET;ORAL

LEVOTHYROXINE SODIUM

0.15MG
A076752 008 Jun 16, 2005

0.175MG
A076752 009 Jun 16, 2005

0.2MG
A076752 010 Jun 16, 2005

0.3MG
A076752 011 Jun 16, 2005

LEVOXYL

+ KING PHARMS
0.3MG **
N021301 012 May 25, 2001

THYRO-TABS

+ LLOYD
0.025MG **
N021116 001 Oct 24, 2002

+
0.05MG **
N021116 002 Oct 24, 2002

+
0.075MG **
N021116 003 Oct 24, 2002

+
0.088MG **
N021116 010 Oct 24, 2002

+
0.1MG **
N021116 004 Oct 24, 2002

+
0.112MG **
N021116 011 Oct 24, 2002

+
0.125MG **
N021116 005 Oct 24, 2002

+
0.137MG **
N021116 012 Dec 07, 2004

+
0.15MG **
N021116 006 Oct 24, 2002

+
0.175MG **
N021116 007 Oct 24, 2002

+
0.2MG **
N021116 008 Oct 24, 2002

+
0.3MG **
N021116 009 Oct 24, 2002

LIDOCAINE

AEROSOL;ORAL

XYLOCAINE

ASTRAZENECA
10%
N014394 001

FILM, EXTENDED RELEASE;BUCCAL

DENTIPATCH

NOVEN
23MG/PATCH
N020575 001 May 21, 1996

OINTMENT;TOPICAL

ALPHACAINE

CARLISLE
5%
A084944 001

5%
A084946 001

5%
A084947 001

LIDOCAINE

BELMORA LLC
5%
A080210 001

XYLOCAINE

+ ASTRAZENECA
5% **
N008048 001

PATCH;TOPICAL

DENTIPATCH

NOVEN
46.1MG/PATCH
N020575 002 May 21, 1996

SOLUTION;TOPICAL

XYLOCAINE

ASTRAZENECA
5%
N014127 001

SUPPOSITORY;RECTAL

XYLOCAINE

ASTRAZENECA
100MG
N013077 001

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ALPHACAINE HYDROCHLORIDE

CARLISLE
2%
A084721 001

LIDOCAINE HYDROCHLORIDE

ABBOTT
10%
A087980 001 Feb 02, 1983

20%
A089362 001 May 25, 1988

ABRAXIS PHARM
1%
A080420 001

1%
A086761 001

1.5%
A080420 005

2%
A080420 002

2%
A080420 004

2%
A086761 002

2%
N017508 001

4%
N017508 002

20%
N017508 004

AKORN
1%
A085037 001

2%
A085037 002

BEL MAR
1%
A080710 001

2%
A080760 001

BELMORA LLC
2%
A080504 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-236(of 393)

** See List Footnote



LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE

DELL LABS
1%
A083387 001

2%
A083388 001

ELKINS SINN
0.5%
A085131 001

4%
A084626 001

GD SEARLE LLC
1%
A083135 001

2%
A083135 002

HOSPIRA
1%
A040013 001 Jun 23, 1995

1.5%
A088330 001 May 17, 1984

2%
A088331 001 May 17, 1984

INTL MEDICATION
1%
N017701 002

2%
N017701 001

1GM/VIAL
N018543 001

2GM/VIAL
N018543 002

LUITPOLD
2%
A083198 001

LYPHOMED
1%
A080390 001

2%
A080390 002

MILES
1%
A080414 001

2%
A080414 002

MYLAN LABS LTD
0.5%
A091056 001 Dec 08, 2010

0.5%
A091058 001 Sep 30, 2010

1%
A091056 002 Dec 08, 2010

1%
A091058 002 Sep 30, 2010

2%
A202242 001 Apr 11, 2014

WATSON LABS
1%
A080377 001

1%
A083627 001

2%
A080377 002

2%
A083627 002

WEST-WARD PHARMS INT 1%
A080407 001

2%
A080407 002

WYETH AYERST 1%
A083083 001

2%
A083083 002

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 100MG/100ML
N018461 001

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 200MG/100ML
N018967 001 Mar 30, 1984

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%

HOSPIRA 200MG/100ML
A083158 005

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBOTT 200MG/100ML
N018954 001 Jul 09, 1985

HOSPIRA 200MG/100ML
N018388 001

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 400MG/100ML
N018967 002 Mar 30, 1984

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

HOSPIRA 400MG/100ML
A083158 006

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA 400MG/100ML
N018388 002

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 800MG/100ML
N018967 003 Mar 30, 1984

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA 800MG/100ML
N018388 003 Nov 05, 1982

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

HOSPIRA 1.5%
A088326 001 Jul 31, 1984

10%
A088367 001 Jul 31, 1984

20%
A088368 001 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

INTL MEDICATION 4%
N017702 002

20%
N017702 001

MYLAN LABS LTD 2%
A090665 001 Sep 27, 2010

WEST-WARD PHARMS INT 1%


A084625 001

2%
A084625 002

LIDOCATON

PHARMATON 2%
A084727 001 Aug 17, 1983

LIDOPEN

MERIDIAN MEDCL TECHN 10%
N017549 001

XYLOCAINE

ASTRAZENECA 1%
N010418 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-237(of 393)

** See List Footnote



LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

XYLOCAINE

1.5%
N010418 009

2%
N010418 007

XYLOCAINE 4% PRESERVATIVE FREE

+ FRESENIUS KABI USA 4%
N010417 001

XYLOCAINE DENTAL

DENTSPLY PHARM 2%
N021380 001

XYLOCAINE PRESERVATIVE FREE

FRESENIUS KABI USA 10%
N016801 003

INJECTABLE;SPINAL

XYLOCAINE 1.5% W/ DEXTROSE 7.5%

FRESENIUS KABI USA 1.5%


N016297 001

XYLOCAINE 5% W/ GLUCOSE 7.5%

ASTRAZENECA 5%
N010496 002 Jul 07, 1982

JELLY;TOPICAL

ANESTACON

BLUEPHARMA 2%
A080429 001

LIDOCAINE HYDROCHLORIDE

G AND W LABS INC 2%
A081318 001 Apr 29, 1993

WATSON LABS INC 2%


A040837 001 Mar 23, 2011

SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE VISCOUS

ACTAVIS MID ATLANTIC 2%
A086578 001

INTL MEDICATION 2%
A086389 001 Feb 02, 1982

XYLOCAINE VISCOUS

FRESENIUS KABI USA 2% **
N009470 001

SOLUTION;TOPICAL

LARYNGOTRACHEAL ANESTHESIA KIT

KENDALL IL 4%
A087931 001 Jun 10, 1983

LIDOCAINE HYDROCHLORIDE

LANNETT CO INC 4%
A040710 001 Feb 27, 2007

PACO 4%
A089688 001 Jun 30, 1989

WOCKHARDT BIO AG 4%
A087881 001 Nov 18, 1982

LTA II KIT

HOSPIRA 4%
A080409 001

4%
A088542 001 Jul 31, 1984

PEDIATRIC LTA KIT

ABBOTT 2%
A088572 001 Jul 31, 1984

HOSPIRA 2%
A085995 001

XYLOCAINE 4% PRESERVATIVE FREE

+ FRESENIUS KABI USA 4%
N010417 002

LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE

INJECTABLE;INJECTION

TERRAMYCIN

PFIZER 2%;50MG/ML
A060567 001

2%;125MG/ML
A060567 002

LIDOCAINE; PRILOCAINE

DISC;TOPICAL

EMLA

ASTRAZENECA 2.5%;2.5%
N020962 001 Feb 04, 1998

LINCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

LINCOCIN

PHARMACIA AND UPJOHN EQ 250MG BASE
N050316 001

EQ 500MG BASE
N050316 002

INJECTABLE;INJECTION

LINCOMYCIN HYDROCHLORIDE

WATSON LABS EQ 300MG BASE/ML
A063180 001 Apr 16, 1991

LINDANE

CREAM;TOPICAL

KWELL

REED AND CARNRICK 1%
A084218 001

1%
N006309 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-238(of 393)

** See List Footnote



LINDANE

LOTION;TOPICAL

GAMENE

SOLA BARNES HIND
1%
A084989 001

KWELL

REED AND CARNRICK
1%
A084218 002

1%
N006309 003

LINDANE

WOCKHARDT
1%
A088190 001 Aug 16, 1984

SCABENE

STIEFEL
1%
A086769 001

SHAMPOO;TOPICAL

GAMENE

SOLA BARNES HIND
1%
A084988 001

KWELL

REED AND CARNRICK
1%
A084219 001

1%
N010718 001

SCABENE

STIEFEL
1%
A087940 001 Apr 08, 1983

LINEZOLID

SOLUTION;INTRAVENOUS

ZYVOX

+ PHARMACIA AND UPJOHN
400MG/200ML (2MG/ML)
N021131 002 Apr 18, 2000

TABLET;ORAL

ZYVOX

+ PHARMACIA AND UPJOHN
400MG **
N021130 001 Apr 18, 2000

LIOTHYRONINE SODIUM

TABLET;ORAL

LIOTHYRONINE SODIUM

WATSON LABS
EQ 0.025MG BASE
A085755 001 Jan 25, 1982

EQ 0.05MG BASE
A085753 001 Feb 03, 1982

LIOTRIX (T4;T3)

TABLET;ORAL

EUTHROID-0.5

PARKE DAVIS
0.03MG;0.0075MG
N016680 001

EUTHROID-1

PARKE DAVIS
0.06MG;0.015MG
N016680 002

EUTHROID-2

PARKE DAVIS
0.12MG;0.03MG
N016680 003

EUTHROID-3

PARKE DAVIS
0.18MG;0.045MG
N016680 004

THYROLAR-0.25

+ ALLERGAN SALES LLC
0.0125MG;0.0031MG
N016807 001

THYROLAR-0.5

+ ALLERGAN SALES LLC
0.025MG;0.0063MG
N016807 005

THYROLAR-1

+ ALLERGAN SALES LLC
0.05MG;0.0125MG
N016807 004

THYROLAR-2

+ ALLERGAN SALES LLC
0.1MG;0.025MG
N016807 002

THYROLAR-3

+ ALLERGAN SALES LLC
0.15MG;0.0375MG
N016807 003

THYROLAR-5

ALLERGAN SALES LLC
0.25MG;0.0625MG
N016807 006

LISINOPRIL

TABLET;ORAL

LISINOPRIL

SANDOZ
2.5MG
A075903 001 Jul 01, 2002

2.5MG
A075999 001 Jul 01, 2002

5MG
A075903 002 Jul 01, 2002

5MG
A075999 002 Jul 01, 2002

10MG
A075903 003 Jul 01, 2002

10MG
A075999 003 Jul 01, 2002

20MG
A075903 004 Jul 01, 2002

20MG
A075999 004 Jul 01, 2002

30MG
A075903 005 Jul 01, 2002

30MG
A075999 005 Jul 01, 2002

40MG
A075903 006 Jul 01, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-239(of 393)

** See List Footnote



LISINOPRIL

TABLET;ORAL

LISINOPRIL

40MG A075999 006 Jul 01, 2002

TEVA 2.5MG A075783 001 Jul 01, 2002

5MG A075783 002 Jul 01, 2002

10MG A075783 003 Jul 01, 2002

20MG A075783 004 Jul 01, 2002

30MG A075783 005 Jul 01, 2002

40MG A075783 006 Jul 01, 2002

PRINIVIL

MERCK 2.5MG N019558 006 Jan 28, 1994

LITHIUM CARBONATE

CAPSULE;ORAL

ESKALITH

NOVEN THERAP 300MG N016860 001

LITHIUM CARBONATE

ABLE 150MG A076823 001 Jun 29, 2004

300MG A076121 001 Sep 27, 2001

300MG A076823 002 Jun 29, 2004



600MG A076823 003 Jun 29, 2004

APOTEX INC 300MG A076795 001 Nov 22, 2004

USL PHARMA 300MG A072542 001 Feb 01, 1989

WATSON LABS 300MG A070407 001 Mar 19, 1987

LITHONATE

SOLVAY 300MG N016782 001

TABLET;ORAL

ESKALITH

JDS PHARMS 300MG N017971 001

LITHANE

BAYER PHARMS 300MG N018833 001 Jul 18, 1985

LITHIUM CARBONATE

HIKMA INTL PHARMS 300MG A078715 001 Dec 28, 2010

PFIZER 300MG N016834 001

LITHOTABS

SOLVAY 300MG N016980 001

TABLET, EXTENDED RELEASE;ORAL

ESKALITH CR

JDS PHARMS 450MG ** N018152 001 Mar 29, 1982

LITHIUM CARBONATE

ABLE 300MG A076382 001 Apr 21, 2003

BARR 300MG A076170 001 Jun 10, 2002



450MG A076366 001 Aug 21, 2003

HIKMA INTL PHARMS 450MG A076490 001 Jun 17, 2003



LITHIUM CITRATE

SYRUP;ORAL

LITHONATE

SOLVAY EQ 300MG CARBONATE/5ML N017672 001

LOMEFLOXACIN HYDROCHLORIDE

TABLET;ORAL

MAXAQUIN

PHARMACIA EQ 400MG BASE N020013 001 Feb 21, 1992

LOMUSTINE

CAPSULE;ORAL

GLEOSTINE

+ CORDEN PHARMA 5MG N017588 004 Dec 19, 2014

LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL

IMODIUM

J AND J CONSUMER INC 2MG ** N017690 001

+ 2MG ** N017694 001

LOPERAMIDE HYDROCHLORIDE

ROXANE 2MG A073080 001 Nov 27, 1991

TEVA 2MG A073122 001 Aug 30, 1991

YAOPHARMA CO LTD 2MG A072993 001 Aug 28, 1992


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-240(of 393)

** See List Footnote



LOPERAMIDE HYDROCHLORIDE

SOLUTION;ORAL

IMODIUM

JANSSEN PHARMS 1MG/5ML N019037 001 Jul 31, 1984

LOPERAMIDE HYDROCHLORIDE

ALLIED 1MG/5ML A073079 001 Apr 30, 1992

ALPHARMA US PHARMS 1MG/5ML A073187 001 Sep 15, 1992

DURAMED PHARMS BARR 1MG/5ML A074991 001 Dec 29, 1997



TEVA 1MG/5ML A073478 001 Jun 23, 1995

WATSON LABS 1MG/5ML A073062 001 May 28, 1993

TABLET;ORAL

LOPERAMIDE HYDROCHLORIDE

ABLE 2MG A073528 001 Nov 30, 1993

CONTRACT PHARMACAL 2MG A073254 001 Jul 30, 1993

PERRIGO 2MG A074194 001 Oct 30, 1992

TABLET, CHEWABLE;ORAL

IMODIUM A-D EZ CHEWS

+ J AND J CONSUMER INC 2MG N020448 001 Jul 24, 1997

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET, CHEWABLE;ORAL

IMODIUM MULTI-SYMPTOM RELIEF

+ J AND J CONSUMER INC 2MG;125MG N020606 001 Jun 26, 1996

LOPINAVIR; RITONAVIR

CAPSULE;ORAL

KALETRA

ABBVIE 133.3MG;33.3MG N021226 001 Sep 15, 2000

LORACARBEF

CAPSULE;ORAL

LORABID

KING PHARMS 200MG N050668 001 Dec 31, 1991

400MG N050668 002 Apr 05, 1996

FOR SUSPENSION;ORAL

LORABID

KING PHARMS 100MG/5ML N050667 001 Dec 31, 1991

200MG/5ML N050667 002 Dec 31, 1991

LORATADINE

SYRUP;ORAL

CLARITIN HIVES RELIEF

+ BAYER HEALTHCARE LLC 1MG/ML ** N020641 003 Nov 19, 2003

LORATADINE

APOTEX INC 1MG/ML A075565 001 Oct 05, 2004

RANBAXY LABS LTD 1MG/ML A076529 001 Aug 20, 2004

TABLET;ORAL

LORATADINE

PERRIGO 10MG N021512 001 Jun 24, 2004

LORATADINE; PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

LORATADINE AND PSEUDOEPHEDRINE SULFATE

ACTAVIS LABS FL INC 5MG;120MG A076208 001 Jan 28, 2004

LORAZEPAM

INJECTABLE;INJECTION

LORAZEPAM

AKORN 2MG/ML A074974 001 Jul 23, 1998

BEDFORD 2MG/ML A077076 001 Jul 13, 2005

4MG/ML A077076 002 Jul 13, 2005

DAVA PHARMS INC 2MG/ML A074793 001 Mar 16, 2000

4MG/ML A074793 002 Mar 16, 2000

HOSPIRA 2MG/ML A074280 001 May 27, 1994

2MG/ML A074300 001 Apr 12, 1994

4MG/ML A074280 002 May 27, 1994

4MG/ML A074300 003 Mar 19, 1997



MYLAN ASI 2MG/ML A200217 001 Apr 04, 2017

2MG/ML A200542 001 Apr 28, 2017

4MG/ML A200217 002 Apr 04, 2017

4MG/ML A200542 002 Apr 28, 2017

WATSON LABS 2MG/ML A074276 001 Apr 15, 1994


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-241(of 393)

** See List Footnote



LORAZEPAM

INJECTABLE;INJECTION

LORAZEPAM

4MG/ML A074276 002 Apr 15, 1994

WATSON LABS INC 1MG/0.5ML A074551 003 Sep 12, 1996

2MG/ML A074535 001 Sep 12, 1996

2MG/ML A074551 001 Sep 12, 1996

4MG/ML A074535 002 Sep 12, 1996

4MG/ML A074551 002 Sep 12, 1996

WEST-WARD PHARMS INT 2MG/ML A074496 001 Sep 28, 1998

4MG/ML A074496 002 Sep 28, 1998

LORAZEPAM PRESERVATIVE FREE



BEDFORD LABS 2MG/ML A077074 001 Jul 13, 2005

4MG/ML A077074 002 Jul 13, 2005

SOLUTION;ORAL

LORAZEPAM

ROXANE 0.5MG/5ML A074648 001 Mar 18, 1997

TABLET;ORAL

LORAZ

QUANTUM PHARMICS 0.5MG A070200 001 Aug 09, 1985

1MG A070201 001 Aug 09, 1985

2MG A070202 001 Aug 09, 1985

LORAZEPAM

AM THERAP 0.5MG A070727 001 Mar 07, 1986

1MG A070728 001 Mar 07, 1986

2MG A070729 001 Mar 07, 1986

ANDA REPOSITORY 0.5MG A072555 002 Mar 29, 1991

1MG A072555 003 Mar 29, 1991

2MG A072555 001 Mar 29, 1991

HALSEY 0.5MG A071434 001 Sep 01, 1987

1MG A071435 001 Sep 01, 1987

2MG A071436 001 Sep 01, 1987

MUTUAL PHARM 0.5MG A070472 001 Dec 10, 1985



1MG A070473 001 Dec 10, 1985

2MG A070474 001 Dec 10, 1985

MYLAN 0.5MG A071591 002 Oct 13, 1987

1MG A071591 003 Oct 13, 1987

2MG A071591 001 Oct 13, 1987

PAR PHARM 0.5MG A070675 001 Dec 01, 1986

1MG A070676 001 Dec 01, 1986

2MG A070677 001 Dec 01, 1986

SANDOZ 0.5MG A071193 001 Apr 15, 1988

1MG A071194 001 Apr 15, 1988

2MG A071195 001 Apr 15, 1988

SUN PHARM INDS LTD 0.5MG A076045 001 Aug 29, 2001

1MG A076045 002 Aug 29, 2001

2MG A076045 003 Aug 29, 2001

SUPERPHARM 0.5MG A071245 001 Feb 09, 1987



1MG A071246 001 Feb 09, 1987

2MG A071247 001 Feb 09, 1987

USL PHARMA 1MG A070539 001 Dec 22, 1986

2MG A070540 001 Dec 22, 1986

WARNER CHILCOTT 1MG A071038 001 Jan 12, 1988

2MG A071039 001 Jan 12, 1988

WATSON LABS 0.5MG A071086 001 Mar 23, 1987

0.5MG A071117 001 Jul 24, 1986

1MG A071087 001 Mar 23, 1987

1MG A071118 001 Jul 24, 1986

2MG A071088 001 Mar 23, 1987

2MG A071110 001 Jul 24, 1986

LOSARTAN POTASSIUM

TABLET;ORAL

COZAAR

+ MERCK SHARP DOHME 25MG N020386 001 Apr 14, 1995

+ 50MG N020386 002 Apr 14, 1995

LOSARTAN POTASSIUM

APOTEX CORP 25MG A090790 001 Oct 06, 2010

50MG A090790 002 Oct 06, 2010

100MG A090790 003 Oct 06, 2010

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-242(of 393)

** See List Footnote



LOTEPREDNOL ETABONATE

SUSPENSION/DROPS;OPHTHALMIC

LOTEMAX

PHARMOS
0.5%
N020841 001 Mar 09, 1998

LOVASTATIN

TABLET;ORAL

LOVASTATIN

MYLAN
10MG
A075935 001 Dec 17, 2001

20MG
A075935 002 Dec 17, 2001

40MG
A075935 003 Dec 17, 2001

MEVACOR

+ MERCK
10MG **
N019643 002 Mar 28, 1991

+
20MG **
N019643 003 Aug 31, 1987

+
40MG **
N019643 004 Dec 14, 1988

TABLET, EXTENDED RELEASE;ORAL

ALTOPREV

COVIS PHARMA BV
10MG
N021316 001 Jun 26, 2002

LOXAPINE HYDROCHLORIDE

CONCENTRATE;ORAL

LOXITANE C

ACTAVIS LABS UT INC
EQ 25MG BASE/ML
N017658 001

INJECTABLE;INJECTION

LOXITANE IM

ACTAVIS LABS UT INC
EQ 50MG BASE/ML
N018039 001

LOXAPINE SUCCINATE

CAPSULE;ORAL

LOXITANE

+ ACTAVIS LABS UT INC
EQ 5MG BASE **
N017525 001

+
EQ 10MG BASE **
N017525 002

+
EQ 25MG BASE **
N017525 003

+
EQ 50MG BASE **
N017525 004

TABLET;ORAL

LOXITANE

+ ACTAVIS LABS UT INC
EQ 10MG BASE **
N017525 006

+
EQ 25MG BASE **
N017525 007

+
EQ 50MG BASE **
N017525 008

LUCINACTANT

SUSPENSION;INTRATRACHEAL

SURFAXIN

WINDTREE THERAP
8.5ML
N021746 001 Mar 06, 2012

LUTROPIN ALFA

INJECTABLE;SUBCUTANEOUS

LUVERIS

EMD SERONO
75 IU/VIAL
N021322 001 Oct 08, 2004

LYPRESSIN

SOLUTION;NASAL

DIAPID

NOVARTIS
0.185MG/ML
N016755 001

MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

INJECTABLE;INJECTION

PLASMA-LYTE 56 IN PLASTIC CONTAINER

BAXTER HLTHCARE 32MG/100ML;128MG/100ML;234MG/100ML
N019047 001 Jun 15, 1984

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM

CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE



INJECTABLE;INJECTION

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER

B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019006 001 Apr 04, 1984

G/100ML;530MG/100ML;500MG/100ML;12MG/10

0ML

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-243(of 393)

** See List Footnote



MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION

ISOLYTE S IN PLASTIC CONTAINER

B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N018252 001

/100ML;500MG/100ML

SOLUTION;IRRIGATION

PHYSIOSOL IN PLASTIC CONTAINER

HOSPIRA INC 14MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 001

/100ML;502MG/100ML

PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER



HOSPIRA INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 002 Jul 08, 1982

/100ML;502MG/100ML

SYNOVALYTE IN PLASTIC CONTAINER



BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N019326 001 Jan 25, 1985

/100ML;502MG/100ML

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

TABLET;ORAL

MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

SANTARUS 343MG;20MG;750MG N022456 001 Dec 04, 2009

343MG;40MG;750MG N022456 002 Dec 04, 2009

TABLET, CHEWABLE;ORAL

ZEGERID

SANTARUS 700MG;20MG;600MG N021850 001 Mar 24, 2006

700MG;40MG;600MG N021850 002 Mar 24, 2006

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

BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE



SOLUTION;ORAL
SUCLEAR
+ BRAINTREE LABS 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A N203595 001 Jan 18, 2013
,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86G
M,5.6GM **
MALATHION
LOTION;TOPICAL
MALATHION
MYLAN PHARMS INC 0.5% A078743 001 Mar 06, 2009
MANGAFODIPIR TRISODIUM
INJECTABLE;INJECTION
TESLASCAN
IC TARGETS 37.9MG/ML N020652 001 Nov 26, 1997
MANGANESE CHLORIDE TETRAHYDRATE

FOR SOLUTION;ORAL

LUMENHANCE

BRACCO 3.49MG/GM N020686 001 Dec 19, 1997

MANGANESE SULFATE

INJECTABLE;INJECTION

MANGANESE SULFATE

ABRAXIS PHARM EQ 0.1MG MANGANESE/ML N019228 001 May 05, 1987

MANNITOL

INJECTABLE;INJECTION

MANNITOL 10%

B BRAUN 10GM/100ML N016080 002

HOSPIRA 10GM/100ML N016269 002

MILES 10GM/100ML N016472 002

MANNITOL 10% IN PLASTIC CONTAINER

ICU MEDICAL INC 10GM/100ML N019603 002 Jan 08, 1987

MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER

B BRAUN 10GM/100ML N016080 006



MANNITOL 15%

B BRAUN 15GM/100ML N016080 003

HOSPIRA 15GM/100ML N016269 003

MILES 15GM/100ML N016472 005

MANNITOL 15% IN PLASTIC CONTAINER

ICU MEDICAL INC 15GM/100ML N019603 003 Jan 08, 1990

MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%

B BRAUN 15GM/100ML N016080 005


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-244(of 393)

** See List Footnote



MANNITOL

INJECTABLE;INJECTION

MANNITOL 20%

B BRAUN
20GM/100ML
N014738 001

20GM/100ML
N016080 004

HOSPIRA
20GM/100ML
N016269 004

MILES
20GM/100ML
N016472 004

MANNITOL 25%

ABRAXIS PHARM
12.5GM/50ML
A086754 001

HOSPIRA
12.5GM/50ML
N016269 005

IGI LABS INC
12.5GM/50ML
A089239 001 May 06, 1987

12.5GM/50ML
A089240 001 May 06, 1987

MERCK
12.5GM/50ML
N005620 001

WATSON LABS
12.5GM/50ML
A087460 001 Jun 27, 1983

MANNITOL 5%

B BRAUN
5GM/100ML
N016080 001

HOSPIRA
5GM/100ML
N016269 001

MANNITOL 5% IN PLASTIC CONTAINER

ICU MEDICAL INC 5GM/100ML
N019603 001 Jan 08, 1987

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

B BRAUN 5GM/100ML
N016080 007

SOLUTION;IRRIGATION

RESECTISOL

B BRAUN 5GM/100ML
N016704 002

MANNITOL; SORBITOL

SOLUTION;IRRIGATION

SORBITOL-MANNITOL

HOSPIRA 540MG/100ML;2.7GM/100ML
A080224 001

SORBITOL-MANNITOL IN PLASTIC CONTAINER

HOSPIRA
540MG/100ML;2.7GM/100ML
N017636 001

MAPROTILINE HYDROCHLORIDE

TABLET;ORAL

LUDIOMIL

NOVARTIS
25MG
N017543 001

50MG
N017543 002

75MG
N017543 003 Sep 30, 1982

MAPROTILINE HYDROCHLORIDE

AM THERAP
25MG
A072129 001 Jan 14, 1988

50MG
A072130 001 Jan 14, 1988

75MG
A072131 001 Jan 14, 1988

WATSON LABS
25MG
A071943 001 Dec 30, 1987

50MG
A071944 001 Dec 30, 1987

75MG
A071945 001 Dec 30, 1987

75MG
A072164 001 Jun 01, 1988

WATSON LABS TEVA
25MG
A072162 001 Jun 01, 1988

50MG
A072163 001 Jun 01, 1988

MASOPROCOL

CREAM;TOPICAL

ACTINEX

UNIV AZ CANCER CTR
10%
N019940 001 Sep 04, 1992

MAZINDOL

TABLET;ORAL

MAZANOR

WYETH AYERST
1MG
N017980 002

2MG
N017980 001

SANOREX

+ HEXIM
1MG **
N017247 001

+
2MG **
N017247 002

MEBENDAZOLE

TABLET, CHEWABLE;ORAL

VERMOX

+ JANSSEN PHARMS
100MG **
N017481 001

+
500MG
N208398 001 Oct 19, 2016

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-245(of 393)

** See List Footnote



MEBUTAMATE

TABLET;ORAL

DORMATE

MEDPOINTE PHARM HLC 600MG
N017374 001

MECAMYLAMINE HYDROCHLORIDE

TABLET;ORAL

INVERSINE

+ TARGACEPT 2.5MG **
N010251 001

MECASERMIN RINFABATE RECOMBINANT

INJECTABLE;SUBCUTANEOUS

IPLEX

INSMED
36MG/0.6ML
N021884 001 Dec 12, 2005

MECHLORETHAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

MUSTARGEN

+ RECORDATI RARE
10MG/VIAL
N006695 001

MECLIZINE HYDROCHLORIDE

TABLET;ORAL

ANTIVERT

CASPER PHARMA LLC
12.5MG
N010721 006

25MG
N010721 004

50MG
N010721 001 Jan 20, 1982

MECLIZINE HYDROCHLORIDE

ABC HOLDING
12.5MG
A085253 001

25MG
A085252 001

AMNEAL PHARMS
50MG
A201451 003 Feb 23, 2011

ANABOLIC
25MG
A085891 001

ANI PHARMS INC
12.5MG
A084975 001

25MG
A084657 001

BUNDY
12.5MG
A084382 001

25MG
A084872 001

IVAX SUB TEVA PHARMS 12.5MG
A083784 001

KV PHARM
12.5MG
A085524 001

25MG
A085523 001

MYLAN PHARMS INC
50MG
A202640 003 Sep 17, 2012

PAR PHARM
50MG
A089674 001 Mar 31, 1988

PLIVA
12.5MG
A088732 001 Dec 11, 1985

25MG
A088734 001 Dec 11, 1985

RISING PHARMS
12.5MG
A040179 001 Jan 30, 1997

25MG
A040179 002 Jan 30, 1997

SUPERPHARM
12.5MG
A089113 001 Aug 20, 1985

25MG
A089114 001 Aug 20, 1985

UDL
12.5MG
A088256 001 Jun 13, 1983

25MG
A088257 001 Jun 13, 1983

VANGARD
12.5MG
A087877 001 Apr 20, 1982

25MG
A087620 001 Jan 04, 1982

WATSON LABS
12.5MG
A085195 001

12.5MG
A085269 001

25MG
A085740 001

TABLET, CHEWABLE;ORAL

ANTIVERT

CASPER PHARMA LLC
25MG
N010721 005

MECLIZINE HYDROCHLORIDE

IVAX SUB TEVA PHARMS 25MG
A084976 001

NEXGEN PHARMA INC
25MG
A086392 001

PLIVA
25MG
A088733 001 Dec 11, 1985

MECLOCYCLINE SULFOSALICYLATE

CREAM;TOPICAL

MECLAN

JOHNSON AND JOHNSON
1%
N050518 001

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

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DISCONTINUED DRUG PRODUCT LIST 6-246(of 393)

** See List Footnote



MECLOFENAMATE SODIUM

CAPSULE;ORAL

MECLODIUM

QUANTUM PHARMICS EQ 50MG BASE A071380 001 Jul 14, 1987

EQ 100MG BASE A071381 001 Jul 14, 1987

MECLOFENAMATE SODIUM

AM THERAP EQ 50MG BASE A071362 001 Feb 10, 1987

EQ 100MG BASE A071363 001 Feb 10, 1987

BARR EQ 50MG BASE A072848 001 Mar 20, 1989

EQ 100MG BASE A072809 001 Mar 20, 1989

FOSUN PHARMA EQ 50MG BASE A072262 001 Nov 29, 1988

EQ 100MG BASE A072263 001 Nov 29, 1988

PAR PHARM EQ 50MG BASE A072077 001 Mar 10, 1988

EQ 100MG BASE A072078 001 Mar 10, 1988

USL PHARMA EQ 50MG BASE A071007 001 Mar 25, 1988

EQ 100MG BASE A071008 001 Mar 25, 1988

VITARINE EQ 50MG BASE A071710 001 Jun 15, 1988

EQ 100MG BASE A071684 001 Jun 15, 1988

WATSON LABS EQ 50MG BASE A070400 001 Nov 25, 1986

EQ 50MG BASE A071468 001 Apr 15, 1987

EQ 50MG BASE A071640 001 Aug 11, 1987

EQ 100MG BASE A070401 001 Nov 25, 1986



EQ 100MG BASE A071641 001 Aug 11, 1987

WATSON LABS TEVA EQ 100MG BASE A071469 001 Apr 15, 1987

MECLOMEN

PARKE DAVIS EQ 50MG BASE N018006 001

EQ 100MG BASE N018006 002

MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

DEPO-PROVERA

+ PHARMACIA AND UPJOHN 100MG/ML ** N012541 002

MEDROXYPROGESTERONE ACETATE

SANDOZ INC 150MG/ML A078711 001 May 20, 2009

TEVA PHARMS USA 150MG/ML A076552 001 Oct 27, 2004



TABLET;ORAL

AMEN

AMARIN PHARMS 10MG A083242 001

CURRETAB

SOLVAY 10MG A085686 001

CYCRIN

ESI 2.5MG A081239 001 Oct 30, 1992

5MG A081240 001 Oct 30, 1992

10MG A089386 001 Sep 09, 1987

MEDROXYPROGESTERONE ACETATE

DURAMED PHARMS BARR 2.5MG A040311 001 Dec 01, 1999

5MG A040311 002 Dec 01, 1999

10MG A040311 003 Dec 01, 1999

USL PHARMA 10MG A088484 001 Jul 26, 1984

MEDRYSONE

SUSPENSION;OPHTHALMIC

HMS

ALLERGAN 1% N016624 003

MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL

LARIAM

+ ROCHE 250MG ** N019591 001 May 02, 1989

MEFLOQUINE HYDROCHLORIDE

HIKMA INTL PHARMS 250MG A077699 001 Apr 21, 2010

SANDOZ 250MG A076175 001 Feb 20, 2002



US ARMY WALTER REED 250MG ** N019578 001 May 02, 1989

MEGESTROL ACETATE

SUSPENSION;ORAL

MEGACE

+ BRISTOL MYERS SQUIBB 40MG/ML ** N020264 001 Sep 10, 1993

MEGESTROL ACETATE

APOTEX INC 40MG/ML A077404 001 Feb 16, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-247(of 393)

** See List Footnote



MEGESTROL ACETATE

TABLET;ORAL

MEGACE

+ BRISTOL MYERS SQUIBB 20MG ** N016979 001

+ 40MG ** N016979 002

MEGESTROL ACETATE

TEVA 40MG A074745 001 Feb 27, 1998

USL PHARMA 20MG A070646 001 Oct 02, 1987

40MG A070647 001 Oct 02, 1987

MELOXICAM

SUSPENSION;ORAL

MOBIC

+ BOEHRINGER INGELHEIM 7.5MG/5ML ** N021530 001 Jun 01, 2004

TABLET;ORAL

MELOXICAM

ANDA REPOSITORY 7.5MG A077935 001 Jul 19, 2006

15MG A077935 002 Jul 19, 2006

CR DOUBLE CRANE 7.5MG A078039 001 Dec 14, 2006

15MG A078039 002 Dec 14, 2006

IMPAX LABS INC 7.5MG A077930 001 Jul 19, 2006

15MG A077930 002 Jul 19, 2006

MYLAN 7.5MG A077923 001 Jul 19, 2006

7.5MG A077934 001 Jul 20, 2006

15MG A077923 002 Jul 19, 2006

15MG A077934 002 Jul 20, 2006

ROXANE 7.5MG A077925 001 Jul 19, 2006

15MG A077925 002 Jul 19, 2006

SUN PHARM INDS INC 7.5MG A077937 001 Jul 19, 2006

15MG A077937 002 Jul 19, 2006

YABAO PHARM 7.5MG A077933 001 Jul 19, 2006

15MG A077933 002 Jul 19, 2006

MELPHALAN HYDROCHLORIDE

INJECTABLE;INJECTION

ALKERAN

+ APOTEX INC EQ 50MG BASE/VIAL ** N020207 001 Nov 18, 1992

MELPHALAN HYDROCHLORIDE

MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090299 001 Oct 27, 2009

MEMANTINE HYDROCHLORIDE

SOLUTION;ORAL

NAMENDA

+ ALLERGAN SALES LLC 2MG/ML N021627 001 Apr 18, 2005

TABLET;ORAL

MEMANTINE HYDROCHLORIDE

ORCHID HLTHCARE 5MG A090044 001 Mar 12, 2012

10MG A090044 002 Mar 12, 2012

MENADIOL SODIUM DIPHOSPHATE

INJECTABLE;INJECTION

KAPPADIONE

LILLY 10MG/ML N005725 001

SYNKAYVITE

ROCHE 5MG/ML N003718 004

10MG/ML N003718 006

37.5MG/ML N003718 008

TABLET;ORAL

SYNKAYVITE

ROCHE 5MG N003718 010

MENADIONE

TABLET;ORAL

MENADIONE

LILLY 5MG N002139 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-248(of 393)

** See List Footnote



MENOTROPINS (FSH;LH)

INJECTABLE;INJECTION

HUMEGON

ORGANON USA INC 75 IU/VIAL;75 IU/VIAL N020328 001 Sep 01, 1994

150 IU/VIAL;150 IU/VIAL N020328 002 Sep 01, 1994

MENOTROPINS

FERRING 75 IU/VIAL;75 IU/VIAL A073598 001 Jan 30, 1997

150 IU/VIAL;150 IU/VIAL A073599 001 Jan 30, 1997

PERGONAL

SERONO 75 IU/AMP;75 IU/AMP N017646 001

150 IU/AMP;150 IU/AMP N017646 002 May 20, 1985

REPRONEX

FERRING 150 IU/VIAL;150 IU/VIAL N021047 002 Aug 27, 1999

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

REPRONEX

FERRING 75 IU/VIAL;75 IU/VIAL N021047 001 Aug 27, 1999

MEPENZOLATE BROMIDE

SOLUTION;ORAL

CANTIL

SANOFI AVENTIS US 25MG/5ML N010679 004

TABLET;ORAL

CANTIL

+ SANOFI AVENTIS US 25MG N010679 003

MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEMEROL

US PHARM HOLDINGS 25MG/ML N005010 007

50MG/ML N005010 002

75MG/ML N005010 009

100MG/ML N005010 003

MEPERIDINE HYDROCHLORIDE

ABBOTT 25MG/ML A080388 001

50MG/ML A080385 001

50MG/ML A080387 001

75MG/ML A080389 001

100MG/ML A080386 001

BAXTER HLTHCARE 25MG/ML A088279 001 Jun 15, 1984

50MG/ML A088280 001 Jun 15, 1984

75MG/ML A088281 001 Jun 15, 1984

100MG/ML A088282 001 Jun 15, 1984

IGI LABS INC 25MG/ML A089781 001 Mar 31, 1989

50MG/ML A089782 001 Mar 31, 1989

50MG/ML A089783 001 Mar 31, 1989

50MG/ML A089784 001 Mar 31, 1989

75MG/ML A089785 001 Mar 31, 1989

100MG/ML A089786 001 Mar 31, 1989

100MG/ML A089787 001 Mar 31, 1989

100MG/ML A089788 001 Mar 31, 1989

INTL MEDICATION 10MG/ML A086332 001

PARKE DAVIS 50MG/ML A080364 002

75MG/ML A080364 003

100MG/ML A080364 001

WATSON LABS 50MG/ML A073444 001 Mar 17, 1992

100MG/ML A073445 001 Mar 17, 1992

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

HOSPIRA 10MG/ML A040305 001 Mar 10, 1999

ICU MEDICAL INC 10MG/ML A088432 001 Aug 16, 1984

INTL MEDICATION 10MG/ML A081309 001 Aug 30, 1993

SPECGX LLC 10MG/ML A040163 001 May 12, 1997

WATSON LABS 10MG/ML A073443 001 Mar 17, 1992



SYRUP;ORAL

DEMEROL

US PHARM HOLDINGS 50MG/5ML ** N005010 005

TABLET;ORAL

MEPERIDINE HYDROCHLORIDE

BARR 50MG A088639 001 Jul 02, 1984

100MG A088640 001 Sep 19, 1984

DURAMED PHARMS BARR 50MG A040318 001 Oct 05, 1999


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-249(of 393)

** See List Footnote



MEPERIDINE HYDROCHLORIDE

TABLET;ORAL

MEPERIDINE HYDROCHLORIDE

100MG
A040318 002 Oct 05, 1999

SUN PHARM INDUSTRIES 50MG
A080448 001

100MG A080448 002

WATSON LABS 50MG A040186 001 Jun 30, 1997

100MG A040186 002 Jun 30, 1997

WYETH AYERST 50MG A080454 001

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

MEPERGAN

WEST-WARD PHARMS INT 25MG/ML;25MG/ML
N011730 001

MEPHENTERMINE SULFATE

INJECTABLE;INJECTION

WYAMINE SULFATE

BAXTER HLTHCARE CORP EQ 15MG BASE/ML
N008248 002

EQ 30MG BASE/ML
N008248 001

MEPHENYTOIN

TABLET;ORAL

MESANTOIN

+ NOVARTIS
100MG **
N006008 001

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

ARESTOCAINE HYDROCHLORIDE

SOLVAY
3%
A084777 002 Apr 18, 1982

CARBOCAINE

+ EASTMAN KODAK
3% **
N012125 003

ISOCAINE HYDROCHLORIDE

SEPTODONT INC
3%
A080925 001

MEPIVACAINE HYDROCHLORIDE

BELMORA LLC
3%
A083559 001

HOSPIRA INC
3%
A040806 001 Apr 28, 2008

INTL MEDICATION SYS


1%
A087509 001 Oct 05, 1982

WATSON LABS
1%
A088769 001 Nov 20, 1984

2%
A088770 001 Nov 20, 1984

POLOCAINE

DENTSPLY PHARM
3%
A088653 001 Aug 21, 1984

MEPREDNISONE

TABLET;ORAL

BETAPAR

SCHERING
4MG
N016053 002

MEPROBAMATE

CAPSULE;ORAL

EQUANIL

WYETH AYERST
400MG
N012455 002

CAPSULE, EXTENDED RELEASE;ORAL

MEPROSPAN

MEDPOINTE PHARM HLC
200MG
N011284 001

400MG
N011284 002

TABLET;ORAL

AMOSENE

FERNDALE LABS
400MG
A084030 001

BAMATE

ALRA
200MG
A080380 001

400MG
A080380 002

EQUANIL

WYETH AYERST
200MG
N010028 005

400MG
N010028 004

MEPRIAM

TEVA
400MG
N016069 001

MEPROBAMATE

AUROLIFE PHARMA LLC
400MG
A080655 001

BARR
600MG
A084230 001

ELKINS SINN
200MG
N015426 002

400MG
N015426 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-250(of 393)

** See List Footnote



MEPROBAMATE

TABLET;ORAL

MEPROBAMATE

HEATHER 400MG
N016928 003

600MG
A084329 001

IMPAX LABS 200MG
N014322 002

400MG
N014322 001

IVAX SUB TEVA PHARMS 200MG
N015438 001

400MG N015438 002

600MG A084181 001

IVC INDS 400MG A084153 001

LANNETT 200MG N014882 002

400MG N014882 001

LEDERLE 400MG A086299 001

LEE KM 400MG A089538 001 Nov 25, 1987

MALLARD 400MG N015072 002

MK LABS 200MG N014368 004

400MG N014368 002

MYLAN 400MG A083618 001

NEXGEN PHARMA INC 200MG A084220 001

400MG A084589 001

PARKE DAVIS 200MG A084744 001

400MG A084744 002

PERRIGO 200MG A084546 001

400MG A084547 001

PHARMAVITE 400MG A084438 001

PUREPAC PHARM 200MG A084804 001

400MG A084804 002

PVT FORM 400MG N014601 001

ROXANE 600MG A084332 001

SANDOZ 200MG N014547 002

400MG N014547 001

SCHERER LABS 400MG A083343 001

SOLVAY 200MG A084435 001

STANLABS PHARM 200MG N014474 002

400MG N014474 004

SUN PHARM INDUSTRIES 200MG
A080699 001

400MG A080699 002

TABLICAPS 400MG A083494 001

TARO 200MG A200998 001 May 23, 2011

400MG A200998 002 May 23, 2011

USL PHARMA 200MG A087825 001 Mar 18, 1982



400MG A087826 001 Mar 18, 1982

VALEANT PHARM INTL 200MG N015139 006

400MG N015139 005

VANGARD 400MG A088011 001 Jul 14, 1982

WATSON LABS 200MG A085720 001

400MG A085721 001

600MG A084274 001

600MG A085719 001

WEST WARD 200MG N015417 003

400MG N015417 002

WHITEWORTH TOWN PLSN 200MG
A083830 001

400MG
A083442 001

MILTOWN

+ MEDPOINTE PHARM HLC 200MG ** N009698 004

+ 400MG ** N009698 002

600MG A083919 001

NEURAMATE

HALSEY 200MG
N014359 002

400MG
N014359 001

TRANMEP

SOLVAY 400MG
A084369 001

400MG
N016249 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-251(of 393)

** See List Footnote



MEQUINOL; TRETINOIN

SOLUTION;TOPICAL

SOLAGE

AQUA PHARMS
2%;0.01%
N020922 001 Dec 10, 1999

MEROPENEM

INJECTABLE;INJECTION

MEROPENEM

SANDOZ
500MG/VIAL
A091201 001 Mar 29, 2011

1GM/VIAL
A091201 002 Mar 29, 2011

MERSALYL SODIUM; THEOPHYLLINE

INJECTABLE;INJECTION

MERSALYL-THEOPHYLLINE

WATSON LABS
100MG/ML;50MG/ML
A084875 001

MESALAMINE

ENEMA;RECTAL

MESALAMINE

G AND W LABS INC
4GM/60ML
A076841 001 Sep 30, 2004

SUPPOSITORY;RECTAL

CANASA

ALLERGAN SALES LLC
500MG
N021252 001 Jan 05, 2001

ROWASA

+ MEDA PHARMS
500MG **
N019919 001 Dec 18, 1990

TABLET, DELAYED RELEASE;ORAL

ASACOL

APIL
400MG
N019651 001 Jan 31, 1992

MESNA

INJECTABLE;INTRAVENOUS

MESNA

MYLAN INSTITUTIONAL
100MG/ML
A076488 001 Mar 08, 2012

MYLAN LABS LTD
100MG/ML
A203364 001 Jul 18, 2014

MESORIDAZINE BESYLATE

CONCENTRATE;ORAL

SERENTIL

NOVARTIS
EQ 25MG BASE/ML
N016997 001

INJECTABLE;INJECTION

SERENTIL

NOVARTIS
EQ 25MG BASE/ML
N016775 001

TABLET;ORAL

SERENTIL

NOVARTIS
EQ 10MG BASE
N016774 001

EQ 25MG BASE
N016774 002

EQ 50MG BASE
N016774 003

EQ 100MG BASE
N016774 004

MESTRANOL; NORETHINDRONE

TABLET;ORAL-20

NORINYL

ACTAVIS LABS UT INC
0.1MG;2MG
N013625 004

TABLET;ORAL-21

NORETHIN 1/50M-21

WATSON LABS
0.05MG;1MG
A071539 001 Apr 12, 1988

NORETHINDRONE AND MESTRANOL

WATSON LABS
0.05MG;1MG
A070758 001 Jul 01, 1988

NORINYL 1+50 21-DAY

ACTAVIS LABS UT INC
0.05MG;1MG
N013625 002

NORINYL 1+80 21-DAY

GD SEARLE LLC
0.08MG;1MG
N016724 001

ORTHO-NOVUM 1/50 21

ORTHO MCNEIL PHARM


0.05MG;1MG
N012728 004

ORTHO-NOVUM 1/80 21

ORTHO MCNEIL PHARM


0.08MG;1MG
N016715 001

ORTHO-NOVUM 10-21

ORTHO MCNEIL PHARM
0.06MG;10MG
N012728 001

ORTHO-NOVUM 2-21

ORTHO MCNEIL PHARM
0.1MG;2MG
N012728 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-252(of 393)

** See List Footnote



MESTRANOL; NORETHINDRONE

TABLET;ORAL-28

NORETHIN 1/50M-28

WATSON LABS 0.05MG;1MG A071540 001 Apr 12, 1988

NORETHINDRONE AND MESTRANOL



WATSON LABS 0.05MG;1MG A070759 001 Jul 01, 1988

NORINYL 1+80 28-DAY

GD SEARLE LLC 0.08MG;1MG N016725 001

ORTHO-NOVUM 1/50 28

ORTHO MCNEIL JANSSEN 0.05MG;1MG N016709 001



ORTHO-NOVUM 1/80 28

ORTHO MCNEIL PHARM 0.08MG;1MG N016715 002



MESTRANOL; NORETHYNODREL

TABLET;ORAL

ENOVID

GD SEARLE LLC 0.075MG;5MG N010976 008

0.15MG;9.85MG N010976 005

TABLET;ORAL-20

ENOVID

GD SEARLE LLC 0.075MG;5MG N010976 004

ENOVID-E

GD SEARLE LLC 0.1MG;2.5MG N010976 006

TABLET;ORAL-21

ENOVID-E 21

GD SEARLE LLC 0.1MG;2.5MG N010976 007

METAPROTERENOL SULFATE

AEROSOL, METERED;INHALATION

ALUPENT

BOEHRINGER INGELHEIM 0.65MG/INH N016402 001

SOLUTION;INHALATION

ALUPENT

BOEHRINGER INGELHEIM 0.4% N018761 002 Oct 10, 1986

0.6% N018761 001 Jun 30, 1983

5% N017659 001

METAPROTERENOL SULFATE

APOTEX INC 0.4% A075402 001 Feb 28, 2001

0.6% A075403 001 Feb 28, 2001

ASTRAZENECA 0.4% A071275 001 Jul 27, 1988

0.6% A071018 001 Jul 27, 1988

DEY 0.33% A071806 001 Aug 05, 1988

0.5% A071805 001 Aug 05, 1988

5% A070805 001 Aug 17, 1987

MYLAN SPECIALITY LP 0.4% A071786 001 Aug 05, 1988

0.6% A070804 001 Aug 17, 1987

NEPHRON 0.4% A071855 001 Jul 14, 1988



0.6% A071726 001 Jul 14, 1988

WOCKHARDT 0.4% A075586 001 May 30, 2002

0.6% A075586 002 May 30, 2002

5% A072190 001 Jun 07, 1988



PROMETA

MURO 5% A073340 001 Mar 30, 1992

SYRUP;ORAL

ALUPENT

BOEHRINGER INGELHEIM 10MG/5ML N017571 001

METAPROTERENOL SULFATE

APOTEX INC 10MG/5ML A075235 001 Jan 27, 2000

G AND W LABS INC 10MG/5ML A072761 001 Feb 27, 1992

10MG/5ML A073034 001 Aug 30, 1991

MORTON GROVE 10MG/5ML A071656 001 Oct 13, 1987



WOCKHARDT 10MG/5ML A074702 001 Mar 24, 1997

PROMETA

MURO 10MG/5ML A072023 001 Sep 15, 1988

TABLET;ORAL

ALUPENT

BOEHRINGER INGELHEIM 10MG N015874 002

20MG N015874 001

METAPROTERENOL SULFATE

AM THERAP 10MG A072054 001 Jun 23, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-253(of 393)

** See List Footnote



METAPROTERENOL SULFATE

TABLET;ORAL

METAPROTERENOL SULFATE

20MG
A072055 001 Jun 23, 1988

TEVA
10MG
A072519 001 Mar 30, 1990

20MG
A072520 001 Mar 30, 1990

USL PHARMA
10MG
A071013 001 Jan 25, 1988

20MG
A071014 001 Jan 25, 1988

WATSON LABS
10MG
A073013 001 Jan 31, 1991

20MG
A072795 001 Jan 31, 1991

METARAMINOL BITARTRATE

INJECTABLE;INJECTION

ARAMINE

+ MERCK
EQ 10MG BASE/ML **
N009509 002 Dec 22, 1987

METARAMINOL BITARTRATE

ABRAXIS PHARM
EQ 10MG BASE/ML
A080431 001

ELKINS SINN
EQ 10MG BASE/ML
A083363 001

FRESENIUS KABI USA
EQ 10MG BASE/ML
A080722 001

GD SEARLE LLC
EQ 10MG BASE/ML
A086418 001

EQ 20MG BASE/ML
A086418 002

METAXALONE

TABLET;ORAL

METAXALONE

+ PRIMUS PHARMS
640MG **
N022503 001 Jun 01, 2015

SKELAXIN

+ KING PHARMS
400MG **
N013217 001

METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLUCOPHAGE

+ BRISTOL MYERS SQUIBB
625MG **
N020357 003 Nov 05, 1998

+
750MG **
N020357 004 Nov 05, 1998

METFORMIN HYDROCHLORIDE

BARR
500MG
A075971 001 Jan 25, 2002

850MG
A075971 002 Jan 25, 2002

1GM
A075971 003 Jan 25, 2002

IPCA LABS LTD
500MG
A078422 001 Aug 06, 2007

850MG
A078422 002 Aug 06, 2007

1GM
A078422 003 Aug 06, 2007

IVAX SUB TEVA PHARMS


500MG
A075975 001 Jan 24, 2002

625MG
A075975 004 Jan 24, 2002

750MG
A075975 005 Jan 24, 2002

850MG
A075975 002 Jan 24, 2002

1GM
A075975 003 Jan 24, 2002

MYLAN PHARMS INC
500MG
A075969 001 Jan 29, 2002

850MG
A075969 002 Jan 29, 2002

1GM
A075969 003 Jan 29, 2002

PROVIDENT PHARM
500MG
A077853 001 Jul 28, 2006

850MG
A077853 002 Jul 28, 2006

1GM
A077853 003 Jul 28, 2006

SANDOZ
500MG
A075985 001 Jan 25, 2002

850MG
A075985 002 Jan 25, 2002

1GM
A075985 003 Jan 25, 2002

TEVA
500MG
A076328 001 Dec 16, 2002

850MG
A076328 002 Dec 16, 2002

1GM
A076328 003 Dec 16, 2002

WATSON LABS
500MG
A075979 001 Jan 24, 2002

850MG
A075979 002 Jan 24, 2002

1GM
A075979 003 Jan 24, 2002

WATSON LABS FLORIDA
500MG
A075961 001 Jan 25, 2002

850MG
A075961 002 Jan 25, 2002

1GM
A075961 003 Jan 25, 2002

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

ACTAVIS ELIZABETH
500MG
A076450 001 Oct 01, 2004

750MG
A076878 001 Apr 13, 2005

BARR
500MG
A076496 001 Nov 25, 2005

IMPAX LABS
500MG
A076249 001 Jul 30, 2004

750MG
A076985 001 Sep 13, 2005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-254(of 393)

** See List Footnote



METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

IVAX SUB TEVA PHARMS 500MG A076545 001 Dec 01, 2003

MYLAN 500MG A076650 001 Sep 13, 2005

750MG A077113 001 Sep 08, 2005

RANBAXY LABS LTD 500MG A076413 001 Jun 18, 2004



750MG A077211 001 Jun 29, 2005

SANDOZ 500MG A076223 001 Dec 14, 2004

SUN PHARM INDUSTRIES 500MG A077124 001 Dec 21, 2005

TORRENT PHARMS LTD 750MG A079226 001 Feb 18, 2010

WATSON LABS INC 500MG A076818 001 Dec 14, 2004

METFORMIN HYDROCHLORIDE; REPAGLINIDE

TABLET;ORAL

PRANDIMET

+ NOVO NORDISK INC 500MG;1MG N022386 001 Jun 23, 2008

+ 500MG;2MG N022386 002 Jun 23, 2008

REPAGLINIDE AND METFORMIN HYDROCHLORIDE

LUPIN LTD 500MG;1MG A200624 001 Jul 15, 2015

500MG;2MG A200624 002 Jul 15, 2015

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDAMET
+ SB PHARMCO 500MG;EQ 1MG BASE ** N021410 001 Oct 10, 2002
+ 500MG;EQ 2MG BASE ** N021410 002 Oct 10, 2002
+ 500MG;EQ 4MG BASE ** N021410 003 Oct 10, 2002
+ 1GM;EQ 2MG BASE ** N021410 004 Aug 25, 2003
+ 1GM;EQ 4MG BASE ** N021410 005 Aug 25, 2003
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
TEVA 500MG;EQ 2MG BASE A077337 001 May 07, 2014
500MG;EQ 1MG BASE A077337 005 May 19, 2017
500MG;EQ 4MG BASE A077337 002 May 07, 2014
1GM;EQ 4MG BASE A077337 004 May 07, 2014
1GM;EQ 2MG BASE A077337 003 May 07, 2014
METHACHOLINE CHLORIDE
FOR SOLUTION;INHALATION
PROVOCHOLINE
+ METHAPHARM 1600MG/VIAL N019193 002 Aug 29, 2016
METHACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 140MG BASE A060641 001
EQ 280MG BASE A060641 002
SYRUP;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 70MG BASE/5ML A060641 003
METHADONE HYDROCHLORIDE
POWDER;FOR RX COMPOUNDING
METHADONE HYDROCHLORIDE
MALLINCKRODT INC 50GM/BOT N006383 002
100GM/BOT N006383 003
500GM/BOT N006383 004
SYRUP;ORAL
DOLOPHINE HYDROCHLORIDE
WEST-WARD PHARMS INT 10MG/30ML N006134 004
TABLET;ORAL
METHADONE HYDROCHLORIDE
ROXANE 5MG A088108 001 Mar 08, 1983
10MG A088109 001 Mar 08, 1983
40MG A074081 001 Apr 28, 1995
VISTAPHARM 5MG A040241 001 May 29, 1998
TABLET, DISPERSIBLE;ORAL
WESTADONE
SANDOZ 2.5MG N017108 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-255(of 393)

** See List Footnote


METHADONE HYDROCHLORIDE
TABLET, EFFERVESCENT;ORAL
WESTADONE
SANDOZ 5MG N017108 002

10MG N017108 003

40MG N017108 004

METHAMPHETAMINE HYDROCHLORIDE
TABLET;ORAL
METHAMPEX
TEVA 10MG A083889 001

METHAMPHETAMINE HYDROCHLORIDE

ABLE
5MG
A040529 001 Feb 25, 2004

REXAR
5MG
A084931 001

10MG
A084931 002

TEVA
5MG
A086359 001

TABLET, EXTENDED RELEASE;ORAL

DESOXYN

RECORDATI RARE
5MG
N005378 004

10MG
N005378 003

15MG
N005378 005

METHANTHELINE BROMIDE

TABLET;ORAL

BANTHINE

SHIRE
50MG
N007390 001

METHARBITAL

TABLET;ORAL

GEMONIL

ABBVIE
100MG
N008322 001

METHAZOLAMIDE

TABLET;ORAL

METHAZOLAMIDE

APPLIED ANAL
25MG
A040011 001 Jul 17, 1997

50MG
A040011 002 Jul 17, 1997

SANDOZ
25MG
A040102 001 Aug 28, 1996

50MG
A040102 002 Aug 28, 1996

NEPTAZANE

+ LEDERLE
25MG **
N011721 002 Nov 25, 1991

+
50MG **
N011721 001

METHDILAZINE

TABLET, CHEWABLE;ORAL

TACARYL

WESTWOOD SQUIBB
3.6MG
N011950 009

METHDILAZINE HYDROCHLORIDE

SYRUP;ORAL

METHDILAZINE HYDROCHLORIDE

ALPHARMA US PHARMS
4MG/5ML
A087122 001

TACARYL

WESTWOOD SQUIBB
4MG/5ML
N011950 007

TABLET;ORAL

TACARYL

WESTWOOD SQUIBB
8MG
N011950 006

METHICILLIN SODIUM

INJECTABLE;INJECTION

STAPHCILLIN

APOTHECON
EQ 900MG BASE/VIAL
A061449 001

EQ 900MG BASE/VIAL
N050117 001

EQ 3.6GM BASE/VIAL
A061449 002

EQ 3.6GM BASE/VIAL
N050117 002

EQ 5.4GM BASE/VIAL
A061449 003

EQ 5.4GM BASE/VIAL
N050117 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-256(of 393)

** See List Footnote



METHIMAZOLE

TABLET;ORAL

METHIMAZOLE

ECI PHARMS LLC
15MG
A040619 003 Jul 12, 2005

20MG
A040547 004 Feb 18, 2005

MYLAN
20MG
A040350 003 Jun 07, 2001

TAPAZOLE

+ KING PHARMS
5MG **
N007517 002

+
10MG **
N007517 004

METHIXENE HYDROCHLORIDE

TABLET;ORAL

TREST

NOVARTIS
1MG
N013420 001

METHOCARBAMOL

INJECTABLE;INJECTION

METHOCARBAMOL

MARSAM PHARMS LLC
100MG/ML
A089849 001 Dec 27, 1991

WATSON LABS
100MG/ML
A086459 001

TABLET;ORAL

DELAXIN

FERNDALE LABS
500MG
A085454 001

FORBAXIN

FOREST LABS
750MG
A085136 001

METHOCARBAMOL

ABLE
500MG
A040413 001 Mar 17, 2003

750MG
A040413 002 Mar 17, 2003

AM THERAP
500MG
A089417 001 Feb 11, 1987

750MG
A089418 001 Feb 11, 1987

ASCOT
500MG
A087660 001 Oct 27, 1982

750MG
A087661 001 Oct 27, 1982

CLONMEL HLTHCARE
500MG
A085961 001

750MG
A085963 001

FOSUN PHARMA
500MG
A084616 001

750MG
A084615 001

HEATHER
500MG
A084675 001

750MG
A084924 001

IMPAX LABS
500MG
A084927 001

750MG
A084928 001

INWOOD LABS
500MG
A085137 001

IVAX SUB TEVA PHARMS 500MG
A084648 001

750MG A084649 001

KV PHARM 500MG A085660 001

750MG A085658 001

LANNETT CO INC 500MG A084756 002 Mar 31, 2003

750MG A084756 001

MYLAN 500MG A084259 001

750MG A084323 001

NYLOS 750MG A085033 001

PIONEER PHARMS 500MG A088731 001 Dec 13, 1985

750MG A089082 001 Dec 13, 1985

PURACAP PHARM 500MG A084231 002

750MG A084471 001

PUREPAC PHARM 500MG A085718 001

750MG A085718 002

ROXANE 500MG A088646 001 Feb 29, 1984

750MG A088647 001 Feb 29, 1984

SANDOZ 500MG A087283 001

750MG A087282 001

SOLVAY 500MG A084448 001

750MG A084449 001

SUN PHARM INDUSTRIES 500MG
A084488 001

750MG A084486 001

SUPERPHARM 500MG A087589 001 Jan 22, 1982

750MG A087590 001 Jan 22, 1982

TABLICAPS 500MG A084846 001

UPSHER SMITH 500MG A087453 001

750MG A087454 001

WATSON LABS 500MG A083605 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-257(of 393)

** See List Footnote



METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL

500MG A085180 001

750MG A083605 002

750MG A085192 001

METHOHEXITAL SODIUM

INJECTABLE;INJECTION

BREVITAL SODIUM

PAR STERILE PRODUCTS 200MG/VIAL N011559 004 Dec 21, 2012

5GM/VIAL N011559 003

METHOTREXATE

SOLUTION;SUBCUTANEOUS

OTREXUP

+ ANTARES PHARMA INC 7.5MG/0.4ML (7.5MG/0.4ML) N204824 005 Nov 07, 2014

OTREXUP PFS

+ ANTARES PHARMA INC 10MG/0.4ML (10MG/0.4ML) N204824 009 May 31, 2017

+ 15MG/0.6ML (15MG/0.6ML) N204824 010 May 31, 2017

+ 17.5MG/0.7ML (17.5MG/0.7ML) N204824 011 May 31, 2017

+ 20MG/0.8ML (20MG/0.8ML) N204824 012 May 31, 2017

+ 22.5MG/0.9ML (22.5MG/0.9ML) N204824 013 May 31, 2017

+ 25MG/ML (25MG/ML) N204824 014 May 31, 2017

RASUVO

+ MEDAC PHARMA INC 27.5MG/0.55ML (27.5MG/0.55ML) N205776 009 Jul 10, 2014

METHOTREXATE SODIUM

INJECTABLE;INJECTION

ABITREXATE

ABIC EQ 25MG BASE/ML A089161 001 Mar 10, 1987

EQ 50MG BASE/VIAL A089354 001 Jul 17, 1987

EQ 100MG BASE/VIAL A089355 001 Jul 17, 1987

EQ 250MG BASE/VIAL A089356 001 Jul 17, 1987

FOLEX

PHARMACIA AND UPJOHN EQ 25MG BASE/VIAL A087695 001 Apr 08, 1983

EQ 50MG BASE/VIAL A087695 002 Apr 08, 1983

EQ 100MG BASE/VIAL A087695 003 Apr 08, 1983

EQ 250MG BASE/VIAL A088954 001 Oct 24, 1985



FOLEX PFS

PHARMACIA AND UPJOHN EQ 25MG BASE/ML A081242 001 Aug 23, 1991

EQ 25MG BASE/ML A089180 001 Jan 03, 1986



METHOTREXATE LPF

HOSPIRA EQ 25MG BASE/ML N011719 007 Mar 31, 1982

METHOTREXATE PRESERVATIVE FREE

HOSPIRA EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N011719 014 Apr 13, 2005

+ EQ 500MG BASE/20ML (EQ 25MG BASE/ML) ** N011719 013 Apr 13, 2005

EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) N011719 011 Apr 13, 2005

METHOTREXATE SODIUM

ABRAXIS PHARM EQ 2.5MG BASE/ML A089323 001 Jun 13, 1986

EQ 20MG BASE/VIAL A088935 001 Oct 11, 1985

EQ 25MG BASE/ML A089263 001 Jun 13, 1986

EQ 25MG BASE/ML A089322 001 Jun 13, 1986

EQ 50MG BASE/VIAL A088936 001 Oct 11, 1985

EQ 100MG BASE/VIAL A088937 001 Oct 11, 1985

FRESENIUS KABI USA EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040263 002 Feb 26, 1999

HOSPIRA EQ 2.5MG BASE/ML N011719 004

EQ 20MG BASE/VIAL N011719 001

EQ 25MG BASE/ML N011719 005

EQ 50MG BASE/VIAL N011719 003

EQ 100MG BASE/VIAL N011719 006

NORBROOK EQ 25MG BASE/ML A088648 001 May 09, 1986

PHARMACHEMIE USA EQ 25MG BASE/ML A089158 001 Jul 08, 1988



METHOTREXATE SODIUM PRESERVATIVE FREE

HOSPIRA EQ 1GM BASE/VIAL N011719 009 Apr 07, 1988

MEXATE

BRISTOL EQ 20MG BASE/VIAL A086358 001

EQ 50MG BASE/VIAL A086358 002

EQ 100MG BASE/VIAL A086358 003

EQ 250MG BASE/VIAL A086358 004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-258(of 393)

** See List Footnote



METHOTREXATE SODIUM

INJECTABLE;INJECTION

MEXATE-AQ

BRISTOL MYERS
EQ 25MG BASE/ML
A088760 001 Feb 14, 1985

MEXATE-AQ PRESERVED

BRISTOL MYERS SQUIBB
EQ 25MG BASE/ML
A089887 001 Apr 14, 1989

TABLET;ORAL

METHOTREXATE SODIUM

DURAMED PHARMS BARR
EQ 2.5MG BASE
A040233 001 Jun 17, 1999

METHOXAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

VASOXYL

GLAXOSMITHKLINE
10MG/ML
N006772 002

20MG/ML
N006772 001

METHOXSALEN

CAPSULE;ORAL

8-MOP

+ VALEANT PHARM INTL
10MG
N009048 001

METHOXSALEN

ANI PHARMS INC
10MG
A087781 001 Jun 08, 1982

LOTION;TOPICAL

OXSORALEN

+ VALEANT PHARM INTL
1%
N009048 002

METHSCOPOLAMINE BROMIDE

TABLET;ORAL

METHSCOPOLAMINE BROMIDE

PVT FORM
2.5MG
A080970 001

PAMINE

FOUGERA PHARMS
2.5MG **
N008848 001

PAMINE FORTE

FOUGERA PHARMS
5MG **
N008848 002 Mar 25, 2003

METHSUXIMIDE

CAPSULE;ORAL

CELONTIN

+ PARKE DAVIS
150MG
N010596 007

METHYCLOTHIAZIDE

TABLET;ORAL

AQUATENSEN

MEDPOINTE PHARM HLC
5MG
N017364 001

ENDURON

+ ABBVIE
2.5MG **
N012524 001

+
5MG **
N012524 004

METHYCLOTHIAZIDE

IVAX PHARMS
2.5MG
A087913 001 Jun 03, 1982

5MG
A087786 001 May 18, 1982

MYLAN
2.5MG
A087671 001 Aug 17, 1982

PAR PHARM
2.5MG
A089135 001 Feb 12, 1986

5MG
A089136 001 Feb 12, 1986

USL PHARMA
5MG
A088745 001 Mar 21, 1985

WATSON LABS
2.5MG
A085487 001 Mar 11, 1982

2.5MG
A088750 001 Sep 06, 1984

5MG
A085476 001 Mar 11, 1982

5MG
A088724 001 Sep 06, 1984

YAOPHARMA CO LTD
2.5MG
A089835 001 Aug 18, 1988

5MG
A089837 001 Aug 18, 1988

METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE

TABLET;ORAL

EUTRON

ABBOTT 5MG;25MG
N016047 001

METHYCLOTHIAZIDE; RESERPINE

TABLET;ORAL

DIUTENSEN-R

MEDPOINTE PHARM HLC 2.5MG;0.1MG
N012708 005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-259(of 393)

** See List Footnote



METHYL AMINOLEVULINATE HYDROCHLORIDE

CREAM;TOPICAL

METVIXIA

GALDERMA LABS LP
EQ 16.8% BASE
N021415 001 Jul 27, 2004

METHYLDOPA

SUSPENSION;ORAL

ALDOMET

MERCK
250MG/5ML
N018389 001

TABLET;ORAL

ALDOMET

+ MERCK
125MG **
N013400 003

+
250MG **
N013400 001

+
500MG **
N013400 002

METHYLDOPA

ACCORD HLTHCARE
125MG
A070070 003 Oct 15, 1985

DURAMED PHARMS BARR
250MG
A071006 001 Dec 16, 1986

500MG
A071009 001 Dec 16, 1986

HALSEY
125MG
A071751 001 Mar 28, 1988

250MG
A071752 001 Mar 28, 1988

500MG
A071753 001 Mar 28, 1988

PAR PHARM
125MG
A070535 001 Jan 02, 1987

250MG
A070536 001 Jan 02, 1987

500MG
A070537 001 Jan 02, 1987

PARKE DAVIS
125MG
A070331 001 Apr 15, 1986

250MG
A070332 001 Apr 15, 1986

500MG
A070333 001 Apr 15, 1986

PLIVA
125MG
A072126 001 Jul 07, 1988

250MG
A072127 001 Jul 07, 1988

500MG
A072128 001 Jul 07, 1988

PUREPAC PHARM
125MG
A070749 001 Feb 07, 1986

250MG
A070750 001 Feb 07, 1986

500MG
A070452 001 Feb 07, 1986

ROXANE
125MG
A070192 001 Apr 25, 1986

250MG
A070193 001 Apr 25, 1986

500MG
A070194 001 Apr 25, 1986

SUN PHARM INDUSTRIES


125MG
A070073 001 Oct 09, 1986

250MG
A070060 001 Oct 09, 1986

500MG
A070074 001 Oct 09, 1986

SUPERPHARM
250MG
A070669 001 Jun 23, 1989

500MG
A070670 001 Jun 23, 1989

TEVA
125MG
A071105 001 Dec 05, 1986

250MG
A071106 001 Dec 05, 1986

500MG
A071067 001 Dec 05, 1986

WATSON LABS
125MG
A070245 001 Feb 25, 1986

125MG
A070260 001 Jun 24, 1985

250MG
A070246 001 Feb 25, 1986

250MG
A070261 001 Jun 24, 1985

250MG
A070703 001 Jun 06, 1986

500MG
A070247 001 Feb 25, 1986

500MG
A070262 001 Jun 24, 1985

YAOPHARMA CO LTD
125MG
A071700 001 Mar 02, 1988

250MG
N018934 001 Jun 29, 1984

500MG
N018934 002 Jun 29, 1984

METHYLDOPATE HYDROCHLORIDE

INJECTABLE;INJECTION

ALDOMET

+ MERCK
50MG/ML **
N013401 001

METHYLDOPATE HYDROCHLORIDE

ABRAXIS PHARM
50MG/ML
A070652 001 Jun 03, 1986

BAXTER HLTHCARE
50MG/ML
A070291 001 Jul 01, 1986

HOSPIRA
50MG/ML
A070691 001 Jun 19, 1987

50MG/ML
A070698 001 Jun 15, 1987

50MG/ML
A070699 001 Jun 15, 1987

50MG/ML
A070849 001 Jun 19, 1987

MARSAM PHARMS LLC
50MG/ML
A071812 001 Dec 22, 1987

SMITH AND NEPHEW
50MG/ML
A070841 001 Jan 02, 1987

TEVA PARENTERAL
50MG/ML
A072974 001 Nov 22, 1991

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-260(of 393)

** See List Footnote



METHYLERGONOVINE MALEATE

TABLET;ORAL

METHERGINE

+ EDISON THERAPS LLC 0.2MG ** N006035 003

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

RITALIN LA

+ NOVARTIS 60MG ** N021284 005 Oct 27, 2014

TABLET;ORAL

METHYLPHENIDATE HYDROCHLORIDE

ABLE 5MG A040404 001 Mar 29, 2001

10MG A040404 002 Mar 29, 2001

20MG A040404 003 Mar 29, 2001

ACTAVIS ELIZABETH 5MG A040321 001 Feb 05, 2002

10MG A040321 002 Feb 05, 2002

20MG A040321 003 Feb 05, 2002

TABLET, CHEWABLE;ORAL

METHYLIN

+ SPECGX LLC 2.5MG ** N021475 001 Apr 15, 2003
+ 5MG ** N021475 002 Apr 15, 2003
+ 10MG ** N021475 003 Apr 15, 2003
TABLET, EXTENDED RELEASE;ORAL
METADATE ER
LANNETT CO INC 10MG A040306 001 Oct 20, 1999
METHYLPHENIDATE HYDROCHLORIDE
ABLE 20MG A076032 001 May 09, 2001
ACTAVIS ELIZABETH 20MG A075450 001 Dec 21, 2001
WATSON LABS 20MG A040410 001 Feb 09, 2001
RITALIN-SR
+ NOVARTIS 20MG N018029 001 Mar 30, 1982
METHYLPREDNISOLONE
TABLET;ORAL
MEDROL
PHARMACIA AND UPJOHN 24MG N011153 005
METHYLPREDNISOLONE
HEATHER 4MG A085650 001
PAR PHARM 16MG A089207 001 Apr 25, 1988
24MG A089208 001 Apr 25, 1988
32MG A089209 001 Apr 25, 1988
SANDOZ 4MG A087341 001
TIANJIN TIANYAO 4MG A204072 001 May 14, 2018
WATSON LABS 4MG A086161 001 Feb 09, 1982
16MG A086159 001 Feb 09, 1982
METHYLPREDNISOLONE ACETATE
ENEMA;RECTAL
MEDROL
PHARMACIA AND UPJOHN 40MG/BOT N018102 001
INJECTABLE;INJECTION
M-PREDROL
BEL MAR 40MG/ML A086666 001
80MG/ML A087135 001
METHYLPREDNISOLONE ACETATE
AKORN 40MG/ML A086903 001 Oct 20, 1982
80MG/ML A086903 002 Oct 20, 1982
WATSON LABS 20MG/ML A085597 001
20MG/ML A087248 001
40MG/ML A085374 001
40MG/ML A085600 001
80MG/ML A085595 001
80MG/ML A086507 001
OINTMENT;TOPICAL
MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25% N012421 001
1% N012421 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-261(of 393)

** See List Footnote



METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE

CREAM;TOPICAL

NEO-MEDROL ACETATE

PHARMACIA AND UPJOHN 0.25%;EQ 3.5MG BASE/GM A060611 002

1%;EQ 3.5MG BASE/GM A060611 001

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION

A-METHAPRED

ABBOTT EQ 40MG BASE/VIAL A089573 001 Feb 22, 1991

EQ 125MG BASE/VIAL A089574 001 Feb 22, 1991

EQ 500MG BASE/VIAL A089575 001 Feb 22, 1991

EQ 1GM BASE/VIAL A089576 001 Feb 22, 1991

HOSPIRA EQ 40MG BASE/VIAL A085853 001

EQ 125MG BASE/VIAL A085855 001

EQ 500MG BASE/VIAL A085854 001

EQ 500MG BASE/VIAL A089173 001 Aug 18, 1987

EQ 1GM BASE/VIAL A085852 001



EQ 1GM BASE/VIAL A089174 001 Aug 18, 1987

HOSPIRA INC EQ 40MG BASE/VIAL A040793 001 Nov 25, 2008



EQ 125MG BASE/VIAL A040827 001 Nov 25, 2008

METHYLPREDNISOLONE

ELKINS SINN EQ 125MG BASE/VIAL A086906 002

EQ 500MG BASE/VIAL A086906 003

EQ 1GM BASE/VIAL A086906 004

ORGANON USA INC EQ 500MG BASE/VIAL A087535 001 Jun 25, 1982

EQ 1GM BASE/VIAL A087535 002 Jun 25, 1982

METHYLPREDNISOLONE SODIUM SUCCINATE

ABRAXIS PHARM EQ 40MG BASE/VIAL A088676 001 Jun 08, 1984

EQ 40MG BASE/VIAL A089143 001 Mar 28, 1986

EQ 125MG BASE/VIAL A088677 001 Jun 08, 1984

EQ 125MG BASE/VIAL A089144 001 Mar 28, 1986

EQ 500MG BASE/VIAL A088678 001 Jun 08, 1984

EQ 500MG BASE/VIAL A089186 001 Mar 28, 1986

EQ 500MG BASE/VIAL A089187 001 Mar 28, 1986

EQ 1GM BASE/VIAL A088679 001 Jun 08, 1984

EQ 1GM BASE/VIAL A089188 001 Mar 28, 1986

EQ 1GM BASE/VIAL A089189 001 Mar 28, 1986

BEDFORD LABS EQ 40MG BASE/VIAL A040662 001 Feb 21, 2007

EQ 125MG BASE/VIAL A040641 002 Feb 21, 2007

EQ 500MG BASE/VIAL A040641 003 Feb 21, 2007

EQ 500MG BASE/VIAL A040709 001 Feb 21, 2007

EQ 1GM BASE/VIAL A040641 004 Feb 21, 2007

EQ 1GM BASE/VIAL A040709 002 Feb 21, 2007

ELKINS SINN EQ 40MG BASE/VIAL A086906 001

INTL MEDICATION EQ 40MG BASE/VIAL A087812 001 Feb 09, 1983

EQ 125MG BASE/VIAL A087813 001 Feb 09, 1983

EQ 500MG BASE/VIAL A087851 001 Feb 09, 1983

EQ 1GM BASE/VIAL A087852 001 Feb 09, 1983

TEVA PARENTERAL EQ 125MG BASE/VIAL A081266 001 Nov 30, 1992

EQ 500MG BASE/VIAL A081267 001 Nov 30, 1992

EQ 1GM BASE/VIAL A081268 001 Nov 30, 1992

WATSON LABS EQ 40MG BASE/VIAL A086953 001 Jul 22, 1982

EQ 125MG BASE/VIAL A087030 001 Jul 22, 1982

EQ 500MG BASE/VIAL A088523 001 Jul 24, 1984

EQ 1GM BASE/VIAL A088524 001 Jul 24, 1984

METHYLPREDNISOLONE; NEOMYCIN SULFATE

OINTMENT;OPHTHALMIC

NEO-MEDROL

PHARMACIA AND UPJOHN 0.1%;EQ 3.5MG BASE/GM A060645 001

METHYLTESTOSTERONE

CAPSULE;ORAL

METHYLTESTOSTERONE

HEATHER 10MG A084967 001

VIRILON

STAR PHARMS FL 10MG A087750 001 Nov 24, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-262(of 393)

** See List Footnote


METHYLTESTOSTERONE
TABLET;BUCCAL
ANDROID 5
VALEANT PHARM INTL 5MG A087222 001

ORETON
SCHERING 10MG A080281 001

TABLET;BUCCAL, SUBLINGUAL
METANDREN
NOVARTIS 5MG N003240 004

10MG N003240 001

10MG N003240 005

25MG N003240 003

METHYLTESTOSTERONE
IMPAX LABS 10MG A084287 001

LILLY 10MG A080256 001

25MG A080256 002

PUREPAC PHARM 10MG A080308 001

10MG A080475 001

10MG A080475 002

25MG A080475 003

PVT FORM 5MG A083836 001

TABLICAPS 10MG A085125 001

USL PHARMA 10MG A080271 001

TABLET;ORAL
ANDROID 10
VALEANT PHARMS NORTH 10MG
A086450 001

METHYLTESTOSTERONE

IMPAX LABS 25MG
A084310 001

INWOOD LABS 10MG
A080839 001

25MG
A080973 001

KV PHARM 10MG
A084312 001

LANNETT 10MG
A087092 001 Nov 05, 1982

25MG
A087111 001 Jan 27, 1983

PARKE DAVIS 10MG
A084244 001

25MG
A084241 001

PUREPAC PHARM 10MG
A080309 001

25MG
A080310 001

PVT FORM 5MG
A080214 001

10MG
A080214 002

25MG
A080214 003

TABLICAPS 10MG
A080313 001

25MG
A085270 001

WATSON LABS 10MG
A080933 001

25MG
A080931 001

WEST WARD 10MG
A084331 001

25MG
A084331 002

25MG
A084642 001

ORETON METHYL

SCHERING 10MG
N003158 001

25MG
N003158 002

METHYPRYLON

CAPSULE;ORAL

NOLUDAR

ROCHE 300MG
N009660 008

ELIXIR;ORAL

NOLUDAR

ROCHE 50MG/5ML
N009660 007

TABLET;ORAL

NOLUDAR

ROCHE 50MG
N009660 002

200MG
N009660 004

METHYSERGIDE MALEATE

TABLET;ORAL

SANSERT

NOVARTIS 2MG
N012516 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-263(of 393)

** See List Footnote



METOCLOPRAMIDE HYDROCHLORIDE

CONCENTRATE;ORAL

METOCLOPRAMIDE INTENSOL

ROXANE EQ 10MG BASE/ML A072995 001 Jan 30, 1992

INJECTABLE;INJECTION

METOCLOPRAMIDE HYDROCHLORIDE

BEDFORD EQ 5MG BASE/ML A072155 001 Mar 30, 1992

EQ 5MG BASE/ML A072244 001 Mar 30, 1992

EQ 5MG BASE/ML A072247 001 May 18, 1992

HOSPIRA EQ 5MG BASE/ML A070505 001 Jun 23, 1989



EQ 5MG BASE/ML A070506 001 Jun 22, 1989

EQ 5MG BASE/ML A070847 001 Nov 07, 1988

EQ 5MG BASE/ML A071291 001 Mar 03, 1989

EQ 5MG BASE/ML A071990 001 Jan 18, 1989

EQ 5MG BASE/ML A073117 001 Jan 17, 1991

EQ 5MG BASE/ML A074147 001 Aug 02, 1996

LYPHOMED EQ 10MG BASE/2ML A070293 001 Jan 24, 1986



NORBROOK EQ 10MG BASE/2ML A070892 001 Aug 26, 1988

SMITH AND NEPHEW EQ 5MG BASE/ML A070623 001 Mar 02, 1987

EQ 10MG BASE/2ML A070622 001 Mar 02, 1987

REGLAN

WEST-WARD PHARMS INT EQ 5MG BASE/ML N017862 001

EQ 10MG BASE/ML N017862 004 May 28, 1987

SOLUTION;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

ACTAVIS MID ATLANTIC EQ 5MG BASE/5ML A071340 001 Aug 18, 1988

LANNETT CO INC EQ 5MG BASE/5ML A073680 001 Oct 27, 1992



MORTON GROVE EQ 5MG BASE/5ML A070949 001 Mar 06, 1987

PACO EQ 5MG BASE/5ML A071665 001 Dec 05, 1988

ROXANE EQ 5MG BASE/5ML A072038 001 Dec 05, 1988

TEVA EQ 5MG BASE/5ML A070819 001 Jul 10, 1987

EQ 5MG BASE/5ML A071315 001 Jun 30, 1993

REGLAN

+ ROBINS AH EQ 5MG BASE/5ML ** N018821 001 Mar 25, 1983

TABLET;ORAL

CLOPRA

QUANTUM PHARMICS EQ 5MG BASE A072384 001 Jun 02, 1988

EQ 10MG BASE A070294 001 Jul 29, 1985

CLOPRA-"YELLOW"

QUANTUM PHARMICS EQ 10MG BASE A070632 001 Oct 28, 1985

MAXOLON

KING PHARMS EQ 10MG BASE A070106 001 Mar 04, 1986

METOCLOPRAMIDE HYDROCHLORIDE

CLONMEL EQ 10MG BASE A072639 001 May 09, 1991

HALSEY EQ 10MG BASE A070906 001 Oct 28, 1986



INTERPHARM EQ 10MG BASE A071213 001 Sep 24, 1986

MUTUAL PHARM EQ 10MG BASE A070660 001 Feb 10, 1987



NORTHSTAR HLTHCARE EQ 5MG BASE A078374 001 Nov 30, 2007

EQ 10MG BASE A078374 002 Nov 30, 2007

PAR PHARM EQ 10MG BASE A070342 001 Mar 25, 1986

SANDOZ EQ 5MG BASE A072436 001 Jun 22, 1989

EQ 10MG BASE A070850 001 Feb 03, 1987

SCHERING EQ 10MG BASE A070598 001 Feb 02, 1987

SUN PHARM INDUSTRIES EQ 5MG BASE A071536 002 Jan 16, 1997

EQ 10MG BASE A071536 001 Apr 28, 1993

SUPERPHARM EQ 10MG BASE A070926 001 Jun 26, 1987



USL PHARMA EQ 10MG BASE A070339 001 Jul 29, 1985

WATSON LABS EQ 10MG BASE A070363 001 Mar 02, 1987

EQ 10MG BASE A070453 001 Jun 06, 1986

EQ 10MG BASE A070511 001 Jan 22, 1986

EQ 10MG BASE A070645 001 May 11, 1987

YAOPHARMA CO LTD EQ 5MG BASE A074478 001 Oct 05, 1995



EQ 10MG BASE A072215 001 Jan 30, 1990

EQ 10MG BASE A074478 002 Oct 05, 1995

TABLET, ORALLY DISINTEGRATING;ORAL

METOZOLV ODT

+ SALIX PHARMS EQ 5MG BASE N022246 001 Sep 04, 2009

+ EQ 10MG BASE ** N022246 002 Sep 04, 2009


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-264(of 393)

** See List Footnote



METOCLOPRAMIDE HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL

REGLAN ODT
MEDA PHARMS EQ 5MG BASE N021793 001 Jun 10, 2005
EQ 10MG BASE N021793 002 Jun 10, 2005
METOCURINE IODIDE
INJECTABLE;INJECTION
METUBINE IODIDE
LILLY 2MG/ML N006632 003
METOLAZONE
TABLET;ORAL
DIULO
GD SEARLE LLC 2.5MG N018535 001
5MG N018535 002
10MG N018535 003
METOLAZONE
ROXANE 10MG A076482 002 Apr 29, 2004
TEVA 2.5MG A076600 001 Jan 06, 2004
5MG A076833 001 Mar 01, 2004
10MG A075543 003 Dec 24, 2003
WATSON LABS 10MG A076891 001 Jul 21, 2004
MYKROX
LANNETT CO INC 0.5MG N019532 001 Oct 30, 1987
METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE;ORAL
LOPRESSOR
NOVARTIS EQ 100MG TARTRATE N019786 001 Dec 27, 1989
EQ 200MG TARTRATE N019786 002 Dec 27, 1989
EQ 300MG TARTRATE N019786 003 Dec 27, 1989
EQ 400MG TARTRATE N019786 004 Dec 27, 1989
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
NESHER PHARMS EQ 25MG TARTRATE A077779 001 Mar 20, 2008
EQ 50MG TARTRATE A077176 001 May 14, 2008
EQ 100MG TARTRATE A076640 002 May 18, 2007
EQ 200MG TARTRATE A076640 001 May 18, 2007
SANDOZ EQ 25MG TARTRATE A076969 001 Jul 31, 2006
EQ 50MG TARTRATE A076969 002 May 18, 2007
EQ 100MG TARTRATE A076969 003 Mar 20, 2008
EQ 200MG TARTRATE A076969 004 Mar 20, 2008
METOPROLOL TARTRATE
INJECTABLE;INJECTION
METOPROLOL TARTRATE
WATSON LABS 1MG/ML A074032 001 Dec 21, 1993
TABLET;ORAL
METOPROLOL TARTRATE
APOTHECON 50MG A074258 001 Jan 27, 1994
100MG A074258 002 Jan 27, 1994
MYLAN 50MG A073666 001 Dec 21, 1993
100MG A073666 002 Dec 21, 1993
PUREPAC PHARM 50MG A074380 001 Jul 29, 1994
100MG A074380 002 Jul 29, 1994
RENATA 50MG A074453 001 Apr 27, 1995
100MG A074453 002 Apr 27, 1995
TEVA 50MG A074143 001 Sep 30, 1994
100MG A074143 002 Sep 30, 1994
TEVA PHARMS 50MG A074333 001 Jan 27, 1994
100MG A074333 002 Jan 27, 1994
YAOPHARMA CO LTD 50MG A073288 001 Mar 25, 1994
100MG A073289 001 Mar 25, 1994

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-265(of 393)

** See List Footnote



METRIZAMIDE

INJECTABLE;INJECTION

AMIPAQUE

GE HEALTHCARE 2.5GM/VIAL N017982 003 Sep 12, 1983

3.75GM/VIAL N017982 001



6.75GM/VIAL N017982 002

13.5GM/VIAL N017982 004 Sep 12, 1983

METRONIDAZOLE

CAPSULE;ORAL

METRONIDAZOLE

ABLE 375MG A076505 001 Nov 13, 2003

INJECTABLE;INJECTION

FLAGYL I.V. RTU IN PLASTIC CONTAINER

PFIZER 500MG/100ML N018353 002

METRO I.V.

B BRAUN 500MG/100ML N018674 001 Aug 31, 1982

METRONIDAZOLE

ABBOTT 500MG/100ML N018889 001 Nov 18, 1983

ABRAXIS PHARM 500MG/100ML A070071 001 Dec 03, 1984

INTL MEDICATION 500MG/100ML A070004 001 May 08, 1985

WATSON LABS 500MG/100ML A070042 001 Dec 20, 1984



500MG/100ML A070170 001 Apr 01, 1986

WEST-WARD PHARMS INT 500MG/100ML N018907 001 Mar 30, 1984



TABLET;ORAL

METROMIDOL

LABS AF 250MG A074523 001 Oct 24, 1996

500MG A074523 002 Oct 24, 1996

METRONIDAZOLE

ABLE 250MG A076519 001 Jun 27, 2003

500MG A076519 002 Jun 27, 2003

CHARTWELL MOLECULES 250MG N018845 001 Aug 18, 1983

500MG N018930 001 Aug 18, 1983

FOSUN PHARMA 250MG N018620 001 Mar 04, 1982



250MG N018740 001 Oct 22, 1982

500MG N018620 002 Jun 02, 1983

500MG N018740 002 Oct 22, 1982

HALSEY 250MG A070021 001 Apr 02, 1985

500MG A070593 001 Feb 27, 1986



IVAX SUB TEVA PHARMS 250MG N018517 001

500MG N018517 002 May 05, 1982

LNK 250MG N019029 001 Apr 10, 1984

MUTUAL PHARM 250MG N018818 001 Feb 16, 1983



500MG N018818 002 Feb 16, 1983

SUPERPHARM 250MG A070008 001 Dec 11, 1984

500MG A070009 001 Dec 11, 1984

WATSON LABS 250MG N018599 001 Sep 17, 1982

250MG N018764 001 Sep 17, 1982

500MG N018599 002 Feb 13, 1984



500MG N018764 002 Dec 20, 1982

PROTOSTAT

ORTHO MCNEIL PHARM 250MG N018871 001 Mar 02, 1983

500MG N018871 002 Mar 02, 1983

SATRIC

SAVAGE LABS 250MG A070029 001 Mar 19, 1985

500MG A070731 001 Jun 08, 1987

TABLET, EXTENDED RELEASE;ORAL

FLAGYL ER

+ GD SEARLE LLC 750MG N020868 001 Nov 26, 1997

METRONIDAZOLE

ABLE 750MG A076462 001 Jun 25, 2003

ALEMBIC PHARMS LTD 750MG A090222 001 May 05, 2010

METRONIDAZOLE HYDROCHLORIDE

INJECTABLE;INJECTION

FLAGYL I.V.

PFIZER EQ 500MG BASE/VIAL ** N018353 001

METRONIDAZOLE HYDROCHLORIDE

ABRAXIS PHARM EQ 500MG BASE/VIAL A070295 001 Oct 15, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-266(of 393)

** See List Footnote



METYRAPONE

TABLET;ORAL

METOPIRONE

LABORATORIE HRA 250MG N012911 001

MEXILETINE HYDROCHLORIDE

CAPSULE;ORAL

MEXILETINE HYDROCHLORIDE

ANI PHARMS INC 150MG A074450 001 May 16, 1996

200MG A074450 002 May 16, 1996

250MG A074450 003 May 16, 1996

WATSON LABS 150MG A074711 001 Feb 26, 1997



150MG A074865 001 Apr 13, 1998

200MG A074711 002 Feb 26, 1997



200MG A074865 002 Apr 13, 1998

250MG A074711 003 Feb 26, 1997



250MG A074865 003 Apr 13, 1998

MEXITIL

+ BOEHRINGER INGELHEIM 150MG N018873 002 Dec 30, 1985

+ 200MG N018873 003 Dec 30, 1985

+ 250MG N018873 004 Dec 30, 1985

MEZLOCILLIN SODIUM MONOHYDRATE

INJECTABLE;INJECTION

MEZLIN

BAYER PHARMS EQ 1GM BASE/VIAL A062333 001

EQ 1GM BASE/VIAL A062372 005 Jan 13, 1983

EQ 1GM BASE/VIAL N050549 001

EQ 2GM BASE/VIAL A062333 002

EQ 2GM BASE/VIAL A062372 001 May 13, 1982

EQ 2GM BASE/VIAL N050549 002



EQ 3GM BASE/VIAL A062333 003

EQ 3GM BASE/VIAL A062372 002 May 13, 1982

EQ 3GM BASE/VIAL A062697 001 Jan 22, 1987



EQ 3GM BASE/VIAL N050549 003

EQ 4GM BASE/VIAL A062333 004

EQ 4GM BASE/VIAL A062372 003 May 13, 1982

EQ 4GM BASE/VIAL A062697 002 Jan 22, 1987



EQ 4GM BASE/VIAL N050549 004

EQ 20GM BASE/VIAL A062372 004 Mar 02, 1988

EQ 20GM BASE/VIAL N050549 005 Mar 02, 1988

MICONAZOLE

INJECTABLE;INJECTION

MONISTAT

JANSSEN PHARMA 10MG/ML N018040 001

MICONAZOLE NITRATE

CREAM;TOPICAL

MONISTAT-DERM

INSIGHT PHARMS 2% N017494 001

CREAM;VAGINAL

MICONAZOLE NITRATE

TEVA 2% A074136 001 Jan 04, 1995

TEVA PHARMS 2% A074030 001 Oct 30, 1992

CREAM, SUPPOSITORY;TOPICAL, VAGINAL

M-ZOLE 7 DUAL PACK

ACTAVIS MID ATLANTIC 2%,100MG A074586 001 Jul 17, 1997

MICONAZOLE 7 COMBINATION PACK

G AND W LABS 2%,100MG A076585 001 Mar 26, 2004

LOTION;TOPICAL

MONISTAT-DERM

INSIGHT PHARMS 2% N017739 001

TAMPON;VAGINAL

MONISTAT 5

PERSONAL PRODS 100MG N018592 001 Oct 27, 1989

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-267(of 393)

** See List Footnote



MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE

AKORN INC EQ 5MG BASE/ML A075481 001 Jun 30, 2000

APOTHECON EQ 1MG BASE/ML A075620 001 Nov 01, 2000

EQ 5MG BASE/ML A075620 002 Nov 01, 2000

EQ 5MG BASE/ML A075641 001 Oct 19, 2000

BAXTER HLTHCARE CORP EQ 1MG BASE/ML A075637 001 Oct 31, 2000

EQ 5MG BASE/ML A075637 002 Oct 31, 2000

BEDFORD EQ 5MG BASE/ML A075249 001 Jun 23, 2000

BEN VENUE EQ 5MG BASE/ML A075455 001 Jun 20, 2000

HOSPIRA EQ 1MG BASE/ML A075396 001 Jun 20, 2000

EQ 5MG BASE/ML A075396 002 Jun 20, 2000

EQ 5MG BASE/ML A075484 001 Jun 20, 2000

HOSPIRA INC EQ 1MG BASE/ML A075409 002 Jun 20, 2000

EQ 5MG BASE/ML A075409 001 Jun 20, 2000

IGI LABS INC EQ 5MG BASE/ML A075263 001 Jun 26, 2000

INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005

EQ 5MG BASE/ML A076144 002 Jan 26, 2005

INTL MEDICATION EQ 1MG BASE/ML A076020 001 Jul 16, 2004

EQ 5MG BASE/ML A076020 002 Jul 16, 2004

WOCKHARDT EQ 1MG BASE/ML A078141 001 May 30, 2008

EQ 1MG BASE/ML A078511 001 Nov 10, 2008



EQ 5MG BASE/ML A078141 002 May 30, 2008

EQ 5MG BASE/ML A078511 002 Nov 10, 2008



VERSED

+ HLR EQ 1MG BASE/ML ** N018654 002 May 26, 1987

+ EQ 5MG BASE/ML ** N018654 001 Dec 20, 1985



SYRUP;ORAL

MIDAZOLAM HYDROCHLORIDE

APOTEX INC EQ 2MG BASE/ML A077115 001 Sep 09, 2005

SUN PHARM INDS LTD EQ 2MG BASE/ML A076058 001 Mar 15, 2002

VERSED

+ ROCHE EQ 2MG BASE/ML ** N020942 001 Oct 15, 1998

MIDODRINE HYDROCHLORIDE

TABLET;ORAL

PROAMATINE

+ SHIRE LLC 2.5MG N019815 001 Sep 06, 1996

+ 5MG N019815 002 Sep 06, 1996

+ 10MG N019815 003 Mar 20, 2002



MILNACIPRAN HYDROCHLORIDE

TABLET;ORAL

MILNACIPRAN HYDROCHLORIDE

AMNEAL PHARMS 12.5MG A205081 001 Apr 22, 2016

25MG A205081 002 Apr 22, 2016

50MG A205081 003 Apr 22, 2016

100MG A205081 004 Apr 22, 2016

USPHARMA WINDLAS 12.5MG A205071 001 Jan 27, 2016



25MG A205071 002 Jan 27, 2016

50MG A205071 003 Jan 27, 2016

100MG A205071 004 Jan 27, 2016

MILRINONE LACTATE

INJECTABLE;INJECTION

MILRINONE LACTATE

BAXTER HLTHCARE CORP EQ 1MG BASE/ML A076427 001 Sep 21, 2004

HOSPIRA EQ 1MG BASE/ML A075830 001 May 28, 2002

EQ 1MG BASE/ML A075884 001 May 28, 2002

MYLAN INSTITUTIONAL EQ 1MG BASE/ML A076428 001 Jun 16, 2003



WEST-WARD PHARMS INT EQ 1MG BASE/ML A075852 001 May 28, 2002

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER



B BRAUN EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076414 001 Aug 18, 2004

BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076259 001 Aug 08, 2002

RENAISSANCE SSA LLC EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A077151 001 Jul 20, 2005

WEST-WARD PHARMS INT EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075510 001 May 28, 2002

PRIMACOR

+ SANOFI AVENTIS US EQ 1MG BASE/ML ** N019436 001 Dec 31, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-268(of 393)

** See List Footnote



MILRINONE LACTATE

INJECTABLE;INJECTION

PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

+ SANOFI AVENTIS US EQ 10MG BASE/100ML ** N020343 001 Aug 09, 1994

+ EQ 15MG BASE/100ML ** N020343 002 Aug 09, 1994

+ EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) N020343 003 Aug 09, 1994

**

+ EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) N020343 004 Aug 09, 1994

**

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

MINOCIN

+ PRECISION DERMAT EQ 75MG BASE ** N050649 003 Feb 12, 2001

TRIAX PHARMS EQ 50MG BASE N050315 002

EQ 100MG BASE N050315 001

CAPSULE, EXTENDED RELEASE;ORAL

XIMINO

SUN PHARM INDS LTD EQ 67.5MG BASE N201922 002 Jul 11, 2012

EQ 112.5MG BASE N201922 004 Jul 11, 2012

INJECTABLE;INJECTION

MINOCIN

LEDERLE EQ 100MG BASE/VIAL A062139 001

SUSPENSION;ORAL

MINOCIN

PRECISION DERMAT EQ 50MG BASE/5ML N050445 001

TABLET;ORAL

MINOCYCLINE HYDROCHLORIDE

+ TRIAX PHARMS EQ 50MG BASE ** N050451 003 Aug 10, 1982

+ EQ 100MG BASE ** N050451 002 Aug 10, 1982

TABLET, EXTENDED RELEASE;ORAL



MINOCYCLINE HYDROCHLORIDE

BARR LABS INC EQ 45MG BASE A065485 001 Mar 17, 2009

EQ 80MG BASE A065485 007 Apr 26, 2017

EQ 90MG BASE A065485 002 Mar 17, 2009



EQ 105MG BASE A065485 008 Apr 26, 2017

EQ 135MG BASE A065485 003 Mar 17, 2009



IMPAX LABS INC EQ 45MG BASE A090024 001 Feb 03, 2009

EQ 90MG BASE A090024 002 Feb 03, 2009

EQ 135MG BASE A090024 003 Feb 03, 2009

MYLAN PHARMS INC EQ 45MG BASE A090911 001 Jul 20, 2010

EQ 90MG BASE A090911 002 Jul 20, 2010

EQ 135MG BASE A090911 003 Jul 20, 2010

SOLODYN

+ MEDICIS EQ 45MG BASE ** N050808 001 May 08, 2006

+ EQ 90MG BASE ** N050808 002 May 08, 2006

+ EQ 135MG BASE ** N050808 003 May 08, 2006



MINOXIDIL

SOLUTION;TOPICAL

MINOXIDIL (FOR MEN)

APOTEX INC 2% A074924 001 Apr 29, 1998

BAUSCH AND LOMB 2% A074643 001 Apr 09, 1996

COPLEY PHARM 2% A074500 001 May 23, 1996

SIGHT PHARMS 2% A074743 002 Oct 18, 1996



TEVA 2% A074589 001 Apr 05, 1996

MINOXIDIL (FOR WOMEN)

APOTEX INC 2% A074924 002 Apr 29, 1998

SIGHT PHARMS 2% A074743 001 Oct 18, 1996



MINOXIDIL EXTRA STRENGTH (FOR MEN)

APOTEX INC 5% A075839 001 Oct 01, 2001



TABLET;ORAL

LONITEN

+ PHARMACIA AND UPJOHN 2.5MG ** N018154 001

+ 10MG ** N018154 003

MINODYL

QUANTUM PHARMICS 2.5MG A072153 001 Jul 13, 1988

10MG A071534 001 Mar 19, 1987

MINOXIDIL

ROYCE LABS 2.5MG A071799 001 Nov 10, 1987

10MG A071796 001 Nov 10, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-269(of 393)

** See List Footnote



MINOXIDIL

TABLET;ORAL

MINOXIDIL

USL PHARMA 2.5MG A071537 001 Dec 16, 1988

MIPOMERSEN SODIUM

SOLUTION;SUBCUTANEOUS

KYNAMRO

+ KASTLE THERAPS LLC 200MG/ML (200MG/ML) N203568 001 Jan 29, 2013

MIRTAZAPINE

TABLET;ORAL

MIRTAZAPINE

ACTAVIS ELIZABETH 15MG A076241 001 Jun 25, 2003

15MG A076308 001 Jun 20, 2003

30MG A076241 002 Jun 25, 2003

30MG A076308 002 Jun 20, 2003

45MG A076241 003 Jun 25, 2003

45MG A076308 003 Jun 20, 2003

ACTAVIS LABS FL INC 15MG A076336 001 Jun 20, 2003

30MG A076336 002 Jun 20, 2003

45MG A076336 003 Jun 20, 2003

IVAX SUB TEVA PHARMS 15MG A076244 001 Dec 22, 2003

30MG A076244 002 Dec 22, 2003

45MG A076244 003 Dec 22, 2003

MYLAN PHARMS INC 15MG A076176 001 Jun 19, 2003

30MG A076176 002 Jun 19, 2003

45MG A076176 003 Jun 19, 2003

ROXANE 15MG A076270 001 Jun 19, 2003

30MG A076270 002 Jun 19, 2003

45MG A076270 003 Jun 19, 2003

UPSHER SMITH LABS 15MG A076189 001 Jun 19, 2003

30MG A076189 002 Jun 19, 2003

45MG A076189 003 Jun 19, 2003

REMERON

+ ORGANON USA INC 45MG N020415 003 Mar 17, 1997

TABLET, ORALLY DISINTEGRATING;ORAL

MIRTAZAPINE

ACTAVIS ELIZABETH 15MG A076689 001 Aug 31, 2005

15MG A077959 001 Feb 14, 2011



30MG A076689 002 Aug 31, 2005

30MG A077959 002 Feb 14, 2011



45MG A076689 003 Aug 31, 2005

45MG A077959 003 Feb 14, 2011



ACTAVIS LABS FL INC 15MG A076307 001 Dec 17, 2003

30MG A076307 002 Dec 17, 2003

45MG A076307 003 Feb 28, 2006

MITOMYCIN

INJECTABLE;INJECTION

MITOMYCIN

HOSPIRA 20MG/VIAL A064106 001 Nov 29, 1995

WEST-WARD PHARMS INT 5MG/VIAL A064117 001 Apr 19, 1995

20MG/VIAL A064117 002 Apr 19, 1995

40MG/VIAL A064117 003 Jun 02, 1999



MITOZYTREX

+ SUPERGEN 5MG/VIAL ** N050763 001 Nov 14, 2002

MUTAMYCIN

+ BRISTOL 5MG/VIAL ** N050450 001

+ 20MG/VIAL ** N050450 002

BRISTOL MYERS 5MG/VIAL A062336 001

20MG/VIAL A062336 002

40MG/VIAL A062336 003 Mar 10, 1988

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

MITOXANTRONE HYDROCHLORIDE

FRESENIUS KABI ONCOL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078606 001 May 14, 2008

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A078606 002 May 14, 2008

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078606 003 May 14, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-270(of 393)

** See List Footnote



MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

NOVANTRONE

EMD SERONO
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
N019297 001 Dec 23, 1987

+
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **
N019297 002 Dec 23, 1987

+
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **
N019297 003 Dec 23, 1987

MIVACURIUM CHLORIDE

INJECTABLE;INJECTION

MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

ABBVIE
EQ 0.5MG BASE/ML
N020098 002 Jan 22, 1992

EQ 50MG BASE/100ML
N020098 003 Jan 22, 1992

MIVACURIUM CHLORIDE

MYLAN LABS LTD
EQ 2MG BASE/ML
A078562 001 Apr 30, 2009

SOLUTION;INTRAVENOUS

MIVACRON

+ ABBVIE
EQ 2MG BASE/ML (EQ 2MG BASE/ML) **
N020098 001 Jan 22, 1992

+
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
N020098 004 Jan 22, 1992

+
EQ 20MG BASE/10ML (EQ 2MG BASE/ML)
N020098 005 Jan 22, 1992

MOEXIPRIL HYDROCHLORIDE

TABLET;ORAL

UNIVASC

UCB INC
7.5MG **
N020312 001 Apr 19, 1995

15MG **
N020312 002 Apr 19, 1995

MOLINDONE HYDROCHLORIDE

CAPSULE;ORAL

MOBAN

+ ENDO PHARMS
5MG **
N017111 001

+
10MG **
N017111 002

+
25MG **
N017111 003

CONCENTRATE;ORAL

MOBAN

ENDO PHARMS
20MG/ML
N017938 001

TABLET;ORAL

MOBAN

+ ENDO PHARMS
5MG **
N017111 004

+
10MG **
N017111 005

+
25MG **
N017111 006

+
50MG **
N017111 007

+
100MG **
N017111 008

MOMETASONE FUROATE

CREAM;TOPICAL

ELOCON

MERCK SHARP DOHME
0.1%
N019625 001 May 06, 1987

OINTMENT;TOPICAL

MOMETASONE FUROATE

TARO
0.1%
A076624 001 Dec 03, 2004

MONOBENZONE

CREAM;TOPICAL

BENOQUIN

VALEANT PHARM INTL
20%
N008173 003

MONOCTANOIN

LIQUID;PERFUSION, BILIARY

MOCTANIN

ETHITEK
100%
N019368 001 Oct 29, 1985

MONTELUKAST SODIUM

TABLET;ORAL

MONTELUKAST SODIUM

APOTEX CORP
EQ 10MG BASE
A201294 001 Aug 03, 2012

TABLET, CHEWABLE;ORAL

MONTELUKAST SODIUM

APOTEX INC
EQ 4MG BASE
A201508 001 Aug 03, 2012

EQ 5MG BASE
A201508 002 Aug 03, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-271(of 393)

** See List Footnote



MORICIZINE HYDROCHLORIDE

TABLET;ORAL

ETHMOZINE

SHIRE 200MG N019753 001 Jun 19, 1990

250MG N019753 002 Jun 19, 1990

300MG N019753 003 Jun 19, 1990

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

AVINZA

KING PHARMS LLC 30MG N021260 001 Mar 20, 2002

45MG N021260 005 Dec 18, 2008

60MG N021260 002 Mar 20, 2002

75MG N021260 006 Dec 18, 2008

90MG N021260 003 Mar 20, 2002

120MG N021260 004 Mar 20, 2002

INJECTABLE;INJECTION

MORPHINE SULFATE

+ HOSPIRA INC 15MG/ML N202515 005 Nov 14, 2011
ICU MEDICAL INC 0.5MG/ML N019917 001 Oct 30, 1992
SPECGX LLC 1MG/ML N020631 001 Jul 03, 1996
2MG/ML N020631 002 Jul 03, 1996
WATSON LABS 0.5MG/ML A073373 001 Sep 30, 1991
0.5MG/ML A073375 001 Sep 30, 1991
1MG/ML A073374 001 Sep 30, 1991
1MG/ML A073376 001 Sep 30, 1991
INJECTABLE, LIPOSOMAL;EPIDURAL
DEPODUR
PACIRA PHARMS INC 10MG/ML (10MG/ML) N021671 001 May 18, 2004
15MG/1.5ML (10MG/ML) N021671 002 May 18, 2004
20MG/2ML (10MG/ML) N021671 003 May 18, 2004
TABLET, EXTENDED RELEASE;ORAL
ARYMO ER
+ EGALET 15MG N208603 001 Jan 09, 2017
+ 30MG N208603 002 Jan 09, 2017
+ 60MG N208603 003 Jan 09, 2017
MORPHINE SULFATE
EPIC PHARMA LLC 15MG A091357 001 Jun 23, 2016
30MG A091357 002 Jun 23, 2016
60MG A091357 003 Jun 23, 2016
100MG A091357 004 Jun 23, 2016
200MG A091357 005 Jun 23, 2016
WATSON LABS 100MG A075656 001 Jan 30, 2001
ORAMORPH SR
XANODYNE PHARMS INC 15MG N019977 004 Nov 23, 1994
30MG N019977 001 Aug 15, 1991
60MG N019977 002 Aug 15, 1991
100MG N019977 003 Aug 15, 1991
MOXALACTAM DISODIUM
INJECTABLE;INJECTION
MOXAM
LILLY EQ 250MG BASE/VIAL N050550 001
EQ 500MG BASE/VIAL N050550 002
EQ 1GM BASE/VIAL N050550 003
EQ 2GM BASE/VIAL N050550 004
EQ 10GM BASE/VIAL N050550 008
MOXIFLOXACIN HYDROCHLORIDE
SOLUTION;INTRAVENOUS
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
+ BAYER HLTHCARE 400MG/250ML (1.6MG/ML) ** N021277 001 Nov 30, 2001
MUPIROCIN
OINTMENT;TOPICAL
BACTROBAN
+ GLAXOSMITHKLINE 2% ** N050591 001 Dec 31, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-272(of 393)

** See List Footnote



MUPIROCIN CALCIUM

CREAM;TOPICAL

BACTROBAN

+ GLAXOSMITHKLINE EQ 2% BASE N050746 001 Dec 11, 1997

OINTMENT;NASAL

BACTROBAN

+ GLAXOSMITHKLINE EQ 2% BASE N050703 001 Sep 18, 1995

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL

MYCOPHENOLATE MOFETIL

APOTEX CORP 250MG A090419 001 Apr 22, 2009

DR REDDYS LABS LTD 250MG A091315 001 Oct 27, 2011



JUBILANT CADISTA 250MG A090762 001 Dec 15, 2014

ZYDUS PHARMS USA INC 250MG A065433 001 May 04, 2009

TABLET;ORAL

MYCOPHENOLATE MOFETIL

APOTEX 500MG A090499 001 Apr 22, 2009

DR REDDYS LABS LTD 500MG A090464 001 Sep 13, 2010

JUBILANT CADISTA 500MG A090661 001 Dec 15, 2014



ZYDUS PHARMS USA INC 500MG A065477 001 May 04, 2009

NABUMETONE

TABLET;ORAL

NABUMETONE

COPLEY PHARM 750MG A075179 001 Jun 06, 2000

OXFORD PHARMS 500MG A079093 001 Feb 27, 2009

750MG A079093 002 Feb 27, 2009

SANDOZ 500MG A075590 001 Feb 25, 2002

750MG A075590 002 Feb 25, 2002

SCIEGEN PHARMS INC 500MG A078420 001 Sep 24, 2008

750MG A078420 002 Sep 24, 2008

RELAFEN

+ SMITHKLINE BEECHAM 500MG ** N019583 001 Dec 24, 1991
+ 750MG ** N019583 002 Dec 24, 1991
NADOLOL
TABLET;ORAL
CORGARD
US WORLDMEDS LLC 120MG N018063 003
160MG N018063 004
NADOLOL
IVAX SUB TEVA PHARMS 120MG A074255 002 Jan 24, 1996
160MG A074255 003 Jan 24, 1996
TEVA PHARMS 80MG A074368 001 Aug 31, 1994
120MG A074368 002 Aug 31, 1994
160MG A074368 003 Aug 31, 1994
NAFCILLIN SODIUM
CAPSULE;ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE N050111 001
FOR SOLUTION;ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE/5ML N050199 001
INJECTABLE;INJECTION
NAFCILLIN SODIUM
APOTHECON EQ 500MG BASE/VIAL A061984 001
EQ 1GM BASE/VIAL A061984 002
EQ 2GM BASE/VIAL A061984 003
EQ 4GM BASE/VIAL A061984 005
SANDOZ EQ 500MG BASE/VIAL A062527 001 Aug 02, 1984
WATSON LABS INC EQ 500MG BASE/VIAL A062844 001 Oct 26, 1988
EQ 1GM BASE/VIAL A062844 002 Oct 26, 1988
EQ 1.5GM BASE/VIAL A062844 003 Oct 26, 1988
EQ 2GM BASE/VIAL A062844 004 Oct 26, 1988
EQ 4GM BASE/VIAL A062844 005 Oct 26, 1988
EQ 10GM BASE/VIAL A063008 001 Sep 29, 1988
NALLPEN
GLAXOSMITHKLINE EQ 500MG BASE/VIAL A061999 001

EQ 1GM BASE/VIAL A061999 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-273(of 393)

** See List Footnote



NAFCILLIN SODIUM

INJECTABLE;INJECTION

NALLPEN

EQ 1GM BASE/VIAL A062755 001 Dec 19, 1986

EQ 2GM BASE/VIAL A061999 003

EQ 2GM BASE/VIAL A062755 002 Dec 19, 1986

EQ 10GM BASE/VIAL A061999 004

UNIPEN

WYETH AYERST EQ 500MG BASE/VIAL ** A062717 001 Dec 16, 1986
+ EQ 500MG BASE/VIAL ** N050320 001
EQ 1GM BASE/VIAL ** A062717 002 Dec 16, 1986
EQ 2GM BASE/VIAL ** A062717 004 Dec 16, 1986
+ EQ 2GM BASE/VIAL ** N050320 003
+ EQ 4GM BASE/VIAL ** N050320 004
+ EQ 10GM BASE/VIAL ** N050320 005
+ EQ 20GM BASE/VIAL ** N050320 006
UNIPEN IN PLASTIC CONTAINER
+ WYETH AYERST EQ 1GM BASE/VIAL ** N050320 002
TABLET;ORAL
UNIPEN
WYETH AYERST EQ 500MG BASE N050462 001
NAFTIFINE HYDROCHLORIDE
CREAM;TOPICAL
NAFTIN
+ SEBELA IRELAND LTD 1% N019599 001 Feb 29, 1988
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE
ABRAXIS PHARM 10MG/ML A070751 001 Jul 02, 1986
20MG/ML A070752 001 Sep 24, 1986
NALBUPHINE HYDROCHLORIDE
ABBOTT 20MG/ML A070917 001 Feb 03, 1989
ABBVIE 1.5MG/ML N020200 001 Mar 12, 1993
BARR 10MG/ML A074471 001 Mar 19, 1998
20MG/ML A074471 002 Mar 19, 1998
IGI LABS INC 10MG/ML A072070 001 Apr 10, 1989
10MG/ML A072071 001 Apr 10, 1989
10MG/ML A072072 001 Apr 10, 1989
20MG/ML A072073 001 Apr 10, 1989
20MG/ML A072074 001 Apr 10, 1989
20MG/ML A072075 001 Apr 10, 1989
NUBAIN
+ PAR PHARM INC 10MG/ML ** N018024 001
+ 20MG/ML ** N018024 002 May 27, 1982
NALIDIXIC ACID
SUSPENSION;ORAL
NEGGRAM
SANOFI AVENTIS US 250MG/5ML N017430 001
TABLET;ORAL
NALIDIXIC ACID
SUN PHARM INDUSTRIES 250MG A070270 001 Jun 29, 1988
500MG A070271 001 Jun 29, 1988
1GM A070272 001 Jun 29, 1988
WATSON LABS 250MG A071936 001 Jun 29, 1988
500MG A072061 001 Jun 29, 1988
1GM A071919 001 Jun 29, 1988
NEGGRAM
SANOFI AVENTIS US 250MG N014214 002
500MG N014214 004
1GM N014214 005
NALMEFENE HYDROCHLORIDE
INJECTABLE;INJECTION
REVEX
+ EUROHLTH INTL SARL EQ 0.1MG BASE/ML ** N020459 001 Apr 17, 1995
+ EQ 1MG BASE/ML ** N020459 002 Apr 17, 1995

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-274(of 393)

** See List Footnote



NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION

NALOXONE

WEST-WARD PHARMS INT
0.4MG/ML
A070298 001 Sep 24, 1986

0.4MG/ML
A070496 001 Sep 24, 1986

WYETH AYERST
0.02MG/ML
A070188 001 Sep 24, 1986

0.02MG/ML
A070189 001 Sep 24, 1986

0.4MG/ML
A070190 001 Sep 24, 1986

0.4MG/ML
A070191 001 Sep 24, 1986

NALOXONE HYDROCHLORIDE

ABRAXIS PHARM
0.02MG/ML
A070648 001 Nov 17, 1986

0.02MG/ML
A070661 001 Nov 17, 1986

0.4MG/ML
A070649 001 Nov 17, 1986

1MG/ML
A071604 001 Dec 16, 1988

ASTRAZENECA
0.02MG/ML
A072081 001 Apr 11, 1989

EUROHLTH INTL SARL


0.02MG/ML
A071272 001 May 24, 1988

1MG/ML
A071273 001 May 24, 1988

1MG/ML
A071274 001 May 24, 1988

1MG/ML
A071287 001 May 24, 1988

HOSPIRA
0.02MG/ML
A070171 001 Sep 24, 1986

0.02MG/ML
A070252 001 Jan 16, 1987

0.02MG/ML
A070253 001 Jan 16, 1987

0.4MG/ML
A070255 001 Jan 07, 1987

IGI LABS INC
0.02MG/ML
A072082 001 Apr 11, 1989

0.02MG/ML
A072083 001 Apr 11, 1989

0.02MG/ML
A072084 001 Apr 11, 1989

0.02MG/ML
A072085 001 Apr 11, 1989

0.4MG/ML
A072086 001 Apr 11, 1989

0.4MG/ML
A072087 001 Apr 11, 1989

0.4MG/ML
A072088 001 Apr 11, 1989

0.4MG/ML
A072089 001 Apr 11, 1989

0.4MG/ML
A072090 001 Apr 11, 1989

1MG/ML
A072091 001 Apr 11, 1989

1MG/ML
A072092 001 Apr 11, 1989

1MG/ML
A072093 001 Apr 11, 1989

INTL MEDICATION
0.4MG/ML
A070417 001 Sep 24, 1986

1MG/ML
A072115 001 Apr 27, 1988

MARSAM PHARMS LLC


0.4MG/ML
A071811 001 Jul 19, 1988

SMITH AND NEPHEW
0.02MG/ML
A071671 001 Nov 17, 1987

0.4MG/ML
A071681 001 Nov 17, 1987

0.4MG/ML
A071682 001 Nov 17, 1987

SOLOPAK
0.02MG/ML
A071672 001 Nov 17, 1987

0.4MG/ML
A071683 001 Nov 17, 1987

WATSON LABS
0.4MG/ML
A071339 001 Nov 18, 1987

NARCAN

+ ADAPT
0.02MG/ML **
N016636 002

+
0.4MG/ML **
N016636 001

+
1MG/ML **
N016636 003 Jun 14, 1982

BRISTOL MYERS SQUIBB
0.4MG/ML
A071083 001 Jul 28, 1988

1MG/ML
A071084 001 Jul 28, 1988

1MG/ML
A071311 001 Jul 28, 1988

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

EVZIO

+ KALEO INC 0.4MG/0.4ML (0.4MG/0.4ML)
N205787 001 Apr 03, 2014

SPRAY, METERED;NASAL

NARCAN

+ ADAPT 2MG/SPRAY
N208411 002 Jan 24, 2017

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

TARGINIQ

+ PURDUE PHARMA LP 5MG;10MG
N205777 001 Jul 23, 2014

+ 10MG;20MG
N205777 002 Jul 23, 2014

+ 20MG;40MG
N205777 003 Jul 23, 2014

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-275(of 393)

** See List Footnote



NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN NX

SANOFI AVENTIS US EQ 0.5MG BASE;EQ 50MG BASE ** N018733 001 Dec 16, 1982

NALTREXONE HYDROCHLORIDE

TABLET;ORAL

NALTREXONE HYDROCHLORIDE

FOSUN PHARMA 50MG A075434 001 Mar 08, 2000
REVIA
TEVA WOMENS 50MG N018932 001 Nov 20, 1984
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

TROXYCA ER

PFIZER INC 1.2MG;10MG N207621 001 Aug 19, 2016

2.4MG;20MG N207621 002 Aug 19, 2016

3.6MG;30MG N207621 003 Aug 19, 2016

4.8MG;40MG N207621 004 Aug 19, 2016

7.2MG;60MG N207621 005 Aug 19, 2016

9.6MG;80MG N207621 006 Aug 19, 2016



NANDROLONE DECANOATE

INJECTABLE;INJECTION

DECA-DURABOLIN

ASPEN GLOBAL INC 50MG/ML N013132 001 Jun 12, 1986

100MG/ML N013132 002 Jun 12, 1986

+ 200MG/ML ** N013132 003 Jun 12, 1986

NANDROLONE DECANOATE

ABRAXIS PHARM 100MG/ML A088290 001 Oct 03, 1983

200MG/ML A088317 001 Oct 14, 1983

AKORN 100MG/ML A087519 001 Sep 28, 1983

WATSON LABS 50MG/ML A086385 001 Jan 13, 1984



50MG/ML A087598 001 Oct 06, 1983

50MG/ML A088554 001 Feb 10, 1986

100MG/ML A086598 001 Jan 13, 1984

100MG/ML A087599 001 Oct 06, 1983

200MG/ML A088128 001 Dec 05, 1983

NANDROLONE PHENPROPIONATE

INJECTABLE;INJECTION

DURABOLIN

ORGANON USA INC 25MG/ML N011891 001

50MG/ML N011891 002

NANDROLONE PHENPROPIONATE

WATSON LABS 25MG/ML A086386 001 Jun 17, 1983

50MG/ML A087488 001 Jun 17, 1983

NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ALBALON

ALLERGAN 0.1% ** A080248 001

NAFAZAIR

BAUSCH AND LOMB 0.1% A040073 001 May 25, 1994

PHARMAFAIR 0.1% A088101 001 Apr 15, 1983

NAPHAZOLINE HYDROCHLORIDE

AKORN INC 0.1% A083590 001

NAPHCON FORTE

ALCON 0.1% A080229 001

OPCON

BAUSCH AND LOMB 0.1% A087506 001

VASOCON

NOVARTIS 0.1% A080235 002 Mar 24, 1983

NAPROXEN

TABLET;ORAL

NAPROSYN

+ ATNAHS PHARMA US 250MG N017581 002

+ 375MG N017581 003

NAPROXEN

CHARTWELL MOLECULES 250MG A074410 001 Apr 28, 1995

375MG A074410 002 Apr 28, 1995


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

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DISCONTINUED DRUG PRODUCT LIST 6-276(of 393)

** See List Footnote



NAPROXEN

TABLET;ORAL

NAPROXEN

500MG A074410 003 Apr 28, 1995

DAVA PHARMS INC 250MG A074105 001 Dec 21, 1993



375MG A074105 002 Dec 21, 1993

500MG A074105 003 Dec 21, 1993

FOSUN PHARMA 250MG A074140 001 Dec 21, 1993

375MG A074140 002 Dec 21, 1993

500MG A074140 003 Dec 21, 1993

HAMILTON PHARMS 250MG A074110 001 Oct 30, 1992

375MG A074110 002 Oct 30, 1992

500MG A074110 003 Oct 30, 1992

HIKMA INTL PHARMS 250MG A076494 001 Jan 14, 2004

375MG A076494 002 Jan 14, 2004

500MG A076494 003 Jan 14, 2004

IVAX SUB TEVA PHARMS 250MG A074111 001 Feb 28, 1995

375MG A074111 002 Feb 28, 1995

500MG A074111 003 Feb 28, 1995

PLIVA 250MG A074182 001 Jun 27, 1996

375MG A074182 002 Jun 27, 1996

500MG A074182 003 Jun 27, 1996

PUREPAC PHARM 250MG A074263 001 Dec 21, 1993

375MG A074263 002 Dec 21, 1993

500MG A074263 003 Dec 21, 1993

ROXANE 250MG A074211 001 Feb 28, 1994

375MG A074211 002 Feb 28, 1994

500MG A074211 003 Feb 28, 1994

TEVA 250MG A074129 001 Dec 21, 1993

250MG A074216 001 Apr 11, 1996

375MG A074129 002 Dec 21, 1993



375MG A074216 002 Apr 11, 1996

500MG A074129 003 Dec 21, 1993



500MG A074216 003 Apr 11, 1996

TEVA PHARMS 250MG A074207 001 Dec 21, 1993



375MG A074207 002 Dec 21, 1993

500MG A074207 003 Dec 21, 1993

WATSON LABS 250MG A074457 001 May 31, 1995

375MG A074457 002 May 31, 1995

500MG A074457 003 May 31, 1995

WATSON LABS TEVA 250MG A074163 001 Feb 10, 1995



375MG A074163 002 Feb 10, 1995

500MG A074163 003 Feb 10, 1995

TABLET, DELAYED RELEASE;ORAL

NAPROXEN

ACTAVIS ELIZABETH 375MG A074936 001 Feb 24, 1998

500MG A074936 002 Feb 24, 1998

FOSUN PHARMA 375MG A075061 001 Feb 18, 1998

500MG A075061 002 Feb 18, 1998

MYLAN PHARMS INC 375MG A075390 001 Apr 19, 2001

500MG A075390 002 Apr 19, 2001



NAPROXEN SODIUM

TABLET;ORAL

ANAPROX

+ ATNAHS PHARMA US EQ 250MG BASE N018164 001

NAPROXEN SODIUM

ABLE EQ 250MG BASE A076544 001 Aug 22, 2003

EQ 500MG BASE A076544 002 Aug 22, 2003

CONTRACT PHARMACAL EQ 200MG BASE A074789 001 Feb 27, 1997



HAMILTON PHARMS EQ 250MG BASE A074106 001 Aug 31, 1993

EQ 500MG BASE A074106 002 Aug 31, 1993

HIKMA EQ 250MG BASE A074480 002 Feb 18, 1998



EQ 500MG BASE A074480 001 May 14, 1996

IVAX SUB TEVA PHARMS EQ 250MG BASE A074230 001 Mar 14, 1995

EQ 500MG BASE A074230 002 Mar 14, 1995

MYLAN EQ 250MG BASE A074367 001 Aug 31, 1994

EQ 500MG BASE A074367 002 Aug 31, 1994

PLD ACQUISITIONS LLC EQ 200MG BASE A074646 001 Jan 13, 1997

PLIVA EQ 250MG BASE A074242 001 Jun 20, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-277(of 393)
** See List Footnote
NAPROXEN SODIUM
TABLET;ORAL
NAPROXEN SODIUM
EQ 500MG BASE A074242 002 Jun 20, 1996
PUREPAC PHARM EQ 250MG BASE A074319 001 Mar 20, 1995
EQ 500MG BASE A074319 002 Mar 20, 1995
ROXANE EQ 250MG BASE A074257 001 Dec 21, 1993
EQ 500MG BASE A074257 002 Dec 21, 1993
SANDOZ EQ 250MG BASE A074162 001 Dec 21, 1993
EQ 250MG BASE A074495 001 Dec 05, 1994
EQ 500MG BASE A074162 002 Dec 21, 1993
EQ 500MG BASE A074495 002 Dec 05, 1994
TEVA EQ 250MG BASE A074142 001 Dec 21, 1993
EQ 500MG BASE A074142 002 Dec 21, 1993
TEVA PHARMS EQ 250MG BASE A074289 001 Jan 27, 1994
EQ 500MG BASE A074289 002 Jan 27, 1994
WATSON LABS EQ 250MG BASE A074195 001 Dec 21, 1993
EQ 250MG BASE A074455 001 May 31, 1995
EQ 500MG BASE A074195 002 Dec 21, 1993
EQ 500MG BASE A074455 002 May 31, 1995
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

TABLET;ORAL

TREXIMET

+ PERNIX IRELAND LTD 60MG;EQ 10MG BASE N021926 002 May 14, 2015

NARATRIPTAN HYDROCHLORIDE

TABLET;ORAL

NARATRIPTAN

APOTEX CORP EQ 1MG BASE A091373 001 Apr 22, 2011

EQ 2.5MG BASE A091373 002 Apr 22, 2011



NATEGLINIDE

TABLET;ORAL

NATEGLINIDE

TEVA PHARMS 60MG A077467 001 Sep 09, 2009

120MG A077467 002 Sep 09, 2009



NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

NEBIVOLOL HYDROCHLORIDE

ALKEM LABS LTD EQ 2.5MG BASE A203741 001 Jun 24, 2015

EQ 5MG BASE A203741 002 Jun 24, 2015

EQ 10MG BASE A203741 003 Jun 24, 2015

EQ 20MG BASE A203741 004 Jun 24, 2015

AMERIGEN PHARMS LTD EQ 2.5MG BASE A203659 001 Apr 16, 2015

EQ 5MG BASE A203659 002 Apr 16, 2015

EQ 10MG BASE A203659 003 Apr 16, 2015

EQ 20MG BASE A203659 004 Apr 16, 2015

GLENMARK PHARMS LTD EQ 2.5MG BASE A203821 001 May 25, 2017

EQ 5MG BASE A203821 002 May 25, 2017

EQ 10MG BASE A203821 003 May 25, 2017

EQ 20MG BASE A203821 004 May 25, 2017

INDCHEMIE HEALTH EQ 2.5MG BASE A203828 001 Jul 29, 2015



EQ 5MG BASE A203828 002 Jul 29, 2015

EQ 10MG BASE A203828 003 Jul 29, 2015

EQ 20MG BASE A203828 004 Jul 29, 2015

TORRENT PHARMS LTD EQ 2.5MG BASE A203966 001 Mar 02, 2018

EQ 5MG BASE A203966 002 Mar 02, 2018

EQ 10MG BASE A203966 003 Mar 02, 2018

EQ 20MG BASE A203966 004 Mar 02, 2018

WATSON LABS INC EQ 2.5MG BASE A203683 001 Nov 27, 2015

EQ 5MG BASE A203683 002 Nov 27, 2015

EQ 10MG BASE A203683 003 Nov 27, 2015

EQ 20MG BASE A203683 004 Nov 27, 2015

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-278(of 393)

** See List Footnote



NEDOCROMIL SODIUM

AEROSOL, METERED;INHALATION

TILADE

KING PHARMS LLC 1.75MG/INH N019660 001 Dec 30, 1992

SOLUTION;INHALATION

TILADE

SANOFI AVENTIS US 0.5% N020750 001 Oct 01, 1997

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

ANI PHARMS INC 50MG A076072 001 Sep 16, 2003

100MG A076072 002 Sep 16, 2003

150MG A076072 003 Sep 16, 2003

200MG A076072 004 Sep 16, 2003

250MG A076072 005 Sep 16, 2003

DR REDDYS LABS INC 50MG A076309 001 Sep 16, 2003

100MG A076309 002 Sep 16, 2003

150MG A076309 003 Sep 16, 2003

200MG A076309 004 Sep 16, 2003

250MG A076309 005 Sep 16, 2003

FOSUN PHARMA 50MG A076302 001 Sep 16, 2003

100MG A076302 002 Sep 16, 2003

150MG A076302 003 Sep 16, 2003

200MG A076302 004 Sep 16, 2003

250MG A076302 005 Sep 16, 2003

IVAX SUB TEVA PHARMS 50MG A075763 001 Sep 16, 2003

100MG A075763 002 Sep 16, 2003

150MG A075763 003 Sep 16, 2003

200MG A075763 004 Sep 16, 2003

250MG A075763 005 Sep 16, 2003

MYLAN 100MG A076129 002 Sep 16, 2003

150MG A076129 003 Sep 16, 2003

200MG A076129 004 Sep 16, 2003

250MG A076129 005 Sep 16, 2003

ROXANE 50MG A076196 001 Sep 16, 2003

100MG A076196 002 Sep 16, 2003

150MG A076196 003 Sep 16, 2003

200MG A076196 004 Sep 16, 2003

250MG A076196 005 Sep 16, 2003

SUN PHARM INDS LTD 50MG A076409 001 Sep 16, 2003

100MG A076409 002 Sep 16, 2003

150MG A076409 003 Sep 16, 2003

200MG A076409 004 Sep 16, 2003

250MG A076409 005 Sep 16, 2003

WATSON LABS 100MG A076073 002 Sep 16, 2003

150MG A076073 003 Sep 16, 2003

200MG A076073 004 Sep 16, 2003

250MG A076073 005 Sep 16, 2003

SERZONE

+ BRISTOL MYERS SQUIBB 50MG ** N020152 001 Dec 22, 1994

+ 100MG ** N020152 002 Dec 22, 1994

+ 150MG ** N020152 003 Dec 22, 1994

+ 200MG ** N020152 004 Dec 22, 1994

+ 250MG ** N020152 005 Dec 22, 1994

+ 300MG ** N020152 006 Dec 22, 1994

NELFINAVIR MESYLATE

POWDER;ORAL

VIRACEPT

AGOURON PHARMS EQ 50MG BASE/SCOOPFUL N020778 001 Mar 14, 1997

NEOMYCIN SULFATE

POWDER;FOR RX COMPOUNDING

NEO-RX

X GEN PHARMS 100% A061579 001

SOLUTION;ORAL

MYCIFRADIN

PHARMACIA AND UPJOHN EQ 87.5MG BASE/5ML N050285 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-279(of 393)

** See List Footnote



NEOMYCIN SULFATE

SOLUTION;ORAL

NEO-FRADIN

X GEN PHARMS EQ 87.5MG BASE/5ML
A065010 001 May 23, 2002

TABLET;ORAL

MYCIFRADIN

PHARMACIA AND UPJOHN EQ 350MG BASE
A060520 001

NEOBIOTIC

PFIZER EQ 350MG BASE
A060475 001

NEOMYCIN SULFATE

BRISTOL MYERS SQUIBB 500MG
A060365 001

LANNETT 500MG
A060607 001

LILLY 500MG
A060385 001

ROXANE 500MG
A062173 001

SANDOZ 500MG
A061586 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CREAM;TOPICAL

NEOSPORIN

GLAXOSMITHKLINE
EQ 3.5MG BASE/GM;10,000 UNITS/GM
N050176 002 Jan 14, 1985

OINTMENT;OPHTHALMIC

STATROL

ALCON
EQ 3.5MG BASE/GM;10,000 UNITS/GM
N050344 002

SOLUTION/DROPS;OPHTHALMIC

STATROL

ALCON
EQ 3.5MG BASE/ML;16,250 UNITS/ML
A062339 001 Nov 30, 1984

EQ 3.5MG BASE/ML;16,250 UNITS/ML
N050456 001

NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

POLY-PRED

ALLERGAN EQ 0.35% BASE;10,000 UNITS/ML;0.5%
N050081 002

NEOMYCIN SULFATE; PREDNISOLONE ACETATE

OINTMENT;OPHTHALMIC

NEO-DELTA-CORTEF

PHARMACIA AND UPJOHN EQ 3.5MG BASE/GM;0.25%
A061039 002

EQ 3.5MG BASE/GM;0.5%
A061039 001

SUSPENSION/DROPS;OPHTHALMIC

NEO-DELTA-CORTEF

PHARMACIA AND UPJOHN EQ 3.5MG BASE/ML;0.25%
A061037 001

NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE

OINTMENT;OPHTHALMIC

NEO-HYDELTRASOL

MERCK EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE
N050378 001

NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYTREX A

SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
A062598 001 Jul 21, 1986

NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE

FOUGERA EQ 3.5MG BASE/GM;0.1%
A062600 001 Jul 21, 1986

PHARMADERM EQ 3.5MG BASE/GM;0.1%
A062595 001 Jul 21, 1986

OINTMENT;TOPICAL

MYTREX A

SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
A062609 001 May 23, 1986

NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE

FOUGERA EQ 3.5MG BASE/GM;0.1%
A062608 001 May 23, 1986

PHARMADERM EQ 3.5MG BASE/GM;0.1%


A062607 001 May 23, 1986

NETILMICIN SULFATE

INJECTABLE;INJECTION

NETROMYCIN

SCHERING EQ 10MG BASE/ML
N050544 001 Feb 28, 1983

EQ 25MG BASE/ML
N050544 002 Feb 28, 1983

EQ 100MG BASE/ML
N050544 003 Feb 28, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-280(of 393)

** See List Footnote



NEVIRAPINE

TABLET;ORAL

NEVIRAPINE

APOTEX INC
200MG
A203021 001 May 22, 2012

TECH ORGANIZED
200MG
A203176 001 May 22, 2012

TABLET, EXTENDED RELEASE;ORAL

NEVIRAPINE

APOTEX INC
400MG
A205258 001 Apr 03, 2014

TECH ORGANIZED
100MG
A207467 001 Jul 31, 2017

400MG
A207467 002 Jul 31, 2017

NIACIN

CAPSULE;ORAL

WAMPOCAP

MEDPOINTE PHARM HLC
500MG
N011073 003

TABLET;ORAL

NIACIN

EVERYLIFE
500MG
A083203 001

HALSEY
500MG
A083453 001

HIKMA PHARMS
500MG
A083718 001

IMPAX LABS
500MG
A083115 001

IVAX SUB TEVA PHARMS 500MG
A083180 001

MK LABS 500MG A083525 001

PUREPAC PHARM 500MG A083271 001

SANDOZ 500MG A083306 001

TABLICAPS 500MG A084237 001

WATSON LABS 500MG A083136 001

500MG A083305 001

500MG A085172 001

NICOLAR
SANOFI AVENTIS US 500MG A083823 001

TABLET, EXTENDED RELEASE;ORAL

NIASPAN

ABBVIE 375MG
N020381 001 Jul 28, 1997

NIASPAN TITRATION STARTER PACK

ABBVIE 375MG;500MG;750MG
N020381 005 Jul 28, 1997

NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE

SUSPENSION;ORAL

TPN

INTL MINERALS
15MG/5ML;3.75MG/5ML;600MG/5ML
N008378 003

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

CARDENE

CHIESI USA INC
20MG **
N019488 001 Dec 21, 1988

30MG **
N019488 002 Dec 21, 1988

NICARDIPINE HYDROCHLORIDE

WATSON LABS
20MG
A074670 001 Oct 28, 1996

30MG
A074670 002 Oct 28, 1996

CAPSULE, EXTENDED RELEASE;ORAL

CARDENE SR

+ CHIESI USA INC
30MG **
N020005 001 Feb 21, 1992

+
45MG **
N020005 002 Feb 21, 1992

+
60MG **
N020005 003 Feb 21, 1992

INJECTABLE;INJECTION

CARDENE

+ CHIESI USA INC
25MG/10ML (2.5MG/ML)
N019734 001 Jan 30, 1992

NICARDIPINE HYDROCHLORIDE

LUITPOLD
25MG/10ML (2.5MG/ML)
A090534 001 Nov 17, 2009

MYLAN INSTITUTIONAL
25MG/10ML (2.5MG/ML)
A090664 001 Nov 17, 2009

NAVINTA LLC
25MG/10ML (2.5MG/ML)
A090125 001 Nov 17, 2009

SUN PHARMA GLOBAL
25MG/10ML (2.5MG/ML)
N078405 001 Nov 17, 2009

WEST-WARD PHARMS INT
25MG/10ML (2.5MG/ML)
A078714 001 Dec 28, 2009

WOCKHARDT
25MG/10ML (2.5MG/ML)
A090671 001 Nov 17, 2009

INJECTABLE;INTRAVENOUS

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

+ CHIESI USA INC 40MG/200ML (0.2MG/ML)
N019734 005 Nov 07, 2008

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

EXELA PHARMA SCIENCE 20MG/200ML (0.1MG/ML)
N022276 002 Apr 07, 2016

40MG/200ML (0.2MG/ML)
N022276 003 Apr 07, 2016

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-281(of 393)

** See List Footnote



NICLOSAMIDE

TABLET, CHEWABLE;ORAL

NICLOCIDE

BAYER PHARMS 500MG N018669 001 May 14, 1982

NICOTINE

FILM, EXTENDED RELEASE;TRANSDERMAL

NICOTROL

MCNEIL CONS 15MG/16HR N020536 001 Jul 03, 1996

PROSTEP

AVEVA 11MG/24HR N019983 003 Dec 23, 1998

22MG/24HR N019983 004 Dec 23, 1998

NICOTINE POLACRILEX

GUM, CHEWING;BUCCAL

NICOTINE POLACRILEX

IVAX SUB TEVA PHARMS EQ 2MG BASE A076880 001 Feb 18, 2009

EQ 4MG BASE A077850 001 Feb 18, 2009

THRIVE

GLAXOSMITHKLINE CONS EQ 2MG BASE A077658 001 Jun 19, 2007

EQ 4MG BASE A077656 001 Jun 19, 2007

NIFEDIPINE

CAPSULE;ORAL

ADALAT

BAYER PHARMS 10MG N019478 001 Nov 27, 1985

20MG N019478 002 Sep 17, 1986

NIFEDIPINE

CHASE LABS NJ 10MG A072409 001 Jul 04, 1990

20MG A073421 001 Jun 19, 1991

TEVA 10MG A072651 001 Feb 19, 1992

PROCARDIA

+ PFIZER 20MG ** N018482 002 Jul 24, 1986

TABLET, EXTENDED RELEASE;ORAL

AFEDITAB CR

WATSON LABS 60MG A075659 001 Oct 26, 2001

WATSON LABS TEVA 30MG A075128 001 Mar 10, 2000

NIFEDIPINE

MARTEC USA LLC 90MG A075414 003 Mar 23, 2004

MYLAN 30MG A075108 001 Dec 17, 1999

MYLAN LABS LTD 30MG A090602 001 Sep 13, 2010

60MG A090602 002 Sep 13, 2010

90MG A090602 003 Sep 13, 2010



NILUTAMIDE

TABLET;ORAL

NILANDRON

CONCORDIA PHARMS INC 50MG N020169 001 Sep 19, 1996

NIMODIPINE

CAPSULE;ORAL

NIMOTOP

+ BAYER PHARMS 30MG ** N018869 001 Dec 28, 1988

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL

SULAR

+ COVIS PHARMA BV 10MG ** N020356 001 Feb 02, 1995

+ 20MG ** N020356 002 Feb 02, 1995

+ 25.5MG ** N020356 006 Jan 02, 2008

+ 30MG ** N020356 003 Feb 02, 1995

+ 40MG ** N020356 004 Feb 02, 1995

NITRIC OXIDE

GAS;INHALATION

INOMAX

+ MALLINCKRODT HOSP 100PPM ** N020845 002 Dec 23, 1999

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-282(of 393)

** See List Footnote


NITROFURANTOIN
CAPSULE;ORAL
NITROFURANTOIN
WATSON LABS 50MG A084326 001

100MG A084326 002

TABLET;ORAL
FURADANTIN
PROCTER AND GAMBLE 50MG N008693 001

100MG N008693 002

FURALAN
LANNETT 50MG A080017 001

100MG A080017 002

NITROFURANTOIN
ELKINS SINN 50MG A080003 001

100MG A080003 002

IVAX SUB TEVA PHARMS 50MG
A080078 002

100MG A080078 001

SANDOZ 50MG A080043 001

100MG A080043 002

WATSON LABS 50MG A080447 001

50MG A085797 001

100MG A080447 002

100MG A085796 001

WHITEWORTH TOWN PLSN 100MG
A084085 002

NITROFURANTOIN SODIUM

INJECTABLE;INJECTION

IVADANTIN

PROCTER AND GAMBLE EQ 180MG BASE/VIAL
N012402 001

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

NITROFURANTOIN

MYLAN 100MG
A074967 002 Jul 09, 1997

SANDOZ 25MG
A074336 001 Jan 25, 1995

50MG
A074336 002 Jan 25, 1995

100MG
A074336 003 Jan 25, 1995

WATSON LABS 25MG
A073696 001 Dec 31, 1992

50MG
A073696 002 Dec 31, 1992

100MG
A073696 003 Dec 31, 1992

NITROFURANTOIN MACROCRYSTALLINE

WATSON LABS 50MG
A070248 001 Jun 24, 1988

100MG
A070249 001 Jun 24, 1988

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

RANBAXY LABS LTD


75MG;25MG
A076951 001 Mar 30, 2005

NITROFURAZONE

CREAM;TOPICAL

FURACIN

SHIRE
0.2%
A083789 001

DRESSING;TOPICAL

ACTIN-N

SHERWOOD MEDCL
0.2%
N017343 001

OINTMENT;TOPICAL

FURACIN

SHIRE
0.2%
N005795 001

NITROFURAZONE

AMBIX
0.2%
A086077 001

LANNETT
0.2%
A084393 001

PERRIGO NEW YORK
0.2%
A084968 001

TARO
0.2%
A086156 001

WENDT
0.2%
A086766 001

POWDER;TOPICAL

FURACIN

SHIRE
0.2%
A083791 001

SOLUTION;TOPICAL

NITROFURAZONE

PERRIGO NEW YORK
0.2%
A085130 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-283(of 393)

** See List Footnote



NITROFURAZONE

SOLUTION;TOPICAL

NITROFURAZONE

WENDT 0.2% A087081 001

NITROGLYCERIN

AEROSOL;SUBLINGUAL

NITROLINGUAL

POHL BOSKAMP 0.4MG/SPRAY N018705 001 Oct 31, 1985

FILM, EXTENDED RELEASE;TRANSDERMAL

NITROGLYCERIN

LANNETT CO INC 0.2MG/HR A075115 001 Aug 10, 2004

0.4MG/HR A075115 002 Aug 10, 2004

MYLAN TECHNOLOGIES 0.1MG/HR A074992 004 Nov 12, 1999



0.2MG/HR A074992 003 Nov 12, 1999

0.4MG/HR A074992 002 Nov 12, 1999

0.6MG/HR A074992 001 Nov 12, 1999

TRANSDERM-NITRO

+ NOVARTIS 0.1MG/HR ** N020144 001 Feb 27, 1996

+ 0.2MG/HR ** N020144 002 Feb 27, 1996

+ 0.4MG/HR ** N020144 003 Feb 27, 1996

+ 0.6MG/HR ** N020144 004 Feb 27, 1996

+ 0.8MG/HR ** N020144 005 Feb 27, 1996

INJECTABLE;INJECTION

NITRO IV

POHL BOSKAMP 5MG/ML N018672 002 Aug 30, 1983

NITRO-BID

SANOFI AVENTIS US 5MG/ML N018621 001 Jan 05, 1982

10MG/ML A071159 001 Feb 28, 1990

NITROGLYCERIN

ABRAXIS PHARM 5MG/ML A070077 001 Dec 13, 1985

5MG/ML A071203 001 May 08, 1987

+ HOSPIRA 5MG/ML ** N018531 001



INTL MEDICATION 5MG/ML A070026 001 Sep 10, 1985

LUITPOLD 5MG/ML A071492 001 May 24, 1988

SMITH AND NEPHEW 5MG/ML A070633 001 Jun 19, 1986



5MG/ML A070634 001 Jun 19, 1986

NITROGLYCERIN IN DEXTROSE 5%

HOSPIRA 0.1MG/ML A074083 001 Oct 26, 1994

10MG/100ML A071846 001 Aug 31, 1990

20MG/100ML A071847 001 Aug 31, 1990

40MG/100ML A071848 001 Aug 31, 1990

NITROL

RORER 0.8MG/ML N018774 001 Jan 19, 1983

NITRONAL

POHL BOSKAMP 1MG/ML N018672 001 Aug 30, 1983

NITROSTAT

PARKE DAVIS 0.8MG/ML N018588 001

5MG/ML A070863 001 Jan 08, 1987

5MG/ML N018588 002 Dec 23, 1983

10MG/ML A070871 001 Jan 08, 1987

10MG/ML A070872 001 Jan 08, 1987

TRIDIL

HOSPIRA 0.5MG/ML N018537 002 Jun 16, 1983

5MG/ML N018537 001

NIZATIDINE

CAPSULE;ORAL

AXID

SMITHKLINE BEECHAM 150MG N019508 001 Apr 12, 1988

300MG N019508 002 Apr 12, 1988

NIZATIDINE

ANI PHARMS INC 150MG A075461 001 Jul 08, 2002

300MG A075461 002 Jul 08, 2002

APOTEX INC 150MG A076383 001 Jan 23, 2003

300MG A076383 002 Jan 23, 2003

MYLAN PHARMS INC 150MG A075934 001 Jul 09, 2002

300MG A075934 002 Jul 09, 2002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-284(of 393)

** See List Footnote



NIZATIDINE

SOLUTION;ORAL

AXID

+ BRAINTREE 15MG/ML ** N021494 001 May 25, 2004

NONOXYNOL-9

AEROSOL;VAGINAL

DELFEN

PERSONAL PRODS 12.5% N014349 002

NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

NOREPINEPHRINE BITARTRATE

METRICS PHARM EQ 1MG BASE/ML A040522 001 Sep 30, 2004

NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

RAVOCAINE AND NOVOCAIN W/ LEVOPHED

EASTMAN KODAK EQ 0.033MG BASE/ML;2%;0.4% N008592 003



NORETHINDRONE

TABLET;ORAL

NORLUTIN

PARKE DAVIS 5MG N010895 002

NORETHINDRONE ACETATE

TABLET;ORAL

AYGESTIN

+ DURAMED RES 5MG N018405 001 Apr 21, 1982

NORLUTATE

PARKE DAVIS 5MG N012184 002

NORFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

CHIBROXIN

MERCK 0.3% N019757 001 Jun 17, 1991

TABLET;ORAL

NOROXIN

+ MERCK 400MG ** N019384 002 Oct 31, 1986

NORGESTREL

TABLET;ORAL

OPILL

+ LABORATOIRE HRA 0.075MG N017031 001

NORTRIPTYLINE HYDROCHLORIDE

CAPSULE;ORAL

AVENTYL HYDROCHLORIDE

LILLY EQ 10MG BASE N014684 001

EQ 25MG BASE N014684 002

NORTRIPTYLINE HYDROCHLORIDE

ANI PHARMS INC EQ 10MG BASE A074054 001 Dec 31, 1992

EQ 25MG BASE A074054 002 Dec 31, 1992

EQ 50MG BASE A074054 003 Dec 31, 1992

EQ 75MG BASE A074054 004 Dec 31, 1992

AUROLIFE PHARMA LLC EQ 10MG BASE A074835 001 Jun 30, 1997

EQ 25MG BASE A074835 002 Jun 30, 1997

EQ 50MG BASE A074835 003 Jun 30, 1997

EQ 75MG BASE A074835 004 Jun 30, 1997

MYLAN EQ 10MG BASE A074234 001 Jul 26, 1993

EQ 25MG BASE A074234 002 Jul 26, 1993

EQ 50MG BASE A074234 003 Jul 26, 1993

EQ 75MG BASE A074234 004 Jul 26, 1993

TEVA EQ 10MG BASE A073667 001 Apr 11, 1996

EQ 25MG BASE A073667 002 Apr 11, 1996

EQ 50MG BASE A073667 003 Apr 11, 1996

EQ 75MG BASE A073667 004 Apr 11, 1996

SOLUTION;ORAL

AVENTYL

+ RANBAXY EQ 10MG BASE/5ML ** N014685 001

PAMELOR

SPECGX LLC EQ 10MG BASE/5ML N018012 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-285(of 393)

** See List Footnote



NYSTATIN

CREAM;TOPICAL

CANDEX

BAYER PHARMS
100,000 UNITS/GM
A061810 001

MYCOSTATIN

DELCOR ASSET CORP
100,000 UNITS/GM **
A060575 001

MYKINAC

ALPHARMA US PHARMS
100,000 UNITS/GM
A062387 001 Jul 29, 1982

NILSTAT

LEDERLE
100,000 UNITS/GM
A061445 001

NYSTATIN

TARO
100,000 UNITS/GM
A062457 001 Jul 28, 1983

LOTION;TOPICAL

CANDEX

BAYER PHARMS
100,000 UNITS/ML
N050233 001

OINTMENT;TOPICAL

MYCOSTATIN

DELCOR ASSET CORP
100,000 UNITS/GM **
A060571 001

MYKINAC

ALPHARMA US PHARMS
100,000 UNITS/GM
A062731 001 Sep 22, 1986

NILSTAT

LEDERLE
100,000 UNITS/GM
A061444 001

PASTILLE;ORAL

MYCOSTATIN

DELCOR ASSET CORP
200,000 UNITS
N050619 001 Apr 09, 1987

POWDER;ORAL

BARSTATIN 100

BARLAN
100%
A062489 001 Apr 27, 1988

NILSTAT

+ DAVA PHARMS INC
100% **
N050576 001 Dec 22, 1983

NYSTATIN

PADDOCK LLC
100%
A062613 001 Nov 26, 1985

POWDER;TOPICAL

MYCOSTATIN

DELCOR ASSET CORP
100,000 UNITS/GM **
A060578 001

NYSTATIN

NESHER PHARMS
100,000 UNITS/GM
A065321 001 Aug 18, 2006

SUPPOSITORY;VAGINAL

NYSERT

WARNER CHILCOTT
100,000 UNITS
N050478 001

SUSPENSION;ORAL

MYCOSTATIN

DELCOR ASSET CORP
100,000 UNITS/ML
A061533 001

NILSTAT

+ GLENMARK GENERICS
100,000 UNITS/ML **
N050299 001

NYSTATIN

ALPHARMA US PHARMS
100,000 UNITS/ML
A062571 001 Oct 29, 1985

G AND W LABS INC
100,000 UNITS/ML
A062349 001 Jul 14, 1982

100,000 UNITS/ML
A062776 001 Dec 17, 1987

MORTON GROVE
100,000 UNITS/ML
A062835 001 Nov 19, 1987

PHARMADERM
100,000 UNITS/ML
A062518 001 Jul 06, 1984

PHARMAFAIR
100,000 UNITS/ML
A062541 001 Jan 16, 1985

SOCORRO
100,000 UNITS/ML
A062832 001 Dec 27, 1991

TEVA
100,000 UNITS/ML
A062670 001 Jun 18, 1987

NYSTEX

SAVAGE LABS
100,000 UNITS/ML
A062519 001 Jul 06, 1984

TABLET;ORAL

MYCOSTATIN

DELCOR ASSET CORP
500,000 UNITS
A060574 001

NILSTAT

LEDERLE
500,000 UNITS
A061151 001

NYSTATIN

QUANTUM PHARMICS
500,000 UNITS
A062525 001 Oct 29, 1984

SANDOZ
500,000 UNITS
A062065 001

USL PHARMA
500,000 UNITS
A062524 001 Nov 26, 1985

WATSON LABS
500,000 UNITS
A062402 001 Dec 16, 1982

TABLET;VAGINAL

KOROSTATIN

HOLLAND RANTOS
100,000 UNITS
A061718 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-286(of 393)

** See List Footnote



NYSTATIN

TABLET;VAGINAL

MYCOSTATIN

DELCOR ASSET CORP 100,000 UNITS A060577 001

NILSTAT

LEDERLE 100,000 UNITS A061325 001

NYSTATIN

FOUGERA 100,000 UNITS A062459 001 Nov 09, 1983

ODYSSEY PHARMS 100,000 UNITS A062615 001 Oct 17, 1985

PHARMADERM 100,000 UNITS A062460 001 Nov 09, 1983

QUANTUM PHARMICS 100,000 UNITS A062509 001 Apr 03, 1984

SANDOZ 100,000 UNITS A061965 001



TEVA 100,000 UNITS A062502 001 Dec 23, 1983

WATSON LABS 100,000 UNITS A062176 001

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

MYCO-TRIACET II

TEVA 100,000 UNITS/GM;0.1% A061954 002 Sep 20, 1985

MYCOLOG-II

DELCOR ASSET CORP 100,000 UNITS/GM;0.1% ** A060576 002 May 01, 1985

MYLAN PHARMS INC 100,000 UNITS/GM;0.1% ** A062606 001 May 15, 1985

MYTREX F

SAVAGE LABS 100,000 UNITS/GM;0.1% A062597 001 Oct 08, 1985

NYSTATIN AND TRIAMCINOLONE ACETONIDE

ALPHARMA US PHARMS 100,000 UNITS/GM;0.1% A063010 001 Dec 20, 1988

PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062186 002 Jun 06, 1985

PHARMAFAIR 100,000 UNITS/GM;0.1% A062657 001 Jul 30, 1986

TARO 100,000 UNITS/GM;0.1% A062347 001 Mar 30, 1987

NYSTATIN TRIAMCINOLONE ACETONIDE

PHARMADERM 100,000 UNITS/GM;0.1% A062596 001 Oct 08, 1985

OINTMENT;TOPICAL

MYCO-TRIACET II

TEVA 100,000 UNITS/GM;0.1% A062045 002 Nov 26, 1985

MYCOLOG-II

MYLAN PHARMS INC 100,000 UNITS/GM;0.1% ** A060572 001 Jun 28, 1985

MYTREX F

SAVAGE LABS 100,000 UNITS/GM;0.1% A062601 001 Oct 09, 1985

NYSTATIN AND TRIAMCINOLONE ACETONIDE

PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062280 002 Oct 10, 1985

PHARMAFAIR 100,000 UNITS/GM;0.1% A062656 001 Jul 30, 1986

NYSTATIN-TRIAMCINOLONE ACETONIDE

PHARMADERM 100,000 UNITS/GM;0.1% A062603 001 Oct 09, 1985

OCTREOTIDE ACETATE

INJECTABLE;INJECTION

OCTREOTIDE ACETATE

SUN PHARM INDS EQ 0.05MG BASE/ML A077329 001 Mar 04, 2008

EQ 0.1MG BASE/ML A077329 002 Mar 04, 2008

EQ 0.2MG BASE/ML A077330 001 Mar 04, 2008

EQ 0.5MG BASE/ML A077329 003 Mar 04, 2008

EQ 1MG BASE/ML A077331 001 Mar 04, 2008

WOCKHARDT USA EQ 0.2MG BASE/ML A090986 001 May 11, 2011

EQ 1MG BASE/ML A090986 002 May 11, 2011

OCTREOTIDE ACETATE PRESERVATIVE FREE



WOCKHARDT USA EQ 0.05MG BASE/ML A090985 001 May 11, 2011

EQ 0.1MG BASE/ML A090985 002 May 11, 2011

EQ 0.5MG BASE/ML A090985 003 May 11, 2011



OFLOXACIN

INJECTABLE;INJECTION

FLOXIN

ORTHO MCNEIL PHARM 20MG/ML N020087 002 Mar 31, 1992

40MG/ML N020087 003 Mar 31, 1992

FLOXIN IN DEXTROSE 5%

ORTHO MCNEIL PHARM 400MG/100ML N020087 001 Mar 31, 1992

FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

ORTHO MCNEIL PHARM 4MG/ML N020087 004 Mar 31, 1992

400MG/100ML N020087 005 Mar 31, 1992

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-287(of 393)

** See List Footnote



OFLOXACIN

INJECTABLE;INJECTION

OFLOXACIN

BEDFORD 40MG/ML A075762 001 Jan 16, 2002

SOLUTION/DROPS;OPHTHALMIC

OFLOXACIN

APOTEX INC 0.3% A076513 001 May 14, 2004

SANDOZ 0.3% A076848 001 Nov 25, 2008



SOLUTION/DROPS;OTIC

FLOXIN OTIC

+ DAIICHI 0.3% ** N020799 001 Dec 16, 1997

TABLET;ORAL

FLOXIN

JANSSEN PHARMS 200MG ** N019735 001 Dec 28, 1990

300MG ** N019735 002 Dec 28, 1990

400MG ** N019735 003 Dec 28, 1990

OFLOXACIN

LARKEN LABS 200MG A076093 001 Sep 02, 2003

300MG A076093 002 Sep 02, 2003

RANBAXY LABS LTD 200MG A076220 001 Sep 02, 2003

300MG A076220 002 Sep 02, 2003

400MG A076220 003 Sep 02, 2003



OLANZAPINE

TABLET;ORAL

OLANZAPINE

AJANTA PHARMA LTD 2.5MG A206711 001 Aug 30, 2016

5MG A206711 002 Aug 30, 2016

7.5MG A206711 003 Aug 30, 2016

10MG A206711 004 Aug 30, 2016

15MG A206711 005 Aug 30, 2016

20MG A206711 006 Aug 30, 2016

MYLAN PHARMS INC 2.5MG A076866 001 Apr 23, 2012

5MG A076866 002 Apr 23, 2012

7.5MG A076866 003 Apr 23, 2012

10MG A076866 004 Apr 23, 2012

15MG A076866 005 Apr 23, 2012

20MG A076866 006 Apr 23, 2012

TABLET, ORALLY DISINTEGRATING;ORAL



OLANZAPINE

AJANTA PHARMA LTD 5MG A204320 001 May 30, 2017

10MG A204320 002 May 30, 2017

15MG A204320 003 May 30, 2017

20MG A204320 004 May 30, 2017



OLIVE OIL; SOYBEAN OIL

INJECTABLE;INJECTION

CLINOLIPID 20%

+ BAXTER HLTHCARE CORP 16%(160GM/1000ML);4% (40GM/1000ML) N204508 001 Oct 03, 2013

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

ZAMBON SPA EQ 0.1% BASE A204706 001 Dec 07, 2015

OMEGA-3-ACID ETHYL ESTERS TYPE A

CAPSULE;ORAL

OMTRYG

+ OSMOTICA 1.2GM CONTAINS AT LEAST 900MG OF THE N204977 001 Apr 23, 2014

ETHYL ESTERS OF OMEGA-3 FATTY ACIDS



OMEGA-3-CARBOXYLIC ACIDS

CAPSULE;ORAL

EPANOVA

+ ASTRAZENECA PHARMS 1GM CONTAINS AT LEAST 850MG OF N205060 001 May 05, 2014

POLYUNSATURATED FATTY ACIDS


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-288(of 393)

** See List Footnote



OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

PRILOSEC

+ ASTRAZENECA PHARMS 10MG ** N019810 003 Oct 05, 1995

+ 20MG ** N019810 001 Sep 14, 1989

+ 40MG ** N019810 002 Jan 15, 1998



ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

CHARTWELL MOLECULES 4MG A077406 003 Dec 26, 2006

8MG A077406 004 Dec 26, 2006

16MG A077406 001 Dec 26, 2006

24MG A077406 002 Dec 26, 2006

NESHER PHARMS 4MG A077717 001 Jun 25, 2007

8MG A077717 002 Jun 25, 2007

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ONDANSETRON HYDROCHLORIDE

APOTEX INC EQ 2MG BASE/ML A077368 001 Dec 26, 2006

HOSPIRA EQ 2MG BASE/ML A076695 001 Dec 26, 2006

LANNETT CO INC EQ 2MG BASE/ML A090116 001 Apr 14, 2010

EQ 2MG BASE/ML A090883 001 Aug 05, 2010

LUITPOLD EQ 2MG BASE/ML A077582 001 Dec 26, 2006



MYLAN LABS LTD EQ 2MG BASE/ML A078257 001 Apr 23, 2008

PLIVA HRVATSKA DOO EQ 2MG BASE/ML A077544 001 Dec 26, 2006

SAGENT PHARMS EQ 2MG BASE/ML A078180 001 Mar 26, 2007

SUN PHARM INDS (IN) EQ 2MG BASE/ML A077172 001 Dec 26, 2006

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

HOSPIRA EQ 0.64MG BASE/ML A076978 001 Feb 26, 2007

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

APOTEX INC EQ 2MG BASE/ML A077343 001 Dec 26, 2006

HOSPIRA EQ 2MG BASE/ML A076696 001 Dec 26, 2006

LUITPOLD EQ 2MG BASE/ML A077387 001 Dec 26, 2006

MYLAN LABS LTD EQ 2MG BASE/ML A078244 001 Apr 23, 2008

SUN PHARM INDS LTD EQ 2MG BASE/ML A077173 001 Dec 26, 2006

TARO PHARMS IRELAND EQ 2MG BASE/ML A078014 001 Mar 21, 2008

ZOFRAN

+ NOVARTIS PHARMS CORP EQ 2MG BASE/ML ** N020007 001 Jan 04, 1991

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

+ GLAXOSMITHKLINE EQ 0.64MG BASE/ML ** N020403 001 Jan 31, 1995

ZOFRAN PRESERVATIVE FREE

+ NOVARTIS PHARMS CORP EQ 2MG BASE/ML ** N020007 003 Dec 10, 1993

TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

CHARTWELL MOLECULES EQ 4MG BASE A077303 001 Jun 25, 2007

EQ 8MG BASE A077303 002 Jun 25, 2007

EQ 24MG BASE A077303 004 Jun 25, 2007

HIKMA INTL PHARMS EQ 4MG BASE A077545 001 Sep 06, 2007

EQ 8MG BASE A077545 002 Sep 06, 2007

EQ 24MG BASE A077545 003 Sep 06, 2007

TARO EQ 4MG BASE A077729 001 Mar 28, 2011



EQ 8MG BASE A077729 002 Mar 28, 2011

EQ 24MG BASE A077729 003 Mar 28, 2011

ORPHENADRINE CITRATE

INJECTABLE;INJECTION

NORFLEX

+ TELIGENT 30MG/ML N013055 001

ORPHENADRINE CITRATE

WATSON LABS 30MG/ML A087062 001

TABLET, EXTENDED RELEASE;ORAL

NORFLEX

+ MEDICIS 100MG N012157 001

ORPHENADRINE CITRATE

ASCOT 100MG A088067 001 Apr 06, 1983

SANDOZ 100MG A085046 001



WATSON LABS 100MG A084303 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-289(of 393)

** See List Footnote



ORPHENADRINE HYDROCHLORIDE

TABLET;ORAL

DISIPAL

3M
50MG
N010653 001

OSELTAMIVIR PHOSPHATE

FOR SUSPENSION;ORAL

TAMIFLU

ROCHE
EQ 12MG BASE/ML
N021246 001 Dec 14, 2000

OXACILLIN SODIUM

CAPSULE;ORAL

BACTOCILL

GLAXOSMITHKLINE
EQ 250MG BASE
A061336 001

EQ 250MG BASE
A062241 001

EQ 500MG BASE
A061336 002

EQ 500MG BASE
A062241 002

OXACILLIN SODIUM

ANI PHARMS INC
EQ 250MG BASE
A062222 001

EQ 500MG BASE
A062222 002

APOTHECON
EQ 250MG BASE
A061450 002

EQ 500MG BASE
A061450 001

PROSTAPHLIN

APOTHECON
EQ 500MG BASE
N050118 002

FOR SOLUTION;ORAL

BACTOCILL

GLAXOSMITHKLINE
EQ 250MG BASE/5ML
A062321 001

OXACILLIN SODIUM

APOTHECON
EQ 250MG BASE/5ML
A061457 001

TEVA
EQ 250MG BASE/5ML
A062252 001

PROSTAPHLIN

APOTHECON
EQ 250MG BASE/5ML
N050194 001

INJECTABLE;INJECTION

BACTOCILL

GLAXOSMITHKLINE
EQ 500MG BASE/VIAL **
A061334 009 Mar 26, 1982

EQ 1GM BASE/VIAL **
A061334 006 Mar 26, 1982

EQ 1GM BASE/VIAL **
A062736 001 Dec 19, 1986

EQ 2GM BASE/VIAL **
A061334 007 Mar 26, 1982

EQ 2GM BASE/VIAL **
A062736 002 Dec 19, 1986

EQ 4GM BASE/VIAL **
A061334 008 Mar 26, 1982

EQ 10GM BASE/VIAL **
A061334 010

OXACILLIN SODIUM

+ APOTHECON EQ 250MG BASE/VIAL **
N050195 001

+ EQ 500MG BASE/VIAL **
N050195 002

+ EQ 1GM BASE/VIAL **
N050195 003

+ EQ 2GM BASE/VIAL **
N050195 004

+ EQ 4GM BASE/VIAL **
N050195 005

ELKINS SINN EQ 250MG BASE/VIAL
A062711 001 Feb 03, 1989

EQ 500MG BASE/VIAL
A062711 002 Feb 03, 1989

EQ 1GM BASE/VIAL
A062711 003 Feb 03, 1989

EQ 2GM BASE/VIAL
A062711 004 Feb 03, 1989

EQ 4GM BASE/VIAL
A062711 005 Feb 03, 1989

EQ 10GM BASE/VIAL
A062711 006 Feb 03, 1989

ISTITUTO BIO ITA SPA EQ 125MG BASE/VIAL
A062798 003 Dec 11, 1995

EQ 250MG BASE/VIAL
A062798 004 Dec 11, 1995

EQ 500MG BASE/VIAL
A062798 005 Dec 11, 1995

EQ 1GM BASE/VIAL
A062798 001 Dec 11, 1995

EQ 2GM BASE/VIAL
A062798 002 Dec 11, 1995

MYLAN LABS LTD EQ 1GM BASE/VIAL
A091486 001 Aug 25, 2014

EQ 2GM BASE/VIAL
A091486 002 Aug 25, 2014

SANDOZ EQ 250MG BASE/VIAL


A061490 001

EQ 500MG BASE/VIAL
A061490 002

EQ 1GM BASE/VIAL
A061490 003

EQ 2GM BASE/VIAL
A061490 004

EQ 10GM BASE/VIAL
A061490 006 May 09, 1991

WATSON LABS INC EQ 250MG BASE/VIAL


A062856 001 Oct 26, 1988

EQ 500MG BASE/VIAL
A062856 002 Oct 26, 1988

EQ 1GM BASE/VIAL
A062856 003 Oct 26, 1988

EQ 2GM BASE/VIAL
A062856 004 Oct 26, 1988

EQ 4GM BASE/VIAL
A062856 005 Oct 26, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-290(of 393)

** See List Footnote



OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

EQ 10GM BASE/VIAL A062984 001 Sep 29, 1988

POWDER;INTRAVENOUS

OXACILLIN SODIUM

SANDOZ EQ 1GM BASE/VIAL A062737 001 Dec 23, 1986

EQ 2GM BASE/VIAL A062737 002 Dec 23, 1986

OXALIPLATIN

INJECTABLE;IV (INFUSION)

ELOXATIN

+ SANOFI AVENTIS US 50MG/VIAL ** N021492 001 Aug 09, 2002
+ 100MG/VIAL ** N021492 002 Aug 09, 2002
+ 200MG/40ML (5MG/ML) ** N021759 003 Nov 17, 2006
OXALIPLATIN
FRESENIUS KABI ONCOL 50MG/VIAL A078810 001 Aug 07, 2009
100MG/VIAL A078810 002 Aug 07, 2009
SANDOZ 50MG/VIAL A090849 001 Apr 28, 2011
100MG/VIAL A090849 002 Apr 28, 2011
SANDOZ INC 50MG/10ML (5MG/ML) A078812 001 Aug 07, 2009
100MG/20ML (5MG/ML) A078812 002 Aug 07, 2009
OXAMNIQUINE
CAPSULE;ORAL
VANSIL
PFIZER 250MG N018069 001
OXANDROLONE
TABLET;ORAL
OXANDRIN
+ GEMINI LABS LLC 2.5MG N013718 001
+ 10MG N013718 002 Nov 05, 2001
OXANDROLONE
ROXANE 2.5MG A077249 001 Jul 10, 2007
10MG A077249 002 Jul 10, 2007
SANDOZ 2.5MG A076897 001 Dec 01, 2006
10MG A076897 002 Dec 01, 2006
OXAPROZIN
TABLET;ORAL
OXAPROZIN
ACTAVIS ELIZABETH 600MG A075843 001 Oct 03, 2001
MYLAN 600MG A075851 001 Aug 17, 2001
MYLAN PHARMS INC 600MG A075847 001 Feb 28, 2001
SANDOZ 600MG A075842 001 Apr 12, 2001
600MG A075850 001 Apr 27, 2001
WATSON LABS 600MG A075848 001 Feb 09, 2001
OXAPROZIN POTASSIUM
TABLET;ORAL
DAYPRO ALTA
GD SEARLE 600MG N020776 001 Oct 17, 2002
OXAZEPAM
CAPSULE;ORAL
OXAZEPAM
AM THERAP 10MG A071955 001 Mar 03, 1988
15MG A071956 001 Mar 03, 1988
30MG A071957 001 Mar 03, 1988
FRONTIDA BIOPHARM 10MG A071026 002 Aug 10, 1987
15MG A071026 003 Aug 10, 1987
30MG A071026 001 Aug 10, 1987
IVAX SUB TEVA PHARMS 10MG A070943 001 Aug 03, 1987
15MG A070944 001 Aug 03, 1987
30MG A070945 001 Aug 03, 1987
MYLAN 10MG A071713 001 Oct 20, 1987
15MG A071714 001 Oct 20, 1987
30MG A071715 001 Oct 20, 1987
WATSON LABS 15MG A072953 001 Sep 28, 1990
30MG A072954 001 Sep 28, 1990
WATSON LABS TEVA 10MG A072952 001 Sep 28, 1990

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-291(of 393)

** See List Footnote



OXAZEPAM

CAPSULE;ORAL

SERAX

ALPHARMA US PHARMS
10MG **
N015539 002

15MG **
N015539 004

30MG **
N015539 006

ZAXOPAM

QUANTUM PHARMICS
10MG
A070650 001 Mar 01, 1988

15MG
A070640 001 Mar 01, 1988

30MG
A070641 001 Mar 01, 1988

TABLET;ORAL

OXAZEPAM

PARKE DAVIS
15MG
A071508 001 Feb 02, 1987

SUN PHARM INDUSTRIES
15MG
A070683 001 Jan 16, 1987

WATSON LABS
15MG
A071494 001 Apr 21, 1987

SERAX

ALPHARMA US PHARMS
15MG **
N015539 008

OXCARBAZEPINE

TABLET;ORAL

OXCARBAZEPINE

JUBILANT CADISTA
150MG
A090239 001 Jan 25, 2010

300MG
A090239 002 Jan 25, 2010

600MG
A090239 003 Jan 25, 2010

OXPRENOLOL HYDROCHLORIDE

CAPSULE;ORAL

TRASICOR

NOVARTIS
20MG
N018166 001 Dec 28, 1983

40MG
N018166 002 Dec 28, 1983

80MG
N018166 003 Dec 28, 1983

160MG
N018166 004 Dec 28, 1983

OXTRIPHYLLINE

SOLUTION;ORAL

CHOLEDYL

PARKE DAVIS
100MG/5ML
N009268 012 Nov 27, 1984

OXTRIPHYLLINE

MORTON GROVE
100MG/5ML
A088243 001 Dec 05, 1983

SYRUP;ORAL

CHOLEDYL

PARKE DAVIS
50MG/5ML
N009268 011

OXTRIPHYLLINE PEDIATRIC

MORTON GROVE
50MG/5ML
A088242 001 Dec 05, 1983

TABLET, DELAYED RELEASE;ORAL

CHOLEDYL

PARKE DAVIS
100MG
N009268 003

200MG
N009268 007

OXTRIPHYLLINE

WATSON LABS
100MG
A087866 001 Aug 25, 1983

200MG
A087835 001 Aug 25, 1983

TABLET, EXTENDED RELEASE;ORAL

CHOLEDYL SA

WARNER CHILCOTT LLC
400MG
A087863 001 May 24, 1983

600MG
A086742 001

OXYBUTYNIN

FILM, EXTENDED RELEASE;TRANSDERMAL

OXYBUTYNIN

BARR LABS DIV TEVA
3.9MG/24HR
A090526 001 Mar 04, 2014

GEL, METERED;TRANSDERMAL

GELNIQUE 3%

+ ALLERGAN SALES LLC
3%
N202513 001 Dec 07, 2011

OXYBUTYNIN CHLORIDE

SYRUP;ORAL

DITROPAN

+ ORTHO MCNEIL JANSSEN 5MG/5ML **
N018211 001

OXYBUTYNIN CHLORIDE

APOTEX INC 5MG/5ML
A074997 001 Oct 15, 1997

MIKART 5MG/5ML
A075039 001 Jan 29, 1999

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-292(of 393)

** See List Footnote



OXYBUTYNIN CHLORIDE

TABLET;ORAL

DITROPAN

+ JANSSEN PHARMS 5MG ** N017577 001

OXYBUTYNIN CHLORIDE

QUANTUM PHARMICS 5MG A072296 001 Dec 08, 1988

USL PHARMA 5MG A070746 001 Mar 10, 1988

WATSON LABS 5MG A072485 001 Apr 19, 1989

TABLET, EXTENDED RELEASE;ORAL



DITROPAN XL

+ JANSSEN PHARMS 15MG ** N020897 003 Jun 22, 1999

OXYCODONE HYDROCHLORIDE

TABLET;ORAL

ROXYBOND

DAIICHI SANKYO INC 5MG N209777 001 Apr 20, 2017

15MG N209777 002 Apr 20, 2017

30MG N209777 003 Apr 20, 2017

TABLET, EXTENDED RELEASE;ORAL



ROXICODONE

ROXANE 10MG N020932 001 Oct 26, 1998

30MG N020932 002 Oct 26, 1998

OXYMETAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OCUCLEAR

BAYER HEALTHCARE LLC 0.025% N018471 001 May 30, 1986

OXYMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION

OPANA

+ ENDO PHARMS 1MG/ML N011707 002

1.5MG/ML N011707 001

SUPPOSITORY;RECTAL

NUMORPHAN

ENDO PHARMS 5MG N011738 004

TABLET, EXTENDED RELEASE;ORAL

OPANA ER

ENDO PHARMS 5MG ** N021610 001 Jun 22, 2006
+ 5MG N201655 001 Dec 09, 2011
7.5MG ** N021610 005 Feb 29, 2008
+ 7.5MG N201655 002 Dec 09, 2011
10MG ** N021610 002 Jun 22, 2006
+ 10MG N201655 003 Dec 09, 2011
15MG ** N021610 006 Feb 29, 2008
+ 15MG N201655 004 Dec 09, 2011
20MG ** N021610 003 Jun 22, 2006
+ 20MG N201655 005 Dec 09, 2011
30MG ** N021610 007 Feb 29, 2008
+ 30MG N201655 006 Dec 09, 2011
40MG ** N021610 004 Jun 22, 2006
+ 40MG N201655 007 Dec 09, 2011
OXYMORPHONE HYDROCHLORIDE
PAR PHARM 5MG A200792 001 Oct 24, 2014
7.5MG A200792 002 Oct 24, 2014
10MG A200792 003 Oct 24, 2014
15MG A200792 004 Oct 24, 2014
20MG A200792 005 Oct 24, 2014
30MG A200792 006 Oct 24, 2014
40MG A200792 007 Oct 24, 2014
SUN PHARM INDS LTD 5MG A203506 001 Apr 24, 2015
7.5MG A203506 002 Apr 24, 2015
10MG A203506 003 Apr 24, 2015
15MG A203506 004 Apr 24, 2015
20MG A203506 005 Apr 24, 2015
30MG A203506 006 Apr 24, 2015
40MG A203506 007 Apr 24, 2015

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-293(of 393)

** See List Footnote



OXYPHENBUTAZONE

TABLET;ORAL

OXYPHENBUTAZONE

WATSON LABS
100MG
A088399 001 Sep 17, 1984

TANDEARIL

NOVARTIS
100MG
N012542 004 Sep 03, 1982

OXYPHENCYCLIMINE HYDROCHLORIDE

TABLET;ORAL

DARICON

PFIZER
10MG
N011612 001

OXYPHENONIUM BROMIDE

TABLET;ORAL

ANTRENYL

NOVARTIS
5MG
N008492 002

OXYTETRACYCLINE

TABLET;ORAL

TERRAMYCIN

PFIZER
250MG
N050287 001

OXYTETRACYCLINE CALCIUM

SYRUP;ORAL

TERRAMYCIN

PFIZER
EQ 125MG BASE/5ML
A060595 001

OXYTETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

OXY-KESSO-TETRA

FERRANTE
EQ 250MG BASE
A060179 001

OXYTETRACYCLINE HYDROCHLORIDE

HIKMA PHARMS
EQ 250MG BASE
A060770 001

IMPAX LABS
EQ 250MG BASE
A060760 001

PROTER
EQ 250MG BASE
A060869 001

PUREPAC PHARM
EQ 250MG BASE
A060634 001

TERRAMYCIN

PFIZER
EQ 125MG BASE
N050286 001

EQ 250MG BASE
N050286 002

INJECTABLE;INJECTION

TERRAMYCIN

PFIZER
EQ 250MG BASE/VIAL
A060586 001

EQ 500MG BASE/VIAL
A060586 002

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

TERRAMYCIN W/ POLYMYXIN B SULFATE

CASPER PHARMA LLC EQ 5MG BASE/GM;10,000 UNITS/GM


N061015 001

OINTMENT;OTIC

TERRAMYCIN W/ POLYMYXIN

PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM


A061841 001

TABLET;VAGINAL

TERRAMYCIN-POLYMYXIN

PFIZER EQ 100MG BASE;100,000 UNITS
A061009 001

OXYTOCIN

INJECTABLE;INJECTION

OXYTOCIN

TEVA PHARMS USA 10USP UNITS/ML (10USP UNITS/ML)
A077453 001 Jan 24, 2008

100USP UNITS/10ML (10USP UNITS/ML)
A077453 002 Jan 24, 2008

OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

+ ABBOTT 1USP UNITS/100ML **
N019185 004 Mar 29, 1985

+ 2USP UNITS/100ML **
N019185 003 Mar 29, 1985

OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

+ ABBOTT 2USP UNITS/100ML **
N019185 002 Mar 29, 1985

OXYTOCIN 5 USP UNITS IN DEXTROSE 5%

+ ABBOTT 1USP UNITS/100ML **
N019185 001 Mar 29, 1985

SYNTOCINON

NOVARTIS 10USP UNITS/ML
N018245 001

SOLUTION;NASAL

SYNTOCINON

RTRX 40USP UNITS/ML
N012285 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-294(of 393)

** See List Footnote



PACLITAXEL

INJECTABLE;INJECTION

PACLITAXEL

ACCORD HLTHCARE 6MG/ML A075436 001 Nov 12, 2004
HOSPIRA 6MG/ML A076233 001 Aug 01, 2002
MYLAN 6MG/ML A075278 001 Jan 25, 2002
PLIVA LACHEMA 6MG/ML A077413 001 Mar 12, 2008
TEVA PHARMS USA 6MG/ML A075297 001 Jan 25, 2002
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
+ JANSSEN PHARMS 12MG ** N021999 004 Dec 19, 2006
PALONOSETRON HYDROCHLORIDE
CAPSULE;ORAL
ALOXI
+ HELSINN HLTHCARE EQ 0.5MG BASE ** N022233 001 Aug 22, 2008
SOLUTION;INTRAVENOUS
PALONOSETRON HYDROCHLORIDE
DR REDDYS LABS LTD EQ 0.075MG BASE/1.5ML (EQ 0.05MG N203050 001 Mar 01, 2016
BASE/ML)
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N203050 002 Mar 01, 2016
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
AREDIA
+ NOVARTIS 30MG/VIAL ** N020036 001 Oct 31, 1991
60MG/VIAL N020036 003 May 06, 1993
90MG/VIAL N020036 004 May 06, 1993
PAMIDRONATE DISODIUM
AESGEN 30MG/VIAL A075594 001 May 06, 2002
90MG/VIAL A075594 002 May 06, 2002
MN PHARMS 30MG/VIAL A078300 001 Mar 10, 2009
90MG/VIAL A078300 002 Mar 10, 2009
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE;ORAL
COTAZYM
ORGANON USA INC 30,000USP UNITS;8,000USP N020580 001 Dec 09, 1996
UNITS;30,000USP UNITS
CAPSULE, DELAYED RELEASE;ORAL
ULTRESA
+ FOREST LABS INC 27,600USP UNITS;13,800USP N022222 001 Mar 01, 2012
UNITS;27,600USP UNITS
+ 41,400USP UNITS;20,700USP N022222 002 Mar 01, 2012
UNITS;41,400USP UNITS
+ 46,000USP UNITS;23,000USP N022222 003 Mar 01, 2012
UNITS;46,000USP UNITS
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
ELKINS SINN 1MG/ML A072058 001 Mar 23, 1988
2MG/ML A072059 001 Mar 23, 1988
2MG/ML A072060 001 Mar 23, 1988
HOSPIRA 2MG/ML A072321 001 Jan 19, 1989
IGI LABS INC 1MG/ML A072210 001 Mar 31, 1988
2MG/ML A072211 001 Mar 31, 1988
2MG/ML A072212 001 Mar 31, 1988
2MG/ML A072213 001 Mar 31, 1988
PAVULON
+ ORGANON USA INC 1MG/ML N017015 002
+ 2MG/ML N017015 001
PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
PANTOPRAZOLE SODIUM
SUN PHARM INDS LTD EQ 20MG BASE A077058 001 Sep 10, 2007
EQ 20MG BASE A200794 001 May 02, 2012
EQ 40MG BASE A077058 002 Sep 10, 2007
EQ 40MG BASE A200794 002 May 02, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-295(of 393)

** See List Footnote



PARAMETHADIONE

CAPSULE;ORAL

PARADIONE

ABBVIE 150MG N006800 003

300MG N006800 001

SOLUTION;ORAL

PARADIONE

ABBVIE 300MG/ML N006800 002

PARAMETHASONE ACETATE

TABLET;ORAL

HALDRONE

LILLY 1MG N012772 005

2MG N012772 006

PARGYLINE HYDROCHLORIDE

TABLET;ORAL

EUTONYL

ABBOTT 10MG N013448 002

25MG N013448 003

50MG N013448 004

PARICALCITOL

CAPSULE;ORAL

ZEMPLAR

+ ABBVIE 4MCG ** N021606 003 May 26, 2005

PAROMOMYCIN SULFATE

CAPSULE;ORAL

HUMATIN

KING PFIZER EQ 250MG BASE A062310 001

PARKEDALE EQ 250MG BASE A060521 001

SYRUP;ORAL

HUMATIN

PARKE DAVIS EQ 125MG BASE/5ML A060522 001

PAROXETINE HYDROCHLORIDE

CAPSULE;ORAL

PAXIL
+ APOTEX TECHNOLOGIES EQ 10MG BASE ** N020885 001 Oct 09, 1998
+ EQ 20MG BASE ** N020885 002 Oct 09, 1998
+ EQ 30MG BASE ** N020885 003 Oct 09, 1998
+ EQ 40MG BASE ** N020885 004 Oct 09, 1998
SUSPENSION;ORAL
PAROXETINE HYDROCHLORIDE
APOTEX INC EQ 10MG BASE/5ML A077395 001 Dec 05, 2006
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
MYLAN PHARMS INC EQ 10MG BASE A075716 001 Mar 08, 2004
EQ 20MG BASE A075716 002 Mar 08, 2004
EQ 30MG BASE A075716 003 Mar 08, 2004
EQ 40MG BASE A075716 004 Mar 08, 2004
ROXANE EQ 10MG BASE A078026 001 Jun 29, 2007
EQ 20MG BASE A078026 002 Jun 29, 2007
EQ 30MG BASE A078026 003 Jun 29, 2007
EQ 40MG BASE A078026 004 Jun 29, 2007
TEVA PHARMS EQ 10MG BASE A077082 001 Jun 29, 2007
EQ 20MG BASE A077082 002 Jun 29, 2007
EQ 30MG BASE A077082 003 Jun 29, 2007
EQ 40MG BASE A077082 004 Jun 29, 2007
UPSHER SMITH LABS EQ 10MG BASE A075566 001 Mar 08, 2004
EQ 20MG BASE A075566 002 Mar 08, 2004
EQ 30MG BASE A075566 003 Mar 08, 2004
EQ 40MG BASE A075566 004 Mar 08, 2004
PAXIL
APOTEX TECHNOLOGIES EQ 50MG BASE N020031 004 Dec 29, 1992

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

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DISCONTINUED DRUG PRODUCT LIST 6-296(of 393)

** See List Footnote



PAZOPANIB HYDROCHLORIDE

TABLET;ORAL

VOTRIENT

NOVARTIS PHARMS CORP EQ 400MG BASE N022465 002 Oct 19, 2009

PEGINESATIDE ACETATE

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

OMONTYS
TAKEDA PHARMS USA EQ 10MG BASE/ML (EQ 10MG BASE/ML) N202799 007 Mar 27, 2012
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N202799 008 Mar 27, 2012
OMONTYS PRESERVATIVE FREE
TAKEDA PHARMS USA EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) N202799 001 Mar 27, 2012
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) N202799 002 Mar 27, 2012
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) N202799 003 Mar 27, 2012
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) N202799 004 Mar 27, 2012
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) N202799 005 Mar 27, 2012
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) N202799 006 Mar 27, 2012
PEMIROLAST POTASSIUM
SOLUTION/DROPS;OPHTHALMIC
ALAMAST
SANTEN 0.1% N021079 001 Sep 24, 1999
PEMOLINE
TABLET;ORAL
CYLERT
ABBOTT 18.75MG N016832 001
37.5MG N016832 002
75MG N016832 003
PEMOLINE
ACTAVIS ELIZABETH 18.75MG A075595 001 Feb 28, 2000
37.5MG A075595 002 Feb 28, 2000
75MG A075595 003 Feb 28, 2000
FOSUN PHARMA 18.75MG A075286 001 Dec 27, 1999
37.5MG A075286 002 Jun 30, 1999
75MG A075286 003 Jun 30, 1999
MALLINCKRODT 18.75MG A075726 003 Mar 30, 2001
37.5MG A075726 002 Mar 30, 2001
75MG A075726 001 Mar 30, 2001
TEVA PHARMS 18.75MG A075030 003 Feb 22, 2000
37.5MG A075030 001 Jan 29, 1999
75MG A075030 002 Jan 29, 1999
VINTAGE PHARMS 18.75MG A075328 001 Apr 19, 2000
37.5MG A075328 002 Apr 19, 2000
75MG A075328 003 Apr 19, 2000
WATSON LABS 18.75MG A075287 001 Jun 13, 2001
37.5MG A075287 002 Sep 18, 2000
75MG A075287 003 Sep 18, 2000
TABLET, CHEWABLE;ORAL
CYLERT
ABBOTT 37.5MG N017703 001
PEMOLINE
ACTAVIS ELIZABETH 37.5MG A075678 001 Jul 26, 2000
TEVA PHARMS 37.5MG A075555 001 Feb 18, 2000
PENBUTOLOL SULFATE
TABLET;ORAL
LEVATOL
+ AUXILIUM PHARMS LLC 10MG ** N018976 001 Dec 30, 1987
+ 20MG ** N018976 004 Jan 05, 1989
PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
ATON 125MG N019853 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-297(of 393)

** See List Footnote



PENICILLIN G BENZATHINE

INJECTABLE;INJECTION

BICILLIN L-A

+ KING PHARMS LLC
300,000 UNITS/ML
N050141 003

WYETH AYERST
300,000 UNITS/ML
N050131 001

PERMAPEN

CASPER PHARMA LLC
600,000 UNITS/ML
N060014 001

SUSPENSION;ORAL

BICILLIN

WYETH AYERST
300,000 UNITS/5ML
N050126 002

TABLET;ORAL

BICILLIN

WYETH AYERST
200,000 UNITS
N050128 001

PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE

INJECTABLE;INJECTION

BICILLIN C-R

+ KING PHARMS LLC
150,000 UNITS/ML;150,000 UNITS/ML
N050138 002

PENICILLIN G POTASSIUM

FOR SOLUTION;ORAL

PENICILLIN

TEVA
200,000 UNITS/5ML
A060307 002

400,000 UNITS/5ML
A060307 004

PENICILLIN G POTASSIUM

MYLAN
200,000 UNITS/5ML
A060752 003

250,000 UNITS/5ML
A060752 002

400,000 UNITS/5ML
A060752 001

PUREPAC PHARM
250,000 UNITS/5ML
A061740 001

400,000 UNITS/5ML
A061740 002

PENICILLIN-2

TEVA
250,000 UNITS/5ML
A060307 003

PENTIDS '200'

APOTHECON
200,000 UNITS/5ML
A062149 001

PENTIDS '400'

APOTHECON
400,000 UNITS/5ML
A062149 002

PFIZERPEN G

PFIZER
400,000 UNITS/5ML
A060587 001

INJECTABLE;INJECTION

PENICILLIN G POTASSIUM

APOTHECON
1,000,000 UNITS/VIAL
A060362 001

5,000,000 UNITS/VIAL
A060362 003

10,000,000 UNITS/VIAL
A060362 004

20,000,000 UNITS/VIAL
A060362 002

CONSOLIDATED PHARM
500,000 UNITS/VIAL
A060806 001

1,000,000 UNITS/VIAL
A060806 002

5,000,000 UNITS/VIAL
A060806 003

10,000,000 UNITS/VIAL
A060806 004

LILLY
200,000 UNITS/VIAL
A060384 004

500,000 UNITS/VIAL
A060384 003

1,000,000 UNITS/VIAL
A060384 002

5,000,000 UNITS/VIAL
A060384 001

20,000,000 UNITS/VIAL
A060384 005

20,000,000 UNITS/VIAL
A060601 001

PARKE DAVIS
1,000,000 UNITS/VIAL
A062003 001

5,000,000 UNITS/VIAL
A062003 002

PFIZER
20,000,000 UNITS/VIAL
A060074 003

SANDOZ
1,000,000 UNITS/VIAL **
A065079 001 Aug 30, 2002

WATSON LABS INC


1,000,000 UNITS/VIAL
A062991 001 Sep 13, 1988

5,000,000 UNITS/VIAL
A062991 002 Sep 13, 1988

10,000,000 UNITS/VIAL
A062991 003 Sep 13, 1988

20,000,000 UNITS/VIAL
A062991 004 Sep 13, 1988

PFIZERPEN

PFIZER
1,000,000 UNITS/VIAL **
A060657 001

TABLET;ORAL

PENICILLIN G POTASSIUM

APOTHECON
250,000 UNITS
A060392 003

IVAX SUB TEVA PHARMS 400,000 UNITS
A060073 004

LILLY 250,000 UNITS
A060403 001

MYLAN 200,000 UNITS
A060781 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-298(of 393)

** See List Footnote



PENICILLIN G POTASSIUM

TABLET;ORAL

PENICILLIN G POTASSIUM

250,000 UNITS
A060781 002

400,000 UNITS
A060781 003

500,000 UNITS
A060781 005

800,000 UNITS
A060781 004

PUREPAC PHARM
200,000 UNITS
A061588 001

250,000 UNITS
A061588 002

400,000 UNITS
A061588 003

TEVA
200,000 UNITS
A060306 001

250,000 UNITS
A060306 002

400,000 UNITS
A060306 003

500,000 UNITS
A060306 004

WYETH AYERST
200,000 UNITS
A060413 001

250,000 UNITS
A060413 002

400,000 UNITS
A060413 003

PENTIDS '200'

APOTHECON
200,000 UNITS
A062155 001

PENTIDS '250'

APOTHECON
250,000 UNITS
A062155 002

PENTIDS '400'

APOTHECON
400,000 UNITS
A060392 004

400,000 UNITS
A062155 003

PENTIDS '800'

APOTHECON
800,000 UNITS
A060392 005

800,000 UNITS
A062155 004

PFIZERPEN G

PFIZER
50,000 UNITS
A060075 001

100,000 UNITS
A060075 002

200,000 UNITS
A060075 003

250,000 UNITS
A060075 004

400,000 UNITS
A060075 005

800,000 UNITS
A060075 006

PENICILLIN G PROCAINE

INJECTABLE;INJECTION

DURACILLIN A.S.

LILLY
300,000 UNITS/ML
A060093 001

PENICILLIN G PROCAINE

CONSOLIDATED PHARM
300,000 UNITS/ML
A060800 001

600,000 UNITS/1.2ML
A060800 002

PARKE DAVIS
300,000 UNITS/ML
A062029 001

PFIZER
300,000 UNITS/VIAL
A060099 001

1,500,000 UNITS/VIAL
A060099 002

PFIZERPEN-AS

PFIZER
300,000 UNITS/ML
A060286 001

600,000 UNITS/ML
A060286 002

PENICILLIN G SODIUM

INJECTABLE;INJECTION

PENICILLIN G SODIUM

BRISTOL MYERS SQUIBB 5,000,000 UNITS/VIAL
A061935 001

COPANOS 5,000,000 UNITS/VIAL
A061051 001

PHARMACIA AND UPJOHN 1,000,000 UNITS/VIAL
A061046 001

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

PENICILLIN G SODIUM

WATSON LABS INC
5,000,000 UNITS/VIAL
A063014 001 Sep 13, 1988

PENICILLIN V

FOR SUSPENSION;ORAL

V-CILLIN

LILLY
125MG/0.6ML
A060002 001

PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

BEEPEN-VK

GLAXOSMITHKLINE
EQ 125MG BASE/5ML
A062270 001

EQ 250MG BASE/5ML
A062270 002

BETAPEN-VK

APOTHECON
EQ 125MG BASE/5ML
A061149 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-299(of 393)

** See List Footnote



PENICILLIN V POTASSIUM

FOR SOLUTION;ORAL

BETAPEN-VK

EQ 250MG BASE/5ML
A061149 002

LEDERCILLIN VK

LEDERLE
EQ 125MG BASE/5ML
A060136 001

EQ 250MG BASE/5ML
A060136 002

PEN-VEE K

WYETH AYERST
EQ 125MG BASE/5ML
A060007 001

EQ 250MG BASE/5ML
A060007 002

PENAPAR-VK

PARKE DAVIS
EQ 125MG BASE/5ML
A062002 001

EQ 250MG BASE/5ML
A062002 002

PENICILLIN V POTASSIUM

AM ANTIBIOTICS
EQ 125MG BASE/5ML
A061529 001

EQ 250MG BASE/5ML
A061529 002

MYLAN
EQ 125MG BASE/5ML
A061624 002

EQ 250MG BASE/5ML
A061624 001

PUREPAC PHARM
EQ 125MG BASE/5ML
A061758 001

EQ 250MG BASE/5ML
A061758 002

PFIZERPEN VK

PFIZER
EQ 125MG BASE/5ML
A061815 001

EQ 250MG BASE/5ML
A061815 002

V-CILLIN K

LILLY
EQ 125MG BASE/5ML
A060004 001

EQ 250MG BASE/5ML
A060004 002

VEETIDS

APOTHECON
EQ 125MG BASE/5ML
A061410 001

EQ 250MG BASE/5ML
A061410 002

VEETIDS '125'

APOTHECON
EQ 125MG BASE/5ML
A061206 001

EQ 125MG BASE/5ML
A062153 001

VEETIDS '250'

APOTHECON
EQ 250MG BASE/5ML
A061206 002

EQ 250MG BASE/5ML
A062153 002

TABLET;ORAL

BEEPEN-VK

GLAXOSMITHKLINE
EQ 250MG BASE
A062273 001

EQ 500MG BASE
A062273 002

BETAPEN-VK

BRISTOL
EQ 250MG BASE
A061150 001

EQ 500MG BASE
A061150 002

LEDERCILLIN VK

LEDERLE
EQ 250MG BASE
A060134 001

EQ 500MG BASE
A060134 002

PEN-VEE K

WYETH AYERST
EQ 125MG BASE
A060006 001

EQ 250MG BASE
A060006 002

EQ 500MG BASE
A060006 003

PENAPAR-VK

PARKE DAVIS
EQ 250MG BASE
A062001 001

EQ 500MG BASE
A062001 002

PENICILLIN V POTASSIUM

AM ANTIBIOTICS
EQ 250MG BASE
A061528 001

EQ 500MG BASE
A061528 002

IVAX SUB TEVA PHARMS EQ 125MG BASE
A060518 001

EQ 250MG BASE
A060518 002

EQ 500MG BASE
A060518 003

MYLAN
EQ 250MG BASE
A061530 001

EQ 500MG BASE
A061530 002

PUREPAC PHARM
EQ 125MG BASE
A061571 001

EQ 250MG BASE
A061571 002

EQ 500MG BASE
A061571 003

PFIZERPEN VK

PFIZER
EQ 250MG BASE
A061836 001

EQ 500MG BASE
A061836 002

UTICILLIN VK

PHARMACIA AND UPJOHN EQ 250MG BASE
A061651 001

EQ 500MG BASE
A061651 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-300(of 393)

** See List Footnote



PENICILLIN V POTASSIUM

TABLET;ORAL

V-CILLIN K

LILLY
EQ 125MG BASE **
A060003 001

EQ 250MG BASE **
A060003 002

EQ 500MG BASE **
A060003 003

VEETIDS

APOTHECON
EQ 250MG BASE
A061411 001

EQ 500MG BASE
A061411 002

VEETIDS '250'

APOTHECON
EQ 250MG BASE
A061164 001

EQ 250MG BASE
A062156 002

VEETIDS '500'

APOTHECON
EQ 500MG BASE
A061164 002

EQ 500MG BASE
A062156 001

PENTAGASTRIN

INJECTABLE;INJECTION

PEPTAVLON

+ WYETH AYERST
0.25MG/ML **
N017048 001

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION

NEBUPENT

FRESENIUS KABI USA
600MG/VIAL
N019887 002 Mar 22, 1996

INJECTABLE;INJECTION

PENTACARINAT

ARMOUR PHARM
300MG/VIAL
A073447 001 Apr 28, 1994

PENTAMIDINE ISETHIONATE

BAXTER HLTHCARE
300MG/VIAL
A073617 001 Dec 18, 1995

HOSPIRA
300MG/VIAL
A073479 001 Jun 30, 1992

WATSON LABS
300MG/VIAL
A074303 001 Aug 17, 1995

PENTAZOCINE HYDROCHLORIDE

TABLET;ORAL

TALWIN 50

SANOFI AVENTIS US
EQ 50MG BASE
N016732 001

PENTAZOCINE LACTATE

INJECTABLE;INJECTION

TALWIN

+ HOSPIRA
EQ 30MG BASE/ML
N016194 001

PENTETATE CALCIUM TRISODIUM YB-169

INJECTABLE;INJECTION

YTTERBIUM YB 169 DTPA

3M
2mCi/ML
N017518 001

PENTOBARBITAL

ELIXIR;ORAL

NEMBUTAL

OAK PHARMS
18.2MG/5ML
A083244 001

PENTOBARBITAL SODIUM

CAPSULE;ORAL

NEMBUTAL SODIUM

OAK PHARMS
30MG
A084095 001

50MG
A084093 001

100MG
A083245 001

PENTOBARBITAL SODIUM

LANNETT
50MG
A085937 001

100MG
A085915 001

VITARINE
100MG
A083284 001

WHITEWORTH TOWN PLSN 100MG
A083338 001

SODIUM PENTOBARBITAL
ANABOLIC 100MG A084590 001

ELKINS SINN 100MG A083368 001

EVERYLIFE 100MG A083259 001

HALSEY 100MG A084677 001

IVAX SUB TEVA PHARMS 50MG
A083461 001

100MG
A083461 002

PARKE DAVIS 100MG
A084156 001

PERRIGO 100MG
A084560 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-301(of 393)

** See List Footnote



PENTOBARBITAL SODIUM

CAPSULE;ORAL

SODIUM PENTOBARBITAL

PUREPAC PHARM
100MG
A083301 001

VALEANT PHARM INTL
100MG
A083264 001

WATSON LABS
100MG
A085791 001

WYETH AYERST
100MG
A083239 001

INJECTABLE;INJECTION

PENTOBARBITAL SODIUM

ELKINS SINN
50MG/ML
A083270 001

SODIUM PENTOBARBITAL

WYETH AYERST
50MG/ML
A083261 001

SUPPOSITORY;RECTAL

NEMBUTAL

OAK PHARMS
30MG
A083247 001 Jan 25, 1982

60MG
A083247 002 Jan 25, 1982

120MG
A083247 003 Jan 25, 1982

200MG
A083247 004 Jan 25, 1982

TABLET;ORAL

PENTOBARBITAL SODIUM

VITARINE
100MG
A083285 001

SODIUM PENTOBARBITAL

NEXGEN PHARMA INC
100MG
A084238 001

PENTOLINIUM TARTRATE

INJECTABLE;INJECTION

ANSOLYSEN

WYETH AYERST
10MG/ML
N009372 001

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL

PENTOXIFYLLINE

ACTAVIS ELIZABETH
400MG
A074878 001 Jul 09, 1997

HERITAGE PHARMS INC
400MG
A074877 001 Jul 08, 1997

IMPAX LABS
400MG
A075093 001 Aug 10, 1999

PLIVA
400MG
A074874 001 May 25, 1999

TEVA
400MG
A075199 001 Sep 03, 1999

WATSON LABS
400MG
A075107 001 Sep 04, 1998

TRENTAL

+ US PHARM HOLDINGS
400MG **
N018631 001 Aug 30, 1984

PERFLUBRON

LIQUID;ORAL

IMAGENT

ALLIANCE PHARM
100%
N020091 001 Aug 13, 1993

PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE

PASTE;TOPICAL

SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS

US ARMY
50%;50%
N021084 001 Feb 17, 2000

PERGOLIDE MESYLATE

TABLET;ORAL

PERGOLIDE MESYLATE

IVAX SUB TEVA PHARMS
EQ 0.05MG BASE
A076094 001 Sep 04, 2003

EQ 0.25MG BASE
A076094 002 Sep 04, 2003

EQ 1MG BASE
A076094 003 Sep 04, 2003

PAR PHARM
EQ 0.05MG BASE
A076061 001 Nov 27, 2002

EQ 0.25MG BASE
A076061 002 Nov 27, 2002

EQ 1MG BASE
A076061 003 Nov 27, 2002

PERMAX

VALEANT PHARM INTL
EQ 0.05MG BASE
N019385 001 Dec 30, 1988

EQ 0.25MG BASE
N019385 002 Dec 30, 1988

EQ 1MG BASE
N019385 003 Dec 30, 1988

PERINDOPRIL ERBUMINE

TABLET;ORAL

ACEON

+ SYMPLMED PHARMS LLC
2MG
N020184 001 Dec 30, 1993

+
4MG
N020184 002 Dec 30, 1993

+
8MG
N020184 003 Dec 30, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-302(of 393)

** See List Footnote



PERINDOPRIL ERBUMINE

TABLET;ORAL

PERINDOPRIL ERBUMINE

APOTEX 2MG A090463 001 Aug 30, 2010
4MG A090463 002 Aug 30, 2010
8MG A090463 003 Aug 30, 2010
LUPIN LTD 2MG A078263 001 Jan 27, 2010
4MG A078263 002 Jan 27, 2010
8MG A078263 003 Jan 27, 2010
PERMETHRIN
LOTION;TOPICAL
NIX
GLAXOSMITHKLINE 1% N019435 001 Mar 31, 1986
PERPHENAZINE
CONCENTRATE;ORAL
PERPHENAZINE
PHARM ASSOC 16MG/5ML A040360 001 May 25, 2001
TRILAFON
SCHERING 16MG/5ML N011557 001
INJECTABLE;INJECTION
TRILAFON
SCHERING 5MG/ML N011213 002
SYRUP;ORAL
TRILAFON
SCHERING 2MG/5ML N011294 002
TABLET;ORAL
PERPHENAZINE
ANI PHARMS INC 2MG A089707 001 Sep 10, 1987
4MG A089708 001 Sep 10, 1987
8MG A089456 001 Sep 10, 1987
16MG A089457 001 Sep 10, 1987
TRILAFON
+ SCHERING 2MG ** N010775 001
+ 4MG ** N010775 002
+ 8MG ** N010775 003
+ 16MG ** N010775 004
TABLET, EXTENDED RELEASE;ORAL
TRILAFON
SCHERING 8MG N011361 002
PHENACEMIDE
TABLET;ORAL
PHENURONE
+ ABBVIE 500MG ** N007707 001
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE
TABLET;ORAL
AZO GANTANOL
+ ROCHE 100MG;500MG ** N013294 001 Sep 10, 1987
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE
ABLE 200MG,N/A,N/A;N/A,800MG,160MG N021105 001 Jun 26, 2001
PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE
TABLET;ORAL
AZO GANTRISIN
+ ROCHE 50MG;500MG ** N019358 001 Aug 31, 1990
PHENDIMETRAZINE TARTRATE
CAPSULE;ORAL
PHENAZINE
MAST MM 35MG A086523 001
35MG A086524 001
35MG A086525 001
PHENDIMETRAZINE TARTRATE
SANDOZ 35MG A085633 001
35MG A085694 001
35MG A085702 001
VIRTUS PHARMS 35MG A085695 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-303(of 393)

** See List Footnote



PHENDIMETRAZINE TARTRATE
CAPSULE;ORAL
PHENDIMETRAZINE TARTRATE
VITARINE 35MG A085634 001
35MG A085645 001
35MG A085670 001
35MG A086403 001
35MG A086408 001
35MG A086410 001
35MG A087424 001
SPRX-3
SOLVAY 35MG A085897 001
STATOBEX
TEVA 35MG A085507 001
X-TROZINE
SHIRE RICHWOOD 35MG A087394 001 Sep 22, 1982
CAPSULE, EXTENDED RELEASE;ORAL
BONTRIL
VALEANT 105MG A088021 001 Sep 21, 1982
MELFIAT-105
NUMARK 105MG A087487 001 Oct 13, 1982
PHENDIMETRAZINE TARTRATE
GRAHAM DM 105MG A087214 001 May 26, 1982
105MG A088020 001 Aug 16, 1982
105MG A088028 001 Aug 16, 1982
105MG A088062 001 Sep 13, 1982
105MG A088063 001 Sep 10, 1982
105MG A088111 001 Oct 18, 1982
VIRTUS PHARMS 105MG A087378 001
SPRX-105
NUMARK 105MG A088024 001 Dec 22, 1982
X-TROZINE L.A.
SHIRE RICHWOOD 105MG A087371 001 Aug 24, 1982
TABLET;ORAL
ADPHEN
FERNDALE LABS 35MG A083655 001
ALPHAZINE
SANDOZ 35MG A085034 001
CAM-METRAZINE
ABC HOLDING 35MG A085511 001
CAMALL 35MG A085756 001
CHARTWELL RX 35MG A083922 001
35MG A085318 001
35MG A085320 001
35MG A085321 001
DI-METREX
PVT FORM 35MG A085698 001
MELFIAT
NUMARK 35MG A083790 002
METRA
FOREST PHARMS 35MG A083754 001
PHENAZINE
MAST MM 35MG A087305 001
PHENAZINE-35
ABC HOLDING 35MG A085512 001
PHENDIMETRAZINE TARTRATE
BARR 35MG A083644 001
35MG A083684 001
35MG A083686 001
35MG A083687 001
35MG A084831 001
35MG A084834 001
35MG A084835 001
CHARTWELL RX 35MG A085761 001
35MG A085941 001 Jun 27, 1983
FERNDALE LABS 35MG A086834 001 Sep 15, 1983
INWOOD LABS 35MG A084740 001
35MG A084741 001
35MG A084742 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-304(of 393)

** See List Footnote



PHENDIMETRAZINE TARTRATE

TABLET;ORAL

PHENDIMETRAZINE TARTRATE

35MG
A084743 001

IVAX PHARMS 35MG
A085611 001

35MG
A085612 001

IVAX SUB TEVA PHARMS 35MG
A083682 001

KV PHARM 35MG
A084138 001

35MG
A084141 001

35MG
A085525 001

MFG CHEMISTS 35MG
A085914 001

NEXGEN PHARMA INC 35MG
A086020 001

NUMARK 35MG
A083790 001

PVT FORM 35MG
A085199 001

35MG
A085697 001

SANDOZ 35MG
A085402 001

35MG
A085830 001

35MG
A086370 001

SOLVAY 35MG
A083993 001

USL PHARMA 35MG
A083805 001

35MG
A084398 001

35MG
A084399 001

VIRTUS PHARMS 35MG
A085497 001

35MG
A086365 001

VITARINE 35MG
A085519 001

35MG
A086005 001

35MG
A086106 001

WATSON LABS 35MG
A085767 001

35MG
A085768 001

35MG
A085770 001

35MG
A085773 001

PLEGINE

WYETH AYERST 35MG **
N012248 001

STATOBEX

TEVA 35MG
A086013 001

STATOBEX-G

TEVA 35MG
A085095 001

X-TROZINE

SHIRE RICHWOOD 35MG
A086550 001

35MG
A086551 001

35MG
A086552 001

35MG
A086553 001

35MG
A086554 001

PHENINDIONE

TABLET;ORAL

HEDULIN

SANOFI AVENTIS US 50MG
N008767 002

PHENMETRAZINE HYDROCHLORIDE

TABLET;ORAL

PRELUDIN

BOEHRINGER INGELHEIM 25MG
N010460 005

TABLET, EXTENDED RELEASE;ORAL

PRELUDIN

BOEHRINGER INGELHEIM 50MG
N011752 004

75MG
N011752 003

PHENPROCOUMON

TABLET;ORAL

LIQUAMAR

ORGANON USA INC 3MG
N011228 001

PHENSUXIMIDE

CAPSULE;ORAL

MILONTIN

PARKE DAVIS 500MG
N008855 004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-305(of 393)

** See List Footnote



PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

FASTIN

GLAXOSMITHKLINE
30MG **
N017352 001

OBESTIN-30

FERNDALE LABS
30MG
A087144 001

OBY-TRIM

SHIRE RICHWOOD
30MG
A087764 001 Mar 18, 1982

ONA-MAST

MAST MM
30MG
A086511 001

30MG
A086516 001

PHENTERMINE HYDROCHLORIDE

ABC HOLDING
30MG
A085411 001

ABLE
15MG
A040497 001 Mar 13, 2003

30MG
A040403 001 Aug 30, 2001

30MG
A040427 001 Aug 30, 2001

CAMALL
15MG
A086735 001

30MG
A087226 001

CHARTWELL RX
18.75MG
A088576 001 May 23, 1984

30MG
A085417 001

30MG
A086732 002

30MG
A087215 001

37.5MG
A087915 001 Dec 22, 1983

37.5MG
A087918 001 Dec 22, 1983

37.5MG
A087930 001 Oct 14, 1983

37.5MG
A088610 001 Jun 04, 1984

37.5MG
A088611 001 Jun 04, 1984

37.5MG
A088625 001 Aug 23, 1984

DURAMED PHARMS BARR


30MG
A088948 001 Apr 25, 1986

ELITE LABS INC


15MG
A040460 001 Jan 14, 2003

30MG
A040227 001 Jun 18, 1997

30MG
A040448 001 Jan 22, 2003

IVAX PHARMS
30MG
A086329 001

SANDOZ
30MG
A087208 001

30MG
A087223 001

37.5MG
A088414 001 Oct 19, 1983

SUN PHARM INDUSTRIES
37.5MG
A040527 001 Oct 23, 2003

TEVA
30MG
A086911 001

30MG
A087126 001

30MG
A087777 001 Nov 01, 1985

30MG
A088612 001 Apr 04, 1984

30MG
A088613 001 Apr 09, 1984

30MG
A088614 001 Apr 09, 1984

TG UNITED INC
30MG
A040083 001 Mar 07, 1997

UPSHER SMITH LABS
30MG
A084487 001 Apr 09, 1982

30MG
A088430 001 Mar 27, 1984

USL PHARMA
30MG
A088797 001 Dec 10, 1984

VITARINE
30MG
A087202 001

30MG
A087235 001

WATSON LABS
30MG
A086740 001 Mar 21, 1985

TABLET;ORAL

ONA-MAST

MAST MM
8MG
A086260 001

PHENTERMINE HYDROCHLORIDE

ABLE
37.5MG
A040402 001 Aug 30, 2001

ACTAVIS ELIZABETH
37.5MG
A040276 001 Nov 25, 1998

CHARTWELL RX
8MG
A083923 001

8MG
A085319 001

37.5MG
A087805 001 Dec 06, 1982

37.5MG
A088596 001 Apr 04, 1984

IVAX PHARMS
8MG
A085553 001

SANDOZ
8MG
A085671 001

8MG
A085689 001

SANDOZ INC
30MG
A088605 001 Sep 28, 1987

USL PHARMA
8MG
A083804 001

37.5MG
A088910 001 Jul 17, 1985

37.5MG
A088917 001 Jul 17, 1985

VITARINE
8MG
A086453 001

8MG
A086456 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-306(of 393)

** See List Footnote



PHENTERMINE HYDROCHLORIDE

TABLET;ORAL

PHENTERMINE HYDROCHLORIDE

WATSON LABS 8MG A085739 001

TORA
SOLVAY 8MG A084035 001

WILPO
+ SANDOZ 8MG ** N012737 001

TABLET, ORALLY DISINTEGRATING;ORAL

SUPRENZA

CITIUS PHARMS 15MG **
N202088 001 Jun 13, 2011

30MG **
N202088 002 Jun 13, 2011

37.5MG **
N202088 003 Mar 27, 2012

PHENTERMINE RESIN COMPLEX

CAPSULE, EXTENDED RELEASE;ORAL

IONAMIN

UCB INC
EQ 15MG BASE **
N011613 004

EQ 30MG BASE **
N011613 002

PHENTERMINE RESIN 30

QUANTUM PHARMICS
EQ 30MG BASE
A089120 001 Feb 04, 1988

PHENTERMINE RESIN COMPLEX

LANNETT CO INC
EQ 15MG BASE
A040872 001 Jul 28, 2011

EQ 30MG BASE
A040872 002 Jul 28, 2011

PHENTOLAMINE MESYLATE

INJECTABLE;INJECTION

REGITINE

+ NOVARTIS
5MG/VIAL **
N008278 003

PHENYL AMINOSALICYLATE

POWDER;ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC
50%
N011695 002

TABLET;ORAL

PHENY-PAS-TEBAMIN

PHARM RES ASSOC
500MG
N011695 003

PHENYLBUTAZONE

CAPSULE;ORAL

AZOLID

SANOFI AVENTIS US
100MG
A087260 001

BUTAZOLIDIN

NOVARTIS
100MG
N008319 009

PHENYLBUTAZONE

FOSUN PHARMA
100MG
A087774 001 Jun 16, 1982

IVAX PHARMS
100MG
A088218 001 Jun 24, 1983

SUN PHARM INDUSTRIES
100MG
A088994 001 Dec 04, 1985

WATSON LABS
100MG
A087756 001 Dec 17, 1982

TABLET;ORAL

AZOLID

SANOFI AVENTIS US
100MG
A087091 001

BUTAZOLIDIN

NOVARTIS
100MG
N008319 008

PHENYLBUTAZONE

FOSUN PHARMA
100MG
A084339 001

SUN PHARM INDUSTRIES
100MG
A088863 001 Dec 04, 1985

WATSON LABS
100MG
A086151 001

100MG
A087674 001 Apr 21, 1982

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENERGAN VC

+ ANI PHARMS
5MG/5ML;6.25MG/5ML **
N008604 003 Apr 02, 1984

PHERAZINE VC

HALSEY
5MG/5ML;6.25MG/5ML
A088868 001 Mar 02, 1987

PROMETH VC PLAIN

G AND W LABS INC
5MG/5ML;6.25MG/5ML
A088761 001 Nov 08, 1984

PROMETHAZINE VC PLAIN

CENCI
5MG/5ML;6.25MG/5ML
A088815 001 Nov 22, 1985

WOCKHARDT
5MG/5ML;6.25MG/5ML
A088897 001 Jan 04, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-307(of 393)

** See List Footnote



PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE

SOLUTION/DROPS;OPHTHALMIC

PREFRIN-A

ALLERGAN
0.12%;0.1%
N007953 001

PHENYTOIN

SUSPENSION;ORAL

DILANTIN-30

PARKE DAVIS
30MG/5ML
N008762 002

PHENYTOIN

ACTAVIS MID ATLANTIC
125MG/5ML
A089892 001 Sep 25, 1992

PHENYTOIN SODIUM

CAPSULE;ORAL

DIPHENYLAN SODIUM

LANNETT
30MG PROMPT
A080857 001

100MG PROMPT
A080857 002

EXTENDED PHENYTOIN SODIUM

ANI PHARMS INC
100MG EXTENDED
A040435 001 Jun 20, 2003

100MG EXTENDED
A089441 001 Dec 18, 1986

WOCKHARDT
30MG EXTENDED
A040759 001 Dec 18, 2007

WOCKHARDT USA
100MG EXTENDED
A040732 001 Jan 30, 2008

PHENYTEX

WATSON LABS
100MG EXTENDED
A088711 001 Dec 21, 1984

PHENYTOIN SODIUM

PHARMERAL
100MG PROMPT
A085435 001

WATSON LABS
100MG PROMPT
A085894 001

PROMPT PHENYTOIN SODIUM

ANI PHARMS INC
100MG PROMPT
A080259 001

WATSON LABS
100MG PROMPT
A080905 001

INJECTABLE;INJECTION

DILANTIN

PARKE DAVIS
50MG/ML
N010151 001

PHENYTOIN SODIUM

FRESENIUS KABI USA
50MG/ML
A089003 001 May 31, 1985

HOSPIRA
50MG/ML
A089521 001 Mar 17, 1987

50MG/ML
A089744 001 Dec 18, 1987

MARSAM PHARMS LLC
50MG/ML
A089501 001 Oct 13, 1987

50MG/ML
A089779 001 Nov 27, 1992

SMITH AND NEPHEW
50MG/ML
A088519 001 Dec 19, 1984

50MG/ML
A088521 001 Dec 18, 1984

SOLOPAK
50MG/ML
A088520 001 Dec 17, 1984

WARNER CHILCOTT
50MG/ML
A089900 001 Mar 30, 1990

WATSON LABS
50MG/ML
A085434 001

PHYTONADIONE

INJECTABLE;INJECTION

AQUAMEPHYTON

+ TELIGENT
1MG/0.5ML **
N012223 002

+
10MG/ML **
N012223 001

KONAKION

ROCHE
1MG/0.5ML
N011745 001

10MG/ML
N011745 003

PHYTONADIONE

GLAXOSMITHKLINE
1MG/0.5ML
A084060 001

10MG/ML
A084060 002

VITAMIN K1

HOSPIRA
10MG/ML
A087956 001 Jul 25, 1983

PILOCARPINE

INSERT, EXTENDED RELEASE;OPHTHALMIC

OCUSERT PILO-20
AKORN 5MG N017431 001

OCUSERT PILO-40
AKORN 11MG N017548 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-308(of 393)

** See List Footnote



PILOCARPINE HYDROCHLORIDE

GEL;OPHTHALMIC

PILOPINE HS

ALCON 4%
N018796 001 Oct 01, 1984

PINACIDIL

CAPSULE, EXTENDED RELEASE;ORAL

PINDAC

LEO PHARM
12.5MG
N019456 001 Dec 28, 1989

25MG
N019456 002 Dec 28, 1989

PINDOLOL

TABLET;ORAL

PINDOLOL

G AND W LABS INC
5MG
A073661 001 Oct 31, 1993

5MG
A073687 001 Feb 26, 1993

5MG
A074123 001 Apr 17, 1997

10MG
A073661 002 Oct 31, 1993

10MG
A073687 002 Feb 26, 1993

10MG
A074123 002 Apr 17, 1997

MYLAN PHARMS INC


5MG
A074013 001 Sep 24, 1992

10MG
A074018 001 Sep 24, 1992

NOSTRUM LABS
5MG
A074474 001 Oct 28, 1996

10MG
A074474 002 Oct 28, 1996

PUREPAC PHARM
5MG
A074125 001 Apr 28, 1993

10MG
A074125 002 Apr 28, 1993

WATSON LABS
5MG
A074437 001 Feb 27, 1995

10MG
A074437 002 Feb 27, 1995

VISKEN

+ NOVARTIS
5MG **
N018285 001 Sep 03, 1982

+
10MG **
N018285 002 Sep 03, 1982

PIPECURONIUM BROMIDE

INJECTABLE;INJECTION

ARDUAN

ORGANON USA INC
10MG/VIAL
N019638 001 Jun 26, 1990

PIPERACETAZINE

TABLET;ORAL

QUIDE

DOW PHARM
10MG
N013615 001

25MG
N013615 002

PIPERACILLIN SODIUM

INJECTABLE;INJECTION

PIPRACIL

WYETH PHARMS INC
EQ 2GM BASE/VIAL
A062750 001 Oct 13, 1987

+
EQ 2GM BASE/VIAL **
N050545 002

EQ 3GM BASE/VIAL
A062750 002 Oct 13, 1987

+
EQ 3GM BASE/VIAL **
N050545 003

EQ 4GM BASE/VIAL
A062750 003 Oct 13, 1987

+
EQ 4GM BASE/VIAL **
N050545 004

+
EQ 40GM BASE/VIAL **
N050545 006 Sep 30, 1985

PIPERAZINE CITRATE

SYRUP;ORAL

ANTEPAR

GLAXOSMITHKLINE
EQ 500MG BASE/5ML
N009102 001

BRYREL

SANOFI AVENTIS US
EQ 500MG BASE/5ML
N017796 001

MULTIFUGE

BLULINE
EQ 500MG BASE/5ML
N009452 001

PIPERAZINE CITRATE

ALPHARMA US PHARMS
EQ 500MG BASE/5ML
A080774 001

LANNETT
EQ 500MG BASE/5ML
A080963 001

LUITPOLD
EQ 500MG BASE/5ML
A080671 001

VERMIDOL

SOLVAY
EQ 500MG BASE/5ML
A080992 001

TABLET;ORAL

ANTEPAR

GLAXOSMITHKLINE
EQ 500MG BASE
N009102 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-309(of 393)

** See List Footnote



PIPERAZINE CITRATE

TABLET;ORAL

PIPERAZINE CITRATE

IMPAX LABS EQ 250MG BASE A080874 001

PIPERONYL BUTOXIDE; PYRETHRINS

AEROSOL;TOPICAL

RID MOUSSE

BAYER HEALTHCARE LLC 4%;EQ 0.33% BASE N021043 001 Mar 07, 2000

PIPOBROMAN

TABLET;ORAL

VERCYTE

ABBOTT 10MG N016245 001

25MG N016245 002

PIRBUTEROL ACETATE

AEROSOL, METERED;INHALATION

MAXAIR

MEDICIS EQ 0.2MG BASE/INH N020014 001 Nov 30, 1992

VALEANT PHARMS EQ 0.2MG BASE/INH N019009 001 Dec 30, 1986

PIRFENIDONE

TABLET;ORAL

ESBRIET

+ GENENTECH INC 534MG N208780 002 Jan 11, 2017

PIROXICAM

CAPSULE;ORAL

PIROXICAM

CYCLE PHARMS LTD 10MG A073651 001 Feb 26, 1993

20MG A073651 002 Feb 26, 1993

EGIS 10MG A074808 001 Jul 08, 1997

20MG A074808 002 Jul 08, 1997

IVAX SUB TEVA PHARMS 10MG A074148 001 Jun 03, 1996

20MG A074148 002 Jun 03, 1996

MYLAN 10MG A074043 001 Sep 22, 1992

10MG A074102 001 Jul 31, 1992



20MG A074043 002 Sep 22, 1992

20MG A074102 002 Jul 31, 1992



SCS 10MG A074036 001 May 29, 1992

20MG A074036 002 May 29, 1992

TEVA 10MG A073637 001 Jan 28, 1994



20MG A073638 001 Jan 28, 1994

TEVA PHARMS 10MG A074103 001 Aug 28, 1992

20MG A074103 002 Aug 28, 1992

WATSON LABS 10MG A074287 001 May 16, 1996

10MG A074460 001 Sep 29, 1995

20MG A074287 002 May 16, 1996

20MG A074460 002 Sep 29, 1995



PITAVASTATIN SODIUM

TABLET;ORAL

NIKITA

+ LUPIN LTD EQ 1MG BASE N209875 001 Aug 04, 2017

+ EQ 2MG BASE N209875 002 Aug 04, 2017

+ EQ 4MG BASE N209875 003 Aug 04, 2017



PLICAMYCIN

INJECTABLE;INJECTION

MITHRACIN

PFIZER 2.5MG/VIAL N050109 001

PODOFILOX

SOLUTION;TOPICAL

PODOFILOX

BAUSCH AND LOMB INC 0.5% A090184 001 Jul 21, 2010

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-310(of 393)

** See List Footnote



POLYESTRADIOL PHOSPHATE

INJECTABLE;INJECTION

ESTRADURIN

WYETH AYERST 40MG/AMP N010753 001

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

POLYETHYLENE GLYCOL 3350

BRECKENRIDGE PHARM 17GM/SCOOPFUL A077736 001 May 26, 2006

PADDOCK LLC 17GM/SCOOPFUL A090567 001 Oct 15, 2009



TEVA PHARMS 17GM/SCOOPFUL A077445 001 May 04, 2006

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

FOR SOLUTION;ORAL

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

MYLAN 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090409 001 Apr 02, 2010

BOT

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

FOR SOLUTION;ORAL

CLENZ-LYTE

PADDOCK LLC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090769 001 Jun 07, 2010

BOT;22.74GM/BOT

SOLUTION;ORAL

OCL

HOSPIRA 6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284 001 Apr 30, 1986

100ML;1.29GM/100ML

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

ANHYDROUS

FOR SOLUTION;ORAL

COLYTE

MYLAN SPECIALITY LP 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983 005 Oct 26, 1984

T;2.92GM/PACKET;11.36GM/PACKET

227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983 004 Oct 26, 1984

KET;5.53GM/PACKET;21.5GM/PACKET

227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 010 Jan 31, 1989

M/BOT;21.5GM/BOT

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 007 Jun 12, 1987

BOT;22.72GM/BOT

360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983 006 Oct 26, 1984

ET;8.76GM/PACKET;34.08GM/PACKET

COLYTE-FLAVORED

MYLAN SPECIALITY LP 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 008 Nov 14, 1991

M/BOT;21.5GM/BOT

240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 009 Nov 14, 1991

BOT;22.72GM/BOT

PEG 3350 AND ELECTROLYTES



MYLAN 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090928 001 Jan 28, 2010

BOT;22.74GM/BOT

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES



PADDOCK LLC 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090712 001 Feb 25, 2010

BOT;22.72GM/BOT

FOR SUSPENSION;ORAL

CO-LAV

VINTAGE PHARMS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A073428 001 Jan 28, 1992

BOT;22.72GM/BOT

COLOVAGE

DYNAPHARM 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC A071320 001 Apr 20, 1988

KET;5.53GM/PACKET;21.5GM/PACKET

E-Z-EM PREP LYTE



E Z EM 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A071278 001 Nov 21, 1988

BOT;22.74GM/BOT

GLYCOPREP

GOLDLINE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A072319 001 Dec 23, 1988

BOT;22.74GM/BOT

GO-EVAC

VINTAGE PHARMS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073433 001 Apr 28, 1992

BOT;22.74GM/BOT

PEG-LYTE

SANDOZ 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A073098 001 Aug 31, 1993

BOT;22.74GM/BOT

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-311(of 393)

** See List Footnote



POLYMYXIN B SULFATE

INJECTABLE;INJECTION

AEROSPORIN

GLAXOSMITHKLINE
EQ 500,000 U BASE/VIAL
A062036 001

POWDER;FOR RX COMPOUNDING

POLY-RX

X GEN PHARMS
100,000,000 UNITS/BOT
A061578 001

POLYMYXIN B SULFATE

PADDOCK LLC
100,000,000 UNITS/BOT
A062455 001 Jul 27, 1983

POLYTHIAZIDE

TABLET;ORAL

RENESE

PFIZER
1MG
N012845 001

2MG
N012845 002

4MG
N012845 003

POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

MINIZIDE

PFIZER
0.5MG;EQ 1MG BASE
N017986 001

0.5MG;EQ 2MG BASE
N017986 002

0.5MG;EQ 5MG BASE
N017986 003

POLYTHIAZIDE; RESERPINE

TABLET;ORAL

RENESE-R

PFIZER
2MG;0.25MG
N013636 001

POTASSIUM AMINOSALICYLATE

CAPSULE;ORAL

PASKALIUM

GLENWOOD
500MG
N009395 004

POWDER;ORAL

POTASSIUM AMINOSALICYLATE

HEXCEL
100%
A080098 001

TABLET;ORAL

PASKALIUM

GLENWOOD
1GM
N009395 003

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

K-LEASE

SAVAGE LABS 8MEQ
A073398 001 Jan 28, 1992

10MEQ
A072427 001 Mar 28, 1990

POTASSIUM CHLORIDE

NESHER PHARMS 10MEQ
A070980 001 Feb 17, 1987

TEVA 8MEQ
A073531 001 Apr 26, 1996

10MEQ
A073532 001 Apr 26, 1996

FOR SUSPENSION, EXTENDED RELEASE;ORAL

MICRO-K LS

KV PHARM
20MEQ/PACKET
N019561 003 Aug 26, 1988

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

ABRAXIS PHARM
2MEQ/ML
A080204 001

2MEQ/ML
A084290 001

2MEQ/ML
A086713 001

2MEQ/ML
A086714 001

2MEQ/ML
A087787 001 Apr 20, 1982

2MEQ/ML
A087885 001 Feb 03, 1983

AKORN
2MEQ/ML
A088286 001 Sep 05, 1985

BAXTER HLTHCARE
2MEQ/ML
A080203 001

2MEQ/ML
A085499 001

FRESENIUS KABI USA
2MEQ/ML
A087817 001 Oct 20, 1982

GD SEARLE LLC
1MEQ/ML
A086219 001

2MEQ/ML
A086219 002

2MEQ/ML
A086220 002

3MEQ/ML
A086219 003

3MEQ/ML
A086220 001

4MEQ/ML
A086219 004

HOSPIRA
1MEQ/ML
A080205 003

1MEQ/ML
A083345 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-312(of 393)

** See List Footnote



POTASSIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

1.5MEQ/ML
A083345 001

2MEQ/ML
A083345 002

2.4MEQ/ML
A080205 004

3.2MEQ/ML
A080205 005

INTL MEDICATION
2MEQ/ML
A083163 001

LILLY
2MEQ/ML
N007865 002

LUITPOLD
2MEQ/ML
A080221 001

2MEQ/ML
A080736 001

2MEQ/ML
A087584 001

2MEQ/ML
A087585 001

MILES
1MEQ/ML
A080195 002

2MEQ/ML
A080195 001

3MEQ/ML
A080195 003

4MEQ/ML
A080195 004

PHARMA SERVE NY
2MEQ/ML
A086297 001

2MEQ/ML
A087362 001 Mar 08, 1983

WATSON LABS
2MEQ/ML
A086208 001

2MEQ/ML
A089163 001 Mar 10, 1988

2MEQ/ML
A089421 001 Jan 02, 1987

3MEQ/ML
A086210 001

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

+ ICU MEDICAL INC
2.24GM/100ML
N020161 003 Aug 11, 1998

TABLET, EXTENDED RELEASE;ORAL

K+10

FUTURE PAK
10MEQ
A070999 001 Oct 22, 1987

K+8

FUTURE PAK
8MEQ
A070998 001 Jan 25, 1993

KAON CL

SAVAGE LABS
6.7MEQ
N017046 001

KAON CL-10

SAVAGE LABS
10MEQ
N017046 002

KLOTRIX

APOTHECON
10MEQ
N017850 001

POTASSIUM CHLORIDE

COPLEY PHARM
8MEQ
A070618 001 Sep 09, 1987

NESHER PHARMS
20MEQ
A076044 001 Apr 05, 2002

+ SCHERING
10MEQ **
N019439 002 Jun 13, 1986

+
20MEQ **
N019439 001 Jun 13, 1986

SLOW-K

NOVARTIS
8MEQ
N017476 002

TEN-K

NOVARTIS
10MEQ
N019381 001 Apr 16, 1986

POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 37MG/100ML;900MG/100ML N019708 001 Sep 29, 1989

POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER



B BRAUN 75MG/100ML;900MG/100ML
N019708 002 Sep 29, 1989

POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 110MG/100ML;900MG/100ML
N019708 003 Sep 29, 1989

POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 220MG/100ML;900MG/100ML
N019708 005 Sep 29, 1989

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%

+ BAXTER HLTHCARE 224MG/100ML;900MG/100ML
N017648 003

POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUN 300MG/100ML;900MG/100ML
N019708 006 Sep 29, 1989

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

B BRAUN 75MG/100ML;900MG/100ML N018722 001 Nov 09, 1982

BAXTER HLTHCARE 75MG/100ML;900MG/100ML N017648 004

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER

B BRAUN 150MG/100ML;900MG/100ML N018722 002 Nov 09, 1982

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

B BRAUN 220MG/100ML;900MG/100ML N018722 003 Nov 09, 1982

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

B BRAUN 300MG/100ML;900MG/100ML N018722 004 Nov 09, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-313(of 393)

** See List Footnote



POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

INJECTABLE;INJECTION

THAM-E
HOSPIRA 370MG/VIAL;1.75GM/VIAL;36GM/VIAL N013025 001
POTASSIUM CITRATE
FOR SOLUTION;ORAL
POTASSIUM CITRATE
+ UT SW MEDCTR 10MEQ/PACKET ** N019647 002 Oct 13, 1988
+ 20MEQ/PACKET ** N019647 001 Oct 13, 1988
POTASSIUM IODIDE
SOLUTION;ORAL
POTASSIUM IODIDE
ROXANE 1GM/ML ** N018551 001 Feb 19, 1982
TABLET;ORAL
THYRO-BLOCK
MEDA PHARMS 130MG N018307 001
POTASSIUM PERCHLORATE
CAPSULE;ORAL
PERCHLORACAP
MALLINCKRODT 200MG N017551 001
POVIDONE-IODINE
SOLUTION;TOPICAL
E-Z PREP
CLINIPAD 10% N019382 001 Jul 25, 1989
SPONGE;TOPICAL
E-Z PREP
CLINIPAD 5% N019382 002 Jul 25, 1989
E-Z PREP 220
CLINIPAD 5% N019382 003 Jul 25, 1989
PRALIDOXIME CHLORIDE
INJECTABLE;INJECTION
PRALIDOXIME CHLORIDE
BAXTER HLTHCARE CORP 300MG/ML N018799 001 Dec 13, 1982
TABLET;ORAL
PROTOPAM CHLORIDE
WYETH AYERST 500MG N014122 002
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
MIRAPEX
BOEHRINGER INGELHEIM 1.25MG N020667 004 Jul 01, 1997
PRAMIPEXOLE DIHYDROCHLORIDE
ACTAVIS GRP PTC 0.125MG A091254 001 Nov 30, 2010
0.25MG A091254 002 Nov 30, 2010
0.5MG A091254 003 Nov 30, 2010
0.75MG A091254 004 Nov 30, 2010
1MG A091254 005 Nov 30, 2010
1.5MG A091254 006 Nov 30, 2010
SANDOZ 0.125MG A090190 001 Jul 06, 2010
0.25MG A090190 002 Jul 06, 2010
0.5MG A090190 003 Jul 06, 2010
0.75MG A090190 006 Oct 08, 2010
1MG A090190 004 Jul 06, 2010
1.5MG A090190 005 Jul 06, 2010
WATSON LABS 0.125MG A078551 001 Oct 08, 2010
0.25MG A078551 002 Oct 08, 2010
0.5MG A078551 003 Oct 08, 2010
1MG A078551 004 Oct 08, 2010
1.5MG A078551 005 Oct 08, 2010
PRAMLINTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SYMLIN
ASTRAZENECA AB EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) N021332 001 Mar 16, 2005

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-314(of 393)

** See List Footnote



PRAVASTATIN SODIUM

TABLET;ORAL

PRAVACHOL

+ BRISTOL MYERS SQUIBB 10MG ** N019898 002 Oct 31, 1991

PRAVASTATIN SODIUM

MYLAN 10MG A077013 001 Oct 23, 2006

20MG A077013 002 Oct 23, 2006

40MG A077013 003 Oct 23, 2006

80MG A077013 004 Dec 28, 2007

PLIVA HRVATSKA DOO 10MG A077730 001 Nov 21, 2006

20MG A077730 002 Nov 21, 2006

30MG A077730 003 Nov 21, 2006

40MG A077730 005 Nov 21, 2006

RANBAXY LABS LTD 10MG A076445 001 Apr 23, 2007

20MG A076445 002 Apr 23, 2007

40MG A076445 003 Apr 23, 2007

80MG A076445 004 Apr 23, 2007



PRAZEPAM

CAPSULE;ORAL

CENTRAX

PARKE DAVIS 5MG N018144 001

10MG N018144 002

20MG N018144 003 May 10, 1982

PRAZEPAM

USL PHARMA 5MG A070427 001 Nov 06, 1987

10MG A070428 001 Nov 06, 1987

TABLET;ORAL

CENTRAX

PARKE DAVIS 10MG N017415 001

PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

PRAZOSIN HYDROCHLORIDE

AM THERAP EQ 1MG BASE A072782 001 May 16, 1989

EQ 2MG BASE A072783 001 May 16, 1989

EQ 5MG BASE A072784 001 May 16, 1989

ANI PHARMS INC EQ 1MG BASE A072577 002 May 16, 1989

EQ 2MG BASE A072577 001 May 16, 1989

EQ 5MG BASE A072577 003 May 16, 1989

DAVA PHARMS INC EQ 1MG BASE A072705 001 May 16, 1989

EQ 2MG BASE A072706 001 May 16, 1989

EQ 5MG BASE A072707 001 May 16, 1989

PUREPAC PHARM EQ 1MG BASE A072991 001 May 16, 1989

EQ 2MG BASE A072921 001 May 16, 1989

EQ 5MG BASE A072992 001 May 16, 1989

WATSON LABS EQ 1MG BASE A072352 001 May 16, 1989

EQ 2MG BASE A072333 001 May 16, 1989

EQ 5MG BASE A072609 001 May 16, 1989

TABLET, EXTENDED RELEASE;ORAL



MINIPRESS XL

PFIZER 2.5MG N019775 001 Jan 29, 1992

5MG N019775 002 Jan 29, 1992

PREDNISOLONE

CREAM;TOPICAL

METI-DERM

SCHERING 0.5% N010209 002

SYRUP;ORAL

PREDNISOLONE

APOTEX INC 5MG/5ML A040570 001 Aug 25, 2005

15MG/5ML A040571 001 Aug 25, 2005

IVAX SUB TEVA PHARMS 15MG/5ML A040287 001 May 28, 1999

NESHER PHARMS 5MG/5ML A040423 001 Oct 22, 2001



15MG/5ML A040364 001 Apr 10, 2002

TEVA PHARMS 15MG/5ML A040322 001 Jan 19, 2000



WE PHARMS 15MG/5ML A040192 001 May 28, 1998

PRELONE

MURO 5MG/5ML A089654 001 Jan 17, 1989

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-315(of 393)

** See List Footnote



PREDNISOLONE

TABLET;ORAL

CORTALONE

HALSEY 1MG
A080304 003

2.5MG
A080304 002

5MG
A080304 001

DELTA-CORTEF

PHARMACIA AND UPJOHN 5MG
N009987 004

FERNISOLONE-P

FERNDALE LABS 5MG
A083941 001

PREDNISOLONE

AUROLIFE PHARMA LLC 5MG
A084773 001

BARR 5MG
A084426 002

BUNDY 5MG
A083675 001

CHARTWELL RX 5MG
A084542 001

ELKINS SINN 5MG
A080625 001

EVERYLIFE 1MG
A084439 001

2.5MG
A084439 002

5MG
A084439 003

FERRANTE 2.5MG
A080562 001

5MG
A080562 002

FOSUN PHARMA 5MG
A080339 001

HEATHER 5MG
A080326 001

IMPAX LABS 5MG
A080780 001

INWOOD LABS 5MG
A080748 001

IVAX SUB TEVA PHARMS 5MG
A080378 001

LANNETT 5MG A080531 002

MARSHALL PHARMA 5MG A080307 001

PANRAY 1MG A080351 001

5MG A080351 002

PHOENIX LABS NY 5MG A080322 001

PUREPAC PHARM 5MG A080325 001

PVT FORM 5MG A080211 001

ROXANE 5MG A080327 002

SPERTI 1MG A080358 001

2.5MG A080358 002

5MG A080358 003

SUPERPHARM 5MG A088892 001 Feb 26, 1985

TABLICAPS 5MG A085170 001

TEVA 5MG A080398 001

UDL 5MG A087987 001 Jan 18, 1983

VALEANT PHARM INTL 5MG A080236 001

VITARINE 5MG A080534 001

WATSON LABS 5MG A085085 002

5MG A085415 001

5MG A085416 001

WEST WARD 5MG A080324 001

WHITEWORTH TOWN PLSN 5MG
A080342 001

STERANE

PFIZER
5MG
N009996 001

PREDNISOLONE ACETATE

INJECTABLE;INJECTION

METICORTELONE

SCHERING
25MG/ML
N010255 002

PREDNISOLONE ACETATE

AKORN
25MG/ML
A083032 001

50MG/ML
A084492 001

BEL MAR
25MG/ML
A083738 001

50MG/ML
A083738 002

CENT PHARMS
25MG/ML
A084717 001

50MG/ML
A084717 002

WATSON LABS
25MG/ML
A083398 001

25MG/ML
A083654 001

40MG/ML
A083767 001

50MG/ML
A083764 001

50MG/ML
A085781 001

STERANE

PFIZER
25MG/ML
N011446 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-316(of 393)

** See List Footnote



PREDNISOLONE ACETATE

SUSPENSION;ORAL

FLO-PRED

TARO
EQ 5MG BASE/5ML
N022067 001 Jan 17, 2008

EQ 15MG BASE/5ML
N022067 002 Jan 17, 2008

SUSPENSION/DROPS;OPHTHALMIC

ECONOPRED

ALCON
0.125%
N017468 001

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

CETAPRED

ALCON
0.25%;10%
A087771 001 Aug 06, 1993

METIMYD

SCHERING
0.5%;10%
N010210 002 Sep 09, 1984

PREDSULFAIR

PHARMAFAIR
0.5%;10%
A088032 001 Apr 15, 1983

VASOCIDIN

NOVARTIS
0.5%;10%
A088791 001 Oct 05, 1984

SUSPENSION;OPHTHALMIC

ISOPTO CETAPRED

ALCON
0.25%;10%
A087547 001

SUSPENSION/DROPS;OPHTHALMIC

METIMYD

SCHERING
0.5%;10%
N010210 001

PREDAMIDE

AKORN
0.5%;10%
A088059 001 Jul 29, 1983

PREDSULFAIR

PHARMAFAIR
0.5%;10%
A088007 001 Apr 19, 1983

PREDSULFAIR II

PHARMAFAIR
0.2%;10%
A088837 001 Dec 24, 1985

SULPHRIN

BAUSCH AND LOMB
0.5%;10%
A088089 001 Dec 28, 1982

PREDNISOLONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

HYDELTRASOL

MERCK
EQ 20MG PHOSPHATE/ML
N011583 002

PREDNISOLONE SODIUM PHOSPHATE

WATSON LABS EQ 20MG PHOSPHATE/ML
A080517 001

OINTMENT;OPHTHALMIC, OTIC

HYDELTRASOL

MERCK EQ 0.25% PHOSPHATE
N011028 001

SOLUTION;ORAL

ORAPRED

CONCORDIA PHARMS INC EQ 15MG BASE/5ML **
A075117 001 Dec 14, 2000

PREDNISOLONE SODIUM PHOSPHATE

AMNEAL PHARMS
EQ 15MG BASE/5ML
A078345 001 Mar 10, 2009

MEDICIS PHARMS
EQ 15MG BASE/5ML
A075250 001 Jul 12, 2002

NESHER PHARMS
EQ 5MG BASE/5ML
A076982 001 May 24, 2005

EQ 15MG BASE/5ML
A076988 001 May 24, 2005

PHARM ASSOC
EQ 5MG BASE/5ML
A076123 001 Dec 23, 2002

VINTAGE PHARMS
EQ 5MG BASE/5ML
A078416 001 Oct 31, 2007

WE PHARMS
EQ 5MG BASE/5ML
A075181 001 Dec 23, 2002

SOLUTION/DROPS;OPHTHALMIC

INFLAMASE FORTE

NOVARTIS
EQ 0.9% PHOSPHATE
A080751 002

INFLAMASE MILD

NOVARTIS
EQ 0.11% PHOSPHATE
A080751 001

METRETON

SCHERING
EQ 0.5% PHOSPHATE
A083834 001

PREDAIR

PHARMAFAIR
EQ 0.11% PHOSPHATE
A088415 001 Feb 29, 1984

PREDAIR FORTE

PHARMAFAIR
EQ 0.9% PHOSPHATE
A088165 001 Mar 28, 1983

PREDNISOLONE SODIUM PHOSPHATE

AKORN EQ 0.11% PHOSPHATE
A083358 001

EQ 0.9% PHOSPHATE
A083358 002

ALCON PHARMS LTD EQ 0.11% PHOSPHATE
A081043 001 Oct 24, 1991

EQ 0.9% PHOSPHATE
A081044 001 Oct 24, 1991

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-317(of 393)

** See List Footnote



PREDNISOLONE SODIUM PHOSPHATE

SOLUTION/DROPS;OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE



BAUSCH AND LOMB EQ 0.11% PHOSPHATE
A040065 001 Jul 29, 1994

SOLA BARNES HIND EQ 0.11% PHOSPHATE
A084171 001

EQ 0.9% PHOSPHATE
A084168 001

EQ 0.9% PHOSPHATE
A084169 001

EQ 0.9% PHOSPHATE
A084172 001

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

SULSTER

AKORN
EQ 0.23% PHOSPHATE;10%
A074511 001 Jul 30, 1996

VASOCIDIN

+ NOVARTIS
EQ 0.23% PHOSPHATE;10% **
N018988 001 Aug 26, 1988

PREDNISOLONE TEBUTATE

INJECTABLE;INJECTION

HYDELTRA-TBA

MERCK
20MG/ML
N010562 001

PREDNISOLONE TEBUTATE

WATSON LABS
20MG/ML
A083362 001 Feb 17, 1984

PREDNISONE

SOLUTION;ORAL

PREDNISONE

WOCKHARDT
5MG/5ML
A089726 001 Aug 02, 1988

SYRUP;ORAL

LIQUID PRED

MURO
5MG/5ML
A087611 002 Sep 07, 1982

TABLET;ORAL

CORTAN

HALSEY
20MG
A087480 001

DELTA-DOME

BAYER PHARMS
5MG
A080293 001

DELTASONE

+ PHARMACIA AND UPJOHN 2.5MG **
N009986 005

+ 5MG ** N009986 002

+ 10MG ** N009986 006

+ 20MG ** N009986 007

+ 50MG ** N009986 008

FERNISONE
FERNDALE LABS 5MG A083364 001

METICORTEN
+ SCHERING 1MG ** N009766 002

+ 5MG ** N009766 001

ORASONE
SOLVAY 1MG A083009 001

5MG A083009 002

10MG A083009 003

20MG A083009 004

50MG A085999 001

PARACORT
PARKE DAVIS 5MG N010962 002

PREDNICEN-M
SCHWARZ PHARMA 5MG A084655 001

PREDNISONE
AM THERAP 5MG A089387 001 Nov 06, 1986

10MG A089388 001 Nov 06, 1986

20MG A089389 001 Nov 06, 1986

AMNEAL PHARMS NY 5MG A089597 001 Oct 05, 1987

10MG A089598 001 Oct 05, 1987

20MG A089599 001 Oct 05, 1987

AUROLIFE PHARMA LLC 5MG A084774 001

10MG A089983 001 Jan 12, 1989

20MG A085813 001

50MG A089984 001 Jan 12, 1989

BUNDY 5MG A083676 001

CHARTWELL RX 5MG A083059 001

CONTRACT PHARMACAL 5MG A080209 001

DURAMED PHARMS BARR 5MG A088394 001 Oct 04, 1983

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-318(of 393)

** See List Footnote



PREDNISONE
TABLET;ORAL
PREDNISONE
10MG A088395 001 Oct 04, 1983
20MG A088396 001 Oct 04, 1983
ELKINS SINN 5MG A080491 001
20MG A085811 001
EVERYLIFE 1MG A084440 001
2.5MG A084440 002
5MG A084440 003
FERRANTE 2.5MG A080563 001
5MG A080563 002
HALSEY 5MG A080300 001
HEATHER 5MG A080320 001
10MG A084341 001
20MG A084417 001
20MG A085543 001
50MG A086946 001
HIKMA PHARMS 1MG A040890 001 Nov 01, 2010
2.5MG A040538 001 Jan 08, 2004
IMPAX LABS 5MG A080782 001
INWOOD LABS 1MG A080328 001
2.5MG A080306 001
5MG A080279 001
IVAX SUB TEVA PHARMS 5MG A080283 001
10MG A084133 001
20MG A084134 001
KV PHARM 5MG A084236 001
LANNETT 5MG A080514 001
20MG A084275 001
LEDERLE 5MG A086968 001
MARSHALL PHARMA 5MG A080301 001
MUTUAL PHARM 5MG A080701 001
10MG A086595 001
20MG A084634 001
NYLOS 5MG A085115 001
PANRAY 1MG A080350 001
2.5MG A080350 002
5MG A080350 003
PHARMAVITE 5MG A084662 002
PHOENIX LABS NY 5MG A080321 001
20MG A083807 001
PUREPAC PHARM 5MG A080353 001
10MG A086062 001
20MG A086061 001
PVT FORM 20MG A085151 001
REXALL 5MG A080232 001
ROXANE 20MG N017109 001
25MG A087833 001 May 04, 1982
SANDOZ 5MG A080336 002
SCHERER LABS 5MG A080371 001
SPERTI 1MG A080359 001
2.5MG A080359 002
5MG A080359 003
SUN PHARM INDUSTRIES 50MG A086596 001
SUPERPHARM 5MG A088865 001 Oct 25, 1984
10MG A088866 001 Oct 25, 1984
20MG A088867 001 Oct 25, 1984
TEVA 5MG A080397 001
UDL 5MG A087984 001 Jan 18, 1983
10MG A087985 001 Jan 18, 1983
20MG A087986 001 Jan 18, 1983
UPSHER SMITH 5MG A087471 001
20MG A087470 001
VALEANT PHARM INTL 5MG A080237 001
VANGARD 5MG A087682 001 Jan 15, 1982
20MG A087701 001 Jan 15, 1982
VITARINE 5MG A080334 001
5MG A080506 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-319(of 393)

** See List Footnote



PREDNISONE

TABLET;ORAL

PREDNISONE

WATSON LABS 5MG
A085084 002

10MG
A087773 001 Jul 13, 1982

20MG
A086813 001

50MG
A086867 001

50MG
A087772 001 Jul 13, 1982

WHITEWORTH TOWN PLSN 2.5MG
A084913 001

5MG
A080343 001

10MG
A089028 001 Jul 24, 1986

20MG
A084913 002

SERVISONE

LEDERLE
5MG
A080223 001

PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

CITANEST

+ ASTRAZENECA
1% **
N014763 004

+
2% **
N014763 005

+
3% **
N014763 003

CITANEST PLAIN

+ ASTRAZENECA
4% **
N014763 007

CITANEST PLAIN DENTAL

+ DENTSPLY PHARM
4%
N021382 001

PRIMIDONE

SUSPENSION;ORAL

MYSOLINE

NURO PHARMA
250MG/5ML
N010401 001

TABLET;ORAL

PRIMIDONE

DR REDDYS LABS LTD
50MG
A040862 001 Oct 03, 2008

250MG
A040862 002 Oct 03, 2008

HIKMA INTL PHARMS
50MG
A040667 001 Jul 27, 2006

IMPAX LABS
50MG
A040717 001 Feb 12, 2008

250MG
A040717 002 Feb 12, 2008

WATSON LABS
250MG
A085052 001

PROBENECID

TABLET;ORAL

BENEMID

+ MERCK
500MG **
N007898 004

PROBENECID

IVAX SUB TEVA PHARMS
500MG
A083740 001 May 09, 1984

LEDERLE
500MG
A086917 001

WATSON LABS
500MG
A086150 002 Apr 23, 1982

PROBUCOL

TABLET;ORAL

LORELCO

SANOFI AVENTIS US
250MG
N017535 001

500MG
N017535 002 Jul 06, 1988

PROCAINAMIDE HYDROCHLORIDE

CAPSULE;ORAL

PROCAINAMIDE HYDROCHLORIDE

ANI PHARMS INC
250MG
A089219 001 Jul 01, 1986

375MG
A089219 002 Jul 01, 1986

500MG
A089219 003 Jul 01, 1986

ASCOT
250MG
A087542 001 Jan 08, 1982

375MG
A087697 001 Mar 01, 1983

500MG
A087543 001 Jan 08, 1982

IVAX SUB TEVA PHARMS 250MG
A084604 001

375MG A084595 001

500MG A084606 001

LANNETT 250MG A083693 001

500MG A084696 001

LEDERLE 250MG A086942 001

375MG A086952 001

500MG A086943 001

ROXANE 250MG A088989 001 Apr 26, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-320(of 393)

** See List Footnote



PROCAINAMIDE HYDROCHLORIDE

CAPSULE;ORAL

PROCAINAMIDE HYDROCHLORIDE

500MG A088990 001 Apr 26, 1985

VANGARD 250MG A087643 001 Jun 01, 1982



500MG A087875 001 Jun 01, 1982

WATSON LABS 250MG A083287 001

250MG A083795 001

250MG A085167 001

375MG A084403 001

375MG A087020 001

500MG A084280 001

500MG A084357 001

500MG A087021 001

PROCAN

PARKE DAVIS 250MG A085804 001

375MG A087502 001

500MG A085079 001

PROCAPAN

PANRAY 250MG A083553 002

PRONESTYL

+ APOTHECON 250MG ** N007335 001
+ 375MG ** N007335 004
+ 500MG ** N007335 003
INJECTABLE;INJECTION
PROCAINAMIDE HYDROCHLORIDE
ABRAXIS PHARM 100MG/ML A089415 001 Nov 17, 1986
500MG/ML A089416 001 Nov 17, 1986
HOSPIRA 500MG/ML A089537 001 Aug 25, 1987
INTL MEDICATION 500MG/ML A088637 001 Jul 31, 1984
PHARMAFAIR 100MG/ML A088824 001 Nov 20, 1985
500MG/ML A088830 001 Nov 20, 1985
SMITH AND NEPHEW 100MG/ML A088530 001 Mar 04, 1985
500MG/ML A088531 001 Mar 04, 1985
SOLOPAK 500MG/ML A088532 001 Mar 04, 1985
WARNER CHILCOTT 100MG/ML A089528 001 May 03, 1988
500MG/ML A089529 001 May 03, 1988
WATSON LABS 100MG/ML A087079 001
500MG/ML A087080 001
WEST-WARD PHARMS INT 100MG/ML A089029 001 Apr 17, 1986
500MG/ML A089030 001 Apr 17, 1986
PRONESTYL
+ APOTHECON 100MG/ML ** N007335 002
+ 500MG/ML ** N007335 005
TABLET;ORAL
PRONESTYL
APOTHECON 250MG N017371 001
375MG N017371 002
500MG N017371 003
TABLET, EXTENDED RELEASE;ORAL
PROCAINAMIDE HYDROCHLORIDE
ANI PHARMS INC 250MG A088958 001 Dec 02, 1985
250MG A089369 001 Aug 14, 1987
500MG A088959 001 Dec 02, 1985
500MG A088974 001 Jul 22, 1985
500MG A089369 002 Jan 09, 1987
750MG A089369 003 Aug 14, 1987
750MG A089438 001 Mar 23, 1987
1GM A040111 001 Dec 13, 1996
INWOOD LABS 500MG A089840 001 Mar 06, 1989
SANDOZ 500MG A089284 001 Jun 23, 1986
WATSON LABS 250MG A088533 001 Dec 03, 1984
250MG A089026 001 Oct 22, 1985
500MG A088534 001 Dec 03, 1984
500MG A089027 001 Oct 22, 1985
750MG A088535 001 Nov 03, 1984
750MG A089042 001 Oct 22, 1985
1GM A089520 001 Jan 15, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-321(of 393)

** See List Footnote



PROCAINAMIDE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

PROCAN SR

PARKE DAVIS
250MG
A086468 001

PARKEDALE
500MG
A086065 001

750MG
A087510 001 Apr 01, 1982

1GM
A088489 001 Jan 16, 1985

PROCANBID

KING PHARMS
500MG
N020545 001 Jan 31, 1996

1GM
N020545 002 Jan 31, 1996

PRONESTYL-SR

APOTHECON
500MG
A087361 001

PROCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

NOVOCAIN

HOSPIRA
1%
A085362 003

2%
A085362 004

10%
A086797 001

PROCAINE HYDROCHLORIDE

ABRAXIS PHARM
1%
A080384 002

1%
A080421 001

2%
A080384 003

2%
A080421 002

BEL MAR
1%
A080711 001

2%
A080756 001

ELKINS SINN
1%
A083315 001

2%
A083315 002

GD SEARLE LLC
1%
A086202 001

2%
A086202 002

HOSPIRA
1%
A080416 001

2%
A080416 002

MILES
1%
A080415 001

2%
A080415 002

WATSON LABS
1%
A080658 001

1%
A083535 001

2%
A080658 002

2%
A083535 002

PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE

INJECTABLE;INJECTION

ACHROMYCIN
LEDERLE 40MG/VIAL;100MG/VIAL N050276 001

40MG/VIAL;250MG/VIAL N050276 003

TETRACYN
PFIZER 40MG/VIAL;100MG/VIAL A060285 002

40MG/VIAL;250MG/VIAL
A060285 003

PROCAINE MERETHOXYLLINE; THEOPHYLLINE

INJECTABLE;INJECTION

DICURIN PROCAINE

LILLY
100MG/ML;50MG/ML
N008869 001

PROCHLORPERAZINE

SUPPOSITORY;RECTAL

COMPAZINE

GLAXOSMITHKLINE
2.5MG **
N011127 003

5MG **
N011127 001

25MG **
N011127 002

PROCHLORPERAZINE

ABLE
2.5MG
A040407 001 Jul 11, 2001

5MG
A040407 002 Jul 11, 2001

25MG
A040407 003 Jul 11, 2001

PROCHLORPERAZINE EDISYLATE

CONCENTRATE;ORAL

COMPAZINE

GLAXOSMITHKLINE
EQ 10MG BASE/ML
N011276 001

PROCHLORPERAZINE

ALPHARMA US PHARMS
EQ 10MG BASE/ML
A087153 001 Jun 08, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-322(of 393)

** See List Footnote



PROCHLORPERAZINE EDISYLATE

CONCENTRATE;ORAL

PROCHLORPERAZINE EDISYLATE

MORTON GROVE EQ 10MG BASE/ML A088598 001 Oct 25, 1984

INJECTABLE;INJECTION

COMPAZINE

+ GLAXOSMITHKLINE EQ 5MG BASE/ML ** N010742 002

PROCHLORPERAZINE

BAXTER HLTHCARE EQ 5MG BASE/ML A087759 001 Oct 01, 1982

PROCHLORPERAZINE EDISYLATE

HOSPIRA EQ 5MG BASE/ML A089703 001 Apr 07, 1988

MARSAM PHARMS LLC EQ 5MG BASE/ML A089675 001 Dec 05, 1988

SMITH AND NEPHEW EQ 5MG BASE/ML A089251 001 Dec 04, 1986

TEVA PARENTERAL EQ 5MG BASE/ML A040505 001 May 30, 2003

WATSON LABS EQ 5MG BASE/ML A089530 001 Jul 08, 1987



EQ 5MG BASE/ML A089605 001 Jul 08, 1987

EQ 5MG BASE/ML A089606 001 Jul 08, 1987

WEST-WARD PHARMS INT EQ 5MG BASE/ML A089523 001 May 03, 1988

WYETH AYERST EQ 5MG BASE/ML A086348 001



SYRUP;ORAL

COMPAZINE

GLAXOSMITHKLINE EQ 5MG BASE/5ML N011188 001

PROCHLORPERAZINE EDISYLATE

ALPHARMA US PHARMS EQ 5MG BASE/5ML A087154 001 Sep 01, 1982

MORTON GROVE EQ 5MG BASE/5ML A088597 001 Oct 25, 1984



PROCHLORPERAZINE MALEATE

CAPSULE, EXTENDED RELEASE;ORAL

COMPAZINE

GLAXOSMITHKLINE EQ 10MG BASE N011000 001

EQ 10MG BASE N021019 001 Oct 06, 1999

EQ 15MG BASE N011000 002

EQ 15MG BASE N021019 002 Oct 06, 1999

EQ 30MG BASE N011000 003

EQ 75MG BASE N011000 004

TABLET;ORAL

COMPAZINE

GLAXOSMITHKLINE EQ 5MG BASE ** N010571 001

EQ 10MG BASE ** N010571 002

EQ 25MG BASE ** N010571 003

PROCHLORPERAZINE

WATSON LABS EQ 5MG BASE A085580 001

EQ 10MG BASE A085178 001

EQ 25MG BASE A085579 001

PROCHLORPERAZINE MALEATE

DURAMED PHARMS BARR EQ 5MG BASE A040207 001 May 01, 1997

EQ 5MG BASE A089484 001 Jan 20, 1987



EQ 10MG BASE A040207 002 May 01, 1997

EQ 10MG BASE A089485 001 Jan 20, 1987



EQ 25MG BASE A089486 001 Jan 20, 1987

IVAX SUB TEVA PHARMS EQ 5MG BASE A040162 001 Jan 20, 1998

EQ 10MG BASE A040162 002 Jan 20, 1998

SANDOZ EQ 25MG BASE A040101 003 Jul 19, 1996

PROCYCLIDINE HYDROCHLORIDE

TABLET;ORAL

KEMADRIN

MONARCH PHARMS 2MG N009818 005

5MG N009818 003

PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

TEVA PHARMS 100MG A202121 001 Feb 29, 2012

200MG A202121 002 Feb 29, 2012

PROMETRIUM

VIRTUS PHARMS 300MG N019781 003 Oct 15, 1999

INJECTABLE;INJECTION

PROGESTERONE

LILLY 25MG/ML N009238 002

50MG/ML N009238 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-323(of 393)

** See List Footnote



PROGESTERONE

INSERT, EXTENDED RELEASE;INTRAUTERINE

PROGESTASERT

ALZA
38MG N017553 001

PROMAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

SPARINE

WYETH AYERST
30MG/ML N010942 001

100MG/ML N010942 004

INJECTABLE;INJECTION

PROMAZINE HYDROCHLORIDE

WATSON LABS
25MG/ML A084510 001

50MG/ML A084517 001

SPARINE

BAXTER HLTHCARE CORP 25MG/ML N010349 008

50MG/ML N010349 006

SYRUP;ORAL

SPARINE

WYETH AYERST
10MG/5ML N010942 003

TABLET;ORAL

SPARINE

WYETH AYERST
10MG N010348 006

25MG N010348 001

50MG N010348 002

100MG N010348 003

200MG N010348 004

PROMETHAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

PHENERGAN

WYETH AYERST
25MG/ML N008857 002

50MG/ML N008857 003

PROMETHAZINE HYDROCHLORIDE

ABBOTT
25MG/ML A084223 001

50MG/ML A084222 001

AKORN
25MG/ML A083955 002

50MG/ML A083955 001

BEDFORD LABS
25MG/ML A040524 001 Mar 17, 2004

50MG/ML A040524 002 Mar 17, 2004

HOSPIRA
25MG/ML A040372 001 Jun 08, 2000

50MG/ML A040372 002 Jun 08, 2000

50MG/ML A083838 002

LUITPOLD
25MG/ML A040515 001 Mar 19, 2003

MARSAM PHARMS LLC
25MG/ML A089463 001 May 02, 1988

50MG/ML A089477 001 May 02, 1988

MYLAN INSTITUTIONAL
25MG/ML A040471 001 Nov 21, 2002

SANDOZ
25MG/ML A040593 001 Nov 08, 2006

50MG/ML A040593 002 Nov 08, 2006

TEVA PHARMS USA
25MG/ML ** A040454 001 Aug 22, 2002

50MG/ML ** A040454 002 Aug 22, 2002

WATSON LABS
25MG/ML A083532 001

25MG/ML A084591 001

50MG/ML A080629 002

50MG/ML A083532 002

WOCKHARDT
25MG/ML A040785 001 Sep 26, 2008

50MG/ML A040785 002 Sep 26, 2008



ZIPAN-25

ALTANA
25MG/ML A083997 001

ZIPAN-50

ALTANA
50MG/ML A083997 002

SUPPOSITORY;RECTAL

PHENERGAN

+ MYLAN PHARMS INC
12.5MG ** N010926 002

+
25MG ** N010926 001

+
50MG ** N011689 001

PROMETHACON

POLYMEDICA
25MG A084901 001

50MG A084902 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-324(of 393)

** See List Footnote



PROMETHAZINE HYDROCHLORIDE

SUPPOSITORY;RECTAL

PROMETHAZINE HYDROCHLORIDE

ABLE 12.5MG
A040504 001 Apr 11, 2003

25MG
A040504 002 Apr 11, 2003

50MG
A040449 001 Feb 27, 2003

SYRUP;ORAL

MYMETHAZINE FORTIS

USL PHARMA 25MG/5ML
A087996 001 Jan 18, 1983

PROMETH FORTIS

ALPHARMA US PHARMS 25MG/5ML
A084772 001

PROMETH PLAIN

ACTAVIS MID ATLANTIC 6.25MG/5ML
A085953 001

PROMETHAZINE

CENCI
6.25MG/5ML
A089013 001 Sep 20, 1985

PROMETHAZINE HYDROCHLORIDE

KV PHARM
6.25MG/5ML
A085388 001

25MG/5ML
A085385 001

PHARM ASSOC
6.25MG/5ML
A087518 001

WHITEWORTH TOWN PLSN 6.25MG/5ML
A086395 001

PROMETHAZINE HYDROCHLORIDE PLAIN

+ ANI PHARMS
6.25MG/5ML **
N008381 004 Apr 18, 1984

+
25MG/5ML **
N008381 003

TABLET;ORAL

PHENERGAN

+ DELCOR ASSET CORP
12.5MG **
N007935 002

+
25MG **
N007935 003

+
50MG **
N007935 004

PROMETHAZINE HYDROCHLORIDE

ABBOTT
12.5MG
A084160 001

25MG
A084166 001

50MG
A084539 001

ABLE
12.5MG
A040558 001 Jul 01, 2004

25MG
A040558 002 Jul 01, 2004

50MG
A040558 003 Jul 01, 2004

IMPAX LABS
25MG
A084214 002 Jul 07, 1982

50MG
A040791 001 May 20, 2008

IVAX SUB TEVA PHARMS 12.5MG


A083604 001

25MG A083603 001

50MG A083613 001

LANNETT 12.5MG A080949 001

25MG A080949 002

50MG A080949 003

MYLAN 12.5MG A091054 001 Aug 30, 2011

25MG A091054 002 Aug 30, 2011

50MG A091054 003 Aug 30, 2011

PVT FORM 12.5MG A083214 001



25MG A083658 001

SANDOZ 12.5MG A084176 002 May 22, 2009

12.5MG A084233 001



25MG A085146 001

50MG A085146 002

SUN PHARM INDUSTRIES 12.5MG
A084555 001

25MG
A084554 001

50MG
A084557 001

TABLICAPS 12.5MG
A084080 001

25MG
A084027 001

TEVA 25MG
A089109 001 Sep 10, 1985

WATSON LABS 12.5MG


A083401 001

12.5MG
A083712 001

12.5MG
A085986 001

25MG
A083204 001

25MG
A085684 001

50MG
A083403 001

50MG
A085664 001

REMSED

BRISTOL MYERS SQUIBB 25MG
A083176 002

50MG
A083176 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-325(of 393)

** See List Footnote



PROPAFENONE HYDROCHLORIDE

TABLET;ORAL

PROPAFENONE HYDROCHLORIDE

NESHER PHARMS
150MG
A076193 001 Feb 07, 2002

225MG
A076193 002 Feb 07, 2002

300MG
A076193 003 Feb 07, 2002

RYTHMOL

+ GLAXOSMITHKLINE LLC
150MG
N019151 001 Nov 27, 1989

+
225MG
N019151 003 Nov 20, 1992

+
300MG
N019151 002 Nov 27, 1989

PROPANTHELINE BROMIDE

INJECTABLE;INJECTION

PRO-BANTHINE

GD SEARLE LLC
30MG/VIAL
N008843 001

TABLET;ORAL

PRO-BANTHINE

+ SHIRE
7.5MG **
N008732 003

+
15MG **
N008732 002

PROPANTHELINE BROMIDE

ASCOT
15MG
A087663 001 Oct 25, 1982

HEATHER
15MG
A085780 001

IMPAX LABS
15MG
A084541 002

MYLAN
15MG
A083706 001

PAR PHARM
15MG
A088377 001 Dec 08, 1983

PVT FORM
15MG
A080977 001

SANDOZ
15MG
A080928 001

TABLICAPS
15MG
A084428 001

WATSON LABS
15MG
A083029 002

15MG
A083151 001

WEST-WARD PHARMS INT 7.5MG
A080927 001

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

KAINAIR

PHARMAFAIR
0.5%
A088087 001 Jun 07, 1983

OPHTHAINE

+ APOTHECON
0.5% **
N008883 001

OPHTHETIC

+ ALLERGAN
0.5% **
N012583 001

PARACAINE

OPTOPICS
0.5%
A087681 001 Aug 05, 1982

PROPARACAINE HYDROCHLORIDE

SOLA BARNES HIND
0.5%
A084144 001

0.5%
A084151 001

PROPIOLACTONE

SOLUTION;IRRIGATION

BETAPRONE

FOREST LABS
N/A
N011657 001

PROPIOMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

LARGON

WEST-WARD PHARMS INT 20MG/ML
N012382 002

PROPOFOL

INJECTABLE;INJECTION

DIPRIVAN

FRESENIUS KABI USA
10MG/ML
N019627 001 Oct 02, 1989

PROPOFOL

TEVA PARENTERAL
10MG/ML
A075392 001 Sep 19, 2000

WEST-WARD PHARMS INT


10MG/ML
A074848 001 Apr 19, 2005

PROPOXYPHENE HYDROCHLORIDE

CAPSULE;ORAL

DARVON

XANODYNE PHARM
32MG
N010997 001

65MG
N010997 003

DOLENE

HERITAGE PHARMS INC
65MG
A080530 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-326(of 393)

** See List Footnote


PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
KESSO-GESIC
MK LABS 65MG A083544 001

PROPHENE 65
HALSEY 65MG A083538 002

PROPOXYPHENE HYDROCHLORIDE
ALRA 65MG A083184 001

IMPAX LABS 65MG A083317 001

IVAX SUB TEVA PHARMS 32MG
A083597 001

MUTUAL PHARM 65MG A083186 001

MYLAN 32MG A083528 001

65MG A040569 001 Dec 16, 2004

65MG A083299 001

NEXGEN PHARMA INC 65MG A083185 001

PAR PHARM 65MG A080269 001

PUREPAC PHARM 65MG A083278 001

PVT FORM 32MG A083464 001

65MG A083113 001

ROXANE 32MG A083089 001

65MG A083089 002

SANDOZ 32MG A084014 001

65MG A083125 002

65MG A083688 001

65MG A083870 002

65MG A086495 001

TEVA 65MG A088615 001 Oct 22, 1984

VALEANT PHARM INTL 65MG A080783 001

VINTAGE PHARMS 65MG A040908 001 Jul 17, 2009

WATSON LABS 65MG A080908 002

65MG A085190 001

WEST WARD 65MG A083501 001

WHITEWORTH TOWN PLSN 65MG
A084551 001

PROPOXYPHENE HYDROCHLORIDE 65

WARNER CHILCOTT 65MG
A083786 001

PROPOXYPHENE NAPSYLATE

SUSPENSION;ORAL

DARVON-N

AAIPHARMA LLC 50MG/5ML
N016861 001

TABLET;ORAL

DARVON-N

XANODYNE PHARM 100MG
N016862 002

PROPRANOLOL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPRANOLOL HYDROCHLORIDE

INWOOD LABS 60MG A072499 001 Apr 11, 1989

80MG A072500 001 Apr 11, 1989

120MG A072501 001 Apr 11, 1989

160MG A072502 001 Apr 11, 1989

MYLAN 60MG A078022 001 Feb 15, 2007



80MG A078022 002 Feb 15, 2007

120MG A078022 003 Feb 15, 2007

160MG A078022 004 Feb 15, 2007

UPSHER SMITH LABS 60MG A078311 001 Mar 06, 2009

80MG A078311 002 Mar 06, 2009

120MG A078311 003 Mar 06, 2009

160MG A078311 004 Mar 06, 2009

CONCENTRATE;ORAL
PROPRANOLOL HYDROCHLORIDE INTENSOL

ROXANE 80MG/ML
A071388 001 May 15, 1987

INJECTABLE;INJECTION

PROPRANOLOL HYDROCHLORIDE

+ BAXTER HLTHCARE CORP 1MG/ML
N016419 001

FOSUN PHARMA 1MG/ML
A076400 001 Feb 26, 2003

SMITH AND NEPHEW 1MG/ML
A070135 001 Apr 15, 1986

1MG/ML
A070137 001 Apr 15, 1986

SOLOPAK 1MG/ML
A070136 001 Apr 15, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-327(of 393)

** See List Footnote



PROPRANOLOL HYDROCHLORIDE

SOLUTION;ORAL

PROPRANOLOL HYDROCHLORIDE

MORTON GROVE
20MG/5ML
A071984 001 Mar 03, 1989

40MG/5ML
A071985 001 Mar 03, 1989

SUSPENSION;ORAL

INDERAL

WYETH AYERST
10MG/ML
N019536 001 Dec 12, 1986

TABLET;ORAL

INDERAL

+ WYETH PHARMS
10MG **
N016418 001

+
20MG **
N016418 003

+
40MG **
N016418 002

+
60MG **
N016418 009 Oct 18, 1982

+
80MG **
N016418 004

+
90MG **
N016418 010 Oct 18, 1982

PROPRANOLOL HYDROCHLORIDE

ANDA REPOSITORY
10MG
A070319 001 Oct 22, 1985

20MG
A070320 001 Oct 22, 1985

40MG
A070103 001 Oct 22, 1985

60MG
A070321 001 Sep 24, 1986

80MG
A070322 001 Aug 04, 1986

ANI PHARMS INC


90MG
A071977 001 Apr 06, 1988

DAVA PHARMS INC


10MG
A070125 001 Jul 30, 1985

20MG
A070126 001 Jul 30, 1985

40MG
A070127 001 Jul 30, 1985

60MG
A071495 001 Dec 31, 1987

80MG
A070128 001 Jul 30, 1985

90MG
A071496 001 Dec 31, 1987

DURAMED PHARMS BARR
10MG
A070306 001 Sep 09, 1985

20MG
A070307 001 Sep 09, 1985

40MG
A070308 001 Sep 09, 1985

60MG
A070309 001 Oct 01, 1986

80MG
A070310 001 Sep 09, 1985

90MG
A071327 001 Oct 01, 1986

INTERPHARM
10MG
A071368 001 May 05, 1987

20MG
A071369 001 May 05, 1987

40MG
A071370 001 May 05, 1987

80MG
A071371 001 May 05, 1987

IVAX SUB TEVA PHARMS


10MG
A072063 001 Jul 29, 1988

20MG
A072066 001 Jul 29, 1988

40MG
A072067 001 Jul 29, 1988

60MG
A072068 001 Jul 29, 1988

80MG
A072069 001 Jul 29, 1988

LEDERLE
10MG
A072117 001 Jun 23, 1988

20MG
A072118 001 Jun 23, 1988

40MG
A072119 001 Jun 23, 1988

80MG
A072120 001 Jun 23, 1988

MYLAN
60MG
A072275 001 Jun 09, 1989

PAR PHARM
90MG
A071288 001 Oct 22, 1986

PUREPAC PHARM
10MG
A070814 001 Nov 03, 1986

20MG
A070815 001 Nov 03, 1986

40MG
A070816 001 Nov 03, 1986

60MG
A070817 001 Nov 03, 1986

80MG
A070757 001 Nov 03, 1986

ROXANE
10MG
A070516 001 Jul 07, 1986

20MG
A070517 001 Jul 07, 1986

40MG
A070518 001 Jul 07, 1986

60MG
A070519 001 Sep 24, 1986

80MG
A070520 001 Jul 07, 1986

90MG
A070521 001 Sep 24, 1986

SANDOZ
10MG
A071658 001 Jul 05, 1988

20MG
A071687 001 Jul 05, 1988

40MG
A071688 001 Jul 05, 1988

60MG
A072197 001 Jul 05, 1988

80MG
A071689 001 Jul 05, 1988

90MG
A072198 001 Jul 05, 1988

SCHERING
10MG
A070120 001 Aug 06, 1985

20MG
A070121 001 Aug 06, 1985

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-328(of 393)

** See List Footnote



PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

40MG
A070122 001 Aug 06, 1985

60MG
A070123 001 Oct 29, 1986

80MG
A070124 001 Aug 06, 1985

SUPERPHARM 10MG
A071515 001 Jun 08, 1988

20MG
A071516 001 Jun 08, 1988

40MG
A071517 001 Jun 08, 1988

80MG
A071518 001 Jun 08, 1988

TEVA 10MG
A070232 001 Oct 07, 1987

20MG
A070233 001 Jun 23, 1986

40MG
A070234 001 Jun 23, 1986

WARNER CHILCOTT 10MG
A070438 001 Sep 15, 1986

20MG
A070439 001 Sep 15, 1986

40MG
A070440 001 Sep 15, 1986

60MG
A070441 001 Sep 24, 1986

80MG
A070442 001 Sep 15, 1986

WATSON LABS 10MG


A070140 001 Jul 30, 1985

10MG
A070378 001 Mar 19, 1987

20MG
A070141 001 Jul 30, 1985

20MG
A070379 001 Mar 19, 1987

40MG
A070142 001 Jul 30, 1985

40MG
A070380 001 Mar 19, 1987

60MG
A070143 001 Jan 15, 1987

60MG
A070381 001 Mar 19, 1987

60MG
A071098 001 Oct 06, 1986

60MG
A071791 001 Jul 15, 1987

80MG
A070144 001 Jul 30, 1985

80MG
A070382 001 Mar 19, 1987

80MG
A070551 001 Jul 10, 1986

90MG
A071183 001 Oct 06, 1986

90MG
A071792 001 Jul 15, 1987

WATSON LABS TEVA 10MG
A070548 001 Jul 10, 1986

20MG
A070549 001 Apr 11, 1986

40MG
A070550 001 Apr 11, 1986

YAOPHARMA CO LTD 10MG


A070663 001 Jun 13, 1986

20MG
A070664 001 Jun 13, 1986

40MG
A070665 001 Jun 13, 1986

60MG
A070666 001 Oct 10, 1986

80MG
A070667 001 Jun 13, 1986

PROPYLIODONE

SUSPENSION;INTRATRACHEAL

DIONOSIL AQUEOUS

GLAXOSMITHKLINE 50%
N009309 001

DIONOSIL OILY

GLAXOSMITHKLINE 60%
N009309 002

PROPYLTHIOURACIL

TABLET;ORAL

PROPYLTHIOURACIL

ABBOTT 50MG
A084075 001

ANABOLIC 50MG
A080285 001

ANI PHARMS INC 50MG
A080215 001

CHARTWELL RX 50MG
A084543 001

HALSEY 50MG
A080015 001

HIKMA INTL PHARMS 50MG
A080154 001

IMPAX LABS 50MG
A080159 001

LANNETT 50MG
A080016 001

LILLY 50MG
N006213 001

SUN PHARM INDUSTRIES 50MG
A083982 001

TABLICAPS 50MG
A080840 001

WATSON LABS 50MG
A080932 001

50MG
A085201 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-329(of 393)

** See List Footnote



PROTAMINE SULFATE

INJECTABLE;INJECTION

PROTAMINE SULFATE

+ LILLY 10MG/ML **
N006460 002

PHARMACIA AND UPJOHN 50MG/VIAL
N007413 001

250MG/VIAL
N007413 002 Aug 02, 1984

WEST-WARD PHARMS INT


10MG/ML
A089474 001 Nov 05, 1986

10MG/ML
A089475 001 Nov 05, 1986

PROTEIN HYDROLYSATE

INJECTABLE;INJECTION

AMINOSOL 5%

ABBVIE
5%
N005932 012 Jan 31, 1985

HYPROTIGEN 5%

B BRAUN
5%
N006170 003 Jan 10, 1984

PROTIRELIN

INJECTABLE;INJECTION

THYPINONE

ABBOTT
0.5MG/ML
N017638 001

THYREL TRH

FERRING
0.5MG/ML
N018087 001

PROTOKYLOL HYDROCHLORIDE

TABLET;ORAL

VENTAIRE

SANOFI AVENTIS US
2MG
A083459 001

PROTRIPTYLINE HYDROCHLORIDE

TABLET;ORAL

VIVACTIL

TEVA WOMENS
5MG **
N016012 001

10MG **
N016012 002

PSEUDOEPHEDRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

NOVAFED
SANOFI AVENTIS US 120MG N017603 001

SUDAFED 12 HOUR
+ GLAXOSMITHKLINE 120MG ** N017941 002

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

ACTIFED

GLAXOSMITHKLINE 120MG;5MG
N018996 001 Jun 17, 1985

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

KV PHARM
120MG;5MG
A071798 001 Mar 16, 1989

SYRUP;ORAL

ACTAHIST

CENCI
30MG/5ML;1.25MG/5ML
A088344 001 Feb 09, 1984

HISTAFED

CENCI
30MG/5ML;1.25MG/5ML
A088283 001 Apr 20, 1984

MYFED

USL PHARMA
30MG/5ML;1.25MG/5ML
A088116 001 Mar 04, 1983

TRILITRON

NEWTRON PHARMS
30MG/5ML;1.25MG/5ML
A088474 001 Feb 12, 1985

TABLET;ORAL

ALLERFED

PVT FORM
60MG;2.5MG
A088860 001 Jan 31, 1985

CORPHED

FOSUN PHARMA
60MG;2.5MG
A088602 001 Apr 11, 1985

PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE

SANDOZ 60MG;2.5MG
A088193 001 May 17, 1983

TRILITRON

NEWTRON PHARMS 60MG;2.5MG
A088515 001 Jan 09, 1985

TRIPHED

TEVA 60MG;2.5MG
A088630 001 May 17, 1984

TRIPROLIDINE AND PSEUDOEPHEDRINE

WATSON LABS 60MG;2.5MG
A088318 002 Jan 13, 1984

WEST WARD 60MG;2.5MG
A088117 001 Apr 19, 1983

TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

IVAX SUB TEVA PHARMS 60MG;2.5MG
A085273 001 Dec 12, 1984

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-330(of 393)

** See List Footnote



PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

TABLET;ORAL

TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

SUPERPHARM 60MG;2.5MG
A088578 001 Feb 21, 1985

TABLET, EXTENDED RELEASE;ORAL

TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES

KV PHARM 120MG;5MG
A072758 001 Nov 25, 1991

PSEUDOEPHEDRINE POLISTIREX

SUSPENSION, EXTENDED RELEASE;ORAL

PSEUDO-12

UCB INC
EQ 60MG HYDROCHLORIDE/5ML
N019401 001 Jun 19, 1987

PSEUDOEPHEDRINE SULFATE

TABLET, EXTENDED RELEASE;ORAL

AFRINOL

+ SCHERING PLOUGH
120MG
N018191 001

PYRIDOSTIGMINE BROMIDE

TABLET;ORAL

PYRIDOSTIGMINE BROMIDE

ANI PHARMS INC
30MG
A040512 002 Jul 20, 2005

60MG
A040512 001 Oct 08, 2003

IMPAX LABS INC
60MG
A040457 001 Dec 26, 2002

SOLVAY
30MG
A089572 001 Nov 27, 1990

US ARMY
30MG
N020414 001 Feb 05, 2003

PYRIDOXINE HYDROCHLORIDE

INJECTABLE;INJECTION

HEXA-BETALIN

LILLY
100MG/ML
A080854 001

PYRIDOXINE HYDROCHLORIDE

AKORN
100MG/ML
A087967 001 Oct 01, 1982

BEL MAR
100MG/ML
A080761 001

DELL LABS
50MG/ML
A083771 001

100MG/ML
A083772 001

ELKINS SINN
100MG/ML
A080581 001

LUITPOLD
100MG/ML
A080669 001

MYLAN INSTITUTIONAL
100MG/ML
A204879 001 Jul 14, 2016

WATSON LABS
100MG/ML
A080572 001

100MG/ML
A083760 001

PYRILAMINE MALEATE

TABLET;ORAL

PYRILAMINE MALEATE

IMPAX LABS
25MG
A080808 001

WATSON LABS
25MG
A085231 001

PYRIMETHAMINE; SULFADOXINE

TABLET;ORAL

FANSIDAR

ROCHE
25MG;500MG
N018557 001

PYRITHIONE ZINC

LOTION;TOPICAL

HEAD & SHOULDERS CONDITIONER

WARNER CHILCOTT 0.3%
N019412 002 Mar 10, 1986

PYRVINIUM PAMOATE

SUSPENSION;ORAL

POVAN

PARKE DAVIS
EQ 50MG BASE/5ML
N011964 001

TABLET;ORAL

POVAN

PARKE DAVIS
EQ 50MG BASE
N012485 002

QUAZEPAM

TABLET;ORAL

DORAL

GALT PHARMS
7.5MG
N018708 003 Feb 26, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-331(of 393)

** See List Footnote



QUETIAPINE FUMARATE

TABLET;ORAL

QUETIAPINE FUMARATE

ACTAVIS GRP PTC EQ 25MG BASE A201762 001 Feb 27, 2013

EQ 50MG BASE A201762 002 Feb 27, 2013

EQ 100MG BASE A201762 003 Feb 27, 2013

EQ 150MG BASE A201762 004 Feb 27, 2013

EQ 200MG BASE A201762 005 Feb 27, 2013

EQ 300MG BASE A201762 006 Feb 27, 2013

EQ 400MG BASE A201762 007 Feb 27, 2013

MYLAN PHARMS INC EQ 25MG BASE A090323 001 Mar 27, 2012

SEROQUEL

+ ASTRAZENECA PHARMS EQ 150MG BASE ** N020639 004 Dec 20, 1998

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE

ACTAVIS ELIZABETH EQ 5MG BASE A076459 001 Dec 22, 2004

EQ 10MG BASE A076459 002 Dec 22, 2004

EQ 20MG BASE A076459 003 Dec 22, 2004

EQ 40MG BASE A076459 004 Dec 22, 2004

ACTAVIS LABS FL INC EQ 5MG BASE A076049 001 Jan 14, 2005

EQ 10MG BASE A076049 002 Jan 14, 2005

EQ 20MG BASE A076049 003 Jan 14, 2005

EQ 40MG BASE A076049 004 Jan 14, 2005

APOTEX INC EQ 5MG BASE A076240 001 Jan 26, 2006

EQ 10MG BASE A076240 002 Jan 26, 2006

EQ 20MG BASE A076240 003 Jan 26, 2006

EQ 40MG BASE A076240 004 Jan 26, 2006

MYLAN EQ 5MG BASE A076036 001 Jan 28, 2005

EQ 10MG BASE A076036 002 Jan 28, 2005

EQ 20MG BASE A076036 003 Jan 28, 2005

EQ 40MG BASE A076036 004 Jan 28, 2005

SUN PHARM INDS LTD EQ 5MG BASE A076607 001 Dec 15, 2004

EQ 5MG BASE A090800 001 Jun 18, 2009

EQ 10MG BASE A076607 002 Dec 15, 2004

EQ 10MG BASE A090800 002 Jun 18, 2009

EQ 20MG BASE A076607 003 Dec 15, 2004

EQ 20MG BASE A090800 003 Jun 18, 2009

EQ 40MG BASE A076607 004 Dec 15, 2004

EQ 40MG BASE A090800 004 Jun 18, 2009

YAOPHARMA CO LTD EQ 5MG BASE A076803 001 Mar 02, 2005

EQ 10MG BASE A076803 002 Mar 02, 2005

EQ 20MG BASE A076803 003 Mar 02, 2005

EQ 40MG BASE A076803 004 Mar 02, 2005

QUINESTROL

TABLET;ORAL

ESTROVIS

PARKE DAVIS 0.1MG N016768 002

0.2MG N016768 003

QUINETHAZONE

TABLET;ORAL

HYDROMOX

LEDERLE 50MG N013264 001

QUINETHAZONE; RESERPINE

TABLET;ORAL

HYDROMOX R

LEDERLE 50MG;0.125MG N013927 001

QUINIDINE GLUCONATE

INJECTABLE;INJECTION

QUINIDINE GLUCONATE

+ LILLY 80MG/ML N007529 002 Feb 10, 1989

TABLET;ORAL

QUINACT

BAYER HLTHCARE 266MG A085978 001

400MG A086099 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-332(of 393)

** See List Footnote



QUINIDINE GLUCONATE

TABLET, EXTENDED RELEASE;ORAL

DURAQUIN

WARNER CHILCOTT
330MG
N017917 001

QUINAGLUTE

BAYER HLTHCARE
324MG
N016647 001

QUINALAN

LANNETT
324MG
A088081 001 Feb 10, 1986

QUINATIME

WATSON LABS
324MG
A087448 001

QUINIDINE GLUCONATE

ASCOT
324MG
A088582 001 Jun 17, 1985

AUROLIFE PHARMA LLC
324MG
A089894 001 Dec 15, 1988

CYCLE PHARMS LTD
324MG
A088431 001 Jan 06, 1984

HALSEY
324MG
A089476 001 Apr 10, 1987

SUPERPHARM
324MG
A089164 001 Nov 21, 1985

WATSON LABS
324MG
A087785 001 Jan 24, 1983

324MG
A087810 001 Sep 29, 1982

QUINIDINE POLYGALACTURONATE

TABLET;ORAL

CARDIOQUIN

PHARM RES ASSOC
275MG
N011642 002

QUINIDINE SULFATE

CAPSULE;ORAL

CIN-QUIN

SOLVAY
200MG
A085296 001

300MG
A085297 001

QUINIDINE SULFATE

LILLY
200MG
A085103 001

TABLET;ORAL

CIN-QUIN

SOLVAY
100MG
A085299 001

200MG
A084932 001

300MG
A085298 001

QUINIDINE SULFATE

BARR
200MG
A084177 001

CONTRACT PHARMACAL
200MG
A083808 001

CYCLE PHARMS LTD
200MG
A083640 001

300MG
A085632 001

DAVA PHARMS INC
200MG
A087011 001

ELKINS SINN
200MG
A083622 001

EVERYLIFE
200MG
A083439 001

HALSEY
200MG
A083583 001

HIKMA PHARMS
200MG
A083862 001

IMPAX LABS
200MG
A083347 001

IVAX SUB TEVA PHARMS 200MG
A084549 001

KING PHARMS 200MG A085175 001

KV PHARM 200MG A085276 001

LANNETT 200MG A083743 001

LEDERLE 200MG A086176 001

LILLY 200MG A085038 001

PERRIGO 200MG A085322 001

PHARMAVITE 200MG A084627 001

PUREPAC PHARM 200MG A084003 001

SANDOZ 200MG A084631 001

200MG A084914 001

300MG A089839 001 Sep 29, 1988

SCHERER LABS 200MG A085068 001



SUN PHARM INDUSTRIES 100MG A081029 001 Apr 14, 1989

SUPERPHARM 200MG A088973 001 Apr 10, 1985

USL PHARMA 200MG A087837 001 Apr 14, 1982

VALEANT PHARM INTL 200MG A083393 001



VANGARD 200MG A087909 001 Jul 13, 1982

VINTAGE PHARMS 200MG A083963 001

WARNER CHILCOTT 200MG A083879 001

WATSON LABS 100MG A085584 001

200MG A085140 002

WHITEWORTH TOWN PLSN 200MG
A085444 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-333(of 393)

** See List Footnote



QUINIDINE SULFATE

TABLET;ORAL

QUINORA

KEY PHARMS 200MG A083576 001

SCHERING 300MG A085222 001

TABLET, EXTENDED RELEASE;ORAL

QUINIDEX

WYETH PHARMS INC 300MG N012796 002

QUINIDINE SULFATE

G AND W LABS INC 300MG A040045 001 Jun 30, 1994

RABEPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL

ACIPHEX

+ EISAI INC 10MG ** N020973 001 May 29, 2002

RAMIPRIL

CAPSULE;ORAL

RAMIPRIL

ACTAVIS ELIZABETH 1.25MG A077513 001 Jun 18, 2008

2.5MG A077513 002 Jun 18, 2008

5MG A077513 003 Jun 18, 2008

10MG A077513 004 Jun 18, 2008

CIPLA 1.25MG A077004 001 Aug 07, 2008

2.5MG A077004 002 Aug 07, 2008

5MG A077004 003 Aug 07, 2008

10MG A077004 004 Aug 07, 2008

RANBAXY LABS LTD 5MG A078849 001 Mar 06, 2009



10MG A078849 002 Mar 06, 2009

WATSON LABS 5MG A076549 003 Oct 24, 2005

YAOPHARMA CO LTD 1.25MG A077514 001 Jun 18, 2008

2.5MG A077514 002 Jun 18, 2008

5MG A077514 003 Jun 18, 2008

10MG A077514 004 Jun 18, 2008

TABLET;ORAL

ALTACE

+ KING PFIZER 1.25MG ** N022021 001 Feb 27, 2007
+ 2.5MG ** N022021 002 Feb 27, 2007
+ 5MG ** N022021 003 Feb 27, 2007
+ 10MG ** N022021 004 Feb 27, 2007
RAMIPRIL
APOTEX INC 1.25MG A091069 001 Dec 02, 2015
2.5MG A091069 002 Dec 02, 2015
5MG A091069 003 Dec 02, 2015
10MG A091069 004 Dec 02, 2015
MYLAN PHARMS INC 1.25MG A090650 001 Jun 30, 2011
2.5MG A090650 002 Jun 30, 2011
5MG A090650 003 Jun 30, 2011
10MG A090650 004 Jun 30, 2011
ZYDUS PHARMS USA INC 1.25MG A090697 001 Sep 24, 2009
2.5MG A090697 002 Sep 24, 2009
5MG A090697 003 Sep 24, 2009
10MG A090697 004 Sep 24, 2009
RANITIDINE BISMUTH CITRATE
TABLET;ORAL
TRITEC
GLAXOSMITHKLINE 400MG N020559 001 Aug 08, 1996
RANITIDINE HYDROCHLORIDE
CAPSULE;ORAL
RANITIDINE HYDROCHLORIDE
MYLAN EQ 150MG BASE A075564 001 Oct 27, 2000
EQ 300MG BASE A075564 002 Oct 27, 2000
TEVA EQ 150MG BASE A075557 001 Oct 31, 2003
EQ 300MG BASE A075557 002 Oct 31, 2003
ZANTAC 150
+ GLAXOSMITHKLINE EQ 150MG BASE ** N020095 001 Mar 08, 1994
ZANTAC 300
+ GLAXOSMITHKLINE EQ 300MG BASE ** N020095 002 Mar 08, 1994

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-334(of 393)

** See List Footnote



RANITIDINE HYDROCHLORIDE

GRANULE, EFFERVESCENT;ORAL

ZANTAC 150

GLAXO GRP LTD EQ 150MG BASE/PACKET N020251 002 Mar 31, 1994

INJECTABLE;INJECTION

RANITIDINE HYDROCHLORIDE

BEDFORD EQ 25MG BASE/ML A074764 001 Nov 19, 2004

ZANTAC IN PLASTIC CONTAINER

TELIGENT EQ 1MG BASE/ML N019593 002 Sep 27, 1991

EQ 50MG BASE/100ML N019593 001 Dec 17, 1986



SYRUP;ORAL

RANITIDINE HYDROCHLORIDE

APOTEX INC EQ 15MG BASE/ML A077602 001 Sep 17, 2007

RANBAXY EQ 15MG BASE/ML A078448 001 Dec 13, 2007



WOCKHARDT EQ 15MG BASE/ML A079211 001 May 26, 2009

EQ 15MG BASE/ML A079212 001 Feb 23, 2009



ZANTAC

+ GLAXO GRP LTD EQ 15MG BASE/ML N019675 001 Dec 30, 1988

TABLET;ORAL

RANITIDINE HYDROCHLORIDE

BOEHRINGER INGELHEIM EQ 150MG BASE A074662 001 Aug 29, 1997

EQ 300MG BASE A074662 002 Aug 29, 1997

CONTRACT PHARMACAL EQ 75MG BASE A075094 001 Jun 21, 1999



MYLAN EQ 150MG BASE A074023 001 Aug 22, 1997

EQ 150MG BASE A074552 001 Jul 30, 1998



EQ 300MG BASE A074023 002 Aug 22, 1997

EQ 300MG BASE A074552 002 Jul 30, 1998



RANBAXY EQ 75MG BASE A075254 001 Jan 14, 2000

EQ 150MG BASE A075000 001 Jan 30, 1998

EQ 300MG BASE A075000 002 Jan 30, 1998

SANDOZ EQ 75MG BASE A075519 001 Sep 26, 2002

SUN PHARM INDS LTD EQ 75MG BASE A075132 001 Jan 14, 2000

EQ 150MG BASE A075439 001 Apr 19, 2000

EQ 300MG BASE A075439 002 Apr 19, 2000

WATSON LABS EQ 75MG BASE A075212 001 Jan 14, 2000



EQ 150MG BASE A074864 001 Oct 20, 1997

EQ 300MG BASE A074864 002 Oct 20, 1997

WATSON LABS INC EQ 150MG BASE A077426 001 Dec 19, 2005

EQ 300MG BASE A077426 002 Dec 19, 2005

WOCKHARDT EQ 75MG BASE A078884 001 Jul 31, 2008

EQ 150MG BASE A078653 001 Nov 26, 2007

EQ 150MG BASE A078701 001 Nov 12, 2009

EQ 300MG BASE A078701 002 Dec 11, 2009

ZANTAC 150

+ GLAXO GRP LTD EQ 150MG BASE N018703 001 Jun 09, 1983

ZANTAC 300

+ GLAXO GRP LTD EQ 300MG BASE N018703 002 Dec 09, 1985

TABLET, EFFERVESCENT;ORAL

ZANTAC 150

GLAXO GRP LTD EQ 150MG BASE N020251 001 Mar 31, 1994

ZANTAC 25

GLAXO GRP LTD EQ 25MG BASE N020251 003 Apr 01, 2004

ZANTAC 75

+ SANOFI US EQ 75MG BASE ** N020745 001 Feb 26, 1998

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL

RANOLAZINE

LUPIN LTD 500MG A201046 001 Jul 29, 2013

1GM A201046 002 Jul 29, 2013

RAPACURONIUM BROMIDE

INJECTABLE;INJECTION

RAPLON

ORGANON USA INC 100MG/VIAL N020984 001 Aug 18, 1999

200MG/VIAL N020984 002 Aug 18, 1999


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-335(of 393)

** See List Footnote



RASAGILINE MESYLATE

TABLET;ORAL

RASAGILINE MESYLATE

APOTEX INC EQ 0.5MG BASE
A201950 001 Sep 12, 2013
EQ 1MG BASE
A201950 002 Sep 12, 2013
RAUWOLFIA SERPENTINA ROOT

TABLET;ORAL

HIWOLFIA

BOWMAN PHARMS 50MG
N009276 003
50MG
N009276 005
100MG
N009276 004
HYSERPIN

PHYS PRODS VA 50MG
N010581 001
KOGLUCOID

PANRAY 50MG
N009278 001
100MG
N009278 002
RAUDIXIN

APOTHECON 50MG
N008842 001
100MG
N008842 002
RAUSERPIN

FERNDALE LABS 50MG
N009926 002
100MG
N009926 004
RAUVAL

PAL PAK 50MG
N009108 002
100MG
N009108 004
RAUWOLFIA SERPENTINA

BUNDY 50MG
N009477 001
100MG
N009477 002
HALSEY 50MG
A080498 001
100MG
A080498 002
IMPAX LABS 50MG
N009273 001
100MG
N009273 002
IVAX SUB TEVA PHARMS 50MG
N011521 001
100MG
N011521 002
PUREPAC PHARM 50MG
A080842 001
100MG
A080842 002
PVT FORM 50MG
A080583 001
100MG
A080583 002
SOLVAY 50MG
A080500 001
100MG
A080500 002
TABLICAPS 50MG
A083867 001
100MG
A083444 001
VALEANT PHARM INTL 50MG
N009668 001
100MG
N009668 002
WATSON LABS 50MG
A080907 001
100MG
A080914 001
WOLFINA

FOREST PHARMS 50MG
N009255 008
100MG
N009255 006
RESCINNAMINE

CAPSULE;ORAL

CINNASIL

PANRAY 0.5MG
A084736 001
TABLET;ORAL

MODERIL

PFIZER 0.25MG
N010686 003
0.5MG
N010686 006
RESERPINE

ELIXIR;ORAL

SERPASIL

NOVARTIS 0.2MG/4ML
N009115 005
INJECTABLE;INJECTION

SANDRIL

LILLY 2.5MG/ML
N010012 001
SERPASIL

NOVARTIS 2.5MG/ML
N009434 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-336(of 393)

** See List Footnote



RESERPINE
TABLET;ORAL
HISERPIA
BOWMAN PHARMS 0.1MG N009631 002
0.25MG N009631 004
RAU-SED
BRISTOL MYERS SQUIBB 0.1MG N009357 001
0.25MG N009357 004
0.5MG N009357 006
1MG N009357 008
RESERPINE
BARR 0.25MG A080721 002
BELL PHARMA 0.1MG A083058 001
0.25MG A083058 002
BUNDY 0.1MG N009663 001
0.25MG N009663 003
CYCLE PHARMS LTD 0.1MG N009859 001
0.25MG N009859 002
ELKINS SINN 0.1MG A083145 001
0.25MG A083145 002
EVERYLIFE 0.1MG N010441 001
0.25MG N010441 002
0.5MG N010441 003
1MG N010441 004
HALSEY 0.1MG A080457 002
0.25MG A080457 001
1MG A080457 003
HIKMA INTL PHARMS 0.1MG A080975 001
0.25MG A080975 002
1MG A080975 003
IMPAX LABS 0.1MG N009627 001
0.25MG N009627 002
IVAX SUB TEVA PHARMS 0.1MG N011185 001
0.25MG N011185 002
MARSHALL PHARMA 0.1MG A080492 001
0.25MG A080492 002
MK LABS 0.1MG A080525 002
0.25MG A080525 001
MYLAN 1MG A084974 001
PHARMAVITE 0.25MG A084663 001
PUREPAC PHARM 0.1MG A080753 002
0.25MG A080753 001
PVT FORM 0.1MG A086117 001
0.25MG A080582 001
0.25MG A085775 001
1MG A080582 002
REXALL 0.25MG A080637 001
+ SANDOZ 0.1MG N009838 001
+ 0.25MG N009838 002
SOLVAY 0.25MG A080446 001
TABLICAPS 0.25MG A085207 001
TEVA 0.1MG A089020 001 Mar 07, 1985
0.25MG A089019 001 Mar 07, 1985
VALEANT PHARM INTL 0.1MG N009667 001
0.25MG N009667 002
WATSON LABS 0.1MG A080679 001
0.25MG A080393 001
0.25MG A085401 001
1MG A080749 001
WHITEWORTH TOWN PLSN 0.1MG A080723 001
0.25MG A080723 002
1MG A080723 003
SANDRIL
LILLY 0.1MG N009376 004
0.25MG N009376 001
SERPALAN
LANNETT 0.1MG N010124 001
0.25MG N010124 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-337(of 393)

** See List Footnote



RESERPINE

TABLET;ORAL

SERPANRAY

PANRAY 0.1MG N009391 001

0.25MG N009391 002

1MG N009391 004

SERPASIL

NOVARTIS 0.1MG N009115 001

0.25MG N009115 003

1MG N009115 004

SERPATE

VALE 0.1MG N009453 001

0.25MG N009453 002

SERPIVITE

VITARINE 0.25MG N009645 002

RESERPINE; TRICHLORMETHIAZIDE

TABLET;ORAL

METATENSIN #2

SANOFI AVENTIS US 0.1MG;2MG N012972 001

METATENSIN #4

SANOFI AVENTIS US 0.1MG;4MG N012972 002

NAQUIVAL

SCHERING 0.1MG;4MG N012265 003

TRICHLORMETHIAZIDE W/ RESERPINE

WATSON LABS 0.1MG;4MG A085248 001


RIBAVIRIN
CAPSULE;ORAL
REBETOL
MERCK SHARP DOHME 200MG**Indicated for use and comarketed N020903 001 Jun 03, 1998
with Interferon ALFA-2B, Recombinant
(INTRON A), as Rebetron Combination
Therapy**
TABLET;ORAL
COPEGUS
ROCHE 200MG N021511 001 Dec 03, 2002
400MG N021511 002 Jun 21, 2005
RIMANTADINE HYDROCHLORIDE
SYRUP;ORAL
FLUMADINE
FOREST LABS 50MG/5ML N019650 001 Sep 17, 1993
TABLET;ORAL
RIMANTADINE HYDROCHLORIDE
ACTAVIS ELIZABETH 100MG A076375 001 Jan 14, 2003
IMPAX LABS INC 100MG A075916 001 Nov 02, 2001
RIMEXOLONE
SUSPENSION/DROPS;OPHTHALMIC
VEXOL
ALCON 1% N020474 001 Dec 30, 1994
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
+ APIL 75MG ** N020835 004 Apr 16, 2007
TABLET, DELAYED RELEASE;ORAL
RISEDRONATE SODIUM
IMPAX LABS INC 35MG A205066 001 Jun 29, 2018
RISPERIDONE
SOLUTION;ORAL
RISPERIDONE
LANNETT CO INC 1MG/ML A202386 001 Jan 12, 2015
PRECISION DOSE 1MG/ML A076797 001 Jun 28, 2010
WOCKHARDT 1MG/ML A078744 001 Oct 08, 2009
TABLET;ORAL
RISPERDAL
JANSSEN PHARMS 5MG N020272 005 Dec 29, 1993
RISPERIDONE
JUBILANT CADISTA 0.25MG A078828 001 Mar 23, 2009
0.5MG A078828 002 Mar 23, 2009

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-338(of 393)

** See List Footnote



RISPERIDONE

TABLET;ORAL

RISPERIDONE

1MG
A078828 003 Mar 23, 2009

2MG
A078828 004 Mar 23, 2009

3MG
A078828 005 Mar 23, 2009

4MG
A078828 006 Mar 23, 2009

RATIOPHARM
0.25MG
A077784 001 Jun 08, 2010

0.5MG
A077784 002 Jun 08, 2010

1MG
A077784 003 Jun 08, 2010

2MG
A077784 004 Jun 08, 2010

3MG
A077784 005 Jun 08, 2010

4MG
A077784 006 Jun 08, 2010

SYNTHON PHARMS
0.25MG
A078187 001 Oct 22, 2009

0.5MG
A078187 002 Oct 22, 2009

1MG
A078187 003 Oct 22, 2009

2MG
A078187 004 Oct 22, 2009

3MG
A078187 005 Oct 22, 2009

4MG
A078187 006 Oct 22, 2009

WATSON LABS
0.25MG
A077860 001 Dec 05, 2008

0.5MG
A077860 002 Dec 05, 2008

1MG
A077860 003 Dec 05, 2008

2MG
A077860 004 Dec 05, 2008

3MG
A077860 005 Dec 05, 2008

4MG
A077860 006 Dec 05, 2008

WEST WARD PHARMS
0.25MG
A078740 001 May 29, 2009

0.5MG
A078740 002 May 29, 2009

1MG
A078740 003 May 29, 2009

2MG
A078740 004 May 29, 2009

3MG
A078740 005 May 29, 2009

4MG
A078740 006 May 29, 2009

TABLET, ORALLY DISINTEGRATING;ORAL

RISPERIDONE

MYLAN PHARMS INC 0.25MG
A091537 006 Feb 12, 2013

0.5MG
A091537 001 Mar 30, 2011

1MG
A091537 002 Mar 30, 2011

2MG
A091537 003 Mar 30, 2011

3MG
A091537 004 Mar 30, 2011

4MG
A091537 005 Mar 30, 2011

RITODRINE HYDROCHLORIDE

INJECTABLE;INJECTION

RITODRINE HYDROCHLORIDE

ABRAXIS PHARM 10MG/ML
A071188 001 Jul 23, 1987

15MG/ML
A071189 001 Jul 23, 1987

HOSPIRA 10MG/ML
A071618 001 Feb 28, 1991

15MG/ML
A071619 001 Feb 28, 1991

RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRA
30MG/100ML
A071438 001 Jan 22, 1991

YUTOPAR

ASTRAZENECA
10MG/ML
N018580 001

15MG/ML
N018580 002

TABLET;ORAL

YUTOPAR

ASTRAZENECA
10MG
N018555 001

RITONAVIR

CAPSULE;ORAL

NORVIR

ABBOTT
100MG
N020680 001 Mar 01, 1996

+ ABBVIE
100MG
N020945 001 Jun 29, 1999

RIVASTIGMINE TARTRATE

SOLUTION;ORAL

EXELON

NOVARTIS
EQ 2MG BASE/ML
N021025 001 Apr 21, 2000

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-339(of 393)

** See List Footnote



RIZATRIPTAN BENZOATE

TABLET;ORAL

MAXALT

+ MERCK EQ 5MG BASE N020864 001 Jun 29, 1998

RIZATRIPTAN BENZOATE

APOTEX INC EQ 5MG BASE A202244 001 Dec 31, 2012

EQ 10MG BASE A202244 002 Dec 31, 2012

TABLET, ORALLY DISINTEGRATING;ORAL

MAXALT-MLT

+ MERCK EQ 5MG BASE N020865 001 Jun 29, 1998

RIZATRIPTAN BENZOATE

APOTEX INC EQ 5MG BASE A202477 001 Jul 01, 2013

EQ 10MG BASE A202477 002 Jul 01, 2013

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ZEMURON

+ ORGANON USA INC 50MG/5ML (10MG/ML) ** N020214 001 Mar 17, 1994
+ 10MG/ML (10MG/ML) ** N020214 002 Mar 17, 1994
+ 100MG/10ML (10MG/ML) ** N020214 003 Mar 17, 1994
ROFECOXIB
SUSPENSION;ORAL
VIOXX
MERCK 12.5MG/5ML N021052 001 May 20, 1999
25MG/5ML N021052 002 May 20, 1999
TABLET;ORAL
VIOXX
MERCK 12.5MG N021042 001 May 20, 1999
25MG N021042 002 May 20, 1999
50MG N021042 003 Feb 25, 2000
ROFLUMILAST
TABLET;ORAL
ROFLUMILAST
MYLAN PHARMS INC 500MCG A208257 001 Jul 13, 2018
ROLAPITANT HYDROCHLORIDE
EMULSION;INTRAVENOUS
VARUBI
+ TERSERA THERAPS LLC EQ 166.5MG BASE/92.5ML (EQ 1.8MG N208399 001 Oct 25, 2017
BASE/ML)
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
EPIC PHARMA LLC EQ 0.25MG BASE A078230 001 May 20, 2008
EQ 0.5MG BASE A078230 002 May 20, 2008
EQ 1MG BASE A078230 003 May 20, 2008
EQ 2MG BASE A078230 004 May 20, 2008
EQ 3MG BASE A078230 005 May 20, 2008
EQ 4MG BASE A078230 006 May 20, 2008
EQ 5MG BASE A078230 007 May 20, 2008
G AND W LABS INC EQ 0.25MG BASE A077460 001 May 05, 2008
EQ 0.5MG BASE A077460 002 May 05, 2008
EQ 1MG BASE A077460 003 May 05, 2008
EQ 2MG BASE A077460 004 May 05, 2008
EQ 3MG BASE A077460 005 May 05, 2008
EQ 4MG BASE A077460 006 May 05, 2008
EQ 5MG BASE A077460 007 May 19, 2008
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
+ GLAXOSMITHKLINE LLC EQ 3MG BASE ** N022008 002 Jun 13, 2008
ROPINIROLE HYDROCHLORIDE
MYLAN PHARMS INC EQ 2MG BASE A200462 001 Oct 15, 2012
EQ 3MG BASE A200462 002 Oct 15, 2012
EQ 4MG BASE A200462 003 Oct 15, 2012
EQ 6MG BASE A200462 004 Oct 15, 2012
EQ 8MG BASE A200462 005 Oct 15, 2012
EQ 12MG BASE A200462 006 Oct 15, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-340(of 393)

** See List Footnote



ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION

NAROPIN

FRESENIUS KABI USA
50MG/10ML (5MG/ML)
N020533 013 May 01, 1998

75MG/10ML (7.5MG/ML)
N020533 012 Sep 24, 1996

ROSE BENGAL SODIUM I-131

INJECTABLE;INJECTION

ROBENGATOPE

BRACCO
0.5mCi/VIAL
N016224 001

1mCi/VIAL
N016224 002

2mCi/VIAL
N016224 003

SODIUM ROSE BENGAL I 131

SORIN
0.5mCi/ML
N017318 001

ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDIA

+ SB PHARMCO
EQ 8MG BASE
N021071 004 May 25, 1999

ROSIGLITAZONE MALEATE

TEVA
EQ 2MG BASE
A076747 001 Jan 25, 2013

EQ 4MG BASE
A076747 002 Jan 25, 2013

EQ 8MG BASE
A076747 003 Jan 25, 2013

RUFINAMIDE

TABLET;ORAL

BANZEL

+ EISAI INC
100MG **
N021911 001 Nov 14, 2008

SAFFLOWER OIL

INJECTABLE;INJECTION

LIPOSYN 10%

ABBOTT
10% (10GM/100ML)
N018203 001

LIPOSYN 20%

ABBOTT
20% (20GM/100ML)
N018614 001

SAFFLOWER OIL; SOYBEAN OIL

INJECTABLE;INJECTION

LIPOSYN II 10%

HOSPIRA
5%;5% (5GM/100ML)
N018997 001 Aug 27, 1984

LIPOSYN II 20%

HOSPIRA
10%;10% (10GM/100ML)
N018991 001 Aug 27, 1984

SALMETEROL XINAFOATE

AEROSOL, METERED;INHALATION

SEREVENT

GLAXOSMITHKLINE
EQ 0.021MG BASE/INH
N020236 001 Feb 04, 1994

SAQUINAVIR

CAPSULE;ORAL

FORTOVASE

+ HOFFMANN LA ROCHE
200MG **
N020828 001 Nov 07, 1997

SAQUINAVIR MESYLATE

CAPSULE;ORAL

INVIRASE

+ HOFFMANN LA ROCHE
EQ 200MG BASE
N020628 001 Dec 06, 1995

SARALASIN ACETATE

INJECTABLE;INJECTION

SARENIN

PROCTER AND GAMBLE
EQ 0.6MG BASE/ML
N018009 001

SECOBARBITAL SODIUM

CAPSULE;ORAL

SECOBARBITAL SODIUM

ANABOLIC
100MG
A084422 001

BARR
100MG
A084225 001

EVERYLIFE
100MG
A085895 001

HALSEY
100MG
A084676 001

IVAX PHARMS
100MG
A085869 001

KV PHARM
100MG
A085285 001

LANNETT
50MG
A085909 001

100MG
A085903 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-341(of 393)

** See List Footnote



SECOBARBITAL SODIUM

CAPSULE;ORAL

SECOBARBITAL SODIUM

PARKE DAVIS
100MG
A084762 001

PERRIGO
100MG
A084561 001

PUREPAC PHARM
100MG
A085867 001

VALEANT PHARM INTL
100MG
A085477 001

VITARINE
100MG
A085898 001

100MG
A086273 001

WATSON LABS
100MG
A085792 001

WEST WARD
100MG
A084926 001

WHITEWORTH TOWN PLSN 100MG
A085798 001

WYETH AYERST
100MG
A086390 001

INJECTABLE;INJECTION

SECOBARBITAL SODIUM

ELKINS SINN
100MG/VIAL
A083281 001

WYETH AYERST
50MG/ML
A083262 001

SECONAL SODIUM

LILLY
50MG/ML
N007392 002

SUPPOSITORY;RECTAL

SECONAL SODIUM

LILLY
30MG
A086530 001

60MG
A086530 002

120MG
A086530 003

200MG
A086530 004

SECRETIN

INJECTABLE;INJECTION

SECRETIN-FERRING

FERRING
75CU/VIAL
N018290 001

SECRETIN SYNTHETIC PORCINE

FOR SOLUTION;INTRAVENOUS

SECREFLO

CHIRHOCLIN
16MCG/VIAL
N021136 001 Apr 04, 2002

SELEGILINE HYDROCHLORIDE

CAPSULE;ORAL

ELDEPRYL

+ SOMERSET
5MG
N020647 001 May 15, 1996

SELEGILINE HYDROCHLORIDE

LANNETT CO INC
5MG
A075145 001 Sep 15, 2003

TABLET;ORAL

SELEGILINE HYDROCHLORIDE

CHARTWELL MOLECULES
5MG
A074565 001 Aug 02, 1996

5MG
A074641 001 Aug 02, 1996

G AND W LABS INC


5MG
A074537 001 Aug 02, 1996

5MG
A074744 001 Jan 27, 1997

5MG
A074756 001 Nov 25, 1998

SIEGFRIED
5MG
A074672 001 Apr 01, 1997

+ SOMERSET
5MG **
N019334 001 Jun 05, 1989

SELENIUM SULFIDE

LOTION/SHAMPOO;TOPICAL

EXSEL

ALLERGAN HERBERT
2.5%
A083892 001

SELENIUM SULFIDE

ACTAVIS MID ATLANTIC 2.5%
A084394 001

G AND W LABS INC
2.5%
A086209 001

IVAX PHARMS
2.5%
A085777 001

SELSUN

+ CHATTEM
2.5%
N007936 001

SELENOMETHIONINE SE-75

INJECTABLE;INJECTION

SELENOMETHIONINE SE 75

GE HEALTHCARE
250uCi/ML
N017257 001

MALLINCKRODT
100uCi/ML
N017098 001

PHARMALUCENCE
500uCi/ML
N017322 001

SETHOTOPE

BRACCO
85-550uCi/ML
N017047 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-342(of 393)

** See List Footnote



SERMORELIN ACETATE

INJECTABLE;INJECTION

GEREF

+ EMD SERONO EQ 0.05MG BASE/AMP ** N019863 001 Dec 28, 1990

+ EMD SERONO INC EQ 0.5MG BASE/VIAL ** N020443 001 Sep 26, 1997

+ EQ 1MG BASE/VIAL ** N020443 002 Sep 26, 1997



SERTRALINE HYDROCHLORIDE

CONCENTRATE;ORAL

SERTRALINE HYDROCHLORIDE

ACI HEALTHCARE LTD EQ 20MG BASE/ML A076934 001 Jun 30, 2006

RANBAXY LABS LTD EQ 20MG BASE/ML A078053 001 Feb 05, 2007

TABLET;ORAL

SERTRALINE HYDROCHLORIDE

ACI HEALTHCARE LTD EQ 25MG BASE A076881 001 Feb 06, 2007

EQ 50MG BASE A076881 002 Feb 06, 2007

EQ 100MG BASE A076881 003 Feb 06, 2007

ACTAVIS ELIZABETH EQ 25MG BASE A077345 001 Feb 06, 2007

EQ 50MG BASE A077345 002 Feb 06, 2007

EQ 100MG BASE A077345 003 Feb 06, 2007

ANDA REPOSITORY EQ 25MG BASE A077818 001 Feb 06, 2007

EQ 50MG BASE A077818 002 Feb 06, 2007

EQ 100MG BASE A077818 003 Feb 06, 2007

CHARTWELL MOLECULAR EQ 25MG BASE A077162 001 Feb 06, 2007

EQ 50MG BASE A077162 002 Feb 06, 2007

EQ 100MG BASE A077162 003 Feb 06, 2007

FOSUN PHARMA EQ 25MG BASE A077713 001 Feb 06, 2007

EQ 50MG BASE A077713 002 Feb 06, 2007

EQ 100MG BASE A077713 003 Feb 06, 2007

HIKMA PHARMS EQ 25MG BASE A077864 001 Aug 10, 2009

EQ 50MG BASE A077864 002 Aug 10, 2009

EQ 100MG BASE A077864 003 Aug 10, 2009

IVAX SUB TEVA PHARMS EQ 25MG BASE A075719 003 Jun 30, 2006

EQ 50MG BASE A075719 001 Jun 30, 2006

EQ 100MG BASE A075719 002 Jun 30, 2006

MYLAN EQ 25MG BASE A076671 001 Feb 06, 2007

EQ 50MG BASE A076671 002 Feb 06, 2007

EQ 100MG BASE A076671 003 Feb 06, 2007

MYLAN PHARMS INC EQ 25MG BASE A076540 001 Mar 20, 2007

EQ 50MG BASE A076540 002 Mar 20, 2007

EQ 100MG BASE A076540 003 Mar 20, 2007

EQ 100MG BASE A078626 003 Jan 31, 2008

PLIVA HRVATSKA DOO EQ 25MG BASE A077299 001 Feb 06, 2007

EQ 50MG BASE A077299 002 Feb 06, 2007

EQ 100MG BASE A077299 003 Feb 06, 2007

SCIEGEN PHARMS INC EQ 25MG BASE A076442 001 Apr 30, 2007

EQ 50MG BASE A076442 002 Apr 30, 2007

EQ 100MG BASE A076442 003 Apr 30, 2007

SUN PHARM INDS (IN) EQ 25MG BASE A078108 001 Feb 06, 2007

EQ 50MG BASE A078108 002 Feb 06, 2007

EQ 100MG BASE A078108 003 Feb 06, 2007

WATSON LABS TEVA EQ 25MG BASE A077663 001 Feb 06, 2007

EQ 50MG BASE A077663 002 Feb 06, 2007

EQ 100MG BASE A077663 003 Feb 06, 2007

ZOLOFT

+ PFIZER EQ 150MG BASE ** N019839 003 Dec 30, 1991

+ EQ 200MG BASE ** N019839 004 Dec 30, 1991

SEVELAMER HYDROCHLORIDE

CAPSULE;ORAL

RENAGEL

GENZYME 403MG N020926 001 Oct 30, 1998

SIBUTRAMINE HYDROCHLORIDE

CAPSULE;ORAL

MERIDIA

ABBOTT 5MG N020632 001 Nov 22, 1997

10MG N020632 002 Nov 22, 1997

15MG N020632 003 Nov 22, 1997

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-343(of 393)

** See List Footnote



SILDENAFIL CITRATE

TABLET;ORAL

SILDENAFIL CITRATE

ACTAVIS GRP PTC EQ 20MG BASE A200149 001 Feb 25, 2013

APOTEX CORP EQ 20MG BASE A091379 001 Nov 06, 2012

SILVER SULFADIAZINE

CREAM;TOPICAL

SSD AF

DR REDDYS LA 1% N018578 003 Jul 11, 1990

DRESSING;TOPICAL

SILDAFLO

FRANKLIN PHARMS 1% N019608 001 Nov 30, 1989

SIMEPREVIR SODIUM

CAPSULE;ORAL

OLYSIO

+ JANSSEN PRODS EQ 150MG BASE N205123 001 Nov 22, 2013

SIMETHICONE-CELLULOSE

SUSPENSION;ORAL

SONORX

BRACCO 7.5MG/ML N020773 001 Oct 29, 1998

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN

HISUN PHARM HANGZHOU 10MG A206557 001 Nov 13, 2017

20MG A206557 002 Nov 13, 2017

40MG A206557 003 Nov 13, 2017

80MG A206557 004 Nov 13, 2017

IVAX SUB TEVA PHARMS 5MG A076052 001 Jun 23, 2006

10MG A076052 002 Jun 23, 2006

20MG A076052 003 Jun 23, 2006

40MG A076052 004 Jun 23, 2006

80MG A076052 005 Dec 20, 2006

MYLAN PHARMS INC 5MG A090868 001 Jun 08, 2010

10MG A090868 002 Jun 08, 2010

20MG A090868 003 Jun 08, 2010

40MG A090868 004 Jun 08, 2010

80MG A090868 005 Jun 08, 2010

SUN PHARM INDS LTD 5MG A076285 001 Dec 20, 2006

10MG A076285 002 Dec 20, 2006

20MG A076285 003 Dec 20, 2006

40MG A076285 004 Dec 20, 2006

80MG A076285 005 Jun 23, 2006

YAOPHARMA CO LTD 5MG A077766 001 Dec 20, 2006

10MG A077766 002 Dec 20, 2006

20MG A077766 003 Dec 20, 2006

40MG A077766 004 Dec 20, 2006

80MG A077766 005 Dec 20, 2006

TABLET, ORALLY DISINTEGRATING;ORAL

SIMVASTATIN

SYNTHON PHARMS 10MG N021961 001 Oct 09, 2007

20MG N021961 002 Oct 09, 2007

40MG N021961 003 Oct 09, 2007

80MG N021961 004 Oct 09, 2007

SIMVASTATIN; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JUVISYNC

+ MERCK SHARP DOHME 10MG;EQ 50MG BASE ** N202343 004 Sep 18, 2012

+ 10MG;EQ 100MG BASE ** N202343 001 Oct 07, 2011



+ 20MG;EQ 50MG BASE ** N202343 005 Sep 18, 2012

+ 20MG;EQ 100MG BASE ** N202343 002 Oct 07, 2011



+ 40MG;EQ 50MG BASE ** N202343 006 Sep 18, 2012

+ 40MG;EQ 100MG BASE ** N202343 003 Oct 07, 2011


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-344(of 393)

** See List Footnote



SIROLIMUS

TABLET;ORAL

RAPAMUNE

+ PF PRISM CV 5MG **
N021110 003 Feb 23, 2004

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION;ORAL

UCEPHAN

B BRAUN
100MG/ML;100MG/ML
N019530 001 Dec 23, 1987

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE

HOSPIRA INC
0.5MEQ/ML
A202679 001 Mar 07, 2017

0.5MEQ/ML
A202981 001 Mar 04, 2016

SODIUM BICARBONATE IN PLASTIC CONTAINER

+ ABBOTT 0.9MEQ/ML **
N019443 001 Jun 03, 1986

+ 1MEQ/ML **
N019443 002 Jun 03, 1986

SODIUM BICARBONATE; TARTARIC ACID

GRANULE, EFFERVESCENT;ORAL

BAROS

MALLINCKRODT INC 460MG/GM;420MG/GM
N018509 001 Aug 07, 1985

SODIUM CHLORIDE

INJECTABLE;INJECTION

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABRAXIS PHARM 9MG/ML
A088909 001 Feb 07, 1985

SODIUM CHLORIDE

ABBOTT 20GM/100ML
N017013 001

B BRAUN 20GM/100ML
N017038 001

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

B BRAUN
450MG/100ML
N018184 001

MILES
450MG/100ML
N018503 001

SODIUM CHLORIDE 0.9%

+ MEDEFIL INC
18MG/2ML (9MG/ML)
N202832 002 Jan 06, 2012

+
22.5MG/2.5ML (9MG/ML)
N202832 003 Jan 06, 2012

+
27MG/3ML (9MG/ML)
N202832 004 Jan 06, 2012

+
45MG/5ML (9MG/ML)
N202832 005 Jan 06, 2012

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

ABBOTT 9MG/ML
N019218 001 Jul 13, 1984

+ ICU MEDICAL INC 9MG/ML
N019217 001 Jul 13, 1984

+ MEDEFIL INC 9MG/ML (9MG/ML)
N202832 001 Jan 06, 2012

MILES 900MG/100ML
N018502 001

SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER

+ ABRAXIS PHARM 234MG/ML **
N019329 001 Apr 22, 1987

SOLUTION;IRRIGATION

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

BAXTER HLTHCARE 450MG/100ML
N017864 001

450MG/100ML
N018497 001 Feb 19, 1982

HOSPIRA 450MG/100ML
N017670 001

450MG/100ML
N018380 001

SODIUM CHLORIDE IN PLASTIC CONTAINER

MILES
900MG/100ML
N018247 001

SODIUM CHROMATE CR-51

INJECTABLE;INJECTION

CHROMITOPE SODIUM

BRACCO
2mCi/VIAL
N013993 002

200uCi/ML
N013993 001

SODIUM CHROMATE CR 51

MALLINKRODT NUCLEAR
100uCi/ML
N016708 001

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

FLUORINE F-18

+ GE HEALTHCARE
2mCi/ML **
N017042 001

SODIUM FLUORIDE F 18

NIH NCI DCTD
10-200mCi/ML **
N022494 001 Jan 26, 2011

SODIUM FLUORIDE F-18

UIHC PET IMAGING
10-200mCi/ML
A204462 001 Nov 17, 2015

UNIV TX MD ANDERSON
10-200mCi/ML
A203247 001 Dec 23, 2013

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

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6-345(of 393)

** See List Footnote



SODIUM IODIDE I-123

CAPSULE;ORAL

SODIUM IODIDE I 123

CARDINAL HEALTH 418
400uCi
N018671 003 May 27, 1982

GE HEALTHCARE
100uCi
N017630 001

SOLUTION;ORAL

SODIUM IODIDE I 123

GE HEALTHCARE
2mCi/ML **
N017630 002

SODIUM IODIDE I-131

CAPSULE;ORAL

IODOTOPE

BRACCO
1-130mCi
N010929 001

1-150mCi
N010929 003

SODIUM IODIDE I 131

CIS
50uCi
N017316 001

100uCi
N017316 002

JUBILANT DRAXIMAGE
2-200mCi
N021305 004 Nov 18, 2004

MALLINKRODT NUCLEAR
0.8-100mCi
N016515 002

+
0.8-100mCi
N016517 001

15-100uCi
N016517 002

SOLUTION;ORAL

HICON

JUBILANT DRAXIMAGE
1-250mCi/0.25ML
N021305 002 Jan 24, 2003

1-500mCi/0.5ML
N021305 003 Jan 24, 2003

1-1000mCi/ML
N021305 005 Apr 04, 2006

IODOTOPE

BRACCO
7-106mCi/BOT
N010929 002

SODIUM IODIDE I 131

CIS
50mCi/ML
N017315 001

+ MALLINKRODT NUCLEAR
3.5-150mCi/VIAL
N016515 001

SODIUM LACTATE

INJECTABLE;INJECTION

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

B BRAUN 1.87GM/100ML
N018186 001

BAXTER HLTHCARE 1.87GM/100ML
N016692 001

HOSPIRA 1.87GM/100ML
N018249 001

SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER

B BRAUN
1.87GM/100ML
N020004 001 Apr 21, 1992

SODIUM MONOFLUOROPHOSPHATE

GEL;DENTAL

EXTRA-STRENGTH AIM

CHESEBROUGH PONDS
1.2%
N019518 002 Aug 06, 1986

PASTE;DENTAL

EXTRA-STRENGTH AIM

CHESEBROUGH PONDS
1.2%
N019518 001 Jun 03, 1987

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

NIPRIDE

ROCHE
50MG/VIAL
N017546 001

NITROPRESS

ABBOTT
50MG/VIAL
A071555 001 Nov 16, 1987

+ ABBVIE
50MG/VIAL **
N018450 001

HOSPIRA
50MG/VIAL
A070566 001 Jun 09, 1986

SODIUM NITROPRUSSIDE

ABRAXIS PHARM
50MG/VIAL
A070031 001 Jan 17, 1985

+ BAXTER HLTHCARE
50MG/VIAL **
N018581 001 Jul 28, 1982

TEVA PARENTERAL
25MG/ML
A073465 001 Mar 30, 1992

SODIUM PHOSPHATE P-32

SOLUTION;INJECTION, ORAL

PHOSPHOTOPE

BRACCO
1-8mCi/VIAL
N010927 001

SODIUM PHOSPHATE P 32

MALLINCKRODT
0.67mCi/ML
N011777 001

1.5mCi/VIAL
N011777 002

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

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** See List Footnote



SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

VISICOL

SALIX PHARMS 0.398GM;1.102GM N021097 001 Sep 21, 2000

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

NOVEL LABS INC 0.398GM;1.102GM A079247 001 Dec 30, 2011

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

KAYEXALATE

+ CONCORDIA PHARMS INC 453.6GM/BOT ** N011287 001

SODIUM POLYSTYRENE SULFONATE

CITRUSPHRMA 454GM/BOT A040909 001 Dec 03, 2008

WOCKHARDT 453.6GM/BOT A088786 001 Sep 11, 1984

SUSPENSION;ORAL, RECTAL

SODIUM POLYSTYRENE SULFONATE

MORTON GROVE 15GM/60ML A088717 001 Sep 11, 1984

ROXANE 15GM/60ML A088453 001 Nov 17, 1983



SODIUM SUCCINATE

INJECTABLE;INJECTION

SODIUM SUCCINATE

ELKINS SINN 30% A080516 001

SODIUM TETRADECYL SULFATE

INJECTABLE;INJECTION

SOTRADECOL

+ ELKINS SINN 1% ** N005970 004

+ 3% ** N005970 005

SODIUM THIOSULFATE

INJECTABLE;INJECTION

SODIUM THIOSULFATE

US ARMY 250MG/ML N020166 001 Feb 14, 1992

SOMATREM

INJECTABLE;INJECTION

PROTROPIN

GENENTECH 5MG/VIAL N019107 001 Oct 17, 1985

10MG/VIAL N019107 002 Oct 24, 1989

SOMATROPIN

INJECTABLE;INJECTION

ASELLACRIN 10

SERONO 10 IU/VIAL N017726 001

ASELLACRIN 2

SERONO 2 IU/VIAL N017726 002 Jul 21, 1983

BIO-TROPIN

FERRING 4.8MG/VIAL N019774 001 May 25, 1995

CRESCORMON

GENENTECH 4 IU/VIAL N017992 001

SOMATROPIN RECOMBINANT

INJECTABLE;INJECTION

ACCRETROPIN

EMERGENT 5MG/ML (5MG/ML) N021538 001 Jan 23, 2008

GENOTROPIN PRESERVATIVE FREE

+ PHARMACIA AND UPJOHN 1.5MG/VIAL N020280 004 Aug 24, 1995

HUMATROPE

LILLY 2MG/VIAL N019640 001 Jun 23, 1987

NORDITROPIN

NOVO NORDISK INC 4MG/VIAL N019721 001 May 08, 1995

5MG/1.5ML N021148 001 Jun 20, 2000



8MG/VIAL N019721 002 May 08, 1995

10MG/1.5ML N021148 002 Jun 20, 2000



15MG/1.5ML N021148 003 Jun 20, 2000

NORDITROPIN NORDIFLEX

NOVO NORDISK INC 5MG/1.5ML N021148 004 Oct 01, 2004

10MG/1.5ML N021148 005 Oct 01, 2004

15MG/1.5ML N021148 006 Oct 01, 2004

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

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6-347(of 393)

** See List Footnote



SOMATROPIN RECOMBINANT

INJECTABLE;INJECTION

NORDITROPIN NORDIFLEX

30MG/3ML
N021148 007 Mar 10, 2009

NUTROPIN

GENENTECH
5MG/VIAL
N020168 001 Nov 17, 1993

10MG/VIAL
N020168 002 Nov 17, 1993

NUTROPIN AQ

GENENTECH
10MG/2ML (5MG/ML)
N020522 001 Dec 29, 1995

NUTROPIN AQ PEN

+ GENENTECH
10MG/2ML (5MG/ML)
N020522 002 Apr 22, 2002

+
20MG/2ML (10MG/ML)
N020522 006 Jan 03, 2008

NUTROPIN DEPOT

GENENTECH
13.5MG/VIAL
N021075 001 Dec 22, 1999

18MG/VIAL
N021075 002 Dec 22, 1999

22.5MG/VIAL
N021075 003 Dec 22, 1999

SAIZEN

EMD SERONO
4MG/VIAL
N019764 005 Jan 16, 2007

6MG/VIAL
N019764 001 Oct 08, 1996

SEROSTIM

EMD SERONO
8.8MG/VIAL
N020604 004 Sep 06, 2001

VALTROPIN

LG CHEM LTD
5MG/VIAL
N021905 001 Apr 19, 2007

ZORBTIVE

EMD SERONO
4MG/VIAL
N021597 001 Dec 01, 2003

5MG/VIAL
N021597 002 Dec 01, 2003

6MG/VIAL
N021597 003 Dec 01, 2003

INJECTABLE;SUBCUTANEOUS

SEROSTIM LQ

EMD SERONO
6MG/0.5ML (6MG/0.5ML)
N020604 005 Feb 11, 2005

SORBITOL

SOLUTION;IRRIGATION

SORBITOL 3% IN PLASTIC CONTAINER

BAXTER HLTHCARE
3GM/100ML
N018512 001 May 27, 1982

SOTALOL HYDROCHLORIDE

TABLET;ORAL

BETAPACE

COVIS PHARMA BV
320MG
N019865 004 Oct 30, 1992

BETAPACE AF

COVIS PHARMA BV
40MG
N021151 006 Apr 02, 2003

60MG
N021151 007 Apr 02, 2003

100MG
N021151 005 Mar 14, 2003

SOTALOL HYDROCHLORIDE

IMPAX PHARMS
80MG
A075663 001 Nov 07, 2000

120MG
A075663 002 Nov 07, 2000

160MG
A075663 003 Nov 07, 2000

240MG
A075663 004 Nov 07, 2000

MYLAN
80MG
A075237 001 May 01, 2000

80MG
A075725 001 Dec 19, 2000

120MG
A075237 002 May 01, 2000

120MG
A075725 002 Dec 19, 2000

160MG
A075237 003 May 01, 2000

160MG
A075725 003 Dec 19, 2000

240MG
A075237 004 May 01, 2000

240MG
A075725 004 Dec 19, 2000

SUN PHARM INDUSTRIES
80MG
A075515 001 Oct 15, 2001

80MG
A076576 001 Apr 08, 2004

120MG
A075515 004 Oct 15, 2001

120MG
A076576 002 Apr 08, 2004

160MG
A075515 002 Oct 15, 2001

160MG
A076576 003 Apr 08, 2004

240MG
A075515 003 Oct 15, 2001

TEVA
80MG
A076883 001 Jul 26, 2004

120MG
A076883 002 Jul 26, 2004

160MG
A076883 003 Jul 26, 2004

WATSON LABS
80MG
A075238 001 Jul 13, 2000

120MG
A075238 002 Jul 13, 2000

160MG
A075238 003 Jul 13, 2000

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

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6-348(of 393)

** See List Footnote



SOTALOL HYDROCHLORIDE

TABLET;ORAL

SOTALOL HYDROCHLORIDE

240MG
A075238 004 Jul 13, 2000

SOYBEAN OIL

INJECTABLE;INJECTION

LIPOSYN III 10%

HOSPIRA
10%
N018969 001 Sep 24, 1984

LIPOSYN III 20%

HOSPIRA
20%
N018970 001 Sep 25, 1984

LIPOSYN III 30%

HOSPIRA
30%
N020181 001 Jan 13, 1998

SOYACAL 10%

ALPHA THERA
10%
N018465 001 Jun 29, 1983

SOYACAL 20%

ALPHA THERA
20%
N018786 001 Jun 29, 1983

TRAVAMULSION 10%

BAXTER HLTHCARE
10%
N018660 001 Feb 26, 1982

TRAVAMULSION 20%

BAXTER HLTHCARE
20%
N018758 001 Feb 15, 1983

SPARFLOXACIN

TABLET;ORAL

ZAGAM

MYLAN
200MG
N020677 001 Dec 19, 1996

SPECTINOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

TROBICIN

PFIZER
EQ 2GM BASE/VIAL
N050347 001

EQ 4GM BASE/VIAL
N050347 002

SPIRAPRIL HYDROCHLORIDE

TABLET;ORAL

RENORMAX

SCHERING
3MG
N020240 001 Dec 29, 1994

6MG
N020240 002 Dec 29, 1994

12MG
N020240 003 Dec 29, 1994

24MG
N020240 004 Dec 29, 1994

SPIRONOLACTONE

TABLET;ORAL

SPIRONOLACTONE

ASCOT
25MG
A087687 001 Oct 20, 1982

AUROBINDO PHARMA LTD
25MG
A202187 001 Mar 06, 2014

50MG
A202187 002 Mar 06, 2014

100MG
A202187 003 Mar 06, 2014

IVAX PHARMS
25MG
A087108 001

LEDERLE
25MG
A087634 001

MUTUAL PHARM
25MG
A087265 001

MYLAN
25MG
A087086 001

PUREPAC PHARM
25MG
A087998 001 Oct 14, 1983

25MG
A088053 001 Aug 25, 1983

SUPERPHARM
25MG
A089364 001 Nov 07, 1986

UPSHER SMITH
25MG
A087554 001

VANGARD
25MG
A087648 001 Feb 01, 1982

WARNER CHILCOTT
25MG
A087952 001 Nov 18, 1982

WATSON LABS
25MG
A086898 002 Mar 02, 1982

25MG
A087078 001

STANOZOLOL

TABLET;ORAL

WINSTROL

+ LUNDBECK INC
2MG
N012885 001 May 14, 1984

STAVUDINE

CAPSULE;ORAL

STAVUDINE

MYLAN LABS LTD
30MG
A078775 001 Jan 05, 2009

40MG
A078775 002 Jan 05, 2009

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

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6-349(of 393)

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STAVUDINE

CAPSULE;ORAL

ZERIT

BRISTOL MYERS SQUIBB 5MG
N020412 001 Jun 24, 1994

CAPSULE, EXTENDED RELEASE;ORAL

ZERIT XR

BRISTOL MYERS SQUIBB 37.5MG
N021453 001 Dec 31, 2002

50MG
N021453 002 Dec 31, 2002

75MG
N021453 003 Dec 31, 2002

100MG
N021453 004 Dec 31, 2002

FOR SOLUTION;ORAL

STAVUDINE

AUROBINDO PHARMA 1MG/ML
A077774 001 Dec 29, 2008

CIPLA LTD 1MG/ML
A078030 001 Mar 20, 2009

STERILE WATER FOR INJECTION

LIQUID;N/A

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER



ABRAXIS PHARM 100%
A089099 001 Dec 29, 1987

100%
A089100 001 Dec 29, 1987

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

B BRAUN 100%
N019077 001 Mar 02, 1984

STERILE WATER FOR IRRIGATION

LIQUID;IRRIGATION

STERILE WATER IN PLASTIC CONTAINER

MILES
100%
N018246 001

STREPTOMYCIN SULFATE

INJECTABLE;INJECTION

STREPTOMYCIN SULFATE

COPANOS
EQ 500MG BASE/ML
A060684 001

LILLY
EQ 1GM BASE/VIAL
A060107 001

EQ 1GM BASE/2ML
A060404 001

EQ 5GM BASE/VIAL
A060107 002

PFIZER
EQ 1GM BASE/VIAL **
A060076 001

EQ 1GM BASE/2.5ML
A060111 001

EQ 5GM BASE/VIAL **
A060076 002

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

ANECTINE

SANDOZ INC
50MG/ML
N008453 003

500MG/VIAL
N008453 001

1GM/VIAL
N008453 004

QUELICIN PRESERVATIVE FREE

+ HOSPIRA
20MG/ML
N008845 001

50MG/ML
N008845 002

100MG/ML
N008845 004

SUCCINYLCHOLINE CHLORIDE

INTL MEDICATION
100MG/VIAL
A085400 001 Feb 04, 1982

ORGANON USA INC
20MG/ML
A080997 001

SUCOSTRIN

APOTHECON
20MG/ML
N008847 001

100MG/ML
N008847 003

SUCRALFATE

TABLET;ORAL

SUCRALFATE

MYLAN IRELAND LTD
1GM
A074415 001 Jun 08, 1998

SUFENTANIL CITRATE

INJECTABLE;INJECTION

SUFENTANIL CITRATE

WATSON LABS
EQ 0.05MG BASE/ML
A074406 001 Dec 15, 1995

SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

BLEPH-10

ALLERGAN
10%
A084015 001

CETAMIDE

ALCON
10%
A080021 001

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

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6-350(of 393)

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SULFACETAMIDE SODIUM

OINTMENT;OPHTHALMIC

SODIUM SULAMYD

+ SCHERING 10% **
N005963 002

SULFAIR 10

PHARMAFAIR 10%
A088000 001 Dec 22, 1982
SOLUTION/DROPS;OPHTHALMIC

BLEPH-30

ALLERGAN 30%
A080028 002
ISOPTO CETAMIDE

ALCON 15%
A080020 002
OCUSULF-10

MIZA PHARMS USA 10%
A080660 001
OCUSULF-30

MIZA PHARMS USA 30%
A080660 002
SODIUM SULAMYD

+ SCHERING 10% **
N005963 001
+ 30% **
N005963 003
SODIUM SULFACETAMIDE

AKORN 10%
A083021 001
15%
A083021 002
30%
A083021 003
SOLA BARNES HIND 10%
A084143 001
10%
A084145 001
30%
A084146 001
30%
A084147 001
SULF-10

NOVARTIS 10%
A080025 001
SULF-15

NOVARTIS 15%
A089047 001 Oct 31, 1995
SULFACEL-15

OPTOPICS 15%
A080024 001
SULFACETAMIDE SODIUM

AKORN 30%
A040216 001 May 25, 1999
ALCON PHARMS LTD 30%
A089068 001 May 05, 1987
PHARMAFAIR 10%
A088947 001 May 17, 1985
SULFAIR 10

PHARMAFAIR 10%
A087949 001 Dec 13, 1982
SULFAIR FORTE

PHARMAFAIR 30%
A088385 001 Oct 13, 1983
SULFAIR-15

PHARMAFAIR 15%
A088186 001 May 25, 1983
SULTEN-10

BAUSCH AND LOMB 10%
A087818 001 Feb 03, 1983
SULFACYTINE

TABLET;ORAL

RENOQUID

GLENWOOD 250MG
N017569 001
SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

ABBVIE 300MG N004125 005
EVERYLIFE 500MG A080088 001
IMPAX LABS 500MG A080081 001
LANNETT 500MG A080084 001
LEDERLE 500MG N004054 001
+ LILLY 500MG N004122 002
SULFADIAZINE SODIUM

INJECTABLE;INJECTION

SULFADIAZINE SODIUM

LEDERLE 250MG/ML
N004054 002

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

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6-351(of 393)

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SULFADIAZINE; SULFAMERAZINE

SUSPENSION;ORAL

SULFONAMIDES DUPLEX

LILLY
250MG/5ML;250MG/5ML
N006317 007

SULFAMETER

TABLET;ORAL

SULLA

BAYER HLTHCARE
500MG
N016000 002

SULFAMETHIZOLE

TABLET;ORAL

MICROSUL

FOREST PHARMS
1GM
A086012 001

PROKLAR

FOREST PHARMS
500MG
A080273 001

THIOSULFIL

WYETH AYERST
250MG
N008565 001

500MG
N008565 004

SULFAMETHOXAZOLE

SUSPENSION;ORAL

GANTANOL

ROCHE
500MG/5ML
N013664 002

TABLET;ORAL

GANTANOL

ROCHE
500MG
N012715 002

GANTANOL-DS

ROCHE
1GM
N012715 003

SULFAMETHOXAZOLE

ASCOT
500MG
A087662 001 Oct 20, 1982

AUROLIFE PHARMA LLC
500MG
A085844 001

BARR
500MG
A087189 001 Jul 25, 1983

HEATHER
500MG
A086163 001

WATSON LABS
500MG
A085053 001

1GM
A086000 001

UROBAK

SHIONOGI
500MG
A087307 001

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE;INJECTION

BACTRIM

+ SUN PHARM INDS INC
80MG/ML;16MG/ML **
N018374 001

SEPTRA

MONARCH PHARMS
80MG/ML;16MG/ML
N018452 001

SULFAMETHOXAZOLE AND TRIMETHOPRIM

ABRAXIS PHARM
80MG/ML;16MG/ML
A070223 001 Dec 29, 1987

BEDFORD
80MG/ML;16MG/ML
A072383 001 Apr 29, 1992

HOSPIRA
80MG/ML;16MG/ML
A073199 001 Sep 11, 1992

WATSON LABS
80MG/ML;16MG/ML
A071556 001 Dec 29, 1987

WEST-WARD PHARMS INT
80MG/ML;16MG/ML
A070627 001 Dec 29, 1987

80MG/ML;16MG/ML
A070628 001 Dec 29, 1987

SUSPENSION;ORAL

BACTRIM

+ SUN PHARM INDUSTRIES 200MG/5ML;40MG/5ML **
N017560 001

BACTRIM PEDIATRIC

SUN PHARM INDUSTRIES 200MG/5ML;40MG/5ML **
N017560 002

SEPTRA

MONARCH PHARMS 200MG/5ML;40MG/5ML **
N017598 001

SEPTRA GRAPE

MONARCH PHARMS 200MG/5ML;40MG/5ML **
N017598 002 Feb 12, 1986

SULFAMETHOXAZOLE AND TRIMETHOPRIM

ANI PHARMS INC
200MG/5ML;40MG/5ML
A070028 001 Jun 02, 1987

200MG/5ML;40MG/5ML **
A077612 001 Nov 13, 2006

TEVA
200MG/5ML;40MG/5ML
N018812 001 Jan 28, 1983

200MG/5ML;40MG/5ML
N018812 002 Jun 10, 1983

SULFATRIM

PHARM ASSOC
200MG/5ML;40MG/5ML
N018615 002 Jan 07, 1983

SULMEPRIM

USL PHARMA
200MG/5ML;40MG/5ML
A070063 001 Aug 01, 1986

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

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DISCONTINUED DRUG PRODUCT LIST 6-352(of 393)

** See List Footnote



SULFAMETHOXAZOLE; TRIMETHOPRIM

SUSPENSION;ORAL

SULMEPRIM PEDIATRIC

USL PHARMA 200MG/5ML;40MG/5ML A070064 001 Aug 01, 1986

TRIMETH/SULFA

ALPHARMA US PHARMS 200MG/5ML;40MG/5ML A072289 001 May 23, 1988

200MG/5ML;40MG/5ML A072398 001 May 23, 1988

NASKA 200MG/5ML;40MG/5ML A072399 001 May 23, 1988

TABLET;ORAL

COTRIM

TEVA 400MG;80MG A070034 001 May 16, 1985

COTRIM D.S.

TEVA 800MG;160MG A070048 001 Mar 18, 1985

SULFAMETHOPRIM

NOVEL LABS INC 400MG;80MG A070022 001 Feb 15, 1985

SULFAMETHOPRIM-DS

NOVEL LABS INC 800MG;160MG A070032 001 Feb 15, 1985

SULFAMETHOXAZOLE AND TRIMETHOPRIM

FOSUN PHARMA 400MG;80MG A070889 001 Nov 13, 1986

400MG;80MG N018598 003 May 19, 1982

800MG;160MG A070890 001 Nov 13, 1986



HEATHER 400MG;80MG N018946 001 Aug 10, 1984

800MG;160MG N018946 002 Aug 10, 1984

INTERPHARM 400MG;80MG A071299 001 Oct 27, 1987



800MG;160MG A071300 001 Oct 27, 1987

MARTEC USA LLC 400MG;80MG A072408 001 Dec 07, 1988

MUTUAL PHARM 400MG;80MG A070006 001 Nov 14, 1984

PLIVA 400MG;80MG A070215 001 Sep 10, 1985

800MG;160MG A070216 001 Sep 10, 1985

ROXANE 400MG;80MG A072768 001 Aug 30, 1991

TEVA 400MG;80MG N018242 001



800MG;160MG N018242 002

USL PHARMA 400MG;80MG A070203 001 Nov 08, 1985

800MG;160MG A070204 001 Nov 08, 1985

WATSON LABS 400MG;80MG A070002 001 Nov 07, 1984

400MG;80MG N018852 001 May 09, 1983

800MG;160MG A070000 001 Nov 07, 1984



SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

FOSUN PHARMA 800MG;160MG N018598 004 May 19, 1982

MARTEC USA LLC 800MG;160MG A072417 001 Dec 07, 1988



MUTUAL PHARM 800MG;160MG A070007 001 Nov 14, 1984

ROXANE 800MG;160MG A072769 001 Aug 30, 1991

WATSON LABS 800MG;160MG N018854 001 May 09, 1983

SULFATRIM-DS

SUPERPHARM 800MG;160MG A070066 001 Jun 24, 1985

SULFATRIM-SS

SUPERPHARM 400MG;80MG A070065 002 Jun 24, 1985

UROPLUS DS

SHIONOGI 800MG;160MG A071816 001 Sep 28, 1987

UROPLUS SS

SHIONOGI 400MG;80MG A071815 001 Sep 28, 1987

SULFANILAMIDE

CREAM;VAGINAL

SULFANILAMIDE

G AND W LABS INC 15% A088718 001 Sep 19, 1985

SUPPOSITORY;VAGINAL

AVC

MYLAN SPECIALITY LP 1.05GM N006530 004 Jan 27, 1987

SULFAPHENAZOLE

SUSPENSION;ORAL

SULFABID

PHARM RES ASSOC 500MG/5ML N013093 001

TABLET;ORAL

SULFABID

PURDUE FREDERICK 500MG N013092 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-353(of 393)

** See List Footnote



SULFAPYRIDINE

TABLET;ORAL

SULFAPYRIDINE

LILLY 500MG
N000159 001

SULFASALAZINE

SUSPENSION;ORAL

AZULFIDINE

PHARMACIA AND UPJOHN 250MG/5ML
N018605 001

TABLET;ORAL

S.A.S.-500

SOLVAY
500MG
A083450 001

SULFASALAZINE

HERITAGE PHARMS INC
500MG
A080197 001

SANDOZ
500MG
A086184 001

SUN PHARM INDUSTRIES
500MG
A089590 001 Oct 19, 1987

SUPERPHARM
500MG
A089339 001 Oct 26, 1987

WATSON LABS
500MG
A084964 001

500MG
A087197 001

TABLET, DELAYED RELEASE;ORAL

SULFASALAZINE

WATSON LABS
500MG
A088052 001 May 24, 1983

SULFINPYRAZONE

CAPSULE;ORAL

ANTURANE

+ NOVARTIS
200MG **
N011556 004

SULFINPYRAZONE

BARR
200MG
A087666 001 Sep 17, 1982

IVAX PHARMS
200MG
A087770 001 Nov 19, 1982

PAR PHARM
200MG
A088934 001 Sep 06, 1985

VANGARD
200MG
A088666 001 Feb 17, 1984

TABLET;ORAL

ANTURANE

NOVARTIS
100MG **
N011556 003

SULFINPYRAZONE

BARR
100MG
A087665 001 Sep 17, 1982

IVAX PHARMS
100MG
A087769 001 Jun 01, 1982

PAR PHARM
100MG
A088933 001 Sep 06, 1985

WATSON LABS
100MG
A087667 001 May 26, 1982

SULFISOXAZOLE

TABLET;ORAL

GANTRISIN

ROCHE
500MG
N006525 001

SOSOL

MK LABS
500MG
A080036 001

SOXAZOLE

ALRA
500MG
A080366 001

SULFALAR

PARKE DAVIS
500MG
A084955 001

SULFISOXAZOLE

ANI PHARMS INC
500MG
A080142 001

AUROLIFE PHARMA LLC
500MG
A085628 001

BARR
500MG
A084031 001

HEATHER
500MG
A080189 001

IMPAX LABS
500MG
A080109 001

LANNETT
500MG
A080085 001

LEDERLE
500MG
A087649 001

PHARMERAL
500MG
A084385 001

PUREPAC PHARM
500MG
A080087 001

ROXANE
500MG
A080082 001

VALEANT PHARM INTL
500MG
A080268 002

VITARINE
500MG
A087332 001

WATSON LABS
500MG
A085534 001

WEST WARD
500MG
A080379 001

SULSOXIN

SOLVAY
500MG
A080040 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-354(of 393)

** See List Footnote



SULFISOXAZOLE ACETYL

EMULSION;ORAL

LIPO GANTRISIN

ROCHE
EQ 1GM BASE/5ML
N009182 009

SUSPENSION;ORAL

GANTRISIN PEDIATRIC

ROCHE
EQ 500MG BASE/5ML
N009182 004

SYRUP;ORAL

GANTRISIN

ROCHE
EQ 500MG BASE/5ML
N009182 002

SULFISOXAZOLE DIOLAMINE

INJECTABLE;INJECTION

GANTRISIN

ROCHE
EQ 400MG BASE/ML
N006917 001

OINTMENT;OPHTHALMIC

GANTRISIN

ROCHE
EQ 4% BASE
N008414 002

SOLUTION/DROPS;OPHTHALMIC

GANTRISIN

ROCHE
EQ 4% BASE
N007757 002

SULFISOXAZOLE DIOLAMINE

SOLA BARNES HIND
EQ 4% BASE
A084148 001

SULFOXONE SODIUM

TABLET, DELAYED RELEASE;ORAL

DIASONE SODIUM

ABBVIE
165MG
N006044 003

SULFUR

POWDER;TOPICAL

BENSULFOID

POYTHRESS
33.32%
N002918 001

SULINDAC

TABLET;ORAL

CLINORIL

+ MERCK
150MG **
N017911 001

+
200MG **
N017911 002

SULINDAC

ANI PHARMS INC
150MG
A072972 001 Feb 28, 1992

200MG
A072973 001 Feb 28, 1992

EPIC PHARMA LLC
150MG
A073262 002 Sep 06, 1991

200MG
A073262 001 Sep 06, 1991

FOSUN PHARMA
150MG
A072712 001 Aug 30, 1991

200MG
A072713 001 Aug 30, 1991

SUMATRIPTAN

SPRAY;NASAL

IMITREX

GLAXOSMITHKLINE
10MG/SPRAY
N020626 002 Aug 26, 1997

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS

ALSUMA

MERIDIAN MEDCL
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N022377 001 Jun 29, 2010

SUMATRIPTAN SUCCINATE

FRESENIUS KABI USA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A079240 002 Sep 18, 2009

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)


A079240 001 Sep 18, 2009

INJECTALIA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090310 001 Aug 11, 2010

SANDOZ INC
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
A078067 002 Feb 06, 2009

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A078067 001 Feb 06, 2009

TEVA PARENTERAL
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
A078318 001 Feb 06, 2009

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A078318 002 Feb 06, 2009

SUMAVEL DOSEPRO

+ ENDO VENTURES LTD
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
N022239 002 Nov 26, 2013

+
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N022239 001 Jul 15, 2009

SYSTEM;IONTOPHORESIS

ZECUITY

+ TEVA BRANDED PHARM
EQ 6.5MG BASE/4HR
N202278 001 Jan 17, 2013

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-355(of 393)

** See List Footnote



SUMATRIPTAN SUCCINATE

TABLET;ORAL

SUMATRIPTAN SUCCINATE

FOSUN PHARMA
EQ 25MG BASE
A076976 001 Aug 10, 2009

EQ 50MG BASE
A076976 002 Aug 10, 2009

EQ 100MG BASE
A076976 003 Aug 10, 2009

HIKMA PHARMS
EQ 25MG BASE
A078298 001 May 21, 2013

EQ 50MG BASE
A078298 002 May 21, 2013

EQ 100MG BASE
A078298 003 May 21, 2013

MYLAN
EQ 25MG BASE
A077163 001 Nov 02, 2009

EQ 50MG BASE
A077163 002 Nov 02, 2009

EQ 100MG BASE
A077163 003 Nov 02, 2009

ROXANE
EQ 25MG BASE
A078241 001 Aug 10, 2009

EQ 50MG BASE
A078241 002 Aug 10, 2009

EQ 100MG BASE
A078241 003 Aug 10, 2009

TEVA
EQ 25MG BASE
A076840 001 Feb 09, 2009

EQ 50MG BASE
A076840 002 Feb 09, 2009

EQ 100MG BASE
A076840 003 Feb 09, 2009

SUPROFEN

SOLUTION/DROPS;OPHTHALMIC

PROFENAL

ALCON
1%
N019387 001 Dec 23, 1988

SUTILAINS

OINTMENT;TOPICAL

TRAVASE

+ ABBOTT
82,000 UNITS/GM **
N012828 001

TACRINE HYDROCHLORIDE

CAPSULE;ORAL

COGNEX

SHIONOGI INC
EQ 10MG BASE
N020070 001 Sep 09, 1993

EQ 20MG BASE
N020070 002 Sep 09, 1993

EQ 30MG BASE
N020070 003 Sep 09, 1993

EQ 40MG BASE
N020070 004 Sep 09, 1993

TACROLIMUS

CAPSULE;ORAL

TACROLIMUS

WATSON LABS
EQ 5MG BASE
A090402 001 Jul 01, 2010

TALBUTAL

TABLET;ORAL

LOTUSATE

SANOFI AVENTIS US
120MG
N009410 005

TAMOXIFEN CITRATE

TABLET;ORAL

NOLVADEX

+ ASTRAZENECA
EQ 10MG BASE **
N017970 001

+
EQ 20MG BASE **
N017970 002 Mar 21, 1994

TAMOXIFEN CITRATE

ACTAVIS LABS FL INC
EQ 10MG BASE
A076179 001 Feb 20, 2003

EQ 20MG BASE
A076179 002 Feb 20, 2003

AEGIS PHARMS
EQ 10MG BASE
A076398 001 Mar 31, 2003

EQ 20MG BASE
A076398 002 Mar 31, 2003

IVAX SUB TEVA PHARMS
EQ 10MG BASE
A075740 001 Feb 20, 2003

EQ 20MG BASE
A075740 002 Feb 20, 2003

PHARMACHEMIE
EQ 10MG BASE
A074539 001 Mar 31, 2003

ROXANE
EQ 10MG BASE
A076027 001 Feb 20, 2003

EQ 20MG BASE
A076027 002 Feb 20, 2003

TEVA
EQ 10MG BASE
A074504 001 Apr 28, 2003

EQ 20MG BASE
A074504 002 Apr 28, 2003

TAPENTADOL HYDROCHLORIDE

SOLUTION;ORAL

NUCYNTA

+ ASSERTIO
EQ 20MG BASE/ML
N203794 001 Oct 15, 2012

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-356(of 393)

** See List Footnote



TECHNETIUM TC-99M ALBUMIN AGGREGATED

INJECTABLE;INJECTION

TC 99M-LUNGAGGREGATE

GE HEALTHCARE 5mCi/ML
N017848 001

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

INJECTABLE;INJECTION

A-N STANNOUS AGGREGATED ALBUMIN

SYNCOR PHARMS
N/A
N017916 001

AN-MAA

PHARMALUCENCE
N/A
N017792 001

LUNGAGGREGATE REAGENT

GE HEALTHCARE
N/A
N017838 001

MACROTEC

BRACCO
N/A
N017833 001

PULMOLITE

+ JUBILANT DRAXIMAGE
N/A
N017776 001

TECHNESCAN MAA

MALLINCKRODT
N/A
N017842 001

TECHNETIUM TC 99M MAA

GE HEALTHCARE
N/A
N017773 001

TECHNETIUM TC-99M ALBUMIN COLLOID KIT

INJECTABLE;INJECTION

MICROLITE

PHARMALUCENCE N/A
N018263 001 Mar 25, 1983

TECHNETIUM TC-99M ALBUMIN KIT

INJECTABLE;INJECTION

TECHNETIUM TC 99M HSA

GE HEALTHCARE N/A
N017775 001

TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT

INJECTABLE;INJECTION

INSTANT MICROSPHERES

3M N/A
N017832 001

TECHNETIUM TC-99M APCITIDE

INJECTABLE;INJECTION

ACUTECT

CIS BIO INTL SA N/A
N020887 001 Sep 14, 1998

TECHNETIUM TC-99M DEPREOTIDE

INJECTABLE;INJECTION

NEO TECT KIT

CIS BIO INTL SA N/A
N021012 001 Aug 03, 1999

TECHNETIUM TC-99M ETIDRONATE KIT

INJECTABLE;INJECTION

CINTICHEM TECHNETIUM 99M HEDSPA

GE HEALTHCARE N/A
N017653 001

MPI STANNOUS DIPHOSPHONATE

GE HEALTHCARE N/A
N017667 001

OSTEOSCAN

MALLINCKRODT N/A
N017454 001

TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT

GE HEALTHCARE N/A
N017562 001

TECHNETIUM TC-99M FERPENTETATE KIT

INJECTABLE;INJECTION

RENOTEC

BRACCO N/A
N017045 001

TECHNETIUM TC-99M GLUCEPTATE KIT

INJECTABLE;INJECTION

GLUCOSCAN

BRISTOL MYERS SQUIBB N/A
N017907 001

TECHNESCAN GLUCEPTATE

DRAXIMAGE N/A
N018272 001 Jan 27, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-357(of 393)
** See List Footnote
TECHNETIUM TC-99M LIDOFENIN KIT

INJECTABLE;INJECTION

TECHNESCAN HIDA

DRAXIMAGE
N/A N018489 001 Oct 31, 1986
TECHNETIUM TC-99M MEDRONATE

INJECTABLE;INJECTION

DRAXIMAGE MDP-10

JUBILANT DRAXIMAGE
N/A N018035 001
TECHNETIUM TC-99M MEDRONATE KIT

INJECTABLE;INJECTION

AMERSCAN MDP KIT

GE HEALTHCARE
N/A N018335 001 Aug 05, 1982
MDP-BRACCO

CARDINAL HEALTH 414
N/A N018107 001
OSTEOLITE

PHARMALUCENCE
N/A N017972 001
TECHNETIUM TC 99M MPI MDP

GE HEALTHCARE
N/A N018141 001
N/A N018141 002 Jun 12, 1989
TECHNETIUM TC-99M PENTETATE KIT

INJECTABLE;INJECTION

AN-DTPA

JUBILANT DRAXIMAGE
N/A N017714 001
MPI DTPA KIT - CHELATE

GE HEALTHCARE
N/A N017255 001
TECHNETIUM TC-99M PENTETATE KIT

GE HEALTHCARE
N/A N017264 002
TECHNETIUM TC-99M POLYPHOSPHATE KIT

INJECTABLE;INJECTION

SODIUM POLYPHOSPHATE-TIN KIT

GE HEALTHCARE
N/A N017664 001
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT

INJECTABLE;INJECTION

PYROLITE

PHARMALUCENCE
N/A N017684 001
TECHNETIUM TC-99M PYROPHOSPHATE KIT

INJECTABLE;INJECTION

PHOSPHOTEC

BRACCO
N/A N017680 001
TECHNETIUM TC-99M RED BLOOD CELL KIT

INJECTABLE;INJECTION

RBC-SCAN

CADEMA
N/A N020063 001 Jun 11, 1992
TECHNETIUM TC-99M SESTAMIBI KIT

INJECTABLE;INJECTION

MIRALUMA

LANTHEUS MEDCL
N/A N019785 003 May 23, 1997
TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTION;INJECTION, ORAL

SODIUM PERTECHNETATE TC 99M

+ GE HEALTHCARE 2-100mCi/ML ** N017471 001
+ MALLINCKRODT 10-60mCi/ML ** N017725 001
PHARMALUCENCE 12mCi/ML N017321 001
24mCi/ML N017321 002
48mCi/ML N017321 003
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INJECTION, ORAL

MINITEC

BRACCO
0.22-2.22 CI/GENERATOR N017339 001
SOLUTION;INTRAVENOUS

TECHNELITE

LANTHEUS MEDCL
0.0083-2.7 CI/GENERATOR N017771 001
ULTRA-TECHNEKOW FM

MALLINKRODT NUCLEAR
0.25-3 CI/GENERATOR N017243 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-358(of 393)

** See List Footnote



TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INTRAVENOUS, ORAL

TECHNETIUM TC 99M GENERATOR

GE HEALTHCARE
830-16600mCi/GENERATOR
N017693 001

TECHNETIUM TC-99M SUCCIMER KIT

INJECTABLE;INJECTION

MPI DMSA KIDNEY REAGENT

GE HEALTHCARE
N/A
N017944 001 May 18, 1982

TECHNETIUM TC-99M SULFUR COLLOID

SOLUTION;INJECTION, ORAL

TECHNETIUM TC 99M SULFUR COLLOID

GE HEALTHCARE 4mCi/ML
N017456 001

SOLUTION;ORAL

TECHNETIUM TC 99M SULFUR COLLOID

MALLINCKRODT 3mCi/ML
N017724 001

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL

TECHNECOLL
MALLINCKRODT N/A N017059 001

TECHNETIUM TC 99M TSC
GE HEALTHCARE N/A N017784 001

TESULOID
BRACCO N/A N016923 001

TECHNETIUM TC-99M TEBOROXIME KIT

INJECTABLE;INJECTION

CARDIOTEC

BRACCO N/A
N019928 001 Dec 19, 1990

TECHNETIUM TC-99M TETROFOSMIN KIT

INJECTABLE;INJECTION

MYOVIEW

+ GE HEALTHCARE
N/A
N020372 001 Feb 09, 1996

TEGASEROD MALEATE

TABLET;ORAL

ZELNORM

US WORLDMEDS LLC
EQ 2MG BASE
N021200 001 Jul 24, 2002

EQ 6MG BASE
N021200 002 Jul 24, 2002

TELAPREVIR

TABLET;ORAL

INCIVEK

VERTEX PHARMS
375MG
N201917 001 May 23, 2011

TELAVANCIN HYDROCHLORIDE

POWDER;INTRAVENOUS

VIBATIV

+ CUMBERLAND PHARMS
EQ 250MG BASE/VIAL
N022110 001 Sep 11, 2009

TELBIVUDINE

SOLUTION;ORAL

TYZEKA

NOVARTIS
100MG/5ML
N022154 001 Apr 28, 2009

TABLET;ORAL

TYZEKA

+ NOVARTIS
600MG
N022011 001 Oct 25, 2006

TELITHROMYCIN

TABLET;ORAL

KETEK

SANOFI AVENTIS US
300MG
N021144 002 Feb 09, 2005

400MG
N021144 001 Apr 01, 2004

TELMISARTAN

TABLET;ORAL

TELMISARTAN

WATSON LABS
40MG
A078710 002 Jan 08, 2014

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-359(of 393)

** See List Footnote



TEMAZEPAM

CAPSULE;ORAL

TEMAZ

QUANTUM PHARMICS
15MG
A070564 001 Oct 15, 1985

30MG
A070547 001 Oct 15, 1985

TEMAZEPAM

DURAMED PHARMS BARR
15MG
A071708 001 Sep 29, 1988

30MG
A071709 001 Sep 29, 1988

SUN PHARM INDUSTRIES


15MG
A071174 001 Jul 10, 1986

30MG
A071175 001 Jul 10, 1986

USL PHARMA
15MG
A070489 001 Jul 07, 1986

30MG
A070490 001 Jul 07, 1986

WATSON LABS
15MG
A070383 001 Mar 23, 1987

15MG
A071446 001 May 21, 1993

30MG
A070384 001 Mar 23, 1987

30MG
A071447 001 May 21, 1993

TEMOZOLOMIDE

CAPSULE;ORAL

TEMOZOLOMIDE

MYLAN PHARMS INC
5MG
A205227 001 Jun 29, 2016

20MG
A205227 002 Jun 29, 2016

100MG
A205227 003 Jun 29, 2016

140MG
A205227 004 Jun 29, 2016

180MG
A205227 005 Jun 29, 2016

250MG
A205227 006 Jun 29, 2016

TENIPOSIDE

INJECTABLE;INJECTION

VUMON

+ HQ SPECLT PHARMA
10MG/ML
N020119 001 Jul 14, 1992

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

HYTRIN

+ ABBOTT
EQ 1MG BASE **
N020347 001 Dec 14, 1994

+
EQ 2MG BASE **
N020347 002 Dec 14, 1994

+
EQ 5MG BASE **
N020347 003 Dec 14, 1994

+
EQ 10MG BASE **
N020347 004 Dec 14, 1994

TERAZOSIN HYDROCHLORIDE

MYLAN TECHNOLOGIES
EQ 1MG BASE
A075384 001 Dec 01, 2000

EQ 2MG BASE
A075384 002 Dec 01, 2000

EQ 5MG BASE
A075384 003 Dec 01, 2000

EQ 10MG BASE
A075384 004 Dec 01, 2000

RANBAXY LABS LTD
EQ 1MG BASE
A076021 001 Aug 22, 2002

EQ 2MG BASE
A076021 002 Aug 22, 2002

EQ 5MG BASE
A076021 003 Aug 22, 2002

EQ 10MG BASE
A076021 004 Aug 22, 2002

SANDOZ
EQ 1MG BASE
A075667 001 Jul 28, 2000

EQ 2MG BASE
A075667 002 Jul 28, 2000

EQ 5MG BASE
A075667 003 Jul 28, 2000

EQ 10MG BASE
A075667 004 Jul 28, 2000

TABLET;ORAL

HYTRIN

ABBOTT
EQ 1MG BASE
N019057 001 Aug 07, 1987

EQ 2MG BASE
N019057 002 Aug 07, 1987

EQ 5MG BASE
N019057 003 Aug 07, 1987

EQ 10MG BASE
N019057 004 Aug 07, 1987

TERAZOSIN HYDROCHLORIDE

IVAX SUB TEVA PHARMS
EQ 1MG BASE
A074530 001 Apr 21, 2000

EQ 2MG BASE
A074530 002 Apr 21, 2000

EQ 5MG BASE
A074530 003 Apr 21, 2000

EQ 10MG BASE
A074530 004 Apr 21, 2000

SANDOZ
EQ 1MG BASE
A074315 001 Dec 31, 1998

EQ 1MG BASE
A074657 001 Apr 28, 2000

EQ 2MG BASE
A074315 002 Dec 31, 1998

EQ 2MG BASE
A074657 002 Apr 28, 2000

EQ 5MG BASE
A074315 003 Dec 31, 1998

EQ 5MG BASE
A074657 003 Apr 28, 2000

EQ 10MG BASE
A074315 004 Dec 31, 1998

EQ 10MG BASE
A074657 004 Apr 28, 2000

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-360(of 393)

** See List Footnote



TERAZOSIN HYDROCHLORIDE

TABLET;ORAL

TERAZOSIN HYDROCHLORIDE

TEVA
EQ 1MG BASE
A074446 001 May 18, 2000

EQ 2MG BASE
A074446 002 May 18, 2000

EQ 5MG BASE
A074446 003 May 18, 2000

EQ 10MG BASE
A074446 004 May 18, 2000

TERBINAFINE

GEL;TOPICAL

LAMISIL

GLAXOSMITHKLINE CONS
1%
N020846 001 Apr 29, 1998

TERBINAFINE HYDROCHLORIDE

CREAM;TOPICAL

LAMISIL

NOVARTIS
1%
N020192 001 Dec 30, 1992

GRANULE;ORAL

LAMISIL

+ NOVARTIS
EQ 125MG BASE/PACKET
N022071 001 Sep 28, 2007

+
EQ 187.5MG BASE/PACKET
N022071 002 Sep 28, 2007

SOLUTION;TOPICAL

LAMISIL

GLAXOSMITHKLINE CONS
1%
N020749 001 Oct 17, 1997

TABLET;ORAL

TERBINAFINE HYDROCHLORIDE

APOTEX
EQ 250MG BASE
A078199 001 Jul 02, 2007

GEDEON RICHTER USA
EQ 250MG BASE
A077065 001 Jul 02, 2007

MYLAN
EQ 250MG BASE
A077136 001 Jul 02, 2007

EQ 250MG BASE
A077195 001 Jul 02, 2007

ROXANE
EQ 250MG BASE
A077223 001 Jul 02, 2007

WOCKHARDT
EQ 250MG BASE
A078229 001 Jul 02, 2007

TERBUTALINE SULFATE

AEROSOL, METERED;INHALATION

BRETHAIRE

NOVARTIS
0.2MG/INH
N018762 001 Aug 17, 1984

BRICANYL

SANOFI AVENTIS US
0.2MG/INH
N018000 001 Mar 19, 1985

INJECTABLE;INJECTION

BRETHINE

+ PHARMACARE
1MG/ML **
N018571 001

BRICANYL

SANOFI AVENTIS US
1MG/ML
N017466 001

TERBUTALINE SULFATE

TEVA PHARMS USA
1MG/ML
A076853 001 Jul 20, 2004

TABLET;ORAL

BRICANYL

SANOFI AVENTIS US
2.5MG
N017618 001

5MG
N017618 002

TERCONAZOLE

CREAM;VAGINAL

TERAZOL 3

+ JANSSEN PHARMS
0.8%
N019964 001 Feb 21, 1991

TERAZOL 7

+ JANSSEN PHARMS
0.4%
N019579 001 Dec 31, 1987

SUPPOSITORY;VAGINAL

TERAZOL 3

+ JANSSEN PHARMS
80MG
N019641 001 May 24, 1988

TERCONAZOLE

FOUGERA PHARMS
80MG
A076850 001 Jul 12, 2006

TERIPARATIDE ACETATE

INJECTABLE;INJECTION

PARATHAR

SANOFI AVENTIS US
200 UNITS/VIAL
N019498 001 Dec 23, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-361(of 393)

** See List Footnote



TERIPARATIDE RECOMBINANT HUMAN

INJECTABLE;SUBCUTANEOUS

FORTEO

LILLY 0.75MG/3ML (0.25MG/ML)
N021318 001 Nov 26, 2002

TESTOLACTONE

INJECTABLE;INJECTION

TESLAC

BRISTOL MYERS SQUIBB 100MG/ML
N016119 001

TABLET;ORAL

TESLAC

BRISTOL MYERS SQUIBB 50MG
N016118 001

250MG
N016118 002

TESTOSTERONE

FILM, EXTENDED RELEASE;TRANSDERMAL

ANDRODERM

ALLERGAN SALES LLC
2.5MG/24HR
N020489 001 Sep 29, 1995

5MG/24HR
N020489 002 May 02, 1997

TESTODERM

ALZA
4MG/24HR
N019762 001 Oct 12, 1993

6MG/24HR
N019762 002 Oct 12, 1993

TESTODERM TTS

ALZA
5MG/24HR
N020791 001 Dec 18, 1997

GEL;TRANSDERMAL

TESTOSTERONE

ANI PHARMS INC
25MG/2.5GM PACKET
N202763 001 Feb 14, 2012

50MG/5GM PACKET
N202763 002 Feb 14, 2012

PERRIGO ISRAEL
25MG/2.5GM PACKET
N203098 002 Jan 31, 2013

50MG/5GM PACKET
N203098 003 Jan 31, 2013

GEL, METERED;TRANSDERMAL

TESTOSTERONE

PERRIGO ISRAEL
12.5MG/1.25GM ACTUATION
N203098 001 Jan 31, 2013

INJECTABLE;INJECTION

TESTOSTERONE

WATSON LABS
25MG/ML
A086420 001 May 10, 1983

50MG/ML
A086419 001 Aug 23, 1983

100MG/ML
A086417 001 Jul 07, 1983

SOLUTION, METERED;TRANSDERMAL

AXIRON

+ ELI LILLY AND CO
30MG/1.5ML ACTUATION **
N022504 001 Nov 23, 2010

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

DEPO-TESTOSTERONE

PHARMACIA AND UPJOHN 50MG/ML
A085635 001

TESTOSTERONE CYPIONATE

WATSON LABS
100MG/ML
A084401 001

100MG/ML
A086029 001

200MG/ML
A084401 002

TESTOSTERONE ENANTHATE

INJECTABLE;INJECTION

DELATESTRYL

ENDO PHARMS
200MG/ML
N009165 001

+
200MG/ML
N009165 003

TESTOSTERONE ENANTHATE

MYLAN INSTITUTIONAL
200MG/ML
A040647 001 Oct 05, 2009

WATSON LABS
100MG/ML
A083667 001

100MG/ML
A085599 001

200MG/ML
A083667 002

TESTOSTERONE PROPIONATE

INJECTABLE;INJECTION

TESTOSTERONE PROPIONATE

BEL MAR
25MG/ML
A080741 001

50MG/ML
A080742 001

100MG/ML
A080743 001

ELKINS SINN
25MG/ML
A080276 001

LILLY
50MG/ML
A080254 002

WATSON LABS
25MG/ML
A080188 001

25MG/ML
A085490 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-362(of 393)

** See List Footnote



TESTOSTERONE PROPIONATE

INJECTABLE;INJECTION

TESTOSTERONE PROPIONATE

50MG/ML
A080188 002

50MG/ML
A085490 002

100MG/ML
A080188 003

100MG/ML
A083595 003

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

BRISTACYCLINE

BRISTOL
250MG
A061658 001

250MG
A061888 001

500MG
A061658 002

500MG
A061888 002

CYCLOPAR

WARNER CHILCOTT
250MG
A061725 001

250MG
A062175 001

250MG
A062332 001

500MG
A061725 002

500MG
A062332 002

PANMYCIN

PHARMACIA AND UPJOHN 250MG
A060347 001

RETET
SOLVAY 250MG A061443 001

500MG A061443 002

ROBITET
WYETH AYERST 250MG A061734 001

500MG A061734 002

SUMYCIN
APOTHECON 100MG A060429 002

125MG A060429 004

250MG A060429 001

500MG A060429 003

TETRACHEL
ANGUS 250MG A060343 001

500MG A060343 003

TETRACYCLINE HYDROCHLORIDE
ABBOTT 250MG A061802 001

500MG A061802 002

ANI PHARMS INC 250MG A061471 001

ELKINS SINN 250MG A060059 001

FERRANTE 125MG A060173 001

250MG A060173 002

HEATHER 250MG A061148 001

500MG A061148 002

HIKMA PHARMS 250MG A060768 001

500MG A060768 002

IMPAX LABS 100MG A060469 002

250MG A060469 001

500MG A060469 003

IVAX SUB TEVA PHARMS 250MG
A060704 001

500MG A060704 002

MAST MM 250MG A062085 001

MYLAN 250MG A060783 001

500MG A060783 002

PUREPAC PHARM 250MG A060290 001

500MG A060290 002

PVT FORM 250MG A062686 001 Jul 24, 1986

500MG A062686 002 Jul 24, 1986

ROXANE 500MG A061214 002

SUN PHARM INDUSTRIES 250MG
A060736 001

500MG A060736 002

SUPERPHARM 250MG A062540 001 Mar 21, 1985

500MG A062540 002 Mar 21, 1985

VALEANT PHARM INTL 250MG A060471 001

500MG A060471 002

WARNER CHILCOTT 250MG A062300 001

500MG A062300 002

WATSON LABS 250MG A062103 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-363(of 393)

** See List Footnote


TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
TETRACYCLINE HYDROCHLORIDE
250MG A062343 001

500MG A062103 002

500MG A062343 002

WYETH AYERST 250MG A061685 001

500MG A061685 002

TETRACYN
PFIPHARMECS 250MG A060082 003

500MG A060082 004

FIBER, EXTENDED RELEASE;PERIODONTAL

ACTISITE

SCHIFF AND CO
12.7MG/FIBER
N050653 001 Mar 25, 1994

FOR SOLUTION;TOPICAL

TOPICYCLINE

SHIRE
2.2MG/ML
N050493 001

INJECTABLE;INJECTION

ACHROMYCIN

LEDERLE
250MG/VIAL
N050273 002

500MG/VIAL
N050273 003

TETRACYN

PFIZER
250MG/VIAL
A060096 001

500MG/VIAL
A060096 002

OINTMENT;OPHTHALMIC

ACHROMYCIN

STORZ
10MG/GM
N050266 001

SUSPENSION;ORAL

ACHROMYCIN V

LEDERLE
125MG/5ML
N050263 002

SUMYCIN

PAR PHARM
125MG/5ML
A060400 001

TETRACYCLINE HYDROCHLORIDE

ALPHARMA US PHARMS
125MG/5ML
A060633 001

FERRANTE
125MG/5ML
A060174 001

PROTER
125MG/5ML
A060446 001

PUREPAC PHARM
125MG/5ML
A060291 001

TETRACYN

PFIPHARMECS
125MG/5ML
A060095 001

TETRAMED

IVAX SUB TEVA PHARMS 125MG/5ML
A061468 001

SUSPENSION/DROPS;OPHTHALMIC

ACHROMYCIN

STORZ 1%
N050268 001

TABLET;ORAL

PANMYCIN

PHARMACIA AND UPJOHN 250MG
A061705 001

500MG
A061705 002

SUMYCIN

PAR PHARM
50MG
A061147 003

100MG
A061147 002

250MG
A061147 001

500MG
A061147 004

TETRACYCLINE PHOSPHATE COMPLEX

CAPSULE;ORAL

TETREX

BRISTOL
EQ 100MG HYDROCHLORIDE
A061653 001

EQ 250MG HYDROCHLORIDE
A061653 002

EQ 250MG HYDROCHLORIDE
A061889 002

EQ 250MG HYDROCHLORIDE
N050212 002

EQ 500MG HYDROCHLORIDE
A061653 003

EQ 500MG HYDROCHLORIDE
A061889 001

EQ 500MG HYDROCHLORIDE
N050212 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-364(of 393)

** See List Footnote



THALLOUS CHLORIDE TL-201

INJECTABLE;INJECTION

THALLOUS CHLORIDE TL 201

BRACCO 1mCi/ML
N018548 001 Dec 30, 1982

TRACE LIFE 1mCi/ML
A075569 001 Nov 21, 2001

INJECTABLE;INTRAVENOUS

THALLOUS CHLORIDE TL 201

+ LANTHEUS MEDCL 2mCi/ML
N017806 002 Oct 09, 1998

MALLINKRODT NUCLEAR 2mCi/ML
A077698 001 Nov 09, 2006

THEOPHYLLINE

CAPSULE;ORAL

BRONKODYL

SANOFI AVENTIS US 100MG
A085264 001

200MG
A085264 002

ELIXOPHYLLIN

FOREST LABS 100MG
A085545 001 Jul 31, 1984

200MG
A083921 001 Jul 31, 1984

SOMOPHYLLIN-T

FISONS 100MG
A087155 001 Feb 25, 1985

200MG
A087155 002 Feb 25, 1985

250MG
A087155 003 Feb 25, 1985

THEOPHYLLINE

KV PHARM 100MG
A085263 001

200MG
A085263 002

SCHERER RP 100MG
A084731 002 Nov 07, 1986

200MG
A084731 001 Nov 07, 1986

250MG
A084731 003 Nov 07, 1986

CAPSULE, EXTENDED RELEASE;ORAL

AEROLATE III

FLEMING PHARMS 65MG
A085075 003 Nov 24, 1986

AEROLATE JR

FLEMING PHARMS 130MG
A085075 002 Nov 24, 1986

AEROLATE SR

FLEMING PHARMS 260MG
A085075 001 Nov 24, 1986

ELIXOPHYLLIN SR

FOREST LABS 125MG
A086826 001 Jan 29, 1985

250MG
A086826 002 Jan 29, 1985

SLO-BID

SANOFI AVENTIS US 50MG
A088269 001 Jan 31, 1985

75MG
A089539 001 May 10, 1989

100MG
A087892 001 Jan 31, 1985

125MG
A089540 001 May 10, 1989

200MG
A087893 001 Jan 31, 1985

300MG
A087894 001 Jan 31, 1985

SLO-PHYLLIN

SANOFI AVENTIS US 60MG
A085206 001 May 24, 1982

125MG
A085203 001 May 24, 1982

250MG
A085205 001 May 24, 1982

SOMOPHYLLIN-CRT

GRAHAM DM 50MG
A087763 001 Feb 27, 1985

100MG
A087194 001

200MG
A088382 001 Feb 27, 1985

250MG
A087193 001

300MG
A088383 001 Feb 27, 1985

THEO-DUR

SCHERING 50MG
A088022 001 Sep 10, 1985

75MG
A088015 001 Sep 10, 1985

125MG
A088016 001 Sep 10, 1985

200MG
A087995 001 Sep 10, 1985

THEOBID

WHITBY 260MG
A085983 001 Mar 20, 1985

THEOBID JR.

WHITBY 130MG
A087854 001 Mar 20, 1985

THEOCLEAR L.A.-130

SCHWARZ PHARMA 130MG
A086569 001 May 27, 1982

THEOCLEAR L.A.-260

SCHWARZ PHARMA 260MG
A086569 002 May 27, 1982

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-365(of 393)

** See List Footnote



THEOPHYLLINE

CAPSULE, EXTENDED RELEASE;ORAL

THEOPHYL-SR

ORTHO MCNEIL PHARM
125MG
A086480 001 Feb 08, 1985

250MG
A086471 001 Feb 08, 1985

THEOPHYLLINE

CENT PHARMS
125MG
A088654 001 Feb 12, 1985

250MG
A088689 001 Feb 12, 1985

HOSPIRA
100MG
A089976 001 Jan 04, 1995

200MG
A089977 001 Jan 04, 1995

300MG
A089932 001 Jan 04, 1995

INWOOD LABS
100MG
A040052 001 Feb 14, 1994

125MG
A040052 002 Feb 14, 1994

200MG
A040052 003 Feb 14, 1994

300MG
A040052 004 Feb 14, 1994

SANDOZ
260MG
A087462 001 May 11, 1982

THEOPHYLLINE-SR

SCHERER RP
300MG
A088255 001 Jun 12, 1986

THEOVENT

SCHERING
125MG
A087010 001 Jan 31, 1985

250MG
A087910 001 Jan 31, 1985

ELIXIR;ORAL

ELIXOMIN

CENCI
80MG/15ML
A088303 001 Jan 25, 1984

LANOPHYLLIN

LANNETT
80MG/15ML
A084578 001

THEOLIXIR

PANRAY
80MG/15ML
A084559 001

THEOPHYL-225

ORTHO MCNEIL PHARM
112.5MG/15ML
A086485 001

THEOPHYLLINE

ALPHARMA US PHARMS
80MG/15ML
A089223 001 May 27, 1988

CENCI
80MG/15ML
A087679 001 Apr 15, 1982

CHARTWELL RX
80MG/15ML
A085952 001

HALSEY
80MG/15ML
A085169 001

PHARM ASSOC
80MG/15ML
A086720 001

PRECISION DOSE
80MG/15ML
A085863 001

ROXANE
80MG/15ML
A084739 001

TARO
80MG/15ML
A089626 001 Oct 28, 1988

WOCKHARDT
80MG/15ML
A086748 001

INJECTABLE;INJECTION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 40MG/100ML
N019083 001 Nov 07, 1984

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 80MG/100ML
N019083 002 Nov 07, 1984

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 160MG/100ML
N019083 003 Nov 07, 1984

THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 200MG/100ML
N019212 001 Nov 07, 1984

200MG/100ML
N019826 004 Aug 14, 1992

THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUN 4MG/ML
N019212 003 Nov 07, 1984

400MG/100ML
N019212 002 Nov 07, 1984

400MG/100ML
N019826 005 Aug 14, 1992

THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARE 4MG/ML
N018649 007 Jul 26, 1982

40MG/100ML
N018649 001 Jul 26, 1982

80MG/100ML
N018649 002 Jul 26, 1982

160MG/100ML
N018649 003 Jul 26, 1982

200MG/100ML
N018649 004 Jul 26, 1982

320MG/100ML
N018649 006 Nov 13, 1985

400MG/100ML
N018649 005 Jul 26, 1982

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

+ HOSPIRA INC
4MG/ML
N019211 007 Dec 14, 1984

+
40MG/100ML
N019211 001 Dec 14, 1984

80MG/100ML
N019211 002 Dec 14, 1984

+
160MG/100ML
N019211 003 Dec 14, 1984

200MG/100ML
N019211 004 Dec 14, 1984

+
320MG/100ML
N019211 006 Jan 20, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-366(of 393)

** See List Footnote



THEOPHYLLINE

INJECTABLE;INJECTION

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

400MG/100ML
N019211 005 Dec 14, 1984

SOLUTION;ORAL

AEROLATE

FLEMING PHARMS
150MG/15ML
A089141 001 Dec 03, 1986

THEOLAIR

3M
80MG/15ML
A086107 001

THEOPHYLLINE

ROXANE
80MG/15ML
A087449 001 Sep 15, 1983

SUSPENSION;ORAL

ELIXICON

FOREST LABS
100MG/5ML
A085502 001

SYRUP;ORAL

ACCURBRON

SANOFI AVENTIS US
150MG/15ML
A088746 001 Nov 22, 1985

AQUAPHYLLIN

FERNDALE LABS
80MG/15ML
A087917 001 Jan 18, 1983

SLO-PHYLLIN

SANOFI AVENTIS US
80MG/15ML
A085187 001

THEOCLEAR-80

CENT PHARMS
80MG/15ML
A087095 001 Mar 01, 1982

THEOPHYLLINE

ALPHARMA US PHARMS
80MG/15ML
A086001 001

150MG/15ML
A086545 001

TABLET;ORAL

QUIBRON-T

MONARCH PHARMS
300MG
A088656 001 Aug 22, 1985

SLO-PHYLLIN

SANOFI AVENTIS US
100MG
A085202 001

200MG
A085204 001

THEOCLEAR-100

CENT PHARMS
100MG
A085353 002

THEOCLEAR-200

CENT PHARMS
200MG
A085353 001

THEOLAIR

MEDICIS
125MG
A086399 001

250MG
A086399 002

THEOPHYL-225

ORTHO MCNEIL PHARM
225MG
A084726 001

TABLET, CHEWABLE;ORAL

THEOPHYL

ORTHO MCNEIL PHARM
100MG
A086506 001 Sep 12, 1985

TABLET, EXTENDED RELEASE;ORAL

DURAPHYL

FOREST LABS
100MG
A088503 001 Apr 03, 1985

200MG
A088504 001 Apr 03, 1985

300MG
A088505 001 Apr 03, 1985

LABID

WARNER CHILCOTT
250MG
A087225 001

QUIBRON-T/SR

MONARCH PHARMS
300MG
A087563 001 Jun 21, 1983

SUSTAIRE

ROERIG
100MG
A085665 001

300MG
A085665 002

T-PHYL

PHARM RES ASSOC
200MG
A088253 001 Aug 17, 1983

THEO-DUR

SCHERING
100MG
A085328 001

200MG
A086998 001

300MG
A085328 002

450MG
A089131 001 Jun 25, 1986

THEOCHRON

NOSTRUM PHARMS LLC
300MG
A087400 002 Jan 11, 1983

THEOLAIR-SR

3M
200MG
A088369 001 Jul 16, 1987

250MG
A086363 002 Jul 16, 1987

300MG
A088364 001 Jul 16, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-367(of 393)

** See List Footnote



THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL

THEOLAIR-SR

500MG
A089132 001 Jul 16, 1987

THEOPHYLLINE

ABLE
300MG
A040548 001 Apr 30, 2004

400MG
A040543 001 Apr 27, 2004

450MG
A040546 001 Apr 30, 2004

600MG
A040539 001 Apr 27, 2004

INWOOD LABS
450MG
A040034 001 Apr 28, 1995

TEVA PHARMS
450MG
A081236 001 Nov 09, 1992

UNI-DUR

SCHERING
400MG
A089822 001 Jan 04, 1995

600MG
A089823 001 Jan 04, 1995

THEOPHYLLINE SODIUM GLYCINATE

ELIXIR;ORAL

SYNOPHYLATE

CENT PHARMS
EQ 165MG BASE/15ML
N006333 008

TABLET;ORAL

ASBRON

NOVARTIS
EQ 150MG BASE
A085148 001

THIABENDAZOLE

SUSPENSION;ORAL

MINTEZOL

MERCK SHARP DOHME
500MG/5ML
N016097 001

TABLET, CHEWABLE;ORAL

MINTEZOL

MERCK SHARP DOHME
500MG
N016096 001

THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

BETALIN S

LILLY
100MG/ML
A080853 001

THIAMINE HYDROCHLORIDE

ABRAXIS PHARM
100MG/ML
A080509 001

AKORN
100MG/ML
A087968 001 Oct 01, 1982

BEL MAR
100MG/ML
A080718 001

200MG/ML
A080712 001

DELL LABS
100MG/ML
A083775 001

HOSPIRA
100MG/ML
A040079 001 May 03, 1996

LUITPOLD
100MG/ML
A080667 001

PARKE DAVIS
100MG/ML
A080770 001

WATSON LABS
100MG/ML
A080571 001

100MG/ML
A083534 001

200MG/ML
A080571 002

200MG/ML
A083534 002

WEST-WARD PHARMS INT 100MG/ML
A080575 001

WYETH AYERST
100MG/ML
A080553 001

THIAMYLAL SODIUM

INJECTABLE;INJECTION

SURITAL

PARKEDALE
1GM/VIAL
N007600 003

5GM/VIAL
N007600 005

10GM/VIAL
N007600 009

THIETHYLPERAZINE MALATE

INJECTABLE;INJECTION

TORECAN

NOVARTIS
5MG/ML
N012754 002

THIETHYLPERAZINE MALEATE

SUPPOSITORY;RECTAL

TORECAN

NOVARTIS
10MG
N013247 001

TABLET;ORAL

TORECAN

NOVARTIS
10MG
N012753 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-368(of 393)

** See List Footnote



THIOPENTAL SODIUM

SUSPENSION;RECTAL

PENTOTHAL

ABBOTT
400MG/GM
N011679 001

THIORIDAZINE

SUSPENSION;ORAL

MELLARIL-S

NOVARTIS
EQ 25MG HYDROCHLORIDE/5ML **
N017923 001

EQ 100MG HYDROCHLORIDE/5ML **
N017923 002

THIORIDAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

MELLARIL

NOVARTIS
30MG/ML **
N011808 012

100MG/ML **
N011808 018

THIORIDAZINE HYDROCHLORIDE

ACTAVIS MID ATLANTIC
100MG/ML
A088229 001 Aug 23, 1983

ALPHARMA US PHARMS
30MG/ML
A087766 001 Apr 26, 1983

ANI PHARMS INC


30MG/ML
A089602 001 Nov 09, 1987

100MG/ML
A089603 001 Nov 09, 1987

HI TECH PHARMA
30MG/ML
A040125 001 Aug 16, 1996

100MG/ML
A040126 001 Aug 16, 1996

PHARM ASSOC
30MG/ML
A040187 001 Aug 28, 1997

100MG/ML
A040213 001 May 29, 1998

SANDOZ
30MG/ML
A088307 001 Nov 23, 1983

100MG/ML
A088308 001 Nov 23, 1983

WOCKHARDT
30MG/ML
A088258 001 Jul 25, 1983

100MG/ML
A088227 001 Jul 05, 1983

THIORIDAZINE HYDROCHLORIDE INTENSOL

ROXANE
30MG/ML
A088941 001 Dec 16, 1985

100MG/ML
A088942 001 Dec 16, 1985

TABLET;ORAL

MELLARIL

+ NOVARTIS
10MG **
N011808 003

+
15MG **
N011808 016

+
25MG **
N011808 006

+
50MG **
N011808 011

+
100MG **
N011808 009

+
150MG **
N011808 017

+
200MG **
N011808 015

THIORIDAZINE HYDROCHLORIDE

ANI PHARMS INC
10MG
A088270 001 Apr 14, 1983

10MG
A088493 001 May 17, 1985

15MG
A088271 001 Apr 14, 1983

25MG
A088272 001 Apr 14, 1983

50MG
A088194 001 Apr 14, 1983

100MG
A088273 001 Oct 03, 1983

100MG
A088456 001 May 17, 1985

FOSUN PHARMA
10MG
A088131 001 Aug 30, 1983

15MG
A088132 001 Aug 30, 1983

25MG
A088133 001 Aug 30, 1983

50MG
A088134 001 Aug 30, 1983

100MG
A088135 001 Nov 20, 1984

150MG
A088136 001 Sep 17, 1986

200MG
A088137 001 Sep 17, 1986

MUTUAL PHARM
10MG
A088375 001 Nov 18, 1983

25MG
A087264 001 Nov 18, 1983

50MG
A088370 001 Nov 18, 1983

100MG
A088379 001 Nov 16, 1983

MYLAN
10MG
A088332 001 Jun 27, 1983

25MG
A088333 001 Jun 27, 1983

50MG
A088334 001 Jun 27, 1983

100MG
A088335 001 Nov 18, 1983

PAR PHARM
10MG
A088351 001 Dec 05, 1983

15MG
A088352 001 Dec 05, 1983

25MG
A088336 001 Dec 05, 1983

50MG
A088322 001 Dec 05, 1983

100MG
A088480 001 Dec 29, 1983

150MG
A089764 001 Feb 09, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-369(of 393)

** See List Footnote



THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

THIORIDAZINE HYDROCHLORIDE

200MG
A089765 001 Feb 09, 1988

ROXANE
10MG
A088663 001 Mar 15, 1984

25MG
A088664 001 Mar 15, 1984

50MG
A088665 001 Mar 15, 1984

100MG
A089048 001 Feb 26, 1985

SUN PHARM INDUSTRIES
15MG
A088461 001 Nov 18, 1983

150MG
A088737 001 Sep 26, 1984

200MG
A088738 001 Oct 16, 1984

SUPERPHARM
10MG
A089103 001 Jul 02, 1985

25MG
A089104 001 Jul 02, 1985

50MG
A089105 001 Jul 02, 1985

WATSON LABS
10MG
A088412 001 Sep 12, 1983

10MG
A088476 001 Nov 08, 1983

10MG
A088561 001 May 11, 1984

15MG
A088345 001 Jul 28, 1983

15MG
A088562 001 May 11, 1984

25MG
A088296 001 Jul 28, 1983

25MG
A088478 001 Nov 08, 1983

25MG
A088755 001 Jul 24, 1984

50MG
A088323 001 Jul 28, 1983

50MG
A088479 001 Nov 08, 1983

50MG
A088563 001 May 11, 1984

100MG
A088284 001 Aug 25, 1983

100MG
A088564 001 May 11, 1984

100MG
A088736 001 Jul 24, 1984

150MG
A088410 001 Mar 05, 1984

150MG
A088869 001 Jun 28, 1985

200MG
A088381 001 Mar 14, 1984

WATSON LABS TEVA
15MG
A088477 001 Nov 08, 1983

25MG
A088567 001 May 11, 1984

200MG
A088872 001 Apr 26, 1985

WEST WARD
10MG
A088658 001 Mar 26, 1984

15MG
A088659 001 Mar 26, 1984

25MG
A088660 001 Mar 26, 1984

50MG
A088661 001 Mar 26, 1984

THIOTEPA

INJECTABLE;INJECTION

THIOPLEX

+ IMMUNEX
15MG/VIAL **
N020058 001 Dec 22, 1994

THIOTEPA

FRESENIUS KABI USA
15MG/VIAL
A075698 001 Sep 20, 2001

IMMUNEX
15MG/VIAL
N011683 001

TEVA PARENTERAL
15MG/VIAL **
A075730 001 Apr 20, 2001

30MG/VIAL **
A075730 002 Apr 20, 2001

THIOTHIXENE

CAPSULE;ORAL

NAVANE

+ PFIZER
1MG **
N016584 001

+
2MG **
N016584 002

+
5MG **
N016584 003

+
10MG **
N016584 004

+
20MG **
N016584 005

THIOTHIXENE

AM THERAP
1MG
A071884 001 Aug 12, 1987

2MG
A071885 001 Aug 12, 1987

5MG
A071886 001 Aug 12, 1987

10MG
A071887 001 Aug 12, 1987

20MG
A072200 001 Dec 17, 1987

SANDOZ
1MG
A071529 002 Jun 24, 1987

2MG
A071529 003 Jun 24, 1987

5MG
A071529 001 Jun 24, 1987

10MG
A071529 004 Jun 24, 1987

WATSON LABS
1MG
A070600 001 Jun 05, 1987

2MG
A070601 001 Jun 05, 1987

2MG
A071626 001 Jun 25, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-370(of 393)

** See List Footnote



THIOTHIXENE

CAPSULE;ORAL

THIOTHIXENE

5MG A070602 001 Jun 05, 1987

5MG A071627 001 Jun 25, 1987

10MG A070603 001 Jun 05, 1987

10MG A071628 001 Jun 25, 1987

THIOTHIXENE HYDROCHLORIDE

CONCENTRATE;ORAL

NAVANE

PFIZER EQ 5MG BASE/ML N016758 001

THIOTHIXENE HYDROCHLORIDE

ALPHARMA US PHARMS EQ 5MG BASE/ML A070969 001 Oct 16, 1987

PACO EQ 1MG BASE/ML A071917 001 Sep 20, 1989

EQ 5MG BASE/ML A071939 001 Dec 16, 1988



TEVA EQ 5MG BASE/ML A071184 001 Jun 22, 1987

TEVA PHARMS EQ 5MG BASE/ML A071554 001 Oct 16, 1987

THIOTHIXENE HYDROCHLORIDE INTENSOL

CYCLE PHARMS LTD EQ 5MG BASE/ML A073494 001 Jun 30, 1992

INJECTABLE;INJECTION

NAVANE

PFIZER EQ 2MG BASE/ML N016904 001

EQ 10MG BASE/VIAL N016904 002

THYROGLOBULIN

TABLET;ORAL

PROLOID

PARKE DAVIS 16MG N002245 009

32MG N002245 005

65MG N002245 002

100MG N002245 008

130MG N002245 010

200MG N002245 007

325MG N002245 004

THYROGLOBULIN

IMPAX LABS 64.8MG A080151 001

THYROTROPIN

INJECTABLE;INJECTION

THYTROPAR

SANOFI AVENTIS US 10 IU/VIAL N008682 001

TIAGABINE HYDROCHLORIDE

TABLET;ORAL

GABITRIL

CEPHALON 6MG N020646 006 Nov 29, 2005

8MG N020646 007 Nov 29, 2005

10MG N020646 008 Nov 29, 2005

20MG N020646 004 Sep 30, 1997

TICARCILLIN DISODIUM

INJECTABLE;INJECTION

TICAR

GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050497 001

EQ 3GM BASE/VIAL A062690 001 Dec 19, 1986

EQ 3GM BASE/VIAL N050497 002

EQ 6GM BASE/VIAL N050497 003

EQ 20GM BASE/VIAL N050497 004

EQ 30GM BASE/VIAL N050497 005 Apr 04, 1984

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLID

ROCHE PALO 125MG N019979 001 Mar 24, 1993

250MG N019979 002 Oct 31, 1991

TICLOPIDINE HYDROCHLORIDE

ACTAVIS ELIZABETH 250MG A075253 001 Aug 20, 1999

MYLAN 250MG A075161 001 Sep 13, 1999

250MG A075316 001 Nov 02, 1999



WATSON LABS 250MG A075309 001 Apr 26, 2000

YAOPHARMA CO LTD 250MG A075318 001 Aug 20, 1999


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-371(of 393)

** See List Footnote



TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLOPIDINE HYDROCHLORIDE

250MG A075326 001 Aug 20, 1999

TILUDRONATE DISODIUM

TABLET;ORAL

SKELID

+ SANOFI AVENTIS US EQ 200MG BASE ** N020707 001 Mar 07, 1997

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AKORN EQ 0.25% BASE A074465 001 Mar 25, 1997

EQ 0.25% BASE A074515 001 Mar 25, 1997

APOTEX INC EQ 0.25% BASE A075411 001 Sep 08, 2000

EQ 0.5% BASE A075412 001 Sep 08, 2000

FOUGERA EQ 0.25% BASE A074667 001 Mar 25, 1997



EQ 0.5% BASE A074668 001 Mar 25, 1997

TABLET;ORAL

BLOCADREN

MERCK 5MG ** N018017 001

10MG ** N018017 002

20MG ** N018017 004

TIMOLOL MALEATE

QUANTUM PHARMICS 5MG A072466 001 May 19, 1989

10MG A072467 001 May 19, 1989

20MG A072468 001 May 19, 1989

TEVA 5MG A072648 001 Jun 16, 1993



10MG A072649 001 Jun 16, 1993

20MG A072650 001 Jun 16, 1993

USL PHARMA 5MG A072001 001 Apr 11, 1989

10MG A072002 001 Apr 11, 1989

20MG A072003 001 Apr 11, 1989

WATSON LABS 5MG A072269 001 Apr 11, 1989

5MG A072917 001 Jul 31, 1991



10MG A072270 001 Apr 11, 1989

10MG A072918 001 Jul 31, 1991



20MG A072271 001 Apr 11, 1989

20MG A072919 001 Jul 31, 1991



YAOPHARMA CO LTD 5MG A072550 001 Apr 13, 1989

10MG A072551 001 Apr 13, 1989

20MG A072552 001 Apr 13, 1989



TINZAPARIN SODIUM

INJECTABLE;INJECTION

INNOHEP

LEO PHARMA AS 20,000 IU/ML N020484 001 Jul 14, 2000

TIOCONAZOLE

CREAM;TOPICAL

TZ-3

PFIZER 1% N018682 001 Feb 18, 1983

TIROFIBAN HYDROCHLORIDE

INJECTABLE;INJECTION

AGGRASTAT

MEDICURE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912 001 May 14, 1998

EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) N020913 001 May 14, 1998

TIZANIDINE HYDROCHLORIDE

TABLET;ORAL

TIZANIDINE HYDROCHLORIDE

ACTAVIS ELIZABETH EQ 2MG BASE A076283 001 Jul 12, 2002

EQ 4MG BASE A076283 002 Jul 12, 2002

BARR EQ 2MG BASE A076371 001 Apr 09, 2003

EQ 4MG BASE A076371 002 Apr 09, 2003

IVAX SUB TEVA PHARMS EQ 2MG BASE A076321 001 Sep 30, 2004

EQ 4MG BASE A076321 002 Sep 30, 2004

MYLAN PHARMS INC EQ 2MG BASE A076282 001 Dec 16, 2003

EQ 4MG BASE A076282 002 Dec 16, 2003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-372(of 393)

** See List Footnote



TIZANIDINE HYDROCHLORIDE

TABLET;ORAL

ZANAFLEX

+ COVIS PHARMA BV EQ 2MG BASE ** N020397 002 Feb 04, 2000

TOBRAMYCIN

SOLUTION/DROPS;OPHTHALMIC

TOBRAMYCIN

ALCON PHARMS LTD 0.3% A063176 001 May 25, 1994

APOTEX INC 0.3% A065087 001 Feb 25, 2002



TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

NEBCIN

LILLY EQ 10MG BASE/ML A062008 004
EQ 10MG BASE/ML A062707 001 Apr 29, 1987
+ EQ 10MG BASE/ML ** N050477 005
EQ 40MG BASE/ML A062008 001
+ EQ 1.2GM BASE/VIAL ** N050519 001
TOBRAMYCIN SULFATE
APOTHECON EQ 10MG BASE/ML A064021 001 May 31, 1994
EQ 40MG BASE/ML A064021 002 May 31, 1994
EQ 40MG BASE/ML A064026 001 May 31, 1994
HOSPIRA EQ 10MG BASE/ML A063080 001 Apr 30, 1991
EQ 40MG BASE/ML A063161 001 May 29, 1991
IGI LABS INC EQ 10MG BASE/ML A063119 001 Oct 31, 1994
EQ 40MG BASE/ML A063120 001 Oct 31, 1994
EQ 40MG BASE/ML A063121 001 Oct 31, 1994
EQ 40MG BASE/ML A063122 001 Oct 31, 1994
WATSON LABS INC EQ 10MG BASE/ML A062945 001 Aug 09, 1989
EQ 40MG BASE/ML A062945 002 Aug 09, 1989
WEST-WARD PHARMS INT EQ 10MG BASE/ML A063113 001 Apr 26, 1991
EQ 10MG BASE/ML A063128 001 Nov 27, 1991
EQ 40MG BASE/ML A063118 001 Jul 29, 1991
EQ 40MG BASE/ML A063127 001 Nov 27, 1991
TOBRAMYCIN SULFATE (PHARMACY BULK)
HOSPIRA EQ 40MG BASE/ML ** A063116 001 May 18, 1992
TOCAINIDE HYDROCHLORIDE
TABLET;ORAL
TONOCARD
ASTRAZENECA 400MG N018257 001 Nov 09, 1984
600MG N018257 002 Nov 09, 1984
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
BARR 100MG A070162 001 Jan 14, 1986
250MG A070163 001 Jan 14, 1986
500MG A070164 001 Jan 14, 1986
DURAMED PHARMS BARR 100MG A070165 001 Jan 10, 1986
250MG A070166 001 Jan 10, 1986
500MG A070167 001 Jan 10, 1986
G AND W LABS INC 100MG N018894 001 Nov 02, 1984
250MG N018894 002 Nov 02, 1984
500MG N018894 003 Nov 02, 1984
INTERPHARM 250MG A071270 001 Sep 23, 1986
500MG A071271 001 Sep 23, 1986
PAR PHARM 100MG A070159 001 Jan 06, 1986
250MG A070160 001 Jan 06, 1986
500MG A070161 001 Jan 06, 1986
SUN PHARM INDUSTRIES 100MG A071357 001 Jul 16, 1987
250MG A071358 001 Jul 16, 1987
500MG A071359 001 Jul 16, 1987
SUPERPHARM 250MG A070763 001 Jun 16, 1986
500MG A070764 001 Jun 16, 1986
USL PHARMA 100MG A071355 001 Jan 11, 1988
250MG A070168 001 Apr 02, 1986
500MG A070169 001 Apr 02, 1986
WATSON LABS 100MG A070242 001 Aug 01, 1986
100MG A070513 001 Jan 09, 1986

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-373(of 393)

** See List Footnote



TOLAZAMIDE

TABLET;ORAL

TOLAZAMIDE

250MG
A070243 001 Aug 01, 1986

250MG
A070514 001 Jan 09, 1986

500MG
A070244 001 Aug 01, 1986

500MG
A070515 001 Jan 09, 1986

YAOPHARMA CO LTD 100MG
A071633 001 Dec 09, 1987

250MG
A070289 001 Mar 13, 1986

500MG
A070290 001 Mar 13, 1986

TOLINASE

+ PHARMACIA AND UPJOHN 100MG **
N015500 002

+ 250MG **
N015500 004

+ 500MG **
N015500 005

TOLAZOLINE HYDROCHLORIDE

INJECTABLE;INJECTION

PRISCOLINE

NOVARTIS 25MG/ML
N006403 005 Feb 22, 1985

TOLBUTAMIDE

TABLET;ORAL

ORINASE

PHARMACIA AND UPJOHN 250MG **
N010670 002

500MG **
N010670 001

TOLBUTAMIDE

ALRA
500MG
A086141 001

ASCOT
500MG
A087541 001 Mar 01, 1983

BARR
500MG
A087121 001

DAVA PHARMS INC
500MG
A086926 001

IVAX PHARMS
500MG
A087093 001

PARKE DAVIS
500MG
A086047 001

PUREPAC PHARM
500MG
A088950 001 Jun 17, 1985

SANDOZ
500MG
N012678 001

SUPERPHARM
500MG
A088893 001 Nov 19, 1984

VANGARD
500MG
A087876 001 Apr 20, 1982

WATSON LABS
250MG
A089110 001 May 29, 1987

500MG
A086109 001

500MG
A087318 001

500MG
A089111 001 May 29, 1987

YAOPHARMA CO LTD
500MG
A086574 001

TOLBUTAMIDE SODIUM

INJECTABLE;INJECTION

ORINASE DIAGNOSTIC

PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL
N012095 001

TOLCAPONE

TABLET;ORAL

TASMAR

VALEANT PHARMS LLC 200MG
N020697 002 Jan 29, 1998

TOLMETIN SODIUM

CAPSULE;ORAL

TOLECTIN DS

ORTHO MCNEIL JANSSEN EQ 400MG BASE
N018084 001

TOLMETIN SODIUM

ACTAVIS ELIZABETH EQ 400MG BASE
A073308 001 Jan 24, 1992

FOSUN PHARMA EQ 400MG BASE
A073462 001 Apr 30, 1992

IVAX SUB TEVA PHARMS EQ 400MG BASE


A073392 001 Jan 24, 1992

SUN PHARM INDUSTRIES EQ 400MG BASE
A073311 001 Nov 27, 1991

TEVA EQ 400MG BASE
A073519 001 May 29, 1992

TABLET;ORAL

TOLECTIN

ORTHO MCNEIL JANSSEN EQ 200MG BASE
N017628 001

TOLECTIN 600

ORTHO MCNEIL JANSSEN
EQ 600MG BASE
N017628 002 Mar 08, 1989

TOLMETIN SODIUM

ACTAVIS ELIZABETH
EQ 600MG BASE
A073527 001 Jun 30, 1992

FOSUN PHARMA
EQ 200MG BASE
A073588 001 Jul 31, 1992

EQ 600MG BASE
A074002 001 Sep 27, 1993

G AND W LABS INC


EQ 600MG BASE
A074399 001 Mar 28, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-374(of 393)

** See List Footnote



TOLMETIN SODIUM

TABLET;ORAL

TOLMETIN SODIUM

EQ 600MG BASE A074729 001 Feb 27, 1997

SUN PHARM INDUSTRIES EQ 200MG BASE A073310 001 Nov 27, 1991

TOLTERODINE TARTRATE

TABLET;ORAL

TOLTERODINE TARTRATE

APOTEX CORP 1MG A200164 001 Sep 25, 2012

2MG A200164 002 Sep 25, 2012



TOLVAPTAN

TABLET;ORAL

SAMSCA

+ OTSUKA AMERICA PHARM 60MG ** N022275 003 May 19, 2009

TOPIRAMATE

CAPSULE;ORAL

TOPAMAX SPRINKLE

JANSSEN PHARMS 50MG N020844 003 Oct 26, 1998

TOPIRAMATE

BARR 15MG A076448 001 Apr 15, 2009

25MG A076448 002 Apr 15, 2009

FOSUN PHARMA 15MG A079206 001 Oct 14, 2009



25MG A079206 002 Oct 14, 2009

MYLAN 15MG A078418 001 Oct 14, 2009

25MG A078418 002 Oct 14, 2009

TABLET;ORAL

TOPAMAX

JANSSEN PHARMS 300MG N020505 003 Dec 24, 1996

400MG N020505 006 Dec 24, 1996

TOPIRAMATE

ACTAVIS TOTOWA 25MG A078637 001 Feb 27, 2013

50MG A078637 002 Feb 27, 2013

100MG A078637 003 Feb 27, 2013

200MG A078637 004 Feb 27, 2013

BARR 25MG A076315 001 Mar 27, 2009

100MG A076315 002 Mar 27, 2009

200MG A076315 003 Mar 27, 2009

HIKMA PHARMS 25MG A091185 001 Nov 25, 2013

50MG A091185 002 Nov 25, 2013

100MG A091185 003 Nov 25, 2013

200MG A091185 004 Nov 25, 2013

MYLAN 25MG A076314 001 Mar 27, 2009

50MG A076314 002 Mar 27, 2009

100MG A076314 003 Mar 27, 2009

200MG A076314 004 Mar 27, 2009

PLIVA HRVATSKA DOO 25MG A077905 001 Mar 30, 2009

50MG A077905 002 Mar 30, 2009

100MG A077905 003 Mar 30, 2009

200MG A077905 004 Mar 30, 2009

ROXANE 25MG A076306 001 Mar 27, 2009

50MG A076306 002 Mar 27, 2009

100MG A076306 003 Mar 27, 2009

200MG A076306 004 Mar 27, 2009

WATSON LABS 25MG A077643 001 Mar 27, 2009

50MG A077643 002 Mar 27, 2009

100MG A077643 003 Mar 27, 2009

200MG A077643 004 Mar 27, 2009

WOCKHARDT USA 25MG A090353 001 Sep 01, 2010

50MG A090353 002 Sep 01, 2010

100MG A090353 003 Sep 01, 2010

200MG A090353 004 Sep 01, 2010


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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-375(of 393)

** See List Footnote



TOPOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

TOPOTECAN HYDROCHLORIDE

FRESENIUS KABI ONCOL EQ 4MG BASE/VIAL A091376 001 Nov 29, 2010

SUN PHARM INDS LTD EQ 4MG BASE/VIAL A202203 001 Aug 29, 2013

SOLUTION;INTRAVENOUS

TOPOTECAN

+ SANDOZ INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) ** N200199 001 Feb 25, 2011
+ EQ 3MG BASE/3ML (EQ 1MG BASE/ML) ** N200199 002 Feb 25, 2011
+ EQ 4MG BASE/4ML (EQ 1MG BASE/ML) ** N200199 003 Feb 25, 2011
TORSEMIDE
INJECTABLE;INJECTION
DEMADEX
+ ROCHE 50MG/5ML (10MG/ML) ** N020137 002 Aug 23, 1993
+ 20MG/2ML (10MG/ML) ** N020137 001 Aug 23, 1993
TORSEMIDE
LUITPOLD 20MG/2ML (10MG/ML) A090656 001 Apr 21, 2010
50MG/5ML (10MG/ML) A090656 002 Apr 21, 2010
WEST-WARD PHARMS INT 20MG/2ML (10MG/ML) A078007 001 Jun 11, 2008
50MG/5ML (10MG/ML) A078007 002 Jun 11, 2008
TABLET;ORAL
TORSEMIDE
SUN PHARM INDS 5MG A078478 001 Feb 26, 2008
10MG A078478 002 Feb 26, 2008
20MG A078478 003 Feb 26, 2008
100MG A078478 004 Feb 26, 2008
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
ACCORD HLTHCARE 50MG A202390 001 May 16, 2013
ACTAVIS ELIZABETH 50MG A075960 001 Jun 19, 2002
ASTA 50MG A075974 001 Jul 12, 2002
FOSUN PHARMA 50MG A075968 001 Jun 25, 2002
IVAX SUB TEVA PHARMS 50MG A075963 001 Jul 03, 2002
MYLAN PHARMS INC 50MG A075980 001 Nov 21, 2002
NORTHSTAR HLTHCARE 50MG A078935 001 May 26, 2010
WATSON LABS 50MG A075962 001 Jun 24, 2002
ULTRAM
JANSSEN PHARMS 100MG N020281 001 Mar 03, 1995
TABLET, EXTENDED RELEASE;ORAL
RYZOLT
+ PURDUE PHARMA 100MG ** N021745 001 Dec 30, 2008
+ 200MG ** N021745 002 Dec 30, 2008
+ 300MG ** N021745 003 Dec 30, 2008
ULTRAM ER
+ VALEANT PHARMS 100MG N021692 001 Sep 08, 2005
+ 200MG N021692 002 Sep 08, 2005
+ 300MG N021692 003 Sep 08, 2005
TABLET, ORALLY DISINTEGRATING;ORAL
RYBIX ODT
SHIONOGI INC 50MG N021693 001 May 05, 2005
TRAMETINIB DIMETHYL SULFOXIDE
TABLET;ORAL
MEKINIST
+ NOVARTIS PHARMS CORP EQ 1MG N204114 002 May 29, 2013
TRANDOLAPRIL
TABLET;ORAL
MAVIK
+ ABBVIE 1MG N020528 001 Apr 26, 1996
+ 2MG N020528 002 Apr 26, 1996
+ 4MG N020528 003 Apr 26, 1996
TRANDOLAPRIL
CIPLA 1MG A077307 002 Jun 12, 2007
2MG A077307 001 Jun 12, 2007
4MG A077307 003 Jun 12, 2007
DR REDDYS LABS LTD 1MG A078493 001 Aug 25, 2008
2MG A078493 002 Aug 25, 2008

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-376(of 393)

** See List Footnote



TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL

4MG A078493 003 Aug 25, 2008

EPIC PHARMA LLC 1MG A077256 001 Jun 12, 2007



2MG A077256 002 Jun 12, 2007

4MG A077256 003 Jun 12, 2007

INVAGEN PHARMS 1MG A078320 001 Jun 12, 2007

2MG A078320 002 Jun 12, 2007

4MG A078320 003 Jun 12, 2007

MYLAN 1MG A078346 001 Apr 28, 2008

2MG A078346 002 Apr 28, 2008

4MG A078346 003 Apr 28, 2008

WATSON LABS 1MG A077805 001 Jun 12, 2007



2MG A077805 002 Jun 12, 2007

4MG A077805 003 Jun 12, 2007

TRANEXAMIC ACID

TABLET;ORAL

CYKLOKAPRON

PHARMACIA AND UPJOHN 500MG N019280 001 Dec 30, 1986

TRANEXAMIC ACID

AMERIGEN PHARMS LTD 650MG A203256 001 Jul 25, 2016

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

IZBA

+ NOVARTIS PHARMS CORP 0.003% ** N204822 001 May 15, 2014

TRAVATAN

+ ALCON PHARMS LTD 0.004% ** N021257 001 Mar 16, 2001

TRAZODONE HYDROCHLORIDE

TABLET;ORAL

DESYREL

+ PRAGMA 50MG ** N018207 001
+ 100MG ** N018207 002
+ 150MG ** N018207 003 Mar 25, 1985
+ 300MG ** N018207 004 Nov 07, 1988
TRAZODONE HYDROCHLORIDE
AM THERAP 50MG A071139 001 Oct 29, 1986
100MG A071140 001 Oct 29, 1986
AUROLIFE PHARMA LLC 50MG A072484 001 Apr 30, 1990
FOSUN PHARMA 100MG A072483 001 Apr 30, 1990
MYLAN 50MG A071405 001 Feb 27, 1991
100MG A071406 001 Feb 27, 1991
MYLAN PHARMS INC 50MG A090514 001 Jun 02, 2009
100MG A090514 002 Jun 02, 2009
150MG A090514 003 Jun 02, 2009
300MG A090514 004 Jun 02, 2009
QUANTUM PHARMICS 100MG A070921 001 Dec 01, 1986
TEVA 150MG A074357 001 Apr 30, 1997
USL PHARMA 50MG A070491 001 Apr 29, 1987
100MG A070492 001 Apr 29, 1987
WATSON LABS 50MG A070857 001 Oct 10, 1986
50MG A071112 001 Nov 17, 1986
100MG A070858 001 Oct 10, 1986
100MG A071113 001 Nov 17, 1986
TRIALODINE
QUANTUM PHARMICS 50MG A070942 001 Dec 01, 1986
TABLET, EXTENDED RELEASE;ORAL
OLEPTRO
+ ANGELINI PHARMA 150MG ** N022411 001 Feb 02, 2010
+ 300MG ** N022411 002 Feb 02, 2010
TRETINOIN
CAPSULE;ORAL
VESANOID
+ CHEPLAPHARM 10MG ** N020438 001 Nov 22, 1995
CREAM;TOPICAL
TRETINOIN
ALLERGAN SALES LLC 0.0375% A090098 001 Mar 22, 2010

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-377(of 393)

** See List Footnote


TRETINOIN
CREAM;TOPICAL
TRETINOIN
0.075% A202209 001 Oct 11, 2012

SOLUTION;TOPICAL
RETIN-A
+ VALEANT INTL 0.05% N016921 001

TRETINOIN
TEVA PHARMS 0.05% A074873 001 Jun 19, 1998

WOCKHARDT 0.05% A075260 001 Jan 25, 1999

SWAB;TOPICAL
RETIN-A
VALEANT INTL 0.05% N016921 002

TRIAMCINOLONE
TABLET;ORAL
ARISTOCORT
ASTELLAS 1MG N011161 009

2MG N011161 004

4MG N011161 007

8MG N011161 011

16MG N011161 010

KENACORT
DELCOR ASSET CORP 1MG N011283 003

2MG N011283 008

4MG N011283 006

8MG N011283 010

TRIAMCINOLONE
BARR 2MG A084286 001

2MG A084318 001

4MG A084267 001

4MG A084319 001

8MG A084268 001

8MG A084320 001

IMPAX LABS 4MG A084340 001

IVAX SUB TEVA PHARMS 4MG
A083750 001

MYLAN
2MG
A084406 001

PUREPAC PHARM
2MG
A084020 002

4MG
A084020 003

ROXANE
2MG
A084708 001

4MG
A084709 001

8MG
A084707 001

SANDOZ
4MG
A085601 001

TEVA
4MG
A084775 001

WATSON LABS
4MG
A084270 001

4MG
A085834 001

TRIAMCINOLONE ACETONIDE

AEROSOL, METERED;INHALATION

AZMACORT

ABBVIE
0.1MG/INH
N018117 001 Apr 23, 1982

AEROSOL, METERED;NASAL

NASACORT

SANOFI AVENTIS US
0.055MG/INH
N019798 001 Jul 11, 1991

CREAM;TOPICAL

ARISTOCORT

ASTELLAS
0.025%
A083017 003

0.1%
A083016 004

0.5%
A083015 002

ARISTOCORT A

ASTELLAS
0.025%
A083017 004

0.025%
A088818 001 Oct 16, 1984

0.1%
A083016 005

0.1%
A088819 001 Oct 16, 1984

0.5%
A083015 003

0.5%
A088820 001 Oct 16, 1984

FLUTEX

IVAX PHARMS 0.025%
A085539 001

0.1%
A085539 002

0.5%
A085539 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-378(of 393)

** See List Footnote



TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

KENALOG

DELCOR ASSET CORP 0.5% A083943 001

KENALOG-H

DELCOR ASSET CORP 0.1% A086240 001

TRIACET

TEVA 0.025% A084908 001

0.1% A084908 002

0.5% A084908 003

TRIACORT

SOLVAY 0.1% A087113 001

TRIAMCINOLONE ACETONIDE

ACTAVIS MID ATLANTIC 0.1% A087798 001 Jun 04, 1982

ALPHARMA US PHARMS 0.025% A087797 001 Jun 07, 1982

AMBIX 0.025% A087932 001 May 09, 1983

MORTON GROVE 0.025% A088094 001 Sep 01, 1983

0.1% A088095 001 Sep 01, 1983

0.5% A088096 001 Sep 01, 1983

PHARMADERM 0.025% A087990 001 Jul 07, 1983



0.1% A087991 001 Jul 07, 1983

0.5% A087992 001 Jul 07, 1983

PHARMAFAIR 0.025% A087921 001 Aug 10, 1982

0.1% A087912 001 Aug 10, 1982

0.5% A087922 001 Aug 10, 1982

TARO 0.025% A040038 001 Oct 26, 1994



0.025% A086277 001

0.1% A086276 001

0.5% A086275 001

TOPIDERM 0.025% A089274 001 Feb 21, 1989

0.1% A089275 001 Feb 21, 1989

0.5% A089276 001 Feb 21, 1989

TRIATEX

IVAX PHARMS 0.025% A087430 001 Nov 01, 1988

0.1% A087429 001 Nov 01, 1988

0.5% A087428 001 Nov 01, 1988

TRYMEX

SAVAGE LABS 0.025% A088196 001 Mar 25, 1983

0.1% A088197 001 Mar 25, 1983

0.5% A088198 001 Mar 25, 1983

GEL;TOPICAL

ARISTOGEL

ASTELLAS 0.1% A083380 001

INJECTABLE;INJECTION

TRIAMCINOLONE ACETONIDE

PARNELL 3MG/ML N019503 001 Oct 16, 1987

SANDOZ INC 10MG/ML A090166 001 May 27, 2009

40MG/ML A090164 001 Jun 01, 2009



WATSON LABS 40MG/ML A085825 001

INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL

TRIVARIS

+ ALLERGAN 8MG/0.1ML (8MG/0.1ML) ** N022220 001 Jun 16, 2008

LOTION;TOPICAL

KENALOG

DELCOR ASSET CORP 0.025% ** A084343 001
+ 0.025% ** N011602 003
0.1% ** A084343 002
+ 0.1% ** N011602 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.025% A087191 001 Sep 08, 1982
0.1% A087192 001 Sep 08, 1982
OINTMENT;TOPICAL
ARISTOCORT
ASTELLAS 0.1% A080750 004
0.5% ** A080745 002
ARISTOCORT A
ASTELLAS 0.1% A080750 003
0.1% A088780 001 Oct 01, 1984
0.5% ** A080745 003

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-379(of 393)

** See List Footnote



TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL

ARISTOCORT A

0.5% A088781 001 Oct 05, 1984

FLUTEX

IVAX PHARMS 0.025% A087375 001 Nov 01, 1988

0.1% A087377 001 Nov 01, 1988

0.5% A087376 001 Nov 01, 1988

KENALOG

DELCOR ASSET CORP 0.5% ** A083944 001

+ MYLAN PHARMS INC 0.025% N011600 003

+ 0.1% N011600 001

TRIAMCINOLONE ACETONIDE

ACTAVIS MID ATLANTIC 0.1% A087799 001 Jun 07, 1982

ALPHARMA US PHARMS 0.5% A089913 001 Dec 23, 1988

MORTON GROVE 0.025% A088090 001 Sep 01, 1983

0.1% A088091 001 Sep 01, 1983

0.5% A088092 001 Sep 01, 1983

PHARMADERM 0.025% A088692 001 Aug 02, 1984

0.1% A088690 001 Aug 02, 1984

TARO 0.025% A040040 001 Sep 30, 1994

0.025% A040374 001 Jun 05, 2001



0.1% A087902 001 Dec 27, 1982

0.5% A040386 001 Jun 05, 2001

TRYMEX

SAVAGE LABS 0.025% A088693 001 Aug 02, 1984

0.1% A088691 001 Aug 02, 1984

PASTE;DENTAL

KENALOG IN ORABASE

+ DELCOR ASSET CORP 0.1% ** N012097 001

ORALONE

TARO 0.1% A071383 001 Jul 06, 1987

SPRAY, METERED;NASAL

ALLERNAZE

LUPIN ATLANTIS 0.05MG/SPRAY N020120 001 Feb 04, 2000

NASACORT HFA

SANOFI AVENTIS US 0.055MG/SPRAY N020784 001 Apr 07, 2004

TRIAMCINOLONE ACETONIDE

PERRIGO ISRAEL 0.055MG/SPRAY A078104 001 Jul 30, 2009

TRIAMCINOLONE DIACETATE

INJECTABLE;INJECTION

ARISTOCORT

FOSUN PHARMA 25MG/ML N011685 003

+ 40MG/ML ** N012802 001

TRIAMCINOLONE DIACETATE

AKORN 25MG/ML A085122 001

40MG/ML A086394 001

WATSON LABS 40MG/ML A084072 001

40MG/ML A085529 001

SYRUP;ORAL

ARISTOCORT

ASTELLAS 2MG/5ML N011960 004

KENACORT

DELCOR ASSET CORP EQ 4MG BASE/5ML N012515 001

TRIAZOLAM

TABLET;ORAL

HALCION

PHARMACIA AND UPJOHN 0.5MG N017892 002 Nov 15, 1982

TRIAZOLAM

WATSON LABS 0.125MG A074445 001 Oct 20, 1995

0.25MG A074445 002 Oct 20, 1995

TRICHLORMETHIAZIDE

TABLET;ORAL

METAHYDRIN

SANOFI AVENTIS US 2MG N012594 001 Jun 16, 1988

4MG N012594 002 Jun 16, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-380(of 393)

** See List Footnote



TRICHLORMETHIAZIDE

TABLET;ORAL

NAQUA

SCHERING
2MG
N012265 001

4MG
N012265 002

TRICHLOREX

LANNETT
4MG
A083436 001

4MG
A085630 001

TRICHLORMAS

MAST MM
4MG
A086259 001

TRICHLORMETHIAZIDE

CHARTWELL RX
4MG
A085568 001

IMPAX LABS
4MG
A083967 001

PAR PHARM
2MG
A087007 001

4MG
A087005 001

SANDOZ
4MG
A086171 001

WATSON LABS
2MG
A083847 001

2MG
A086458 001

4MG
A083462 001

4MG
A083855 001

4MG
A085962 001

TRICLOFOS SODIUM

SOLUTION;ORAL

TRICLOS

SANOFI AVENTIS US 1.5GM/15ML
N016830 001

TABLET;ORAL

TRICLOS

SANOFI AVENTIS US 750MG
N016809 002

TRIDIHEXETHYL CHLORIDE

INJECTABLE;INJECTION

PATHILON

LEDERLE 10MG/ML
N009729 001

TABLET;ORAL

PATHILON

LEDERLE 25MG
N009489 005

TRIFLUOPERAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

STELAZINE

+ GLAXOSMITHKLINE EQ 10MG BASE/ML **
N011552 006

TRIFLUOPERAZINE HYDROCHLORIDE

FOSUN PHARMA
EQ 10MG BASE/ML
A085787 001 Apr 15, 1982

WOCKHARDT
EQ 10MG BASE/ML
A088143 001 Jul 26, 1983

INJECTABLE;INJECTION

STELAZINE

+ GLAXOSMITHKLINE
EQ 2MG BASE/ML **
N011552 005

TABLET;ORAL

STELAZINE

+ GLAXOSMITHKLINE
EQ 1MG BASE **
N011552 001

+
EQ 2MG BASE **
N011552 002

+
EQ 5MG BASE **
N011552 003

+
EQ 10MG BASE **
N011552 004

TRIFLUOPERAZINE HYDROCHLORIDE

DURAMED PHARMS BARR EQ 1MG BASE
A088967 001 Apr 23, 1985

EQ 2MG BASE
A088968 001 Apr 23, 1985

EQ 5MG BASE
A088969 001 Apr 23, 1985

EQ 10MG BASE
A088970 001 Apr 23, 1985

IVAX PHARMS EQ 1MG BASE


A087612 001 Nov 19, 1982

EQ 2MG BASE
A087613 001 Nov 19, 1982

EQ 5MG BASE
A087328 001 Nov 19, 1982

EQ 10MG BASE
A087614 001 Nov 19, 1982

SANDOZ EQ 1MG BASE
A040153 001 Oct 25, 1996

EQ 2MG BASE
A040153 002 Oct 25, 1996

EQ 5MG BASE
A040153 003 Oct 25, 1996

EQ 10MG BASE
A040153 004 Oct 25, 1996

WATSON LABS EQ 1MG BASE
A085975 001 Jun 23, 1988

EQ 2MG BASE
A085976 001 Jun 23, 1988

EQ 5MG BASE
A085973 001 Jun 23, 1988

EQ 10MG BASE
A088710 001 Jun 23, 1988

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-381(of 393)

** See List Footnote



TRIFLUPROMAZINE

SUSPENSION;ORAL

VESPRIN

APOTHECON EQ 50MG HYDROCHLORIDE/5ML
N011491 004

TRIFLUPROMAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

VESPRIN

APOTHECON 3MG/ML
N011325 005

10MG/ML
N011325 004

20MG/ML
N011325 001

TABLET;ORAL

VESPRIN

BRISTOL MYERS SQUIBB 10MG
N011123 001

25MG
N011123 002

50MG
N011123 003

TRIHEXYPHENIDYL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

ARTANE

LEDERLE 5MG
N006773 010

5MG
N012947 001

ELIXIR;ORAL

ARTANE

LEDERLE 2MG/5ML
N006773 009

TRIHEXYPHENIDYL HYDROCHLORIDE

PHARM VENTURES 2MG/5ML
A089514 001 Apr 07, 1989

TABLET;ORAL

ARTANE

+ LEDERLE 2MG **
N006773 005

+ 5MG **
N006773 003

TREMIN

SCHERING 2MG
A080381 001

5MG
A080381 003

TRIHEXYPHENIDYL HYDROCHLORIDE

HIKMA PHARMS
2MG
A040337 002 Feb 16, 2000

5MG
A040337 001 Feb 16, 2000

NYLOS
5MG
A085622 001

VANGARD
2MG
A088035 001 Jul 30, 1982

WATSON LABS
2MG
A040184 001 Feb 06, 1998

2MG
A085117 001

5MG
A040184 002 Feb 06, 1998

5MG
A085105 001

TRILOSTANE

CAPSULE;ORAL

MODRASTANE

BIOENVISION
30MG
N018719 002 Dec 31, 1984

60MG
N018719 001 Dec 31, 1984

TRIMEPRAZINE TARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

TEMARIL

ALLERGAN HERBERT
EQ 5MG BASE
N011316 004

SYRUP;ORAL

TEMARIL

ALLERGAN HERBERT
EQ 2.5MG BASE/5ML
N011316 003

TRIMEPRAZINE TARTRATE

ALPHARMA US PHARMS
EQ 2.5MG BASE/5ML
A085015 001 Feb 18, 1982

MORTON GROVE
EQ 2.5MG BASE/5ML
A088285 001 Apr 11, 1985

TABLET;ORAL

TEMARIL

ALLERGAN HERBERT
EQ 2.5MG BASE
N011316 001

TRIMETHADIONE

CAPSULE;ORAL

TRIDIONE

ABBVIE
300MG
N005856 005

SOLUTION;ORAL

TRIDIONE

ABBVIE
200MG/5ML
N005856 002

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-382(of 393)

** See List Footnote



TRIMETHAPHAN CAMSYLATE

INJECTABLE;INJECTION

ARFONAD

ROCHE 50MG/ML
N008983 001

TRIMETHOBENZAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

TRIMETHOBENZAMIDE HYDROCHLORIDE

HOSPIRA
100MG/ML
A088804 001 Apr 03, 1987

SMITH AND NEPHEW


100MG/ML
A088960 001 Apr 04, 1986

100MG/ML
A089043 001 Apr 04, 1986

SOLOPAK
100MG/ML
A089094 001 Apr 04, 1986

WATSON LABS
100MG/ML
A086577 001 Oct 19, 1982

100MG/ML
A087939 001 Dec 28, 1982

TRIMETHOPRIM

TABLET;ORAL

PROLOPRIM

MONARCH PHARMS
100MG
N017943 001

200MG
N017943 003 Jul 14, 1982

TRIMETHOPRIM

SUN PHARM INDUSTRIES
100MG
A070494 001 Jan 22, 1986

200MG
A070495 001 Sep 24, 1986

TEVA
200MG **
A071259 001 Jun 18, 1987

TRIMPEX

ROCHE
100MG
N017952 001

TRIMPEX 200

ROCHE
200MG
N017952 002 Nov 09, 1982

TRIMETHOPRIM HYDROCHLORIDE

SOLUTION;ORAL

PRIMSOL

ALLEGIS
EQ 25MG BASE/5ML
N074374 001 Jun 23, 1995

TRIMETREXATE GLUCURONATE

INJECTABLE;INJECTION

NEUTREXIN

MEDIMMUNE ONCOLOGY
EQ 25MG BASE/VIAL
N020326 001 Dec 17, 1993

EQ 200MG BASE/VIAL
N020326 002 Jul 31, 1998

TRIMIPRAMINE MALEATE

CAPSULE;ORAL

TRIMIPRAMINE MALEATE

USL PHARMA
EQ 25MG BASE
A071283 001 Dec 08, 1987

EQ 50MG BASE
A071284 001 Dec 08, 1987

EQ 100MG BASE
A071285 001 Dec 08, 1987

TRIOXSALEN

TABLET;ORAL

TRISORALEN

VALEANT PHARM INTL
5MG
N012697 001

TRIPELENNAMINE CITRATE

ELIXIR;ORAL

PBZ

NOVARTIS
EQ 25MG HYDROCHLORIDE/5ML
N005914 004

TRIPELENNAMINE HYDROCHLORIDE

TABLET;ORAL

PBZ

NOVARTIS
25MG
A083149 001

50MG
N005914 002

TRIPELENNAMINE HYDROCHLORIDE

ANABOLIC 50MG A083037 001

BARR 50MG A080744 001

HEATHER 50MG A083989 001

IMPAX LABS 50MG A080785 001

LANNETT 50MG A083557 001

NYLOS 50MG A085412 001

PARKE DAVIS 25MG A083625 001

50MG A083626 001

WATSON LABS 50MG A080713 001

50MG A080790 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-383(of 393)

** See List Footnote



TRIPELENNAMINE HYDROCHLORIDE

TABLET;ORAL

TRIPELENNAMINE HYDROCHLORIDE

50MG
A085188 001

TABLET, EXTENDED RELEASE;ORAL

PBZ-SR

NOVARTIS 50MG
N010533 002

100MG
N010533 001

TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)

CREAM;VAGINAL

GYNE-SULF

G AND W LABS
3.7%;2.86%;3.42%
A088607 001 Jun 09, 1986

SULTRIN

ORTHO MCNEIL PHARM
3.7%;2.86%;3.42%
N005794 001

TRIPLE SULFA

ALPHARMA US PHARMS
3.7%;2.86%;3.42%
A087864 001 Sep 01, 1982

FOUGERA
3.7%;2.86%;3.42%
A086424 001

PERRIGO NEW YORK
3.7%;2.86%;3.42%
A087285 001 Nov 15, 1982

TRYSUL

SAVAGE LABS
3.7%;2.86%;3.42%
A087887 001 Jul 23, 1982

VAGILIA

G AND W LABS INC
3.7%;2.86%;3.42%
A088821 001 Nov 09, 1987

TABLET;VAGINAL

SULTRIN

ORTHO MCNEIL PHARM
184MG;143.75MG;172.5MG
N005794 002

TRIPLE SULFA

FOUGERA
184MG;143.75MG;172.5MG
A088463 001 Jan 03, 1985

PHARMADERM
184MG;143.75MG;172.5MG
A088462 001 Jan 03, 1985

TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

ACTIDIL

GLAXOSMITHKLINE
1.25MG/5ML
N011496 002 Jul 01, 1983

MYIDYL

USL PHARMA
1.25MG/5ML
A087963 001 Jan 18, 1983

TRIPROLIDINE HYDROCHLORIDE

ALPHARMA US PHARMS
1.25MG/5ML
A085940 001

HALSEY
1.25MG/5ML
A088735 001 Jan 17, 1985

PHARM ASSOC
1.25MG/5ML
A087514 001 Feb 10, 1982

TABLET;ORAL

ACTIDIL

GLAXOSMITHKLINE
2.5MG
N011110 002 Jul 01, 1983

TRIPROLIDINE HYDROCHLORIDE

VITARINE
2.5MG
A085610 001

WATSON LABS
2.5MG
A085094 001

TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

SUSPENSION;ORAL

LANTRISUL

LANNETT 167MG/5ML;167MG/5ML;167MG/5ML
A080123 002

NEOTRIZINE

LILLY 167MG/5ML;167MG/5ML;167MG/5ML
N006317 012

SULFALOID

FOREST PHARMS 167MG/5ML;167MG/5ML;167MG/5ML
A080100 001

SULFOSE

WYETH AYERST 167MG/5ML;167MG/5ML;167MG/5ML
A080013 002

TERFONYL

BRISTOL MYERS SQUIBB 167MG/5ML;167MG/5ML;167MG/5ML
N006904 002

TRIPLE SULFA

ALPHARMA US PHARMS
167MG/5ML;167MG/5ML;167MG/5ML
A080280 001

TRIPLE SULFAS

LEDERLE
167MG/5ML;167MG/5ML;167MG/5ML
N006920 003

TABLET;ORAL

NEOTRIZINE

LILLY
167MG;167MG;167MG
N006317 011

SULFA-TRIPLE #2

IMPAX LABS
167MG;167MG;167MG
A080079 001

SULFALOID

FOREST PHARMS
167MG;167MG;167MG
A080099 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-384(of 393)

** See List Footnote



TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

TABLET;ORAL

SULFOSE

WYETH AYERST 167MG;167MG;167MG
A080013 001

TERFONYL

BRISTOL MYERS SQUIBB 167MG;167MG;167MG
N006904 001

TRIPLE SULFA

PUREPAC PHARM
167MG;167MG;167MG
A080086 001

TRIPLE SULFAS

LEDERLE
167MG;167MG;167MG
N006920 002

TRIPLE SULFOID

PAL PAK
167MG;167MG;167MG
A080094 001

TROGLITAZONE

TABLET;ORAL

PRELAY

SANKYO
200MG
N020719 001 Jan 29, 1997

300MG
N020719 003 Aug 04, 1997

400MG
N020719 002 Jan 29, 1997

REZULIN

PFIZER PHARMS
200MG
N020720 001 Jan 29, 1997

300MG
N020720 003 Aug 04, 1997

400MG
N020720 002 Jan 29, 1997

TROLAMINE POLYPEPTIDE OLEATE CONDENSATE

SOLUTION/DROPS;OTIC

CERUMENEX

PHARM RES ASSOC
10%
N011340 002

TROLEANDOMYCIN

CAPSULE;ORAL

TAO

PFIZER
EQ 250MG BASE
N050336 002

SUSPENSION;ORAL

TAO

PFIZER
EQ 125MG BASE/5ML
N050332 001

TROMETHAMINE

INJECTABLE;INJECTION

THAM

+ HOSPIRA
3.6GM/100ML
N013025 002

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

MYDRIACYL

ALCON
0.5% **
N012111 002

1% **
N012111 004

MYDRIAFAIR

PHARMAFAIR
0.5%
A088274 001 Sep 16, 1983

1%
A088230 001 Sep 16, 1983

TROPICAMIDE

AKORN
1%
A088447 001 Aug 28, 1985

ALCON PHARMS LTD


1%
A089172 001 Dec 28, 1990

MIZA PHARMS USA
0.5%
A087636 001 Jul 30, 1982

1%
A087637 001 Aug 09, 1982

WATSON LABS
0.5%
A089171 001 Dec 28, 1990

TROSPIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

SANCTURA XR

+ ALLERGAN
60MG **
N022103 001 Aug 03, 2007

TROSPIUM CHLORIDE

UPSHER SMITH LABS
60MG
A091635 001 Apr 29, 2015

TABLET;ORAL

SANCTURA

+ ALLERGAN
20MG **
N021595 001 May 28, 2004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-385(of 393)

** See List Footnote



TROVAFLOXACIN MESYLATE

TABLET;ORAL

TROVAN

PFIZER EQ 100MG BASE
N020759 001 Dec 18, 1997

EQ 200MG BASE
N020759 002 Dec 18, 1997

TUBOCURARINE CHLORIDE

INJECTABLE;INJECTION

TUBOCURARINE CHLORIDE

BRISTOL MYERS SQUIBB 3MG/ML
N005657 001

HOSPIRA
3MG/ML
N006095 001

LILLY
3MG/ML
N006325 001

TYROPANOATE SODIUM

CAPSULE;ORAL

BILOPAQUE

GE HEALTHCARE
750MG
N013731 001

UNOPROSTONE ISOPROPYL

SOLUTION/DROPS;OPHTHALMIC

RESCULA

+ SUCAMPO PHARMA LLC
0.15% **
N021214 001 Aug 03, 2000

URACIL MUSTARD

CAPSULE;ORAL

URACIL MUSTARD

SHIRE
1MG
N012892 001

UREA

INJECTABLE;INJECTION

STERILE UREA

HOSPIRA
40GM/VIAL
N017698 001

UREAPHIL

HOSPIRA
40GM/VIAL
N012154 001

UREA C-13

FOR SOLUTION;ORAL

BREATHTEK UBT FOR H-PYLORI

OTSUKA AMERICA
EQ 75MG/POUCH
N020586 002 May 10, 2001

HELICOSOL

METABOLIC SOLUTIONS
125MG/VIAL
N021092 001 Dec 17, 1999

MERETEK UBT KIT (W/ PRANACTIN)

OTSUKA AMERICA
125MG/VIAL
N020586 001 Sep 17, 1996

PYLORI-CHEK BREATH TEST

DXS DEVICES
100MG/VIAL
N020900 001 Feb 04, 1999

UROFOLLITROPIN

INJECTABLE;INTRAMUSCULAR

METRODIN

SERONO
75 IU/AMP
N019415 002 Sep 18, 1986

150 IU/AMP
N019415 003 Sep 18, 1986

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

BRAVELLE

+ FERRING
75 IU/VIAL
N021289 001 May 06, 2002

INJECTABLE;SUBCUTANEOUS

FERTINEX

SERONO
75 IU/AMP
N019415 005 Aug 23, 1996

150 IU/AMP
N019415 004 Aug 23, 1996

UROKINASE

INJECTABLE;INJECTION

KINLYTIC

MICROBIX BIOSYSTEMS
5,000 IU/VIAL
N021846 003

9,000 IU/VIAL
N021846 002

250,000 IU/VIAL
N021846 001

URSODIOL

CAPSULE;ORAL

ACTIGALL

ALLERGAN SALES LLC
150MG
N019594 001 Dec 31, 1987

URSODIOL

IMPAX LABS INC
300MG
A077895 001 Jul 27, 2006

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-386(of 393)

** See List Footnote



URSODIOL

TABLET;ORAL

URSODIOL

TEVA PHARMS USA 250MG A079184 001 May 13, 2009

500MG A079184 002 May 13, 2009



VALACYCLOVIR HYDROCHLORIDE

TABLET;ORAL

VALACYCLOVIR HYDROCHLORIDE

MYLAN EQ 500MG BASE A078070 001 May 24, 2010

EQ 1GM BASE A078070 002 May 24, 2010



VALDECOXIB

TABLET;ORAL

BEXTRA

GD SEARLE 10MG N021341 002 Nov 16, 2001

20MG N021341 003 Nov 16, 2001

VALPROIC ACID

CAPSULE;ORAL

VALPROIC ACID

PAR PHARM 250MG A070431 001 Feb 28, 1986

SCHERER RP 250MG A070195 001 Jul 02, 1987

USL PHARMA 250MG A070631 001 Jun 11, 1987

CAPSULE, DELAYED RELEASE;ORAL

STAVZOR

+ BIONPHARMA INC 125MG ** N022152 001 Jul 29, 2008
+ 250MG ** N022152 002 Jul 29, 2008
+ 500MG ** N022152 003 Jul 29, 2008
SYRUP;ORAL
VALPROIC ACID
APOTEX INC 250MG/5ML A077105 001 Jul 29, 2005
VALSARTAN
CAPSULE;ORAL
DIOVAN
NOVARTIS 80MG N020665 001 Dec 23, 1996
160MG N020665 002 Dec 23, 1996
SOLUTION;ORAL
PREXXARTAN
+ CARMEL BIOSCIENCES 20MG/5ML N209139 001 Dec 19, 2017
+ 80MG/20ML N209139 002 Dec 19, 2017
TABLET;ORAL
VALSARTAN
WATSON LABS INC 40MG A090642 001 Jan 05, 2015
80MG A090642 002 Jan 05, 2015
160MG A090642 003 Jan 05, 2015
320MG A090642 004 Jan 05, 2015
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOMYCIN HYDROCHLORIDE
FRESENIUS KABI USA EQ 125MG BASE A065453 001 Jun 18, 2012
EQ 250MG BASE A065453 002 Jun 18, 2012
FOR SOLUTION;ORAL
VANCOCIN HYDROCHLORIDE
ANI PHARMS INC EQ 250MG BASE/5ML A061667 002 Jul 13, 1983
EQ 500MG BASE/6ML A061667 001
VANCOLED
LEDERLE EQ 250MG BASE/5ML A063321 002 Oct 15, 1993
EQ 500MG BASE/6ML A063321 003 Oct 15, 1993
INJECTABLE;INJECTION
VANCOCIN HYDROCHLORIDE
ANI PHARMS INC EQ 500MG BASE/VIAL ** A060180 001
EQ 500MG BASE/VIAL A062476 001 Mar 15, 1984
EQ 500MG BASE/VIAL A062716 001 Mar 13, 1987
EQ 500MG BASE/VIAL ** A062812 001 Nov 17, 1987
EQ 1GM BASE/VIAL ** A060180 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062476 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062716 002 Mar 13, 1987
EQ 1GM BASE/VIAL ** A062812 002 Nov 17, 1987
EQ 10GM BASE/VIAL ** A062812 003 Nov 17, 1987

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-387(of 393)

** See List Footnote



VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

VANCOLED

WEST-WARD PHARMS INT EQ 500MG BASE/VIAL ** A062682 001 Jul 22, 1986

EQ 1GM BASE/VIAL ** A062682 002 Mar 30, 1988

EQ 2GM BASE/VIAL ** A062682 003 May 11, 1988

EQ 5GM BASE/VIAL ** A062682 004 May 11, 1988

EQ 10GM BASE/VIAL ** A062682 005 May 11, 1988

VANCOMYCIN HYDROCHLORIDE

MYLAN LABS LTD EQ 10GM BASE/VIAL A091469 001 Jul 01, 2011

TEVA PHARMS USA EQ 500MG BASE/VIAL A201251 001 Dec 23, 2015

EQ 1GM BASE/VIAL A201251 002 Dec 23, 2015

EQ 5GM BASE/VIAL A201250 001 Dec 23, 2015

EQ 10GM BASE/VIAL A201250 002 Dec 23, 2015

WEST-WARD PHARMS INT EQ 500MG BASE/VIAL A062879 001 Aug 02, 1988

EQ 1GM BASE/VIAL A062879 002 Aug 02, 1988

XELLIA PHARMS APS EQ 500MG BASE/VIAL A091377 001 Sep 09, 2015

EQ 1GM BASE/VIAL A091377 002 Sep 09, 2015

EQ 5GM BASE/VIAL A206243 001 Dec 23, 2015



EQ 10GM BASE/VIAL A206243 002 Dec 23, 2015

VANCOR

PHARMACIA AND UPJOHN EQ 500MG BASE/VIAL A062956 001 Aug 01, 1988

EQ 1GM BASE/VIAL A062956 002 Aug 01, 1988



VARDENAFIL HYDROCHLORIDE

TABLET;ORAL

LEVITRA

+ BAYER HLTHCARE 2.5MG N021400 003 Aug 19, 2003

VASOPRESSIN TANNATE

INJECTABLE;INJECTION

PITRESSIN TANNATE

+ PARKE DAVIS 5PRESSOR UNITS/ML ** N003402 001

VECURONIUM BROMIDE

INJECTABLE;INJECTION

NORCURON

+ ORGANON USA INC 10MG/VIAL ** N018776 002 Apr 30, 1984

+ 20MG/VIAL ** N018776 003 Jan 03, 1992



VECURONIUM BROMIDE

HOSPIRA 4MG/VIAL A075558 001 Sep 11, 2001

WATSON LABS 10MG/VIAL A074334 001 Aug 31, 1995

20MG/VIAL A074334 002 Aug 31, 1995

WEST-WARD PHARMS INT 10MG/VIAL A075218 001 Aug 23, 1999

20MG/VIAL A075218 002 Aug 23, 1999



VELAGLUCERASE ALFA

POWDER;INTRAVENOUS

VPRIV

SHIRE HUMAN GENETIC 200 UNITS/VIAL N022575 002 Feb 26, 2010

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

EFFEXOR XR

WYETH PHARMS EQ 100MG BASE N020699 003 Oct 20, 1997

VENLAFAXINE HYDROCHLORIDE

ANCHEN PHARMS EQ 37.5MG BASE A078087 001 Mar 16, 2012

EQ 75MG BASE A078087 002 Mar 16, 2012

EQ 150MG BASE A078087 003 Mar 16, 2012

MYLAN EQ 37.5MG BASE A078789 001 Jun 01, 2011

EQ 75MG BASE A078789 002 Jun 01, 2011

EQ 150MG BASE A078789 003 Jun 01, 2011

TABLET;ORAL

EFFEXOR

+ WYETH PHARMS INC EQ 12.5MG BASE ** N020151 001 Dec 28, 1993

+ EQ 25MG BASE ** N020151 002 Dec 28, 1993

+ EQ 37.5MG BASE ** N020151 006 Dec 28, 1993

+ EQ 50MG BASE ** N020151 003 Dec 28, 1993

+ EQ 75MG BASE ** N020151 004 Dec 28, 1993

+ EQ 100MG BASE ** N020151 005 Dec 28, 1993

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-388(of 393)

** See List Footnote



VENLAFAXINE HYDROCHLORIDE

TABLET;ORAL

VENLAFAXINE HYDROCHLORIDE

FOSUN PHARMA
EQ 25MG BASE
A077515 001 Jun 13, 2008

EQ 37.5MG BASE
A077515 002 Jun 13, 2008

EQ 50MG BASE
A077515 003 Jun 13, 2008

EQ 75MG BASE
A077515 004 Jun 13, 2008

EQ 100MG BASE
A077515 005 Jun 13, 2008

PLIVA HRVATSKA DOO
EQ 25MG BASE
A078517 001 Jun 13, 2008

EQ 37.5MG BASE
A078517 002 Jun 13, 2008

EQ 50MG BASE
A078517 003 Jun 13, 2008

EQ 75MG BASE
A078517 004 Jun 13, 2008

EQ 100MG BASE
A078517 005 Jun 13, 2008

VERAPAMIL HYDROCHLORIDE

INJECTABLE;INJECTION

CALAN

GD SEARLE LLC
2.5MG/ML
N019038 001 Mar 30, 1984

ISOPTIN

+ MT ADAMS
2.5MG/ML **
N018485 001

VERAPAMIL HYDROCHLORIDE

ABRAXIS PHARM
2.5MG/ML
A070348 001 May 01, 1986

BEDFORD
2.5MG/ML
A072888 001 Jul 28, 1995

HOSPIRA
2.5MG/ML
A070577 001 Feb 02, 1987

2.5MG/ML
A070739 001 May 06, 1987

2.5MG/ML
A070740 001 May 06, 1987

INTL MEDICATION
2.5MG/ML
A070451 001 Dec 16, 1985

LUITPOLD
2.5MG/ML
A070225 001 Nov 12, 1985

2.5MG/ML
A070617 001 Nov 12, 1985

MARSAM PHARMS LLC
2.5MG/ML
A072233 001 Feb 26, 1993

2.5MG/ML
A073485 001 Sep 27, 1993

SMITH AND NEPHEW


2.5MG/ML
A070696 001 Jul 31, 1987

2.5MG/ML
A070697 001 Jul 31, 1987

SOLOPAK
2.5MG/ML
A070695 001 Jul 31, 1987

TABLET;ORAL

CALAN

GD SEARLE LLC
40MG
N018817 003 Feb 23, 1988

160MG
N018817 004 Feb 23, 1988

ISOPTIN

+ MT ADAMS
40MG
N018593 003 Nov 23, 1987

+
80MG
N018593 001 Mar 08, 1982

+
120MG
N018593 002 Mar 08, 1982

VERAPAMIL HYDROCHLORIDE

ACTAVIS ELIZABETH
80MG
A071019 001 Sep 24, 1986

120MG
A070468 001 Sep 24, 1986

MUTUAL PHARM
80MG
A070482 001 Sep 24, 1986

120MG
A070483 001 Sep 24, 1986

PLIVA
40MG
A072751 001 Feb 23, 1996

80MG
A072124 001 Jan 26, 1989

120MG
A072125 001 Jan 26, 1989

SUN PHARM INDUSTRIES
80MG
A071489 002 Jan 13, 1988

120MG
A071489 001 Jan 13, 1988

WARNER CHILCOTT
80MG
A070340 001 Sep 24, 1986

120MG
A070341 001 Sep 24, 1986

WATSON LABS
40MG
A072799 001 Apr 28, 1989

40MG
A072923 001 Jun 29, 1993

80MG
A070855 001 Sep 24, 1986

80MG
A071366 001 Oct 01, 1986

120MG
A070856 001 Sep 24, 1986

120MG
A071367 001 Oct 01, 1986

YAOPHARMA CO LTD
40MG
A073168 001 Jul 31, 1992

80MG
A071423 001 May 24, 1988

120MG
A071424 001 May 25, 1988

TABLET, EXTENDED RELEASE;ORAL

CALAN SR

+ PFIZER
180MG **
N019152 002 Dec 15, 1989

COVERA-HS

GD SEARLE LLC
180MG
N020552 001 Feb 26, 1996

240MG
N020552 002 Feb 26, 1996

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-389(of 393)

** See List Footnote



VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE

APOTEX CORP
120MG
A200878 001 Apr 20, 2012

180MG
A200878 002 Apr 20, 2012

240MG
A200878 003 Apr 20, 2012

PLIVA
240MG
A072922 001 Mar 01, 1996

VERATRUM VIRIDE ROOT

TABLET;ORAL

VERTAVIS

MEDPOINTE PHARM HLC
130CSR UNIT
N005691 002

VIDARABINE

INJECTABLE;INJECTION

VIRA-A

PARKEDALE
EQ 187.4MG BASE/ML
N050523 001

OINTMENT;OPHTHALMIC

VIRA-A

PARKEDALE
3%
N050486 001

VINBLASTINE SULFATE

INJECTABLE;INJECTION

VELBAN

+ LILLY
10MG/VIAL
N012665 001

VINBLASTINE SULFATE

ABRAXIS PHARM
10MG/VIAL
A089011 001 Nov 18, 1985

HOSPIRA
10MG/VIAL
A089565 001 Aug 18, 1987

VINCRISTINE SULFATE

INJECTABLE;INJECTION

ONCOVIN

LILLY
1MG/VIAL
N014103 001

1MG/ML
N014103 003 Mar 07, 1984

5MG/VIAL
N014103 002

VINCASAR PFS

TEVA PARENTERAL
1MG/ML
A071426 001 Jul 17, 1987

VINCREX

BRISTOL MYERS SQUIBB
5MG/VIAL
A070867 001 Jul 12, 1988

VINCRISTINE SULFATE

ABIC
1MG/ML
A070873 001 Feb 19, 1987

ABRAXIS PHARM
1MG/ML
A070411 001 Sep 10, 1986

FRESENIUS KABI USA


1MG/ML
A076296 001 Dec 20, 2002

1MG/ML
A076401 001 Oct 28, 2003

HOSPIRA
1MG/VIAL
A071559 001 Apr 11, 1988

2MG/VIAL
A071560 001 Apr 11, 1988

5MG/VIAL
A071561 001 Apr 11, 1988

VINORELBINE TARTRATE

INJECTABLE;INJECTION

VINORELBINE TARTRATE

EBEWE PHARMA
EQ 10MG BASE/ML
A078408 001 Feb 13, 2008

MYLAN LABS LTD
EQ 10MG BASE/ML
A200148 001 Aug 31, 2012

VIOMYCIN SULFATE

INJECTABLE;INJECTION

VIOCIN SULFATE

PFIZER
EQ 1GM BASE/VIAL
A061086 001

EQ 5GM BASE/VIAL
A061086 002

VITAMIN A

CAPSULE;ORAL

AQUASOL A

ASTRAZENECA
25,000USP UNITS
A083080 002

50,000USP UNITS
A083080 001

VITAMIN A

BANNER PHARMACAPS
50,000USP UNITS
A083973 001

CHASE CHEM
50,000 IU
A083351 001

EVERYLIFE
50,000 IU
A083134 001

IMPAX LABS
50,000USP UNITS
A080952 001

WEST WARD
50,000USP UNITS
A080985 001

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST
6-390(of 393)

** See List Footnote



VITAMIN A PALMITATE

CAPSULE;ORAL

AFAXIN

STERLING WINTHROP
EQ 50,000 UNITS BASE
A083187 001

ALPHALIN

LILLY
EQ 50,000 UNITS BASE
A080883 001

DEL-VI-A

DEL RAY LABS
EQ 50,000 UNITS BASE
A080830 001

VI-DOM-A

BAYER PHARMS
EQ 50,000 UNITS BASE
A080972 001

VITAMIN A

BANNER PHARMACAPS
EQ 50,000 UNITS BASE
A080702 001

BRISTOL MYERS SQUIBBEQ 50,000 UNITS BASE
A080860 001

CHASE CHEM
EQ 50,000 UNITS BASE
A080746 001

EQ 50,000 UNITS BASE
A083207 001

ELKINS SINN
EQ 50,000 UNITS BASE
A085479 001

EVERYLIFE
EQ 50,000 UNITS BASE
A080943 001

EQ 50,000 UNITS BASE
A083114 001

IMPAX LABS
EQ 50,000 UNITS BASE
A080953 001

EQ 50,000 UNITS BASE
A080955 001

IVAX SUB TEVA PHARMS EQ 50,000 UNITS BASE
A083035 001

EQ 50,000 UNITS BASE
A083190 001

MK LABS
EQ 25,000 UNITS BASE
A083457 002

EQ 50,000 UNITS BASE
A083457 001

WEST WARD
EQ 50,000 UNITS BASE
A080967 001

WHARTON LABS
EQ 50,000 UNITS BASE
A083665 001

VITAMIN A PALMITATE

ARCUM
EQ 50,000 UNITS BASE
A083311 001

EQ 50,000 UNITS BASE
A083321 001

BANNER PHARMACAPS
EQ 50,000 UNITS BASE
A083948 001

EQ 50,000 UNITS BASE
A083981 001

VITAMIN A SOLUBILIZED

TEVA
EQ 50,000 UNITS BASE
A080921 001

INJECTABLE;INJECTION

VITAMIN A PALMITATE

BEL MAR
EQ 50,000 UNITS BASE/ML
A080819 001

VORICONAZOLE

FOR SUSPENSION;ORAL

VORICONAZOLE

MYLAN PHARMS INC
200MG/5ML
A202361 001 May 28, 2013

VORTIOXETINE HYDROBROMIDE

TABLET;ORAL

TRINTELLIX

+ TAKEDA PHARMS USA
EQ 15MG BASE **
N204447 003 Sep 30, 2013

WARFARIN POTASSIUM

TABLET;ORAL

ATHROMBIN-K

PHARM RES ASSOC
2MG
N011771 007

5MG
N011771 004

10MG
N011771 005

25MG
N011771 006

WARFARIN SODIUM

INJECTABLE;INJECTION

COUMADIN

BRISTOL MYERS SQUIBB
5MG/VIAL
N009218 024 Feb 07, 1995

50MG/VIAL
N009218 020

75MG/VIAL
N009218 012

TABLET;ORAL

ATHROMBIN

PHARM RES ASSOC
5MG
N011771 003

10MG
N011771 002

25MG
N011771 001

PANWARFIN

ABBOTT
2MG
N017020 001

2.5MG
N017020 002

5MG
N017020 003

7.5MG
N017020 004

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-391(of 393)

** See List Footnote



WARFARIN SODIUM

TABLET;ORAL

PANWARFIN

10MG N017020 005

WARFARIN SODIUM

MYLAN 1MG A040415 001 Sep 27, 2004

2MG A040415 002 Sep 27, 2004

2.5MG A040415 003 Sep 29, 2004

3MG A040415 004 Sep 27, 2004

4MG A040415 005 Sep 27, 2004

5MG A040415 006 Sep 27, 2004

6MG A040415 007 Sep 27, 2004

7.5MG A040415 008 Sep 27, 2004

10MG A040415 009 Sep 27, 2004

USL PHARMA 2MG A088719 001 Jun 27, 1985



2.5MG A088720 001 Aug 06, 1985

5MG A088721 001 Jul 02, 1985



WATSON LABS 2MG A086123 001 Aug 17, 1982

2.5MG A086120 001 Aug 17, 1982

5MG A086119 001 Aug 17, 1982

7.5MG A086118 001 Aug 17, 1982

10MG A086122 001 Aug 17, 1982

YAOPHARMA CO LTD 1MG A040196 001 Sep 30, 1997

2MG A040196 002 Sep 30, 1997

2.5MG A040196 003 Sep 30, 1997

3MG A040196 008 Jul 26, 2000



4MG A040196 004 Sep 30, 1997

5MG A040196 005 Sep 30, 1997

6MG A040196 009 Jul 26, 2000



7.5MG A040196 006 Sep 30, 1997

10MG A040196 007 Sep 30, 1997



XENON XE-127

GAS;INHALATION

XENON XE 127

MALLINCKRODT 5mCi/VIAL N018536 001 Oct 01, 1982

10mCi/VIAL N018536 002 Oct 01, 1982

XENON XE-133

GAS;INHALATION

XENON XE 133

GE HEALTHCARE 1 CI/AMP N017256 002

10mCi/VIAL N017687 002

20mCi/VIAL N017687 003

GEN ELECTRIC 5-100 CI/CYLINDER N017550 001

0.25-5 CI/AMP N017550 003

XENON XE 133-V.S.S.

GE HEALTHCARE 10mCi/VIAL N017687 001

INJECTABLE;INJECTION

XENON XE 133

GE HEALTHCARE 1.3-1.7 CI/AMP N017256 001

LANTHEUS MEDCL 6.3mCi/ML N017283 001

SOLUTION;INHALATION, INJECTION

XENEISOL

MALLINCKRODT 18-25mCi/AMP N017262 002

XYLOSE

POWDER;ORAL

XYLO-PFAN

SAVAGE LABS 25GM/BOT N017605 001

XYLOSE

LYNE 25GM/BOT N018856 001 Mar 26, 1987

ZALCITABINE

TABLET;ORAL

HIVID

ROCHE 0.375MG N020199 001 Jun 19, 1992

0.75MG N020199 002 Jun 19, 1992

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-392(of 393)

** See List Footnote



ZALEPLON

CAPSULE;ORAL

ZALEPLON

MYLAN 5MG A077238 001 Jun 06, 2008

10MG A077238 002 Jun 06, 2008

UPSHER SMITH LABS 5MG A078095 001 Jun 06, 2008

5MG A078706 001 Jun 06, 2008

10MG A078095 002 Jun 06, 2008

10MG A078706 002 Jun 06, 2008

ZICONOTIDE ACETATE

INJECTABLE;INTRATHECAL

PRIALT

TERSERA THERAPS LLC 200MCG/2ML (100MCG/ML) N021060 003 Dec 28, 2004

ZIDOVUDINE

INJECTABLE;INJECTION

ZIDOVUDINE

LIAONING CHENGDA 10MG/ML A204538 001 Nov 26, 2013

TABLET;ORAL

RETROVIR

VIIV HLTHCARE 200MG N020518 001 Dec 19, 1995

+ 300MG ** N020518 002 Oct 04, 1996

ZIDOVUDINE

AUROBINDO PHARMA 60MG N022294 001 Jul 23, 2009
HEC PHARM 300MG A202058 001 Oct 07, 2011
MATRIX LABS LTD 100MG N200732 001 Feb 23, 2011
RANBAXY LABS LTD 300MG A077327 001 Sep 19, 2005
ZILEUTON
TABLET;ORAL
ZYFLO
CHIESI USA INC 300MG N020471 001 Dec 09, 1996
ZINC SULFATE
INJECTABLE;INJECTION
ZINC SULFATE
ABRAXIS PHARM EQ 1MG ZINC/ML N019229 002 May 05, 1987
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL
ZIPRASIDONE HYDROCHLORIDE
MYLAN PHARMS INC EQ 20MG BASE A202395 001 Oct 10, 2013
EQ 40MG BASE A202395 002 Oct 10, 2013
EQ 60MG BASE A202395 003 Oct 10, 2013
EQ 80MG BASE A202395 004 Oct 10, 2013
SUSPENSION;ORAL
GEODON
PFIZER INC EQ 10MG BASE/ML N021483 001 Mar 29, 2006
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
ZOLEDRONIC ACID
SUN PHARMA GLOBAL EQ 4MG BASE/VIAL A090018 001 Mar 04, 2013
EQ 4MG BASE/5ML A202746 001 Mar 04, 2013
ZOMETA
+ NOVARTIS EQ 4MG BASE/VIAL ** N021223 001 Aug 20, 2001
ZOLMITRIPTAN
TABLET;ORAL
ZOLMITRIPTAN
APOTEX INC 2.5MG A202078 001 May 14, 2013
5MG A202078 002 May 14, 2013
MYLAN PHARMS INC 2.5MG A203186 001 May 14, 2013
5MG A203186 002 May 14, 2013
SUN PHARMA GLOBAL 2.5MG A203476 001 Nov 13, 2014
5MG A203476 002 Nov 13, 2014
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
APOTEX INC 2.5MG A202476 001 May 14, 2013
5MG A202476 002 May 14, 2013

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

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST



DISCONTINUED DRUG PRODUCT LIST 6-393(of 393)

** See List Footnote



ZOLPIDEM TARTRATE

TABLET;ORAL

ZOLPIDEM TARTRATE

DR REDDYS LABS LTD 5MG
A077985 001 Apr 23, 2007

10MG
A077985 002 Apr 23, 2007

HIKMA 5MG
A078129 001 Apr 30, 2008

10MG
A078129 002 Apr 30, 2008

MYLAN PHARMS INC 5MG


A078016 001 Apr 23, 2007

10MG
A078016 002 Apr 23, 2007

STRIDES VIVIMED 5MG


A076062 001 Apr 23, 2007

10MG
A076062 002 Apr 23, 2007

SUN PHARM INDS LTD 5MG


A078055 001 Apr 23, 2007

10MG
A078055 002 Apr 23, 2007

SUN PHARM INDUSTRIES 5MG


A077288 001 Apr 23, 2007

10MG
A077288 002 Apr 23, 2007

SYNTHON PHARMS 5MG


A077540 001 Apr 23, 2007

10MG
A077540 002 Apr 23, 2007

WATSON LABS 5MG


A077773 001 Apr 23, 2007

10MG
A077773 002 Apr 23, 2007

TABLET, EXTENDED RELEASE;ORAL

ZOLPIDEM TARTRATE

SYNTHON PHARMS 6.25MG
A078483 001 Apr 12, 2011

12.5MG
A078483 002 Jun 06, 2011

TABLET, ORALLY DISINTEGRATING;ORAL

TOVALT ODT

BIOVAIL LABS INTL 5MG
N021412 001 Apr 25, 2007

10MG
N021412 002 Apr 25, 2007

ZONISAMIDE

CAPSULE;ORAL

ZONEGRAN

+ SUNOVION PHARMS INC 50MG
N020789 002 Aug 22, 2003

ZONISAMIDE

ANI PHARMS INC 25MG
A077639 001 Dec 22, 2005

25MG
A077641 003 Dec 22, 2005

50MG
A077639 002 Dec 22, 2005

50MG
A077641 002 Dec 22, 2005

100MG
A077639 003 Dec 22, 2005

100MG
A077641 001 Dec 22, 2005

AUROBINDO PHARMA LTD 25MG
A077645 002 Sep 29, 2006

50MG
A077645 003 Sep 29, 2006

100MG
A077645 001 Dec 22, 2005

EPIC PHARMA LLC 25MG
A077876 001 Feb 21, 2007

50MG
A077876 002 Feb 21, 2007

100MG
A077876 003 Feb 21, 2007

MYLAN PHARMS INC 25MG
A077647 001 Dec 22, 2005

50MG
A077647 002 Dec 22, 2005

100MG
A077647 003 Dec 22, 2005

ROXANE 25MG
A077648 001 Dec 22, 2005

50MG
A077648 002 Dec 22, 2005

100MG
A077648 003 Dec 22, 2005

SUN PHARM INDUSTRIES 25MG
A077635 001 Dec 22, 2005

50MG
A077635 002 Dec 22, 2005

100MG
A077635 003 Dec 22, 2005

UPSHER SMITH LABS 25MG
A077644 001 Dec 22, 2005

50MG
A077644 002 Dec 22, 2005

100MG
A077644 003 Dec 22, 2005

WATSON LABS 25MG
A077650 001 Apr 20, 2006

50MG
A077650 002 Apr 20, 2006

100MG
A077650 003 Apr 20, 2006

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

39TH EDITION – 2019 - APPROVED DRUG PRODUCTS LIST


7-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of Orphan Designations and Approvals is available at:

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/de
fault.htm
39TH EDITION - 2019 - APPROVED DRUG PRODUCTS LIST
8-1

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY


ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

ACETAMINOPHEN;ASPIRIN;BUTALBITAL ASPIRIN;CAFFEINE;CARISOPRODOL;
CAPSULE OR TABLET; ORAL CODEINE PHOSPHATE
160-165MG;160-165MG;50MG TABLET; ORAL
325MG;325MG;50MG 160MG;32MG;200MG;16MG

ACETAMINOPHEN;ASPIRIN;BUTALBITAL; ASPIRIN;CARISOPRODOL
CAFFEINE TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG
160-165MG;160-165MG;50MG;40MG
325MG;325MG;50MG;40MG
ASPIRIN;CARISOPRODOL;
CODEINE PHOSPHATE
ACETAMINOPHEN;BUTALBITAL TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG;16MG
325MG;50MG

ASPIRIN;MEPROBAMATE
ACETAMINOPHEN;BUTALBITAL;CAFFEINE TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG
325MG;50MG;40MG

ASPIRIN;METHOCARBAMOL
AMINOPHYLLINE TABLET; ORAL
TABLET; ORAL 325MG;400MG
100MG;200MG

CHLOROTHIAZIDE
ASPIRIN;BUTALBITAL TABLET; ORAL
CAPSULE OR TABLET; ORAL 250MG
325MG;50MG
650MG;50MG
HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
ASPIRIN;BUTALBITAL;CAFFEINE 10MG;25MG;
CAPSULE OR TABLET; ORAL 50MG;100MG
325MG;50MG;40MG
650MG;50MG;40MG
PREDNISONE
TABLET; ORAL
ASPIRIN;CAFFEINE;CARISOPRODOL 1MG;2.5MG;5MG;10MG;
TABLET; ORAL 20MG;25MG;50MG
160MG;32MG;200MG
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 1

APPENDIX A - PRODUCT NAME INDEX

** A **

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE

ABELCET, AMPHOTERICIN B

ABILIFY, ARIPIPRAZOLE

ABILIFY MAINTENA KIT, ARIPIPRAZOLE

ABILIFY MYCITE KIT, ARIPIPRAZOLE

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ABLYSINOL, ALCOHOL

ABRAXANE, PACLITAXEL

ABREVA, DOCOSANOL (OTC)

ABSORICA, ISOTRETINOIN

ABSTRAL, FENTANYL CITRATE

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACANYA, BENZOYL PEROXIDE

ACARBOSE, ACARBOSE

ACCOLATE, ZAFIRLUKAST

ACCUNEB, ALBUTEROL SULFATE

ACCUPRIL, QUINAPRIL HYDROCHLORIDE

ACCURETIC, HYDROCHLOROTHIAZIDE

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ACEPHEN, ACETAMINOPHEN (OTC)

ACETADOTE, ACETYLCYSTEINE

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ACETAMINOPHEN

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

ACETASOL HC, ACETIC ACID, GLACIAL

ACETAZOLAMIDE, ACETAZOLAMIDE

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACETIC ACID, ACETIC ACID, GLACIAL

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

ACETYLCYSTEINE, ACETYLCYSTEINE

ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE

ACIPHEX, RABEPRAZOLE SODIUM

ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM

ACITRETIN, ACITRETIN

ACTHREL, CORTICORELIN OVINE TRIFLUTATE

ACTICLATE, DOXYCYCLINE HYCLATE

ACTIGALL, URSODIOL

ACTIQ, FENTANYL CITRATE

ACTIVELLA, ESTRADIOL

ACTONEL, RISEDRONATE SODIUM

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

ACTOS, PIOGLITAZONE HYDROCHLORIDE

ACULAR, KETOROLAC TROMETHAMINE

ACULAR LS, KETOROLAC TROMETHAMINE

ACUVAIL, KETOROLAC TROMETHAMINE

ACYCLOVIR, ACYCLOVIR

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ACZONE, DAPSONE

ADAGEN, PEGADEMASE BOVINE

ADALAT CC, NIFEDIPINE

ADAPALENE, ADAPALENE

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADASUVE, LOXAPINE

ADCIRCA, TADALAFIL

ADDERALL XR 10, AMPHETAMINE ASPARTATE

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 2

APPENDIX A - PRODUCT NAME INDEX

** A **

ADDERALL XR 5, AMPHETAMINE ASPARTATE

ADDYI, FLIBANSERIN

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

ADEMPAS, RIOCIGUAT

ADENOSINE, ADENOSINE

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ADLYXIN, LIXISENATIDE

ADMELOG, INSULIN LISPRO

ADMELOG SOLOSTAR, INSULIN LISPRO

ADRENACLICK, EPINEPHRINE

ADRENALIN, EPINEPHRINE

ADREVIEW, IOBENGUANE SULFATE I-123

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

ADVIL, IBUPROFEN (OTC)

ADVIL, IBUPROFEN SODIUM (OTC)

ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL COLD AND SINUS, IBUPROFEN (OTC)

ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)

ADVIL LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MULTI-SYMPTOM COLD & FLU, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ADZENYS ER, AMPHETAMINE

ADZENYS XR-ODT, AMPHETAMINE

AEMCOLO, RIFAMYCIN

AEROSPAN HFA, FLUNISOLIDE

AFINITOR, EVEROLIMUS

AFINITOR DISPERZ, EVEROLIMUS

AFIRMELLE, ETHINYL ESTRADIOL

AFREZZA, INSULIN RECOMBINANT HUMAN

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

AGGRENOX, ASPIRIN

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

AIRDUO RESPICLICK, FLUTICASONE PROPIONATE

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

AKBETA, LEVOBUNOLOL HYDROCHLORIDE

AKOVAZ, EPHEDRINE SULFATE

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

AKTEN, LIDOCAINE HYDROCHLORIDE

AKTIPAK, BENZOYL PEROXIDE

AKTOB, TOBRAMYCIN

AKYNZEO, FOSNETUPITANT CHLORIDE HYDROCHLORIDE

AKYNZEO, NETUPITANT

ALA-CORT, HYDROCORTISONE

ALA-SCALP, HYDROCORTISONE

ALAVERT, LORATADINE (OTC)

ALAWAY, KETOTIFEN FUMARATE (OTC)

ALBENDAZOLE, ALBENDAZOLE

ALBENZA, ALBENDAZOLE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALCAINE, PROPARACAINE HYDROCHLORIDE

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

ALDARA, IMIQUIMOD

ALECENSA, ALECTINIB HYDROCHLORIDE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALEVE, NAPROXEN SODIUM (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 3

APPENDIX A - PRODUCT NAME INDEX

** A **

ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

ALFENTA, ALFENTANIL HYDROCHLORIDE

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALIMTA, PEMETREXED DISODIUM

ALINIA, NITAZOXANIDE

ALIQOPA, COPANLISIB DIHYDROCHLORIDE

ALKERAN, MELPHALAN

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLI, ORLISTAT (OTC)

ALLOPURINOL, ALLOPURINOL

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

ALLZITAL, ACETAMINOPHEN

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

ALOCRIL, NEDOCROMIL SODIUM

ALOMIDE, LODOXAMIDE TROMETHAMINE

ALOPRIM, ALLOPURINOL SODIUM

ALORA, ESTRADIOL

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

ALOXI, PALONOSETRON HYDROCHLORIDE

ALPHAGAN P, BRIMONIDINE TARTRATE

ALPRAZOLAM, ALPRAZOLAM

ALPROSTADIL, ALPROSTADIL

ALREX, LOTEPREDNOL ETABONATE

ALTABAX, RETAPAMULIN

ALTACE, RAMIPRIL

ALTAFLUOR BENOX, BENOXINATE HYDROCHLORIDE

ALTAVERA, ETHINYL ESTRADIOL

ALTOPREV, LOVASTATIN

ALTRENO, TRETINOIN

ALUNBRIG, BRIGATINIB

ALVESCO, CICLESONIDE

ALYACEN 1/35, ETHINYL ESTRADIOL

ALYACEN 7/7/7, ETHINYL ESTRADIOL

AMABELZ, ESTRADIOL

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMARYL, GLIMEPIRIDE

AMBIEN, ZOLPIDEM TARTRATE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBISOME, AMPHOTERICIN B

AMCINONIDE, AMCINONIDE

AMELUZ, AMINOLEVULINIC ACID HYDROCHLORIDE

AMERGE, NARATRIPTAN HYDROCHLORIDE

AMICAR, AMINOCAPROIC ACID

AMIDATE, ETOMIDATE

AMIFOSTINE, AMIFOSTINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMINO ACIDS, AMINO ACIDS

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

AMINOSYN 10%, AMINO ACIDS

AMINOSYN 3.5% M, AMINO ACIDS

AMINOSYN 8.5%, AMINO ACIDS

AMINOSYN 8.5% W/ELECTROLYTES, AMINO ACIDS

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 4

APPENDIX A - PRODUCT NAME INDEX

** A **

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITIZA, LUBIPROSTONE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

AMMONIA N 13, AMMONIA N-13

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

AMMONIUM LACTATE, AMMONIUM LACTATE

AMMONUL, SODIUM BENZOATE

AMNESTEEM, ISOTRETINOIN

AMOXAPINE, AMOXAPINE

AMOXICILLIN, AMOXICILLIN

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXIL, AMOXICILLIN

AMPHADASE, HYALURONIDASE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

AMPHOTERICIN B, AMPHOTERICIN B

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

AMPYRA, DALFAMPRIDINE

AMRINONE LACTATE, INAMRINONE LACTATE

AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE

AMYVID, FLORBETAPIR F-18

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

ANADROL-50, OXYMETHOLONE

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ANAPROX DS, NAPROXEN SODIUM

ANASTROZOLE, ANASTROZOLE

ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

ANCOBON, FLUCYTOSINE

ANDRODERM, TESTOSTERONE

ANDROGEL, TESTOSTERONE

ANDROID 25, METHYLTESTOSTERONE

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

ANGELIQ, DROSPIRENONE

ANGIOMAX, BIVALIRUDIN

ANNOVERA, ETHINYL ESTRADIOL

ANORO ELLIPTA, UMECLIDINIUM BROMIDE

ANTABUSE, DISULFIRAM

ANTARA (MICRONIZED), FENOFIBRATE

ANTHELIOS 20, AVOBENZONE (OTC)

ANTHELIOS 40, AVOBENZONE (OTC)

ANTHELIOS SX, AVOBENZONE (OTC)

ANTIZOL, FOMEPIZOLE

ANUSOL HC, HYDROCORTISONE

APADAZ, ACETAMINOPHEN

APIDRA, INSULIN GLULISINE RECOMBINANT

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT

APLENZIN, BUPROPION HYDROBROMIDE

APOKYN, APOMORPHINE HYDROCHLORIDE

APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE

APREPITANT, APREPITANT

APRISO, MESALAMINE

APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE

APTIOM, ESLICARBAZEPINE ACETATE

APTIVUS, TIPRANAVIR

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 5

APPENDIX A - PRODUCT NAME INDEX

** A **

AQUASOL A, VITAMIN A PALMITATE

ARAKODA, TAFENOQUINE SUCCINATE

ARANELLE, ETHINYL ESTRADIOL

ARAVA, LEFLUNOMIDE

ARCAPTA NEOHALER, INDACATEROL MALEATE

ARESTIN, MINOCYCLINE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

ARGATROBAN IN 0.9% SODIUM CHLORIDE, ARGATROBAN

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARICEPT, DONEPEZIL HYDROCHLORIDE

ARIDOL KIT, MANNITOL

ARIKAYCE KIT, AMIKACIN SULFATE

ARIMIDEX, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

ARISTADA, ARIPIPRAZOLE LAUROXIL

ARISTADA INITIO KIT, ARIPIPRAZOLE LAUROXIL

ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

ARIXTRA, FONDAPARINUX SODIUM

ARMODAFINIL, ARMODAFINIL

ARMONAIR RESPICLICK, FLUTICASONE PROPIONATE

ARNUITY ELLIPTA, FLUTICASONE FUROATE

AROMASIN, EXEMESTANE

ARRANON, NELARABINE

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ARTHROTEC, DICLOFENAC SODIUM

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE

ASACOL HD, MESALAMINE

ASCLERA, POLIDOCANOL

ASCOR, ASCORBIC ACID

ASENAPINE MALEATE, ASENAPINE MALEATE

ASHLYNA, ETHINYL ESTRADIOL

ASMANEX HFA, MOMETASONE FUROATE

ASMANEX TWISTHALER, MOMETASONE FUROATE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ASTAGRAF XL, TACROLIMUS

ASTELIN, AZELASTINE HYDROCHLORIDE

ASTEPRO, AZELASTINE HYDROCHLORIDE

ASTRAMORPH PF, MORPHINE SULFATE

ATACAND, CANDESARTAN CILEXETIL

ATACAND HCT, CANDESARTAN CILEXETIL

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATELVIA, RISEDRONATE SODIUM

ATENOLOL, ATENOLOL

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATHENTIA NEXT, LEVONORGESTREL (OTC)

ATIVAN, LORAZEPAM

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE, ATOVAQUONE

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRALIN, TRETINOIN

ATRIDOX, DOXYCYCLINE HYCLATE

ATRIPLA, EFAVIRENZ

ATROPEN, ATROPINE SULFATE

ATROPINE SULFATE, ATROPINE SULFATE

ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE

ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE, ATROPINE SULFATE

ATROVENT HFA, IPRATROPIUM BROMIDE

AUBAGIO, TERIFLUNOMIDE

AUGMENTIN '125', AMOXICILLIN

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN '875', AMOXICILLIN

AUGMENTIN XR, AMOXICILLIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 6

APPENDIX A - PRODUCT NAME INDEX

** A **

AUROVELA 1.5/30, ETHINYL ESTRADIOL

AUROVELA 1/20, ETHINYL ESTRADIOL

AUROVELA 24 FE, ETHINYL ESTRADIOL

AUROVELA FE 1.5/30, ETHINYL ESTRADIOL

AUROVELA FE 1/20, ETHINYL ESTRADIOL

AURYXIA, FERRIC CITRATE

AUSTEDO, DEUTETRABENAZINE

AUVI-Q, EPINEPHRINE

AVAGARD, ALCOHOL (OTC)

AVAGE, TAZAROTENE

AVALIDE, HYDROCHLOROTHIAZIDE

AVANDIA, ROSIGLITAZONE MALEATE

AVAPRO, IRBESARTAN

AVC, SULFANILAMIDE

AVEED, TESTOSTERONE UNDECANOATE

AVELOX, MOXIFLOXACIN HYDROCHLORIDE

AVIANE-28, ETHINYL ESTRADIOL

AVITA, TRETINOIN

AVODART, DUTASTERIDE

AVYCAZ, AVIBACTAM SODIUM

AXERT, ALMOTRIPTAN MALATE

AXID AR, NIZATIDINE (OTC)

AXUMIN, FLUCICLOVINE F-18

AYUNA, ETHINYL ESTRADIOL

AZACITIDINE, AZACITIDINE

AZACTAM, AZTREONAM

AZACTAM IN PLASTIC CONTAINER, AZTREONAM

AZASAN, AZATHIOPRINE

AZASITE, AZITHROMYCIN

AZATHIOPRINE, AZATHIOPRINE

AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM

AZEDRA, IOBENGUANE I-131

AZELAIC ACID, AZELAIC ACID

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZELEX, AZELAIC ACID

AZILECT, RASAGILINE MESYLATE

AZITHROMYCIN, AZITHROMYCIN

AZOPT, BRINZOLAMIDE

AZOR, AMLODIPINE BESYLATE

AZTREONAM, AZTREONAM

AZULFIDINE, SULFASALAZINE

AZULFIDINE EN-TABS, SULFASALAZINE

** B **

BACIIM, BACITRACIN

BACITRACIN, BACITRACIN

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ZINC

BACLOFEN, BACLOFEN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BACTRIM, SULFAMETHOXAZOLE

BACTRIM DS, SULFAMETHOXAZOLE

BAL, DIMERCAPROL

BALANCED SALT, CALCIUM CHLORIDE

BALCOLTRA, ETHINYL ESTRADIOL

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BALZIVA-28, ETHINYL ESTRADIOL

BANZEL, RUFINAMIDE

BARACLUDE, ENTECAVIR

BASAGLAR, INSULIN GLARGINE

BAXDELA, DELAFLOXACIN MEGLUMINE

BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE

BEKYREE, DESOGESTREL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 7

APPENDIX A - PRODUCT NAME INDEX

** B **

BELBUCA, BUPRENORPHINE HYDROCHLORIDE

BELEODAQ, BELINOSTAT

BELRAPZO, BENDAMUSTINE HYDROCHLORIDE

BELSOMRA, SUVOREXANT

BELVIQ, LORCASERIN HYDROCHLORIDE

BELVIQ XR, LORCASERIN HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BENDEKA, BENDAMUSTINE HYDROCHLORIDE

BENICAR, OLMESARTAN MEDOXOMIL

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENZACLIN, BENZOYL PEROXIDE

BENZAMYCIN, BENZOYL PEROXIDE

BENZNIDAZOLE, BENZNIDAZOLE

BENZONATATE, BENZONATATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BEPREVE, BEPOTASTINE BESILATE

BESIVANCE, BESIFLOXACIN HYDROCHLORIDE

BETA-VAL, BETAMETHASONE VALERATE

BETADINE, POVIDONE-IODINE

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

BETAPACE, SOTALOL HYDROCHLORIDE

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BETHKIS, TOBRAMYCIN

BETIMOL, TIMOLOL

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

BEVESPI AEROSPHERE, FORMOTEROL FUMARATE

BEVYXXA, BETRIXABAN

BEXAROTENE, BEXAROTENE

BEYAZ, DROSPIRENONE

BICALUTAMIDE, BICALUTAMIDE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

BICNU, CARMUSTINE

BIDIL, HYDRALAZINE HYDROCHLORIDE

BIJUVA, ESTRADIOL

BIKTARVY, BICTEGRAVIR SODIUM

BILTRICIDE, PRAZIQUANTEL

BIMATOPROST, BIMATOPROST

BINOSTO, ALENDRONATE SODIUM

BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH SUBSALICYLATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BIVALIRUDIN, BIVALIRUDIN

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BLEPH-10, SULFACETAMIDE SODIUM

BLEPHAMIDE, PREDNISOLONE ACETATE

BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE

BLISOVI 24 FE, ETHINYL ESTRADIOL

BLISOVI FE 1.5/30, ETHINYL ESTRADIOL

BLISOVI FE 1/20, ETHINYL ESTRADIOL

BLOXIVERZ, NEOSTIGMINE METHYLSULFATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 8

APPENDIX A - PRODUCT NAME INDEX

** B **

BONIVA, IBANDRONATE SODIUM

BONJESTA, DOXYLAMINE SUCCINATE

BONTRIL PDM, PHENDIMETRAZINE TARTRATE

BORTEZOMIB, BORTEZOMIB

BOSULIF, BOSUTINIB MONOHYDRATE

BRAFTOVI, ENCORAFENIB

BREO ELLIPTA, FLUTICASONE FUROATE

BRETHINE, TERBUTALINE SULFATE

BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVICON 28-DAY, ETHINYL ESTRADIOL

BREVITAL SODIUM, METHOHEXITAL SODIUM

BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)

BRIDION, SUGAMMADEX SODIUM

BRIELLYN, ETHINYL ESTRADIOL

BRILINTA, TICAGRELOR

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BRISDELLE, PAROXETINE MESYLATE

BRIVIACT, BRIVARACETAM

BROMFED-DM, BROMPHENIRAMINE MALEATE

BROMFENAC SODIUM, BROMFENAC SODIUM

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE,

BROMSITE, BROMFENAC SODIUM

BRONCHO SALINE, SODIUM CHLORIDE (OTC)

BROVANA, ARFORMOTEROL TARTRATE

BRYHALI, HALOBETASOL PROPIONATE

BSS, CALCIUM CHLORIDE

BSS PLUS, CALCIUM CHLORIDE

BUDESONIDE, BUDESONIDE (OTC)

BUDESONIDE, BUDESONIDE

BUMETANIDE, BUMETANIDE

BUMEX, BUMETANIDE

BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE

BUPHENYL, SODIUM PHENYLBUTYRATE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE, BUPRENORPHINE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUSULFAN, BUSULFAN

BUSULFEX, BUSULFAN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

BUTAPAP, ACETAMINOPHEN

BUTENAFINE HYDROCHLORIDE, BUTENAFINE HYDROCHLORIDE (OTC)

BUTISOL SODIUM, BUTABARBITAL SODIUM

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTRANS, BUPRENORPHINE

BYDUREON, EXENATIDE SYNTHETIC

BYDUREON BCISE, EXENATIDE

BYDUREON PEN, EXENATIDE SYNTHETIC

BYETTA, EXENATIDE SYNTHETIC

BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 9

APPENDIX A - PRODUCT NAME INDEX

** B **

BYVALSON, NEBIVOLOL HYDROCHLORIDE

** C **

CABERGOLINE, CABERGOLINE

CABOMETYX, CABOZANTINIB S-MALATE

CADUET, AMLODIPINE BESYLATE

CAFCIT, CAFFEINE CITRATE

CAFERGOT, CAFFEINE

CAFFEINE CITRATE, CAFFEINE CITRATE

CALAN, VERAPAMIL HYDROCHLORIDE

CALAN SR, VERAPAMIL HYDROCHLORIDE

CALCIPOTRIENE, CALCIPOTRIENE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCITONIN-SALMON, CALCITONIN SALMON

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM

CALCIUM GLUCONATE, CALCIUM GLUCONATE

CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE

CALDOLOR, IBUPROFEN

CALQUENCE, ACALABRUTINIB

CAMBIA, DICLOFENAC POTASSIUM

CAMILA, NORETHINDRONE

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

CANASA, MESALAMINE

CANCIDAS, CASPOFUNGIN ACETATE

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CAPASTAT SULFATE, CAPREOMYCIN SULFATE

CAPECITABINE, CAPECITABINE

CAPEX, FLUOCINOLONE ACETONIDE

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

CAPRELSA, VANDETANIB

CAPREOMYCIN SULFATE, CAPREOMYCIN SULFATE

CAPTOPRIL, CAPTOPRIL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CARAC, FLUOROURACIL

CARAFATE, SUCRALFATE

CARBAGLU, CARGLUMIC ACID

CARBAMAZEPINE, CARBAMAZEPINE

CARBATROL, CARBAMAZEPINE

CARBIDOPA, CARBIDOPA

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARDIZEM, DILTIAZEM HYDROCHLORIDE

CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

CARDIZEM LA, DILTIAZEM HYDROCHLORIDE

CARDURA, DOXAZOSIN MESYLATE

CARDURA XL, DOXAZOSIN MESYLATE

CARISOPRODOL, CARISOPRODOL

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CARMUSTINE, CARMUSTINE

CARNITOR, LEVOCARNITINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 10

APPENDIX A - PRODUCT NAME INDEX

** C **

CARNITOR SF, LEVOCARNITINE

CAROSPIR, SPIRONOLACTONE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CARTIA XT, DILTIAZEM HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE

CASODEX, BICALUTAMIDE

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CASPORYN HC, HYDROCORTISONE

CASSIPA, BUPRENORPHINE HYDROCHLORIDE

CATAPRES, CLONIDINE HYDROCHLORIDE

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

CAVERJECT, ALPROSTADIL

CAVERJECT IMPULSE, ALPROSTADIL

CAYSTON, AZTREONAM

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFIXIME, CEFIXIME

CEFOTAN, CEFOTETAN DISODIUM

CEFOTAXIME, CEFOTAXIME SODIUM

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOTETAN, CEFOTETAN DISODIUM

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM

CEFOXITIN, CEFOXITIN SODIUM

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTAZIDIME, CEFTAZIDIME

CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CELEBREX, CELECOXIB

CELECOXIB, CELECOXIB

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CELEXA, CITALOPRAM HYDROBROMIDE

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

CELONTIN, METHSUXIMIDE

CENTANY, MUPIROCIN

CEPHALEXIN, CEPHALEXIN

CEQUA, CYCLOSPORINE

CERDELGA, ELIGLUSTAT TARTRATE

CEREBYX, FOSPHENYTOIN SODIUM

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

CEREZYME, IMIGLUCERASE

CERINTA, ETHINYL ESTRADIOL

CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE

CERVIDIL, DINOPROSTONE

CESAMET, NABILONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 11

APPENDIX A - PRODUCT NAME INDEX

** C **

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE

CETROTIDE, CETRORELIX

CETYLEV, ACETYLCYSTEINE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHANTIX, VARENICLINE TARTRATE

CHEMET, SUCCIMER

CHENODIOL, CHENODIOL

CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)

CHILDREN'S ADVIL, IBUPROFEN (OTC)

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)

CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CLARITIN, LORATADINE (OTC)

CHILDREN'S ELIXSURE, IBUPROFEN (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)

CHILDREN'S MOTRIN, IBUPROFEN (OTC)

CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

CHLOROTHIAZIDE, CHLOROTHIAZIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORTHALIDONE, CHLORTHALIDONE

CHLORZOXAZONE, CHLORZOXAZONE

CHOLAC, LACTULOSE

CHOLBAM, CHOLIC ACID

CHOLESTYRAMINE, CHOLESTYRAMINE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CHOLINE C-11, CHOLINE C-11

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIALIS, TADALAFIL

CICLOPIROX, CICLOPIROX

CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)

CIDOFOVIR, CIDOFOVIR

CILOSTAZOL, CILOSTAZOL

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 12

APPENDIX A - PRODUCT NAME INDEX

** C **

CIMDUO, LAMIVUDINE

CIMETIDINE, CIMETIDINE (OTC)

CIMETIDINE, CIMETIDINE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CINVANTI, APREPITANT

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRODEX, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

CLADRIBINE, CLADRIBINE

CLARAVIS, ISOTRETINOIN

CLARINEX, DESLORATADINE

CLARINEX D 24 HOUR, DESLORATADINE

CLARINEX-D 12 HOUR, DESLORATADINE

CLARITHROMYCIN, CLARITHROMYCIN

CLARITIN, LORATADINE (OTC)

CLARITIN HIVES RELIEF, LORATADINE (OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)

CLARITIN REDITABS, LORATADINE (OTC)

CLARITIN-D, LORATADINE (OTC)

CLARITIN-D 24 HOUR, LORATADINE (OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLENPIQ, CITRIC ACID

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEVIPREX, CLEVIDIPINE

CLIMARA, ESTRADIOL

CLIMARA PRO, ESTRADIOL

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLINDAGEL, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

CLINDESSE, CLINDAMYCIN PHOSPHATE

CLINDETS, CLINDAMYCIN PHOSPHATE

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 13

APPENDIX A - PRODUCT NAME INDEX

** C **

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBEX, CLOBETASOL PROPIONATE

CLODERM, CLOCORTOLONE PIVALATE

CLOFARABINE, CLOFARABINE

CLOLAR, CLOFARABINE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE, CLONIDINE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLOROTEKAL, CHLOROPROCAINE HYDROCHLORIDE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOZAPINE, CLOZAPINE

CLOZARIL, CLOZAPINE

COARTEM, ARTEMETHER

CODEINE SULFATE, CODEINE SULFATE

COGENTIN, BENZTROPINE MESYLATE

COL-PROBENECID, COLCHICINE

COLAZAL, BALSALAZIDE DISODIUM

COLCHICINE, COLCHICINE

COLCRYS, COLCHICINE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

COLESTID, COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

COLGATE TOTAL, SODIUM FLUORIDE (OTC)

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

COLOCORT, HYDROCORTISONE

COLPREP KIT, MAGNESIUM SULFATE

COLY-MYCIN M, COLISTIMETHATE SODIUM

COLY-MYCIN S, COLISTIN SULFATE

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

COMBIGAN, BRIMONIDINE TARTRATE

COMBIPATCH, ESTRADIOL

COMBIVENT RESPIMAT, ALBUTEROL SULFATE

COMBIVIR, LAMIVUDINE

COMETRIQ, CABOZANTINIB S-MALATE

COMPLERA, EMTRICITABINE

COMPRO, PROCHLORPERAZINE

COMTAN, ENTACAPONE

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

CONDYLOX, PODOFILOX

CONRAY, IOTHALAMATE MEGLUMINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 14

APPENDIX A - PRODUCT NAME INDEX

** C **

CONRAY 43, IOTHALAMATE MEGLUMINE

CONSENSI, AMLODIPINE BESYLATE

CONSTILAC, LACTULOSE

CONTRAVE, BUPROPION HYDROCHLORIDE

CONZIP, TRAMADOL HYDROCHLORIDE

COPAXONE, GLATIRAMER ACETATE

COPIKTRA, DUVELISIB

CORDRAN, FLURANDRENOLIDE

CORDRAN SP, FLURANDRENOLIDE

COREG, CARVEDILOL

COREG CR, CARVEDILOL PHOSPHATE

CORGARD, NADOLOL

CORLANOR, IVABRADINE HYDROCHLORIDE

CORLOPAM, FENOLDOPAM MESYLATE

CORMAX, CLOBETASOL PROPIONATE

CORPHEDRA, EPHEDRINE SULFATE

CORTEF, HYDROCORTISONE

CORTENEMA, HYDROCORTISONE

CORTIFOAM, HYDROCORTISONE ACETATE

CORTISONE ACETATE, CORTISONE ACETATE

CORTISPORIN, BACITRACIN ZINC

CORTISPORIN, HYDROCORTISONE ACETATE

CORTROSYN, COSYNTROPIN

CORVERT, IBUTILIDE FUMARATE

CORZIDE, BENDROFLUMETHIAZIDE

COSMEGEN, DACTINOMYCIN

COSOPT, DORZOLAMIDE HYDROCHLORIDE

COSOPT PF, DORZOLAMIDE HYDROCHLORIDE

COSYNTROPIN, COSYNTROPIN

COTELLIC, COBIMETINIB FUMARATE

COTEMPLA XR-ODT, METHYLPHENIDATE

COUMADIN, WARFARIN SODIUM

COZAAR, LOSARTAN POTASSIUM

CREON, PANCRELIPASE (AMYLASE

CRESEMBA, ISAVUCONAZONIUM SULFATE

CRESTOR, ROSUVASTATIN CALCIUM

CRINONE, PROGESTERONE

CRIXIVAN, INDINAVIR SULFATE

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

CROMOLYN SODIUM, CROMOLYN SODIUM

CROTAN, CROTAMITON

CRYSELLE, ETHINYL ESTRADIOL

CUBICIN, DAPTOMYCIN

CUBICIN RF, DAPTOMYCIN

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CUPRIMINE, PENICILLAMINE

CUROSURF, PORACTANT ALFA

CUTIVATE, FLUTICASONE PROPIONATE

CUVPOSA, GLYCOPYRROLATE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYANOKIT, HYDROXOCOBALAMIN

CYCLAFEM 0.5/35, ETHINYL ESTRADIOL

CYCLAFEM 1/35, ETHINYL ESTRADIOL

CYCLAFEM 7/7/7, ETHINYL ESTRADIOL

CYCLESSA, DESOGESTREL

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYCLOSET, BROMOCRIPTINE MESYLATE

CYCLOSPORINE, CYCLOSPORINE

CYKLOKAPRON, TRANEXAMIC ACID

CYMBALTA, DULOXETINE HYDROCHLORIDE

CYONANZ, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 15

APPENDIX A - PRODUCT NAME INDEX

** C **

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

CYSTADANE, BETAINE

CYSTAGON, CYSTEAMINE BITARTRATE

CYSTARAN, CYSTEAMINE HYDROCHLORIDE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE

CYTARABINE, CYTARABINE

CYTOMEL, LIOTHYRONINE SODIUM

CYTOTEC, MISOPROSTOL

CYTOVENE, GANCICLOVIR SODIUM

** D **

D.H.E. 45, DIHYDROERGOTAMINE MESYLATE

DACARBAZINE, DACARBAZINE

DACOGEN, DECITABINE

DACTINOMYCIN, DACTINOMYCIN

DAKLINZA, DACLATASVIR DIHYDROCHLORIDE

DALFAMPRIDINE, DALFAMPRIDINE

DALIRESP, ROFLUMILAST

DALVANCE, DALBAVANCIN HYDROCHLORIDE

DANAZOL, DANAZOL

DANTRIUM, DANTROLENE SODIUM

DANTROLENE SODIUM, DANTROLENE SODIUM

DAPSONE, DAPSONE

DAPTOMYCIN, DAPTOMYCIN

DARAPRIM, PYRIMETHAMINE

DARIFENACIN, DARIFENACIN HYDROBROMIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DARUNAVIR ETHANOLATE, DARUNAVIR ETHANOLATE

DASETTA 1/35, ETHINYL ESTRADIOL

DASETTA 7/7/7, ETHINYL ESTRADIOL

DATSCAN, IOFLUPANE I-123

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DAURISMO, GLASDEGIB

DAYPRO, OXAPROZIN

DAYSEE, ETHINYL ESTRADIOL

DAYTRANA, METHYLPHENIDATE

DDAVP, DESMOPRESSIN ACETATE

DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DECITABINE, DECITABINE

DEFERASIROX, DEFERASIROX

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEFINITY, PERFLUTREN

DEFITELIO, DEFIBROTIDE SODIUM

DELESTROGEN, ESTRADIOL VALERATE

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELSTRIGO, DORAVIRINE

DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)

DELZICOL, MESALAMINE

DEMADEX, TORSEMIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DEMSER, METYROSINE

DENAVIR, PENCICLOVIR

DEPACON, VALPROATE SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 16

APPENDIX A - PRODUCT NAME INDEX

** D **

DEPAKENE, VALPROIC ACID

DEPAKOTE, DIVALPROEX SODIUM

DEPAKOTE ER, DIVALPROEX SODIUM

DEPEN, PENICILLAMINE

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMABET, BETAMETHASONE VALERATE

DERMATOP, PREDNICARBATE

DERMATOP E EMOLLIENT, PREDNICARBATE

DERMOTIC, FLUOCINOLONE ACETONIDE

DESCOVY, EMTRICITABINE

DESFERAL, DEFEROXAMINE MESYLATE

DESFLURANE, DESFLURANE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESLORATADINE, DESLORATADINE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DESOGEN, DESOGESTREL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DESONATE, DESONIDE

DESONIDE, DESONIDE

DESOWEN, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

DESVENLAFAXINE, DESVENLAFAXINE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DETROL, TOLTERODINE TARTRATE

DETROL LA, TOLTERODINE TARTRATE

DEXAMETHASONE, DEXAMETHASONE

DEXAMETHASONE INTENSOL, DEXAMETHASONE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

DEXFERRUM, IRON DEXTRAN

DEXILANT, DEXLANSOPRAZOLE

DEXLANSOPRAZOLE, DEXLANSOPRAZOLE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DEXTENZA, DEXAMETHASONE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, DEXTROMETHORPHAN HYDROBROMIDE

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 17

APPENDIX A - PRODUCT NAME INDEX

** D **

DEXTROSE 25%, DEXTROSE

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER,

DEXTROSE 50%, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DEXYCU KIT, DEXAMETHASONE

DIABETA, GLYBURIDE

DIACOMIT, STIRIPENTOL

DIAMOX, ACETAZOLAMIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIASTAT, DIAZEPAM

DIASTAT ACUDIAL, DIAZEPAM

DIAZEPAM, DIAZEPAM

DIAZEPAM INTENSOL, DIAZEPAM

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DICLEGIS, DOXYLAMINE SUCCINATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE), DICYCLOMINE HYDROCHLORIDE

DIDANOSINE, DIDANOSINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 18

APPENDIX A - PRODUCT NAME INDEX

** D **

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DIFFERIN, ADAPALENE (OTC)

DIFFERIN, ADAPALENE

DIFICID, FIDAXOMICIN

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

DIFLUCAN, FLUCONAZOLE

DIFLUNISAL, DIFLUNISAL

DIGOXIN, DIGOXIN

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DILANTIN, PHENYTOIN

DILANTIN, PHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

DILATRATE-SR, ISOSORBIDE DINITRATE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DILTZAC, DILTIAZEM HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE

DIOVAN, VALSARTAN

DIOVAN HCT, HYDROCHLOROTHIAZIDE

DIPENTUM, OLSALAZINE SODIUM

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIPRIVAN, PROPOFOL

DIPROLENE, BETAMETHASONE DIPROPIONATE

DIPROLENE AF, BETAMETHASONE DIPROPIONATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DISULFIRAM, DISULFIRAM

DITROPAN XL, OXYBUTYNIN CHLORIDE

DIURIL, CHLOROTHIAZIDE

DIURIL, CHLOROTHIAZIDE SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DIVIGEL, ESTRADIOL

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOCETAXEL, DOCETAXEL

DOCOSANOL, DOCOSANOL (OTC)

DOFETILIDE, DOFETILIDE

DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPRAM, DOXAPRAM HYDROCHLORIDE

DOPTELET, AVATROMBOPAG MALEATE

DORAL, QUAZEPAM

DORYX, DOXYCYCLINE HYCLATE

DORYX MPC, DOXYCYCLINE HYCLATE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOTAREM, GADOTERATE MEGLUMINE

DOVONEX, CALCIPOTRIENE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 19

APPENDIX A - PRODUCT NAME INDEX

** D **

DOXYCYCLINE, DOXYCYCLINE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

DRAX EXAMETAZIME, TECHNETIUM TC-99M EXAMETAZIME KIT

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE

DRISDOL, ERGOCALCIFEROL

DRONABINOL, DRONABINOL

DROPERIDOL, DROPERIDOL

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE

DROXIA, HYDROXYUREA

DSUVIA, SUFENTANIL CITRATE

DTPA, TECHNETIUM TC-99M PENTETATE KIT

DUAC, BENZOYL PEROXIDE

DUAVEE, BAZEDOXIFENE ACETATE

DUETACT, GLIMEPIRIDE

DUEXIS, FAMOTIDINE

DULERA, FORMOTEROL FUMARATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUODOTE, ATROPINE

DUOPA, CARBIDOPA

DURACLON, CLONIDINE HYDROCHLORIDE

DURAGESIC-100, FENTANYL

DURAGESIC-12, FENTANYL

DURAGESIC-25, FENTANYL

DURAGESIC-37, FENTANYL

DURAGESIC-50, FENTANYL

DURAGESIC-75, FENTANYL

DURAMORPH PF, MORPHINE SULFATE

DURAPREP, IODINE POVACRYLEX (OTC)

DUREZOL, DIFLUPREDNATE

DURLAZA, ASPIRIN

DUTASTERIDE, DUTASTERIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

DUTOPROL, HYDROCHLOROTHIAZIDE

DUVOID, BETHANECHOL CHLORIDE

DUZALLO, ALLOPURINOL

DYANAVEL XR, AMPHETAMINE

DYAZIDE, HYDROCHLOROTHIAZIDE

DYCLOPRO, DYCLONINE HYDROCHLORIDE

DYMISTA, AZELASTINE HYDROCHLORIDE

DYNACIN, MINOCYCLINE HYDROCHLORIDE

DYRENIUM, TRIAMTERENE

** E **

E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

E-Z-HD, BARIUM SULFATE

E-Z-PAQUE, BARIUM SULFATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

EC-NAPROSYN, NAPROXEN

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ECOZA, ECONAZOLE NITRATE

EDARBI, AZILSARTAN KAMEDOXOMIL

EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

EDEX, ALPROSTADIL

EDLUAR, ZOLPIDEM TARTRATE

EDURANT, RILPIVIRINE HYDROCHLORIDE

EFAVIRENZ, EFAVIRENZ

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 20

APPENDIX A - PRODUCT NAME INDEX

** E **

EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE

EFFIENT, PRASUGREL HYDROCHLORIDE

EFUDEX, FLUOROURACIL

EGRIFTA, TESAMORELIN ACETATE

ELELYSO, TALIGLUCERASE ALFA

ELEPSIA XR, LEVETIRACETAM

ELESTAT, EPINASTINE HYDROCHLORIDE

ELESTRIN, ESTRADIOL

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

ELIDEL, PIMECROLIMUS

ELIFEMME, ETHINYL ESTRADIOL

ELIGARD, LEUPROLIDE ACETATE

ELIMITE, PERMETHRIN

ELINEST, ETHINYL ESTRADIOL

ELIQUIS, APIXABAN

ELIXOPHYLLIN, THEOPHYLLINE

ELLA, ULIPRISTAL ACETATE

ELLENCE, EPIRUBICIN HYDROCHLORIDE

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

ELMIRON, PENTOSAN POLYSULFATE SODIUM

ELOCON, MOMETASONE FUROATE

ELOXATIN, OXALIPLATIN

EMADINE, EMEDASTINE DIFUMARATE

EMBEDA, MORPHINE SULFATE

EMBELINE, CLOBETASOL PROPIONATE

EMBELINE E, CLOBETASOL PROPIONATE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

EMEND, APREPITANT

EMEND, FOSAPREPITANT DIMEGLUMINE

EMFLAZA, DEFLAZACORT

EMLA, LIDOCAINE

EMOQUETTE, DESOGESTREL

EMSAM, SELEGILINE

EMTRICITABINE, EMTRICITABINE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

EMTRIVA, EMTRICITABINE

EMVERM, MEBENDAZOLE

ENABLEX, DARIFENACIN HYDROBROMIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRILAT, ENALAPRILAT

ENDARI, L-GLUTAMINE

ENDOMETRIN, PROGESTERONE

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

ENPRESSE-28, ETHINYL ESTRADIOL

ENSKYCE, DESOGESTREL

ENSTILAR, BETAMETHASONE DIPROPIONATE

ENTACAPONE, ENTACAPONE

ENTECAVIR, ENTECAVIR

ENTEREG, ALVIMOPAN

ENTOCORT EC, BUDESONIDE

ENTRESTO, SACUBITRIL

ENULOSE, LACTULOSE

ENVARSUS XR, TACROLIMUS

EOVIST, GADOXETATE DISODIUM

EPANED, ENALAPRIL MALEATE

EPANED KIT, ENALAPRIL MALEATE

EPCLUSA, SOFOSBUVIR

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPIDIOLEX, CANNABIDIOL

EPIDUO, ADAPALENE

EPIDUO FORTE, ADAPALENE

EPIFOAM, HYDROCORTISONE ACETATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 21

APPENDIX A - PRODUCT NAME INDEX

** E **

EPINEPHRINE, EPINEPHRINE

EPINEPHRINE (AUTOINJECTOR), EPINEPHRINE

EPIPEN, EPINEPHRINE

EPIPEN JR., EPINEPHRINE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPITOL, CARBAMAZEPINE

EPIVIR, LAMIVUDINE

EPIVIR-HBV, LAMIVUDINE

EPLERENONE, EPLERENONE

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

EPROSARTAN MESYLATE, EPROSARTAN MESYLATE

EPTIFIBATIDE, EPTIFIBATIDE

EPZICOM, ABACAVIR SULFATE

EQUETRO, CARBAMAZEPINE

ERAXIS, ANIDULAFUNGIN

ERGOCALCIFEROL, ERGOCALCIFEROL

ERGOLOID MESYLATES, ERGOLOID MESYLATES

ERGOMAR, ERGOTAMINE TARTRATE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ERIVEDGE, VISMODEGIB

ERLEADA, APALUTAMIDE

ERRIN, NORETHINDRONE

ERTACZO, SERTACONAZOLE NITRATE

ERTAPENEM SODIUM, ERTAPENEM SODIUM

ERY-TAB, ERYTHROMYCIN

ERYC, ERYTHROMYCIN

ERYGEL, ERYTHROMYCIN

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN, ERYTHROMYCIN

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ESBRIET, PIRFENIDONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESKATA, HYDROGEN PEROXIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM

ESTARYLLA, ETHINYL ESTRADIOL

ESTAZOLAM, ESTAZOLAM

ESTRACE, ESTRADIOL

ESTRADIOL, ESTRADIOL

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ESTRING, ESTRADIOL

ESTROGEL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

ESTROSTEP FE, ETHINYL ESTRADIOL

ESZOPICLONE, ESZOPICLONE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

ETHACRYNIC ACID, ETHACRYNIC ACID

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

ETHAMOLIN, ETHANOLAMINE OLEATE

ETHOSUXIMIDE, ETHOSUXIMIDE

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ETHYOL, AMIFOSTINE

ETIDRONATE DISODIUM, ETIDRONATE DISODIUM

ETODOLAC, ETODOLAC

ETOMIDATE, ETOMIDATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 22

APPENDIX A - PRODUCT NAME INDEX

** E **

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

ETOPOSIDE, ETOPOSIDE

EUCRISA, CRISABOROLE

EURAX, CROTAMITON

EUTHYROX, LEVOTHYROXINE SODIUM **

EVAMIST, ESTRADIOL

EVEKEO, AMPHETAMINE SULFATE

EVEROLIMUS, EVEROLIMUS

EVISTA, RALOXIFENE HYDROCHLORIDE

EVOCLIN, CLINDAMYCIN PHOSPHATE

EVOMELA, MELPHALAN HYDROCHLORIDE

EVOTAZ, ATAZANAVIR SULFATE

EVOXAC, CEVIMELINE HYDROCHLORIDE

EVZIO, NALOXONE HYDROCHLORIDE

EXALGO, HYDROMORPHONE HYDROCHLORIDE

EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)

EXELDERM, SULCONAZOLE NITRATE

EXELON, RIVASTIGMINE

EXELON, RIVASTIGMINE TARTRATE

EXEMESTANE, EXEMESTANE

EXFORGE, AMLODIPINE BESYLATE

EXFORGE HCT, AMLODIPINE BESYLATE

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)

EXJADE, DEFERASIROX

EXONDYS 51, ETEPLIRSEN

EXPAREL, BUPIVACAINE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

EXTINA, KETOCONAZOLE

EXTRANEAL, ICODEXTRIN

EZALLOR, ROSUVASTATIN CALCIUM

EZETIMIBE, EZETIMIBE

EZETIMIBE AND ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

** F **

FABIOR, TAZAROTENE

FACTIVE, GEMIFLOXACIN MESYLATE

FALLBACK SOLO, LEVONORGESTREL (OTC)

FALMINA, ETHINYL ESTRADIOL

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE (OTC)

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)

FANAPT, ILOPERIDONE

FARESTON, TOREMIFENE CITRATE

FARXIGA, DAPAGLIFLOZIN

FARYDAK, PANOBINOSTAT LACTATE

FASLODEX, FULVESTRANT

FAYOSIM, ETHINYL ESTRADIOL

FAZACLO ODT, CLOZAPINE

FELBAMATE, FELBAMATE

FELBATOL, FELBAMATE

FELDENE, PIROXICAM

FELODIPINE, FELODIPINE

FEMARA, LETROZOLE

FEMCON FE, ETHINYL ESTRADIOL

FEMHRT, ETHINYL ESTRADIOL

FEMRING, ESTRADIOL ACETATE

FENOFIBRATE, FENOFIBRATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FENOGLIDE, FENOFIBRATE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 23

APPENDIX A - PRODUCT NAME INDEX

** F **

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FENTANYL CITRATE, FENTANYL CITRATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

FENTORA, FENTANYL CITRATE

FERAHEME, FERUMOXYTOL

FERRIPROX, DEFERIPRONE

FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FIASP, INSULIN ASPART

FIASP FLEXTOUCH, INSULIN ASPART

FIBRICOR, FENOFIBRIC ACID

FINACEA, AZELAIC ACID

FINASTERIDE, FINASTERIDE

FIORICET W/ CODEINE, ACETAMINOPHEN

FIORINAL, ASPIRIN

FIORINAL W/CODEINE, ASPIRIN

FIRAZYR, ICATIBANT ACETATE

FIRDAPSE, AMIFAMPRIDINE PHOSPHATE

FIRMAGON, DEGARELIX ACETATE

FIRVANQ KIT, VANCOMYCIN HYDROCHLORIDE

FLAC, FLUOCINOLONE ACETONIDE

FLAGYL, METRONIDAZOLE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLAREX, FLUOROMETHOLONE ACETATE

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLECTOR, DICLOFENAC EPOLAMINE

FLOLAN, EPOPROSTENOL SODIUM

FLOLIPID, SIMVASTATIN

FLOMAX, TAMSULOSIN HYDROCHLORIDE

FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)

FLONASE SENSIMIST ALLERGY RELIEF, FLUTICASONE FUROATE (OTC)

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

FLOVENT HFA, FLUTICASONE PROPIONATE

FLOXURIDINE, FLOXURIDINE

FLUCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUCONAZOLE, FLUCONAZOLE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCYTOSINE, FLUCYTOSINE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUMADINE, RIMANTADINE HYDROCHLORIDE

FLUMAZENIL, FLUMAZENIL

FLUNISOLIDE, FLUNISOLIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 24

APPENDIX A - PRODUCT NAME INDEX

** F **

FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUORESCITE, FLUORESCEIN SODIUM

FLUOROPLEX, FLUOROURACIL

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUOXYMESTERONE, FLUOXYMESTERONE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURANDRENOLIDE, FLURANDRENOLIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

FLUTAMIDE, FLUTAMIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FML, FLUOROMETHOLONE

FML FORTE, FLUOROMETHOLONE

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

FOLLISTIM AQ, FOLLITROPIN ALFA/BETA

FOLOTYN, PRALATREXATE

FOMEPIZOLE, FOMEPIZOLE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

FORANE, ISOFLURANE

FORFIVO XL, BUPROPION HYDROCHLORIDE

FORTAMET, METFORMIN HYDROCHLORIDE

FORTAZ, CEFTAZIDIME

FORTEO, TERIPARATIDE RECOMBINANT HUMAN

FORTESTA, TESTOSTERONE

FOSAMAX, ALENDRONATE SODIUM

FOSAMAX PLUS D, ALENDRONATE SODIUM

FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FOSCAVIR, FOSCARNET SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FOSRENOL, LANTHANUM CARBONATE

FRAGMIN, DALTEPARIN SODIUM

FREAMINE HBC 6.9%, AMINO ACIDS

FREAMINE III 10%, AMINO ACIDS

FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5%, AMINO ACIDS

FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS

FROVA, FROVATRIPTAN SUCCINATE

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

FURADANTIN, NITROFURANTOIN

FUROSEMIDE, FUROSEMIDE

FUSILEV, LEVOLEUCOVORIN CALCIUM

FUZEON, ENFUVIRTIDE

FYAVOLV, ETHINYL ESTRADIOL

FYCOMPA, PERAMPANEL

** G **

GABAPENTIN, GABAPENTIN

GABITRIL, TIAGABINE HYDROCHLORIDE

GABLOFEN, BACLOFEN

GADAVIST, GADOBUTROL

GALAFOLD, MIGALASTAT HYDROCHLORIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 25

APPENDIX A - PRODUCT NAME INDEX

** G **

GALZIN, ZINC ACETATE

GANCICLOVIR, GANCICLOVIR

GANCICLOVIR, GANCICLOVIR SODIUM

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

GANIRELIX ACETATE, GANIRELIX ACETATE

GASTROCROM, CROMOLYN SODIUM

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

GATIFLOXACIN, GATIFLOXACIN

GATTEX KIT, TEDUGLUTIDE RECOMBINANT

GAVISCON, ALUMINUM HYDROXIDE (OTC)

GELNIQUE, OXYBUTYNIN CHLORIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GEMFIBROZIL, GEMFIBROZIL

GEMIFLOXACIN MESYLATE, GEMIFLOXACIN MESYLATE

GEMZAR, GEMCITABINE HYDROCHLORIDE

GEN-XENE, CLORAZEPATE DIPOTASSIUM

GENERLAC, LACTULOSE

GENGRAF, CYCLOSPORINE

GENOPTIC, GENTAMICIN SULFATE

GENOTROPIN, SOMATROPIN RECOMBINANT

GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT

GENTAK, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENVOYA, COBICISTAT

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

GIAPREZA, ANGIOTENSIN II ACETATE

GIAZO, BALSALAZIDE DISODIUM

GILDAGIA, ETHINYL ESTRADIOL

GILDESS 1.5/30, ETHINYL ESTRADIOL

GILDESS 1/20, ETHINYL ESTRADIOL

GILDESS 24 FE, ETHINYL ESTRADIOL

GILDESS FE 1.5/30, ETHINYL ESTRADIOL

GILDESS FE 1/20, ETHINYL ESTRADIOL

GILENYA, FINGOLIMOD HYDROCHLORIDE

GILOTRIF, AFATINIB DIMALEATE

GLATIRAMER ACETATE, GLATIRAMER ACETATE

GLATOPA, GLATIRAMER ACETATE

GLEEVEC, IMATINIB MESYLATE

GLEOLAN, AMINOLEVULINIC ACID HYDROCHLORIDE

GLEOSTINE, LOMUSTINE

GLIADEL, CARMUSTINE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE, GLIPIZIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLOFIL-125, IOTHALAMATE SODIUM I-125

GLUCAGEN, GLUCAGON HYDROCHLORIDE

GLUCAGON, GLUCAGON

GLUCAGON, GLUCAGON HYDROCHLORIDE

GLUCOPHAGE, METFORMIN HYDROCHLORIDE

GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE

GLUCOTROL, GLIPIZIDE

GLUCOTROL XL, GLIPIZIDE

GLUMETZA, METFORMIN HYDROCHLORIDE

GLYBURIDE, GLYBURIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)

GLYCOLAX, POLYETHYLENE GLYCOL 3350

GLYCOPYRROLATE, GLYCOPYRROLATE

GLYDO, LIDOCAINE HYDROCHLORIDE

GLYNASE, GLYBURIDE

GLYRX-PF, GLYCOPYRROLATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 26

APPENDIX A - PRODUCT NAME INDEX

** G **

GLYSET, MIGLITOL

GLYXAMBI, EMPAGLIFLOZIN

GOCOVRI, AMANTADINE HYDROCHLORIDE

GOLYTELY, POLYETHYLENE GLYCOL 3350

GONAL-F, FOLLITROPIN ALFA/BETA

GONAL-F RFF, FOLLITROPIN ALFA/BETA

GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA

GONITRO, NITROGLYCERIN

GOPRELTO, COCAINE HYDROCHLORIDE

GRALISE, GABAPENTIN

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GUAIFENESIN, GUAIFENESIN (OTC)

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

GUANABENZ ACETATE, GUANABENZ ACETATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

** H **

H.P. ACTHAR GEL, CORTICOTROPIN

HABITROL, NICOTINE (OTC)

HAILEY 1.5/30, ETHINYL ESTRADIOL

HAILEY FE 1.5/30, ETHINYL ESTRADIOL

HAILEY FE 1/20, ETHINYL ESTRADIOL

HALAVEN, ERIBULIN MESYLATE

HALCION, TRIAZOLAM

HALDOL, HALOPERIDOL DECANOATE

HALDOL, HALOPERIDOL LACTATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HALOG, HALCINONIDE

HALOPERIDOL, HALOPERIDOL

HALOPERIDOL, HALOPERIDOL LACTATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HARVONI, LEDIPASVIR

HEATHER, NORETHINDRONE

HECTOROL, DOXERCALCIFEROL

HEMABATE, CARBOPROST TROMETHAMINE

HEMANGEOL, PROPRANOLOL HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPATAMINE 8%, AMINO ACIDS

HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

HEPSERA, ADEFOVIR DIPIVOXIL

HER STYLE, LEVONORGESTREL (OTC)

HETLIOZ, TASIMELTEON

HEXALEN, ALTRETAMINE

HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 27

APPENDIX A - PRODUCT NAME INDEX

** H **

HICON, SODIUM IODIDE I-131

HIPREX, METHENAMINE HIPPURATE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

HORIZANT, GABAPENTIN ENACARBIL

HUMALOG, INSULIN LISPRO RECOMBINANT

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMATROPE, SOMATROPIN RECOMBINANT

HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

HUMULIN R, INSULIN HUMAN

HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN R KWIKPEN, INSULIN HUMAN

HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDREA, HYDROXYUREA

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

HYDROCORTISONE, HYDROCORTISONE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

HYDROXYUREA, HYDROXYUREA

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN

HYSINGLA, HYDROCODONE BITARTRATE

HYZAAR, HYDROCHLOROTHIAZIDE

** I **

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBRANCE, PALBOCICLIB

IBU-TAB, IBUPROFEN

IBU-TAB 200, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN LYSINE, IBUPROFEN LYSINE

IBUPROFEN SODIUM, IBUPROFEN SODIUM (OTC)

IBUPROHM, IBUPROFEN (OTC)

IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

IC-GREEN, INDOCYANINE GREEN

ICLEVIA, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 28

APPENDIX A - PRODUCT NAME INDEX

** I **

ICLUSIG, PONATINIB HYDROCHLORIDE

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE

IDHIFA, ENASIDENIB MESYLATE

IDKIT:HP, CITRIC ACID

IFEX, IFOSFAMIDE

IFOSFAMIDE, IFOSFAMIDE

ILEVRO, NEPAFENAC

ILOPERIDONE, ILOPERIDONE

ILUVIEN, FLUOCINOLONE ACETONIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

IMBRUVICA, IBRUTINIB

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IMIQUIMOD, IMIQUIMOD

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

IMPAVIDO, MILTEFOSINE

IMPOYZ, CLOBETASOL PROPIONATE

IMURAN, AZATHIOPRINE

IMVEXXY, ESTRADIOL

INAPSINE, DROPERIDOL

INBRIJA, LEVODOPA

INCASSIA, NORETHINDRONE

INCRELEX, MECASERMIN RECOMBINANT

INCRUSE ELLIPTA, UMECLIDINIUM BROMIDE

INDAPAMIDE, INDAPAMIDE

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

INDICLOR, INDIUM IN-111 CHLORIDE

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

INDOCIN, INDOMETHACIN

INDOCIN, INDOMETHACIN SODIUM

INDOCYANINE GREEN, INDOCYANINE GREEN

INDOMETHACIN, INDOMETHACIN

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

INFANTS' FEVERALL, ACETAMINOPHEN (OTC)

INFASURF PRESERVATIVE FREE, CALFACTANT

INFED, IRON DEXTRAN

INFUGEM, GEMCITABINE HYDROCHLORIDE

INFUMORPH, MORPHINE SULFATE

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC, ASCORBIC ACID

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INGENOL MEBUTATE, INGENOL MEBUTATE

INGREZZA, VALBENAZINE TOSYLATE

INJECTAFER, FERRIC CARBOXYMALTOSE

INLYTA, AXITINIB

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

INOMAX, NITRIC OXIDE

INSPRA, EPLERENONE

INTEGRILIN, EPTIFIBATIDE

INTELENCE, ETRAVIRINE

INTERMEZZO, ZOLPIDEM TARTRATE

INTRALIPID 10%, SOYBEAN OIL

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

INTRAROSA, PRASTERONE

INTROVALE, ETHINYL ESTRADIOL

INTUNIV, GUANFACINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 29

APPENDIX A - PRODUCT NAME INDEX

** I **

INVANZ, ERTAPENEM SODIUM

INVEGA, PALIPERIDONE

INVEGA SUSTENNA, PALIPERIDONE PALMITATE

INVEGA TRINZA, PALIPERIDONE PALMITATE

INVELTYS, LOTEPREDNOL ETABONATE

INVIRASE, SAQUINAVIR MESYLATE

INVOKAMET, CANAGLIFLOZIN

INVOKAMET XR, CANAGLIFLOZIN

INVOKANA, CANAGLIFLOZIN

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

IOSAT, POTASSIUM IODIDE (OTC)

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

IRBESARTAN, IRBESARTAN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRESSA, GEFITINIB

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISENTRESS, RALTEGRAVIR POTASSIUM

ISENTRESS HD, RALTEGRAVIR POTASSIUM

ISIBLOOM, DESOGESTREL

ISOFLURANE, ISOFLURANE

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISONIAZID, ISONIAZID

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

ISOPTO ATROPINE, ATROPINE SULFATE

ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

ISORDIL, ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

ISOSULFAN BLUE, ISOSULFAN BLUE

ISOTRETINOIN, ISOTRETINOIN

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

ISRADIPINE, ISRADIPINE

ISTALOL, TIMOLOL MALEATE

ISTODAX, ROMIDEPSIN

ISUPREL, ISOPROTERENOL HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

IVERMECTIN, IVERMECTIN

IVY BLOCK, BENTOQUATAM (OTC)

IXEMPRA KIT, IXABEPILONE

** J **

JADENU, DEFERASIROX

JADENU SPRINKLE, DEFERASIROX

JAIMIESS, ETHINYL ESTRADIOL

JAKAFI, RUXOLITINIB PHOSPHATE

JALYN, DUTASTERIDE

JANTOVEN, WARFARIN SODIUM

JANUMET, METFORMIN HYDROCHLORIDE

JANUMET XR, METFORMIN HYDROCHLORIDE

JANUVIA, SITAGLIPTIN PHOSPHATE

JARDIANCE, EMPAGLIFLOZIN

JEANATOPE, ALBUMIN IODINATED I-125 SERUM

JENCYCLA, NORETHINDRONE

JENTADUETO, LINAGLIPTIN

JENTADUETO XR, LINAGLIPTIN

JEVTANA KIT, CABAZITAXEL

JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 30

APPENDIX A - PRODUCT NAME INDEX

** J **

JUBLIA, EFINACONAZOLE

JULUCA, DOLUTEGRAVIR SODIUM

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)

JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)

JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)

JUXTAPID, LOMITAPIDE MESYLATE

JYNARQUE, TOLVAPTAN

** K
**

K-TAB, POTASSIUM CHLORIDE

KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

KADIAN, MORPHINE SULFATE

KAITLIB FE, ETHINYL ESTRADIOL

KALETRA, LOPINAVIR

KALEXATE, SODIUM POLYSTYRENE SULFONATE

KALLIGA, DESOGESTREL

KALYDECO, IVACAFTOR

KAPSPARGO SPRINKLE, METOPROLOL SUCCINATE

KAPVAY, CLONIDINE HYDROCHLORIDE

KARBINAL ER, CARBINOXAMINE MALEATE

KARIVA, DESOGESTREL

KAZANO, ALOGLIPTIN BENZOATE

KEFLEX, CEPHALEXIN

KELNOR, ETHINYL ESTRADIOL

KENALOG, TRIAMCINOLONE ACETONIDE

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

KENGREAL, CANGRELOR

KEPPRA, LEVETIRACETAM

KEPPRA XR, LEVETIRACETAM

KERYDIN, TAVABOROLE

KETALAR, KETAMINE HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

KETOZOLE, KETOCONAZOLE

KEVEYIS, DICHLORPHENAMIDE

KHAPZORY, LEVOLEUCOVORIN

KHEDEZLA, DESVENLAFAXINE

KIMIDESS, DESOGESTREL

KINEVAC, SINCALIDE

KIONEX, SODIUM POLYSTYRENE SULFONATE

KISQALI, RIBOCICLIB SUCCINATE

KISQALI FEMARA CO-PACK (COPACKAGED), LETROZOLE

KITABIS PAK, TOBRAMYCIN

KLARON, SULFACETAMIDE SODIUM

KLONOPIN, CLONAZEPAM

KLOR-CON, POTASSIUM CHLORIDE

KLOR-CON M10, POTASSIUM CHLORIDE

KLOR-CON M15, POTASSIUM CHLORIDE

KLOR-CON M20, POTASSIUM CHLORIDE

KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE

KORLYM, MIFEPRISTONE

KOVANAZE, OXYMETAZOLINE HYDROCHLORIDE

KRINTAFEL, TAFENOQUINE SUCCINATE

KURVELO, ETHINYL ESTRADIOL

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

KYBELLA, DEOXYCHOLIC ACID

KYLEENA, LEVONORGESTREL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 31

APPENDIX A - PRODUCT NAME INDEX

** K **

KYPROLIS, CARFILZOMIB

** L **

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACRISERT, HYDROXYPROPYL CELLULOSE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTULOSE, LACTULOSE

LAMICTAL, LAMOTRIGINE

LAMICTAL CD, LAMOTRIGINE

LAMICTAL ODT, LAMOTRIGINE

LAMICTAL XR, LAMOTRIGINE

LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)

LAMISIL, TERBINAFINE HYDROCHLORIDE

LAMISIL AT, TERBINAFINE (OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)

LAMIVUDINE, LAMIVUDINE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LANIAZID, ISONIAZID

LANORINAL, ASPIRIN

LANOXIN, DIGOXIN

LANOXIN PEDIATRIC, DIGOXIN

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LANTHANUM CARBONATE, LANTHANUM CARBONATE

LANTUS, INSULIN GLARGINE RECOMBINANT

LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT

LARIN 1.5/30, ETHINYL ESTRADIOL

LARIN 1/20, ETHINYL ESTRADIOL

LARIN 24 FE, ETHINYL ESTRADIOL

LARIN FE 1.5/30, ETHINYL ESTRADIOL

LARIN FE 1/20, ETHINYL ESTRADIOL

LAROTID, AMOXICILLIN

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LASIX, FUROSEMIDE

LASTACAFT, ALCAFTADINE

LATANOPROST, LATANOPROST

LATISSE, BIMATOPROST

LATUDA, LURASIDONE HYDROCHLORIDE

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

LAZANDA, FENTANYL CITRATE

LEFLUNOMIDE, LEFLUNOMIDE

LENVIMA, LENVATINIB MESYLATE

LERIBANE, ETHINYL ESTRADIOL

LESCOL XL, FLUVASTATIN SODIUM

LESSINA-28, ETHINYL ESTRADIOL

LETAIRIS, AMBRISENTAN

LETROZOLE, LETROZOLE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUKERAN, CHLORAMBUCIL

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVEMIR, INSULIN DETEMIR RECOMBINANT

LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT

LEVETIRACETAM, LEVETIRACETAM

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVITRA, VARDENAFIL HYDROCHLORIDE

LEVO-T, LEVOTHYROXINE SODIUM **

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

LEVOCARNITINE, LEVOCARNITINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 32

APPENDIX A - PRODUCT NAME INDEX

** L **

LEVOFLOXACIN, LEVOFLOXACIN

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LEVONEST, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVOPHED, NOREPINEPHRINE BITARTRATE

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LEVOXYL, LEVOTHYROXINE SODIUM **

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

LEXAPRO, ESCITALOPRAM OXALATE

LEXISCAN, REGADENOSON

LEXIVA, FOSAMPRENAVIR CALCIUM

LIALDA, MESALAMINE

LIBRAX, CHLORDIAZEPOXIDE HYDROCHLORIDE

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

LICART, DICLOFENAC EPOLAMINE

LIDEX, FLUOCINONIDE

LIDEX-E, FLUOCINONIDE

LIDOCAINE, LIDOCAINE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

LIDODERM, LIDOCAINE

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

LILETTA, LEVONORGESTREL

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

LINCOMYCIN, LINCOMYCIN HYDROCHLORIDE

LINDANE, LINDANE

LINEZOLID, LINEZOLID

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID

LINZESS, LINACLOTIDE

LIORESAL, BACLOFEN

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LIPIODOL, ETHIODIZED OIL

LIPITOR, ATORVASTATIN CALCIUM

LIPOFEN, FENOFIBRATE

LIQUID E-Z-PAQUE, BARIUM SULFATE

LISINOPRIL, LISINOPRIL

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

LITHIUM CITRATE, LITHIUM CITRATE

LITHOBID, LITHIUM CARBONATE

LITHOSTAT, ACETOHYDROXAMIC ACID

LIVALO, PITAVASTATIN CALCIUM

LO LOESTRIN FE, ETHINYL ESTRADIOL

LO SIMPESSE, ETHINYL ESTRADIOL

LO-ZUMANDIMINE, DROSPIRENONE

LOCOID, HYDROCORTISONE BUTYRATE

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 33

APPENDIX A - PRODUCT NAME INDEX

** L **

LODOSYN, CARBIDOPA

LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL

LOESTRIN 21 1/20, ETHINYL ESTRADIOL

LOESTRIN 24 FE, ETHINYL ESTRADIOL

LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL

LOESTRIN FE 1/20, ETHINYL ESTRADIOL

LOGILIA, ULIPRISTAL ACETATE

LOKELMA, SODIUM ZIRCONIUM CYCLOSILICATE

LOMAIRA, PHENTERMINE HYDROCHLORIDE

LOMOTIL, ATROPINE SULFATE

LONHALA MAGNAIR KIT, GLYCOPYRROLATE

LONSURF, TIPIRACIL HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPID, GEMFIBROZIL

LOPINAVIR AND RITONAVIR, LOPINAVIR

LOPRESSOR, METOPROLOL TARTRATE

LOPRESSOR HCT, HYDROCHLOROTHIAZIDE

LOPROX, CICLOPIROX

LOPURIN, ALLOPURINOL

LORATADINE, LORATADINE (OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE REDIDOSE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

LORAZEPAM INTENSOL, LORAZEPAM

LORBRENA, LORLATINIB

LORYNA, DROSPIRENONE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSEASONIQUE, ETHINYL ESTRADIOL

LOTEMAX, LOTEPREDNOL ETABONATE

LOTENSIN, BENAZEPRIL HYDROCHLORIDE

LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE

LOTREL, AMLODIPINE BESYLATE

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)

LOTRISONE, BETAMETHASONE DIPROPIONATE

LOTRONEX, ALOSETRON HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

LOVENOX, ENOXAPARIN SODIUM

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

LOW-OGESTREL-28, ETHINYL ESTRADIOL

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

LUCEMYRA, LOFEXIDINE HYDROCHLORIDE

LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

LUMIFY, BRIMONIDINE TARTRATE (OTC)

LUMIGAN, BIMATOPROST

LUNESTA, ESZOPICLONE

LUPANETA PACK, LEUPROLIDE ACETATE

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-PED, LEUPROLIDE ACETATE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

LUTATHERA, LUTETIUM DOTATATE LU-177

LUTRATE DEPOT KIT, LEUPROLIDE ACETATE

LUVOX, FLUVOXAMINE MALEATE

LUXIQ, BETAMETHASONE VALERATE

LUZU, LULICONAZOLE

LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT

LYNPARZA, OLAPARIB

LYRICA, PREGABALIN

LYRICA CR, PREGABALIN

LYSODREN, MITOTANE

LYSTEDA, TRANEXAMIC ACID

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 34

APPENDIX A - PRODUCT NAME INDEX

** M **

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

M.V.I. ADULT, ASCORBIC ACID

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. PEDIATRIC, ASCORBIC ACID

MACRILEN, MACIMORELIN ACETATE

MACROBID, NITROFURANTOIN

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

MACUGEN, PEGAPTANIB SODIUM

MAFENIDE ACETATE, MAFENIDE ACETATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNEVIST, GADOPENTETATE DIMEGLUMINE

MAKENA, HYDROXYPROGESTERONE CAPROATE

MAKENA (AUTOINJECTOR), HYDROXYPROGESTERONE CAPROATE

MAKENA PRESERVATIVE FREE, HYDROXYPROGESTERONE CAPROATE

MALARONE, ATOVAQUONE

MALARONE PEDIATRIC, ATOVAQUONE

MALATHION, MALATHION

MALMOREDE, ETHINYL ESTRADIOL

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 25%, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARINOL, DRONABINOL

MARLISSA, ETHINYL ESTRADIOL

MARPLAN, ISOCARBOXAZID

MARQIBO KIT, VINCRISTINE SULFATE

MATULANE, PROCARBAZINE HYDROCHLORIDE

MAVYRET, GLECAPREVIR

MAXALT, RIZATRIPTAN BENZOATE

MAXALT-MLT, RIZATRIPTAN BENZOATE

MAXIDEX, DEXAMETHASONE

MAXIPIME, CEFEPIME HYDROCHLORIDE

MAXITROL, DEXAMETHASONE

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MEDROL, METHYLPREDNISOLONE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEFENAMIC ACID, MEFENAMIC ACID

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

MEGACE ES, MEGESTROL ACETATE

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

MEGESTROL ACETATE, MEGESTROL ACETATE

MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE

MEKTOVI, BINIMETINIB

MELAMISA, DROSPIRENONE

MELOXICAM, MELOXICAM

MELPHALAN, MELPHALAN

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 35

APPENDIX A - PRODUCT NAME INDEX

** M **

MEMBRANEBLUE, TRYPAN BLUE

MEN'S ROGAINE, MINOXIDIL (OTC)

MENEST, ESTROGENS, ESTERIFIED

MENOPUR, MENOTROPINS (FSH

MENOSTAR, ESTRADIOL

MENTAX, BUTENAFINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

MEPHYTON, PHYTONADIONE

MEPROBAMATE, MEPROBAMATE

MEPRON, ATOVAQUONE

MERCAPTOPURINE, MERCAPTOPURINE

MEROPENEM, MEROPENEM

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM

MERREM, MEROPENEM

MESALAMINE, MESALAMINE

MESNA, MESNA

MESNEX, MESNA

MESTINON, PYRIDOSTIGMINE BROMIDE

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

METADATE ER, METHYLPHENIDATE HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METASTRON, STRONTIUM CHLORIDE SR-89

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHERGINE, METHYLERGONOVINE MALEATE

METHIMAZOLE, METHIMAZOLE

METHOCARBAMOL, METHOCARBAMOL

METHOCARBAMOL AND ASPIRIN, ASPIRIN

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOXSALEN, METHOXSALEN

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLDOPA, METHYLDOPA

METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOLAZONE, METOLAZONE

METOPIRONE, METYRAPONE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROGEL-VAGINAL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 36

APPENDIX A - PRODUCT NAME INDEX

** M **

METRONIDAZOLE, METRONIDAZOLE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MIACALCIN, CALCITONIN SALMON

MIBELAS 24 FE, ETHINYL ESTRADIOL

MICARDIS, TELMISARTAN

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICONAZOLE 3, MICONAZOLE NITRATE (OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE 7, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICORT-HC, HYDROCORTISONE ACETATE

MICRO-K, POTASSIUM CHLORIDE

MICRO-K 10, POTASSIUM CHLORIDE

MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN 1/20, ETHINYL ESTRADIOL

MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN FE 1/20, ETHINYL ESTRADIOL

MICRONOR, NORETHINDRONE

MICROZIDE, HYDROCHLOROTHIAZIDE

MIDAMOR, AMILORIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MIDOL LIQUID GELS, IBUPROFEN (OTC)

MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MIFEPREX, MIFEPRISTONE

MIGERGOT, CAFFEINE

MIGLITOL, MIGLITOL

MIGLUSTAT, MIGLUSTAT

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MILI, ETHINYL ESTRADIOL

MILRINONE LACTATE, MILRINONE LACTATE

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MINASTRIN 24 FE, ETHINYL ESTRADIOL

MINIPRESS, PRAZOSIN HYDROCHLORIDE

MINIRIN, DESMOPRESSIN ACETATE

MINITRAN, NITROGLYCERIN

MINIVELLE, ESTRADIOL

MINOCIN, MINOCYCLINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOLIRA, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL (OTC)

MINOXIDIL, MINOXIDIL

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

MIOSTAT, CARBACHOL

MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)

MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE

MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE

MIRENA, LEVONORGESTREL

MIRTAZAPINE, MIRTAZAPINE

MIRVASO, BRIMONIDINE TARTRATE

MISOPROSTOL, MISOPROSTOL

MITIGARE, COLCHICINE

MITIGO, MORPHINE SULFATE

MITOMYCIN, MITOMYCIN

MITOSOL, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 37

APPENDIX A - PRODUCT NAME INDEX

** M **

MOBIC, MELOXICAM

MODAFINIL, MODAFINIL

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3, MICONAZOLE NITRATE (OTC)

MONISTAT 3, MICONAZOLE NITRATE

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)

MONISTAT 7, MICONAZOLE NITRATE (OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONO-LINYAH, ETHINYL ESTRADIOL

MONODOX, DOXYCYCLINE

MONOKET, ISOSORBIDE MONONITRATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MONUROL, FOSFOMYCIN TROMETHAMINE

MORPHABOND ER, MORPHINE SULFATE

MORPHINE SULFATE, MORPHINE SULFATE

MOTEGRITY, PRUCALOPRIDE SUCCINATE

MOTOFEN, ATROPINE SULFATE

MOTRIN IB, IBUPROFEN (OTC)

MOVANTIK, NALOXEGOL OXALATE

MOVIPREP, ASCORBIC ACID

MOXEZA, MOXIFLOXACIN HYDROCHLORIDE

MOXIDECTIN, MOXIDECTIN

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN

MOZOBIL, PLERIXAFOR

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MS CONTIN, MORPHINE SULFATE

MUCINEX, GUAIFENESIN (OTC)

MUCINEX D, GUAIFENESIN (OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MULPLETA, LUSUTROMBOPAG

MULTAQ, DRONEDARONE HYDROCHLORIDE

MULTIHANCE, GADOBENATE DIMEGLUMINE

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MUPIROCIN, MUPIROCIN

MUPIROCIN, MUPIROCIN CALCIUM

MUSE, ALPROSTADIL

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

MYCAMINE, MICAFUNGIN SODIUM

MYCOBUTIN, RIFABUTIN

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

MYDAYIS, AMPHETAMINE ASPARTATE

MYDRIACYL, TROPICAMIDE

MYFORTIC, MYCOPHENOLIC ACID

MYKACET, NYSTATIN

MYLERAN, BUSULFAN

MYORISAN, ISOTRETINOIN

MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT

MYRBETRIQ, MIRABEGRON

MYSOLINE, PRIMIDONE

MYTESI, CROFELEMER

MYZILRA, ETHINYL ESTRADIOL

** N **

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 38

APPENDIX A - PRODUCT NAME INDEX

** N **

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NAFTIN, NAFTIFINE HYDROCHLORIDE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALFON, FENOPROFEN CALCIUM

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NALOXONE, NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NAMENDA, MEMANTINE HYDROCHLORIDE

NAMENDA XR, MEMANTINE HYDROCHLORIDE

NAMZARIC, DONEPEZIL HYDROCHLORIDE

NANDROLONE DECANOATE, NANDROLONE DECANOATE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

NAPRELAN, NAPROXEN SODIUM

NAPROSYN, NAPROXEN

NAPROXEN, NAPROXEN

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NARCAN, NALOXONE HYDROCHLORIDE

NARDIL, PHENELZINE SULFATE

NAROPIN, ROPIVACAINE HYDROCHLORIDE

NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC)

NASCOBAL, CYANOCOBALAMIN

NASONEX, MOMETASONE FUROATE

NATACYN, NATAMYCIN

NATAZIA, DIENOGEST

NATEGLINIDE, NATEGLINIDE

NATESTO, TESTOSTERONE

NATRECOR, NESIRITIDE RECOMBINANT

NATROBA, SPINOSAD

NAVELBINE, VINORELBINE TARTRATE

NEBUPENT, PENTAMIDINE ISETHIONATE

NEDOCROMIL SODIUM, NEDOCROMIL SODIUM

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

NEO-SYNALAR, FLUOCINOLONE ACETONIDE

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NEOPAP, ACETAMINOPHEN (OTC)

NEOPROFEN, IBUPROFEN LYSINE

NEORAL, CYCLOSPORINE

NEOSPORIN, BACITRACIN ZINC

NEOSPORIN, GRAMICIDIN

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NEPHRAMINE 5.4%, AMINO ACIDS

NERLYNX, NERATINIB MALEATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

NESINA, ALOGLIPTIN BENZOATE

NETSPOT, GALLIUM DOTATATE GA-68

NEUPRO, ROTIGOTINE

NEURACEQ, FLORBETABEN F-18

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

NEURONTIN, GABAPENTIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 39

APPENDIX A - PRODUCT NAME INDEX

** N **

NEVANAC, NEPAFENAC

NEVIRAPINE, NEVIRAPINE

NEXAVAR, SORAFENIB TOSYLATE

NEXESTA FE, ETHINYL ESTRADIOL

NEXIUM, ESOMEPRAZOLE MAGNESIUM

NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXPLANON, ETONOGESTREL

NEXTERONE, AMIODARONE HYDROCHLORIDE

NIACIN, NIACIN

NIACOR, NIACIN

NIASPAN, NIACIN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NICODERM CQ, NICOTINE (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

NICORETTE (MINT), NICOTINE POLACRILEX (OTC)

NICOTINE, NICOTINE (OTC)

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

NICOTROL, NICOTINE

NIFEDIPINE, NIFEDIPINE

NIKKI, DROSPIRENONE

NILANDRON, NILUTAMIDE

NILUTAMIDE, NILUTAMIDE

NIMBEX, CISATRACURIUM BESYLATE

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMODIPINE, NIMODIPINE

NINLARO, IXAZOMIB CITRATE

NIPENT, PENTOSTATIN

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, SODIUM NITROPRUSSIDE

NISOLDIPINE, NISOLDIPINE

NITHIODOTE, SODIUM NITRITE

NITRO-DUR, NITROGLYCERIN

NITROFURANTOIN, NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROGLYCERIN, NITROGLYCERIN

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

NITROMIST, NITROGLYCERIN

NITROPRESS, SODIUM NITROPRUSSIDE

NITROSTAT, NITROGLYCERIN

NITYR, NITISINONE

NIX, PERMETHRIN (OTC)

NIZATIDINE, NIZATIDINE

NIZORAL, KETOCONAZOLE

NIZORAL A-D, KETOCONAZOLE (OTC)

NOCDURNA, DESMOPRESSIN ACETATE

NOCTIVA, DESMOPRESSIN ACETATE

NOR-QD, NORETHINDRONE

NORCO, ACETAMINOPHEN

NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

NORETHINDRONE, NORETHINDRONE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL

NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL

NORINYL 1+50 28-DAY, MESTRANOL

NORITATE, METRONIDAZOLE

NORMOCARB HF 25, MAGNESIUM CHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 40

APPENDIX A - PRODUCT NAME INDEX

** N **

NORMOCARB HF 35, MAGNESIUM CHLORIDE

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

NORPACE, DISOPYRAMIDE PHOSPHATE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPRAMIN, DESIPRAMINE HYDROCHLORIDE

NORTHERA, DROXIDOPA

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NORVASC, AMLODIPINE BESYLATE

NORVIR, RITONAVIR

NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLOG, INSULIN ASPART RECOMBINANT

NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT

NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT

NOXAFIL, POSACONAZOLE

NOXIVENT, NITRIC OXIDE

NUCYNTA, TAPENTADOL HYDROCHLORIDE

NUCYNTA ER, TAPENTADOL HYDROCHLORIDE

NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

NUPLAZID, PIMAVANSERIN TARTRATE

NUTRESTORE, L-GLUTAMINE

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

NUTROPIN AQ NUSPIN, SOMATROPIN RECOMBINANT

NUVARING, ETHINYL ESTRADIOL

NUVESSA, METRONIDAZOLE

NUVIGIL, ARMODAFINIL

NUZYRA, OMADACYCLINE TOSYLATE

NYLIA 1/35, ETHINYL ESTRADIOL

NYLIA 7/7/7, ETHINYL ESTRADIOL

NYMALIZE, NIMODIPINE

NYSTATIN, NYSTATIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTOP, NYSTATIN

** O **

OBREDON, GUAIFENESIN

OCALIVA, OBETICHOLIC ACID

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCUFEN, FLURBIPROFEN SODIUM

OCUFLOX, OFLOXACIN

ODEFSEY, EMTRICITABINE

ODOMZO, SONIDEGIB PHOSPHATE

OFEV, NINTEDANIB ESYLATE

OFIRMEV, ACETAMINOPHEN

OFLOXACIN, OFLOXACIN

OGEN 5, ESTROPIPATE

OGESTREL 0.5/50-28, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 41

APPENDIX A - PRODUCT NAME INDEX

** O **

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OLUMIANT, BARICITINIB

OLUX, CLOBETASOL PROPIONATE

OLUX E, CLOBETASOL PROPIONATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OMEGAVEN, FISH OIL TRIGLYCERIDES

OMEPRAZOLE, OMEPRAZOLE (OTC)

OMEPRAZOLE, OMEPRAZOLE

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMIDRIA, KETOROLAC TROMETHAMINE

OMNARIS, CICLESONIDE

OMNIPAQUE 12, IOHEXOL

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNIPAQUE 9, IOHEXOL

OMNIPRED, PREDNISOLONE ACETATE

OMNISCAN, GADODIAMIDE

OMNITROPE, SOMATROPIN RECOMBINANT

ONDANSETRON, ONDANSETRON

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONEXTON, BENZOYL PEROXIDE

ONFI, CLOBAZAM

ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE

ONIVYDE, IRINOTECAN HYDROCHLORIDE

ONMEL, ITRACONAZOLE

ONPATTRO, PATISIRAN SODIUM

ONZETRA XSAIL, SUMATRIPTAN SUCCINATE

OPANA, OXYMORPHONE HYDROCHLORIDE

OPCICON ONE-STEP, LEVONORGESTREL (OTC)

OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

OPSUMIT, MACITENTAN

OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

OPTIRAY 240, IOVERSOL

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

OPTISON, ALBUMIN HUMAN

ORABLOC, ARTICAINE HYDROCHLORIDE

ORACEA, DOXYCYCLINE

ORALTAG, IOHEXOL

ORAP, PIMOZIDE

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

ORAQIX, LIDOCAINE

ORAVERSE, PHENTOLAMINE MESYLATE

ORAVIG, MICONAZOLE

ORBACTIV, ORITAVANCIN DIPHOSPHATE

ORENITRAM, TREPROSTINIL DIOLAMINE

ORFADIN, NITISINONE

ORILISSA, ELAGOLIX SODIUM

ORKAMBI, IVACAFTOR

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

ORSYTHIA, ETHINYL ESTRADIOL

ORTHO CYCLEN-28, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL

ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 42

APPENDIX A - PRODUCT NAME INDEX

** O **

ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL

ORVATEN, MIDODRINE HYDROCHLORIDE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OSENI, ALOGLIPTIN BENZOATE

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMOLEX ER, AMANTADINE HYDROCHLORIDE

OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

OSPHENA, OSPEMIFENE

OTEZLA, APREMILAST

OTICAIR, HYDROCORTISONE

OTIPRIO, CIPROFLOXACIN

OTOVEL, CIPROFLOXACIN HYDROCHLORIDE

OTREXUP, METHOTREXATE

OVIDE, MALATHION

OVIDREL, CHORIOGONADOTROPIN ALFA

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

OXANDROLONE, OXANDROLONE

OXAPROZIN, OXAPROZIN

OXAYDO, OXYCODONE HYDROCHLORIDE

OXAZEPAM, OXAZEPAM

OXCARBAZEPINE, OXCARBAZEPINE

OXICONAZOLE NITRATE, OXICONAZOLE NITRATE

OXISTAT, OXICONAZOLE NITRATE

OXSORALEN-ULTRA, METHOXSALEN

OXTELLAR XR, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

OXYCONTIN, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

OXYTROL, OXYBUTYNIN

OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)

OZEMPIC, SEMAGLUTIDE

OZURDEX, DEXAMETHASONE

** P **

PACERONE, AMIODARONE HYDROCHLORIDE

PACITAXEL, PACLITAXEL

PACLITAXEL, PACLITAXEL

PALIPERIDONE, PALIPERIDONE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCREAZE, PANCRELIPASE (AMYLASE

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PANDEL, HYDROCORTISONE PROBUTATE

PANRETIN, ALITRETINOIN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARAGARD T 380A, COPPER

PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE

PARICALCITOL, PARICALCITOL

PARLODEL, BROMOCRIPTINE MESYLATE

PARNATE, TRANYLCYPROMINE SULFATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 43

APPENDIX A - PRODUCT NAME INDEX

** P **

PAROEX, CHLORHEXIDINE GLUCONATE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

PAROXETINE, PAROXETINE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PAROXETINE MESYLATE, PAROXETINE MESYLATE

PARSABIV, ETELCALCETIDE

PASER, AMINOSALICYLIC ACID

PATADAY, OLOPATADINE HYDROCHLORIDE

PATANASE, OLOPATADINE HYDROCHLORIDE

PATANOL, OLOPATADINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAZEO, OLOPATADINE HYDROCHLORIDE

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

PEDIATRIC ADVIL, IBUPROFEN (OTC)

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PEGANONE, ETHOTOIN

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PENICILLIN-VK, PENICILLIN V POTASSIUM

PENLAC, CICLOPIROX

PENNSAID, DICLOFENAC SODIUM

PENTAM, PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

PENTASA, MESALAMINE

PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM

PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PENTOSTATIN, PENTOSTATIN

PENTOXIFYLLINE, PENTOXIFYLLINE

PENTOXIL, PENTOXIFYLLINE

PEPCID, FAMOTIDINE

PEPCID AC, FAMOTIDINE (OTC)

PEPCID COMPLETE, CALCIUM CARBONATE (OTC)

PERCOCET, ACETAMINOPHEN

PERCODAN, ASPIRIN

PERFOROMIST, FORMOTEROL FUMARATE

PERIDEX, CHLORHEXIDINE GLUCONATE

PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PERIOCHIP, CHLORHEXIDINE GLUCONATE

PERIOGARD, CHLORHEXIDINE GLUCONATE

PERMETHRIN, PERMETHRIN (OTC)

PERMETHRIN, PERMETHRIN

PERPHENAZINE, PERPHENAZINE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

PERSANTINE, DIPYRIDAMOLE

PERSERIS KIT, RISPERIDONE

PERTZYE, PANCRELIPASE (AMYLASE

PEXEVA, PAROXETINE MESYLATE

PFIZERPEN, PENICILLIN G POTASSIUM

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENELZINE SULFATE, PHENELZINE SULFATE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PHENYTOIN, PHENYTOIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 44

APPENDIX A - PRODUCT NAME INDEX

** P **

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PHILITH, ETHINYL ESTRADIOL

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE

PHOTOFRIN, PORFIMER SODIUM

PHOTREXA, RIBOFLAVIN 5'-PHOSPHATE SODIUM

PHOTREXA VISCOUS IN DEXTRAN 20%, RIBOFLAVIN 5'-PHOSPHATE SODIUM

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYTONADIONE, PHYTONADIONE

PICATO, INGENOL MEBUTATE

PIFELTRO, DORAVIRINE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PIMECROLIMUS, PIMECROLIMUS

PIMOZIDE, PIMOZIDE

PIMTREA, DESOGESTREL

PINDOLOL, PINDOLOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIPERACILLIN, PIPERACILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIRMELLA 1/35, ETHINYL ESTRADIOL

PIRMELLA 7/7/7, ETHINYL ESTRADIOL

PIROXICAM, PIROXICAM

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

PITOCIN, OXYTOCIN

PLAN B ONE-STEP, LEVONORGESTREL (OTC)

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLAVIX, CLOPIDOGREL BISULFATE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PLENVU, ASCORBIC ACID

PLIAGLIS, LIDOCAINE

PODOFILOX, PODOFILOX

POLMON, DEXCHLORPHENIRAMINE MALEATE

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POLYTRIM, POLYMYXIN B SULFATE

POMALYST, POMALIDOMIDE

PONSTEL, MEFENAMIC ACID

PORTIA-28, ETHINYL ESTRADIOL

POTASSIUM ACETATE, POTASSIUM ACETATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 45

APPENDIX A - PRODUCT NAME INDEX

** P **

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 46

APPENDIX A - PRODUCT NAME INDEX

** P **

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

POTASSIUM IODIDE, POTASSIUM IODIDE (OTC)

POVIDONE IODINE, POVIDONE-IODINE (OTC)

PRADAXA, DABIGATRAN ETEXILATE MESYLATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAMOSONE, HYDROCORTISONE ACETATE

PRANDIN, REPAGLINIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVACHOL, PRAVASTATIN SODIUM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZIQUANTEL, PRAZIQUANTEL

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PRE-OP, HEXACHLOROPHENE

PRE-OP II, HEXACHLOROPHENE

PRE-PEN, BENZYLPENICILLOYL POLYLYSINE

PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE

PRECOSE, ACARBOSE

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

PRED-G, GENTAMICIN SULFATE

PREDNICARBATE, PREDNICARBATE

PREDNISOLONE, PREDNISOLONE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISONE, PREDNISONE

PREDNISONE INTENSOL, PREDNISONE

PREGNYL, GONADOTROPIN, CHORIONIC

PRELONE, PREDNISOLONE

PREMARIN, ESTROGENS, CONJUGATED

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

PREMPHASE 14/14, ESTROGENS, CONJUGATED

PREMPRO, ESTROGENS, CONJUGATED

PREPIDIL, DINOPROSTONE

PREPOPIK, CITRIC ACID

PRESTALIA, AMLODIPINE BESYLATE

PREVACID, LANSOPRAZOLE

PREVACID 24 HR, LANSOPRAZOLE (OTC)

PREVALITE, CHOLESTYRAMINE

PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PREVIFEM, ETHINYL ESTRADIOL

PREVYMIS, LETERMOVIR

PREZCOBIX, COBICISTAT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 47

APPENDIX A - PRODUCT NAME INDEX

** P **

PREZISTA, DARUNAVIR ETHANOLATE

PRIALT, ZICONOTIDE ACETATE

PRIFTIN, RIFAPENTINE

PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE

PRILOSEC, OMEPRAZOLE MAGNESIUM

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)

PRIMAQUINE, PRIMAQUINE PHOSPHATE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

PRIMATENE MIST, EPINEPHRINE (OTC)

PRIMAXIN, CILASTATIN SODIUM

PRIMIDONE, PRIMIDONE

PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE

PRINIVIL, LISINOPRIL

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISTIQ, DESVENLAFAXINE SUCCINATE

PROAIR HFA, ALBUTEROL SULFATE

PROAIR RESPICLICK, ALBUTEROL SULFATE

PROBALAN, PROBENECID

PROBENECID, PROBENECID

PROBENECID AND COLCHICINE, COLCHICINE

PROBUPHINE, BUPRENORPHINE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROCALAMINE, AMINO ACIDS

PROCARDIA, NIFEDIPINE

PROCARDIA XL, NIFEDIPINE

PROCHLORPERAZINE, PROCHLORPERAZINE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROCOMP, PROCHLORPERAZINE MALEATE

PROCTOFOAM HC, HYDROCORTISONE ACETATE

PROCYSBI, CYSTEAMINE BITARTRATE

PROFERDEX, IRON DEXTRAN

PROGESTERONE, PROGESTERONE

PROGLYCEM, DIAZOXIDE

PROGRAF, TACROLIMUS

PROHANCE, GADOTERIDOL

PROHANCE MULTIPACK, GADOTERIDOL

PROLENSA, BROMFENAC SODIUM

PROMACTA, ELTROMBOPAG OLAMINE

PROMACTA KIT, ELTROMBOPAG OLAMINE

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETH VC W/ CODEINE, CODEINE PHOSPHATE

PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE

PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

PROMETRIUM, PROGESTERONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

PROPECIA, FINASTERIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 48

APPENDIX A - PRODUCT NAME INDEX

** P **

PROPOFOL, PROPOFOL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

PROSCAR, FINASTERIDE

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

PROSTIN E2, DINOPROSTONE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROTAMINE SULFATE, PROTAMINE SULFATE

PROTONIX, PANTOPRAZOLE SODIUM

PROTONIX IV, PANTOPRAZOLE SODIUM

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

PROTOPIC, TACROLIMUS

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

PROVAYBLUE, METHYLENE BLUE

PROVENTIL-HFA, ALBUTEROL SULFATE

PROVERA, MEDROXYPROGESTERONE ACETATE

PROVIGIL, MODAFINIL

PROVOCHOLINE, METHACHOLINE CHLORIDE

PROZAC, FLUOXETINE HYDROCHLORIDE

PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

PULMICORT FLEXHALER, BUDESONIDE

PULMICORT RESPULES, BUDESONIDE

PUR-WASH, PURIFIED WATER (OTC)

PURINETHOL, MERCAPTOPURINE

PURIXAN, MERCAPTOPURINE

PYLERA, BISMUTH SUBCITRATE POTASSIUM

PYRAZINAMIDE, PYRAZINAMIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

PYTEST, UREA, C-14

PYTEST KIT, UREA, C-14

** Q **

QBRELIS, LISINOPRIL

QBREXZA, GLYCOPYRRONIUM TOSYLATE

QMIIZ ODT, MELOXICAM

QNASL, BECLOMETHASONE DIPROPIONATE

QOLIANA, BRIMONIDINE TARTRATE

QSYMIA, PHENTERMINE HYDROCHLORIDE

QTERN, DAPAGLIFLOZIN

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

QUALAQUIN, QUININE SULFATE

QUARTETTE, ETHINYL ESTRADIOL

QUASENSE, ETHINYL ESTRADIOL

QUDEXY XR, TOPIRAMATE

QUELICIN, SUCCINYLCHOLINE CHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINARETIC, HYDROCHLOROTHIAZIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

QUININE SULFATE, QUININE SULFATE

QUTENZA, CAPSAICIN

QVAR REDIHALER, BECLOMETHASONE DIPROPIONATE

** R **

R-GENE 10, ARGININE HYDROCHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RADICAVA, EDARAVONE

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 49

APPENDIX A - PRODUCT NAME INDEX

** R **

RADIOGENIX SYSTEM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMELTEON, RAMELTEON

RAMIPRIL, RAMIPRIL

RANEXA, RANOLAZINE

RANITIDINE, RANITIDINE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RAPAFLO, SILODOSIN

RAPAMUNE, SIROLIMUS

RAPIVAB, PERAMIVIR

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RASUVO, METHOTREXATE

RAVICTI, GLYCEROL PHENYLBUTYRATE

RAYALDEE, CALCIFEDIOL

RAYOS, PREDNISONE

RAZADYNE, GALANTAMINE HYDROBROMIDE

RAZADYNE ER, GALANTAMINE HYDROBROMIDE

READI-CAT 2, BARIUM SULFATE

READI-CAT 2 SMOOTHIES, BARIUM SULFATE

READYPREP CHG, CHLORHEXIDINE GLUCONATE (OTC)

REBETOL, RIBAVIRIN

RECLAST, ZOLEDRONIC ACID

RECTIV, NITROGLYCERIN

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

REGONOL, PYRIDOSTIGMINE BROMIDE

RELENZA, ZANAMIVIR

RELISTOR, METHYLNALTREXONE BROMIDE

RELPAX, ELETRIPTAN HYDROBROMIDE

REMERON, MIRTAZAPINE

REMERON SOLTAB, MIRTAZAPINE

REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE

REMODULIN, TREPROSTINIL

RENACIDIN, CITRIC ACID

RENAGEL, SEVELAMER HYDROCHLORIDE

RENOVA, TRETINOIN

RENVELA, SEVELAMER CARBONATE

REPAGLINIDE, REPAGLINIDE

REPREXAIN, HYDROCODONE BITARTRATE

REQUIP, ROPINIROLE HYDROCHLORIDE

REQUIP XL, ROPINIROLE HYDROCHLORIDE

RESCRIPTOR, DELAVIRDINE MESYLATE

RESECTISOL IN PLASTIC CONTAINER, MANNITOL

RESTASIS, CYCLOSPORINE

RESTASIS MULTIDOSE, CYCLOSPORINE

RESTORIL, TEMAZEPAM

RETIN-A, TRETINOIN

RETIN-A MICRO, TRETINOIN

RETIN-A-MICRO, TRETINOIN

RETISERT, FLUOCINOLONE ACETONIDE

RETROVIR, ZIDOVUDINE

REVATIO, SILDENAFIL CITRATE

REVLIMID, LENALIDOMIDE

REVONTO, DANTROLENE SODIUM

REXULTI, BREXPIPRAZOLE

REYATAZ, ATAZANAVIR SULFATE

REZIRA, HYDROCODONE BITARTRATE

RHINOCORT ALLERGY, BUDESONIDE (OTC)

RHOFADE, OXYMETAZOLINE HYDROCHLORIDE

RHOPRESSA, NETARSUDIL DIMESYLATE

RIBASPHERE, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

RIDAURA, AURANOFIN

RIFABUTIN, RIFABUTIN

RIFADIN, RIFAMPIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 50

APPENDIX A - PRODUCT NAME INDEX

** R **

RIFAMATE, ISONIAZID

RIFAMPIN, RIFAMPIN

RIFATER, ISONIAZID

RILUTEK, RILUZOLE

RILUZOLE, RILUZOLE

RIMACTANE, RIFAMPIN

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

RIMSO-50, DIMETHYL SULFOXIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

RIOMET, METFORMIN HYDROCHLORIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERDAL, RISPERIDONE

RISPERDAL CONSTA, RISPERIDONE

RISPERIDONE, RISPERIDONE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITONAVIR, RITONAVIR

RIVASTIGMINE, RIVASTIGMINE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

ROCALTROL, CALCITRIOL

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROFLUMILAST, ROFLUMILAST

ROGAINE (FOR MEN), MINOXIDIL (OTC)

ROGAINE (FOR WOMEN), MINOXIDIL (OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

ROWASA, MESALAMINE

ROWEEPRA, LEVETIRACETAM

ROXICET, ACETAMINOPHEN

ROXICODONE, OXYCODONE HYDROCHLORIDE

ROZEREM, RAMELTEON

RUBRACA, RUCAPARIB CAMSYLATE

RUBY-FILL, RUBIDIUM CHLORIDE RB-82

RUFINAMIDE, RUFINAMIDE

RYANODEX, DANTROLENE SODIUM

RYDAPT, MIDOSTAURIN

RYTARY, CARBIDOPA

RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

RYZODEG 70/30, INSULIN ASPART

** S **

SABRIL, VIGABATRIN

SAFYRAL, DROSPIRENONE

SAIZEN, SOMATROPIN RECOMBINANT

SALAGEN, PILOCARPINE HYDROCHLORIDE

SALONPAS, MENTHOL (OTC)

SAMSCA, TOLVAPTAN

SANCUSO, GRANISETRON

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN, OCTREOTIDE ACETATE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

SAPHRIS, ASENAPINE MALEATE

SARAFEM, FLUOXETINE HYDROCHLORIDE

SAVAYSA, EDOXABAN TOSYLATE

SAVELLA, MILNACIPRAN HYDROCHLORIDE

SAXENDA, LIRAGLUTIDE RECOMBINANT

SCANDONEST L, LEVONORDEFRIN

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 51

APPENDIX A - PRODUCT NAME INDEX

** S **

SCLEROSOL, TALC

SCOPOLAMINE, SCOPOLAMINE

SEASONALE, ETHINYL ESTRADIOL

SEASONIQUE, ETHINYL ESTRADIOL

SECONAL SODIUM, SECOBARBITAL SODIUM

SEEBRI, GLYCOPYRROLATE

SEGLUROMET, ERTUGLIFLOZIN

SEIZALAM, MIDAZOLAM HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

SELFEMRA, FLUOXETINE HYDROCHLORIDE

SELZENTRY, MARAVIROC

SEMPREX-D, ACRIVASTINE

SENSIPAR, CINACALCET HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

SEPTRA, SULFAMETHOXAZOLE

SEPTRA DS, SULFAMETHOXAZOLE

SEREVENT, SALMETEROL XINAFOATE

SERNIVO, BETAMETHASONE DIPROPIONATE

SEROMYCIN, CYCLOSERINE

SEROQUEL, QUETIAPINE FUMARATE

SEROQUEL XR, QUETIAPINE FUMARATE

SEROSTIM, SOMATROPIN RECOMBINANT

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SETLAKIN, ETHINYL ESTRADIOL

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SEVOFLURANE, SEVOFLURANE

SEYSARA, SARECYCLINE HYDROCHLORIDE

SFROWASA, MESALAMINE

SIGNIFOR, PASIREOTIDE DIASPARTATE

SIGNIFOR LAR KIT, PASIREOTIDE PAMOATE

SIKLOS, HYDROXYUREA

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILENOR, DOXEPIN HYDROCHLORIDE

SILODOSIN, SILODOSIN

SILVADENE, SILVER SULFADIAZINE

SIMBRINZA, BRIMONIDINE TARTRATE

SIMPESSE, ETHINYL ESTRADIOL

SIMVASTATIN, SIMVASTATIN

SINE-AID IB, IBUPROFEN (OTC)

SINEMET, CARBIDOPA

SINEMET CR, CARBIDOPA

SINGULAIR, MONTELUKAST SODIUM

SINUVA, MOMETASONE FUROATE

SIROLIMUS, SIROLIMUS

SIRTURO, BEDAQUILINE FUMARATE

SITAVIG, ACYCLOVIR

SIVEXTRO, TEDIZOLID PHOSPHATE

SKELAXIN, METAXALONE

SKLICE, IVERMECTIN

SKYLA, LEVONORGESTREL

SMOFLIPID 20%, FISH OIL

SODIUM ACETATE, SODIUM ACETATE

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SODIUM IODIDE I 123, SODIUM IODIDE I-123

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 52

APPENDIX A - PRODUCT NAME INDEX

** S **

SODIUM IODIDE I 131, SODIUM IODIDE I-131

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM NITRITE, SODIUM NITRITE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SODIUM OXYBATE, SODIUM OXYBATE

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE

SODIUM THIOSULFATE, SODIUM THIOSULFATE

SOJOURN, SEVOFLURANE

SOLARAZE, DICLOFENAC SODIUM

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SOLIQUA 100/33, INSULIN GLARGINE

SOLODYN, MINOCYCLINE HYDROCHLORIDE

SOLOSEC, SECNIDAZOLE

SOLTAMOX, TAMOXIFEN CITRATE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC)

SOMA, CARISOPRODOL

SOMATULINE DEPOT, LANREOTIDE ACETATE

SOMAVERT, PEGVISOMANT

SONATA, ZALEPLON

SOOLANTRA, IVERMECTIN

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

SORIATANE, ACITRETIN

SORILUX, CALCIPOTRIENE

SORINE, SOTALOL HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

SOTYLIZE, SOTALOL HYDROCHLORIDE

SOVALDI, SOFOSBUVIR

SPECTAZOLE, ECONAZOLE NITRATE

SPINRAZA, NUSINERSEN SODIUM

SPIRIVA, TIOTROPIUM BROMIDE

SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE

SPIRONOLACTONE, SPIRONOLACTONE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPORANOX, ITRACONAZOLE

SPRINTEC, ETHINYL ESTRADIOL

SPRITAM, LEVETIRACETAM

SPRIX, KETOROLAC TROMETHAMINE

SPRYCEL, DASATINIB

SPS, SODIUM POLYSTYRENE SULFONATE

SPY AGENT GREEN KIT, INDOCYANINE GREEN

SSD, SILVER SULFADIAZINE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

STARLIX, NATEGLINIDE

STAVUDINE, STAVUDINE

STAXYN, VARDENAFIL HYDROCHLORIDE

STEGLATRO, ERTUGLIFLOZIN

STEGLUJAN, ERTUGLIFLOZIN

STENDRA, AVANAFIL

STERILE WATER, STERILE WATER FOR IRRIGATION

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 53

APPENDIX A - PRODUCT NAME INDEX

** S **

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

STERITALC, TALC

STIE-CORT, HYDROCORTISONE

STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE

STIVARGA, REGORAFENIB

STRATTERA, ATOMOXETINE HYDROCHLORIDE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

STRIANT, TESTOSTERONE

STRIBILD, COBICISTAT

STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE

STROMECTOL, IVERMECTIN

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUBLOCADE, BUPRENORPHINE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

SUBSYS, FENTANYL

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUCRAID, SACROSIDASE

SUCRALFATE, SUCRALFATE

SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SUFENTANIL CITRATE, SUFENTANIL CITRATE

SULAR, NISOLDIPINE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFADIAZINE, SULFADIAZINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE

SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE

SULFAMYLON, MAFENIDE ACETATE

SULFASALAZINE, SULFASALAZINE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

SUMATRIPTAN, SUMATRIPTAN

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SUPPRELIN LA, HISTRELIN ACETATE

SUPRANE, DESFLURANE

SUPRAX, CEFIXIME

SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE

SURMONTIL, TRIMIPRAMINE MALEATE

SURVANTA, BERACTANT

SUSTIVA, EFAVIRENZ

SUSTOL, GRANISETRON

SUTENT, SUNITINIB MALATE

SYEDA, DROSPIRENONE

SYMBICORT, BUDESONIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

SYMDEKO (COPACKAGED), IVACAFTOR

SYMFI, EFAVIRENZ

SYMFI LO, EFAVIRENZ

SYMJEPI, EPINEPHRINE

SYMLIN, PRAMLINTIDE ACETATE

SYMPAZAN, CLOBAZAM

SYMPROIC, NALDEMEDINE TOSYLATE

SYMTUZA, COBICISTAT

SYNALAR, FLUOCINOLONE ACETONIDE

SYNAREL, NAFARELIN ACETATE

SYNDROS, DRONABINOL

SYNERA, LIDOCAINE

SYNERCID, DALFOPRISTIN

SYNJARDY, EMPAGLIFLOZIN

SYNJARDY XR, EMPAGLIFLOZIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 54

APPENDIX A - PRODUCT NAME INDEX

** S **

SYNRIBO, OMACETAXINE MEPESUCCINATE

SYNTHROID, LEVOTHYROXINE SODIUM **

SYPRINE, TRIENTINE HYDROCHLORIDE

** T **

TAB-PROFEN, IBUPROFEN (OTC)

TACLONEX, BETAMETHASONE DIPROPIONATE

TACROLIMUS, TACROLIMUS

TADALAFIL, TADALAFIL

TAFINLAR, DABRAFENIB MESYLATE

TAGAMET HB, CIMETIDINE (OTC)

TAGITOL V, BARIUM SULFATE

TAGRISSO, OSIMERTINIB MESYLATE

TALC, TALC

TALZENNA, TALAZOPARIB TOSYLATE

TAMBOCOR, FLECAINIDE ACETATE

TAMIFLU, OSELTAMIVIR PHOSPHATE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TAPAZOLE, METHIMAZOLE

TARCEVA, ERLOTINIB HYDROCHLORIDE

TARGRETIN, BEXAROTENE

TARKA, TRANDOLAPRIL

TASIGNA, NILOTINIB HYDROCHLORIDE

TASMAR, TOLCAPONE

TAVALISSE, FOSTAMATINIB DISODIUM

TAXOL, PACLITAXEL

TAXOTERE, DOCETAXEL

TAYTULLA, ETHINYL ESTRADIOL

TAZAROTENE, TAZAROTENE

TAZICEF, CEFTAZIDIME

TAZORAC, TAZAROTENE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

TECFIDERA, DIMETHYL FUMARATE

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

TECHNIVIE, OMBITASVIR

TEFLARO, CEFTAROLINE FOSAMIL

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TEGSEDI, INOTERSEN SODIUM

TEKTURNA, ALISKIREN HEMIFUMARATE

TEKTURNA HCT, ALISKIREN HEMIFUMARATE

TELMISARTAN, TELMISARTAN

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TEMAZEPAM, TEMAZEPAM

TEMIXYS, LAMIVUDINE

TEMODAR, TEMOZOLOMIDE

TEMOZOLOMIDE, TEMOZOLOMIDE

TEMSIROLIMUS, TEMSIROLIMUS

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

TENORMIN, ATENOLOL

TENUATE, DIETHYLPROPION HYDROCHLORIDE

TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE

TEPADINA, THIOTEPA

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 55

APPENDIX A - PRODUCT NAME INDEX

** T **

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TERCONAZOLE, TERCONAZOLE

TERIFLUNOMIDE, TERIFLUNOMIDE

TERIL, CARBAMAZEPINE

TESSALON, BENZONATATE

TESTIM, TESTOSTERONE

TESTOPEL, TESTOSTERONE

TESTOSTERONE, TESTOSTERONE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TESTRED, METHYLTESTOSTERONE

TETRABENAZINE, TETRABENAZINE

TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TEXACORT, HYDROCORTISONE

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

THALOMID, THALIDOMIDE

THEO-24, THEOPHYLLINE

THEOCHRON, THEOPHYLLINE

THEOPHYLLINE, THEOPHYLLINE

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THERMAZENE, SILVER SULFADIAZINE

THEROXIDIL, MINOXIDIL (OTC)

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOGUANINE, THIOGUANINE

THIOLA, TIOPRONIN

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

THIOTEPA, THIOTEPA

THIOTHIXENE, THIOTHIXENE

THYROGEN, THYROTROPIN ALFA

THYROSAFE, POTASSIUM IODIDE (OTC)

THYROSHIELD, POTASSIUM IODIDE (OTC)

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TIAZAC, DILTIAZEM HYDROCHLORIDE

TIBSOVO, IVOSIDENIB

TICAGRELOR, TICAGRELOR

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TIGLUTIK KIT, RILUZOLE

TIKOSYN, DOFETILIDE

TIMOLOL, TIMOLOL

TIMOLOL MALEATE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE

TINDAMAX, TINIDAZOLE

TINIDAZOLE, TINIDAZOLE

TIOCONAZOLE, TIOCONAZOLE (OTC)

TIROSINT, LEVOTHYROXINE SODIUM

TIS-U-SOL, MAGNESIUM SULFATE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIVICAY, DOLUTEGRAVIR SODIUM

TIVORBEX, INDOMETHACIN

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOBI, TOBRAMYCIN

TOBI PODHALER, TOBRAMYCIN

TOBRADEX, DEXAMETHASONE

TOBRADEX ST, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 56

APPENDIX A - PRODUCT NAME INDEX

** T **

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE

TOBREX, TOBRAMYCIN

TODAY, NONOXYNOL-9 (OTC)

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

TOLAK, FLUOROURACIL

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLCAPONE, TOLCAPONE

TOLMETIN SODIUM, TOLMETIN SODIUM

TOLSURA, ITRACONAZOLE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TOPAMAX, TOPIRAMATE

TOPICORT, DESOXIMETASONE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TOPROL-XL, METOPROLOL SUCCINATE

TOREMIFENE CITRATE, TOREMIFENE CITRATE

TORISEL, TEMSIROLIMUS

TORSEMIDE, TORSEMIDE

TOTECT, DEXRAZOXANE HYDROCHLORIDE

TOUJEO MAX SOLOSTAR, INSULIN GLARGINE RECOMBINANT

TOUJEO SOLOSTAR, INSULIN GLARGINE RECOMBINANT

TOVIAZ, FESOTERODINE FUMARATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

TPOXX, TECOVIRIMAT

TRACLEER, BOSENTAN

TRADJENTA, LINAGLIPTIN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANDATE, LABETALOL HYDROCHLORIDE

TRANDOLAPRIL, TRANDOLAPRIL

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL

TRANEXAMIC ACID, TRANEXAMIC ACID

TRANSDERM SCOP, SCOPOLAMINE

TRANXENE, CLORAZEPATE DIPOTASSIUM

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVATAN Z, TRAVOPROST

TRAVOPROST, TRAVOPROST

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRECATOR, ETHIONAMIDE

TRELEGY ELLIPTA, FLUTICASONE FUROATE

TRELSTAR, TRIPTORELIN PAMOATE

TREPROSTINIL, TREPROSTINIL

TRESIBA, INSULIN DEGLUDEC

TRETINOIN, TRETINOIN

TREXALL, METHOTREXATE SODIUM

TREXIMET, NAPROXEN SODIUM

TREZIX, ACETAMINOPHEN

TRI LO SPRINTEC, ETHINYL ESTRADIOL

TRI-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LEGEST 21, ETHINYL ESTRADIOL

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-LINYAH, ETHINYL ESTRADIOL

TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LO-MILI, ETHINYL ESTRADIOL

TRI-LUMA, FLUOCINOLONE ACETONIDE

TRI-MILI, ETHINYL ESTRADIOL

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 57

APPENDIX A - PRODUCT NAME INDEX

** T **

TRI-PREVIFEM, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

TRIACIN-C, CODEINE PHOSPHATE

TRIAMCINOLONE ACETATE, TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE (OTC)

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIAZOLAM, TRIAZOLAM

TRIBENZOR, AMLODIPINE BESYLATE

TRICOR, FENOFIBRATE

TRIDERM, TRIAMCINOLONE ACETONIDE

TRIDIONE, TRIMETHADIONE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

TRIESENCE, TRIAMCINOLONE ACETONIDE

TRIFERIC, FERRIC PYROPHOSPHATE CITRATE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

TRIFLURIDINE, TRIFLURIDINE

TRIGLIDE, FENOFIBRATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRILEPTAL, OXCARBAZEPINE

TRILIPIX, CHOLINE FENOFIBRATE

TRILYTE, POLYETHYLENE GLYCOL 3350

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

TRINTELLIX, VORTIOXETINE HYDROBROMIDE

TRIOSTAT, LIOTHYRONINE SODIUM

TRIPTODUR KIT, TRIPTORELIN PAMOATE

TRISENOX, ARSENIC TRIOXIDE

TRIUMEQ, ABACAVIR SULFATE

TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)

TRIVORA-28, ETHINYL ESTRADIOL

TRIZIVIR, ABACAVIR SULFATE

TROKENDI XR, TOPIRAMATE

TROPHAMINE, AMINO ACIDS

TROPHAMINE 10%, AMINO ACIDS

TROPICACYL, TROPICAMIDE

TROPICAMIDE, TROPICAMIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

TRULANCE, PLECANATIDE

TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

TRUVADA, EMTRICITABINE

TUDORZA PRESSAIR, ACLIDINIUM BROMIDE

TUSSICAPS, CHLORPHENIRAMINE POLISTIREX

TUSSIGON, HOMATROPINE METHYLBROMIDE

TUXARIN ER, CHLORPHENIRAMINE MALEATE

TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX

TWYNSTA, AMLODIPINE BESYLATE

TYBOST, COBICISTAT

TYDEMY, DROSPIRENONE

TYGACIL, TIGECYCLINE

TYKERB, LAPATINIB DITOSYLATE

TYLENOL, ACETAMINOPHEN (OTC)

TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN

TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN

TYMLOS, ABALOPARATIDE

TYVASO, TREPROSTINIL

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

** U **

U-CORT, HYDROCORTISONE ACETATE

UCERIS, BUDESONIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 58

APPENDIX A - PRODUCT NAME INDEX

** U **

ULESFIA, BENZYL ALCOHOL

ULORIC, FEBUXOSTAT

ULTACAN, ARTICAINE HYDROCHLORIDE

ULTACAN FORTE, ARTICAINE HYDROCHLORIDE

ULTANE, SEVOFLURANE

ULTIVA, REMIFENTANIL HYDROCHLORIDE

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

ULTRACET, ACETAMINOPHEN

ULTRAM, TRAMADOL HYDROCHLORIDE

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

ULTRAVATE, HALOBETASOL PROPIONATE

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 240, IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

UNASYN, AMPICILLIN SODIUM

UNISOM, DOXYLAMINE SUCCINATE (OTC)

UNITHROID, LEVOTHYROXINE SODIUM **

UPTRAVI, SELEXIPAG

URECHOLINE, BETHANECHOL CHLORIDE

UREX, METHENAMINE HIPPURATE

UROCIT-K, POTASSIUM CITRATE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

URSO 250, URSODIOL

URSO FORTE, URSODIOL

URSODIOL, URSODIOL

UTIBRON, GLYCOPYRROLATE

UVADEX, METHOXSALEN

** V **

VABOMERE, MEROPENEM

VAGIFEM, ESTRADIOL

VAGISTAT-1, TIOCONAZOLE (OTC)

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALIUM, DIAZEPAM

VALNAC, BETAMETHASONE VALERATE

VALPROATE SODIUM, VALPROATE SODIUM

VALPROIC ACID, VALPROIC ACID

VALSARTAN, VALSARTAN

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

VALTREX, VALACYCLOVIR HYDROCHLORIDE

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

VANDAZOLE, METRONIDAZOLE

VANIQA, EFLORNITHINE HYDROCHLORIDE

VANOS, FLUOCINONIDE

VANTAS, HISTRELIN ACETATE

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VARIBAR HONEY, BARIUM SULFATE

VARIBAR NECTAR, BARIUM SULFATE

VARIBAR PUDDING, BARIUM SULFATE

VARIBAR THIN HONEY, BARIUM SULFATE

VARITHENA, POLIDOCANOL

VARUBI, ROLAPITANT HYDROCHLORIDE

VASCEPA, ICOSAPENT ETHYL

VASERETIC, ENALAPRIL MALEATE

VASOSTRICT, VASOPRESSIN

VASOTEC, ENALAPRIL MALEATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 59

APPENDIX A - PRODUCT NAME INDEX

** V **

VAZALORE, ASPIRIN (OTC)

VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE

VECTICAL, CALCITRIOL

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VELCADE, BORTEZOMIB

VELETRI, EPOPROSTENOL SODIUM

VELIVET, DESOGESTREL

VELPHORO, SUCROFERRIC OXYHYDROXIDE

VELTASSA, PATIROMER SORBITEX CALCIUM

VELTIN, CLINDAMYCIN PHOSPHATE

VEMLIDY, TENOFOVIR ALAFENAMIDE FUMARATE

VENCLEXTA, VENETOCLAX

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VENOFER, IRON SUCROSE

VENTAVIS, ILOPROST

VENTOLIN HFA, ALBUTEROL SULFATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VERDESO, DESONIDE

VEREGEN, SINECATECHINS

VERELAN, VERAPAMIL HYDROCHLORIDE

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERSACLOZ, CLOZAPINE

VERZENIO, ABEMACICLIB

VESICARE, SOLIFENACIN SUCCINATE

VFEND, VORICONAZOLE

VIAGRA, SILDENAFIL CITRATE

VIBATIV, TELAVANCIN HYDROCHLORIDE

VIBERZI, ELUXADOLINE

VIBISONE, CYANOCOBALAMIN

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VICTOZA, LIRAGLUTIDE RECOMBINANT

VIDAZA, AZACITIDINE

VIDEX, DIDANOSINE

VIDEX EC, DIDANOSINE

VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM

VIEKIRA XR, DASABUVIR SODIUM

VIENVA, ETHINYL ESTRADIOL

VIGABATRIN, VIGABATRIN

VIGADRONE, VIGABATRIN

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

VIIBRYD, VILAZODONE HYDROCHLORIDE

VIMOVO, ESOMEPRAZOLE MAGNESIUM

VIMPAT, LACOSAMIDE

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VIOKACE, PANCRELIPASE (AMYLASE

VIORELE, DESOGESTREL

VIRACEPT, NELFINAVIR MESYLATE

VIRAMUNE, NEVIRAPINE

VIRAMUNE XR, NEVIRAPINE

VIRAZOLE, RIBAVIRIN

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VIROPTIC, TRIFLURIDINE

VISINE, NAPHAZOLINE HYDROCHLORIDE (OTC)

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISIONBLUE, TRYPAN BLUE

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

VISTARIL, HYDROXYZINE PAMOATE

VISTOGARD, URIDINE TRIACETATE

VISUDYNE, VERTEPORFIN

VITAMIN D, ERGOCALCIFEROL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 60

APPENDIX A - PRODUCT NAME INDEX

** V **

VITAMIN K1, PHYTONADIONE

VITRAKVI, LAROTRECTINIB

VITRASE, HYALURONIDASE

VITUZ, CHLORPHENIRAMINE MALEATE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

VIVELLE-DOT, ESTRADIOL

VIVITROL, NALTREXONE

VIVLODEX, MELOXICAM

VIZAMYL, FLUTEMETAMOL F-18

VIZIMPRO, DACOMITINIB

VOGELXO, TESTOSTERONE

VOLNEA, DESOGESTREL

VOLTAREN, DICLOFENAC SODIUM

VORICONAZOLE, VORICONAZOLE

VOSEVI, SOFOSBUVIR

VOSOL, ACETIC ACID, GLACIAL

VOSOL HC, ACETIC ACID, GLACIAL

VOSPIRE ER, ALBUTEROL SULFATE

VOTRIENT, PAZOPANIB HYDROCHLORIDE

VPRIV, VELAGLUCERASE ALFA

VRAYLAR, CARIPRAZINE HYDROCHLORIDE

VUSION, MICONAZOLE NITRATE

VYFEMLA, ETHINYL ESTRADIOL

VYTORIN, EZETIMIBE

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

VYXEOS, CYTARABINE

VYZULTA, LATANOPROSTENE BUNOD

** W **

WARFARIN SODIUM, WARFARIN SODIUM

WELCHOL, COLESEVELAM HYDROCHLORIDE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE

WERA, ETHINYL ESTRADIOL

WOMEN'S ROGAINE, MINOXIDIL (OTC)

** X **

XADAGO, SAFINAMIDE MESYLATE

XALATAN, LATANOPROST

XALKORI, CRIZOTINIB

XANAX, ALPRAZOLAM

XANAX XR, ALPRAZOLAM

XARELTO, RIVAROXABAN

XATMEP, METHOTREXATE SODIUM

XELJANZ, TOFACITINIB CITRATE

XELJANZ XR, TOFACITINIB CITRATE

XELODA, CAPECITABINE

XELPROS, LATANOPROST

XENAZINE, TETRABENAZINE

XENICAL, ORLISTAT

XENON XE 133, XENON XE-133

XEPI, OZENOXACIN

XERAVA, ERAVACYCLINE DIHYDROCHLORIDE

XERESE, ACYCLOVIR

XERMELO, TELOTRISTAT ETIPRATE

XHANCE, FLUTICASONE PROPIONATE

XIFAXAN, RIFAXIMIN

XIGDUO XR, DAPAGLIFLOZIN

XIIDRA, LIFITEGRAST

XIMINO, MINOCYCLINE HYDROCHLORIDE

XOFIGO, RADIUM RA-223 DICHLORIDE

XOFLUZA, BALOXAVIR MARBOXIL

XOLEGEL, KETOCONAZOLE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

XOPENEX HFA, LEVALBUTEROL TARTRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 61

APPENDIX A - PRODUCT NAME INDEX

** X **

XOSPATA, GILTERITINIB FUMARATE

XTAMPZA ER, OXYCODONE

XTANDI, ENZALUTAMIDE

XTORO, FINAFLOXACIN

XTRELUS, GUAIFENESIN

XULANE, ETHINYL ESTRADIOL

XULTOPHY 100/3.6, INSULIN DEGLUDEC

XURIDEN, URIDINE TRIACETATE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYOSTED (AUTOINJECTOR), TESTOSTERONE ENANTHATE

XYREM, SODIUM OXYBATE

XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

XYZAL ALLERGY 24HR, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

** Y **

YAELA, DROSPIRENONE

YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

YONDELIS, TRABECTEDIN

YONSA, ABIRATERONE ACETATE

YOSPRALA, ASPIRIN

YUPELRI, REVEFENACIN

YUTIQ, FLUOCINOLONE ACETONIDE

** Z **

ZAFIRLUKAST, ZAFIRLUKAST

ZALEPLON, ZALEPLON

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

ZANOSAR, STREPTOZOCIN

ZANTAC, RANITIDINE HYDROCHLORIDE

ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)

ZARONTIN, ETHOSUXIMIDE

ZAROXOLYN, METOLAZONE

ZAVESCA, MIGLUSTAT

ZEGERID, OMEPRAZOLE

ZEGERID OTC, OMEPRAZOLE (OTC)

ZEJULA, NIRAPARIB TOSYLATE

ZELAPAR, SELEGILINE HYDROCHLORIDE

ZELBORAF, VEMURAFENIB

ZEMBRACE SYMTOUCH, SUMATRIPTAN SUCCINATE

ZEMDRI, PLAZOMICIN SULFATE

ZEMPLAR, PARICALCITOL

ZENATANE, ISOTRETINOIN

ZENPEP, PANCRELIPASE (AMYLASE

ZEPATIER, ELBASVIR

ZERBAXA, CEFTOLOZANE SULFATE

ZERIT, STAVUDINE

ZERVIATE, CETIRIZINE HYDROCHLORIDE

ZESTORETIC, HYDROCHLOROTHIAZIDE

ZESTRIL, LISINOPRIL

ZETIA, EZETIMIBE

ZETONNA, CICLESONIDE

ZIAC, BISOPROLOL FUMARATE

ZIAGEN, ABACAVIR SULFATE

ZIANA, CLINDAMYCIN PHOSPHATE

ZIDOVUDINE, ZIDOVUDINE

ZILEUTON, ZILEUTON

ZILRETTA, TRIAMCINOLONE ACETONIDE

ZINACEF, CEFUROXIME SODIUM

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZINGO, LIDOCAINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST A - 62

APPENDIX A - PRODUCT NAME INDEX

** Z **

ZIOPTAN, TAFLUPROST

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZIPSOR, DICLOFENAC POTASSIUM

ZIRGAN, GANCICLOVIR

ZITHROMAX, AZITHROMYCIN

ZOCOR, SIMVASTATIN

ZOFRAN, ONDANSETRON HYDROCHLORIDE

ZOFRAN ODT, ONDANSETRON

ZOHYDRO ER, HYDROCODONE BITARTRATE

ZOLADEX, GOSERELIN ACETATE

ZOLEDRONIC, ZOLEDRONIC ACID

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLINZA, VORINOSTAT

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLOFT, SERTRALINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZOLPIMIST, ZOLPIDEM TARTRATE

ZOMACTON, SOMATROPIN

ZOMETA, ZOLEDRONIC ACID

ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

ZONALON, DOXEPIN HYDROCHLORIDE

ZONEGRAN, ZONISAMIDE

ZONISAMIDE, ZONISAMIDE

ZONTIVITY, VORAPAXAR SULFATE

ZORBTIVE, SOMATROPIN RECOMBINANT

ZORTRESS, EVEROLIMUS

ZORVOLEX, DICLOFENAC

ZOSYN, PIPERACILLIN SODIUM

ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

ZOVIA 1/35E-28, ETHINYL ESTRADIOL

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

ZOVIRAX, ACYCLOVIR

ZTLIDO, LIDOCAINE

ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE

ZUMANDIMINE, DROSPIRENONE

ZUPLENZ, ONDANSETRON

ZURAMPIC, LESINURAD

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

ZYBAN, BUPROPION HYDROCHLORIDE

ZYCLARA, IMIQUIMOD

ZYDELIG, IDELALISIB

ZYFLO, ZILEUTON

ZYFLO CR, ZILEUTON

ZYKADIA, CERITINIB

ZYLET, LOTEPREDNOL ETABONATE

ZYLOPRIM, ALLOPURINOL

ZYMAR, GATIFLOXACIN

ZYMAXID, GATIFLOXACIN

ZYPITAMAG, PITAVASTATIN MAGNESIUM

ZYPREXA, OLANZAPINE

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ZYPREXA ZYDIS, OLANZAPINE

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

ZYTIGA, ABIRATERONE ACETATE

ZYVOX, LINEZOLID

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 1

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** 3 **

3D IMAGING DRUG

* 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

3M

* 3M CO

PERIDEX, CHLORHEXIDINE GLUCONATE

* 3M HEALTH CARE INC

AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)

3M DRUG DELIVERY

* 3M DRUG DELIVERY SYSTEMS

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

PROVENTIL-HFA, ALBUTEROL SULFATE

3M HEALTH CARE

* 3M HEALTH CARE INFECTION PREVENTION DIV

SOLUPREP, CHLORHEXIDINE GLUCONATE (OTC)

** 6 **

60 DEGREES PHARMS

* 60 DEGREES PHARMACEUTICALS LLC

ARAKODA, TAFENOQUINE SUCCINATE

** A **

AAA USA INC

* ADVANCED ACCELERATOR APPLICATIONS USA INC

LUTATHERA, LUTETIUM DOTATATE LU-177

NETSPOT, GALLIUM DOTATATE GA-68

AAIPHARMA LLC

* AAIPHARMA LLC

AZASAN, AZATHIOPRINE

ABBVIE

* ABBVIE INC

ANDROGEL, TESTOSTERONE

CREON, PANCRELIPASE (AMYLASE

CYCLOSPORINE, CYCLOSPORINE

DEPACON, VALPROATE SODIUM

DEPAKENE, VALPROIC ACID

DEPAKOTE ER, DIVALPROEX SODIUM

DEPAKOTE, DIVALPROEX SODIUM

GENGRAF, CYCLOSPORINE

K-TAB, POTASSIUM CHLORIDE

KALETRA, LOPINAVIR

MARINOL, DRONABINOL

NIASPAN, NIACIN

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMBEX, CISATRACURIUM BESYLATE

NORVIR, RITONAVIR

SURVANTA, BERACTANT

SYNTHROID, LEVOTHYROXINE SODIUM **

TARKA, TRANDOLAPRIL

TRICOR, FENOFIBRATE

TRIDIONE, TRIMETHADIONE

TRILIPIX, CHOLINE FENOFIBRATE

ULTANE, SEVOFLURANE

ZEMPLAR, PARICALCITOL

ABBVIE ENDOCRINE

* ABBVIE ENDOCRINE INC

LUPANETA PACK, LEUPROLIDE ACETATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 2

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ABBVIE ENDOCRINE INC

* ABBVIE ENDOCRINE INC

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-PED, LEUPROLIDE ACETATE

ABBVIE INC

* ABBVIE INC

DUOPA, CARBIDOPA

MAVYRET, GLECAPREVIR

NORVIR, RITONAVIR

ORILISSA, ELAGOLIX SODIUM

TECHNIVIE, OMBITASVIR

VENCLEXTA, VENETOCLAX

VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM

VIEKIRA XR, DASABUVIR SODIUM

ABHAI INC

* ABHAI INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ABHAI LLC

* ABHAI LLC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

URSODIOL, URSODIOL

ABON PHARMS LLC

* ABON PHARMACEUTICALS LLC

CLOFARABINE, CLOFARABINE

ABRAXIS BIOSCIENCE

* ABRAXIS BIOSCIENCE LLC

ABRAXANE, PACLITAXEL

ABRAXIS PHARM

* ABRAXIS PHARMACEUTICAL PRODUCTS

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

ACADEMIC PHARMS INC

* ACADEMIC PHARMACEUTICALS INC

BRETYLIUM TOSYLATE, BRETYLIUM TOSYLATE

ACADIA PHARMS INC

* ACADIA PHARMACEUTICALS INC

NUPLAZID, PIMAVANSERIN TARTRATE

ACCELRX LABS

* ACCELRX LABS LLC

CARISOPRODOL, CARISOPRODOL

ACCORD HLTHCARE

* ACCORD HEALTHCARE INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZACITIDINE, AZACITIDINE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BIVALIRUDIN, BIVALIRUDIN

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CAPECITABINE, CAPECITABINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBOPLATIN, CARBOPLATIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 3

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACCORD HEALTHCARE INC

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

DALFAMPRIDINE, DALFAMPRIDINE

DECITABINE, DECITABINE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ENTECAVIR, ENTECAVIR

EPLERENONE, EPLERENONE

EPTIFIBATIDE, EPTIFIBATIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ETOPOSIDE, ETOPOSIDE

EZETIMIBE, EZETIMIBE

FINASTERIDE, FINASTERIDE

FLUOROURACIL, FLUOROURACIL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE, GLIPIZIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL, LISINOPRIL

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLDOPA, METHYLDOPA

MITOMYCIN, MITOMYCIN

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PACLITAXEL, PACLITAXEL

PARICALCITOL, PARICALCITOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RAMIPRIL, RAMIPRIL

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SPIRONOLACTONE, SPIRONOLACTONE

TACROLIMUS, TACROLIMUS

TEMOZOLOMIDE, TEMOZOLOMIDE

TEMSIROLIMUS, TEMSIROLIMUS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 4

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACCORD HEALTHCARE INC

TERIFLUNOMIDE, TERIFLUNOMIDE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ACCORD HLTHCARE INC

* ACCORD HEALTHCARE INC USA

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

TIGECYCLINE, TIGECYCLINE

ACELLA PHARMS LLC

* ACELLA PHARMACEUTICALS LLC

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

ACELRX PHARMS

* ACELRX PHARMACEUTICALS INC

DSUVIA, SUFENTANIL CITRATE

ACHAOGEN INC

* ACHAOGEN INC

ZEMDRI, PLAZOMICIN SULFATE

ACI HEALTHCARE LTD

* ACI HEALTHCARE LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

LEVETIRACETAM, LEVETIRACETAM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ACIC PHARMS

* ACIC PHARMACEUTICALS INC

LEVETIRACETAM, LEVETIRACETAM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

ACLARIS

* ACLARIS THERAPEUTICS INC

ESKATA, HYDROGEN PEROXIDE

RHOFADE, OXYMETAZOLINE HYDROCHLORIDE

ACORDA

* ACORDA THERAPEUTICS INC

AMPYRA, DALFAMPRIDINE

INBRIJA, LEVODOPA

ACS DOBFAR

* ACS DOBFAR SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOXITIN, CEFOXITIN SODIUM

CEFTAZIDIME, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

MEROPENEM, MEROPENEM

ACS DOBFAR SPA

* ACS DOBFAR SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

ERTAPENEM SODIUM, ERTAPENEM SODIUM

MEROPENEM, MEROPENEM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

ACTAVIS ELIZABETH

* ACTAVIS ELIZABETH LLC

ALPRAZOLAM, ALPRAZOLAM

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 5

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS ELIZABETH LLC

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DEFERASIROX, DEFERASIROX

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, DEXTROMETHORPHAN HYDROBROMIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GABAPENTIN, GABAPENTIN

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDAPAMIDE, INDAPAMIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOVASTATIN, LOVASTATIN

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NIFEDIPINE, NIFEDIPINE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OXAZEPAM, OXAZEPAM

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SPIRONOLACTONE, SPIRONOLACTONE

TEMAZEPAM, TEMAZEPAM

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

ALPRAZOLAM, ALPRAZOLAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

MORPHINE SULFATE, MORPHINE SULFATE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

ACTAVIS INC

* ACTAVIS INC

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

METHOXSALEN, METHOXSALEN

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ACTAVIS LABS

* ACTAVIS LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

PERMETHRIN, PERMETHRIN

ACTAVIS LABS FL

* ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

MESALAMINE, MESALAMINE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ACTAVIS LABS FL INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 6

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS LABORATORIES FL INC

BUDESONIDE, BUDESONIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CABERGOLINE, CABERGOLINE

CARTIA XT, DILTIAZEM HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DALFAMPRIDINE, DALFAMPRIDINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

DUTASTERIDE, DUTASTERIDE

FENTANYL CITRATE, FENTANYL CITRATE

FLUTAMIDE, FLUTAMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

LEVETIRACETAM, LEVETIRACETAM

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NAPROXEN SODIUM, NAPROXEN SODIUM

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NITROGLYCERIN, NITROGLYCERIN

OMEPRAZOLE, OMEPRAZOLE

OXYCODONE AND ASPIRIN, ASPIRIN

PALIPERIDONE, PALIPERIDONE

PAROXETINE MESYLATE, PAROXETINE MESYLATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISONE, PREDNISONE

RAMELTEON, RAMELTEON

RISPERIDONE, RISPERIDONE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

TETRABENAZINE, TETRABENAZINE

TRANEXAMIC ACID, TRANEXAMIC ACID

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ACTAVIS LABS NY INC

* ACTAVIS LABORATORIES NY INC

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

ACTAVIS LABS UT INC

* ACTAVIS LABORATORIES UT INC

AZELAIC ACID, AZELAIC ACID

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLONIDINE, CLONIDINE

DOCOSANOL, DOCOSANOL (OTC)

EMLA, LIDOCAINE

FIORICET W/ CODEINE, ACETAMINOPHEN

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

LIDOCAINE, LIDOCAINE

NORINYL 1+50 28-DAY, MESTRANOL

PROGESTERONE, PROGESTERONE

TESTOSTERONE, TESTOSTERONE

* ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

PIMECROLIMUS, PIMECROLIMUS

TESTOSTERONE, TESTOSTERONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 7

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

ACTAVIS LLC

* ACTAVIS LLC

AZACITIDINE, AZACITIDINE

DAPSONE, DAPSONE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

* ACTAVIS LLC AN INDIRECT WHOLLY-OWNED SUB OF TEVA PHARMACEUTICALS USA INC

BUSULFAN, BUSULFAN

DOCETAXEL, DOCETAXEL

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

OXALIPLATIN, OXALIPLATIN

ACTAVIS MID ATLANTIC

* ACTAVIS MID ATLANTIC LLC

ACETASOL HC, ACETIC ACID, GLACIAL

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADAPALENE, ADAPALENE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ENULOSE, LACTULOSE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN, IBUPROFEN (OTC)

LEVETIRACETAM, LEVETIRACETAM

MICONAZOLE 7, MICONAZOLE NITRATE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

NITROFURANTOIN, NITROFURANTOIN

NYSTATIN, NYSTATIN

PROMETH VC W/ CODEINE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

VALNAC, BETAMETHASONE VALERATE

* ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

IBUPROFEN, IBUPROFEN

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

PERMETHRIN, PERMETHRIN (OTC)

ACTAVIS PHARMA

* ACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

MICONAZOLE NITRATE, MICONAZOLE NITRATE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

ACTAVIS TOTOWA

* ACTAVIS TOTOWA LLC

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

REPAGLINIDE, REPAGLINIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 8

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS TOTOWA LLC

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ACTAVIS TOTOWA TEVA

* ACTAVIS TOTOWA LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

FINASTERIDE, FINASTERIDE

ACTELION PHARMS

* ACTELION PHARMACEUTICALS LTD

TRACLEER, BOSENTAN

ACTELION PHARMS LTD

* ACTELION PHARMACEUTICALS LTD

OPSUMIT, MACITENTAN

TRACLEER, BOSENTAN

UPTRAVI, SELEXIPAG

VELETRI, EPOPROSTENOL SODIUM

VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ACTIENT PHARMS

* ACTIENT PHARMACEUTICALS LLC

THEO-24, THEOPHYLLINE

ADAMAS PHARMA

* ADAMAS PHARMA LLC

GOCOVRI, AMANTADINE HYDROCHLORIDE

ADAMIS PHARMS CORP

* ADAMIS PHARMACEUTICALS CORP

SYMJEPI, EPINEPHRINE

ADAPT

* ADAPT PHARMA OPERATIONS LTD

NARCAN, NALOXONE HYDROCHLORIDE

ADARE PHARMS INC

* ADARE PHARMACEUTICALS INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

ADDMEDICA SAS

* ADDMEDICA SAS

SIKLOS, HYDROXYUREA

ADIENNE SA

* ADIENNE SA

TEPADINA, THIOTEPA

AEGERION

* AEGERION PHARMACEUTICALS INC

JUXTAPID, LOMITAPIDE MESYLATE

AERIE PHARMS INC

* AERIE PHARMACEUTICALS INC

RHOPRESSA, NETARSUDIL DIMESYLATE

AGIOS PHARMS INC

* AGIOS PHARMACEUTICALS INC

TIBSOVO, IVOSIDENIB

AGOURON PHARMS

* AGOURON PHARMACEUTICALS LLC

VIRACEPT, NELFINAVIR MESYLATE

AILEX PHARMS LLC

* AILEX PHARMACEUTICALS LLC

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH

CROMOLYN SODIUM, CROMOLYN SODIUM

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

AIPING PHARM INC

* AIPING PHARMACEUTICAL INC

BENZONATATE, BENZONATATE

AJANTA PHARMA LTD

* AJANTA PHARMA LTD

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 9

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AJANTA PHARMA LTD

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

ENTACAPONE, ENTACAPONE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

LANSOPRAZOLE, LANSOPRAZOLE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

VORICONAZOLE, VORICONAZOLE

ZOLMITRIPTAN, ZOLMITRIPTAN

AKARX INC

* AKARX INC

DOPTELET, AVATROMBOPAG MALEATE

AKCEA THERAPS

* AKCEA THERAPEUTICS INC

TEGSEDI, INOTERSEN SODIUM

AKORN

* AKORN INC

ADENOSINE, ADENOSINE

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

AKBETA, LEVOBUNOLOL HYDROCHLORIDE

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

AKTEN, LIDOCAINE HYDROCHLORIDE

AKTOB, TOBRAMYCIN

ALFENTA, ALFENTANIL HYDROCHLORIDE

ATROPINE SULFATE, ATROPINE SULFATE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN, BACITRACIN

BAL, DIMERCAPROL

BALANCED SALT, CALCIUM CHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CALCITRIOL, CALCITRIOL

CAPASTAT SULFATE, CAPREOMYCIN SULFATE

CARBOPLATIN, CARBOPLATIN

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CROMOLYN SODIUM, CROMOLYN SODIUM

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPTIFIBATIDE, EPTIFIBATIDE

ERYTHROMYCIN, ERYTHROMYCIN

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

GENTAK, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IC-GREEN, INDOCYANINE GREEN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 10

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AKORN INC

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LATANOPROST, LATANOPROST

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NEDOCROMIL SODIUM, NEDOCROMIL SODIUM

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OFLOXACIN, OFLOXACIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE

PARICALCITOL, PARICALCITOL

PYRAZINAMIDE, PYRAZINAMIDE

RIFAMPIN, RIFAMPIN

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIMOLOL, TIMOLOL

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TROPICACYL, TROPICAMIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

AKORN INC

* AKORN INC

ACETYLCYSTEINE, ACETYLCYSTEINE

APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CYCLOPENTOLATE HYDROCHLORIDE, CYCLOPENTOLATE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DRONABINOL, DRONABINOL

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

INAPSINE, DROPERIDOL

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 11

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AKORN INC

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ALCON

* ALCON LABORATORIES INC

BSS PLUS, CALCIUM CHLORIDE

BSS, CALCIUM CHLORIDE

MIOSTAT, CARBACHOL

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

ALCON LABS

* ALCON LABORATORIES LTD

TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE

ALCON LABS INC

* ALCON LABORATORIES INC

ALCAINE, PROPARACAINE HYDROCHLORIDE

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

FLUORESCITE, FLUORESCEIN SODIUM

ISOPTO ATROPINE, ATROPINE SULFATE

ALCON PHARMS LTD

* ALCON PHARMACEUTICALS LTD

BETADINE, POVIDONE-IODINE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

ALEMBIC LTD

* ALEMBIC LTD

LITHIUM CARBONATE, LITHIUM CARBONATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ALEMBIC PHARMS LTD

* ALEMBIC PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CELECOXIB, CELECOXIB

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DESVENLAFAXINE, DESVENLAFAXINE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FAMOTIDINE, FAMOTIDINE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

ITRACONAZOLE, ITRACONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LINEZOLID, LINEZOLID

LITHIUM CARBONATE, LITHIUM CARBONATE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 12

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALEMBIC PHARMACEUTICALS LTD

MODAFINIL, MODAFINIL

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

THEOPHYLLINE, THEOPHYLLINE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ALEOR DERMACEUTICALS

* ALEOR DERMACEUTICALS LTD

LIDOCAINE, LIDOCAINE

ALIGNSCIENCE PHARMA

* ALIGNSCIENCE PHARMA INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

ALIMERA SCIENCES INC

* ALIMERA SCIENCES INC

ILUVIEN, FLUOCINOLONE ACETONIDE

ALKALOIDA ZRT

* ALKALOIDA CHEMICAL CO ZRT

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ALKEM

* ALKEM LABORATORIES LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ALKEM LABS LTD

* ALKEM LABORATORIES LTD

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

CAPECITABINE, CAPECITABINE

CEFIXIME, CEFIXIME

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DALFAMPRIDINE, DALFAMPRIDINE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

FINASTERIDE, FINASTERIDE

GABAPENTIN, GABAPENTIN

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LIDOCAINE, LIDOCAINE

LINEZOLID, LINEZOLID

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 13

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALKEM LABORATORIES LTD

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

ALKERMES

* ALKERMES INC

VIVITROL, NALTREXONE

ALKERMES INC

* ALKERMES INC

ARISTADA INITIO KIT, ARIPIPRAZOLE LAUROXIL

ARISTADA, ARIPIPRAZOLE LAUROXIL

ALLEGIANCE HLTHCARE

* ALLEGIANCE HEALTHCARE CORP

POVIDONE IODINE, POVIDONE-IODINE (OTC)

ALLEGIS

* ALLEGIS HOLDINGS LLC

PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE

ALLERGAN

* ALLERGAN

ACULAR LS, KETOROLAC TROMETHAMINE

ALPHAGAN P, BRIMONIDINE TARTRATE

BLEPH-10, SULFACETAMIDE SODIUM

GENOPTIC, GENTAMICIN SULFATE

ZYMAXID, GATIFLOXACIN

* ALLERGAN INC

ACULAR, KETOROLAC TROMETHAMINE

ACUVAIL, KETOROLAC TROMETHAMINE

ACZONE, DAPSONE

ALOCRIL, NEDOCROMIL SODIUM

ALPHAGAN P, BRIMONIDINE TARTRATE

AVAGE, TAZAROTENE

COMBIGAN, BRIMONIDINE TARTRATE

ELESTAT, EPINASTINE HYDROCHLORIDE

LASTACAFT, ALCAFTADINE

LATISSE, BIMATOPROST

LUMIGAN, BIMATOPROST

OCUFLOX, OFLOXACIN

OZURDEX, DEXAMETHASONE

POLYTRIM, POLYMYXIN B SULFATE

RESTASIS MULTIDOSE, CYCLOSPORINE

RESTASIS, CYCLOSPORINE

TAZORAC, TAZAROTENE

ZYMAR, GATIFLOXACIN

* ALLERGAN PHARMACEUTICAL

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE

BLEPHAMIDE, PREDNISOLONE ACETATE

FML FORTE, FLUOROMETHOLONE

FML, FLUOROMETHOLONE

OCUFEN, FLURBIPROFEN SODIUM

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

PRED-G, GENTAMICIN SULFATE

ALLERGAN HOLDINGS

* ALLERGAN HOLDINGS UNLTD CO

VIBERZI, ELUXADOLINE

ALLERGAN SALES LLC

* ALLERGAN SALES LLC

ACTIGALL, URSODIOL

ALORA, ESTRADIOL

ANDRODERM, TESTOSTERONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 14

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALLERGAN SALES LLC

AVYCAZ, AVIBACTAM SODIUM

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

BREVICON 28-DAY, ETHINYL ESTRADIOL

BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

BYVALSON, NEBIVOLOL HYDROCHLORIDE

CANASA, MESALAMINE

CARAFATE, SUCRALFATE

CELEXA, CITALOPRAM HYDROBROMIDE

CONDYLOX, PODOFILOX

CRINONE, PROGESTERONE

DALVANCE, DALBAVANCIN HYDROCHLORIDE

ESTRACE, ESTRADIOL

FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE

FIORINAL W/CODEINE, ASPIRIN

FIORINAL, ASPIRIN

GELNIQUE, OXYBUTYNIN CHLORIDE

INFED, IRON DEXTRAN

KADIAN, MORPHINE SULFATE

LEXAPRO, ESCITALOPRAM OXALATE

LINZESS, LINACLOTIDE

MICROZIDE, HYDROCHLOROTHIAZIDE

NAMENDA, MEMANTINE HYDROCHLORIDE

NAMZARIC, DONEPEZIL HYDROCHLORIDE

NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL

NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL

OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)

OXYTROL, OXYBUTYNIN

PYLERA, BISMUTH SUBCITRATE POTASSIUM

RAPAFLO, SILODOSIN

RECTIV, NITROGLYCERIN

SAVELLA, MILNACIPRAN HYDROCHLORIDE

TEFLARO, CEFTAROLINE FOSAMIL

TRELSTAR, TRIPTORELIN PAMOATE

URSO 250, URSODIOL

URSO FORTE, URSODIOL

VIIBRYD, VILAZODONE HYDROCHLORIDE

VRAYLAR, CARIPRAZINE HYDROCHLORIDE

ALLERQUEST

* ALLERQUEST LLC

PRE-PEN, BENZYLPENICILLOYL POLYLYSINE

ALLIED

* ALLIED PHARMA INC

CLARITHROMYCIN, CLARITHROMYCIN

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

ALLIED PHARMA INC

* ALLIED PHARMA INC

CLARITHROMYCIN, CLARITHROMYCIN

ALLOS

* ALLOS THERAPEUTICS INC

FOLOTYN, PRALATREXATE

ALMIRALL

* ALMIRALL LLC

SEYSARA, SARECYCLINE HYDROCHLORIDE

ALNYLAM PHARMS INC

* ALNYLAM PHARMACEUTICALS INC

ONPATTRO, PATISIRAN SODIUM

ALPHARMA PHARMS

* ALPHARMA PHARMACEUTICALS LLC

EMBEDA, MORPHINE SULFATE

ALRA

* ALRA LABORATORIES INC

CHOLAC, LACTULOSE

CONSTILAC, LACTULOSE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 15

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALRA LABORATORIES INC

GEN-XENE, CLORAZEPATE DIPOTASSIUM

IBU-TAB 200, IBUPROFEN (OTC)

IBU-TAB, IBUPROFEN

ALTAIRE PHARMS INC

* ALTAIRE PHARMACEUTICALS INC

ALTAFLUOR BENOX, BENOXINATE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)

OFLOXACIN, OFLOXACIN

ALTATHERA PHARMS LLC

* ALTATHERA PHARMACEUTICALS LLC

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

ALVOGEN

* ALVOGEN GROUP HOLDINGS 2 LLC

DAPSONE, DAPSONE

ETHACRYNIC ACID, ETHACRYNIC ACID

OFLOXACIN, OFLOXACIN

* ALVOGEN GROUP HOLDINGS 3 LLC

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FORFIVO XL, BUPROPION HYDROCHLORIDE

* ALVOGEN GROUP HOLDINGS LLC

ADALAT CC, NIFEDIPINE

* ALVOGEN INC

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

ALVOGEN INC

* ALVOGEN INC

ACETYLCYSTEINE, ACETYLCYSTEINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

VORICONAZOLE, VORICONAZOLE

ALVOGEN MALTA

* ALVOGEN MALTA OPERATIONS LTD

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

BUDESONIDE, BUDESONIDE

CARBIDOPA, CARBIDOPA

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DISULFIRAM, DISULFIRAM

EXEMESTANE, EXEMESTANE

FELBAMATE, FELBAMATE

MACROBID, NITROFURANTOIN

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

MELPHALAN, MELPHALAN

NAPRELAN, NAPROXEN SODIUM

NATEGLINIDE, NATEGLINIDE

NEVIRAPINE, NEVIRAPINE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RIVASTIGMINE, RIVASTIGMINE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SPECTAZOLE, ECONAZOLE NITRATE

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

TENORMIN, ATENOLOL

ZESTORETIC, HYDROCHLOROTHIAZIDE

ZESTRIL, LISINOPRIL

ALVOGEN PINE BROOK

* ALVOGEN PINE BROOK LLC

ESTRADIOL, ESTRADIOL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 16

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

AM ANTIBIOTICS

* AMERICAN ANTIBIOTICS INC

AMOXICILLIN, AMOXICILLIN

AMAG PHARMA USA

* AMAG PHARMA USA INC

MAKENA (AUTOINJECTOR), HYDROXYPROGESTERONE CAPROATE

MAKENA PRESERVATIVE FREE, HYDROXYPROGESTERONE CAPROATE

MAKENA, HYDROXYPROGESTERONE CAPROATE

AMAG PHARMS INC

* AMAG PHARMACEUTICALS INC

FERAHEME, FERUMOXYTOL

INTRAROSA, PRASTERONE

AMARIN PHARMS

* AMARIN PHARMACEUTICALS IRELAND LTD

VASCEPA, ICOSAPENT ETHYL

AMERIGEN PHARMS LTD

* AMERIGEN PHARMACEUTICALS LTD

BEXAROTENE, BEXAROTENE

CARBIDOPA, CARBIDOPA

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

INDAPAMIDE, INDAPAMIDE

MIGLUSTAT, MIGLUSTAT

TEMOZOLOMIDE, TEMOZOLOMIDE

AMGEN

* AMGEN INC

SENSIPAR, CINACALCET HYDROCHLORIDE

AMGEN INC

* AMGEN INC

CORLANOR, IVABRADINE HYDROCHLORIDE

AMICUS THERAPS US

* AMICUS THERAPEUTICS US INC

GALAFOLD, MIGALASTAT HYDROCHLORIDE

AMNEAL PHARM

* AMNEAL PHARMACEUTICAL

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FOLIC ACID, FOLIC ACID

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

AMNEAL PHARMS

* AMNEAL PHARMACEUTICALS

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOVAQUONE, ATOVAQUONE

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CAPECITABINE, CAPECITABINE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ENTECAVIR, ENTECAVIR

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESTRADIOL, ESTRADIOL

FELBAMATE, FELBAMATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 17

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

INDOMETHACIN, INDOMETHACIN

ITRACONAZOLE, ITRACONAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

LINEZOLID, LINEZOLID

LORAZEPAM, LORAZEPAM

MEROPENEM, MEROPENEM

METAXALONE, METAXALONE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NIACIN, NIACIN

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN

NIZATIDINE, NIZATIDINE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

TEMOZOLOMIDE, TEMOZOLOMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

WARFARIN SODIUM, WARFARIN SODIUM

* AMNEAL PHARMACEUTICALS HOLDINGS GMBH

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

* AMNEAL PHARMACEUTICALS OF NEW YORK LLC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUDESONIDE, BUDESONIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CELECOXIB, CELECOXIB

DUTASTERIDE, DUTASTERIDE

EPTIFIBATIDE, EPTIFIBATIDE

EXEMESTANE, EXEMESTANE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 18

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS OF NEW YORK LLC

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PARICALCITOL, PARICALCITOL

PRASUGREL, PRASUGREL HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RIVASTIGMINE, RIVASTIGMINE

SPIRONOLACTONE, SPIRONOLACTONE

TOBRAMYCIN, TOBRAMYCIN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALSARTAN, VALSARTAN

VIGABATRIN, VIGABATRIN

AMNEAL PHARMS CO

* AMNEAL PHARMACEUTICALS CO GMBH

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARGATROBAN, ARGATROBAN

BUMETANIDE, BUMETANIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUSULFAN, BUSULFAN

CARMUSTINE, CARMUSTINE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLOFARABINE, CLOFARABINE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DOCETAXEL, DOCETAXEL

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ERYTHROMYCIN, ERYTHROMYCIN

ETHACRYNIC ACID, ETHACRYNIC ACID

ETODOLAC, ETODOLAC

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

NADOLOL, NADOLOL

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OXAPROZIN, OXAPROZIN

PARICALCITOL, PARICALCITOL

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PHYTONADIONE, PHYTONADIONE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 19

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS CO GMBH

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SILODOSIN, SILODOSIN

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TERIFLUNOMIDE, TERIFLUNOMIDE

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

URSODIOL, URSODIOL

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

AMNEAL PHARMS LLC

* AMNEAL PHARMACEUTICALS LLC

ACTIVELLA, ESTRADIOL

AZATHIOPRINE, AZATHIOPRINE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)

FENOFIBRATE, FENOFIBRATE

FLUOCINONIDE, FLUOCINONIDE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

RITONAVIR, RITONAVIR

TIGECYCLINE, TIGECYCLINE

AMNEAL PHARMS NY

* AMNEAL PHARMACEUTICALS NY LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALPRAZOLAM, ALPRAZOLAM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

REPREXAIN, HYDROCODONE BITARTRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

* AMNEAL PHARMACEUTICALS OF NY LLC

BEXAROTENE, BEXAROTENE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

ISOTRETINOIN, ISOTRETINOIN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PROGESTERONE, PROGESTERONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

AMPHASTAR PHARM

* AMPHASTAR PHARMACEUTICAL INC

AMPHADASE, HYALURONIDASE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

AMPHASTAR PHARMS INC

* AMPHASTAR PHARMACEUTICALS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 20

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMPHASTAR PHARMACEUTICALS INC

CORTROSYN, COSYNTROPIN

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

AMRING PHARMS

* AMRING PHARMACEUTICALS INC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

LATANOPROST, LATANOPROST

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

ANACOR PHARMS INC

* ANACOR PHARMACEUTICALS INC

EUCRISA, CRISABOROLE

KERYDIN, TAVABOROLE

ANBEX

* ANBEX INC

IOSAT, POTASSIUM IODIDE (OTC)

ANBISON LAB

* ANBISON LABORATORY CO LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

MONTELUKAST SODIUM, MONTELUKAST SODIUM

ANCHEN PHARMS

* ANCHEN PHARMACEUTICALS INC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRETINOIN, TRETINOIN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* ANCHEN PHARMACEUTICALS TAIWAN INC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

* ANCHEN PHARMACEUTICALS, INC

ALPRAZOLAM, ALPRAZOLAM

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

ANDA REPOSITORY

* ANDA REPOSITORY LLC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

IMIQUIMOD, IMIQUIMOD

LEVOCARNITINE, LEVOCARNITINE

LORAZEPAM, LORAZEPAM

MOMETASONE FUROATE, MOMETASONE FUROATE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PRIMIDONE, PRIMIDONE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ANDRX LABS LLC

* ANDRX LABS LLC

FORTAMET, METFORMIN HYDROCHLORIDE

ANI PHARMS

* ANI PHARMACEUTICALS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 21

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ANI PHARMACEUTICALS INC

CORTENEMA, HYDROCORTISONE

LACTULOSE, LACTULOSE

LUVOX, FLUVOXAMINE MALEATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

ANI PHARMS INC

* ANI PHARMACEUTICALS INC

ALPRAZOLAM, ALPRAZOLAM

ARIMIDEX, ANASTROZOLE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ATACAND HCT, CANDESARTAN CILEXETIL

ATACAND, CANDESARTAN CILEXETIL

BRETHINE, TERBUTALINE SULFATE

CASODEX, BICALUTAMIDE

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CHOLESTYRAMINE, CHOLESTYRAMINE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ETODOLAC, ETODOLAC

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

FELBAMATE, FELBAMATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GLIPIZIDE, GLIPIZIDE

GUANABENZ ACETATE, GUANABENZ ACETATE

INDAPAMIDE, INDAPAMIDE

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LITHOBID, LITHIUM CARBONATE

LORAZEPAM, LORAZEPAM

METHAZOLAMIDE, METHAZOLAMIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NILUTAMIDE, NILUTAMIDE

NIZATIDINE, NIZATIDINE

OXCARBAZEPINE, OXCARBAZEPINE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PINDOLOL, PINDOLOL

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALPROIC ACID, VALPROIC ACID

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ANTARES PHARMA INC

* ANTARES PHARMA INC

OTREXUP, METHOTREXATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

XYOSTED (AUTOINJECTOR), TESTOSTERONE ENANTHATE

ANTIBIOTICE

* ANTIBIOTICE SA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

ANTRIM PHARMS LLC

* ANTRIM PHARMACEUTICALS LLC

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

APC PHARMS LLC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 22

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APC PHARMACEUTICALS LLC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

APEX PHARMS INC

* APEX PHARMACEUTICALS INC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

APGDI

* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC

MYRBETRIQ, MIRABEGRON

APICORE US

* APICORE US LLC

TETRABENAZINE, TETRABENAZINE

APIL

* ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

ACTONEL, RISEDRONATE SODIUM

ASACOL HD, MESALAMINE

ATELVIA, RISEDRONATE SODIUM

DELZICOL, MESALAMINE

ENABLEX, DARIFENACIN HYDROBROMIDE

ESTROSTEP FE, ETHINYL ESTRADIOL

FEMCON FE, ETHINYL ESTRADIOL

FEMHRT, ETHINYL ESTRADIOL

LO LOESTRIN FE, ETHINYL ESTRADIOL

LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL

LOESTRIN 21 1/20, ETHINYL ESTRADIOL

LOESTRIN 24 FE, ETHINYL ESTRADIOL

LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL

LOESTRIN FE 1/20, ETHINYL ESTRADIOL

MINASTRIN 24 FE, ETHINYL ESTRADIOL

NOR-QD, NORETHINDRONE

NORCO, ACETAMINOPHEN

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

SARAFEM, FLUOXETINE HYDROCHLORIDE

TAYTULLA, ETHINYL ESTRADIOL

APNAR PHARMA LP

* APNAR PHARMA LP

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

APOLLO PHARMS INC

* APOLLO PHARMACEUTICALS INC

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

APOPHARMA INC

* APOPHARMA INC

FERRIPROX, DEFERIPRONE

APOTEX

* APOTEX INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CIMETIDINE, CIMETIDINE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYCLOSPORINE, CYCLOSPORINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FAMCICLOVIR, FAMCICLOVIR

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 23

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

FAMOTIDINE, FAMOTIDINE

FLUCONAZOLE, FLUCONAZOLE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

LAMIVUDINE, LAMIVUDINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

APOTEX CORP

* APOTEX CORP

CLARITHROMYCIN, CLARITHROMYCIN

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RILUZOLE, RILUZOLE

APOTEX INC

* APOTEX INC

ABACAVIR SULFATE, ABACAVIR SULFATE

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACYCLOVIR, ACYCLOVIR

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALKERAN, MELPHALAN

ALPRAZOLAM, ALPRAZOLAM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE, ATOVAQUONE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZONATATE, BENZONATATE

BICALUTAMIDE, BICALUTAMIDE

BIMATOPROST, BIMATOPROST

BIVALIRUDIN, BIVALIRUDIN

BUDESONIDE, BUDESONIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CALCITONIN-SALMON, CALCITONIN SALMON

CARBAMAZEPINE, CARBAMAZEPINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFPROZIL, CEFPROZIL

CELECOXIB, CELECOXIB

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CICLOPIROX, CICLOPIROX

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 24

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

EZETIMIBE, EZETIMIBE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMATINIB MESYLATE, IMATINIB MESYLATE

IMIQUIMOD, IMIQUIMOD

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL, LEVONORGESTREL (OTC)

LOVASTATIN, LOVASTATIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MODAFINIL, MODAFINIL

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

NABUMETONE, NABUMETONE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OXCARBAZEPINE, OXCARBAZEPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERIDONE, RISPERIDONE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TEMOZOLOMIDE, TEMOZOLOMIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERIFLUNOMIDE, TERIFLUNOMIDE

TIGECYCLINE, TIGECYCLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANEXAMIC ACID, TRANEXAMIC ACID

TRAVOPROST, TRAVOPROST

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 25

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* APOTEX INC ETOBICOKE SITE

ACYCLOVIR, ACYCLOVIR

ALLOPURINOL, ALLOPURINOL

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DILTZAC, DILTIAZEM HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

LEFLUNOMIDE, LEFLUNOMIDE

LISINOPRIL, LISINOPRIL

LORATADINE, LORATADINE (OTC)

MELOXICAM, MELOXICAM

MIRTAZAPINE, MIRTAZAPINE

OXAPROZIN, OXAPROZIN

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TORSEMIDE, TORSEMIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BUDESONIDE, BUDESONIDE (OTC)

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

RISPERIDONE, RISPERIDONE

* APOTEX INC.

DILTZAC, DILTIAZEM HYDROCHLORIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

APOTEX TECHNOLOGIES

* APOTEX TECHNOLOGIES INC

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

APOTHECON

* APOTHECON INC DIV BRISTOL MYERS SQUIBB

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

APP PHARMS

* APP PHARMACEUTICALS LLC

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

APPCO PHARMA LLC

* APPCO PHARMA LLC

CHLORTHALIDONE, CHLORTHALIDONE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

APRECIA PHARMS

* APRECIA PHARMACEUTICALS LLC

SPRITAM, LEVETIRACETAM

APTAPHARMA INC

* APTAPHARMA INC

IBUPROFEN, IBUPROFEN (OTC)

AQUA PHARMS

* AQUA PHARMACEUTICALS

CORDRAN SP, FLURANDRENOLIDE

CORDRAN, FLURANDRENOLIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 26

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AQUA PHARMACEUTICALS

MONODOX, DOXYCYCLINE

VERDESO, DESONIDE

* AQUA PHARMACEUTICALS LLC

FLUOROPLEX, FLUOROURACIL

XOLEGEL, KETOCONAZOLE

AQUA PHARMS LLC

* AQUA PHARMACEUTICALS LLC

ACTICLATE, DOXYCYCLINE HYCLATE

ACZONE, DAPSONE

ALTABAX, RETAPAMULIN

AZELEX, AZELAIC ACID

CORDRAN, FLURANDRENOLIDE

VELTIN, CLINDAMYCIN PHOSPHATE

AQUESTIVE THERAP

* AQUESTIVE THERAPEUTICS

SYMPAZAN, CLOBAZAM

ARALEZ PHARMS

* ARALEZ PHARMACEUTICALS TRADING DAC

TOPROL-XL, METOPROLOL SUCCINATE

ZONTIVITY, VORAPAXAR SULFATE

ARALEZ PHARMS INC

* ARALEZ PHARMACEUTICALS INC

FIBRICOR, FENOFIBRIC ACID

ARBOR PHARMS LLC

* ARBOR PHARMACEUTICALS LLC

BIDIL, HYDRALAZINE HYDROCHLORIDE

CETYLEV, ACETYLCYSTEINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

EDARBI, AZILSARTAN KAMEDOXOMIL

EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

ERY-TAB, ERYTHROMYCIN

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

EVEKEO, AMPHETAMINE SULFATE

GLIADEL, CARMUSTINE

HORIZANT, GABAPENTIN ENACARBIL

NYMALIZE, NIMODIPINE

SKLICE, IVERMECTIN

SOTYLIZE, SOTALOL HYDROCHLORIDE

TRIPTODUR KIT, TRIPTORELIN PAMOATE

ARCO PHARMS LLC

* ARCO PHARMACEUTICALS LLC

THYROSHIELD, POTASSIUM IODIDE (OTC)

AREVA PHARMS

* AREVA PHARMACEUTICALS INC

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

ARIAD

* ARIAD PHARMACEUTICALS INC

ALUNBRIG, BRIGATINIB

ICLUSIG, PONATINIB HYDROCHLORIDE

ARISE PHARMS

* ARISE PHARMACEUTICALS LLC

IBUPROFEN, IBUPROFEN (OTC)

LAMIVUDINE, LAMIVUDINE

ARMSTRONG PHARMS

* ARMSTRONG PHARMACEUTICALS INC

PRIMATENE MIST, EPINEPHRINE (OTC)

ARRAY BIOPHARMA INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 27

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ARRAY BIOPHARMA INC

BRAFTOVI, ENCORAFENIB

MEKTOVI, BINIMETINIB

ASCEND THERAPS US

* ASCEND THERAPEUTICS US LLC

ESTROGEL, ESTRADIOL

ASCENT PHARMS INC

* ASCENT PHARMACEUTICALS INC

DUTASTERIDE, DUTASTERIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN (OTC)

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

ASPEN GLOBAL

* ASPEN GLOBAL INC

MYLERAN, BUSULFAN

ASPEN GLOBAL INC

* ASPEN GLOBAL INC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CYCLESSA, DESOGESTREL

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

LEUKERAN, CHLORAMBUCIL

MYLERAN, BUSULFAN

THIOGUANINE, THIOGUANINE

ASSERTIO

* ASSERTIO THERAPEUTICS INC

CAMBIA, DICLOFENAC POTASSIUM

GRALISE, GABAPENTIN

ZIPSOR, DICLOFENAC POTASSIUM

ASTELLAS

* ASTELLAS PHARMA US INC

AMBISOME, AMPHOTERICIN B

ASTAGRAF XL, TACROLIMUS

CRESEMBA, ISAVUCONAZONIUM SULFATE

LEXISCAN, REGADENOSON

MYCAMINE, MICAFUNGIN SODIUM

PROGRAF, TACROLIMUS

VESICARE, SOLIFENACIN SUCCINATE

XOSPATA, GILTERITINIB FUMARATE

XTANDI, ENZALUTAMIDE

ASTRAL

* ASTRAL STERITECH PVT LTD

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

ASTRAZENECA

* ASTRAZENECA LP

PULMICORT FLEXHALER, BUDESONIDE

SYMBICORT, BUDESONIDE

* ASTRAZENECA PHARMACEUTICALS LP

FASLODEX, FULVESTRANT

ZOMIG, ZOLMITRIPTAN

ZOMIG-ZMT, ZOLMITRIPTAN

* ASTRAZENECA UK LTD

CALQUENCE, ACALABRUTINIB

SEROQUEL XR, QUETIAPINE FUMARATE

ASTRAZENECA AB

* ASTRAZENECA AB

BYDUREON BCISE, EXENATIDE

BYDUREON PEN, EXENATIDE SYNTHETIC

BYDUREON, EXENATIDE SYNTHETIC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 28

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ASTRAZENECA AB

BYETTA, EXENATIDE SYNTHETIC

FARXIGA, DAPAGLIFLOZIN

KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE

ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE

QTERN, DAPAGLIFLOZIN

SYMLIN, PRAMLINTIDE ACETATE

XIGDUO XR, DAPAGLIFLOZIN

ASTRAZENECA LP

* ASTRAZENECA LP

NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)

ASTRAZENECA PHARMS

* ASTRAZENECA PHARMACEUTICALS LP

ALVESCO, CICLESONIDE

BEVESPI AEROSPHERE, FORMOTEROL FUMARATE

BRILINTA, TICAGRELOR

DALIRESP, ROFLUMILAST

IRESSA, GEFITINIB

LOKELMA, SODIUM ZIRCONIUM CYCLOSILICATE

LYNPARZA, OLAPARIB

MOVANTIK, NALOXEGOL OXALATE

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXIUM, ESOMEPRAZOLE MAGNESIUM

OMNARIS, CICLESONIDE

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)

PULMICORT RESPULES, BUDESONIDE

RHINOCORT ALLERGY, BUDESONIDE (OTC)

SEROQUEL, QUETIAPINE FUMARATE

TAGRISSO, OSIMERTINIB MESYLATE

TUDORZA PRESSAIR, ACLIDINIUM BROMIDE

ZETONNA, CICLESONIDE

ATHENEX INC

* ATHENEX INC

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

VALPROATE SODIUM, VALPROATE SODIUM

ATLAS PHARMS LLC

* ATLAS PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ATNAHS PHARMA US

* ATNAHS PHARMA US LTD

ANAPROX DS, NAPROXEN SODIUM

EC-NAPROSYN, NAPROXEN

NAPROSYN, NAPROXEN

ATON

* ATON PHARMA INC

CUPRIMINE, PENICILLAMINE

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

LACRISERT, HYDROXYPROPYL CELLULOSE

LODOSYN, CARBIDOPA

SYPRINE, TRIENTINE HYDROCHLORIDE

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

ATON PHARMA VPNA

* ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC

DEMSER, METYROSINE

AUCTA PHARMS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 29

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUCTA PHARMACEUTICALS LLC

VIGADRONE, VIGABATRIN

AUROBINDO

* AUROBINDO PHARMA LTD

AMOXICILLIN, AMOXICILLIN

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NEVIRAPINE, NEVIRAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA

* AUROBINDO PHARMA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

* AUROBINDO PHARMA LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ATENOLOL, ATENOLOL

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CARISOPRODOL, CARISOPRODOL

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIDANOSINE, DIDANOSINE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MELOXICAM, MELOXICAM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RIBAVIRIN, RIBAVIRIN

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

STAVUDINE, STAVUDINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 30

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

TORSEMIDE, TORSEMIDE

TRANDOLAPRIL, TRANDOLAPRIL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD

* AUROBINDO PHARMA LIMITED

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

LEVOFLOXACIN, LEVOFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* AUROBINDO PHARMA LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AFIRMELLE, ETHINYL ESTRADIOL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARIPIPRAZOLE, ARIPIPRAZOLE

ARMODAFINIL, ARMODAFINIL

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATHENTIA NEXT, LEVONORGESTREL (OTC)

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AUROVELA 1.5/30, ETHINYL ESTRADIOL

AUROVELA 1/20, ETHINYL ESTRADIOL

AUROVELA 24 FE, ETHINYL ESTRADIOL

AUROVELA FE 1.5/30, ETHINYL ESTRADIOL

AUROVELA FE 1/20, ETHINYL ESTRADIOL

AYUNA, ETHINYL ESTRADIOL

AZITHROMYCIN, AZITHROMYCIN

BIVALIRUDIN, BIVALIRUDIN

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CEFIXIME, CEFIXIME

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CELECOXIB, CELECOXIB

CEPHALEXIN, CEPHALEXIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 31

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT


** A **
* AUROBINDO PHARMA LTD
CYONANZ, ETHINYL ESTRADIOL
DALFAMPRIDINE, DALFAMPRIDINE
DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
EFAVIRENZ, EFAVIRENZ
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ
ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE
ENTACAPONE, ENTACAPONE
ENTECAVIR, ENTECAVIR
EPTIFIBATIDE, EPTIFIBATIDE
ERTAPENEM SODIUM, ERTAPENEM SODIUM
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ESZOPICLONE, ESZOPICLONE
ETOMIDATE, ETOMIDATE
EZETIMIBE, EZETIMIBE
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FESOTERODINE FUMARATE, FESOTERODINE FUMARATE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FINASTERIDE, FINASTERIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
ICLEVIA, ETHINYL ESTRADIOL
INCASSIA, NORETHINDRONE
INDOMETHACIN, INDOMETHACIN
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ISOSULFAN BLUE, ISOSULFAN BLUE
KALLIGA, DESOGESTREL
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 32

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LINEZOLID, LINEZOLID

LO SIMPESSE, ETHINYL ESTRADIOL

LO-ZUMANDIMINE, DROSPIRENONE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MEROPENEM, MEROPENEM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHOCARBAMOL, METHOCARBAMOL

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METRONIDAZOLE, METRONIDAZOLE

MILI, ETHINYL ESTRADIOL

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MODAFINIL, MODAFINIL

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NADOLOL, NADOLOL

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

NEVIRAPINE, NEVIRAPINE

NEXESTA FE, ETHINYL ESTRADIOL

NIACIN, NIACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NYLIA 1/35, ETHINYL ESTRADIOL

NYLIA 7/7/7, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXACILLIN SODIUM, OXACILLIN SODIUM

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 33

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

REPAGLINIDE, REPAGLINIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERIDONE, RISPERIDONE

RITONAVIR, RITONAVIR

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

SIMPESSE, ETHINYL ESTRADIOL

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERIFLUNOMIDE, TERIFLUNOMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRI-LO-MILI, ETHINYL ESTRADIOL

TRI-MILI, ETHINYL ESTRADIOL

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLMITRIPTAN, ZOLMITRIPTAN

ZUMANDIMINE, DROSPIRENONE

* AUROBINDO PHARMA LTD INC

ZIDOVUDINE, ZIDOVUDINE

AUROLIFE PHARMA LLC

* AUROLIFE PHARMA LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DUTASTERIDE, DUTASTERIDE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

AUSTARPHARMA LLC

* AUSTARPHARMA LLC

METHOCARBAMOL, METHOCARBAMOL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

AUXILIUM PHARMS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 34

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUXILIUM PHARMACEUTICALS INC

TESTOPEL, TESTOSTERONE

THEO-24, THEOPHYLLINE

AUXILIUM PHARMS LLC

* AUXILIUM PHARMACEUTICALS LLC

DILATRATE-SR, ISOSORBIDE DINITRATE

EDEX, ALPROSTADIL

ROBAXIN, METHOCARBAMOL

ROBAXIN-750, METHOCARBAMOL

SEMPREX-D, ACRIVASTINE

STRIANT, TESTOSTERONE

TESTIM, TESTOSTERONE

THEO-24, THEOPHYLLINE

AVACOR PRODS

* AVACOR PRODUCTS LLC

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

AVADEL LEGACY

* AVADEL LEGACY PHARMACEUTICALS LLC

BLOXIVERZ, NEOSTIGMINE METHYLSULFATE

VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE

AVADEL SPECLT

* AVADEL SPECIALTY PHARMACEUTICALS LLC

NOCTIVA, DESMOPRESSIN ACETATE

AVANIR PHARMS

* AVANIR PHARMACEUTICALS

ONZETRA XSAIL, SUMATRIPTAN SUCCINATE

* AVANIR PHARMACEUTICALS INC

NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE

AVANTHI INC

* AVANTHI INC

CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

INDOMETHACIN, INDOMETHACIN

LOMAIRA, PHENTERMINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

AVEDRO INC

* AVEDRO INC

PHOTREXA VISCOUS IN DEXTRAN 20%, RIBOFLAVIN 5'-PHOSPHATE SODIUM

PHOTREXA, RIBOFLAVIN 5'-PHOSPHATE SODIUM

AVEMA PHARMA

* AVEMA PHARMA SOLUTIONS

IBUPROFEN, IBUPROFEN (OTC)

AVENT

* AVENT INC

PYTEST KIT, UREA, C-14

PYTEST, UREA, C-14

AVERITAS

* AVERITAS PHARMA INC

QUTENZA, CAPSAICIN

AVEVA

* AVEVA DRUG DELIVERY SYSTEMS INC

CLONIDINE, CLONIDINE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

NICOTINE, NICOTINE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 35

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

AVID RADIOPHARMS INC

* AVID RADIOPHARMACEUTICALS INC

AMYVID, FLORBETAPIR F-18

AVION PHARMS

* AVION PHARMACEUTICALS LLC

BALCOLTRA, ETHINYL ESTRADIOL

AVONDALE PHARMS

* AVONDALE PHARMACEUTICALS LLC

NIACOR, NIACIN

AYTU

* AYTU BIOSCIENCE INC

NATESTO, TESTOSTERONE

TUZISTRA XR, CHLORPHENIRAMINE POLISTIREX

** B **

B BRAUN

* B BRAUN MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINO ACIDS, AMINO ACIDS

BALANCED SALT, CALCIUM CHLORIDE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE

CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE

FREAMINE HBC 6.9%, AMINO ACIDS

FREAMINE III 10%, AMINO ACIDS

FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS

FREAMINE III 8.5%, AMINO ACIDS

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPATAMINE 8%, AMINO ACIDS

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 36

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

NEPHRAMINE 5.4%, AMINO ACIDS

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 37

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROCALAMINE, AMINO ACIDS

RESECTISOL IN PLASTIC CONTAINER, MANNITOL

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE

TROPHAMINE 10%, AMINO ACIDS

TROPHAMINE, AMINO ACIDS

B BRAUN MEDICAL INC

* B BRAUN MEDICAL INC

CLOROTEKAL, CHLOROPROCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM

BARR

* BARR LABORATORIES INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BALZIVA-28, ETHINYL ESTRADIOL

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

DANAZOL, DANAZOL

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DUTASTERIDE, DUTASTERIDE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXYUREA, HYDROXYUREA

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

ISONIAZID, ISONIAZID

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

KARIVA, DESOGESTREL

KELNOR, ETHINYL ESTRADIOL

LEFLUNOMIDE, LEFLUNOMIDE

LESSINA-28, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 38

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **
* BARR LABORATORIES INC
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

ONDANSETRON, ONDANSETRON

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PORTIA-28, ETHINYL ESTRADIOL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

SPRINTEC, ETHINYL ESTRADIOL

TEMOZOLOMIDE, TEMOZOLOMIDE

TREXALL, METHOTREXATE SODIUM

TRI-LEGEST 21, ETHINYL ESTRADIOL

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

WARFARIN SODIUM, WARFARIN SODIUM

* BARR PHARMACEUTICALS

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

BARR LABS DIV TEVA

* BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

BUDESONIDE, BUDESONIDE

BARR LABS INC

* BARR LABORATORIES INC

ACITRETIN, ACITRETIN

CLOZAPINE, CLOZAPINE

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ESTRADIOL, ESTRADIOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN

TRETINOIN, TRETINOIN

TRI LO SPRINTEC, ETHINYL ESTRADIOL

BAUSCH AND LOMB

* BAUSCH AND LOMB INC

ALAWAY, KETOTIFEN FUMARATE (OTC)

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALREX, LOTEPREDNOL ETABONATE

BESIVANCE, BESIFLOXACIN HYDROCHLORIDE

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

ISTALOL, TIMOLOL MALEATE

LATANOPROST, LATANOPROST

LOTEMAX, LOTEPREDNOL ETABONATE

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

OFLOXACIN, OFLOXACIN

OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

PROLENSA, BROMFENAC SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 39

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAUSCH AND LOMB INC

RETISERT, FLUOCINOLONE ACETONIDE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TROPICAMIDE, TROPICAMIDE

VITRASE, HYALURONIDASE

VYZULTA, LATANOPROSTENE BUNOD

ZIRGAN, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE

* BAUSCH AND LOMB PHARMACEUTICALS INC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

ERYTHROMYCIN, ERYTHROMYCIN

FLUNISOLIDE, FLUNISOLIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

OFLOXACIN, OFLOXACIN

OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

OTICAIR, HYDROCORTISONE

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAUSCH AND LOMB INC

* BAUSCH AND LOMB INC

BEPREVE, BEPOTASTINE BESILATE

LOTEMAX, LOTEPREDNOL ETABONATE

LUMIFY, BRIMONIDINE TARTRATE (OTC)

BAXTER HLTHCARE

* BAXTER HEALTHCARE CORP

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 40

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

EXTRANEAL, ICODEXTRIN

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FORANE, ISOFLURANE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

IFEX, IFOSFAMIDE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 41

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MESNEX, MESNA

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NEXTERONE, AMIODARONE HYDROCHLORIDE

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

STERILE WATER, STERILE WATER FOR IRRIGATION

SUPRANE, DESFLURANE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIS-U-SOL, MAGNESIUM SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 42

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP

* BAXTER HEALTHCARE CORP

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, BIVALIRUDIN

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FUROSEMIDE, FUROSEMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOFLOXACIN, LEVOFLOXACIN

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

BAYER

* BAYER HEALTHCARE LLC

ALEVE, NAPROXEN SODIUM (OTC)

ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)

BAYER HEALTHCARE

* BAYER HEALTHCARE PHARMACEUTICALS INC

ALIQOPA, COPANLISIB DIHYDROCHLORIDE

BAYER HEALTHCARE LLC

* BAYER HEALTHCARE LLC

CHILDREN'S CLARITIN, LORATADINE (OTC)

CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)

CLARITIN HIVES RELIEF, LORATADINE (OTC)

CLARITIN REDITABS, LORATADINE (OTC)

CLARITIN, LORATADINE (OTC)

CLARITIN-D 24 HOUR, LORATADINE (OTC)

CLARITIN-D, LORATADINE (OTC)

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)

MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)

ZEGERID OTC, OMEPRAZOLE (OTC)

BAYER HLTHCARE

* BAYER HEALTHCARE CONSUMER CARE

ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

* BAYER HEALTHCARE PHARMACEUTICALS INC

ADEMPAS, RIOCIGUAT

ANGELIQ, DROSPIRENONE

AVELOX, MOXIFLOXACIN HYDROCHLORIDE

BEYAZ, DROSPIRENONE

BILTRICIDE, PRAZIQUANTEL

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 43

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAYER HEALTHCARE PHARMACEUTICALS INC

CLIMARA PRO, ESTRADIOL

CLIMARA, ESTRADIOL

EOVIST, GADOXETATE DISODIUM

GADAVIST, GADOBUTROL

KYLEENA, LEVONORGESTREL

LEVITRA, VARDENAFIL HYDROCHLORIDE

MAGNEVIST, GADOPENTETATE DIMEGLUMINE

MENOSTAR, ESTRADIOL

MIRENA, LEVONORGESTREL

NATAZIA, DIENOGEST

NEXAVAR, SORAFENIB TOSYLATE

PRECOSE, ACARBOSE

SAFYRAL, DROSPIRENONE

SKYLA, LEVONORGESTREL

STAXYN, VARDENAFIL HYDROCHLORIDE

STIVARGA, REGORAFENIB

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 240, IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

XOFIGO, RADIUM RA-223 DICHLORIDE

YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYSHORE PHARMS LLC

* BAYSHORE PHARMACEUTICALS LLC

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

BDSI

* BIODELIVERY SCIENCES INTERNATIONAL INC

BELBUCA, BUPRENORPHINE HYDROCHLORIDE

BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE

BECTON DICKINSON

* BECTON DICKINSON AND CO

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

BECTON DICKINSON CO

* BECTON DICKINSON AND CO

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

BEIJING YILING

* BEIJING YILING BIO-ENGEERING AND TECHNOLOGY CO LTD

ANASTROZOLE, ANASTROZOLE

LETROZOLE, LETROZOLE

BELCHER PHARMS

* BELCHER PHARMACEUTICALS LLC

CEPHALEXIN, CEPHALEXIN

DESLORATADINE, DESLORATADINE

BELCHER PHARMS LLC

* BELCHER PHARMACEUTICALS LLC

ABLYSINOL, ALCOHOL

CEFIXIME, CEFIXIME

EPINEPHRINE, EPINEPHRINE

MEFENAMIC ACID, MEFENAMIC ACID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TACROLIMUS, TACROLIMUS

BELOTECA INC

* BELOTECA INC

ISOSULFAN BLUE, ISOSULFAN BLUE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 44

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

BEXIMCO PHARMS USA

* BEXIMCO PHARMACEUTICALS USA INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

NADOLOL, NADOLOL

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

BEXIMCO USA

* BEXIMCO PHARMACEUTICALS USA INC

CARVEDILOL, CARVEDILOL

BI-COASTAL PHARMA

* BI-COASTAL PHARMA INTERNATIONAL LLC

DUVOID, BETHANECHOL CHLORIDE

BIO NUCLEONICS

* BIO NUCLEONICS INC

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89

BIO PHARM INC

* BIO PHARM INC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

BIO-PHARM INC

* BIO-PHARM INC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

BIOCODEX SA

* BIOCODEX SA

DIACOMIT, STIRIPENTOL

BIOCON LIMITED

* BIOCON LIMITED

SIMVASTATIN, SIMVASTATIN

BIOCON LTD

* BIOCON LTD

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

BIOCRYST

* BIOCRYST PHARMACEUTICALS INC

RAPIVAB, PERAMIVIR

BIOFRONTERA

* BIOFRONTERA BIOSCIENCE GMBH

AMELUZ, AMINOLEVULINIC ACID HYDROCHLORIDE

BIOGEN IDEC

* BIOGEN IDEC INC

SPINRAZA, NUSINERSEN SODIUM

BIOGEN IDEC INC

* BIOGEN IDEC INC

TECFIDERA, DIMETHYL FUMARATE

BIOMARIN PHARM

* BIOMARIN PHARMACEUTICAL INC

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

BIOMEDCL RES FDN

* BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

BIONPHARMA INC

* BIONPHARMA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BENZONATATE, BENZONATATE

BEXAROTENE, BEXAROTENE

CALCITRIOL, CALCITRIOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 45

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BIONPHARMA INC

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLOBAZAM, CLOBAZAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DOFETILIDE, DOFETILIDE

DUTASTERIDE, DUTASTERIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MIDOL LIQUID GELS, IBUPROFEN (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NIMODIPINE, NIMODIPINE

PARICALCITOL, PARICALCITOL

PROGESTERONE, PROGESTERONE

TETRABENAZINE, TETRABENAZINE

VALPROIC ACID, VALPROIC ACID

VITAMIN D, ERGOCALCIFEROL

BLAIREX

* BLAIREX LABORATORIES INC

BRONCHO SALINE, SODIUM CHLORIDE (OTC)

BLUE EARTH

* BLUE EARTH DIAGNOSTICS LTD

AXUMIN, FLUCICLOVINE F-18

BLUEPHARMA

* BLUEPHARMA US INC

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

BOEHRINGER INGELHEIM

* BOEHRINGER INGELHEIM

CATAPRES, CLONIDINE HYDROCHLORIDE

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

GILOTRIF, AFATINIB DIMALEATE

GLYXAMBI, EMPAGLIFLOZIN

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICARDIS, TELMISARTAN

MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

AGGRENOX, ASPIRIN

APTIVUS, TIPRANAVIR

ATROVENT HFA, IPRATROPIUM BROMIDE

COMBIVENT RESPIMAT, ALBUTEROL SULFATE

JARDIANCE, EMPAGLIFLOZIN

JENTADUETO XR, LINAGLIPTIN

JENTADUETO, LINAGLIPTIN

MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE

MOBIC, MELOXICAM

OFEV, NINTEDANIB ESYLATE

PERSANTINE, DIPYRIDAMOLE

PRADAXA, DABIGATRAN ETEXILATE MESYLATE

SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE

SPIRIVA, TIOTROPIUM BROMIDE

STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE

STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE

SYNJARDY XR, EMPAGLIFLOZIN

SYNJARDY, EMPAGLIFLOZIN

TRADJENTA, LINAGLIPTIN

TWYNSTA, AMLODIPINE BESYLATE

VIRAMUNE XR, NEVIRAPINE

VIRAMUNE, NEVIRAPINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 46

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

BOSCOGEN

* BOSCOGEN INC

ACYCLOVIR, ACYCLOVIR

ANASTROZOLE, ANASTROZOLE

ARIPIPRAZOLE, ARIPIPRAZOLE

BICALUTAMIDE, BICALUTAMIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

REPAGLINIDE, REPAGLINIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

BPI LABS LLC

* BPI LABS LLC

ZOLEDRONIC ACID, ZOLEDRONIC ACID

BRACCO

* BRACCO DIAGNOSTICS INC

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

E-Z-HD, BARIUM SULFATE

E-Z-PAQUE, BARIUM SULFATE

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

KINEVAC, SINCALIDE

LIQUID E-Z-PAQUE, BARIUM SULFATE

LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MULTIHANCE, GADOBENATE DIMEGLUMINE

PROHANCE MULTIPACK, GADOTERIDOL

PROHANCE, GADOTERIDOL

READI-CAT 2 SMOOTHIES, BARIUM SULFATE

READI-CAT 2, BARIUM SULFATE

TAGITOL V, BARIUM SULFATE

VARIBAR HONEY, BARIUM SULFATE

VARIBAR NECTAR, BARIUM SULFATE

VARIBAR PUDDING, BARIUM SULFATE

VARIBAR THIN HONEY, BARIUM SULFATE

BRAINTREE

* BRAINTREE LABORATORIES INC

GOLYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

BRAINTREE LABS

* BRAINTREE LABORATORIES INC

SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE

BRECKENRIDGE PHARM

* BRECKENRIDGE PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CILOSTAZOL, CILOSTAZOL

CLOBAZAM, CLOBAZAM

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

ENTECAVIR, ENTECAVIR

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPLERENONE, EPLERENONE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

LANSOPRAZOLE, LANSOPRAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 47

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BRECKENRIDGE PHARMACEUTICAL INC

LEVETIRACETAM, LEVETIRACETAM

MEFENAMIC ACID, MEFENAMIC ACID

MEGESTROL ACETATE, MEGESTROL ACETATE

MELOXICAM, MELOXICAM

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

OMEPRAZOLE, OMEPRAZOLE

OXCARBAZEPINE, OXCARBAZEPINE

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIROXICAM, PIROXICAM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

ROFLUMILAST, ROFLUMILAST

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

BRIGHAM WOMENS

* BRIGHAM AND WOMENS HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

BRIGHAM WOMENS HOSP

* BRIGHAM AND WOMENS HOSP INC

AMMONIA N 13, AMMONIA N-13

BRISTOL MYERS SQUIBB

* BRISTOL MYERS SQUIBB

AZACTAM, AZTREONAM

BARACLUDE, ENTECAVIR

PRAVACHOL, PRAVASTATIN SODIUM

* BRISTOL MYERS SQUIBB CO

AZACTAM IN PLASTIC CONTAINER, AZTREONAM

DROXIA, HYDROXYUREA

GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE

HYDREA, HYDROXYUREA

REYATAZ, ATAZANAVIR SULFATE

SPRYCEL, DASATINIB

SUSTIVA, EFAVIRENZ

VIDEX EC, DIDANOSINE

* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

ELIQUIS, APIXABAN

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

GLUCOPHAGE, METFORMIN HYDROCHLORIDE

ZERIT, STAVUDINE

* BRISTOL MYERS SQUIBB PHARMA CO

COUMADIN, WARFARIN SODIUM

BRISTOL-MYERS SQUIBB

* BRISTOL-MYERS SQUIBB CO

DAKLINZA, DACLATASVIR DIHYDROCHLORIDE

EVOTAZ, ATAZANAVIR SULFATE

VIDEX, DIDANOSINE

ZERIT, STAVUDINE

** C **

CADILA PHARMS LTD

* CADILA PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

GEMFIBROZIL, GEMFIBROZIL

GLYBURIDE, GLYBURIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 48

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CADILA PHARMACEUTICALS LTD

OFLOXACIN, OFLOXACIN

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

TELMISARTAN, TELMISARTAN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

CADISTA PHARMS

* CADISTA PHARMACEUTICALS INC

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

CALL INC

* CALL INC DBA ROCHESTER PHARMACEUTICALS

ADAPALENE, ADAPALENE

CAPELLON PHARMS LLC

* CAPELLON PHARMACEUTICALS LLC

POLMON, DEXCHLORPHENIRAMINE MALEATE

CARDINAL HEALTH 414

* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

CARDINAL HEALTH 418

* CARDINAL HEALTH 418 INC

SODIUM IODIDE I 123, SODIUM IODIDE I-123

CARIBE HOLDINGS

* CARIBE HOLDINGS CAYMAN CO LTD DBA PURACAP CARIBE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

GEMFIBROZIL, GEMFIBROZIL

CARLSBAD

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FAMOTIDINE, FAMOTIDINE

GLIMEPIRIDE, GLIMEPIRIDE

LOVASTATIN, LOVASTATIN

CARLSBAD TECHNOLOGY

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CASI PHARMS INC

* CASI PHARMACEUTICALS INC

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CEFPROZIL, CEFPROZIL

CILOSTAZOL, CILOSTAZOL

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ENTECAVIR, ENTECAVIR

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

LISINOPRIL, LISINOPRIL

METHIMAZOLE, METHIMAZOLE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NABUMETONE, NABUMETONE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

REPAGLINIDE, REPAGLINIDE

RIBAVIRIN, RIBAVIRIN

SPIRONOLACTONE, SPIRONOLACTONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 49

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CASI PHARMACEUTICALS INC

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

CASPER PHARMA LLC

* CASPER PHARMA LLC

AQUASOL A, VITAMIN A PALMITATE

CASPORYN HC, HYDROCORTISONE

FURADANTIN, NITROFURANTOIN

NEOSPORIN, BACITRACIN ZINC

ZYLOPRIM, ALLOPURINOL

CATALENT

* CATALENT PHARMA SOLUTIONS LLC

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

VALPROIC ACID, VALPROIC ACID

CATALYST PHARMS

* CATALYST PHARMACEUTICALS INC

FIRDAPSE, AMIFAMPRIDINE PHOSPHATE

CEDIPROF INC

* CEDIPROF INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

LEVO-T, LEVOTHYROXINE SODIUM **

CELATOR PHARMS

* CELATOR PHARMACEUTICALS INC

VYXEOS, CYTARABINE

CELERITY PHARMS

* CELERITY PHARMACEUTICALS LLC

EPTIFIBATIDE, EPTIFIBATIDE

CELGENE

* CELGENE CORP

ISTODAX, ROMIDEPSIN

POMALYST, POMALIDOMIDE

REVLIMID, LENALIDOMIDE

THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE

CELGENE CORP

* CELGENE CORP

IDHIFA, ENASIDENIB MESYLATE

OTEZLA, APREMILAST

CELLTRION

* CELLTRION INC

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TEMIXYS, LAMIVUDINE

CEPHALON

* CEPHALON INC

ACTIQ, FENTANYL CITRATE

FENTORA, FENTANYL CITRATE

GABITRIL, TIAGABINE HYDROCHLORIDE

NUVIGIL, ARMODAFINIL

PROVIGIL, MODAFINIL

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE

CERECOR INC

* CERECOR INC

ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM

CEYONE

* CEYONE PHARMA LLC

RISPERIDONE, RISPERIDONE

CHANGZHOU PHARM

* CHANGZHOU PHARMACEUTICAL FACTORY

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

CHARTWELL LIFE SCI

* CHARTWELL LIFE SCIENCE LLC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 50

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CHARTWELL LIFE SCIENCE LLC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

CHARTWELL MOLECULAR

* CHARTWELL MOLECULAR HOLDINGS LLC

CARVEDILOL, CARVEDILOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FOLIC ACID, FOLIC ACID

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

RAMIPRIL, RAMIPRIL

RISPERIDONE, RISPERIDONE

CHARTWELL MOLECULES

* CHARTWELL MOLECULES LLC

DISULFIRAM, DISULFIRAM

GEMFIBROZIL, GEMFIBROZIL

NABUMETONE, NABUMETONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

CHARTWELL RX

* CHARTWELL RX SCIENCES LLC

CALCIUM ACETATE, CALCIUM ACETATE

CILOSTAZOL, CILOSTAZOL

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

INDOMETHACIN, INDOMETHACIN

LEVETIRACETAM, LEVETIRACETAM

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

CHARTWELL TETRA

* CHARTWELL TETRA LLC

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

CHATTEM

* CHATTEM INC

UNISOM, DOXYLAMINE SUCCINATE (OTC)

CHEMI SPA

* CHEMI SPA

DECITABINE, DECITABINE

TEMOZOLOMIDE, TEMOZOLOMIDE

CHEMISCH FBRK KRSSLR

* CHEMISCHE FABRIK KREUSSLER & CO. GMBH

ASCLERA, POLIDOCANOL

CHEMO RESEARCH SL

* CHEMO RESEARCH SL

BENZNIDAZOLE, BENZNIDAZOLE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NUVESSA, METRONIDAZOLE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

CHEPLAPHARM

* CHEPLAPHARM ARZNEIMITTEL GMBH

XENICAL, ORLISTAT

CHIESI USA INC

* CHIESI USA INC

BETHKIS, TOBRAMYCIN

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CLEVIPREX, CLEVIDIPINE

CUROSURF, PORACTANT ALFA

KENGREAL, CANGRELOR

ZYFLO CR, ZILEUTON

ZYFLO, ZILEUTON

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 51

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

CHILDRENS HOSP MI

* CHILDRENS HOSP MICHIGAN

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

CHINA RESOURCES

* CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CHIRHOCLIN

* CHIRHOCLIN INC

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CINTEX SVCS

* CINTEX SERVICES LLC

FLURANDRENOLIDE, FLURANDRENOLIDE

CIPHER PHARMS INC

* CIPHER PHARMACEUTICALS INC

CONZIP, TRAMADOL HYDROCHLORIDE

LIPOFEN, FENOFIBRATE

CIPLA

* CIPLA LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

AZACITIDINE, AZACITIDINE

BIVALIRUDIN, BIVALIRUDIN

BUDESONIDE, BUDESONIDE

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CELECOXIB, CELECOXIB

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DECITABINE, DECITABINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOCETAXEL, DOCETAXEL

EFAVIRENZ, EFAVIRENZ

EMTRICITABINE, EMTRICITABINE

ENTECAVIR, ENTECAVIR

EXEMESTANE, EXEMESTANE

FAMCICLOVIR, FAMCICLOVIR

FENOFIBRATE, FENOFIBRATE

FINASTERIDE, FINASTERIDE

FLUTAMIDE, FLUTAMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

MELOXICAM, MELOXICAM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEVIRAPINE, NEVIRAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 52

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CIPLA LTD

TESTOSTERONE, TESTOSTERONE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

ZIDOVUDINE, ZIDOVUDINE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

CIPLA LTD

* CIPLA LTD

ALBENDAZOLE, ALBENDAZOLE

CARBOPLATIN, CARBOPLATIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

TOPIRAMATE, TOPIRAMATE

ZALEPLON, ZALEPLON

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CLINIGEN HLTHCARE

* CLINIGEN HEALTHCARE LTD

ETHYOL, AMIFOSTINE

FOSCAVIR, FOSCARNET SODIUM

TOTECT, DEXRAZOXANE HYDROCHLORIDE

CLOVER PHARMS

* CLOVER PHARMACEUTICALS CORP

AMICAR, AMINOCAPROIC ACID

CLOVIS ONCOLOGY INC

* CLOVIS ONCOLOGY INC

RUBRACA, RUCAPARIB CAMSYLATE

CMP DEV LLC

* CMP DEVELOPMENT LLC

CAROSPIR, SPIRONOLACTONE

CMP PHARMA INC

* CMP PHARMA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

ISONIAZID, ISONIAZID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SPS, SODIUM POLYSTYRENE SULFONATE

TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE

CNTY LINE PHARMS

* COUNTY LINE PHARMACEUTICALS LLC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CICLOPIROX, CICLOPIROX

DYNACIN, MINOCYCLINE HYDROCHLORIDE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FLUOCINONIDE, FLUOCINONIDE

LIDEX, FLUOCINONIDE

LIDEX-E, FLUOCINONIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

TAMBOCOR, FLECAINIDE ACETATE

TRANDATE, LABETALOL HYDROCHLORIDE

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

UREX, METHENAMINE HIPPURATE

COLGATE PALMOLIVE

* COLGATE PALMOLIVE

COLGATE TOTAL, SODIUM FLUORIDE (OTC)

COLGATE PALMOLIVE CO

* COLGATE PALMOLIVE CO

PERIOGARD, CHLORHEXIDINE GLUCONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 53

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

COLGATE-PALMOLIVE CO

* COLGATE-PALMOLIVE CO

PERIOGARD, CHLORHEXIDINE GLUCONATE

COLLEGIUM PHARM INC

* COLLEGIUM PHARMACEUTICAL INC

XTAMPZA ER, OXYCODONE

COMBE

* COMBE INC

VAGISTAT-1, TIOCONAZOLE (OTC)

CONCORD BIOTECH LTD

* CONCORD BIOTECH LTD

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

CONCORDIA LABS INC

* CONCORDIA LABORATORIES INC

PHOTOFRIN, PORFIMER SODIUM

CONCORDIA PHARMS INC

* CONCORDIA PHARMACEUTICALS INC

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DUTOPROL, HYDROCHLOROTHIAZIDE

DYRENIUM, TRIAMTERENE

KAPVAY, CLONIDINE HYDROCHLORIDE

LANOXIN, DIGOXIN

NILANDRON, NILUTAMIDE

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

PARNATE, TRANYLCYPROMINE SULFATE

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

CONTRACT PHARMACAL

* CONTRACT PHARMACAL CORP

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

COOPERSURGICAL

* COOPERSURGICAL INC

PARAGARD T 380A, COPPER

CORCEPT THERAP

* CORCEPT THERAPEUTICS INC

KORLYM, MIFEPRISTONE

CORDEN PHARMA

* CORDEN PHARMA LATINA SPA

GLEOSTINE, LOMUSTINE

COSMO TECHNOLOGIES

* COSMO TECHNOLOGIES LTD

AEMCOLO, RIFAMYCIN

COVIS PHARMA BV

* COVIS PHARMA BV

ALTOPREV, LOVASTATIN

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAPACE, SOTALOL HYDROCHLORIDE

LANOXIN PEDIATRIC, DIGOXIN

LANOXIN, DIGOXIN

PRILOSEC, OMEPRAZOLE MAGNESIUM

RILUTEK, RILUZOLE

SULAR, NISOLDIPINE

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

CPDC

* CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

CPPI CV

* CP PHARMACEUTICALS INTERNATIONAL CV

SUTENT, SUNITINIB MALATE

CRANE PHARMS LLC

* CRANE PHARMACEUTICALS LLC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 54

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CRANE PHARMACEUTICALS LLC

DAPTOMYCIN, DAPTOMYCIN

CROSSMEDIKA SA

* CROSSMEDIKA SA

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

CROWN LABS

* CROWN LABORATORIES INC

ALA-CORT, HYDROCORTISONE

ALA-SCALP, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

CROWN LABS INC

* CROWN LABORATORIES INC

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

CSPC NBP PHARM CO

* CSPC NBP PHARMACEUTICAL CO LTD

BENZONATATE, BENZONATATE

CSPC OUYI PHARM CO

* CSPC OUYI PHARMACEUTICAL CO LTD

AZITHROMYCIN, AZITHROMYCIN

CELECOXIB, CELECOXIB

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

CUBIST PHARMS

* CUBIST PHARMACEUTICALS INC

ENTEREG, ALVIMOPAN

CUBIST PHARMS LLC

* CUBIST PHARMACEUTICALS LLC

CUBICIN RF, DAPTOMYCIN

CUBICIN, DAPTOMYCIN

DIFICID, FIDAXOMICIN

SIVEXTRO, TEDIZOLID PHOSPHATE

ZERBAXA, CEFTOLOZANE SULFATE

CUMBERLAND PHARMS

* CUMBERLAND PHARMACEUTICALS INC

ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

LACTULOSE, LACTULOSE

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

VIBATIV, TELAVANCIN HYDROCHLORIDE

CUSTOPHARM INC

* CUSTOPHARM INC

ACETAMINOPHEN, ACETAMINOPHEN

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

CUTANEA

* CUTANEA LIFE SCIENCES INC

AKTIPAK, BENZOYL PEROXIDE

CYCLE PHARMS LTD

* CYCLE PHARMACEUTICALS LTD

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

NITYR, NITISINONE

CYPRESS PHARM

* CYPRESS PHARMACEUTICAL INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 55

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CYPRESS PHARMACEUTICAL INC

REZIRA, HYDROCODONE BITARTRATE

VITUZ, CHLORPHENIRAMINE MALEATE

ZUTRIPRO, CHLORPHENIRAMINE MALEATE

** D **

DAEWOONG PHARM CO

* DAEWOONG PHARMACEUTICAL CO LTD

MEROPENEM, MEROPENEM

DAIICHI SANKYO

* DAIICHI SANKYO INC

AZOR, AMLODIPINE BESYLATE

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENICAR, OLMESARTAN MEDOXOMIL

TRIBENZOR, AMLODIPINE BESYLATE

WELCHOL, COLESEVELAM HYDROCHLORIDE

DAIICHI SANKYO INC

* DAIICHI SANKYO INC

EVOXAC, CEVIMELINE HYDROCHLORIDE

MORPHABOND ER, MORPHINE SULFATE

SAVAYSA, EDOXABAN TOSYLATE

DAITO PHARMS CO LTD

* DAITO PHARMACEUTICALS CO LTD

RILUZOLE, RILUZOLE

DANCO LABS LLC

* DANCO LABORATORIES LLC

MIFEPREX, MIFEPRISTONE

DAVA INTL INC

* DAVA INTERNATIONAL INC

ALPRAZOLAM, ALPRAZOLAM

DAVA PHARMS INC

* DAVA PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

AMOXICILLIN, AMOXICILLIN

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ATENOLOL, ATENOLOL

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

GLYBURIDE (MICRONIZED), GLYBURIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PROPYLTHIOURACIL, PROPYLTHIOURACIL

PYRAZINAMIDE, PYRAZINAMIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

VOSPIRE ER, ALBUTEROL SULFATE

DAVIS AND GECK

* DAVIS AND GECK DIV AMERICAN CYANAMID CO

PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DBL PHARMS

* DBL PHARMACEUTICALS INC

METHOCARBAMOL, METHOCARBAMOL

DENTSPLY PHARM

* DENTSPLY PHARMACEUTICAL INC

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

ORAQIX, LIDOCAINE

DEPO NF

* DEPO NF SUB LLC A SUB OF ASSERTIO THERAPEUTICS INC

NUCYNTA ER, TAPENTADOL HYDROCHLORIDE

NUCYNTA, TAPENTADOL HYDROCHLORIDE

DEPROCO

* DEPROCO INC

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 56

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DEPROCO INC

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

SCANDONEST L, LEVONORDEFRIN

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

DERMIRA INC

* DERMIRA INC

QBREXZA, GLYCOPYRRONIUM TOSYLATE

DEVA HOLDING AS

* DEVA HOLDING AS

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

TEMOZOLOMIDE, TEMOZOLOMIDE

DEXCEL LTD

* DEXCEL LTD

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

DEXCEL PHARMA

* DEXCEL PHARMA TECHNOLOGIES LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LEVETIRACETAM, LEVETIRACETAM

OMEPRAZOLE, OMEPRAZOLE (OTC)

PERIOCHIP, CHLORHEXIDINE GLUCONATE

DFB ONCOLOGY LTD

* DFB ONCOLOGY LTD

DOCETAXEL, DOCETAXEL

DIAGNOSTIC GREEN

* DIAGNOSTIC GREEN GMBH

INDOCYANINE GREEN, INDOCYANINE GREEN

DIALYSIS SUPS

* DIALYSIS SUPPLIES INC

NORMOCARB HF 25, MAGNESIUM CHLORIDE

NORMOCARB HF 35, MAGNESIUM CHLORIDE

DIGESTIVE CARE INC

* DIGESTIVE CARE INC

PERTZYE, PANCRELIPASE (AMYLASE

DORC

* DORC INTERNATIONAL BV

MEMBRANEBLUE, TRYPAN BLUE

VISIONBLUE, TRYPAN BLUE

DOUGLAS PHARMS

* DOUGLAS PHARMACEUTICALS AMERICA LTD

MYORISAN, ISOTRETINOIN

DOW PHARM

* DOW PHARMACEUTICAL SCIENCES

ACANYA, BENZOYL PEROXIDE

ALTRENO, TRETINOIN

ATRALIN, TRETINOIN

BRYHALI, HALOBETASOL PROPIONATE

ONEXTON, BENZOYL PEROXIDE

OXSORALEN-ULTRA, METHOXSALEN

DR REDDYS LA

* DR REDDYS LABORATORIES LOUISIANA LLC

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LOPURIN, ALLOPURINOL

SSD, SILVER SULFADIAZINE

DR REDDYS LABS INC

* DR REDDYS LABORATORIES INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AUGMENTIN '875', AMOXICILLIN

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 57

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES INC

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LEVOFLOXACIN, LEVOFLOXACIN

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NITROGLYCERIN, NITROGLYCERIN

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROGESTERONE, PROGESTERONE

PROPOFOL, PROPOFOL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SIMVASTATIN, SIMVASTATIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

DR REDDYS LABS LTD

* DR REDDYS LABORATORIES LIMITED

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* DR REDDYS LABORATORIES LTD

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZACITIDINE, AZACITIDINE

BIVALIRUDIN, BIVALIRUDIN

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOFARABINE, CLOFARABINE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DECITABINE, DECITABINE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOCETAXEL, DOCETAXEL

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESZOPICLONE, ESZOPICLONE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 58

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES LTD

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IMATINIB MESYLATE, IMATINIB MESYLATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LATANOPROST, LATANOPROST

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NATEGLINIDE, NATEGLINIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NIZATIDINE, NIZATIDINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMEPRAZOLE, OMEPRAZOLE

OMEPRAZOLE, OMEPRAZOLE (OTC)

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIROLIMUS, SIROLIMUS

TACROLIMUS, TACROLIMUS

TETRABENAZINE, TETRABENAZINE

THIOTEPA, THIOTEPA

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ZAFIRLUKAST, ZAFIRLUKAST

ZEMBRACE SYMTOUCH, SUMATRIPTAN SUCCINATE

ZENATANE, ISOTRETINOIN

ZOLEDRONIC ACID, ZOLEDRONIC ACID

DR REDDYS LABS SA

* DR REDDYS LABORATORIES SA

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 59

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES SA

HABITROL, NICOTINE (OTC)

MERCAPTOPURINE, MERCAPTOPURINE

RAMELTEON, RAMELTEON

TOBRAMYCIN, TOBRAMYCIN

DRAXIMAGE

* DRAXIMAGE INC

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT

DUCHESNAY

* DUCHESNAY INC

BONJESTA, DOXYLAMINE SUCCINATE

DICLEGIS, DOXYLAMINE SUCCINATE

OSPHENA, OSPEMIFENE

DURAMED PHARMS BARR

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

AVIANE-28, ETHINYL ESTRADIOL

CRYSELLE, ETHINYL ESTRADIOL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

ENPRESSE-28, ETHINYL ESTRADIOL

METHYLPREDNISOLONE, METHYLPREDNISOLONE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VELIVET, DESOGESTREL

DUSA

* DUSA PHARMACEUTICALS INC

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

REDDYS

* DOCTOR REDDYS LABORATORIES LTD

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

** E **

EAGLE PHARMS

* EAGLE PHARMACEUTICALS INC

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

BELRAPZO, BENDAMUSTINE HYDROCHLORIDE

BENDEKA, BENDAMUSTINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

RYANODEX, DANTROLENE SODIUM

ECI PHARMS LLC

* ECI PHARMACEUTICALS LLC

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LAMIVUDINE, LAMIVUDINE

LEVETIRACETAM, LEVETIRACETAM

METHIMAZOLE, METHIMAZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

VALPROIC ACID, VALPROIC ACID

XTRELUS, GUAIFENESIN

ECOLAB

* ECOLAB INC

CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)

CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)

ECR

* ECR PHARMACEUTICALS

DEXAMETHASONE, DEXAMETHASONE

ECR PHARMA

* ECR PHARMA

TUSSICAPS, CHLORPHENIRAMINE POLISTIREX

EDENBRIDGE PHARMS

* EDENBRIDGE PHARMACEUTICALS LLC

CARBIDOPA, CARBIDOPA

ETHACRYNIC ACID, ETHACRYNIC ACID

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 60

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EDENBRIDGE PHARMACEUTICALS LLC

ETODOLAC, ETODOLAC

IVERMECTIN, IVERMECTIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TINIDAZOLE, TINIDAZOLE

EDISON THERAPS LLC

* EDISON THERAPEUTICS LLC

METHERGINE, METHYLERGONOVINE MALEATE

EGALET US INC

* EGALET US INC

OXAYDO, OXYCODONE HYDROCHLORIDE

SPRIX, KETOROLAC TROMETHAMINE

EI INC

* EI INC

THEROXIDIL, MINOXIDIL (OTC)

EISAI INC

* EISAI INC

ACIPHEX, RABEPRAZOLE SODIUM

ARICEPT, DONEPEZIL HYDROCHLORIDE

BANZEL, RUFINAMIDE

BELVIQ XR, LORCASERIN HYDROCHLORIDE

BELVIQ, LORCASERIN HYDROCHLORIDE

FYCOMPA, PERAMPANEL

HALAVEN, ERIBULIN MESYLATE

HEXALEN, ALTRETAMINE

LENVIMA, LENVATINIB MESYLATE

PANRETIN, ALITRETINOIN

SALAGEN, PILOCARPINE HYDROCHLORIDE

ELEFSEE PHARMS INTL

* ELEFSEE PHARMACEUTICALS INTERNATIONAL LTD

LAZANDA, FENTANYL CITRATE

ELI LILLY AND CO

* ELI LILLY AND CO

BASAGLAR, INSULIN GLARGINE

EFFIENT, PRASUGREL HYDROCHLORIDE

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

OLUMIANT, BARICITINIB

PROZAC, FLUOXETINE HYDROCHLORIDE

VERZENIO, ABEMACICLIB

ELI LILLY CO

* ELI LILLY CO

ADCIRCA, TADALAFIL

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ELITE LABS

* ELITE LABORATORIES INC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

ELITE LABS INC

* ELITE LABORATORIES INC

DANTROLENE SODIUM, DANTROLENE SODIUM

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

ISRADIPINE, ISRADIPINE

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

EMCURE PHARMS

* EMCURE PHARMACEUTICALS LTD

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

EMCURE PHARMS LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 61

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EMCURE PHARMACEUTICALS LTD

ACARBOSE, ACARBOSE

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BICNU, CARMUSTINE

CIDOFOVIR, CIDOFOVIR

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ETOMIDATE, ETOMIDATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

RIFAMPIN, RIFAMPIN

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TRANEXAMIC ACID, TRANEXAMIC ACID

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

EMD SERONO

* EMD SERONO INC

GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA

GONAL-F RFF, FOLLITROPIN ALFA/BETA

GONAL-F, FOLLITROPIN ALFA/BETA

OVIDREL, CHORIOGONADOTROPIN ALFA

SAIZEN, SOMATROPIN RECOMBINANT

SEROSTIM, SOMATROPIN RECOMBINANT

ZORBTIVE, SOMATROPIN RECOMBINANT

EMD SERONO INC

* EMD SERONO INC

CETROTIDE, CETRORELIX

EMERALD INTL LTD

* EMERALD INTERNATIONAL LTD

BACLOFEN, BACLOFEN

EMMAUS MEDCL

* EMMAUS MEDICAL INC

ENDARI, L-GLUTAMINE

NUTRESTORE, L-GLUTAMINE

ENCORE DERMAT

* ENCORE DERMATOLOGY INC

IMPOYZ, CLOBETASOL PROPIONATE

ENCUBE ETHICALS

* ENCUBE ETHICALS PVT LTD

FLUOCINONIDE, FLUOCINONIDE

ENDO PHARM

* ENDO PHARMACEUTICAL SOLUTIONS INC

SUPPRELIN LA, HISTRELIN ACETATE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

VANTAS, HISTRELIN ACETATE

ENDO PHARMS

* ENDO PHARMACEUTICALS INC

FORTESTA, TESTOSTERONE

FROVA, FROVATRIPTAN SUCCINATE

OPANA, OXYMORPHONE HYDROCHLORIDE

PERCODAN, ASPIRIN

ENDO PHARMS INC

* ENDO PHARMACEUTICALS INC

AVEED, TESTOSTERONE UNDECANOATE

COLY-MYCIN S, COLISTIN SULFATE

MEGACE ES, MEGESTROL ACETATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 62

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* ENDO PHARMACEUTICALS INC

NASCOBAL, CYANOCOBALAMIN

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

EPI HLTH

* EPI HEALTH LLC

CLODERM, CLOCORTOLONE PIVALATE

MINOLIRA, MINOCYCLINE HYDROCHLORIDE

SITAVIG, ACYCLOVIR

EPIC PHARMA

* EPIC PHARMA INC

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

* EPIC PHARMA LLC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

SULINDAC, SULINDAC

TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL

EPIC PHARMA INC

* EPIC PHARMA INC

ESTRADIOL, ESTRADIOL

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

EPIC PHARMA LLC

* EPIC PHARMA LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

GABAPENTIN, GABAPENTIN

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE, GLYBURIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

ESPERO

* ESPERO BIOPHARMA INC

DURLAZA, ASPIRIN

ESSENTIAL ISOTOPES

* ESSENTIAL ISOTOPES LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

ETHYPHARM

* ETHYPHARM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

ETHYPHARM USA CORP

* ETHYPHARM USA CORP

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

EUGIA PHARMA

* EUGIA PHARMA SPECIALITIES LTD

CAPECITABINE, CAPECITABINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 63

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EUGIA PHARMA SPECIALITIES LTD

CARBOPLATIN, CARBOPLATIN

LETROZOLE, LETROZOLE

OXALIPLATIN, OXALIPLATIN

PROGESTERONE, PROGESTERONE

EUROHLTH INTL SARL

* EUROHEALTH INTERNATIONAL SARL

DROPERIDOL, DROPERIDOL

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

EXALENZ BIOSCIENCE

* EXALENZ BIOSCIENCE LTD

IDKIT:HP, CITRIC ACID

EXELA HOLDINGS

* EXELA HOLDINGS INC

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

EXELA PHARMA SCIENCE

* EXELA PHARMA SCIENCES

CAFFEINE CITRATE, CAFFEINE CITRATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

EXELA PHARMA SCS LLC

* EXELA PHARMA SCIENCES LLC

CAFFEINE CITRATE, CAFFEINE CITRATE

GANCICLOVIR, GANCICLOVIR

GLYRX-PF, GLYCOPYRROLATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, SODIUM NITROPRUSSIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM ACETATE, POTASSIUM ACETATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

EXELIXIS

* EXELIXIS INC

COMETRIQ, CABOZANTINIB S-MALATE

EXELIXIS INC

* EXELIXIS INC

CABOMETYX, CABOZANTINIB S-MALATE

EYEPOINT PHARMS

* EYEPOINT PHARMACEUTICALS INC

DEXYCU KIT, DEXAMETHASONE

YUTIQ, FLUOCINOLONE ACETONIDE

EYEVANCE PHARMS

* EYEVANCE PHARMACEUTICALS LLC

ZERVIATE, CETIRIZINE HYDROCHLORIDE

LILLY

* ELI LILLY AND CO

ALIMTA, PEMETREXED DISODIUM

CIALIS, TADALAFIL

CYMBALTA, DULOXETINE HYDROCHLORIDE

EVISTA, RALOXIFENE HYDROCHLORIDE

FORTEO, TERIPARATIDE RECOMBINANT HUMAN

GEMZAR, GEMCITABINE HYDROCHLORIDE

GLUCAGON, GLUCAGON

HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT

HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT

HUMALOG, INSULIN LISPRO RECOMBINANT

HUMATROPE, SOMATROPIN RECOMBINANT

HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 64

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* ELI LILLY AND CO

HUMULIN R KWIKPEN, INSULIN HUMAN

HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)

HUMULIN R, INSULIN HUMAN

HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)

PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE

STRATTERA, ATOMOXETINE HYDROCHLORIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

** F **

FDC LTD

* FDC LTD

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

LATANOPROST, LATANOPROST

OFLOXACIN, OFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE

FDN CONSUMER

* FOUNDATION CONSUMER HEALTHCARE LLC

LEVONORGESTREL, LEVONORGESTREL (OTC)

PLAN B ONE-STEP, LEVONORGESTREL (OTC)

FEINSTEIN

* FEINSTEIN INSTITUTE MEDICAL RESEARCH

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FERA PHARMS

* FERA PHARMACEUTICALS LLC

TOBRAMYCIN, TOBRAMYCIN

FERA PHARMS LLC

* FERA PHARMACEUTICALS LLC

DEXAMETHASONE, DEXAMETHASONE

FERRER INTERNACIONAL

* FERRER INTERNACIONAL SA

XEPI, OZENOXACIN

FERRING

* FERRING PHARMACEUTICALS INC

ACTHREL, CORTICORELIN OVINE TRIFLUTATE

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

ENDOMETRIN, PROGESTERONE

FIRMAGON, DEGARELIX ACETATE

MENOPUR, MENOTROPINS (FSH

MINIRIN, DESMOPRESSIN ACETATE

ZOMACTON, SOMATROPIN

FERRING PHARMS INC

* FERRING PHARMACEUTICALS INC

CERVIDIL, DINOPROSTONE

CLENPIQ, CITRIC ACID

DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DDAVP, DESMOPRESSIN ACETATE

LYSTEDA, TRANEXAMIC ACID

NOCDURNA, DESMOPRESSIN ACETATE

PREPOPIK, CITRIC ACID

STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

FLAMEL IRELAND LTD

* FLAMEL IRELAND LIMITED

AKOVAZ, EPHEDRINE SULFATE

FLAMINGO PHARMS

* FLAMINGO PHARMACEUTICALS LTD

METRONIDAZOLE, METRONIDAZOLE

PIROXICAM, PIROXICAM

FLEXION THERAPS INC

* FLEXION THERAPEUTICS INC

ZILRETTA, TRIAMCINOLONE ACETONIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 65

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

FOREST LABS INC

* FOREST LABORATORIES INC

VIOKACE, PANCRELIPASE (AMYLASE

ZENPEP, PANCRELIPASE (AMYLASE

FOREST LABS LLC

* FOREST LABORATORIES LLC

NAMENDA XR, MEMANTINE HYDROCHLORIDE

SAPHRIS, ASENAPINE MALEATE

FOUGERA PHARMS

* FOUGERA PHARMACEUTICALS INC

ADAPALENE, ADAPALENE

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMCINONIDE, AMCINONIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CUTIVATE, FLUTICASONE PROPIONATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE, HYDROCORTISONE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

OXISTAT, OXICONAZOLE NITRATE

PANDEL, HYDROCORTISONE PROBUTATE

PREDNICARBATE, PREDNICARBATE

SOLARAZE, DICLOFENAC SODIUM

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

FOUGERA PHARMS INC

* FOUGERA PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE, LIDOCAINE

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

TACROLIMUS, TACROLIMUS

VEREGEN, SINECATECHINS

FRESENIUS

* FRESENIUS KABI DEUTSCHLAND GMBH

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 66

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI DEUTSCHLAND GMBH

INTRALIPID 10%, SOYBEAN OIL

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

FRESENIUS KABI

* FRESENIUS KABI ANTI INFECTIVES SRL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

* FRESENIUS KABI AUSTRIA GMBH

LACTULOSE, LACTULOSE

FRESENIUS KABI ONCOL

* FRESENIUS KABI ONCOLOGY PLC

ANASTROZOLE, ANASTROZOLE

BICALUTAMIDE, BICALUTAMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LETROZOLE, LETROZOLE

FRESENIUS KABI USA

* FRESENIUS KABI USA LLC

ACETAMINOPHEN, ACETAMINOPHEN

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ASTRAMORPH PF, MORPHINE SULFATE

ATROPINE SULFATE, ATROPINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

AZTREONAM, AZTREONAM

BACITRACIN, BACITRACIN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BIVALIRUDIN, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BORTEZOMIB, BORTEZOMIB

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCIUM GLUCONATE, CALCIUM GLUCONATE

CARBOPLATIN, CARBOPLATIN

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CEFOTETAN, CEFOTETAN DISODIUM

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAPTOMYCIN, DAPTOMYCIN

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPRIVAN, PROPOFOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 67

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI USA LLC

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GANCICLOVIR, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLUCAGON, GLUCAGON HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

INDOMETHACIN, INDOMETHACIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANNITOL 25%, MANNITOL

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 68

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI USA LLC

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NAROPIN, ROPIVACAINE HYDROCHLORIDE

NEBUPENT, PENTAMIDINE ISETHIONATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OMEGAVEN, FISH OIL TRIGLYCERIDES

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

OXYTOCIN, OXYTOCIN

PACLITAXEL, PACLITAXEL

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTAM, PENTAMIDINE ISETHIONATE

PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTAMINE SULFATE, PROTAMINE SULFATE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SMOFLIPID 20%, FISH OIL

SODIUM ACETATE, SODIUM ACETATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VALPROATE SODIUM, VALPROATE SODIUM

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VIBISONE, CYANOCOBALAMIN

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

FRESENIUS MEDCL

* FRESENIUS MEDICAL CARE NORTH AMERICA

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 69

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS MEDICAL CARE NORTH AMERICA

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

PHOSLO GELCAPS, CALCIUM ACETATE

PHOSLYRA, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

FRONTIDA BIOPHARM

* FRONTIDA BIOPHARM INC

CILOSTAZOL, CILOSTAZOL

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

** G **

G AND W LABS

* G AND W LABORATORIES INC

ACEPHEN, ACETAMINOPHEN (OTC)

CICLOPIROX, CICLOPIROX

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

INDOMETHACIN, INDOMETHACIN

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

PROCHLORPERAZINE, PROCHLORPERAZINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

G AND W LABS INC

* G AND W LABORATORIES INC

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BETA-VAL, BETAMETHASONE VALERATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

LIDOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MYKACET, NYSTATIN

NYSTATIN, NYSTATIN

TAZAROTENE, TAZAROTENE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

GALDERMA LABS

* GALDERMA LABORATORIES INC

CLOBEX, CLOBETASOL PROPIONATE

EPIDUO FORTE, ADAPALENE

GALDERMA LABS LP

* GALDERMA LABORATORIES L P

CLOBEX, CLOBETASOL PROPIONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 70

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GALDERMA LABORATORIES LP

CAPEX, FLUOCINOLONE ACETONIDE

CLOBEX, CLOBETASOL PROPIONATE

DESOWEN, DESONIDE

DIFFERIN, ADAPALENE

DIFFERIN, ADAPALENE (OTC)

EPIDUO, ADAPALENE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

MIRVASO, BRIMONIDINE TARTRATE

ORACEA, DOXYCYCLINE

SOOLANTRA, IVERMECTIN

TRI-LUMA, FLUOCINOLONE ACETONIDE

VECTICAL, CALCITRIOL

GALEN SPECIALTY

* GALEN SPECIALTY PHARMA US LLC

SYNERA, LIDOCAINE

GALEN UK

* GALEN LTD

ADASUVE, LOXAPINE

GALT PHARMS

* GALT PHARMACEUTICALS LLC

DORAL, QUAZEPAM

GATE PHARMS

* GATE PHARMACEUTICALS

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

LINEZOLID, LINEZOLID

GATOR PHARMS

* GATOR PHARMACEUTICALS INC

COLPREP KIT, MAGNESIUM SULFATE

GAVIS PHARMS

* GAVIS PHARMACEUTICALS LLC

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NYSTATIN, NYSTATIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

QUINARETIC, HYDROCHLOROTHIAZIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

GAVIS PHARMS LLC

* GAVIS PHARMACEUTICALS LLC

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

GD SEARLE

* GD SEARLE LLC

CELEBREX, CELECOXIB

DAYPRO, OXAPROZIN

GD SEARLE LLC

* GD SEARLE LLC

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

ARTHROTEC, DICLOFENAC SODIUM

CALAN, VERAPAMIL HYDROCHLORIDE

CYTOTEC, MISOPROSTOL

FLAGYL, METRONIDAZOLE

INSPRA, EPLERENONE

LOMOTIL, ATROPINE SULFATE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPACE, DISOPYRAMIDE PHOSPHATE

SYNAREL, NAFARELIN ACETATE

GE HEALTHCARE

* GE HEALTHCARE

ADREVIEW, IOBENGUANE SULFATE I-123

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

INDICLOR, INDIUM IN-111 CHLORIDE

INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 71

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GE HEALTHCARE

METASTRON, STRONTIUM CHLORIDE SR-89

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT

OMNIPAQUE 12, IOHEXOL

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNIPAQUE 9, IOHEXOL

OMNISCAN, GADODIAMIDE

OPTISON, ALBUMIN HUMAN

TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

VIZAMYL, FLUTEMETAMOL F-18

GE HLTHCARE INC

* GE HEALTHCARE INC

DATSCAN, IOFLUPANE I-123

GEMINI LABS LLC

* GEMINI LABORATORIES LLC

PRANDIN, REPAGLINIDE

GENENTECH

* GENENTECH INC

ERIVEDGE, VISMODEGIB

NUTROPIN AQ NUSPIN, SOMATROPIN RECOMBINANT

GENENTECH INC

* GENENTECH INC

COTELLIC, COBIMETINIB FUMARATE

ESBRIET, PIRFENIDONE

XOFLUZA, BALOXAVIR MARBOXIL

GENERICS

* GENERICS INTERNATIONAL VENTURES ENTERPRISES LLC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

GENEYORK PHARMS

* GENEYORK PHARMACEUTICALS GROUP LLC

PREDNISONE, PREDNISONE

GENUS LIFESCIENCES

* GENUS LIFE SCIENCES INC

GOPRELTO, COCAINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

YOSPRALA, ASPIRIN

* GENUS LIFESCIENCES INC

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

GENZYME

* GENZYME CORP

CEREZYME, IMIGLUCERASE

CLOLAR, CLOFARABINE

MOZOBIL, PLERIXAFOR

RENAGEL, SEVELAMER HYDROCHLORIDE

RENVELA, SEVELAMER CARBONATE

THYROGEN, THYROTROPIN ALFA

GENZYME CORP

* GENZYME CORP

CAPRELSA, VANDETANIB

CERDELGA, ELIGLUSTAT TARTRATE

GILEAD

* GILEAD SCIENCES INC

CAYSTON, AZTREONAM

EMTRIVA, EMTRICITABINE

HEPSERA, ADEFOVIR DIPIVOXIL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 72

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GILEAD SCIENCES INC

LETAIRIS, AMBRISENTAN

RANEXA, RANOLAZINE

TRUVADA, EMTRICITABINE

GILEAD SCIENCES

* GILEAD SCIENCES LLC

ATRIPLA, EFAVIRENZ

GILEAD SCIENCES INC

* GILEAD SCIENCES INC

BIKTARVY, BICTEGRAVIR SODIUM

COMPLERA, EMTRICITABINE

DESCOVY, EMTRICITABINE

EPCLUSA, SOFOSBUVIR

GENVOYA, COBICISTAT

HARVONI, LEDIPASVIR

ODEFSEY, EMTRICITABINE

SOVALDI, SOFOSBUVIR

STRIBILD, COBICISTAT

TYBOST, COBICISTAT

VEMLIDY, TENOFOVIR ALAFENAMIDE FUMARATE

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VOSEVI, SOFOSBUVIR

ZYDELIG, IDELALISIB

GLAND PHARMA LTD

* GLAND PHARMA LTD

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

AZITHROMYCIN, AZITHROMYCIN

CARBOPLATIN, CARBOPLATIN

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CISPLATIN, CISPLATIN

CLOFARABINE, CLOFARABINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

ETOMIDATE, ETOMIDATE

FLUOROURACIL, FLUOROURACIL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM, HEPARIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

MEROPENEM, MEROPENEM

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACITAXEL, PACLITAXEL

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLEDRONIC, ZOLEDRONIC ACID

GLASSHOUSE PHARMS

* GLASSHOUSE PHARMACEUTICALS LTD CANADA

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 73

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLASSHOUSE PHARMACEUTICALS LTD CANADA

FLUOCINONIDE, FLUOCINONIDE

GLAXO GRP ENGLAND

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

INCRUSE ELLIPTA, UMECLIDINIUM BROMIDE

GLAXO GRP LTD

* GLAXO GROUP LTD DBA GLAXOSMITHKLINE

FLOVENT HFA, FLUTICASONE PROPIONATE

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

BREO ELLIPTA, FLUTICASONE FUROATE

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

GLAXOSMITHKLINE

* GLAXOSMITHKLINE

ABREVA, DOCOSANOL (OTC)

AVODART, DUTASTERIDE

BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE

EPIVIR-HBV, LAMIVUDINE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

JALYN, DUTASTERIDE

MALARONE PEDIATRIC, ATOVAQUONE

MALARONE, ATOVAQUONE

NICORETTE (MINT), NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

RELENZA, ZANAMIVIR

VALTREX, VALACYCLOVIR HYDROCHLORIDE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

ZYBAN, BUPROPION HYDROCHLORIDE

* GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC

LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

ANORO ELLIPTA, UMECLIDINIUM BROMIDE

ARNUITY ELLIPTA, FLUTICASONE FUROATE

KRINTAFEL, TAFENOQUINE SUCCINATE

TRELEGY ELLIPTA, FLUTICASONE FUROATE

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

SEREVENT, SALMETEROL XINAFOATE

VENTOLIN HFA, ALBUTEROL SULFATE

GLAXOSMITHKLINE CON

* GLAXOSMITHKLINE CONSUMER HEALTH

TRANSDERM SCOP, SCOPOLAMINE

GLAXOSMITHKLINE CONS

* GLAXOSMITHKLINE CONSUMER HEALTHCARE

ALLI, ORLISTAT (OTC)

EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)

FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)

FLONASE SENSIMIST ALLERGY RELIEF, FLUTICASONE FUROATE (OTC)

LAMISIL AT, TERBINAFINE (OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

PREVACID 24 HR, LANSOPRAZOLE (OTC)

VOLTAREN, DICLOFENAC SODIUM

GLAXOSMITHKLINE LLC

* GLAXOSMITHKLINE LLC

AMERGE, NARATRIPTAN HYDROCHLORIDE

DYAZIDE, HYDROCHLOROTHIAZIDE

FLOLAN, EPOPROSTENOL SODIUM

LAMICTAL CD, LAMOTRIGINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 74

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAXOSMITHKLINE LLC

LAMICTAL ODT, LAMOTRIGINE

LAMICTAL XR, LAMOTRIGINE

LAMICTAL, LAMOTRIGINE

MEPRON, ATOVAQUONE

REQUIP XL, ROPINIROLE HYDROCHLORIDE

REQUIP, ROPINIROLE HYDROCHLORIDE

RYTHMOL SR, PROPAFENONE HYDROCHLORIDE

GLENMARK

* GLENMARK THERAPEUTICS INC USA

ECOZA, ECONAZOLE NITRATE

GLENMARK GENERICS

* GLENMARK GENERICS INC USA

ADAPALENE, ADAPALENE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

IMIQUIMOD, IMIQUIMOD

MOMETASONE FUROATE, MOMETASONE FUROATE

NIZATIDINE, NIZATIDINE

ZONISAMIDE, ZONISAMIDE

* GLENMARK GENERICS LIMITED

BRIELLYN, ETHINYL ESTRADIOL

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* GLENMARK GENERICS LTD

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

ALYACEN 1/35, ETHINYL ESTRADIOL

ALYACEN 7/7/7, ETHINYL ESTRADIOL

ASHLYNA, ETHINYL ESTRADIOL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

CARVEDILOL, CARVEDILOL

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESOXIMETASONE, DESOXIMETASONE

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE, FLUOCINONIDE

HEATHER, NORETHINDRONE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LITHIUM CARBONATE, LITHIUM CARBONATE

MARLISSA, ETHINYL ESTRADIOL

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN, NAPROXEN

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 75

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLENMARK GENERICS LTD

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VIORELE, DESOGESTREL

ZOLMITRIPTAN, ZOLMITRIPTAN

* GLENMARK GENERICS LTD INDIA

INDOMETHACIN, INDOMETHACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

GLENMARK PHARMS

* GLENMARK PHARMACEUTICALS INC

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

TERIFLUNOMIDE, TERIFLUNOMIDE

* GLENMARK PHARMACEUTICALS INC USA

CICLOPIROX, CICLOPIROX

CLOTRIMAZOLE, CLOTRIMAZOLE

MUPIROCIN, MUPIROCIN

* GLENMARK PHARMACEUTICALS LTD

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

* GLENMARK PHARMACEUTICALS SA

ATOVAQUONE, ATOVAQUONE

AZELAIC ACID, AZELAIC ACID

CALCIPOTRIENE, CALCIPOTRIENE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DESONIDE, DESONIDE

HAILEY 1.5/30, ETHINYL ESTRADIOL

HAILEY FE 1.5/30, ETHINYL ESTRADIOL

LINEZOLID, LINEZOLID

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

GLENMARK PHARMS INC

* GLENMARK PHARMACEUTICALS INC USA

CALCIPOTRIENE, CALCIPOTRIENE

LITHIUM CARBONATE, LITHIUM CARBONATE

MUPIROCIN, MUPIROCIN CALCIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

GLENMARK PHARMS LTD

* GLENMARK PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ESTRADIOL, ESTRADIOL

EZETIMIBE, EZETIMIBE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FLUCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

GABAPENTIN, GABAPENTIN

HAILEY FE 1/20, ETHINYL ESTRADIOL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

INDOMETHACIN, INDOMETHACIN

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 76

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLENMARK PHARMACEUTICALS LTD

LIDOCAINE, LIDOCAINE

NAPROXEN SODIUM, NAPROXEN SODIUM

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OXCARBAZEPINE, OXCARBAZEPINE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

RUFINAMIDE, RUFINAMIDE

TACROLIMUS, TACROLIMUS

TELMISARTAN, TELMISARTAN

TRETINOIN, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VORICONAZOLE, VORICONAZOLE

GLENMARK PHARMS SA

* GLENMARK PHARMACEUTICALS SA SWITZERLAND

APREPITANT, APREPITANT

NITROGLYCERIN, NITROGLYCERIN

GLOBAL ISOTOPES LLC

* GLOBAL ISOTOPES LLC DBA ZEVACOR MOLECULAR

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

GP-PHARM SA

* GP-PHARM SA

LUTRATE DEPOT KIT, LEUPROLIDE ACETATE

GRANULES INDIA

* GRANULES INDIA LTD

IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

GRANULES INDIA LTD

* GRANULES INDIA LTD

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

GRANULES PHARMS

* GRANULES PHARMACEUTICALS INC

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

GRAVITI PHARMS

* GRAVITI PHARMACEUTICALS PRIVATE LTD

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

FENOFIBRATE, FENOFIBRATE

GUARDIAN DRUG

* GUARDIAN DRUG CO

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

GUERBET

* GUERBET LLC

DOTAREM, GADOTERATE MEGLUMINE

LIPIODOL, ETHIODIZED OIL

GW RES LTD

* GW RESEARCH LTD

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 77

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GW RESEARCH LTD

EPIDIOLEX, CANNABIDIOL

HANFORD GC

* GC HANFORD MANUFACTURING CO

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

POHL BOSKAMP

* G POHL BOSKAMP GMBH AND CO KG

GONITRO, NITROGLYCERIN

** H **

HAEMONETICS

* HAEMONETICS CORP

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

HAINAN POLY PHARM

* HAINAN POLY PHARMACEUTICAL CO LTD

AZITHROMYCIN, AZITHROMYCIN

GANCICLOVIR, GANCICLOVIR SODIUM

LEVETIRACETAM, LEVETIRACETAM

VORICONAZOLE, VORICONAZOLE

HALOCARBON PRODS

* HALOCARBON PRODUCTS CORP

ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

HALOZYME THERAP

* HALOZYME THERAPEUTICS INC

HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN

HAMELN PHARMA PLUS

* HAMELN PHARMA PLUS GMBH

PENTETATE CALCIUM TRISODIUM, PENTETATE CALCIUM TRISODIUM

PENTETATE ZINC TRISODIUM, PENTETATE ZINC TRISODIUM

HANDA PHARMS LLC

* HANDA PHARMACEUTICALS LLC

LAMOTRIGINE, LAMOTRIGINE

HANGZHOU BINJIANG

* HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

HANSAMED INC

* HANSAMED INC

ULTACAN FORTE, ARTICAINE HYDROCHLORIDE

ULTACAN, ARTICAINE HYDROCHLORIDE

HARRIS PHARM

* HARRIS PHARMACEUTICAL INC

FLUCONAZOLE, FLUCONAZOLE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

HEBEI CHANGSHAN

* HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

HEC PHARM

* HEC PHARM USA INC

CLARITHROMYCIN, CLARITHROMYCIN

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

IBUPROFEN, IBUPROFEN

OLANZAPINE, OLANZAPINE

PRASUGREL, PRASUGREL HYDROCHLORIDE

HELSINN

* HELSINN BIREX PHARMACEUTICALS LTD

VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE

HELSINN HLTHCARE

* HELSINN HEALTHCARE SA

AKYNZEO, FOSNETUPITANT CHLORIDE HYDROCHLORIDE

AKYNZEO, NETUPITANT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 78

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HELSINN HEALTHCARE SA

ALOXI, PALONOSETRON HYDROCHLORIDE

HERCON PHARM

* HERCON PHARMACEUTICAL LLC

NITROGLYCERIN, NITROGLYCERIN

HERITAGE LIFE

* HERITAGE LIFE SCIENCES BARBADOS INC

CLOZARIL, CLOZAPINE

HERITAGE PHARMA

* HERITAGE PHARMA LABS INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAZOLAMIDE, ACETAZOLAMIDE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIFLUNISAL, DIFLUNISAL

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

LITHIUM CARBONATE, LITHIUM CARBONATE

METHIMAZOLE, METHIMAZOLE

NIFEDIPINE, NIFEDIPINE

HERITAGE PHARMS INC

* HERITAGE PHARMACEUTICALS INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE

ACYCLOVIR, ACYCLOVIR

ALPRAZOLAM, ALPRAZOLAM

CALCIUM ACETATE, CALCIUM ACETATE

CARISOPRODOL AND ASPIRIN, ASPIRIN

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DUTASTERIDE, DUTASTERIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FELODIPINE, FELODIPINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDOMETHACIN, INDOMETHACIN

KETOPROFEN, KETOPROFEN

LEFLUNOMIDE, LEFLUNOMIDE

METRONIDAZOLE, METRONIDAZOLE

MODAFINIL, MODAFINIL

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

NYSTATIN, NYSTATIN

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

HERON THERAPS INC

* HERON THERAPEUTICS INC

CINVANTI, APREPITANT

SUSTOL, GRANISETRON

HETERO LABS LTD III

* HETERO LABS LTD UNIT III

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 79

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HETERO LABS LTD UNIT III

ABACAVIR SULFATE, ABACAVIR SULFATE

ATOVAQUONE, ATOVAQUONE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOBAZAM, CLOBAZAM

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

EFAVIRENZ, EFAVIRENZ

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FENOFIBRATE, FENOFIBRATE

FINASTERIDE, FINASTERIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

METHOCARBAMOL, METHOCARBAMOL

NEVIRAPINE, NEVIRAPINE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

RITONAVIR, RITONAVIR

ROFLUMILAST, ROFLUMILAST

SIMVASTATIN, SIMVASTATIN

STAVUDINE, STAVUDINE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TORSEMIDE, TORSEMIDE

ZIDOVUDINE, ZIDOVUDINE

HETERO LABS LTD V

* HETERO LABS LTD UNIT V

ACYCLOVIR, ACYCLOVIR

ARIPIPRAZOLE, ARIPIPRAZOLE

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ENTECAVIR, ENTECAVIR

FAMCICLOVIR, FAMCICLOVIR

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LEVOFLOXACIN, LEVOFLOXACIN

LINEZOLID, LINEZOLID

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MONTELUKAST SODIUM, MONTELUKAST SODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN, TELMISARTAN

TETRABENAZINE, TETRABENAZINE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

HEYL CHEMISCH

* HEYL CHEMISCH PHARMAZEUTISHE FABRIK

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

HI TECH PHARMA

* HI TECH PHARMACAL CO INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CALCIPOTRIENE, CALCIPOTRIENE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CICLOPIROX, CICLOPIROX

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 80

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HI TECH PHARMACAL CO INC

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

CORMAX, CLOBETASOL PROPIONATE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

EMBELINE E, CLOBETASOL PROPIONATE

EMBELINE, CLOBETASOL PROPIONATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

LEVOCARNITINE, LEVOCARNITINE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TIMOLOL MALEATE, TIMOLOL MALEATE

VOSOL HC, ACETIC ACID, GLACIAL

VOSOL, ACETIC ACID, GLACIAL

HI TECH PHARMA CO

* HI TECH PHARMACAL CO INC

FLUNISOLIDE, FLUNISOLIDE

PREDNISOLONE, PREDNISOLONE

HI-TECH PHARMA CO

* HI-TECH PHARMACAL CO INC

BIMATOPROST, BIMATOPROST

FAMOTIDINE, FAMOTIDINE

GATIFLOXACIN, GATIFLOXACIN

LORAZEPAM, LORAZEPAM

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

HI-TECH PHARMACAL

* HI-TECH PHARMACAL CO INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BIMATOPROST, BIMATOPROST

BROMFENAC SODIUM, BROMFENAC SODIUM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

IBUPROFEN, IBUPROFEN

LEVETIRACETAM, LEVETIRACETAM

MEGESTROL ACETATE, MEGESTROL ACETATE

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE

TRIFLURIDINE, TRIFLURIDINE

HIGH TECH PHARMA

* HIGH TECHNOLOGY PHARMACAL CO INC

VALPROIC ACID, VALPROIC ACID

HIKMA

* HIKMA FARMACEUTICA LDA

CEFOTAXIME, CEFOTAXIME SODIUM

* HIKMA PHARMACEUTICALS

AMOXICILLIN, AMOXICILLIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 81

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA PHARMACEUTICALS

CEFACLOR, CEFACLOR

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEPHALEXIN, CEPHALEXIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

HIKMA FARMACEUTICA

* HIKMA FARMACEUTICA (PORTUGAL) SA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CEFOXITIN, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

VALPROATE SODIUM, VALPROATE SODIUM

* HIKMA FARMACEUTICA PORTUGAL LDA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

* HIKMA FARMACEUTICA PORTUGAL SA

CEFOTETAN, CEFOTETAN DISODIUM

CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

ETOMIDATE, ETOMIDATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OXYTOCIN, OXYTOCIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

* HIKMA FARMACEUTICA SA

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HIKMA INTL PHARMS

* HIKMA INTERNATIONAL PHARMACEUTICALS LLC

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CAPTOPRIL, CAPTOPRIL

CARISOPRODOL, CARISOPRODOL

CORTISONE ACETATE, CORTISONE ACETATE

DIGOXIN, DIGOXIN

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCORTISONE, HYDROCORTISONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 82

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA INTERNATIONAL PHARMACEUTICALS LLC

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METHOCARBAMOL, METHOCARBAMOL

MITIGARE, COLCHICINE

PRIMIDONE, PRIMIDONE

HIKMA PHARM CO LTD

* HIKMA PHARM CO LTD

ARGATROBAN, ARGATROBAN

HIKMA PHARMS

* HIKMA PHARMACEUTICALS

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

GEMFIBROZIL, GEMFIBROZIL

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LETROZOLE, LETROZOLE

MODAFINIL, MODAFINIL

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

RIFAMPIN, RIFAMPIN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

* HIKMA PHARMACEUTICALS CO LTD

PARICALCITOL, PARICALCITOL

* HIKMA PHARMACEUTICALS LLC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

DANTROLENE SODIUM, DANTROLENE SODIUM

DOXERCALCIFEROL, DOXERCALCIFEROL

FOLIC ACID, FOLIC ACID

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

OLANZAPINE, OLANZAPINE

PIROXICAM, PIROXICAM

PREDNISONE, PREDNISONE

ZALEPLON, ZALEPLON

HILL DERMAC

* HILL DERMACEUTICALS INC

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE

HILL DERMACEUTICALS

* HILL DERMACEUTICALS INC

TOLAK, FLUOROURACIL

HISAMITSU PHARM CO

* HISAMITSU PHARMACEUTICAL CO INC

SALONPAS, MENTHOL (OTC)

HISUN PHARM HANGZHOU

* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

* HISUN PHARMACEUTICAL HANGZHOU CO LTD

CAPREOMYCIN SULFATE, CAPREOMYCIN SULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

HOFFMANN LA ROCHE

* HOFFMANN LA ROCHE INC

BONIVA, IBANDRONATE SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 83

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOFFMANN LA ROCHE INC

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

XELODA, CAPECITABINE

ZELBORAF, VEMURAFENIB

HOFFMANN-LA ROCHE

* HOFFMANN-LA ROCHE INC

ALECENSA, ALECTINIB HYDROCHLORIDE

INVIRASE, SAQUINAVIR MESYLATE

HONG KONG

* HONG KONG KING-FRIEND INDUSTRIAL CO LTD

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

CYTARABINE, CYTARABINE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

HOPE PHARMS

* HOPE PHARMACEUTICALS

NITHIODOTE, SODIUM NITRITE

SODIUM NITRITE, SODIUM NITRITE

SODIUM THIOSULFATE, SODIUM THIOSULFATE

HORIZON

* HORIZON MEDICINES LLC

DUEXIS, FAMOTIDINE

VIMOVO, ESOMEPRAZOLE MAGNESIUM

HORIZON PHARMA INC

* HORIZON PHARMA INC

BUPHENYL, SODIUM PHENYLBUTYRATE

HORIZON PHARMA USA

* HORIZON PHARMA USA INC

PROCYSBI, CYSTEAMINE BITARTRATE

RAYOS, PREDNISONE

HORIZON THERAPS INC

* HORIZON THERAPEUTICS INC

RAVICTI, GLYCEROL PHENYLBUTYRATE

HOSPIRA

* HOSPIRA INC

A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE

ACETYLCYSTEINE, ACETYLCYSTEINE

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

AMIDATE, ETOMIDATE

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE

ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE

ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE, ATROPINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUMETANIDE, BUMETANIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CORLOPAM, FENOLDOPAM MESYLATE

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CYTARABINE, CYTARABINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 84

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

DACARBAZINE, DACARBAZINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DEXTROSE 25%, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50%, DEXTROSE

DIAZEPAM, DIAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

ENALAPRILAT, ENALAPRILAT

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL CITRATE, FENTANYL CITRATE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEVOPHED, NOREPINEPHRINE BITARTRATE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID

M.V.I. ADULT, ASCORBIC ACID

M.V.I. PEDIATRIC, ASCORBIC ACID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 25%, MANNITOL

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 85

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MORPHINE SULFATE, MORPHINE SULFATE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

POTASSIUM ACETATE, POTASSIUM ACETATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROPOFOL, PROPOFOL

QUELICIN, SUCCINYLCHOLINE CHLORIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM ACETATE, SODIUM ACETATE

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

SUFENTANIL CITRATE, SUFENTANIL CITRATE

TAZICEF, CEFTAZIDIME

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE

* HOSPIRA WORLDWIDE, INC

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NITROPRESS, SODIUM NITROPRUSSIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

HOSPIRA INC

* HOSPIRA INC

ADENOSINE, ADENOSINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ARGATROBAN, ARGATROBAN

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

BIVALIRUDIN, BIVALIRUDIN

BORTEZOMIB, BORTEZOMIB

BUSULFAN, BUSULFAN

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOTAXIME SODIUM, CEFOTAXIME SODIUM

CEFOXITIN, CEFOXITIN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 86

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

CLOFARABINE, CLOFARABINE

DAPTOMYCIN, DAPTOMYCIN

DOCETAXEL, DOCETAXEL

DOXERCALCIFEROL, DOXERCALCIFEROL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MAXIPIME, CEFEPIME HYDROCHLORIDE

MEROPENEM, MEROPENEM

MILRINONE LACTATE, MILRINONE LACTATE

MORPHINE SULFATE, MORPHINE SULFATE

NIPENT, PENTOSTATIN

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PARICALCITOL, PARICALCITOL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

SODIUM BICARBONATE, SODIUM BICARBONATE

TACROLIMUS, TACROLIMUS

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HOSPIRA WORLDWIDE

* HOSPIRA WORLDWIDE PTY

OXALIPLATIN, OXALIPLATIN

HOT SHOTS NM LLC

* HOT SHOTS NUCLEAR MEDICINE LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

HOUSTON CYCLOTRON

* HOUSTON CYCLOTRON PARTNERS LP

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

HQ SPCLT PHARMA

* HQ SPECIALTY PHARMA CORP

CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE

CISPLATIN, CISPLATIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TAXOL, PACLITAXEL

HQ SPECIALITY PHARMA

* HQ SPECIALITY PHARMA LLC

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

HUMANWELL PURACAP

* HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD

DUTASTERIDE, DUTASTERIDE

IBUPROFEN, IBUPROFEN (OTC)

HZNP

* HZNP MEDICINES LLC

MIGERGOT, CAFFEINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 87

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HZNP MEDICINES LLC

PENNSAID, DICLOFENAC SODIUM

ROCHE

* HOFFMANN LA ROCHE INC

BONIVA, IBANDRONATE SODIUM

FUZEON, ENFUVIRTIDE

KLONOPIN, CLONAZEPAM

TAMIFLU, OSELTAMIVIR PHOSPHATE

VALIUM, DIAZEPAM

** I **

IBSA INST BIO

* IBSA INSTITUT BIOCHIMIQUE SA

LICART, DICLOFENAC EPOLAMINE

ICU MEDICAL INC

* ICU MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINOSYN 10%, AMINO ACIDS

AMINOSYN 3.5% M, AMINO ACIDS

AMINOSYN 8.5% W/ELECTROLYTES, AMINO ACIDS

AMINOSYN 8.5%, AMINO ACIDS

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MORPHINE SULFATE, MORPHINE SULFATE

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 88

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* ICU MEDICAL INC

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

IDENTI PHARMS INC

* IDENTI PHARMACEUTICALS INC

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

IDT AUSTRALIA LTD

* IDT AUSTRALIA LTD

TEMOZOLOMIDE, TEMOZOLOMIDE

IMPAX

* IMPAX LABORATORIES LLC

ADRENACLICK, EPINEPHRINE

IMPAX LABS

* IMPAX LABORATORIES INC

ACARBOSE, ACARBOSE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIGOXIN, DIGOXIN

DIPYRIDAMOLE, DIPYRIDAMOLE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE

OMEPRAZOLE, OMEPRAZOLE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RILUZOLE, RILUZOLE

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

IMPAX LABS INC

* IMPAX LABORATORIES INC

ACITRETIN, ACITRETIN

ALBENZA, ALBENDAZOLE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

BUDESONIDE, BUDESONIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 89

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* IMPAX LABORATORIES INC

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

EMVERM, MEBENDAZOLE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

LAMOTRIGINE, LAMOTRIGINE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MORPHINE SULFATE, MORPHINE SULFATE

NABUMETONE, NABUMETONE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RYTARY, CARBIDOPA

SEVELAMER CARBONATE, SEVELAMER CARBONATE

URSODIOL, URSODIOL

IMPAX PHARMS

* IMPAX PHARMACEUTICALS

GEMFIBROZIL, GEMFIBROZIL

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

INCYTE CORP

* INCYTE CORP

JAKAFI, RUXOLITINIB PHOSPHATE

INDICUS PHARMA

* INDICUS PHARMA LLC

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LETROZOLE, LETROZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

INDIVIOR INC

* INDIVIOR INC

BUPRENEX, BUPRENORPHINE HYDROCHLORIDE

PERSERIS KIT, RISPERIDONE

SUBLOCADE, BUPRENORPHINE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

INDOCO REMEDIES

* INDOCO REMEDIES LTD

ALLOPURINOL, ALLOPURINOL

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

GLIMEPIRIDE, GLIMEPIRIDE

INFORLIFE

* INFORLIFE SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

INGENUS PHARMS LLC

* INGENUS PHARMACEUTICALS LLC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

CABERGOLINE, CABERGOLINE

CARBOPLATIN, CARBOPLATIN

CICLOPIROX, CICLOPIROX

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 90

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INGENUS PHARMACEUTICALS LLC

CLOFARABINE, CLOFARABINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

OXALIPLATIN, OXALIPLATIN

TOLCAPONE, TOLCAPONE

INGENUS PHARMS NJ

* INGENUS PHARMACEUTICALS NJ LLC

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

INNOGENIX

* INNOGENIX LLC

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

INSMED INC

* INSMED INC

ARIKAYCE KIT, AMIKACIN SULFATE

INST BIOCHEM

* INSTITUT BIOCHEMIQUE SA

FLECTOR, DICLOFENAC EPOLAMINE

INSTITUT BIOCHIMIQUE

* INSTITUT BIOCHIMIQUE SA (IBSA)

TIROSINT, LEVOTHYROXINE SODIUM

INSYS DEV CO INC

* INSYS DEVELOPMENT CO INC

SUBSYS, FENTANYL

SYNDROS, DRONABINOL

INTAS PHARMS USA

* INTAS PHARMACEUTICALS USA

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

INTELLIPHARMACEUTICS

* INTELLIPHARMACEUTICS CORP

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

INTERCEPT PHARMS INC

* INTERCEPT PHARMACEUTICALS INC

OCALIVA, OBETICHOLIC ACID

INTERGEL PHARM

* INTERGEL PHARMACEUTICAL INC

NIFEDIPINE, NIFEDIPINE

INTERGEL PHARMS INC

* INTERGEL PHARMACEUTICALS INC

DUTASTERIDE, DUTASTERIDE

INTERPHARMA PRAHA AS

* INTERPHARMA PRAHA AS

ORALTAG, IOHEXOL

INTERSECT ENT INC

* INTERSECT ENT INC

SINUVA, MOMETASONE FUROATE

INTL MEDICATED

* INTERNATIONAL MEDICATED SYSTEMS LTD

MILRINONE LACTATE, MILRINONE LACTATE

INTL MEDICATION

* INTERNATIONAL MEDICATION SYSTEM

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 91

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INTERNATIONAL MEDICATION SYSTEM

PHYTONADIONE, PHYTONADIONE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

* INTERNATIONAL MEDICATION SYSTEMS LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

INTL MEDICATION SYS

* INTERNATIONAL MEDICATION SYSTEMS LTD

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

LORAZEPAM, LORAZEPAM

SODIUM BICARBONATE, SODIUM BICARBONATE

INVAGEN PHARMS

* INVAGEN PHARMACEUTICALS INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CALCIUM ACETATE, CALCIUM ACETATE

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

OLANZAPINE, OLANZAPINE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

INVATECH PHARMA

* INVATECH PHARMA SOLUTIONS LLC

CALCITRIOL, CALCITRIOL

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

INVENTIA HLTHCARE

* INVENTIA HEALTHCARE PRIVATE LTD

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

ILOPERIDONE, ILOPERIDONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 92

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INVENTIA HEALTHCARE PRIVATE LTD

LANSOPRAZOLE, LANSOPRAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

IONETIX

* IONETIX CORP

AMMONIA N 13, AMMONIA N-13

IPCA LABS LTD

* IPCA LABORATORIES LTD

ALLOPURINOL, ALLOPURINOL

ATENOLOL, ATENOLOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

FUROSEMIDE, FUROSEMIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

IPR

* IPR PHARMACEUTICALS INC

CRESTOR, ROSUVASTATIN CALCIUM

ZOMIG, ZOLMITRIPTAN

IPSEN INC

* IPSEN BIOPHARMACEUTICALS INC

INCRELEX, MECASERMIN RECOMBINANT

ONIVYDE, IRINOTECAN HYDROCHLORIDE

IPSEN PHARMA

* IPSEN PHARMA BIOTECH SAS

SOMATULINE DEPOT, LANREOTIDE ACETATE

IROKO PHARMS

* IROKO PHARMACEUTICALS LLC

INDOCIN, INDOMETHACIN

IROKO PHARMS LLC

* IROKO PHARMACEUTICALS LLC

TIVORBEX, INDOMETHACIN

VIVLODEX, MELOXICAM

ZORVOLEX, DICLOFENAC

IRONSHORE PHARMS

* IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC

JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE

IRONWOOD PHARMS INC

* IRONWOOD PHARMACEUTICALS INC

DUZALLO, ALLOPURINOL

ZURAMPIC, LESINURAD

ISO TEX

* ISO TEX DIAGNOSTICS INC

JEANATOPE, ALBUMIN IODINATED I-125 SERUM

MEGATOPE, ALBUMIN IODINATED I-131 SERUM

ISOTEX

* ISOTEX DIAGNOSTICS

GLOFIL-125, IOTHALAMATE SODIUM I-125

ISTITUTO BIO ITA SPA

* ISTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 93

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* ISTITUTO BIOCHIMICO ITALIANO SPA

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIPERACILLIN, PIPERACILLIN SODIUM

ITALFARMACO SPA

* ITALFARMACO SPA

TIGLUTIK KIT, RILUZOLE

IVAX PHARMS

* IVAX PHARMACEUTICALS INC

VALSARTAN, VALSARTAN

IVAX PHARMS INC

* IVAX PHARMACEUTICALS INC

OLANZAPINE, OLANZAPINE

IVAX SUB TEVA PHARMS

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUMETANIDE, BUMETANIDE

CABERGOLINE, CABERGOLINE

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CIMETIDINE, CIMETIDINE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDOMETHACIN, INDOMETHACIN

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METHYLDOPA, METHYLDOPA

MISOPROSTOL, MISOPROSTOL

NADOLOL, NADOLOL

OXAPROZIN, OXAPROZIN

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

** J **

J AND J CONSUMER INC

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION

CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)

CHILDREN'S MOTRIN, IBUPROFEN (OTC)

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)

MOTRIN IB, IBUPROFEN (OTC)

PEPCID AC, FAMOTIDINE (OTC)

PEPCID COMPLETE, CALCIUM CARBONATE (OTC)

SINE-AID IB, IBUPROFEN (OTC)

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 94

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION

TYLENOL, ACETAMINOPHEN (OTC)

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

JACOBUS

* JACOBUS PHARMACEUTICAL CO

DAPSONE, DAPSONE

PASER, AMINOSALICYLIC ACID

JANSSEN BIOTECH

* JANSSEN BIOTECH INC

ERLEADA, APALUTAMIDE

ZYTIGA, ABIRATERONE ACETATE

JANSSEN PHARMS

* JANSSEN PHARMACEUTICALS INC

AXERT, ALMOTRIPTAN MALATE

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

DITROPAN XL, OXYBUTYNIN CHLORIDE

DURAGESIC-100, FENTANYL

DURAGESIC-12, FENTANYL

DURAGESIC-25, FENTANYL

DURAGESIC-37, FENTANYL

DURAGESIC-50, FENTANYL

DURAGESIC-75, FENTANYL

ELMIRON, PENTOSAN POLYSULFATE SODIUM

HALDOL, HALOPERIDOL DECANOATE

HALDOL, HALOPERIDOL LACTATE

INVEGA SUSTENNA, PALIPERIDONE PALMITATE

INVEGA TRINZA, PALIPERIDONE PALMITATE

INVEGA, PALIPERIDONE

INVOKAMET XR, CANAGLIFLOZIN

INVOKAMET, CANAGLIFLOZIN

INVOKANA, CANAGLIFLOZIN

MICRONOR, NORETHINDRONE

NIZORAL, KETOCONAZOLE

ORTHO CYCLEN-28, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL

ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL

ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL

ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL

RAZADYNE ER, GALANTAMINE HYDROBROMIDE

RAZADYNE, GALANTAMINE HYDROBROMIDE

RISPERDAL CONSTA, RISPERIDONE

RISPERDAL, RISPERIDONE

SPORANOX, ITRACONAZOLE

TOPAMAX, TOPIRAMATE

TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN

TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN

ULTRACET, ACETAMINOPHEN

ULTRAM, TRAMADOL HYDROCHLORIDE

XARELTO, RIVAROXABAN

JANSSEN PRODS

* JANSSEN PRODUCTS LP

EDURANT, RILPIVIRINE HYDROCHLORIDE

PREZCOBIX, COBICISTAT

PREZISTA, DARUNAVIR ETHANOLATE

SYMTUZA, COBICISTAT

YONDELIS, TRABECTEDIN

JANSSEN R AND D

* JANSSEN RESEARCH AND DEVELOPMENT LLC

INTELENCE, ETRAVIRINE

JANSSEN RES AND DEV

* JANSSEN RESEARCH AND DEVELOPMENT LLC

DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

JANSSEN THERAP

* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 95

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

SIRTURO, BEDAQUILINE FUMARATE

JAZZ PHARMS

* JAZZ PHARMACEUTICALS INC

XYREM, SODIUM OXYBATE

JAZZ PHARMS III

* JAZZ PHARMACEUTICALS III INTERNATIONAL LTD

FAZACLO ODT, CLOZAPINE

JAZZ PHARMS INC

* JAZZ PHARMACEUTICALS INC

DEFITELIO, DEFIBROTIDE SODIUM

JIANGSU HANSOH PHARM

* JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

JIANGSU HENGRUI MED

* JIANGSU HENGRUI MEDICINE CO LTD

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

GABAPENTIN, GABAPENTIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LETROZOLE, LETROZOLE

OXALIPLATIN, OXALIPLATIN

THIOTEPA, THIOTEPA

JOHNS HOPKINS UNIV

* JOHNS HOPKINS UNIV

AMMONIA N 13, AMMONIA N-13

JOHNSON AND JOHNSON

* JOHNSON AND JOHNSON CONSUMER INC

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISINE, NAPHAZOLINE HYDROCHLORIDE (OTC)

* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES

MEN'S ROGAINE, MINOXIDIL (OTC)

ROGAINE (FOR MEN), MINOXIDIL (OTC)

ROGAINE (FOR WOMEN), MINOXIDIL (OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

WOMEN'S ROGAINE, MINOXIDIL (OTC)

* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS DIV MCNEIL-PPC INC

NIZORAL A-D, KETOCONAZOLE (OTC)

JOURNEY

* JOURNEY MEDICAL CORP

EXELDERM, SULCONAZOLE NITRATE

JUBILANT CADISTA

* JUBILANT CADISTA PHARMACEUTICALS INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

PREDNISONE, PREDNISONE

PROCOMP, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

JUBILANT DRAXIMAGE

* JUBILANT DRAXIMAGE INC

DRAX EXAMETAZIME, TECHNETIUM TC-99M EXAMETAZIME KIT

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE

DTPA, TECHNETIUM TC-99M PENTETATE KIT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 96

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JUBILANT DRAXIMAGE INC

HICON, SODIUM IODIDE I-131

RUBY-FILL, RUBIDIUM CHLORIDE RB-82

SODIUM IODIDE I 131, SODIUM IODIDE I-131

* JUBILANT DRAXIMAGE RADIOPHARMACIES INC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

* JUBILANT DRAXIMAGE USA INC

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

JUBILANT GENERICS

* JUBILANT GENERICS LTD

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CELECOXIB, CELECOXIB

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FELODIPINE, FELODIPINE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN, IRBESARTAN

ITRACONAZOLE, ITRACONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NIACIN, NIACIN

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RISPERIDONE, RISPERIDONE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SPIRONOLACTONE, SPIRONOLACTONE

TELMISARTAN, TELMISARTAN

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

ZOLMITRIPTAN, ZOLMITRIPTAN

JUBILANT HOLLISTRSTR

* JUBILANT HOLLISTERSTIER LLC

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STEVENS J

* JEROME STEVENS PHARMACEUTICALS INC

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

DIGOXIN, DIGOXIN

METHOCARBAMOL AND ASPIRIN, ASPIRIN

UNITHROID, LEVOTHYROXINE SODIUM **

** K **

GRIFFEN

* KW GRIFFEN CO

BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)

KADMON PHARMS LLC

* KADMON PHARMACEUTICALS LLC

RIBASPHERE, RIBAVIRIN

RIBAVIRIN, RIBAVIRIN

KAI PHARMS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 97

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **

* KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC

PARSABIV, ETELCALCETIDE

KALA PHARMS INC

* KALA PHARMACEUTICALS INC

INVELTYS, LOTEPREDNOL ETABONATE

KALEO INC

* KALEO INC

AUVI-Q, EPINEPHRINE

EVZIO, NALOXONE HYDROCHLORIDE

KEMPHARM

* KEMPHARM INC

APADAZ, ACETAMINOPHEN

KERYX BIOPHARMS

* KERYX BIOPHARMACEUTICALS INC

AURYXIA, FERRIC CITRATE

KETTERING MEDCTR

* KETTERING MEDCTR

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

KING PHARMS

* KING PHARMACEUTICALS INC

SYNERCID, DALFOPRISTIN

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC

CYTOMEL, LIOTHYRONINE SODIUM

LEVOXYL, LEVOTHYROXINE SODIUM **

TUSSIGON, HOMATROPINE METHYLBROMIDE

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC

SKELAXIN, METAXALONE

KING PHARMS LLC

* KING PHARMACEUTICALS LLC

ALTACE, RAMIPRIL

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

CORZIDE, BENDROFLUMETHIAZIDE

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

SILVADENE, SILVER SULFADIAZINE

TAPAZOLE, METHIMAZOLE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

KITOV PHARMS LTD

* KITOV PHARMACEUTICALS LTD

CONSENSI, AMLODIPINE BESYLATE

KNIGHT THERAPS

* KNIGHT THERAPEUTICS USA INC

IMPAVIDO, MILTEFOSINE

KOWA CO

* KOWA CO LTD

LIVALO, PITAVASTATIN CALCIUM

KREITCHMAN PET CTR

* KREITCHMAN PET CENTER

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

KRKA TOVARNA ZDRAVIL

* KRKA TOVARNA ZDRAVIL DD NOVO MESTO

LANSOPRAZOLE, LANSOPRAZOLE

KVK TECH

* KVK TECH INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KALEXATE, SODIUM POLYSTYRENE SULFONATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 98

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **

* KVK TECH INC

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

KVK TECH INC

* KVK TECH INC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

KYOWA KIRIN

* KYOWA KIRIN INC

FARESTON, TOREMIFENE CITRATE

SANCUSO, GRANISETRON

KYTHERA BIOPHARMS

* KYTHERA BIOPHARMACEUTICALS INC

KYBELLA, DEOXYCHOLIC ACID

** L **

L PERRIGO CO

* L PERRIGO CO

CIMETIDINE, CIMETIDINE (OTC)

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

LA JOLLA PHARMA

* LA JOLLA PHARMA LLC

GIAPREZA, ANGIOTENSIN II ACETATE

LAB HRA PHARMA

* LABORATOIRE HRA PHARMA

ELLA, ULIPRISTAL ACETATE

LABORATOIRE HRA

* LABORATOIRE HRA PHARMA

LYSODREN, MITOTANE

LABORATORIE HRA

* LABORATORIE HRA PHARMA

METOPIRONE, METYRAPONE

LABORATORIOS GRIFOLS

* LABORATORIOS GRIFOLS SA

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

LABORATORIOS SALVAT

* LABORATORIOS SALVAT SA

OTOVEL, CIPROFLOXACIN HYDROCHLORIDE

LABS LEON FARMA

* LABORATORIOS LEON FARMA SA

ALTAVERA, ETHINYL ESTRADIOL

ELIFEMME, ETHINYL ESTRADIOL

ESTARYLLA, ETHINYL ESTRADIOL

INTROVALE, ETHINYL ESTRADIOL

ISIBLOOM, DESOGESTREL

JAIMIESS, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LORYNA, DROSPIRENONE

SYEDA, DROSPIRENONE

TRI-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL

VIENVA, ETHINYL ESTRADIOL

VOLNEA, DESOGESTREL

LABS LICONSA

* LABORATORIOUS LICONSA SA

LANSOPRAZOLE, LANSOPRAZOLE

LANDELA PHARM

* LANDELA PHARMACEUTICAL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 99

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LANDELA PHARMACEUTICAL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LANNETT

* LANNETT CO INC

ACETAZOLAMIDE, ACETAZOLAMIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

LANIAZID, ISONIAZID

LANORINAL, ASPIRIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

PROBALAN, PROBENECID

LANNETT CO INC

* LANNETT CO INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETIC ACID, ACETIC ACID, GLACIAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BACLOFEN, BACLOFEN

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CODEINE SULFATE, CODEINE SULFATE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DANAZOL, DANAZOL

DEXAMETHASONE, DEXAMETHASONE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DIAZEPAM, DIAZEPAM

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DRONABINOL, DRONABINOL

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

GLYCOLAX, POLYETHYLENE GLYCOL 3350

GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCORTISONE, HYDROCORTISONE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LACTULOSE, LACTULOSE

LAMIVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

LOPINAVIR AND RITONAVIR, LOPINAVIR

LORATADINE, LORATADINE (OTC)

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 100

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LANNETT CO INC

METADATE ER, METHYLPHENIDATE HYDROCHLORIDE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METAXALONE, METAXALONE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MONOKET, ISOSORBIDE MONONITRATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NIACIN, NIACIN

NYSTATIN, NYSTATIN

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE, PREDNISOLONE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

RISPERIDONE, RISPERIDONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN, SUMATRIPTAN

TEMOZOLOMIDE, TEMOZOLOMIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THEOPHYLLINE, THEOPHYLLINE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

URSODIOL, URSODIOL

VALPROIC ACID, VALPROIC ACID

ZAROXOLYN, METOLAZONE

LANTHEUS MEDCL

* LANTHEUS MEDICAL IMAGING INC

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

DEFINITY, PERFLUTREN

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

XENON XE 133, XENON XE-133

LANTHEUS MEDICAL

* LANTHEUS MEDICAL IMAGING INC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

LARKEN LABS

* LARKEN LABORATORIES INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

OFLOXACIN, OFLOXACIN

LARKEN LABS INC

* LARKEN LABORATORIES INC

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN

ALLZITAL, ACETAMINOPHEN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

DEXAMETHASONE, DEXAMETHASONE

LAURUS LABS LTD

* LAURUS LABS LTD

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

LAVIPHARM LABS

* LAVIPHARM LABORATORIES INC

FENTANYL-100, FENTANYL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 101

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LAVIPHARM LABORATORIES INC

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

LEADIANT BIOSCI INC

* LEADIANT BIOSCIENCES INC

ABELCET, AMPHOTERICIN B

ADAGEN, PEGADEMASE BOVINE

CARNITOR SF, LEVOCARNITINE

CARNITOR, LEVOCARNITINE

CYSTARAN, CYSTEAMINE HYDROCHLORIDE

MATULANE, PROCARBAZINE HYDROCHLORIDE

LEADING PHARMA LLC

* LEADING PHARMA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

FOLIC ACID, FOLIC ACID

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

NIFEDIPINE, NIFEDIPINE

LEO LABS

* LEO LABORATORIES LTD

PICATO, INGENOL MEBUTATE

LEO PHARMA AS

* LEO PHARMA AS

DESONATE, DESONIDE

DOVONEX, CALCIPOTRIENE

ENSTILAR, BETAMETHASONE DIPROPIONATE

FINACEA, AZELAIC ACID

PROTOPIC, TACROLIMUS

TACLONEX, BETAMETHASONE DIPROPIONATE

LEXICON PHARMS INC

* LEXICON PHARMACEUTICALS INC

XERMELO, TELOTRISTAT ETIPRATE

LG CHEM LTD

* LG CHEM LTD

FACTIVE, GEMIFLOXACIN MESYLATE

LIEBEL-FLARSHEIM

* LIEBEL-FLARSHEIM CO LLC

CONRAY 43, IOTHALAMATE MEGLUMINE

CONRAY, IOTHALAMATE MEGLUMINE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

OPTIRAY 240, IOVERSOL

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

LIFE MOLECULAR

* LIFE MOLECULAR IMAGING SA

NEURACEQ, FLORBETABEN F-18

LIFEPHARMA

* LIFEPHARMA FZE

LACTULOSE, LACTULOSE

LNK

* LNK INTERNATIONAL INC

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LNK INTL INC

* LNK INTERNATIONAL INC

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 102

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

LOREAL USA

* LOREAL USA PRODUCTS INC

ANTHELIOS 20, AVOBENZONE (OTC)

ANTHELIOS 40, AVOBENZONE (OTC)

ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

LOTUS PHARM CO LTD

* LOTUS PHARMACEUTICAL CO LTD

ROWEEPRA, LEVETIRACETAM

* LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT

CALCIUM ACETATE, CALCIUM ACETATE

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL (OTC)

PARICALCITOL, PARICALCITOL

LOXO ONCOLOGY INC

* LOXO ONCOLOGY INC

VITRAKVI, LAROTRECTINIB

LUITPOLD

* LUITPOLD PHARMACEUTICALS INC

ACETYLCYSTEINE, ACETYLCYSTEINE

ADENOSINE, ADENOSINE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUSULFAN, BUSULFAN

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYCLOSPORINE, CYCLOSPORINE

DACTINOMYCIN, DACTINOMYCIN

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXFERRUM, IRON DEXTRAN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL

EPINEPHRINE, EPINEPHRINE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ETOMIDATE, ETOMIDATE

FLOXURIDINE, FLOXURIDINE

FOMEPIZOLE, FOMEPIZOLE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GANCICLOVIR, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

INJECTAFER, FERRIC CARBOXYMALTOSE

LEVETIRACETAM, LEVETIRACETAM

LEVOCARNITINE, LEVOCARNITINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MANNITOL 25%, MANNITOL

METHOCARBAMOL, METHOCARBAMOL

METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 103

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUITPOLD PHARMACEUTICALS INC

METOPROLOL TARTRATE, METOPROLOL TARTRATE

NANDROLONE DECANOATE, NANDROLONE DECANOATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NITROGLYCERIN, NITROGLYCERIN

OLANZAPINE, OLANZAPINE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROGESTERONE, PROGESTERONE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

VENOFER, IRON SUCROSE

ZIDOVUDINE, ZIDOVUDINE

LUKARE MEDICAL LLC

* LUKARE MEDICAL LLC

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

LUNDBECK NA LTD

* LUNDBECK NA LTD

NORTHERA, DROXIDOPA

LUNDBECK PHARMS LLC

* LUNDBECK PHARMACEUTICALS LLC

ONFI, CLOBAZAM

SABRIL, VIGABATRIN

LUPIN

* LUPIN INC

SOLOSEC, SECNIDAZOLE

TOBRAMYCIN, TOBRAMYCIN

* LUPIN LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOVASTATIN, LOVASTATIN

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN ATLANTIS

* LUPIN ATLANTIS HOLDINGS SA

ANTARA (MICRONIZED), FENOFIBRATE

BUDESONIDE, BUDESONIDE

DESOXIMETASONE, DESOXIMETASONE

MIBELAS 24 FE, ETHINYL ESTRADIOL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

LUPIN LTD

* LUPIN LIMITED

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 104

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN LIMITED

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* LUPIN LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE

AMABELZ, ESTRADIOL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

ARMODAFINIL, ARMODAFINIL

ATOVAQUONE, ATOVAQUONE

AZITHROMYCIN, AZITHROMYCIN

BEKYREE, DESOGESTREL

BIMATOPROST, BIMATOPROST

BLISOVI 24 FE, ETHINYL ESTRADIOL

BLISOVI FE 1.5/30, ETHINYL ESTRADIOL

BLISOVI FE 1/20, ETHINYL ESTRADIOL

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CALCIUM ACETATE, CALCIUM ACETATE

CELECOXIB, CELECOXIB

CIPROFLOXACIN, CIPROFLOXACIN

CLARITHROMYCIN, CLARITHROMYCIN

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DAYSEE, ETHINYL ESTRADIOL

DECITABINE, DECITABINE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENSKYCE, DESOGESTREL

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

FALLBACK SOLO, LEVONORGESTREL (OTC)

FAMOTIDINE, FAMOTIDINE

FAYOSIM, ETHINYL ESTRADIOL

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FYAVOLV, ETHINYL ESTRADIOL

GABAPENTIN, GABAPENTIN

GATIFLOXACIN, GATIFLOXACIN

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

JENCYCLA, NORETHINDRONE

KAITLIB FE, ETHINYL ESTRADIOL

KURVELO, ETHINYL ESTRADIOL

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 105

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN LTD

MEFENAMIC ACID, MEFENAMIC ACID

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NIACIN, NIACIN

NIKKI, DROSPIRENONE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OMEPRAZOLE, OMEPRAZOLE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIRMELLA 1/35, ETHINYL ESTRADIOL

PIRMELLA 7/7/7, ETHINYL ESTRADIOL

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RIFABUTIN, RIFABUTIN

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILODOSIN, SILODOSIN

SUPRAX, CEFIXIME

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TESTOSTERONE, TESTOSTERONE

TETRABENAZINE, TETRABENAZINE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TYDEMY, DROSPIRENONE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VYFEMLA, ETHINYL ESTRADIOL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LUPIN PHARMS

* LUPIN PHARMACEUTICALS INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

DESLORATADINE, DESLORATADINE

MELOXICAM, MELOXICAM

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RIFAMPIN, RIFAMPIN

SUPRAX, CEFIXIME

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

LYMOL MEDCL

* LYMOL MEDICAL CORP

SCLEROSOL, TALC

TALC, TALC

LYNE

* LYNE LABORATORIES INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

LEVOCARNITINE, LEVOCARNITINE

NYSTATIN, NYSTATIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 106

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

PERRIGO

* L PERRIGO CO

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

TAB-PROFEN, IBUPROFEN (OTC)

TIOCONAZOLE, TIOCONAZOLE (OTC)

** M **

MA GENERAL HOSP

* MASSACHUSETTS GENERAL HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

MACLEODS PHARMS LTD

* MACLEODS PHARMACEUTICALS LTD

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CELECOXIB, CELECOXIB

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DARIFENACIN, DARIFENACIN HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

FAMCICLOVIR, FAMCICLOVIR

FLUOCINONIDE, FLUOCINONIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEVIRAPINE, NEVIRAPINE

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 107

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MACLEODS PHARMACEUTICALS LTD

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRIAMCINOLONE ACETATE, TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

MAGNA PHARMS

* MAGNA PHARMACEUTICALS INC

ZOLPIMIST, ZOLPIDEM TARTRATE

MAIA PHARMS INC

* MAIA PHARMACEUTICALS INC

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

MAINPOINTE

* MAINPOINTE PHARMACEUTICALS LLC

TUXARIN ER, CHLORPHENIRAMINE MALEATE

MALLINCKRODT ARD

* MALLINCKRODT ARD INC

H.P. ACTHAR GEL, CORTICOTROPIN

MALLINCKRODT HOSP

* MALLINCKRODT HOSP PRODUCTS IP LTD

INOMAX, NITRIC OXIDE

OFIRMEV, ACETAMINOPHEN

UVADEX, METHOXSALEN

MALLINKRODT NUCLEAR

* MALLINCKRODT NUCLEAR MEDICINE LLC

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

SODIUM IODIDE I 123, SODIUM IODIDE I-123

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

XENON XE 133, XENON XE-133

MANNKIND

* MANNKIND CORP

AFREZZA, INSULIN RECOMBINANT HUMAN

MARINA BIOTECH

* MARINA BIOTECH INC

PRESTALIA, AMLODIPINE BESYLATE

MARKSANS PHARMA

* MARKSANS PHARMA LTD

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

IBUPROFEN, IBUPROFEN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 108

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MARKSANS PHARMA LTD

IBUPROFEN, IBUPROFEN (OTC)

LORATADINE, LORATADINE (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

PARICALCITOL, PARICALCITOL

MARNEL PHARMS

* MARNEL PHARMACEUTICALS LLC

CROTAN, CROTAMITON

MAYER LABS INC

* MAYER LABORATORIES INC

TODAY, NONOXYNOL-9 (OTC)

MAYNE PHARMA

* MAYNE PHARMA INTERNATIONAL PTY LTD

DORYX MPC, DOXYCYCLINE HYCLATE

DORYX, DOXYCYCLINE HYCLATE

ERYC, ERYTHROMYCIN

* MAYNE PHARMA LLC

BUDESONIDE, BUDESONIDE

CAMILA, NORETHINDRONE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CLARITHROMYCIN, CLARITHROMYCIN

CLONIDINE, CLONIDINE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ERRIN, NORETHINDRONE

ESTAZOLAM, ESTAZOLAM

ESTRADIOL, ESTRADIOL

FABIOR, TAZAROTENE

FENTANYL-100, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

FLUOROURACIL, FLUOROURACIL

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LOW-OGESTREL-28, ETHINYL ESTRADIOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MICROGESTIN 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN 1/20, ETHINYL ESTRADIOL

MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL

MICROGESTIN FE 1/20, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

SORILUX, CALCIPOTRIENE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL

TRIMETHOPRIM, TRIMETHOPRIM

TRIVORA-28, ETHINYL ESTRADIOL

ZOVIA 1/35E-28, ETHINYL ESTRADIOL

MAYNE PHARMA INC

* MAYNE PHARMA INC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 109

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MAYNE PHARMA INC

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DOFETILIDE, DOFETILIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NYSTATIN, NYSTATIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

MAYNE PHARMA INTL

* MAYNE PHARMA INTERNATIONAL PTY LTD

TOLSURA, ITRACONAZOLE

MCGUFF

* MCGUFF PHARMACEUTICALS INC

ASCOR, ASCORBIC ACID

MCNEIL

* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC

IBUPROFEN, IBUPROFEN (OTC)

MCNEIL CONS

* MCNEIL CONSUMER HEALTHCARE

SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

MCPRF

* MAYO CLINIC PET RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MDGH

* MEDICINES DEVELOPMENT FOR GLOBAL HEALTH

MOXIDECTIN, MOXIDECTIN

MEDAC PHARMA INC

* MEDAC PHARMA INC

RASUVO, METHOTREXATE

MEDEFIL INC

* MEDEFIL INC

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

MEDICINES360

* MEDICINES360

LILETTA, LEVONORGESTREL

MEDICIS

* MEDICIS PHARMACEUTICAL CORP

ALDARA, IMIQUIMOD

AMMONUL, SODIUM BENZOATE

CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM

LOPROX, CICLOPIROX

LUZU, LULICONAZOLE

METROGEL-VAGINAL, METRONIDAZOLE

MINITRAN, NITROGLYCERIN

SOLODYN, MINOCYCLINE HYDROCHLORIDE

VANOS, FLUOCINONIDE

ZIANA, CLINDAMYCIN PHOSPHATE

ZYCLARA, IMIQUIMOD

MEDICURE

* MEDICURE INTERNATIONAL INC

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

MEDIMETRIKS PHARMS

* MEDIMETRIKS PHARMACEUTICALS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 110

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MEDIMETRIKS PHARMACEUTICALS INC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

LOPROX, CICLOPIROX

NEO-SYNALAR, FLUOCINOLONE ACETONIDE

SYNALAR, FLUOCINOLONE ACETONIDE

MEDLINE INDUSTRIES

* MEDLINE INDUSTRIES INC

READYPREP CHG, CHLORHEXIDINE GLUCONATE (OTC)

MEDTECH PRODUCTS

* MEDTECH PRODUCTS INC

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3, MICONAZOLE NITRATE

MONISTAT 3, MICONAZOLE NITRATE (OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 7, MICONAZOLE NITRATE (OTC)

NIX, PERMETHRIN (OTC)

TAGAMET HB, CIMETIDINE (OTC)

MELINTA

* MELINTA SUBSIDIARY CORP

BAXDELA, DELAFLOXACIN MEGLUMINE

MELINTA THERAP

* MELINTA THERAPEUTICS INC

ORBACTIV, ORITAVANCIN DIPHOSPHATE

MEM SLOAN-KETTERING

* MEMORIAL SLOAN-KETTERING CANCER CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

MERCK

* MERCK AND CO INC

CANCIDAS, CASPOFUNGIN ACETATE

EMEND, APREPITANT

FOSAMAX PLUS D, ALENDRONATE SODIUM

MAXALT, RIZATRIPTAN BENZOATE

MAXALT-MLT, RIZATRIPTAN BENZOATE

PRIMAXIN, CILASTATIN SODIUM

PROSCAR, FINASTERIDE

ZOLINZA, VORINOSTAT

* MERCK RESEARCH LABORATORIES DIV MERCK CO INC

PRINIVIL, LISINOPRIL

PROPECIA, FINASTERIDE

SINGULAIR, MONTELUKAST SODIUM

TRUSOPT, DORZOLAMIDE HYDROCHLORIDE

MERCK AND CO INC

* MERCK AND CO INC

EMEND, FOSAPREPITANT DIMEGLUMINE

FOSAMAX, ALENDRONATE SODIUM

MERCK SHARP DOHME

* MERCK SHARP AND DOHME CORP

ASMANEX HFA, MOMETASONE FUROATE

ASMANEX TWISTHALER, MOMETASONE FUROATE

BELSOMRA, SUVOREXANT

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CLARINEX D 24 HOUR, DESLORATADINE

CLARINEX, DESLORATADINE

CLARINEX-D 12 HOUR, DESLORATADINE

COZAAR, LOSARTAN POTASSIUM

CRIXIVAN, INDINAVIR SULFATE

DIPROLENE AF, BETAMETHASONE DIPROPIONATE

DIPROLENE, BETAMETHASONE DIPROPIONATE

DULERA, FORMOTEROL FUMARATE

ELOCON, MOMETASONE FUROATE

GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE

HYZAAR, HYDROCHLOROTHIAZIDE

INVANZ, ERTAPENEM SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 111

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MERCK SHARP AND DOHME CORP

ISENTRESS HD, RALTEGRAVIR POTASSIUM

ISENTRESS, RALTEGRAVIR POTASSIUM

JANUMET XR, METFORMIN HYDROCHLORIDE

JANUMET, METFORMIN HYDROCHLORIDE

JANUVIA, SITAGLIPTIN PHOSPHATE

LOTRISONE, BETAMETHASONE DIPROPIONATE

NASONEX, MOMETASONE FUROATE

NOXAFIL, POSACONAZOLE

PREVYMIS, LETERMOVIR

REBETOL, RIBAVIRIN

SEGLUROMET, ERTUGLIFLOZIN

SINEMET CR, CARBIDOPA

SINEMET, CARBIDOPA

STEGLATRO, ERTUGLIFLOZIN

STEGLUJAN, ERTUGLIFLOZIN

STROMECTOL, IVERMECTIN

TEMODAR, TEMOZOLOMIDE

ZEPATIER, ELBASVIR

MERIDIAN MEDCL

* MERIDIAN MEDICAL TECHNOLOGIES INC

DUODOTE, ATROPINE

MERIDIAN MEDCL TECHN

* MERIDIAN MEDICAL TECHNOLOGIES INC

ATROPEN, ATROPINE SULFATE

MORPHINE SULFATE, MORPHINE SULFATE

PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE

SEIZALAM, MIDAZOLAM HYDROCHLORIDE

MERLION PHARMS GMBH

* MERLION PHARMACEUTICALS GMBH

XTORO, FINAFLOXACIN

MERRO PHARM

* MERRO PHARMACEUTICAL CO LTD

IBUPROFEN, IBUPROFEN (OTC)

MERZ PHARMS

* MERZ PHARMACEUTICALS LLC

CUVPOSA, GLYCOPYRROLATE

METHAPHARM

* METHAPHARM INC

PROVOCHOLINE, METHACHOLINE CHLORIDE

METUCHEN PHARMS

* METUCHEN PHARMACEUTICALS LLC

STENDRA, AVANAFIL

MICRO LABS

* MICRO LABS LTD

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

CAFFEINE CITRATE, CAFFEINE CITRATE

CELECOXIB, CELECOXIB

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

MEFENAMIC ACID, MEFENAMIC ACID

METHAZOLAMIDE, METHAZOLAMIDE

PIROXICAM, PIROXICAM

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

TELMISARTAN, TELMISARTAN

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

MICRO LABS LTD

* MICRO LABS LTD

NEVIRAPINE, NEVIRAPINE

MICRO LABS LTD INDIA

* MICRO LABS LTD INDIA

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

CROMOLYN SODIUM, CROMOLYN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 112

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MICRO LABS LTD INDIA

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

MIDATECH PHARMA US

* MIDATECH PHARMA US INC

ORAVIG, MICONAZOLE

SOLTAMOX, TAMOXIFEN CITRATE

ZUPLENZ, ONDANSETRON

MIDWEST MEDCL

* MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV

AMMONIA N 13, AMMONIA N-13

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MIKART

* MIKART LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZONATATE, BENZONATATE

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTAPAP, ACETAMINOPHEN

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CHLORZOXAZONE, CHLORZOXAZONE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ETHOSUXIMIDE, ETHOSUXIMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

ISONIAZID, ISONIAZID

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

MIKART INC

* MIKART INC

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

MILLENNIUM PHARMS

* MILLENNIUM PHARMACEUTICALS INC

NINLARO, IXAZOMIB CITRATE

VELCADE, BORTEZOMIB

MILLICENT

* MILLICENT HOLDINGS LTD

FEMRING, ESTRADIOL ACETATE

MIPS CRF

* MIPS CYCLOTRON AND RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MISSION PHARMA

* MISSION PHARMACAL CO

BINOSTO, ALENDRONATE SODIUM

LITHOSTAT, ACETOHYDROXAMIC ACID

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TEXACORT, HYDROCORTISONE

THIOLA, TIOPRONIN

TINDAMAX, TINIDAZOLE

UROCIT-K, POTASSIUM CITRATE

MISSION PHARMACAL CO

* MISSION PHARMACAL CO

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

POTASSIUM IODIDE, POTASSIUM IODIDE (OTC)

MIST PHARMS LLC

* MIST PHARMACEUTICALS LLC

NITROMIST, NITROGLYCERIN

MITSUBISHI TANABE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 113

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MITSUBISHI TANABE PHARMA CORP

RADICAVA, EDARAVONE

MOBERG PHARMA NORTH

* MOBERG PHARMA NORTH AMERICA LLC

CHILDREN'S ELIXSURE, IBUPROFEN (OTC)

MOBIUS THERAP

* MOBIUS THERAPEUTICS LLC

MITOSOL, MITOMYCIN

MOLNLYCKE HLTH

* MOLNLYCKE HEALTH CARE

HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

MONARCH PHARMS

* MONARCH PHARMACEUTICALS LLC

CORTISPORIN, BACITRACIN ZINC

CORTISPORIN, HYDROCORTISONE ACETATE

MENEST, ESTROGENS, ESTERIFIED

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSPORIN, GRAMICIDIN

SEPTRA DS, SULFAMETHOXAZOLE

SEPTRA, SULFAMETHOXAZOLE

VIROPTIC, TRIFLURIDINE

MONTEREY PHARMS LLC

* MONTEREY PHARMACEUTICALS LLC

METHOCARBAMOL, METHOCARBAMOL

MOUNTAIN

* MOUNTAIN LLC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

METAXALONE, METAXALONE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

MSD INTL

* MSD INTERNATIONAL GMBH

VYTORIN, EZETIMIBE

MSD INTL GMBH

* MSD INTERNATIONAL GMBH

ZETIA, EZETIMIBE

MSD MERCK CO

* MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

DELSTRIGO, DORAVIRINE

EMEND, APREPITANT

PIFELTRO, DORAVIRINE

SINGULAIR, MONTELUKAST SODIUM

ZOCOR, SIMVASTATIN

MSN LABS PVT LTD

* MSN LABORATORIES PRIVATE LTD

CAPECITABINE, CAPECITABINE

CLOFARABINE, CLOFARABINE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILODOSIN, SILODOSIN

MURTY PHARMS

* MURTY PHARMACEUTICALS INC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

MUSTAFA NEVZAT ILAC

* MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

MUTUAL PHARM

* MUTUAL PHARMACEUTICAL CO INC

PREDNISONE, PREDNISONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 114

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

MYLAN

* MYLAN PHARMACEUTICALS

FENOFIBRATE, FENOFIBRATE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

* MYLAN PHARMACEUTICALS INC

ACARBOSE, ACARBOSE

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALLOPURINOL, ALLOPURINOL

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

AVITA, TRETINOIN

AZATHIOPRINE, AZATHIOPRINE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUDESONIDE, BUDESONIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CHLOROTHIAZIDE, CHLOROTHIAZIDE

CHLORPROPAMIDE, CHLORPROPAMIDE

CHLORTHALIDONE, CHLORTHALIDONE

CIMETIDINE, CIMETIDINE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLOZAPINE, CLOZAPINE

CYSTAGON, CYSTEAMINE BITARTRATE

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 115

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

ESTRADIOL, ESTRADIOL

ESTROPIPATE, ESTROPIPATE

ETIDRONATE DISODIUM, ETIDRONATE DISODIUM

ETOPOSIDE, ETOPOSIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FELODIPINE, FELODIPINE

FENOFIBRATE, FENOFIBRATE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLIPIZIDE, GLIPIZIDE

GLYBURIDE (MICRONIZED), GLYBURIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

INDOMETHACIN, INDOMETHACIN

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LAMOTRIGINE, LAMOTRIGINE

LATANOPROST, LATANOPROST

LEVETIRACETAM, LEVETIRACETAM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOVASTATIN, LOVASTATIN

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MENTAX, BUTENAFINE HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLDOPA, METHYLDOPA

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIRTAZAPINE, MIRTAZAPINE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 116

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

NISOLDIPINE, NISOLDIPINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENTOXIFYLLINE, PENTOXIFYLLINE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PROBENECID, PROBENECID

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

STAVUDINE, STAVUDINE

SULINDAC, SULINDAC

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TACROLIMUS, TACROLIMUS

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

THIOTHIXENE, THIOTHIXENE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLMETIN SODIUM, TOLMETIN SODIUM

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

URSODIOL, URSODIOL

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE

MYLAN ASI

* MYLAN ASI LLC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

AZITHROMYCIN, AZITHROMYCIN

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 117

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN ASI LLC

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

MYLAN INSTITUTIONAL

* MYLAN INSTITUTIONAL INC

SULFAMYLON, MAFENIDE ACETATE

* MYLAN INSTITUTIONAL LLC

ACETYLCYSTEINE, ACETYLCYSTEINE

ALOPRIM, ALLOPURINOL SODIUM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

AZACITIDINE, AZACITIDINE

BIVALIRUDIN, BIVALIRUDIN

CARBOPLATIN, CARBOPLATIN

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CIDOFOVIR, CIDOFOVIR

COSYNTROPIN, COSYNTROPIN

DANTROLENE SODIUM, DANTROLENE SODIUM

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DURACLON, CLONIDINE HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

FOMEPIZOLE, FOMEPIZOLE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

ISOSULFAN BLUE, ISOSULFAN BLUE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PENTOSTATIN, PENTOSTATIN

RIMSO-50, DIMETHYL SULFOXIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

ULTIVA, REMIFENTANIL HYDROCHLORIDE

MYLAN IRELAND LTD

* MYLAN IRELAND LTD

ARIXTRA, FONDAPARINUX SODIUM

CARBAMAZEPINE, CARBAMAZEPINE

MIACALCIN, CALCITONIN SALMON

PIROXICAM, PIROXICAM

THEOPHYLLINE, THEOPHYLLINE

YUPELRI, REVEFENACIN

MYLAN LABS

* MYLAN LABORATORIES LTD

NEVIRAPINE, NEVIRAPINE

MYLAN LABS LTD

* MYLAN LABORATORIES LTD

ADENOSINE, ADENOSINE

AMIFOSTINE, AMIFOSTINE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 118

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN LABORATORIES LTD

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BUSULFAN, BUSULFAN

CAPREOMYCIN SULFATE, CAPREOMYCIN SULFATE

CARBOPLATIN, CARBOPLATIN

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CIMDUO, LAMIVUDINE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOFARABINE, CLOFARABINE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYTARABINE, CYTARABINE

DACTINOMYCIN, DACTINOMYCIN

DAPTOMYCIN, DAPTOMYCIN

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DOCETAXEL, DOCETAXEL

DOCETAXEL, DOCETAXEL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

EPTIFIBATIDE, EPTIFIBATIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ETOMIDATE, ETOMIDATE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GANCICLOVIR, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM, HEPARIN SODIUM

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MITOMYCIN, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 119

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN LABORATORIES LTD

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SYMFI, EFAVIRENZ

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

MYLAN PHARMS INC

* MYLAN PHARMACEUTICALS INC

ABACAVIR SULFATE, ABACAVIR SULFATE

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACITRETIN, ACITRETIN

ACYCLOVIR, ACYCLOVIR

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMNESTEEM, ISOTRETINOIN

ARMODAFINIL, ARMODAFINIL

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

AVITA, TRETINOIN

BACLOFEN, BACLOFEN

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CABERGOLINE, CABERGOLINE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CAPECITABINE, CAPECITABINE

CAPTOPRIL, CAPTOPRIL

CELECOXIB, CELECOXIB

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 120

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DENAVIR, PENCICLOVIR

DESLORATADINE, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIGOXIN, DIGOXIN

DISULFIRAM, DISULFIRAM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

EFAVIRENZ, EFAVIRENZ

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

ELIMITE, PERMETHRIN

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

EPLERENONE, EPLERENONE

EPROSARTAN MESYLATE, EPROSARTAN MESYLATE

ERYGEL, ERYTHROMYCIN

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESTRADIOL, ESTRADIOL

ESZOPICLONE, ESZOPICLONE

EVOCLIN, CLINDAMYCIN PHOSPHATE

EXEMESTANE, EXEMESTANE

EXTINA, KETOCONAZOLE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUOROURACIL, FLUOROURACIL

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

GABAPENTIN, GABAPENTIN

GATIFLOXACIN, GATIFLOXACIN

GLATIRAMER ACETATE, GLATIRAMER ACETATE

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

INDOMETHACIN, INDOMETHACIN

ITRACONAZOLE, ITRACONAZOLE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LINEZOLID, LINEZOLID

LITHIUM CARBONATE, LITHIUM CARBONATE

LUXIQ, BETAMETHASONE VALERATE

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYCLOTHIAZIDE, METHYCLOTHIAZIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 121

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

MODAFINIL, MODAFINIL

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLIC ACID, MYCOPHENOLIC ACID

NABUMETONE, NABUMETONE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NEVIRAPINE, NEVIRAPINE

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

OLUX E, CLOBETASOL PROPIONATE

OLUX, CLOBETASOL PROPIONATE

OMEPRAZOLE, OMEPRAZOLE

PALIPERIDONE, PALIPERIDONE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PERPHENAZINE, PERPHENAZINE

PHENYTOIN, PHENYTOIN

PINDOLOL, PINDOLOL

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISONE, PREDNISONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RASAGILINE MESYLATE, RASAGILINE MESYLATE

REPAGLINIDE, REPAGLINIDE

RILUZOLE, RILUZOLE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

RUFINAMIDE, RUFINAMIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

SYMFI LO, EFAVIRENZ

TADALAFIL, TADALAFIL

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TOLAZAMIDE, TOLAZAMIDE

TOLBUTAMIDE, TOLBUTAMIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAVOPROST, TRAVOPROST

TRETINOIN, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIAZOLAM, TRIAZOLAM

TRILYTE, POLYETHYLENE GLYCOL 3350

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VORICONAZOLE, VORICONAZOLE

VUSION, MICONAZOLE NITRATE

ZIDOVUDINE, ZIDOVUDINE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 122

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

ZONALON, DOXEPIN HYDROCHLORIDE

ZOVIRAX, ACYCLOVIR

* MYLAN PHARMACEUTICALS INC.

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

NIZATIDINE, NIZATIDINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

MYLAN SPECIALITY LP

* MYLAN SPECIALTY LP

ACCUNEB, ALBUTEROL SULFATE

AEROSPAN HFA, FLUNISOLIDE

ANADROL-50, OXYMETHOLONE

ASTELIN, AZELASTINE HYDROCHLORIDE

ASTEPRO, AZELASTINE HYDROCHLORIDE

AVC, SULFANILAMIDE

BUTISOL SODIUM, BUTABARBITAL SODIUM

CESAMET, NABILONE

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

CORTIFOAM, HYDROCORTISONE ACETATE

CROMOLYN SODIUM, CROMOLYN SODIUM

DEMADEX, TORSEMIDE

DEPEN, PENICILLAMINE

DIPENTUM, OLSALAZINE SODIUM

DYMISTA, AZELASTINE HYDROCHLORIDE

EDLUAR, ZOLPIDEM TARTRATE

ELESTRIN, ESTRADIOL

EPIFOAM, HYDROCORTISONE ACETATE

EPIPEN JR., EPINEPHRINE

EPIPEN, EPINEPHRINE

FELBATOL, FELBAMATE

GASTROCROM, CROMOLYN SODIUM

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

MUSE, ALPROSTADIL

PROCTOFOAM HC, HYDROCORTISONE ACETATE

ROWASA, MESALAMINE

SFROWASA, MESALAMINE

SOMA, CARISOPRODOL

TOBI PODHALER, TOBRAMYCIN

TOBI, TOBRAMYCIN

MYLAN SPECLT

* MYLAN SPECIALTY LP

PERFOROMIST, FORMOTEROL FUMARATE

MYLAN TECHNOLOGIES

* MYLAN TECHNOLOGIES INC

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CLONIDINE, CLONIDINE

ESTRADIOL, ESTRADIOL

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

LIDOCAINE, LIDOCAINE

NITROGLYCERIN, NITROGLYCERIN

RIVASTIGMINE, RIVASTIGMINE

XULANE, ETHINYL ESTRADIOL

MYLAN TEORANTA

* MYLAN TEORANTA

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

** N **

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 123

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

NALPROPION

* NALPROPION PHARMACEUTICALS INC

CONTRAVE, BUPROPION HYDROCHLORIDE

NAMIGEN LLC

* NAMIGEN LLC

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

NANG KUANG PHARM CO

* NANG KUANG PHARMACEUTICAL CO LTD

LINEZOLID, LINEZOLID

NANJING KING-FRIEND

* NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

CARBOPLATIN, CARBOPLATIN

HEPARIN SODIUM, HEPARIN SODIUM

NAPO PHARMS INC

* NAPO PHARMACEUTICALS INC

MYTESI, CROFELEMER

NATCO PHARMA

* NATCO PHARMA LTD

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

NATCO PHARMA LTD

* NATCO PHARMA LIMITED

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

* NATCO PHARMA LTD

ALPRAZOLAM, ALPRAZOLAM

ANASTROZOLE, ANASTROZOLE

ARMODAFINIL, ARMODAFINIL

AZACITIDINE, AZACITIDINE

CARISOPRODOL, CARISOPRODOL

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

GLYCOPYRROLATE, GLYCOPYRROLATE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LANTHANUM CARBONATE, LANTHANUM CARBONATE

LETROZOLE, LETROZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

NAVINTA LLC

* NAVINTA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CARMUSTINE, CARMUSTINE

FAMOTIDINE, FAMOTIDINE

FOMEPIZOLE, FOMEPIZOLE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

METHOCARBAMOL, METHOCARBAMOL

RIBAVIRIN, RIBAVIRIN

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

NCM USA BRONX LLC

* NCM USA BRONX LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

NEOPHARMA

* NEOPHARMA INC

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMOXIL, AMOXICILLIN

ANASTROZOLE, ANASTROZOLE

AUGMENTIN '125', AMOXICILLIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 124

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NEOPHARMA INC

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN XR, AMOXICILLIN

IRBESARTAN, IRBESARTAN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LAROTID, AMOXICILLIN

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

NEOS THERAP INC

* NEOS THERAPEUTICS INC

HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

NEOS THERAPS

* NEOS THERAPEUTICS

ADZENYS XR-ODT, AMPHETAMINE

NEOS THERAPS INC

* NEOS THERAPEUTICS INC

ADZENYS ER, AMPHETAMINE

COTEMPLA XR-ODT, METHYLPHENIDATE

NEPHRON

* NEPHRON CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

* NEPHRON PHARMACEUTICALS CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

NESHER PHARMS

* NESHER PHARMACEUTICALS USA LLC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

MICRO-K 10, POTASSIUM CHLORIDE

MICRO-K, POTASSIUM CHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NYSTATIN, NYSTATIN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

NEUROCRINE

* NEUROCRINE BIOSCIENCES INC

INGREZZA, VALBENAZINE TOSYLATE

NEW RIVER

* NEW RIVER PHARMACEUTICALS INC

PROFERDEX, IRON DEXTRAN

NEXGEN PHARMA

* NEXGEN PHARMA INC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHENODIOL, CHENODIOL

GLYCOPYRROLATE, GLYCOPYRROLATE

MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

NEXGEN PHARMA INC

* NEXGEN PHARMA INC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

NEXTWAVE PHARMS

* NEXTWAVE PHARMACEUTICALS INC

QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE

NEXUS PHARMS

* NEXUS PHARMACEUTICALS INC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 125

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NEXUS PHARMACEUTICALS INC

BUSULFAN, BUSULFAN

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

NIAGARA PHARMS

* NIAGARA PHARMACEUTICALS INC

PUR-WASH, PURIFIED WATER (OTC)

NODEN PHARMA

* NODEN PHARMA DAC

TEKTURNA HCT, ALISKIREN HEMIFUMARATE

TEKTURNA, ALISKIREN HEMIFUMARATE

NORTEC DEV ASSOC

* NORTEC DEVELOPMENT ASSOC INC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NORTHLAND

* NORTHLAND NUCLEAR MEDICINE LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

NORTHSTAR HLTHCARE

* NORTHSTAR HEALTHCARE HOLDINGS LTD

ALLOPURINOL, ALLOPURINOL

BACLOFEN, BACLOFEN

GEMFIBROZIL, GEMFIBROZIL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NORTHSTAR MEDICAL

* NORTHSTAR MEDICAL RADIOISOTOPES LLC

RADIOGENIX SYSTEM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

NORTON WATERFORD

* NORTON WATERFORD LTD

QVAR REDIHALER, BECLOMETHASONE DIPROPIONATE

NOSTRUM LABS INC

* NOSTRUM LABORATORIES INC

ACETAZOLAMIDE, ACETAZOLAMIDE

CALCIUM ACETATE, CALCIUM ACETATE

CARISOPRODOL, CARISOPRODOL

DAPSONE, DAPSONE

ELIXOPHYLLIN, THEOPHYLLINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NITROFURANTOIN, NITROFURANTOIN

PINDOLOL, PINDOLOL

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

NOSTRUM PHARMS LLC

* NOSTRUM PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOCHRON, THEOPHYLLINE

NOVA LABS LTD

* NOVA LABORATORIES LTD

PURIXAN, MERCAPTOPURINE

NOVADAQ TECH

* NOVADAQ TECHNOLOGIES ULC

SPY AGENT GREEN KIT, INDOCYANINE GREEN

NOVARTIS

* NOVARTIS PHARMACEUTICALS CORP

AFINITOR, EVEROLIMUS

COARTEM, ARTEMETHER

DESFERAL, DEFEROXAMINE MESYLATE

DIOVAN HCT, HYDROCHLOROTHIAZIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 126

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVARTIS PHARMACEUTICALS CORP

DIOVAN, VALSARTAN

EXELON, RIVASTIGMINE

EXELON, RIVASTIGMINE TARTRATE

EXFORGE HCT, AMLODIPINE BESYLATE

EXFORGE, AMLODIPINE BESYLATE

EXJADE, DEFERASIROX

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

GILENYA, FINGOLIMOD HYDROCHLORIDE

GLEEVEC, IMATINIB MESYLATE

LAMISIL, TERBINAFINE HYDROCHLORIDE

LESCOL XL, FLUVASTATIN SODIUM

LOPRESSOR, METOPROLOL TARTRATE

LOTREL, AMLODIPINE BESYLATE

MYFORTIC, MYCOPHENOLIC ACID

NEORAL, CYCLOSPORINE

RECLAST, ZOLEDRONIC ACID

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

SANDOSTATIN, OCTREOTIDE ACETATE

SIGNIFOR, PASIREOTIDE DIASPARTATE

STARLIX, NATEGLINIDE

TASIGNA, NILOTINIB HYDROCHLORIDE

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TRILEPTAL, OXCARBAZEPINE

VIVELLE-DOT, ESTRADIOL

VOLTAREN, DICLOFENAC SODIUM

ZOMETA, ZOLEDRONIC ACID

ZORTRESS, EVEROLIMUS

NOVARTIS PHARM

* NOVARTIS PHARMACEUTICAL CORP

AFINITOR DISPERZ, EVEROLIMUS

NOVARTIS PHARMS

* NOVARTIS PHARMACEUTICALS CORP

FEMARA, LETROZOLE

NOVARTIS PHARMS CORP

* NOVARTIS PHARMACEUTICALS CORP

ALOMIDE, LODOXAMIDE TROMETHAMINE

ARGATROBAN, ARGATROBAN

ARRANON, NELARABINE

AZOPT, BRINZOLAMIDE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRODEX, CIPROFLOXACIN

DUREZOL, DIFLUPREDNATE

EMADINE, EMEDASTINE DIFUMARATE

ENTRESTO, SACUBITRIL

FARYDAK, PANOBINOSTAT LACTATE

FLAREX, FLUOROMETHOLONE ACETATE

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

ILEVRO, NEPAFENAC

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

JADENU SPRINKLE, DEFERASIROX

JADENU, DEFERASIROX

KISQALI FEMARA CO-PACK (COPACKAGED), LETROZOLE

KISQALI, RIBOCICLIB SUCCINATE

MAXIDEX, DEXAMETHASONE

MAXITROL, DEXAMETHASONE

MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 127

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVARTIS PHARMACEUTICALS CORP

MOXEZA, MOXIFLOXACIN HYDROCHLORIDE

MYDRIACYL, TROPICAMIDE

NATACYN, NATAMYCIN

NEVANAC, NEPAFENAC

OMNIPRED, PREDNISOLONE ACETATE

PATADAY, OLOPATADINE HYDROCHLORIDE

PATANASE, OLOPATADINE HYDROCHLORIDE

PATANOL, OLOPATADINE HYDROCHLORIDE

PAZEO, OLOPATADINE HYDROCHLORIDE

PROMACTA KIT, ELTROMBOPAG OLAMINE

PROMACTA, ELTROMBOPAG OLAMINE

RYDAPT, MIDOSTAURIN

SIGNIFOR LAR KIT, PASIREOTIDE PAMOATE

SIMBRINZA, BRIMONIDINE TARTRATE

TAFINLAR, DABRAFENIB MESYLATE

TOBRADEX ST, DEXAMETHASONE

TOBRADEX, DEXAMETHASONE

TOBREX, TOBRAMYCIN

TRAVATAN Z, TRAVOPROST

TRIESENCE, TRIAMCINOLONE ACETONIDE

TYKERB, LAPATINIB DITOSYLATE

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

VOTRIENT, PAZOPANIB HYDROCHLORIDE

ZOFRAN ODT, ONDANSETRON

ZOFRAN, ONDANSETRON HYDROCHLORIDE

ZYKADIA, CERITINIB

NOVAST LABS

* NOVAST LABORATORIES CHINA LTD

NORETHINDRONE, NORETHINDRONE

* NOVAST LABORATORIES LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, CARISOPRODOL

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

HER STYLE, LEVONORGESTREL (OTC)

INDOMETHACIN, INDOMETHACIN

LARIN 1.5/30, ETHINYL ESTRADIOL

LARIN 1/20, ETHINYL ESTRADIOL

LARIN 24 FE, ETHINYL ESTRADIOL

LARIN FE 1.5/30, ETHINYL ESTRADIOL

LARIN FE 1/20, ETHINYL ESTRADIOL

LERIBANE, ETHINYL ESTRADIOL

MAFENIDE ACETATE, MAFENIDE ACETATE

MALMOREDE, ETHINYL ESTRADIOL

MELAMISA, DROSPIRENONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NADOLOL, NADOLOL

NIFEDIPINE, NIFEDIPINE

NORETHINDRONE, NORETHINDRONE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIMTREA, DESOGESTREL

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

PROBENECID AND COLCHICINE, COLCHICINE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

SETLAKIN, ETHINYL ESTRADIOL

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

YAELA, DROSPIRENONE

NOVAST LABS LTD

* NOVAST LABORATORIES LTD

DASETTA 1/35, ETHINYL ESTRADIOL

DASETTA 7/7/7, ETHINYL ESTRADIOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 128

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **
* NOVAST LABORATORIES LTD
ELINEST, ETHINYL ESTRADIOL
FALMINA, ETHINYL ESTRADIOL
LEVONEST, ETHINYL ESTRADIOL
MONO-LINYAH, ETHINYL ESTRADIOL
PHILITH, ETHINYL ESTRADIOL
TRI-LINYAH, ETHINYL ESTRADIOL
WERA, ETHINYL ESTRADIOL
NOVATECH SA
* NOVATECH SA
STERITALC, TALC
NOVEL LABS INC
* NOVEL LABORATORIES INC
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
CALCIPOTRIENE, CALCIPOTRIENE
CARBIDOPA, CARBIDOPA
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESOXIMETASONE, DESOXIMETASONE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FAMOTIDINE, FAMOTIDINE

FLUCYTOSINE, FLUCYTOSINE

FLUOCINONIDE, FLUOCINONIDE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

LEVONORGESTREL, LEVONORGESTREL (OTC)

LINEZOLID, LINEZOLID

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MISOPROSTOL, MISOPROSTOL

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NITROFURANTOIN, NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PHENELZINE SULFATE, PHENELZINE SULFATE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE

TEMAZEPAM, TEMAZEPAM

TINIDAZOLE, TINIDAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIMETHOPRIM, TRIMETHOPRIM

VORICONAZOLE, VORICONAZOLE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

NOVELGENIX THERAPS

* NOVELGENIX THERAPEUTICS PVT LTD

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NOVEN

* NOVEN PHARMACEUTICALS INC

MINIVELLE, ESTRADIOL

NOVEN PHARMS INC

* NOVEN PHARMACEUTICALS INC

COMBIPATCH, ESTRADIOL

DAYTRANA, METHYLPHENIDATE

NOVITIUM PHARMA

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 129

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVITIUM PHARMA LLC

DAPSONE, DAPSONE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

RANITIDINE, RANITIDINE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

NOVO

* NOVO NORDISK INC

FIASP FLEXTOUCH, INSULIN ASPART

FIASP, INSULIN ASPART

MACRILEN, MACIMORELIN ACETATE

OZEMPIC, SEMAGLUTIDE

RYZODEG 70/30, INSULIN ASPART

SAXENDA, LIRAGLUTIDE RECOMBINANT

TRESIBA, INSULIN DEGLUDEC

XULTOPHY 100/3.6, INSULIN DEGLUDEC

NOVO NORDISK

* NOVO NORDISK PHARMACEUTICALS INC

GLUCAGEN, GLUCAGON HYDROCHLORIDE

NOVO NORDISK INC

* NOVO NORDISK INC

LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT

LEVEMIR, INSULIN DETEMIR RECOMBINANT

NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT

NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)

NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)

NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT

NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT

NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT

NOVOLOG, INSULIN ASPART RECOMBINANT

VAGIFEM, ESTRADIOL

VICTOZA, LIRAGLUTIDE RECOMBINANT

NOVOCOL INC

* NOVOCOL INC

DYCLOPRO, DYCLONINE HYDROCHLORIDE

NPS PHARMS INC

* NPS PHARMACEUTICALS INC

GATTEX KIT, TEDUGLUTIDE RECOMBINANT

NUVO PHARM

* NUVO PHARMACEUTICAL INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

NUVO PHARMS INC

* NUVO PHAMACEUTICALS INC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

FOLIC ACID, FOLIC ACID

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

NXDC

* NX DEVELOPMENT CORP

GLEOLAN, AMINOLEVULINIC ACID HYDROCHLORIDE

NYCOMED US

* NYCOMED US INC

TERCONAZOLE, TERCONAZOLE

** O **

OAK PHARMS

* OAK PHARMACEUTICALS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 130

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* OAK PHARMACEUTICALS INC

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

OAK PHARMS AKORN

* OAK PHARMACEUTICALS INC SUB AKORN INC

COGENTIN, BENZTROPINE MESYLATE

DIURIL, CHLOROTHIAZIDE SODIUM

OAK PHARMS INC

* OAK PHARMACEUTICALS INC

ZIOPTAN, TAFLUPROST

* OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC

AZASITE, AZITHROMYCIN

BETIMOL, TIMOLOL

COSOPT PF, DORZOLAMIDE HYDROCHLORIDE

COSOPT, DORZOLAMIDE HYDROCHLORIDE

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

OC PHARMA

* OC PHARMA LLC

LEVONORGESTREL, LEVONORGESTREL (OTC)

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OCULAR THERAPEUTIX

* OCULAR THERAPEUTIX INC

DEXTENZA, DEXAMETHASONE

ODYSSEY PHARMS

* ODYSSEY PHARMACEUTICALS INC

ANTABUSE, DISULFIRAM

SURMONTIL, TRIMIPRAMINE MALEATE

URECHOLINE, BETHANECHOL CHLORIDE

VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE

OHM

* OHM CORP

IBUPROFEN, IBUPROFEN (OTC)

OHM LABS

* OHM LABORATORIES INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)

IBUPROHM, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

OHM LABS INC

* OHM LABORATORIES INC

EZETIMIBE, EZETIMIBE

GUAIFENESIN, GUAIFENESIN (OTC)

VALSARTAN, VALSARTAN

OLTA PHARMS

* OLTA PHARMACEUTICALS CORP

LINDANE, LINDANE

OMEROS

* OMEROS CORP

OMIDRIA, KETOROLAC TROMETHAMINE

ONY

* ONY INC

INFASURF PRESERVATIVE FREE, CALFACTANT

ONYX THERAP

* ONYX THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC

KYPROLIS, CARFILZOMIB

OPKO IRELAND GLOBAL

* OPKO IRELAND GLOBAL HOLDINGS LTD

RAYALDEE, CALCIFEDIOL

OPTINOSE US INC

* OPTINOSE US INC

XHANCE, FLUTICASONE PROPIONATE

ORAPHARMA

* ORAPHARMA INC

ARESTIN, MINOCYCLINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 131

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

ORCHID HLTHCARE

* ORCHID HEALTHCARE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

GEMIFLOXACIN MESYLATE, GEMIFLOXACIN MESYLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MODAFINIL, MODAFINIL

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

OREXO US INC

* OREXO US INC

ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE

ORGANON SUB MERCK

* ORGANON USA INC A SUB OF MERCK AND CO INC

BRIDION, SUGAMMADEX SODIUM

NUVARING, ETHINYL ESTRADIOL

ORGANON USA INC

* ORGANON USA INC

DESOGEN, DESOGESTREL

FOLLISTIM AQ, FOLLITROPIN ALFA/BETA

GANIRELIX ACETATE, GANIRELIX ACETATE

NEXPLANON, ETONOGESTREL

PREGNYL, GONADOTROPIN, CHORIONIC

REMERON SOLTAB, MIRTAZAPINE

REMERON, MIRTAZAPINE

ORIENT PHARMA CO LTD

* ORIENT PHARMA CO LTD

CARISOPRODOL, CARISOPRODOL

MIGLITOL, MIGLITOL

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

ORION PHARMA

* ORION PHARMA

COMTAN, ENTACAPONE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

ORIT LABS LLC

* ORIT LABORATORIES LLC

BENZONATATE, BENZONATATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 132

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* ORIT LABORATORIES LLC

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ERGOCALCIFEROL, ERGOCALCIFEROL

GLYCOPYRROLATE, GLYCOPYRROLATE

LEVETIRACETAM, LEVETIRACETAM

METRONIDAZOLE, METRONIDAZOLE

ORPHAN EUROPE

* ORPHAN EUROPE

CARBAGLU, CARGLUMIC ACID

* ORPHAN EUROPE SARL

CYSTADANE, BETAINE

OSI PHARMS

* OSI PHARMACEUTICALS INC

TARCEVA, ERLOTINIB HYDROCHLORIDE

OSMOTICA

* OSMOTICA KERESKEDELMI ES SZOLGALTATO KFT

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OSMOTICA PHARM

* OSMOTICA PHARMACEUTICAL

OSMOLEX ER, AMANTADINE HYDROCHLORIDE

* OSMOTICA PHARMACEUTICAL CORP

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

OSMOTICA PHARM CORP

* OSMOTICA PHARMACEUTICAL CORP

KHEDEZLA, DESVENLAFAXINE

OSMOTICA PHARM US

* OSMOTICA PHARMACEUTICAL US LLC

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OTONOMY INC

* OTONOMY INC

OTIPRIO, CIPROFLOXACIN

OTSUKA

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY, ARIPIPRAZOLE

OTSUKA AMERICA PHARM

* OTSUKA AMERICA PHARMACEUTICAL INC

SAMSCA, TOLVAPTAN

OTSUKA PHARM

* OTSUKA PHARMACEUTICAL CO LTD

BUSULFEX, BUSULFAN

OTSUKA PHARM CO LTD

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY MAINTENA KIT, ARIPIPRAZOLE

ABILIFY MYCITE KIT, ARIPIPRAZOLE

DACOGEN, DECITABINE

JYNARQUE, TOLVAPTAN

REXULTI, BREXPIPRAZOLE

OUTLOOK PHARMS

* OUTLOOK PHARMACEUTICALS INC

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

OXFORD PHARMS

* OXFORD PHARMACEUTICALS LLC

ALPRAZOLAM, ALPRAZOLAM

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BACLOFEN, BACLOFEN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 133

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* OXFORD PHARMACEUTICALS LLC

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LORAZEPAM, LORAZEPAM

METHOCARBAMOL, METHOCARBAMOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

RIMACTANE, RIFAMPIN

RISPERIDONE, RISPERIDONE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE, SPIRONOLACTONE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

** P **

P AND L DEV LLC

* P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC

IBUPROFEN, IBUPROFEN (OTC)

PACIFIC PHARMA

* PACIFIC PHARMA

TIMOLOL MALEATE, TIMOLOL MALEATE

* PACIFIC PHARMA INC

TIMOLOL MALEATE, TIMOLOL MALEATE

PACIRA PHARMS INC

* PACIRA PHARMACEUTICALS INC

EXPAREL, BUPIVACAINE

PACK PHARMS LLC

* PACK PHARMACEUTICALS LLC

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PADDOCK LLC

* PADDOCK LABORATORIES LLC

ATOVAQUONE, ATOVAQUONE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CALCIUM ACETATE, CALCIUM ACETATE

CICLOPIROX, CICLOPIROX

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

COLOCORT, HYDROCORTISONE

COMPRO, PROCHLORPERAZINE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

KIONEX, SODIUM POLYSTYRENE SULFONATE

LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

MIDAMOR, AMILORIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NYSTOP, NYSTATIN

PODOFILOX, PODOFILOX

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

REPAGLINIDE, REPAGLINIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 134

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PADDOCK LABORATORIES LLC

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

PANACEA BIOTEC LTD

* PANACEA BIOTEC LTD

PRASUGREL, PRASUGREL HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TACROLIMUS, TACROLIMUS

PAR FORM

* PAR FORMULATIONS PRIVATE LTD

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MAFENIDE ACETATE, MAFENIDE ACETATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

PAR PHARM

* PAR PHARMACEUTICAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

TESTOSTERONE, TESTOSTERONE

* PAR PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

CABERGOLINE, CABERGOLINE

CALCITONIN-SALMON, CALCITONIN SALMON

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

CLONAZEPAM, CLONAZEPAM

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ESTAZOLAM, ESTAZOLAM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUTAMIDE, FLUTAMIDE

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYUREA, HYDROXYUREA

IBUPROFEN, IBUPROFEN (OTC)

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LAMOTRIGINE, LAMOTRIGINE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

NATEGLINIDE, NATEGLINIDE

NIFEDIPINE, NIFEDIPINE

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OXANDROLONE, OXANDROLONE

PIMOZIDE, PIMOZIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 135

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PAR PHARMACEUTICAL INC

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TORSEMIDE, TORSEMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRAVOPROST, TRAVOPROST

URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

PAR PHARM INC

* PAR PHARMACEUTICAL INC

ACCOLATE, ZAFIRLUKAST

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ANTIZOL, FOMEPIZOLE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

COLCHICINE, COLCHICINE

DEXLANSOPRAZOLE, DEXLANSOPRAZOLE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DOFETILIDE, DOFETILIDE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

ENTECAVIR, ENTECAVIR

ETHACRYNIC ACID, ETHACRYNIC ACID

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PRAZIQUANTEL, PRAZIQUANTEL

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLCAPONE, TOLCAPONE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

PAR STERILE PRODUCTS

* PAR STERILE PRODUCTS LLC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADRENALIN, EPINEPHRINE

ARGATROBAN, ARGATROBAN

BREVITAL SODIUM, METHOHEXITAL SODIUM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

COLY-MYCIN M, COLISTIMETHATE SODIUM

CORPHEDRA, EPHEDRINE SULFATE

DANTRIUM, DANTROLENE SODIUM

DELESTROGEN, ESTRADIOL VALERATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

ETOMIDATE, ETOMIDATE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

GANCICLOVIR, GANCICLOVIR SODIUM

KETALAR, KETAMINE HYDROCHLORIDE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 136

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PAR STERILE PRODUCTS LLC

PITOCIN, OXYTOCIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TRIOSTAT, LIOTHYRONINE SODIUM

VASOSTRICT, VASOPRESSIN

PARAGON BIOTECK

* PARAGON BIOTECK INC

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PARAPRO LLC

* PARAPRO LLC

NATROBA, SPINOSAD

PARATEK PHARMS INC

* PARATEK PHARMACEUTICALS INC

NUZYRA, OMADACYCLINE TOSYLATE

PARKE DAVIS

* PARKE DAVIS DIV WARNER LAMBERT CO

CELONTIN, METHSUXIMIDE

CEREBYX, FOSPHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

NARDIL, PHENELZINE SULFATE

NEURONTIN, GABAPENTIN

ZARONTIN, ETHOSUXIMIDE

PARKE-DAVIS

* PARKE-DAVIS DIVISION OF PFIZER INC

DILANTIN, PHENYTOIN SODIUM

ZARONTIN, ETHOSUXIMIDE

PATRIN PHARMA INC

* PATRIN PHARMA INC

FLAC, FLUOCINOLONE ACETONIDE

PERNIX IRELAND LTD

* PERNIX IRELAND LTD

TREXIMET, NAPROXEN SODIUM

PERNIX IRELAND PAIN

* PERNIX IRELAND PAIN LIMITED

ZOHYDRO ER, HYDROCODONE BITARTRATE

PERNIX THERAPS LLC

* PERNIX THERAPEUTICS LLC

SILENOR, DOXEPIN HYDROCHLORIDE

PERRIGO

* PERRIGO CO

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)

PERRIGO CO

* PERRIGO CO OF TENESSEE INC

CICLOPIROX, CICLOPIROX

CLINDETS, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ERYTHROMYCIN, ERYTHROMYCIN

STIE-CORT, HYDROCORTISONE

PERRIGO CO TENNESSEE

* PERRIGO CO TENNESSEE INC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN, BACITRACIN

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ZINC

ERYTHROMYCIN, ERYTHROMYCIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

PERRIGO ISRAEL

* PERRIGO ISRAEL PHARMACEUTICALS LTD

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 137

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PERRIGO ISRAEL PHARMACEUTICALS LTD

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESOXIMETASONE, DESOXIMETASONE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

MESALAMINE, MESALAMINE

MINOXIDIL, MINOXIDIL (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

NITROGLYCERIN, NITROGLYCERIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

TESTOSTERONE, TESTOSTERONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE (OTC)

PERRIGO NEW YORK

* PERRIGO NEW YORK INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CENTANY, MUPIROCIN

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

KETOCONAZOLE, KETOCONAZOLE

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

PERMETHRIN, PERMETHRIN

PERMETHRIN, PERMETHRIN (OTC)

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SELENIUM SULFIDE, SELENIUM SULFIDE

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PERRIGO PHARMA INTL

* PERRIGO PHARMA INTERNATIONAL DAC

CLINDESSE, CLINDAMYCIN PHOSPHATE

ENTOCORT EC, BUDESONIDE

EVAMIST, ESTRADIOL

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

TRETINOIN, TRETINOIN

PERRIGO PHARMS CO

* PERRIGO PHARMACEUTICALS CO

SCOPOLAMINE, SCOPOLAMINE

PERRIGO R AND D

* PERRIGO R AND D CO

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 138

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PERRIGO R AND D CO

DESLORATADINE, DESLORATADINE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN SODIUM, IBUPROFEN SODIUM (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LEVONORGESTREL, LEVONORGESTREL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN, NAPROXEN

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

PERRIGO UK FINCO

* PERRIGO UK FINCO LTD PARTNERSHIP

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ESTRADIOL, ESTRADIOL

FLURANDRENOLIDE, FLURANDRENOLIDE

INGENOL MEBUTATE, INGENOL MEBUTATE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

TESTOSTERONE, TESTOSTERONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

PETNET

* PETNET SOLUTIONS INC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PF PRISM CV

* PF PRISM CV

BOSULIF, BOSUTINIB MONOHYDRATE

CHANTIX, VARENICLINE TARTRATE

INLYTA, AXITINIB

LYRICA CR, PREGABALIN

LYRICA, PREGABALIN

PRISTIQ, DESVENLAFAXINE SUCCINATE

RAPAMUNE, SIROLIMUS

TORISEL, TEMSIROLIMUS

TYGACIL, TIGECYCLINE

VFEND, VORICONAZOLE

XALKORI, CRIZOTINIB

XELJANZ, TOFACITINIB CITRATE

PFIZER

* PFIZER CENTRAL RESEARCH

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 139

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC

ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL COLD AND SINUS, IBUPROFEN (OTC)

ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)

ADVIL LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MULTI-SYMPTOM COLD & FLU, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ADVIL, IBUPROFEN (OTC)

ALAVERT, LORATADINE (OTC)

AXID AR, NIZATIDINE (OTC)

CADUET, AMLODIPINE BESYLATE

CALAN SR, VERAPAMIL HYDROCHLORIDE

CARDURA XL, DOXAZOSIN MESYLATE

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)

CHILDREN'S ADVIL, IBUPROFEN (OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)

ELELYSO, TALIGLUCERASE ALFA

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

GLUCOTROL XL, GLIPIZIDE

GLUCOTROL, GLIPIZIDE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)

LIPITOR, ATORVASTATIN CALCIUM

LORATADINE, LORATADINE (OTC)

MERREM, MEROPENEM

NORVASC, AMLODIPINE BESYLATE

PEDIATRIC ADVIL, IBUPROFEN (OTC)

PROCARDIA, NIFEDIPINE

REVATIO, SILDENAFIL CITRATE

SONATA, ZALEPLON

TESSALON, BENZONATATE

TOVIAZ, FESOTERODINE FUMARATE

UNASYN, AMPICILLIN SODIUM

ZITHROMAX, AZITHROMYCIN

* PFIZER LABORATORIES DIV PFIZER INC

CARDURA, DOXAZOSIN MESYLATE

FELDENE, PIROXICAM

MINIPRESS, PRAZOSIN HYDROCHLORIDE

PFIZERPEN, PENICILLIN G POTASSIUM

PROCARDIA XL, NIFEDIPINE

UNASYN, AMPICILLIN SODIUM

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE PAMOATE

* PFIZER PHARMACEUTICALS INC

DILANTIN, PHENYTOIN

ZOLOFT, SERTRALINE HYDROCHLORIDE

* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD

TIKOSYN, DOFETILIDE

PFIZER CONS HLTHCARE

* PFIZER CONSUMER HEALTHCARE

ADVIL, IBUPROFEN SODIUM (OTC)

PFIZER INC

* PFIZER INC

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

DAURISMO, GLASDEGIB

ELLENCE, EPIRUBICIN HYDROCHLORIDE

FRAGMIN, DALTEPARIN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 140

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC

IBRANCE, PALBOCICLIB

LORBRENA, LORLATINIB

NICOTROL, NICOTINE

TALZENNA, TALAZOPARIB TOSYLATE

VIAGRA, SILDENAFIL CITRATE

VIZIMPRO, DACOMITINIB

XELJANZ XR, TOFACITINIB CITRATE

PFIZER IRELAND

* PFIZER IRELAND PHARMACEUTICALS

RELPAX, ELETRIPTAN HYDROBROMIDE

PFIZER PHARMS

* PFIZER PHARMACEUTICALS LTD

ACCUPRIL, QUINAPRIL HYDROCHLORIDE

ACCURETIC, HYDROCHLOROTHIAZIDE

LOPID, GEMFIBROZIL

NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

PHARM ASSOC

* PHARMACEUTICAL ASSOC INC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LORAZEPAM, LORAZEPAM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* PHARMACEUTICAL ASSOCIATES INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LACTULOSE, LACTULOSE

LEVETIRACETAM, LEVETIRACETAM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

THEOPHYLLINE, THEOPHYLLINE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

PHARMA RES SOFTWARE

* PHARMA RESEARCH SOFTWARE SOLUTION LLC

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PHARMACHEMIE BV

* PHARMACHEMIE BV

CARBOPLATIN, CARBOPLATIN

CISPLATIN, CISPLATIN

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

PHARMACIA AND UPJOHN

* PHARMACIA AND UPJOHN

XANAX XR, ALPRAZOLAM

* PHARMACIA AND UPJOHN CO

AROMASIN, EXEMESTANE

AZULFIDINE EN-TABS, SULFASALAZINE

AZULFIDINE, SULFASALAZINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 141

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMACIA AND UPJOHN CO

BACITRACIN, BACITRACIN

CAVERJECT IMPULSE, ALPROSTADIL

CAVERJECT, ALPROSTADIL

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

CORTEF, HYDROCORTISONE

CORVERT, IBUTILIDE FUMARATE

CYKLOKAPRON, TRANEXAMIC ACID

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DETROL LA, TOLTERODINE TARTRATE

DETROL, TOLTERODINE TARTRATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

ESTRING, ESTRADIOL

GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT

GENOTROPIN, SOMATROPIN RECOMBINANT

GLYNASE, GLYBURIDE

GLYSET, MIGLITOL

HALCION, TRIAZOLAM

HEMABATE, CARBOPROST TROMETHAMINE

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

MEDROL, METHYLPREDNISOLONE

MYCOBUTIN, RIFABUTIN

NICOTROL, NICOTINE

OGEN 5, ESTROPIPATE

PREPIDIL, DINOPROSTONE

PROSTIN E2, DINOPROSTONE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROVERA, MEDROXYPROGESTERONE ACETATE

R-GENE 10, ARGININE HYDROCHLORIDE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

SOMAVERT, PEGVISOMANT

XALATAN, LATANOPROST

XANAX, ALPRAZOLAM

ZINECARD, DEXRAZOXANE HYDROCHLORIDE

ZYVOX, LINEZOLID

* PHARMACIA AND UPJOHN SUB PFIZER INC

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

PHARMACIA UPJOHN

* PHARMACIA AND UPJOHN CO A SUB OF PFIZER INC

COLESTID, COLESTIPOL HYDROCHLORIDE

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

PHARMACYCLICS INC

* PHARMACYCLICS INC

IMBRUVICA, IBRUTINIB

PHARMADAX INC

* PHARMADAX INC

GLYBURIDE, GLYBURIDE

LEVETIRACETAM, LEVETIRACETAM

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

PHARMALUCENCE

* PHARMALUCENCE INC

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 142

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMALUCENCE INC

HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

PHARMASCIENCE INC

* PHARMASCIENCE INC

BUSULFAN, BUSULFAN

DECITABINE, DECITABINE

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

PHARMAXIS LTD

* PHARMAXIS LTD

ARIDOL KIT, MANNITOL

PHARMTAK INC

* PHARMTAK INC

LEVETIRACETAM, LEVETIRACETAM

PHOTOCURE ASA

* PHOTOCURE ASA

CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE

PIERRE FABRE

* PIERRE FABRE MEDICAMENT

NAVELBINE, VINORELBINE TARTRATE

PIERRE FABRE DERMA

* PIERRE FABRE DERMATOLOGIE

HEMANGEOL, PROPRANOLOL HYDROCHLORIDE

PIERREL

* PIERREL S.P.A.

ORABLOC, ARTICAINE HYDROCHLORIDE

PII

* PHARMACEUTICS INTERNATIONAL INC

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

HYDROCORTISONE, HYDROCORTISONE

PIROXICAM, PIROXICAM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PIRAMAL CRITICAL

* PIRAMAL CRITICAL CARE INC

ISOFLURANE, ISOFLURANE

SOJOURN, SEVOFLURANE

* PIRAMAL CRITICAL CARE LTD

GABLOFEN, BACLOFEN

GLYCOPYRROLATE, GLYCOPYRROLATE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

MITIGO, MORPHINE SULFATE

PIRAMAL ENT

* PIRAMAL ENTERPRISES LTD

ISOFLURANE, ISOFLURANE

PIRAMAL HLTHCARE UK

* PIRAMAL HEALTHCARE UK LTD

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

PLD ACQUISITIONS

* PLD ACQUISITIONS LLC DBA AVENA PHARMA SOLUTIONS

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

PLD ACQUISITIONS LLC

* PLD ACQUISITIONS LLC

LORATADINE, LORATADINE (OTC)

ZOLMITRIPTAN, ZOLMITRIPTAN

PLIVA

* PLIVA INC

AZITHROMYCIN, AZITHROMYCIN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CIMETIDINE, CIMETIDINE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 143

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PLIVA INC

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

METRONIDAZOLE, METRONIDAZOLE

NAPROXEN, NAPROXEN

THEOPHYLLINE, THEOPHYLLINE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WARFARIN SODIUM, WARFARIN SODIUM

PLIVA HRVATSKA DOO

* PLIVA HRVATSKA DOO

ADAPALENE, ADAPALENE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

PLIVA LACHEMA

* PLIVA LACHEMA AS

CARBOPLATIN, CARBOPLATIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PLIVA PHARM IND

* PLIVA PHARMACEUTICAL INDUSTRY INC

TORSEMIDE, TORSEMIDE

PLX PHARMA

* PLX PHARMA INC

VAZALORE, ASPIRIN (OTC)

POHL BOSKAMP

* POHL BOSKAMP

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

POLYGEN PHARMS

* POLYGEN PHARMACEUTICALS INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

POLYMEDICA

* POLYMEDICA INDUSTRIES INC

NEOPAP, ACETAMINOPHEN (OTC)

PORTOLA PHARMS INC

* PORTOLA PHARMACEUTICALS INC

BEVYXXA, BETRIXABAN

POWDER PHARMS

* POWDER PHARMACEUTICALS INC

ZINGO, LIDOCAINE HYDROCHLORIDE

PRAGMA

* PRAGMA PHARMACEUTICALS LLC

KEFLEX, CEPHALEXIN

PRAXAIR DISTRIBUTION

* PRAXAIR DISTRIBUTION INC

NOXIVENT, NITRIC OXIDE

PRECISION DERMAT

* PRECISION DERMATOLOGY INC

CLINDAGEL, CLINDAMYCIN PHOSPHATE

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

LOCOID, HYDROCORTISONE BUTYRATE

MINOCIN, MINOCYCLINE HYDROCHLORIDE

PRECISION DOSE INC

* PRECISION DOSE INC

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PRECISION NUCLEAR

* PRECISION NUCLEAR LLC

AMMONIA N 13, AMMONIA N-13

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 144

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PRECISION NUCLEAR LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PRINSTON INC

* PRINSTON PHARMACEUTICAL INC

ARIPIPRAZOLE, ARIPIPRAZOLE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CAPTOPRIL, CAPTOPRIL

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTECAVIR, ENTECAVIR

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FENOFIBRATE, FENOFIBRATE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

NEVIRAPINE, NEVIRAPINE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

PAROXETINE MESYLATE, PAROXETINE MESYLATE

PAROXETINE, PAROXETINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

PROF DSPLS

* PROFESSIONAL DISPOSABLES INC

PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PROGENICS PHARMS INC

* PROGENICS PHARMACEUTICALS INC

AZEDRA, IOBENGUANE I-131

PROMIUS PHARMA LLC

* PROMIUS PHARMA LLC

SERNIVO, BETAMETHASONE DIPROPIONATE

PROVELL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 145

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PROVELL PHARMACEUTICALS LLC

EUTHYROX, LEVOTHYROXINE SODIUM **

PROVENSIS

* PROVENSIS LTD

VARITHENA, POLIDOCANOL

PROVEPHARM SAS

* PROVEPHARM SAS

PROVAYBLUE, METHYLENE BLUE

PTC THERAP

* PTC THERAPEUTICS INC

EMFLAZA, DEFLAZACORT

PULMOFLOW INC

* PULMOFLOW INC

KITABIS PAK, TOBRAMYCIN

PUMA BIOTECH

* PUMA BIOTECHNOLOGY INC

NERLYNX, NERATINIB MALEATE

PURACAP PHARM

* PURACAP PHARMACEUTICAL LLC

MELOXICAM, MELOXICAM

PURACAP PHARM LLC

* PURACAP PHARMACEUTICAL LLC

BENZONATATE, BENZONATATE

ERGOCALCIFEROL, ERGOCALCIFEROL

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PURDUE GMP

* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY

SEROMYCIN, CYCLOSERINE

PURDUE PHARMA

* PURDUE PHARMA PRODUCTS LP

INTERMEZZO, ZOLPIDEM TARTRATE

PURDUE PHARMA LP

* PURDUE PHARMA LP

BUTRANS, BUPRENORPHINE

HYSINGLA, HYDROCODONE BITARTRATE

MS CONTIN, MORPHINE SULFATE

OXYCONTIN, OXYCODONE HYDROCHLORIDE

** Q **

QILU PHARM CO LTD

* QILU PHARMACEUTICAL CO LTD

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

QILU TIANHE

* QILU TIANHE PHARMACEUTICAL CO LTD

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

QINGDAO BAHEAL PHARM

* QINGDAO BAHEAL PHAMACEUTICAL CO LTD

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

QOL MEDCL

* QOL MEDICAL LLC

ETHAMOLIN, ETHANOLAMINE OLEATE

SUCRAID, SACROSIDASE

QUAGEN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 146

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Q **

* QUAGEN PHARMACEUTICALS LLC

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUEEN HAMAMATSU PET

* QUEEN HAMAMATSU PET IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

** R **

R-PHARM US LLC

* R-PHARM US LLC

IXEMPRA KIT, IXABEPILONE

R2 PHARMA LLC

* R2 PHARMA LLC

ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM

RADIUS HEALTH INC

* RADIUS HEALTH INC

TYMLOS, ABALOPARATIDE

RB HLTH

* RB HEALTH US LLC

DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)

MUCINEX D, GUAIFENESIN (OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

RECIP

* RECIP AB

THYROSAFE, POTASSIUM IODIDE (OTC)

RECIPHARM

* RECIPHARM PHARMASERVICES PRIVATE LTD

FLUCYTOSINE, FLUCYTOSINE

RECKITT BENCKISER

* RECKITT BENCKISER LLC

LEVONORGESTREL, LEVONORGESTREL (OTC)

RECORDATI RARE

* RECORDATI RARE DISEASES INC

CHEMET, SUCCIMER

COSMEGEN, DACTINOMYCIN

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

INDOCIN, INDOMETHACIN SODIUM

NEOPROFEN, IBUPROFEN LYSINE

PEGANONE, ETHOTOIN

TRANXENE, CLORAZEPATE DIPOTASSIUM

RECRO GAINESVILLE

* RECRO GAINESVILLE LLC

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERELAN, VERAPAMIL HYDROCHLORIDE

RELYPSA INC

* RELYPSA INC

VELTASSA, PATIROMER SORBITEX CALCIUM

REMPEX PHARMS

* REMPEX PHARMACEUTICALS

MINOCIN, MINOCYCLINE HYDROCHLORIDE

* REMPEX PHARMACEUTICALS A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS INC

VABOMERE, MEROPENEM

RENAISSANCE SSA LLC

* RENAISSANCE SSA LLC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

METHOCARBAMOL, METHOCARBAMOL

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

OXACILLIN SODIUM, OXACILLIN SODIUM

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 147

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RENAISSANCE SSA LLC

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

RENATA

* RENATA LTD

RISPERIDONE, RISPERIDONE

RHODES PHARMS

* RHODES PHARMACEUTICALS LP

APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

RICONPHARMA LLC

* RICONPHARMA LLC

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CHLORTHALIDONE, CHLORTHALIDONE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LIDOCAINE, LIDOCAINE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

RIGEL PHARMS INC

* RIGEL PHARMACEUTICALS INC

TAVALISSE, FOSTAMATINIB DISODIUM

RISING PHARMS

* RISING PHARMACEUTICALS INC

ACETIC ACID, ACETIC ACID, GLACIAL

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BUDESONIDE, BUDESONIDE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CROMOLYN SODIUM, CROMOLYN SODIUM

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

DOXERCALCIFEROL, DOXERCALCIFEROL

DUTASTERIDE, DUTASTERIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCORTISONE, HYDROCORTISONE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LEVOFLOXACIN, LEVOFLOXACIN

METAXALONE, METAXALONE

METHIMAZOLE, METHIMAZOLE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

PARICALCITOL, PARICALCITOL

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

TEMOZOLOMIDE, TEMOZOLOMIDE

TOREMIFENE CITRATE, TOREMIFENE CITRATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VORICONAZOLE, VORICONAZOLE

ZILEUTON, ZILEUTON

ROCHE PALO

* ROCHE PALO ALTO LLC

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

CYTOVENE, GANCICLOVIR SODIUM

ROCKWELL MEDICAL INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 148

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* ROCKWELL MEDICAL INC

TRIFERIC, FERRIC PYROPHOSPHATE CITRATE

ROMARK

* ROMARK LABORATORIES

ALINIA, NITAZOXANIDE

ROUSES POINT PHARMS

* ROUSES POINT PHARMACEUTICALS LLC

LEVETIRACETAM, LEVETIRACETAM

RP SCHERER

* RP SCHERER TECHNOLOGIES LLC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RTRX

* RETROPHIN INC

CHOLBAM, CHOLIC ACID

RUBICON RES PVT LTD

* RUBICON RESEARCH PVT LTD

BACLOFEN, BACLOFEN

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

RXMTM THERAPS LLC

* RXMTM THERAPEUTICS LLC A WHOLLY OWNED SUB OF CUTISPHARMA INC

FIRVANQ KIT, VANCOMYCIN HYDROCHLORIDE

** S **

SAGE PRODS

* SAGE PRODUCTS INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

SAGENT PHARMS

* SAGENT PHARMACEUTICALS INC

ACETYLCYSTEINE, ACETYLCYSTEINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CAFFEINE CITRATE, CAFFEINE CITRATE

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

DAPTOMYCIN, DAPTOMYCIN

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EPTIFIBATIDE, EPTIFIBATIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYDO, LIDOCAINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

IBANDRONATE SODIUM, IBANDRONATE SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LINEZOLID, LINEZOLID

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 149

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SAGENT PHARMACEUTICALS INC

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXACILLIN SODIUM, OXACILLIN SODIUM

OXYTOCIN, OXYTOCIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

PROPOFOL, PROPOFOL

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

SAGENT STRIDES

* SAGENT STRIDES LLC

MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

SALIX PHARMS

* SALIX PHARMACEUTICALS INC

ANUSOL HC, HYDROCORTISONE

DIURIL, CHLOROTHIAZIDE

MOVIPREP, ASCORBIC ACID

OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

PEPCID, FAMOTIDINE

RELISTOR, METHYLNALTREXONE BROMIDE

XIFAXAN, RIFAXIMIN

SALIX PHARMS INC

* SALIX PHARMACEUTICALS INC

PLENVU, ASCORBIC ACID

RELISTOR, METHYLNALTREXONE BROMIDE

SAMSON MEDCL

* SAMSON MEDICAL TECHNOLOGIES LLC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

SANDOZ

* SANDOZ

DOCETAXEL, DOCETAXEL

* SANDOZ INC

ALPRAZOLAM, ALPRAZOLAM

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

APREPITANT, APREPITANT

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFERGOT, CAFFEINE

CARISOPRODOL AND ASPIRIN, ASPIRIN

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN

CARVEDILOL, CARVEDILOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 150

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLARITHROMYCIN, CLARITHROMYCIN

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

COSYNTROPIN, COSYNTROPIN

CYCLOSPORINE, CYCLOSPORINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESLORATADINE, DESLORATADINE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

HALOPERIDOL, HALOPERIDOL

HEPARIN SODIUM, HEPARIN SODIUM

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

ISONIAZID, ISONIAZID

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOVASTATIN, LOVASTATIN

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOLAZONE, METOLAZONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NADOLOL, NADOLOL

NAFCILLIN SODIUM, NAFCILLIN SODIUM

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NIZATIDINE, NIZATIDINE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 151

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

OMNITROPE, SOMATROPIN RECOMBINANT

ONDANSETRON, ONDANSETRON

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXALIPLATIN, OXALIPLATIN

OXAPROZIN, OXAPROZIN

OXAZEPAM, OXAZEPAM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERPHENAZINE, PERPHENAZINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINIDINE SULFATE, QUINIDINE SULFATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIBAVIRIN, RIBAVIRIN

RIFAMPIN, RIFAMPIN

RISPERIDONE, RISPERIDONE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SULFADIAZINE, SULFADIAZINE

TACROLIMUS, TACROLIMUS

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SANDOZ INC

* SANDOZ INC

ACETAMINOPHEN, ACETAMINOPHEN

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ANGIOMAX, BIVALIRUDIN

ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BIMATOPROST, BIMATOPROST

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUDESONIDE, BUDESONIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSULFAN, BUSULFAN

CARBOPLATIN, CARBOPLATIN

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CEFIXIME, CEFIXIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CROMOLYN SODIUM, CROMOLYN SODIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 152

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

DECITABINE, DECITABINE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIGOXIN, DIGOXIN

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EZETIMIBE, EZETIMIBE

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FLUMAZENIL, FLUMAZENIL

GATIFLOXACIN, GATIFLOXACIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLATOPA, GLATIRAMER ACETATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INFUVITE PEDIATRIC, ASCORBIC ACID

ISONIAZID, ISONIAZID

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN

LATANOPROST, LATANOPROST

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LINEZOLID, LINEZOLID

MAXITROL, DEXAMETHASONE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYDRIACYL, TROPICAMIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEVIRAPINE, NEVIRAPINE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROGESTERONE, PROGESTERONE

QOLIANA, BRIMONIDINE TARTRATE

RASAGILINE MESYLATE, RASAGILINE MESYLATE

REGONOL, PYRIDOSTIGMINE BROMIDE

RIBAVIRIN, RIBAVIRIN

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILODOSIN, SILODOSIN

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TELMISARTAN, TELMISARTAN

TERIFLUNOMIDE, TERIFLUNOMIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 153

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TIGECYCLINE, TIGECYCLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBREX, TOBRAMYCIN

TREPROSTINIL, TREPROSTINIL

TRIFLURIDINE, TRIFLURIDINE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SANOCHEMIA CORP USA

* SANOCHEMIA CORP USA

SCANLUX-300, IOPAMIDOL

SCANLUX-370, IOPAMIDOL

SANOFI

* SANOFI GENZYME

HECTOROL, DOXERCALCIFEROL

RENVELA, SEVELAMER CARBONATE

SANOFI AVENTIS US

* SANOFI AVENTIS US INC

JEVTANA KIT, CABAZITAXEL

* SANOFI AVENTIS US LLC

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

AMARYL, GLIMEPIRIDE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBIEN, ZOLPIDEM TARTRATE

APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT

APIDRA, INSULIN GLULISINE RECOMBINANT

ARAVA, LEFLUNOMIDE

AUBAGIO, TERIFLUNOMIDE

AVALIDE, HYDROCHLOROTHIAZIDE

AVAPRO, IRBESARTAN

CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

DIABETA, GLYBURIDE

ELOXATIN, OXALIPLATIN

FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX

FLOMAX, TAMSULOSIN HYDROCHLORIDE

GAVISCON, ALUMINUM HYDROXIDE (OTC)

LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT

LANTUS, INSULIN GLARGINE RECOMBINANT

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

LOVENOX, ENOXAPARIN SODIUM

MULTAQ, DRONEDARONE HYDROCHLORIDE

NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC)

NICODERM CQ, NICOTINE (OTC)

PLAVIX, CLOPIDOGREL BISULFATE

PRIFTIN, RIFAPENTINE

PRIMAQUINE, PRIMAQUINE PHOSPHATE

RIFADIN, RIFAMPIN

RIFAMATE, ISONIAZID

RIFATER, ISONIAZID

TAXOTERE, DOCETAXEL

XYZAL ALLERGY 24HR, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE

SANOFI US

* SANOFI US

ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)

ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)

SANOFI US SERVICES

* SANOFI US SERVICES INC

TOUJEO MAX SOLOSTAR, INSULIN GLARGINE RECOMBINANT

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 154

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANOFI US SERVICES INC

TOUJEO SOLOSTAR, INSULIN GLARGINE RECOMBINANT

SANOFI-AVENTIS US

* SANOFI-AVENTIS US LLC

ADLYXIN, LIXISENATIDE

ADMELOG SOLOSTAR, INSULIN LISPRO

ADMELOG, INSULIN LISPRO

SOLIQUA 100/33, INSULIN GLARGINE

SANTARUS INC

* SANTARUS INC

FENOGLIDE, FENOFIBRATE

GLUMETZA, METFORMIN HYDROCHLORIDE

ZEGERID, OMEPRAZOLE

SAOL THERAPS RES LTD

* SAOL THERAPEUTICS RESEARCH LTD

LIORESAL, BACLOFEN

SAREPTA THERAPS INC

* SAREPTA THERAPEUTICS INC

EXONDYS 51, ETEPLIRSEN

SAVIOR LIFETEC CORP

* SAVIOR LIFETEC CORP

MEROPENEM, MEROPENEM

SAWAI USA

* SAWAI USA INC

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

SB PHARMCO

* SB PHARMCO PUERTO RICO INC

AVANDIA, ROSIGLITAZONE MALEATE

SCHERING

* SCHERING CORP

INTEGRILIN, EPTIFIBATIDE

NOXAFIL, POSACONAZOLE

REBETOL, RIBAVIRIN

SCIECURE PHARMA INC

* SCIECURE PHARMA INC

BUDESONIDE, BUDESONIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

SCIEGEN PHARMS INC

* SCIEGEN PHARMACEUTICALS INC

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARISOPRODOL, CARISOPRODOL

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

SCILEX PHARMS INC

* SCILEX PHARMACEUTICALS

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 155

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SCILEX PHARMACEUTICALS

ZTLIDO, LIDOCAINE

SCINOPHARM TAIWAN

* SCINOPHARM TAIWAN LTD

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

SCIOS LLC

* SCIOS LLC

NATRECOR, NESIRITIDE RECOMBINANT

SEBELA IRELAND LTD

* SEBELA IRELAND LTD

BRISDELLE, PAROXETINE MESYLATE

IMURAN, AZATHIOPRINE

LOTRONEX, ALOSETRON HYDROCHLORIDE

MICORT-HC, HYDROCORTISONE ACETATE

MOTOFEN, ATROPINE SULFATE

NAFTIN, NAFTIFINE HYDROCHLORIDE

ONMEL, ITRACONAZOLE

PEXEVA, PAROXETINE MESYLATE

PRAMOSONE, HYDROCORTISONE ACETATE

RIDAURA, AURANOFIN

SECAN PHARMS

* SECAN PHARMACEUTICALS INC

LEVETIRACETAM, LEVETIRACETAM

SENTYNL THERAPS INC

* SENTYNL THERAPEUTICS INC

ABSTRAL, FENTANYL CITRATE

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

SEPTODONT

* SEPTODONT INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

SEPTODONT HOLDING

* SEPTODONT HOLDING SAS

ORAVERSE, PHENTOLAMINE MESYLATE

SEPTODONT INC

* SEPTODONT INC

LIDOCAINE, LIDOCAINE

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE

PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE

SERB SA

* SERB SA

CYANOKIT, HYDROXOCOBALAMIN

SETON PHARM

* SETON PHARMACEUTICAL LLC

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

SETON PHARMS

* SETON PHARMACEUTICALS LLC

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

SHANDONG XINHUA

* SHANDONG XINHUA PHARMACEUTICAL CO LTD

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

SHANGHAI DESANO

* SHANGHAI DESANO BIO-PHARMACEUTICALS CO LTD

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

SHANGHAI HENGRUI

* SHANGHAI HENGRUI PHARMACEUTICAL CO LTD

DESFLURANE, DESFLURANE

SEVOFLURANE, SEVOFLURANE

SHENZHEN TECHDOW

* SHENZHEN TECHDOW PHARMACEUTICAL CO LTD

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

SHERTECH LABS LLC

* SHERTECH LABORATORIES LLC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 156

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SHERTECH LABORATORIES LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SHILPA MEDICARE

* SHILPA MEDICARE LTD

AZACITIDINE, AZACITIDINE

SHILPA MEDICARE LTD

* SHILPA MEDICARE LTD

CAPECITABINE, CAPECITABINE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

SHIONOGI INC

* SHIONOGI INC

MULPLETA, LUSUTROMBOPAG

PONSTEL, MEFENAMIC ACID

SYMPROIC, NALDEMEDINE TOSYLATE

ULESFIA, BENZYL ALCOHOL

SHIRE

* SHIRE DEVELOPMENT INC

ADDERALL XR 10, AMPHETAMINE ASPARTATE

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

ADDERALL XR 5, AMPHETAMINE ASPARTATE

CARBATROL, CARBAMAZEPINE

INTUNIV, GUANFACINE HYDROCHLORIDE

LIALDA, MESALAMINE

PENTASA, MESALAMINE

SHIRE DEV LLC

* SHIRE DEVELOPMENT LLC

FOSRENOL, LANTHANUM CARBONATE

MOTEGRITY, PRUCALOPRIDE SUCCINATE

MYDAYIS, AMPHETAMINE ASPARTATE

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

XIIDRA, LIFITEGRAST

SHIRE DEVELOPMENT

* SHIRE DEVELOPMENT INC

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

SHIRE HUMAN GENETIC

* SHIRE HUMAN GENETIC THERAPIES INC

VPRIV, VELAGLUCERASE ALFA

SHIRE LLC

* SHIRE DEVELOPMENT LLC

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

FOSRENOL, LANTHANUM CARBONATE

SHIRE ORPHAN THERAP

* SHIRE ORPHAN THERAPIES INC

FIRAZYR, ICATIBANT ACETATE

SIDMAK LABS INDIA

* SIDMAK LABORATORIES INDIA PVT LTD

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

SIGA TECHNOLOGIES

* SIGA TECHNOLOGIES INC

TPOXX, TECOVIRIMAT

SIGMAPHARM LABS LLC

* SIGMAPHARM LABORATORIES LLC

ACITRETIN, ACITRETIN

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

ASENAPINE MALEATE, ASENAPINE MALEATE

DISULFIRAM, DISULFIRAM

DOFETILIDE, DOFETILIDE

ERGOCALCIFEROL, ERGOCALCIFEROL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 157

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SIGMAPHARM LABORATORIES LLC

FLUCYTOSINE, FLUCYTOSINE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

NITROGLYCERIN, NITROGLYCERIN

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SILVERGATE PHARMS

* SILVERGATE PHARMACEUTICALS INC

EPANED KIT, ENALAPRIL MALEATE

EPANED, ENALAPRIL MALEATE

QBRELIS, LISINOPRIL

XATMEP, METHOTREXATE SODIUM

SINOTHERAPEUTICS INC

* SINOTHERAPEUTICS INC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

SKINMEDICA

* SKINMEDICA INC

VANIQA, EFLORNITHINE HYDROCHLORIDE

SKYEPHARMA AG

* SKYEPHARMA AG

TRIGLIDE, FENOFIBRATE

SLAYBACK PHARMA LLC

* SLAYBACK PHARMA LLC

HYDROXYPROGESTERONE CAPROATE, HYDROXYPROGESTERONE CAPROATE

SMITHKLINE BEECHAM

* SMITHKLINE BEECHAM

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

* SMITHKLINE BEECHAM (CORK) LTD IRELAND

COREG CR, CARVEDILOL PHOSPHATE

COREG, CARVEDILOL

SOAPCO

* SOAPCO INC

BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)

SOFGEN PHARMS

* SOFGEN PHARMACEUTICALS

NIMODIPINE, NIMODIPINE

* SOFGEN PHARMACEUTICALS LLC

IBUPROFEN, IBUPROFEN (OTC)

PROGESTERONE, PROGESTERONE

SOFIE

* SOFIE CO DBA SOFIE (FKA ZEVACOR PHARMA INC)

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SOLARIS PHARMA CORP

* SOLARIS PHARMA CORP

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

SOMERSET

* SOMERSET PHARMACEUTICALS INC

EMSAM, SELEGILINE

SOMERSET THERAPS LLC

* SOMERSET THERAPEUTICS LLC

CYANOCOBALAMIN, CYANOCOBALAMIN

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

METHOCARBAMOL, METHOCARBAMOL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 158

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SOMERSET THERAPEUTICS LLC

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

TOBRAMYCIN, TOBRAMYCIN

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SOVEREIGN PHARMS

* SOVEREIGN PHARMACEUTICALS LLC

OBREDON, GUAIFENESIN

SPARC

* SUN PHARMA ADVANCED RESEARCH CO LTD

ELEPSIA XR, LEVETIRACETAM

SPECGX LLC

* SPECGX LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

EXALGO, HYDROMORPHONE HYDROCHLORIDE

FENTANYL CITRATE, FENTANYL CITRATE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

RESTORIL, TEMAZEPAM

ROXICODONE, OXYCODONE HYDROCHLORIDE

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

SPECTRA MDCL DEVICES

* SPECTRA MEDICAL DEVICES INC

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SPECTRON MRC LLC

* SPECTRON MRC LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SPECTRUM PHARMS

* SPECTRUM PHARMACEUTICALS INC

BELEODAQ, BELINOSTAT

EVOMELA, MELPHALAN HYDROCHLORIDE

FUSILEV, LEVOLEUCOVORIN CALCIUM

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 159

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SPECTRUM PHARMACEUTICALS INC

KHAPZORY, LEVOLEUCOVORIN

SPIL

* SUN PHARMA INDUSTRIES LTD

KAPSPARGO SPRINKLE, METOPROLOL SUCCINATE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

SPROUT PHARMS

* SPROUT PHARMACEUTICALS INC

ADDYI, FLIBANSERIN

SQUARE PHARMS LTD

* SQUARE PHARMACEUTICALS LTD

VALSARTAN, VALSARTAN

ST RENATUS

* ST RENATUS LLC

KOVANAZE, OXYMETAZOLINE HYDROCHLORIDE

STAND HOMEOPATH

* STANDARD HOMEOPATHIC CO

IVY BLOCK, BENTOQUATAM (OTC)

STASON PHARMS

* STASON PHARMACEUTICALS INC

PURINETHOL, MERCAPTOPURINE

STERINOVA INC

* STERINOVA INC

HEPARIN SODIUM, HEPARIN SODIUM

STI PHARMA LLC

* STI PHARMA LLC

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXAMETHASONE, DEXAMETHASONE

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

TRIACIN-C, CODEINE PHOSPHATE

STIEFEL

* STIEFEL LABORATORIES INC

DUAC, BENZOYL PEROXIDE

STIEFEL LABS INC

* STIEFEL LABORATORIES INC

SORIATANE, ACITRETIN

STRIDES PHARMA

* STRIDES PHARMA GLOBAL PTE LTD

ABACAVIR SULFATE, ABACAVIR SULFATE

ACARBOSE, ACARBOSE

ACETAZOLAMIDE, ACETAZOLAMIDE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENZONATATE, BENZONATATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CALCITRIOL, CALCITRIOL

CARISOPRODOL, CARISOPRODOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

EFAVIRENZ, EFAVIRENZ

ERGOCALCIFEROL, ERGOCALCIFEROL

GABAPENTIN, GABAPENTIN

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

KETOCONAZOLE, KETOCONAZOLE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LIDOCAINE, LIDOCAINE

MELOXICAM, MELOXICAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 160

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* STRIDES PHARMA GLOBAL PTE LTD

METHOXSALEN, METHOXSALEN

METRONIDAZOLE, METRONIDAZOLE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NEVIRAPINE, NEVIRAPINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PIROXICAM, PIROXICAM

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

TACROLIMUS, TACROLIMUS

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

STRIDES VIVIMED

* STRIDES VIVIMED PTE LTD

ALBENDAZOLE, ALBENDAZOLE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METRONIDAZOLE, METRONIDAZOLE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

STRONGBRIDGE US

* STRONGBRIDGE US INC

KEVEYIS, DICHLORPHENAMIDE

SUCAMPO PHARMA LLC

* SUCAMPO PHARMA AMERICAS LLC

AMITIZA, LUBIPROSTONE

SUN PHARM INDS

* SUN PHARMACEUTICAL INDUSTRIES LTD

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

DESLORATADINE, DESLORATADINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OLANZAPINE, OLANZAPINE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

SUN PHARM INDS (IN)

* SUN PHARMACEUTICAL INDUSTRIES LTD

CEPHALEXIN, CEPHALEXIN

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC

* SUN PHARMACEUTICAL INDUSTRIES INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 161

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES INC

ABSORICA, ISOTRETINOIN

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

BENZONATATE, BENZONATATE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOZAPINE, CLOZAPINE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

ERGOCALCIFEROL, ERGOCALCIFEROL

EURAX, CROTAMITON

FLUMADINE, RIMANTADINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLIPIZIDE, GLIPIZIDE

HALOG, HALCINONIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

INDOMETHACIN, INDOMETHACIN

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

KENALOG, TRIAMCINOLONE ACETONIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NIMODIPINE, NIMODIPINE

OXAPROZIN, OXAPROZIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

REPAGLINIDE, REPAGLINIDE

RISPERIDONE, RISPERIDONE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ULTRAVATE, HALOBETASOL PROPIONATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SUN PHARM INDS LTD

* SUN PHARMACEUTICAL INDUSTRIES LTD

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZITHROMYCIN, AZITHROMYCIN

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 162

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CERINTA, ETHINYL ESTRADIOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FAMOTIDINE, FAMOTIDINE (OTC)

FELODIPINE, FELODIPINE

FENOFIBRATE, FENOFIBRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GANIRELIX ACETATE, GANIRELIX ACETATE

GLYCOPYRROLATE, GLYCOPYRROLATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

INFUGEM, GEMCITABINE HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE REDIDOSE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE (OTC)

ONDANSETRON, ONDANSETRON

OPCICON ONE-STEP, LEVONORGESTREL (OTC)

OXCARBAZEPINE, OXCARBAZEPINE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

RILUZOLE, RILUZOLE

RIOMET, METFORMIN HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TOPIRAMATE, TOPIRAMATE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

XIMINO, MINOCYCLINE HYDROCHLORIDE

SUN PHARM INDUSTRIES

* SUN PHARMACEUTICAL INDUSTRIES INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 163

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES INC

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

BACTRIM DS, SULFAMETHOXAZOLE

BACTRIM, SULFAMETHOXAZOLE

CARISOPRODOL, CARISOPRODOL

CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE

CHLORTHALIDONE, CHLORTHALIDONE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOLOID MESYLATES, ERGOLOID MESYLATES

FELODIPINE, FELODIPINE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LOVASTATIN, LOVASTATIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

MORPHINE SULFATE, MORPHINE SULFATE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NYSTATIN, NYSTATIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PINDOLOL, PINDOLOL

PIROXICAM, PIROXICAM

PREDNISONE, PREDNISONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUALAQUIN, QUININE SULFATE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

QUINIDINE SULFATE, QUINIDINE SULFATE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

TEMAZEPAM, TEMAZEPAM

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

ULTRAVATE, HALOBETASOL PROPIONATE

SUN PHARMA GLOBAL

* SUN PHARMA GLOBAL FZE

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMIFOSTINE, AMIFOSTINE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BROMSITE, BROMFENAC SODIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CEQUA, CYCLOSPORINE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 164

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **
* SUN PHARMA GLOBAL FZE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOFETILIDE, DOFETILIDE
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESZOPICLONE, ESZOPICLONE

EZALLOR, ROSUVASTATIN CALCIUM

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FINASTERIDE, FINASTERIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

ODOMZO, SONIDEGIB PHOSPHATE

OXALIPLATIN, OXALIPLATIN

PALIPERIDONE, PALIPERIDONE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TEMOZOLOMIDE, TEMOZOLOMIDE

TETRABENAZINE, TETRABENAZINE

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

XELPROS, LATANOPROST

YONSA, ABIRATERONE ACETATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* SUN PHARMA GLOBAL INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

CARBOPLATIN, CARBOPLATIN

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

SUNGEN PHARMA

* SUNGEN PHARMA LLC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

SUNNY PHARMTECH INC

* SUNNY PHARMTECH INC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

SUNOVION

* SUNOVION PHARMACEUTICALS INC

BROVANA, ARFORMOTEROL TARTRATE

XOPENEX HFA, LEVALBUTEROL TARTRATE

SUNOVION PHARMS INC

* SUNOVION PHARMACEUTICALS INC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 165

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUNOVION PHARMACEUTICALS INC

APTIOM, ESLICARBAZEPINE ACETATE

ARCAPTA NEOHALER, INDACATEROL MALEATE

LATUDA, LURASIDONE HYDROCHLORIDE

LUNESTA, ESZOPICLONE

SEEBRI, GLYCOPYRROLATE

UTIBRON, GLYCOPYRROLATE

ZONEGRAN, ZONISAMIDE

SUNOVION RESP

* SUNOVION RESPIRATORY DEVELOPMENT INC

LONHALA MAGNAIR KIT, GLYCOPYRROLATE

SUNSHINE LAKE

* SUNSHINE LAKE PHARMA CO LTD

AZITHROMYCIN, AZITHROMYCIN

CLARITHROMYCIN, CLARITHROMYCIN

ENTACAPONE, ENTACAPONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

SUNSTAR AMERICAS

* SUNSTAR AMERICAS INC

PAROEX, CHLORHEXIDINE GLUCONATE

SUPERNUS PHARMS

* SUPERNUS PHARMACEUTICALS INC

OXTELLAR XR, OXCARBAZEPINE

TROKENDI XR, TOPIRAMATE

SUVEN LIFE

* SUVEN LIFE SCIENCES LTD

MALATHION, MALATHION

SVC PHARMA

* SVC PHARMA LP

DRONABINOL, DRONABINOL

SWEDISH ORPHAN

* SWEDISH ORPHAN BIOVITRUM AB PUBL

ORFADIN, NITISINONE

SYNERGY PHARMS

* SYNERGY PHARMACEUTICALS INC

TRULANCE, PLECANATIDE

SYNTHON PHARMS

* SYNTHON PHARMACEUTICALS INC

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

** T **

ACME LABS

* THE ACME LABORATORIES LTD

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

GEN HOSP

* THE GENERAL HOSPITAL CORP

AMMONIA N 13, AMMONIA N-13

METHODIST HOSP RES

* THE METHODIST HOSP RESEARCH INSTITUTE

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

RITEDOSE CORP

* THE RITEDOSE CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

TAIHO ONCOLOGY

* TAIHO ONCOLOGY INC

LONSURF, TIPIRACIL HYDROCHLORIDE

TAKEDA PHARMS USA

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 166

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TAKEDA PHARMACEUTICALS USA INC

ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

ACTOS, PIOGLITAZONE HYDROCHLORIDE

COLCRYS, COLCHICINE

DEXILANT, DEXLANSOPRAZOLE

DUETACT, GLIMEPIRIDE

KAZANO, ALOGLIPTIN BENZOATE

NESINA, ALOGLIPTIN BENZOATE

OSENI, ALOGLIPTIN BENZOATE

PREVACID, LANSOPRAZOLE

ROZEREM, RAMELTEON

TRINTELLIX, VORTIOXETINE HYDROBROMIDE

ULORIC, FEBUXOSTAT

TALON THERAP

* TALON THERAPEUTICS INC

MARQIBO KIT, VINCRISTINE SULFATE

TAMARANG

* TAMARANG SA

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TARO

* TARO PHARMACEUTICAL INDUSTRIES LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FLUCONAZOLE, FLUCONAZOLE

FLUOROURACIL, FLUOROURACIL

GABAPENTIN, GABAPENTIN

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LORATADINE, LORATADINE (OTC)

MELOXICAM, MELOXICAM

METRONIDAZOLE, METRONIDAZOLE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN

* TARO PHARMACEUTICALS USA INC

ACETIC ACID, ACETIC ACID, GLACIAL

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADAPALENE, ADAPALENE

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

DAPSONE, DAPSONE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 167

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICALS USA INC

DERMABET, BETAMETHASONE VALERATE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

KETOZOLE, KETOCONAZOLE

LIDOCAINE, LIDOCAINE

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3, MICONAZOLE NITRATE (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)

U-CORT, HYDROCORTISONE ACETATE

TARO PHARM

* TARO PHARMACEUTICAL INDUSTRIES LTD

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

DESLORATADINE, DESLORATADINE

DESONIDE, DESONIDE

FELBAMATE, FELBAMATE

FLUOROURACIL, FLUOROURACIL

GABAPENTIN, GABAPENTIN

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

METRONIDAZOLE, METRONIDAZOLE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

TERIL, CARBAMAZEPINE

WARFARIN SODIUM, WARFARIN SODIUM

TARO PHARM INDS

* TARO PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE, AMCINONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 168

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICAL INDUSTRIES LTD

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

TARO PHARM INDS LTD

* TARO PHARMACEUTICAL INDUSTRIES LTD

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

DESLORATADINE, DESLORATADINE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE, HYDROCORTISONE

INFANTS' FEVERALL, ACETAMINOPHEN (OTC)

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

OVIDE, MALATHION

TOPICORT, DESOXIMETASONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TARO PHARMS

* TARO PHARMACEUTICALS INC

BUTENAFINE HYDROCHLORIDE, BUTENAFINE HYDROCHLORIDE (OTC)

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

OXICONAZOLE NITRATE, OXICONAZOLE NITRATE

PLIAGLIS, LIDOCAINE

TAZAROTENE, TAZAROTENE

TOPICORT, DESOXIMETASONE

TASMAN PHARMA

* TASMAN PHARMA INC

VERSACLOZ, CLOZAPINE

TCG FLUENT PHARMA

* TCG FLUENT PHARMA INVESTORS LP

FLOLIPID, SIMVASTATIN

TEIKOKU PHARMA USA

* TEIKOKU PHARMA USA INC

LIDODERM, LIDOCAINE

TELIGENT

* TELIGENT OU

CEFOTAN, CEFOTETAN DISODIUM

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

FORTAZ, CEFTAZIDIME

ZANTAC, RANITIDINE HYDROCHLORIDE

ZINACEF, CEFUROXIME SODIUM

TELIGENT PHARMA INC

* TELIGENT PHARMA INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINONIDE, FLUOCINONIDE

FLURANDRENOLIDE, FLURANDRENOLIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE, LIDOCAINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 169

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

TERSERA THERAPS LLC

* TERSERA THERAPEUTICS LLC

ERGOMAR, ERGOTAMINE TARTRATE

PRIALT, ZICONOTIDE ACETATE

QMIIZ ODT, MELOXICAM

VARUBI, ROLAPITANT HYDROCHLORIDE

ZOLADEX, GOSERELIN ACETATE

TESARO INC

* TESARO INC

ZEJULA, NIRAPARIB TOSYLATE

TETRAPHASE PHARMS

* TETRAPHASE PHARMACEUTICALS INC

XERAVA, ERAVACYCLINE DIHYDROCHLORIDE

TEVA

* TEVA NEUROSCIENCE INC

AZILECT, RASAGILINE MESYLATE

* TEVA PHARMACEUTICALS USA INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACYCLOVIR, ACYCLOVIR

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CALCITRIOL, CALCITRIOL

CAPTOPRIL, CAPTOPRIL

CARVEDILOL, CARVEDILOL

CEFACLOR, CEFACLOR

CEFPROZIL, CEFPROZIL

CELECOXIB, CELECOXIB

CEPHALEXIN, CEPHALEXIN

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CLARITHROMYCIN, CLARITHROMYCIN

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIFLUNISAL, DIFLUNISAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPITOL, CARBAMAZEPINE

ESZOPICLONE, ESZOPICLONE

ETODOLAC, ETODOLAC

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

39TH EDITION - 2019 - APPROVED DRUG PRODUCT LIST B - 170

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALZIN, ZINC ACETATE

GEMFI

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