CUMULATIVE SUPPLEMENT 6

JUNE 2013

APPROVED DRUG PRODUCTS

WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 33rd EDITION

Department of Health and Human Services

Food and Drug Administration Center for Drug Evaluation and Research Office of Generic Drugs

2013

Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration

APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 33rd EDITION Cumulative Supplement 6 June 2013 CONTENTS PAGE
1.0 INTRODUCTION ........................................................................................................................................ iii 1.1 How to use the Cumulative Supplement ........................................................................................... iii 1.2 Cumulative Supplement Content....................................................................................................... iv 1.3 Applicant Name Changes................................................................................................................... v 1.4 Levothyroxine Sodium ....................................................................................................................... .v 1.5 Availability of the Edition ................................................................................................................... vi 1.6 Report of Counts for the Prescription Drug Product List .................................................................. vii 1.7 Cumulative Supplement Legend ......................................................................................................viii DRUG PRODUCT LISTS Prescription Drug Product List ....................................................................................................... 1-1 OTC Drug Product List .................................................................................................................. 2-1 Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research List................................... 3-1 Orphan Product Designations and Approvals List ......................................................................... 4-1 Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution ............................................................. 5-1 PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Lists ................................................................................................... A-1 B. Patent and Exclusivity Terms ................................................................................................ B-1

APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 33rd EDITION CUMULATIVE SUPPLEMENT 6 June 2013 1.0 INTRODUCTION

1.1

HOW TO USE THE CUMULATIVE SUPPLEMENT This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations, 30th Edition (the List). The List is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research; and products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons. The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data. The Addendum contains appropriate drug patent and exclusivity information required of the Agency by the "Drug Price Competition and Patent Term Restoration Act of 1984" for the Prescription, OTC, and Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Lists. Because all parts of the publication are subject to changes, additions, or deletions, the List must be used in conjunction with the most current Cumulative Supplement. Users may wish to mark to the left of the ingredient(s) in the List to indicate that changes to that entry appear in the Cumulative Supplement. Drug product information is provided in each Cumulative Supplement for completeness to assist in locating the proper place in the List for the revision. The presence of any therapeutic equivalence code indicates that the drug product is multisource; the deletion of a therapeutic equivalence code indicates that the drug product has become single source. (An infrequent exception exists when a therapeutic equivalence code is revised. In that case, the deletion of the therapeutic equivalence code is followed immediately by the addition of the revised one.) Products that have never been marketed, are for exportation, are for military use, or have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" symbol in the 12th Cumulative Supplement of the 32nd Edition List will then be added to the "Discontinued Drug Product List" appearing in the 33rd Edition. The current Edition Section 2., How To Use The Drug Product Lists, describes the layout and usage of the List.

iii

New additions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >A>. The Patent and Exclusivity List new additions are indicated by the symbol >A> to the left of Patent Number or Exclusivity Code. The >A> symbol is then dropped in subsequent Cumulative Supplements for that item. New deletions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >D> (DELETE) to the left of the line. The information line with the >D> symbol is dropped in subsequent Cumulative Supplements for that item. The Patent and Exclusivity List is arranged in alphabetical order by active ingredient name(s) and trade name. The trade name will follow the active ingredient name separated by a dash symbol. Also shown is the application number and product number (FDA's internal file number) for reference purposes. All patents with their expiration dates are displayed for each application number. Drug substance and drug product patents are indicated as such with DS or DP in the Patent codes column. Use patents are indicated with the symbol "U" followed by a number representing a specific use. Exclusivity information for a specific drug is indicated by an abbreviation followed by the date upon which the exclusivity expires. Refer to the Exclusivity Terms, Section B, in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations. Refer to Section 1.3 for internet access to the most current list of Patent and Exclusivity terms.

1.2

CUMULATIVE SUPPLEMENT CONTENT Since February 2005, we have been providing daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic products which is important for substitution purposes. Previously, a first-time-generic product approved early in the month would not be published in the Cumulative Supplement (CS) for several weeks. The CS monthly update publish goal is by the end of the following months second work week (e.g., Novembers supplement will be updated by the end of the second full work week in December). Currently, the monthly PDF CS includes: Generic product ANDA (Abbreviated New Drug Approval) approvals as of the date of publication. All product changes received and processed as of the date of publication. o Refer to CS Section 1.8 Cumulative Supplement Legend for types of changes o Discontinued products will be processed as of the date of publication. There will be circumstances where a product is discontinued in one month, however, it will be reported in a different month's CS. For example, the Orange Book Staff received a letter November 7 that the product has been discontinued from manufacturing and marketing. The Orange Book subsequently publishes the October CS on November 14. The product will show in the October CS that it is discontinued even though the date of discontinuance is the day that the Orange Book Staff receives notification (November 7). New Drug Application (NDA) approvals appear in the CS month they were approved.

iv

Patent information, also updated daily in the EOB, is current to the date of publication. Exclusivity information is updated monthly and current to the date of publication.

Every effort is made to ensure the Cumulative Supplement is current and accurate. Applicant holders are requested to inform the FDA Orange Book Staff (OBS) of any changes or corrections. The OBS can be contacted by email at [email protected]. Send Changes by FAX: 240-276-8974; mail to: FDA/CDER Orange Book Staff Office of Generic Drugs, HFD-610 7620 Standish Place Rockville, MD 20855-2773 1.3 APPLICANT NAME CHANGES It is not practical to identify in the Cumulative Supplement each and every product involved when an applicant transfers its entire line of approved drug products to another applicant, or when an applicant changes its name. Therefore, the cumulation of these transfers and name changes will be identified in this section only. Where only partial lines of approved products are transferred between applicants, each approved product involved will appear as an applicant name change entry in the Cumulative Supplement. It is also not practical to identify each and every product involved when an applicant name is changed to meet internal publication standards (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this occurs, each product involved (either currently in the Cumulative Supplement or in the following year's edition) will reflect the new abbreviated name. Consequently, it will not appear as an applicant name change entry in the Cumulative Supplement nor will the cumulation of these name changes appear in this section. The Electronic Orange Book Query, updated monthly, will contain the most current applicant holder name. FORMER APPLICANT NAME (FORMER ABBREVIATED NAME) BIONICHE PHARMA USA LLC (BIONICHE PHARMA USA) 1.4 LEVOTHYROXINE SODIUM Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs' sponsors have conducted studies to establish their drugs' therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium drug products. Levothyroxine Sodium (Mylan ANDA 76187) and Levo-T (Alara NDA 21342) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck
v

NEW APPLICANT NAME (NEW ABBREVIATED NAME) MYLAN INSTITUTIONAL LLC (MYLAN LLC)

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

Trade Name

Applicant

Potency

TE Code

Appl No

Product No

UNITHROID LEVOTHYROXINE SODIUM LEVOXYL SYNTHROID LEVO-T SYNTHROID LEVOTHYROXINE SODIUM LEVO-T UNITHROID LEVOTHYROXINE SODIUM LEVOXYL LEVO-T UNITHROID LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM LEVOTHROID LEVOTHYROXINE SODIUM

STEVENS J MYLAN

0.025MG AB1 0.025MG AB1

21210 76187 21301 21402 21342 21402 76187 21342 21210 76752

001 001 001 001 001 001 001 001 001 001

KING PHARMS 0.025MG AB1 ABBOTT 0.025MG AB1 ALARA PHARM 0.025MG AB1 ABBOTT MYLAN 0.025MG AB2 0.025MG AB2

ALARA PHARM 0.025MG AB2 STEVENS J 0.025MG AB2 MERCK KGAA 0.025MG AB2

KUNG PHARMS ALARA PHARM STEVENS J MYLAN

0.025MG 0.025MG 0.025MG 0.025MG

AB3 AB3 AB3 AB3

21301 21342 21210 76187 76752

001 001 001 001 001

MERCK KGAA 0.025MG AB3

LLOYD MYLAN

0.025MG AB4 0.025MG AB4

21116 76187

001 001

1.5 AVAILABILITY OF THE EDITION Since 1997, the Electronic Orange Book Query (EOBQ) http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been available on the internet and has become the updated-every-month Orange Book. The Query provides searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent number. Product search categories are: prescription, over-the-counter, discontinued drugs. There are links to patent and exclusivity information that may be applicable to each product. Commencing with the 25th edition, the Annual Edition and monthly Cumulative Supplements have been provided in downloadable Portable Document Format (PDF) at the EOB home page by clicking on Publications. The PDF annual and cumulative supplements duplicate previous paper
vi

versions. Over time, there will be an archive for the annuals and each year's December Cumulative Supplement. The downloaded Annual Edition and Cumulative Supplements are also available in a paper version (Approved Drug Products with Therapeutic Equivalence Evaluations, ADP) from the U.S. Government Printing Office: http://bookstore.gpo.gov; toll free 866-512-1800. There are historical lists of Orange Book cumulative supplement product monthly changes at http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are ASCII text files of the Orange Book drug product, patent, and exclusivity data at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The drug product text files are provided in eobzip.zip format. The files are updated concurrently with the monthly cumulative supplements. The annual Orange Book Edition Appendices A, B, and C in PDF format are updated quarterly. Effective August 18, 2003, patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from the FDA Forms List, http://www.fda.gov/opacom/morechoices/fdaforms/default.html. The current listing of the Orphan Product Designations and Approvals is available at http://www.fda.gov/orphan/designat/list.htm.

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST DESCRIPTION OF REPORT This report provides summary counts derived from the product information in the Prescription Drug Product List and the current Cumulative Supplement. Products included in the counts are domestically marketed drug products approved for both safety and effectiveness under section 505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved drug products marketed by distributors; those marketed solely abroad; and those now regarded as medical devices, biologics or foods. The baseline column (Dec 2012) refers to the products in the Prescription Drug Product List. For each three-month period, a column of quarterly data is added which incorporates counts of product activity from the previous quarter(s) with those in the baseline count. DEFINITIONS Drug Product For this report, a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts, esters and derivatives) either as a single ingredient or as a combination product provided in a specific dosage form and strength for a given route of administration with approval for marketing by a firm under a particular generic or trade name. New Molecular Entity A new molecular entity is considered an active moiety that has not previously been approved (either as the parent compound or as a salt, ester or derivative of the parent compound) in the United States for use in a drug product either as a single ingredient or as part of a combination.

vii

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST COUNTS CUMULATIVE BY QUARTER

CATEGORIES COUNTED DRUG PRODUCTS LISTED SINGLE SOURCE MULTISOURCE THERAPEUTICALLY EQUIVALENT NOT THERAPEUTICALLY EQUIVALENT EXCEPTIONS1 NEW MOLECULAR ENTITIES APPROVED NUMBER OF APPLICANTS

DEC 2012 15343 2400 (15.9%) 12825 (83.6%) 12683 (82.7%) 142 (0.9%) 78 (0.5%) 17 835

MAR 2013 15445 2467 (16.0%) 12900 (83.5%) 12758 (82.6%) 142 (0.9%) 78 (0.5%) 9 844

JUN 2013 15408 2440 (15.8%) 12890 (83.7%) 12750 (82.7%) 140 (0.9%) 78 (0.5%) 5 841

SEPT 2013

DEC 2013

1 Amino acid-containing products of varying composition (see Introduction, page xx of the List).

1.7 CUMULATIVE SUPPLEMENT LEGEND The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form; Route and then by trade name. The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date. The application number preceded by N is a New Drug Application (NDA or innovator). The application number preceded by an A is an Abbreviated New Drug Application (ANDA or generic). The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred. New ingredient(s), new dosage form; route(s), new trade names, and new product additions are preceded by >A> during the action month. The change month is the current CS month; the change code for new approvals is NEWA. Following months will display the same information without the >A>. Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record change addition being made will be preceded by >A>. Following months will display only the >A> record without the >A>. All changes that occur to the product through the Annual year will be listed. The change month and change code will document the change. The change code and description: NEWA CAHN CAIN CDFR CFTG New drug product approval usually in the supplement month. Applicant holder firm name has changed. Change. There has been a change in the Ingredient(s) name. All products will be deleted under the old name and all products will be added under the changed ingredient(s) name. Change. Dosage Form; Route of Administration. Change. A first time generic for the innovator product. A TE Code is added.
viii

CMFD CMS1 CMS2 CPOT CRLD CTEC CTNA DISC

Change. The product is moved from the Discontinued Section due to a change in marketing status. Change. Miscellaneous addition to list. Change. Miscellaneous deletion from list. Change. Potency amount/unit. Change. Reference Listed Drug. Change. Therapeutic Equivalence Code. Change. Trade Name. Discontinued. The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition.

ix

PRESCRIPTION DRUG PRODUCT LIST RX DRUG PRODUCT LIST -

33RD EDITION 6 June 2013 1-1

CUMULATIVE SUPPLEMENT

ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE @ MIRROR PHARMS LLC 500MG;50MG;40MG ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE @ MIKART 356.4MG;30MG;16MG WRASER PHARMS LLC 356.4MG;30MG;16MG @ 356.4MG;30MG;16MG TABLET; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE BOCA PHARMA 712.8MG;60MG;32MG @ @ MIKART 712.8MG;60MG;32MG 712.8MG;60MG;32MG

A040883 001 Dec 23, 2008 Feb

DISC

>D> >A>

AA

A040109 001 Aug 26, 1997 Feb A040688 001 Apr 03, 2007 Jun A040688 001 Apr 03, 2007 Jun

DISC DISC DISC

>D> >A>

AA

A040701 001 Apr 03, 2007 Jun A040701 001 Apr 03, 2007 Jun A040316 001 Apr 28, 1999 Feb

DISC DISC DISC

ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;15MG AUROLIFE PHARMA LLC 300MG;30MG MIKART @ @ @ 300MG;60MG 300MG;30MG 300MG;30MG 650MG;30MG 650MG;60MG

AA AA >D> >A> AA AA

A202800 001 Apr 15, 2013 Apr A202800 002 Apr 15, 2013 Apr A202800 003 Apr 15, 2013 Apr A089238 001 Feb 25, 1986 Jun A089238 001 Feb 25, 1986 Jun A089231 001 Mar 03, 1986 Feb A089363 001 Sep 09, 1991 Feb

NEWA NEWA NEWA DISC DISC DISC DISC

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

>D> >A>

AA

A089008 001 Feb 21, 1986 Jun A089008 001 Feb 21, 1986 Jun A081067 001 Nov 30, 1989 Feb

DISC DISC DISC

AA

SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN PAI 325MG/15ML;7.5MG/15ML TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CARACO 325MG;5MG 325MG;7.5MG 325MG;10MG 500MG;5MG 500MG;7.5MG 500MG;10MG 650MG;7.5MG 650MG;10MG 660MG;10MG 750MG;7.5MG @ MIKART @ 500MG;2.5MG 650MG;5MG 650MG;7.5MG 650MG;10MG

A040838 001 May 10, 2013 Apr

NEWA

AA AA AA AA AA AA >A> >A> >A> >A> AA AA AA AA

A090118 001 Dec 23, 2008 May A090118 002 Dec 23, 2008 May A090118 003 Dec 23, 2008 May A090265 001 Dec 23, 2008 May A090265 002 Dec 23, 2008 May A090265 003 Dec 23, 2008 May A090380 001 Dec 23, 2008 Jun A090380 002 Dec 23, 2008 Jun A090380 003 Dec 23, 2008 Jun A090380 004 Dec 23, 2008 Jun A089698 001 Aug 25, 1989 Feb A040849 001 Jun 09, 2010 Feb A090380 001 Dec 23, 2008 Jun A090380 002 Dec 23, 2008 Jun

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN DISC DISC CAHN CAHN

>D> >D>

AA AA

SUN PHARM INDS INC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-2

>D> >D>

AA AA AA AA AA

TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN SUN PHARM INDS INC 660MG;10MG 750MG;7.5MG TRIS PHARMA INC 325MG;5MG 325MG;7.5MG 325MG;10MG ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL OXYCODONE AND ACETAMINOPHEN ACTAVIS ELIZABETH 325MG;2.5MG 325MG;5MG 325MG;7.5MG 325MG;10MG ACETAZOLAMIDE TABLET; ORAL ACETAZOLAMIDE @ WATSON LABS ACETAZOLAMIDE SODIUM INJECTABLE; INJECTION ACETAZOLAMIDE SODIUM SAGENT AGILA ACITRETIN CAPSULE; ORAL ACITRETIN BARR LABS INC TEVA PHARMS USA SORIATANE STIEFEL LABS INC

A090380 003 Dec 23, 2008 Jun A090380 004 Dec 23, 2008 Jun A202214 001 Mar 27, 2013 Mar A202214 002 Mar 27, 2013 Mar A202214 003 Mar 27, 2013 Mar

CAHN CAHN NEWA NEWA NEWA

AA AA AA AA

A201447 001 Apr 12, 2013 Apr A201447 002 Apr 12, 2013 Apr A201447 003 Apr 12, 2013 Apr A201447 004 Apr 12, 2013 Apr

NEWA NEWA NEWA NEWA

250MG

A088882 001 Oct 22, 1985 Jan

DISC

AP

EQ 500MG BASE/VIAL

A200880 001 May 09, 2012 Jan

CAHN

AB AB AB AB AB AB AB AB

10MG 25MG 17.5MG 22.5MG 10MG 17.5MG 22.5MG

A091455 001 Apr 04, 2013 Mar A091455 002 Apr 04, 2013 Mar A202897 001 Apr 04, 2013 Mar A202897 002 Apr 04, 2013 Mar N019821 001 Oct 28, 1996 Mar N019821 003 Aug 06, 2009 Mar N019821 004 Aug 06, 2009 Mar N019821 002 Oct 28, 1996 Mar

NEWA NEWA NEWA NEWA CFTG CFTG CFTG CFTG

25MG

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULE; ORAL SEMPREX-D + ACTIENT PHARMS ACYCLOVIR OINTMENT; TOPICAL ACYCLOVIR MYLAN PHARMS INC ZOVIRAX + VALEANT BERMUDA + VALEANT INTL SUSPENSION; ORAL ZOVIRAX + DELCOR ASSET + GLAXOSMITHKLINE

8MG;60MG

N019806 001 Mar 25, 1994 May

CAHN

AB AB AB

5% 5% 5%

A202459 001 Apr 03, 2013 Mar N018604 001 Mar 29, 1982 May N018604 001 Mar 29, 1982 Mar

NEWA CAHN CFTG

>A> >D>

AB AB

200MG/5ML 200MG/5ML

N019909 001 Dec 22, 1989 Jun N019909 001 Dec 22, 1989 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-3

TABLET; BUCCAL SITAVIG + BIOALLIANCE PHARMA ACYCLOVIR; HYDROCORTISONE CREAM; TOPICAL XERESE + VALEANT BERMUDA ADENOSINE INJECTABLE; INJECTION ADENOSINE @ TEVA PHARMS USA @ ALBENDAZOLE TABLET; ORAL ALBENZA + AMEDRA PHARMS ALBUTEROL SULFATE

50MG

N203791 001 Apr 12, 2013 Apr

NEWA

5%;1%

N022436 001 Jul 31, 2009 Apr

CAHN

3MG/ML 3MG/ML

A076564 001 Jun 16, 2004 Apr A078676 001 Jul 31, 2008 Apr

CAHN CAHN

200MG

N020666 001 Jun 11, 1996 Feb

CAHN

BX BX

AEROSOL, METERED; INHALATION PROAIR HFA + TEVA BRANDED PHARM EQ 0.09MG BASE/INH VENTOLIN HFA + GLAXO GRP LTD SOLUTION; INHALATION ALBUTEROL SULFATE @ APOTEX INC @ @ @ EQ 0.09MG BASE/INH

N021457 001 Oct 29, 2004 Apr N020983 001 Apr 19, 2001 May

CAHN CAHN

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

A078623 001 Apr 05, 2010 Apr A078623 002 Apr 05, 2010 Apr A075717 001 Feb 02, 2007 Apr A076391 001 Apr 01, 2003 Apr A072652 001 Feb 21, 1992 Jan A075394 001 Nov 22, 1999 Mar

DISC DISC DISC DISC CAHN DISC

AN

MYLAN SPECLT @ WOCKHARDT EU OPERATN

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE SOLUTION; INHALATION ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE @ APOTEX INC EQ 0.083% BASE;0.017% ALENDRONATE SODIUM SOLUTION; ORAL ALENDRONATE SODIUM ROXANE FOSAMAX + MERCK ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL UROXATRAL + COVIS PHARMA SARL 10MG

A077117 001 Dec 31, 2007 Apr

DISC

AA AA

EQ 70MG BASE/75ML EQ 70MG BASE/75ML

A090520 001 Feb 25, 2013 Feb N021575 001 Sep 17, 2003 Feb

NEWA CFTG

AB

N021287 001 Jun 12, 2003 Apr

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-4

ALLOPURINOL TABLET; ORAL ALLOPURINOL ACCORD HLTHCARE

AB AB

100MG 300MG

A203154 001 May 06, 2013 Apr A203154 002 May 06, 2013 Apr

NEWA NEWA

ALOGLIPTIN BENZOATE TABLET; ORAL NESINA TAKEDA PHARMS USA +

EQ 6.25MG BASE EQ 12.5MG BASE EQ 25MG BASE

N022271 001 Jan 25, 2013 Jan N022271 002 Jan 25, 2013 Jan N022271 003 Jan 25, 2013 Jan

NEWA NEWA NEWA

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE TABLET; ORAL KAZANO TAKEDA PHARMS USA +

EQ 12.5MG BASE;500MG EQ 12.5MG BASE;1GM

N203414 001 Jan 25, 2013 Jan N203414 002 Jan 25, 2013 Jan

NEWA NEWA

ALOGLIPTIN BENZOATE; PIOGLITAZONE TABLET; ORAL OSENI TAKEDA PHARMS USA

EQ 12.5MG BASE;EQ 15MG BASE EQ 12.5MG BASE;EQ 30MG BASE EQ 12.5MG BASE;EQ 45MG BASE EQ 25MG BASE;EQ 15MG BASE EQ 25MG BASE;EQ 30MG BASE

N022426 004 Jan 25, 2013 Jan N022426 005 Jan 25, 2013 Jan N022426 006 Jan 25, 2013 Jan N022426 001 Jan 25, 2013 Jan N022426 002 Jan 25, 2013 Jan N022426 003 Jan 25, 2013 Jan

NEWA NEWA NEWA NEWA NEWA NEWA

EQ 25MG BASE;EQ 45MG BASE

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE TABLET; ORAL OSENI TAKEDA PHARMS USA

EQ 12.5MG BASE;EQ 15MG BASE EQ 12.5MG BASE;EQ 30MG BASE EQ 12.5MG BASE;EQ 45MG BASE EQ 25MG BASE;EQ 15MG BASE EQ 25MG BASE;EQ 30MG BASE

N022426 004 Jan 25, 2013 Feb N022426 005 Jan 25, 2013 Feb N022426 006 Jan 25, 2013 Feb N022426 001 Jan 25, 2013 Feb N022426 002 Jan 25, 2013 Feb N022426 003 Jan 25, 2013 Feb

CAIN CAIN CAIN CAIN CAIN CAIN

+ ALPRAZOLAM

EQ 25MG BASE;EQ 45MG BASE

>D> >D> >D> >D> >A> >A> >A> >A>

AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL ALPRAZOLAM TEVA PHARMS 0.5MG 1MG 2MG 3MG @ TEVA PHARMS USA @ @ @ 0.5MG 1MG 2MG 3MG

A077979 001 Feb 28, 2007 Jun A077979 002 Feb 28, 2007 Jun A077979 003 Feb 28, 2007 Jun A077979 004 Feb 28, 2007 Jun A077979 001 Feb 28, 2007 Jun A077979 002 Feb 28, 2007 Jun A077979 003 Feb 28, 2007 Jun A077979 004 Feb 28, 2007 Jun

DISC DISC DISC DISC DISC DISC DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-5

ALPROSTADIL INJECTABLE; INJECTION ALPROSTADIL TEVA PHARMS USA AMIKACIN SULFATE INJECTABLE; INJECTION AMIKACIN SULFATE @ HOSPIRA >D> >D> >A> >A> AP @ TEVA PHARMS USA AP AMINOPHYLLINE INJECTABLE; INJECTION AMINOPHYLLINE INTL MEDICATION @ PHARMA SERVE NY @ AMIODARONE HYDROCHLORIDE INJECTABLE; INJECTION AMIODARONE HYDROCHLORIDE @ APOTEX INC 50MG/ML AP + MYLAN INSTITUTIONAL @ TEVA PHARMS USA >D> >D> >D> >D> >A> AMLEXANOX PASTE; DENTAL APHTHASOL + ULURU @ AMLODIPINE BESYLATE TABLET; ORAL AMLODIPINE BESYLATE ACCORD HLTHCARE 50MG/ML 50MG/ML @ TEVA PARENTERAL

AP

0.5MG/ML

A075196 001 Apr 30, 1999 Apr

CAHN

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

A063264 001 Nov 30, 1994 Mar A064045 001 Sep 28, 1993 Jun A064045 002 Sep 28, 1993 Jun A064045 001 Sep 28, 1993 Jun A064045 002 Sep 28, 1993 Jun

DISC CAHN CAHN CAHN CAHN

>D> >A> >D> >A>

AP AP

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

A087209 001 Feb 01, 1982 Jun A087209 001 Feb 01, 1982 Jun A087392 001 Dec 15, 1983 Jun A087392 001 Dec 15, 1983 Jun

DISC DISC DISC DISC

A076394 001 Apr 25, 2003 Apr A076217 001 Oct 15, 2002 Apr A076163 001 Sep 05, 2003 Apr

DISC CAHN CAHN

5% 5%

N020511 001 Dec 17, 1996 Jun N020511 001 Dec 17, 1996 Jun

DISC DISC

AB AB AB

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

A202553 001 Apr 29, 2013 Apr A202553 002 Apr 29, 2013 Apr A202553 003 Apr 29, 2013 Apr

NEWA NEWA NEWA

AMLODIPINE BESYLATE; VALSARTAN TABLET; ORAL AMLODIPINE BESYLATE AND VALSARTAN PAR PHARM INC EQ 5MG BASE;160MG EQ 5MG BASE;320MG EQ 10MG BASE;160MG EQ 10MG BASE;320MG EXFORGE NOVARTIS + + EQ 5MG BASE;160MG EQ 5MG BASE;320MG EQ 10MG BASE;160MG EQ 10MG BASE;320MG

AB AB AB AB AB AB AB AB

A090011 001 Mar 28, 2013 Mar A090144 001 Mar 28, 2013 Mar A090011 002 Mar 28, 2013 Mar A090011 004 Mar 28, 2013 Mar N021990 002 Jun 20, 2007 Mar N021990 004 Jun 20, 2007 Mar N021990 003 Jun 20, 2007 Mar N021990 005 Jun 20, 2007 Mar

NEWA NEWA NEWA NEWA CFTG CFTG CFTG CFTG

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-6

AMMONIA N-13 INJECTABLE; INTRAVENOUS AMMONIA N 13 CARDINAL HEALTH 414 + FEINSTEIN MCPRF UCLA BIOMEDICAL

AP AP AP >A> AP

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

(3.75(3.75(3.75(3.75-

A203700 001 Feb 25, 2013 Feb N022119 001 Aug 23, 2007 Feb A203321 001 Feb 25, 2013 Feb A203812 001 Jun 27, 2013 Jun

NEWA CFTG NEWA NEWA

AMOXICILLIN FOR SUSPENSION; ORAL AMOXICILLIN @ RANBAXY @ TABLET; ORAL AMOXICILLIN DAVA PHARMS INC @ TABLET, CHEWABLE; ORAL AMOXICILLIN @ DAVA PHARMS INC @ @ RANBAXY @ AMOXIL @ DR REDDYS LABS INC @

200MG/5ML 400MG/5ML

A065113 001 Nov 29, 2002 Feb A065113 002 Nov 29, 2002 Feb

DISC DISC

>D> >A>

AB

875MG 875MG

A065344 001 Jan 15, 2009 Jun A065344 001 Jan 15, 2009 Jun

DISC DISC

125MG 250MG 200MG 400MG 200MG 400MG

A064139 001 Jan 29, 1996 Mar A064139 002 Jan 29, 1996 Mar A065060 001 Nov 29, 2000 Feb A065060 002 Nov 29, 2000 Feb N050761 001 Apr 15, 1999 Feb N050761 002 Apr 15, 1999 Feb

DISC DISC DISC DISC DISC DISC

TABLET, FOR SUSPENSION; ORAL AMOXICILLIN @ AUROBINDO PHARMA LTD 200MG @ 400MG AMOXICILLIN; CLAVULANATE POTASSIUM TABLET; ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM @ APOTEX INC 250MG;EQ 125MG BASE @ @ @ RANBAXY LABS AB AB AB AB TEVA PHARMS USA AUGMENTIN '250' + DR REDDYS LABS INC AUGMENTIN '500' + DR REDDYS LABS INC AUGMENTIN '875' + DR REDDYS LABS INC 500MG;EQ 125MG BASE 875MG;EQ 125MG BASE 500MG;EQ 125MG BASE 875MG;EQ 125MG BASE 250MG;EQ 125MG BASE 500MG;EQ 125MG BASE 875MG;EQ 125MG BASE

A065324 001 Jan 17, 2007 Jan A065324 002 Jan 17, 2007 Jan

DISC DISC

A065333 001 Feb 24, 2009 Apr A065333 002 Feb 24, 2009 Apr A065317 003 Oct 20, 2008 Apr A065109 001 Nov 04, 2002 Apr A065096 001 Oct 29, 2002 Apr N050564 001 Aug 06, 1984 Apr N050564 002 Aug 06, 1984 Apr N050720 001 Feb 13, 1996 Apr

DISC DISC DISC DISC CRLD CRLD CRLD CRLD

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF TEVA 1.25MG;1.25MG;1.25MG;1.25MG A077488 001 Apr 29, 2013 Apr 2.5MG;2.5MG;2.5MG;2.5MG A077488 002 Apr 29, 2013 Apr 3.75MG;3.75MG;3.75MG;3.75MG A077488 003 Apr 29, 2013 Apr

AB AB AB

NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-7

AB AB AB AB AB AB AB AB AB

CAPSULE, EXTENDED RELEASE; ORAL AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF TEVA 5MG;5MG;5MG;5MG A077488 004 Apr 29, 2013 Apr 6.25MG;6.25MG;6.25MG;6.25MG 7.5MG;7.5MG;7.5MG;7.5MG A077488 005 Apr 29, 2013 Apr A077488 006 Apr 29, 2013 Apr

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE BARR LABS INC 1.25MG;1.25MG;1.25MG;1.25MG A076536 001 Feb 12, 2013 Jan 2.5MG;2.5MG;2.5MG;2.5MG 3.75MG;3.75MG;3.75MG;3.75MG 5MG;5MG;5MG;5MG 6.25MG;6.25MG;6.25MG;6.25MG 7.5MG;7.5MG;7.5MG;7.5MG A076536 002 Feb 12, 2013 Jan A076536 003 Feb 12, 2013 Jan A076536 004 Feb 12, 2013 Jan A076536 005 Feb 12, 2013 Jan A076536 006 Feb 12, 2013 Jan

TABLET; ORAL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE @ TEVA PHARMS 1.25MG;1.25MG;1.25MG;1.25MG A040472 001 Sep 30, 2003 Jan @ 2.5MG;2.5MG;2.5MG;2.5MG A040472 002 Sep 30, 2003 Jan @ @ AMPICILLIN SODIUM INJECTABLE; INJECTION AMPICILLIN SODIUM ACS DOBFAR SPA 5MG;5MG;5MG;5MG 7.5MG;7.5MG;7.5MG;7.5MG A040472 003 Sep 30, 2003 Jan A040472 004 Sep 30, 2003 Jan

DISC DISC DISC DISC

AP AP AP >D> >A> >D> >A> >D> >A> >D> >A> AP AP AP AP

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

A090884 001 Apr 03, 2013 Mar A090884 002 Apr 03, 2013 Mar A090884 003 Apr 03, 2013 Mar A090889 001 Apr 03, 2013 Mar A090354 001 Dec 28, 2009 Jun A090354 001 Dec 28, 2009 Jun A090354 002 Dec 28, 2009 Jun A090354 002 Dec 28, 2009 Jun A090354 003 Dec 28, 2009 Jun A090354 003 Dec 28, 2009 Jun A090354 004 Dec 28, 2009 Jun A090354 004 Dec 28, 2009 Jun

NEWA NEWA NEWA NEWA DISC DISC DISC DISC DISC DISC DISC DISC

ANTIBIOTICE @ @

AP @ @ ANASTROZOLE TABLET; ORAL ANASTROZOLE ACCORD HLTHCARE @ KUDCO IRELAND ARIPIPRAZOLE

AB

1MG 1MG

A090568 001 Jun 28, 2010 Apr A091331 001 Jan 05, 2011 Feb

CAHN DISC

FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR ABILIFY MAINTENA KIT OTSUKA PHARM CO LTD 300MG/VIAL + 400MG/VIAL

N202971 001 Feb 28, 2013 Feb N202971 002 Feb 28, 2013 Feb

NEWA NEWA

ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET; ORAL ORPHENGESIC @ PRINSTON INC ORPHENGESIC FORTE @ PRINSTON INC

385MG;30MG;25MG 770MG;60MG;50MG

A075141 001 May 29, 1998 Apr A075141 002 May 29, 1998 Apr

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-8

ATENOLOL TABLET; ORAL ATENOLOL @ WATSON LABS @ ATORVASTATIN CALCIUM TABLET; ORAL ATORVASTATIN CALCIUM KUDCO IRELAND

50MG 100MG

A073352 001 Dec 27, 1991 Mar A073353 001 Dec 27, 1991 Mar

DISC DISC

AB AB AB AB

EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE EQ 80MG BASE

A091624 001 Apr 05, 2013 Mar A091624 002 Apr 05, 2013 Mar A091624 003 Apr 05, 2013 Mar A091624 004 Apr 05, 2013 Mar

NEWA NEWA NEWA NEWA

ATORVASTATIN CALCIUM; EZETIMIBE TABLET; ORAL LIPTRUZET MERCK SHARP DOHME

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

N200153 001 May 03, 2013 May N200153 002 May 03, 2013 May N200153 003 May 03, 2013 May N200153 004 May 03, 2013 May

NEWA NEWA NEWA NEWA

+ AZELAIC ACID GEL; TOPICAL FINACEA + BAYER HLTHCARE + BHP DERMATOLOGY

>A> >D>

15% 15%

N021470 001 Dec 24, 2002 Jun N021470 001 Dec 24, 2002 Jun

CAHN CAHN

AZITHROMYCIN INJECTABLE; INJECTION AZITHROMYCIN SUN PHARM INDS LTD BACITRACIN OINTMENT; OPHTHALMIC BACITRACIN + FERA PHARMS + PERRIGO CO TENNESSEE

AP

EQ 500MG BASE/VIAL

A090923 001 Apr 02, 2013 Mar

NEWA

>D> >A>

500 UNITS/GM 500 UNITS/GM

A061212 001 A061212 001

Jun Jun

CAHN CAHN

POWDER; FOR RX COMPOUNDING BACI-RX @ X GEN PHARMS 5,000,000 UNITS/BOT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC FERA PHARMS 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM PERRIGO CO TENNESSEE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACITRACIN ZINC; POLYMYXIN B SULFATE OINTMENT; OPHTHALMIC BACITRACIN ZINC AND POLYMYXIN B SULFATE FERA PHARMS 500 UNITS/GM;10,000 UNITS/GM PERRIGO CO TENNESSEE 500 UNITS/GM;10,000 UNITS/GM

A061580 001

Mar

DISC

>D> >A>

AT AT

A060764 002 A060764 002

Jun Jun

CAHN CAHN

>D> >A>

AT AT

A065022 001 Feb 27, 2002 Jun A065022 001 Feb 27, 2002 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-9

BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT; OPHTHALMIC BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE + FERA PHARMS 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM + PERRIGO CO TENNESSEE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACLOFEN INJECTABLE; INTRATHECAL GABLOFEN MALLINCKRODT INC

>D> >A>

A062166 002 A062166 002

Jun Jun

CAHN CAHN

AP AP AP

0.05MG/ML 0.5MG/ML 1MG/ML 2MG/ML

N022462 001 Nov 19, 2010 May N022462 002 Nov 19, 2010 May N022462 004 Jun 22, 2012 May N022462 003 Nov 19, 2010 May

CAHN CAHN CAHN CAHN

BENZONATATE CAPSULE; ORAL BENZONATATE CARACO

AA AA

100MG 200MG

A040587 001 Mar 19, 2008 May A040587 002 Mar 19, 2008 May

CAHN CAHN

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL; TOPICAL ACANYA + DOW PHARM AB BT + BENZACLIN VALEANT BERMUDA

2.5%;1.2% 5%;EQ 1% BASE 5%;EQ 1% BASE

N050819 001 Oct 23, 2008 Apr N050756 001 Dec 21, 2000 Apr N050756 002 Apr 20, 2007 Apr

CAHN CAHN CAHN

BENZOYL PEROXIDE; ERYTHROMYCIN GEL; TOPICAL BENZAMYCIN PAK + VALEANT INTL + VALEANT LUXEMBOURG

>D> >A>

5%;3% 5%;3%

N050769 001 Nov 27, 2000 Jun N050769 001 Nov 27, 2000 Jun

CAHN CAHN

BENZPHETAMINE HYDROCHLORIDE TABLET; ORAL BENZPHETAMINE HYDROCHLORIDE @ COREPHARMA 50MG BENZTROPINE MESYLATE INJECTABLE; INJECTION BENZTROPINE MESYLATE NAVINTA LLC TABLET; ORAL BENZTROPINE MESYLATE @ PROSAM LABS @ @ BETAMETHASONE SYRUP; ORAL CELESTONE @ MERCK SHARP DOHME

A040714 001 Oct 29, 2007 Feb

DISC

AP

1MG/ML

A091525 001 Feb 05, 2013 Jan

NEWA

0.5MG 1MG 2MG

A040699 001 Feb 14, 2008 Mar A040705 001 Feb 14, 2008 Mar A040706 001 Feb 14, 2008 Mar

DISC DISC DISC

0.6MG/5ML

N014215 002

Apr

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-10

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE INJECTABLE; INJECTION CELESTONE SOLUSPAN + MERCK SHARP DOHME BETAMETHASONE VALERATE AEROSOL, FOAM; TOPICAL BETAMETHASONE VALERATE PERRIGO LUXIQ + STIEFEL BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC BETAXOLOL HYDROCHLORIDE @ APOTEX INC EQ 0.5% BASE BETHANECHOL CHLORIDE TABLET; ORAL BETHANECHOL CHLORIDE CARACO

AB

3MG/ML;EQ 3MG BASE/ML

N014602 001

Apr

CAHN

AB AB

0.12% 0.12%

A078337 001 Nov 26, 2012 Apr N020934 001 Feb 28, 1999 Apr

CPOT CPOT

A075446 001 Sep 28, 2000 Apr

DISC

>A> >A> >A> >A> >D> >D> >A> >A> >D> >D> >D> >D>

AA AA AA AA AA AA

5MG 10MG 25MG 50MG

A040897 001 Apr 22, 2009 Jun A040897 002 Apr 22, 2009 Jun A040897 003 Apr 22, 2009 Jun A040897 004 Apr 22, 2009 Jun A040703 001 Mar 27, 2008 Jun A040677 001 Mar 27, 2008 Jun A040703 001 Mar 27, 2008 Jun A040677 001 Mar 27, 2008 Jun A040897 001 Apr 22, 2009 Jun A040897 002 Apr 22, 2009 Jun A040897 003 Apr 22, 2009 Jun A040897 004 Apr 22, 2009 Jun

CAHN CAHN CAHN CAHN DISC DISC DISC DISC CAHN CAHN CAHN CAHN

LANNETT @ LANNETT HOLDINGS INC @

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

AA AA AA AA

SUN PHARM INDS INC

BEXAROTENE CAPSULE; ORAL TARGRETIN + EISAI INC + VALEANT LUXEMBOURG GEL; TOPICAL TARGRETIN + VALEANT LUXEMBOURG + + VALEANT PHARMS INC

>D> >A>

75MG 75MG

N021055 001 Dec 29, 1999 Jun N021055 001 Dec 29, 1999 Jun

CAHN CAHN

>A> >D>

1% 1% 1%

N021056 001 Jun 28, 2000 Jun N021056 001 Jun 28, 2000 Jun N021056 001 Jun 28, 2000 Feb

CAHN CAHN CAHN

BICALUTAMIDE TABLET; ORAL BICALUTAMIDE ACCORD HLTHCARE BLEOMYCIN SULFATE INJECTABLE; INJECTION BLEOMYCIN SULFATE @ PHARMACHEMIE BV

AB

50MG

A078917 001 Jul 06, 2009 Apr

CAHN

EQ 15 UNITS BASE/VIAL

A065201 001 Dec 13, 2007 Feb

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-11

BRIMONIDINE TARTRATE; BRINZOLAMIDE SUSPENSION/DROPS; OPHTHALMIC SIMBRINZA + ALCON RES LTD 0.2%;1% BROMFENAC SODIUM SOLUTION/DROPS; OPHTHALMIC BROMDAY + ISTA PHARMS INC EQ 0.09% ACID AT AT AT PROLENSA + BAUSCH AND LOMB XIBROM @ ISTA PHARMS INC BUDESONIDE SUSPENSION; INHALATION BUDESONIDE @ APOTEX INC @ BROMFENAC SODIUM COASTAL PHARMS LUITPOLD EQ 0.09% ACID EQ 0.09% ACID 0.09% EQ 0.07% ACID EQ 0.09% ACID

N204251 001 Apr 19, 2013 Apr

NEWA

N021664 002 Oct 16, 2010 Apr A201211 001 May 11, 2011 Apr A202030 001 Jan 09, 2013 Apr A202030 001 Jan 09, 2013 Feb N203168 001 Apr 05, 2013 Apr N021664 001 Mar 24, 2005 Apr

CPOT CPOT CPOT CAHN NEWA CPOT

0.25MG/2ML 0.5MG/2ML

A078202 001 Mar 30, 2009 Apr A078202 002 Mar 30, 2009 Apr

DISC DISC

TABLET, EXTENDED RELEASE; ORAL UCERIS + SANTARUS 9MG BUPIVACAINE HYDROCHLORIDE INJECTABLE; INJECTION BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE INTL MEDICATED 0.25% @ AP @ AP @ 0.25% 0.5% 0.5% 0.75% 0.75%

N203634 001 Jan 14, 2013 Jan

NEWA

>D> >A> >D> >A> >D> >A>

AP

A076012 001 Jan 09, 2002 Jun A076012 001 Jan 09, 2002 Jun A076012 002 Jan 09, 2002 Jun A076012 002 Jan 09, 2002 Jun A076012 003 Jan 09, 2002 Jun A076012 003 Jan 09, 2002 Jun

DISC DISC DISC DISC DISC DISC

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET; SUBLINGUAL BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE A091422 001 Feb 22, 2013 Feb EQ 2MG BASE;EQ 0.5MG BASE ACTAVIS ELIZABETH + AMNEAL PHARMS SUBOXONE @ RECKITT BENCKISER AB @ AB + EQ 8MG BASE;EQ 2MG BASE EQ 8MG BASE;EQ 2MG BASE EQ 2MG BASE;EQ 0.5MG BASE EQ 8MG BASE;EQ 2MG BASE EQ 2MG BASE;EQ 0.5MG BASE EQ 2MG BASE;EQ 0.5MG BASE EQ 8MG BASE;EQ 2MG BASE EQ 8MG BASE;EQ 2MG BASE A091422 002 Feb 22, 2013 Apr A091422 002 Feb 22, 2013 Feb A203136 001 Feb 22, 2013 Feb A203136 002 Feb 22, 2013 Feb N020733 001 Oct 08, 2002 Mar N020733 001 Oct 08, 2002 Feb N020733 002 Oct 08, 2002 Mar N020733 002 Oct 08, 2002 Feb

AB AB AB AB AB

NEWA CRLD NEWA NEWA NEWA DISC CFTG DISC CFTG

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-12

BUPROPION HYDROBROMIDE TABLET, EXTENDED RELEASE; ORAL APLENZIN VALEANT BERMUDA 174MG + 348MG 522MG BUPROPION HYDROCHLORIDE TABLET; ORAL BUPROPION HYDROCHLORIDE @ TEVA 75MG @ 100MG TABLET, EXTENDED RELEASE; ORAL BUPROPION HYDROCHLORIDE @ IMPAX LABS 300MG AB1 AB1 AB3 AB1 AB3 BUTOCONAZOLE NITRATE CREAM; VAGINAL BUTOCONAZOLE NITRATE + PERRIGO ISRAEL GYNAZOLE-1 @ KV PHARM BUTORPHANOL TARTRATE INJECTABLE; INJECTION BUTORPHANOL TARTRATE @ APOTEX INC WATSON LABS INC 100MG 150MG 150MG 200MG 300MG

N022108 001 Apr 23, 2008 Apr N022108 002 Apr 23, 2008 Apr N022108 003 Apr 23, 2008 Apr

CAHN CAHN CAHN

A075310 001 Nov 29, 1999 Feb A075310 002 Nov 29, 1999 Feb

CDFR DISC

A077415 002 Dec 15, 2006 Apr A077455 001 Jul 19, 2010 Apr A077455 002 Mar 12, 2008 Apr A077285 001 Nov 26, 2008 Apr A077455 003 Jul 19, 2010 Apr A077285 002 Aug 15, 2008 Apr

DISC CAHN CAHN CAHN CAHN CAHN

2% 2%

A200923 001 May 18, 2012 Mar N019881 001 Feb 07, 1997 Mar

CRLD DISC

2MG/ML

A075697 001 Oct 23, 2001 Apr A075695 001 Oct 23, 2001 Apr A075695 002 Oct 23, 2001 Apr N017857 004 N017857 004 N017857 001 N017857 001 N017857 002 N017857 002 Jun Jun Jun Jun Jun Jun

DISC DISC DISC DISC DISC DISC DISC DISC DISC

BUTORPHANOL TARTRATE PRESERVATIVE FREE @ APOTEX INC 1MG/ML @ >D> >D> >A> >D> >D> >A> >D> >A> AP + @ CABERGOLINE TABLET; ORAL CABERGOLINE APOTEX CORP AP AP STADOL + APOTHECON @ 2MG/ML 2MG/ML 2MG/ML

STADOL PRESERVATIVE FREE + APOTHECON 1MG/ML @ 1MG/ML 2MG/ML 2MG/ML

AB

0.5MG

A201503 001 Mar 08, 2013 Feb

NEWA

CAFFEINE; ERGOTAMINE TARTRATE TABLET; ORAL ERGOTAMINE TARTRATE AND CAFFEINE MIKART 100MG;1MG @ 100MG;1MG

AA

A040590 001 Sep 16, 2005 Mar A040590 001 Sep 16, 2005 Jan

CMFD DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-13

CALCITRIOL CAPSULE; ORAL CALCITRIOL BANNER PHARMACAPS

AB AB

0.25MCG 0.5MCG

A091174 001 May 24, 2013 May A091174 002 May 24, 2013 May

NEWA NEWA

CALCIUM ACETATE CAPSULE; ORAL CALCIUM ACETATE INVAGEN PHARMS TABLET; ORAL CALCIUM ACETATE INVAGEN PHARMS

AB

EQ 169MG CALCIUM

A203135 001 Feb 07, 2013 Jan

NEWA

AB

EQ 169MG CALCIUM

A202420 001 Feb 05, 2013 Jan

NEWA

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;7 N019867 001 Dec 20, 1993 Mar 4MG/100ML;640MG/100ML;500MG/100ML ;74MG/100ML CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION; INTRAPERITONEAL INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER @ FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/1 00ML;538MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER @ FRESENIUS 18.4MG/100ML;2.5GM/100ML;5.08MG/1 00ML;538MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER @ FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/1 00ML;538MG/100ML;448MG/100ML INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER @ FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/ 100ML;538MG/100ML;448MG/100ML

DISC

N020374 001 Jun 13, 1994 Feb

DISC

N020374 002 Jun 13, 1994 Feb

DISC

N020374 003 Jun 13, 1994 Feb

DISC

N020374 004 Jun 13, 1994 Feb

DISC

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INJECTABLE; INTRATHECAL ELLIOTTS B SOLUTION + LUKARE MEDICAL LLC + QOL MEDCL

>A> >D>

0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ N020577 001 Sep 27, 1996 Jun ML;1.9MG/ML;7.3MG/ML;0.2MG/ML 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ N020577 001 Sep 27, 1996 Jun ML;1.9MG/ML;7.3MG/ML;0.2MG/ML

CAHN CAHN

CANAGLIFLOZIN TABLET; ORAL INVOKANA JANSSEN PHARMS + JANSSEN RES AND DEV + CANDESARTAN CILEXETIL TABLET; ORAL ATACAND ASTRAZENECA

100MG 300MG 100MG 300MG

N204042 001 Mar 29, 2013 Apr N204042 002 Mar 29, 2013 Apr N204042 001 Mar 29, 2013 Mar N204042 002 Mar 29, 2013 Mar

CAHN CAHN NEWA NEWA

AB AB

4MG 8MG

N020838 001 Jun 04, 1998 Apr N020838 002 Jun 04, 1998 Apr

CFTG CFTG

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-14

AB AB AB AB AB AB

TABLET; ORAL ATACAND ASTRAZENECA + CANDESARTAN CILEXETIL SANDOZ

16MG 32MG 4MG 8MG 16MG 32MG

N020838 003 Jun 04, 1998 Apr N020838 004 Jun 04, 1998 Apr A078702 001 May 03, 2013 Apr A078702 002 May 03, 2013 Apr A078702 003 May 03, 2013 Apr A078702 004 May 03, 2013 Apr

CFTG CFTG NEWA NEWA NEWA NEWA

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE TABLET; ORAL CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE APOTEX INC 32MG;25MG DR REDDYS LABS LTD 16MG;12.5MG 32MG;12.5MG 32MG;25MG CAPTOPRIL TABLET; ORAL CAPTOPRIL PRINSTON INC @ @ AB @ AB @ AB @ AB @ AB @ AB @ CARBAMAZEPINE CAPSULE, EXTENDED RELEASE; ORAL CARBAMAZEPINE TARO 100MG 200MG 300MG CARBIDOPA; LEVODOPA TABLET, EXTENDED RELEASE; ORAL CARBIDOPA AND LEVODOPA ACCORD HLTHCARE 25MG;100MG 50MG;200MG CARBINOXAMINE MALEATE SUSPENSION, EXTENDED RELEASE; ORAL KARBINAL ER + TRIS PHARMA INC 4MG/5ML TEVA

AB AB AB AB

A202884 003 Jun 03, 2013 May A202965 001 Jun 03, 2013 May A202965 002 Jun 03, 2013 May A202965 003 Jun 03, 2013 May

NEWA NEWA NEWA NEWA

>D> >A> >D> >A> >D> >A> >D> >A> >D> >A> >D> >A> >D> >A> >D> >A>

AB AB

12.5MG 12.5MG 25MG 25MG 50MG 50MG 100MG 100MG 12.5MG 12.5MG 25MG 25MG 50MG 50MG 100MG 100MG

A074477 001 Feb 13, 1996 Jun A074477 001 Feb 13, 1996 Jun A074477 002 Feb 13, 1996 Jun A074477 002 Feb 13, 1996 Jun A074477 003 Feb 13, 1996 Jun A074477 003 Feb 13, 1996 Jun A074477 004 Feb 13, 1996 Jun A074477 004 Feb 13, 1996 Jun A074483 001 Feb 13, 1996 Jun A074483 001 Feb 13, 1996 Jun A074483 002 Feb 13, 1996 Jun A074483 002 Feb 13, 1996 Jun A074483 003 Feb 13, 1996 Jun A074483 003 Feb 13, 1996 Jun A074483 004 Feb 13, 1996 Jun A074483 004 Feb 13, 1996 Jun

DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC

>A> >A> >A>

AB AB AB

A201106 001 Jun 21, 2013 Jun A201106 002 Jun 21, 2013 Jun A201106 003 Jun 21, 2013 Jun

NEWA NEWA NEWA

AB AB

A202323 001 Feb 08, 2013 Jan A202323 002 Feb 08, 2013 Jan

NEWA NEWA

N022556 001 Mar 28, 2013 Mar

NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-15

CARBOPLATIN INJECTABLE; INJECTION CARBOPLATIN @ PLIVA @ @

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

A076602 001 Nov 16, 2004 Feb A076602 002 Nov 16, 2004 Feb A076602 003 Nov 16, 2004 Feb

DISC DISC DISC

INJECTABLE; IV (INFUSION) CARBOPLATIN 50MG/5ML (10MG/ML) @ FRESENIUS KABI USA @ @ PHARMACHEMIE BV @ @ PARAPLATIN @ CORDENPHARMA @ @ @ CARISOPRODOL TABLET; ORAL CARISOPRODOL ACCELRX LABS @ COREPHARMA >D> >A> AA @ CARMUSTINE IMPLANT; INTRACRANIAL GLIADEL + ARBOR PHARMS LLC INJECTABLE; INJECTION BICNU + EMCURE PHARMS LTD CARTEOLOL HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC CARTEOLOL HYDROCHLORIDE @ APOTEX INC 1% CARVEDILOL TABLET; ORAL CARVEDILOL @ WOCKHARDT LTD @ @ @ PROSAM LABS 150MG/15ML (10MG/ML) 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) 450MG/45ML (10MG/ML) 50MG/5ML (10MG/ML) 150MG/15ML (10MG/ML) 450MG/45ML (10MG/ML) 600MG/60ML (10MG/ML)

A077266 001 Feb 15, 2006 Mar A077266 002 Feb 15, 2006 Mar A077679 001 Feb 25, 2009 Apr A077679 002 Feb 25, 2009 Apr A077679 003 Feb 25, 2009 Apr N020452 001 Jul 14, 2003 Mar N020452 002 Jul 14, 2003 Mar N020452 003 Jul 14, 2003 Mar N020452 004 Jan 15, 2004 Mar

DISC DISC DISC DISC DISC CAHN CAHN CAHN CAHN

AA

350MG 350MG 350MG 350MG

A040576 001 Jun 07, 2005 May A040397 001 Sep 21, 2000 Feb A040188 001 Mar 07, 1997 Jun A040188 001 Mar 07, 1997 Jun

CAHN DISC DISC DISC

7.7MG

N020637 001 Sep 23, 1996 Mar

CAHN

100MG/VIAL

N017422 001

Jan

CAHN

A076097 001 Feb 06, 2002 Apr

DISC

3.125MG 6.25MG 12.5MG 25MG

A078786 001 Dec 22, 2009 Feb A078786 002 Dec 22, 2009 Feb A078786 003 Dec 22, 2009 Feb A078786 004 Dec 22, 2009 Feb

DISC DISC DISC DISC

CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION; ORAL CEFADROXIL AUROBINDO @ TEVA PHARMS USA

AB AB

EQ 250MG BASE/5ML EQ 500MG BASE/5ML EQ 250MG BASE/5ML

A065349 001 Apr 25, 2013 Apr A065349 002 Apr 25, 2013 Apr A065278 001 Jan 20, 2006 Mar

NEWA NEWA DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-16

FOR SUSPENSION; ORAL CEFADROXIL @ TEVA PHARMS USA CEFAZOLIN SODIUM INJECTABLE; INJECTION CEFAZOLIN SODIUM + HOSPIRA INC + + + CEFEPIME HYDROCHLORIDE INJECTABLE; INJECTION CEFEPIME HYDROCHLORIDE @ SANDOZ @ @ CEFIXIME FOR SUSPENSION; ORAL SUPRAX + LUPIN LTD LUPIN PHARMS

EQ 500MG BASE/5ML

A065278 002 Jan 20, 2006 Mar

DISC

AP AP AP AP

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

A065226 001 Apr 21, 2005 Feb A065226 002 Apr 21, 2005 Feb A065244 001 Aug 12, 2005 Feb A065247 001 Aug 12, 2005 Feb

CRLD CRLD CRLD CRLD

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

A090291 001 Dec 21, 2010 Mar A090291 002 Dec 21, 2010 Mar A090291 003 Dec 21, 2010 Mar

DISC DISC DISC

500MG/5ML 100MG/5ML 200MG/5ML

N202091 001 Feb 20, 2013 Feb A065129 001 Feb 23, 2004 Feb A065355 001 Apr 10, 2007 Feb

CDFR CDFR CDFR

CEFOTAXIME SODIUM INJECTABLE; INJECTION CEFOTAXIME SODIUM AUROBINDO PHARMA @ AUROBINDO PHARMA LTD CEFTAZIDIME INJECTABLE; INJECTION CEFTAZIDIME AUROBINDO PHARMA

>D> >A>

AP

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

A065516 001 Nov 06, 2009 Jun A065516 001 Nov 06, 2009 Jun

DISC DISC

>D> >D> >D> >D> >A> >A> >A> >A>

AP AP AP AP

500MG/VIAL 1GM/VIAL 2GM/VIAL 6GM/VIAL

A065481 001 May 28, 2010 Jun A065481 002 May 28, 2010 Jun A065481 003 May 28, 2010 Jun A065482 001 May 28, 2010 Jun A065481 001 May 28, 2010 Jun A065481 002 May 28, 2010 Jun A065481 003 May 28, 2010 Jun A065482 001 May 28, 2010 Jun

DISC DISC DISC DISC DISC DISC DISC DISC

@ AUROBINDO PHARMA LTD @ @ @ CEFTRIAXONE SODIUM INJECTABLE; IM-IV CEFTRIAXONE @ AUROBINDO PHARMA LTD @ @ @ AP AP AP AP TEVA PHARMS USA

500MG/VIAL 1GM/VIAL 2GM/VIAL 6GM/VIAL

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

A065505 001 Jul 31, 2008 May A065505 002 Jul 31, 2008 May A065505 003 Jul 31, 2008 May A065505 004 Jul 31, 2008 May A065227 001 Mar 15, 2007 May A065227 002 Mar 15, 2007 May A065227 003 Mar 15, 2007 May A065227 004 Mar 15, 2007 May

DISC DISC DISC DISC CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-17

INJECTABLE; INJECTION CEFTRIAXONE @ AUROBINDO PHARMA LTD CEFUROXIME SODIUM

EQ 10GM BASE/VIAL

A065504 001 Jul 31, 2008 May

DISC

>D> >D> >A>

INJECTABLE; INJECTION ZINACEF IN PLASTIC CONTAINER + COVIS PHARMA EQ 15MG BASE/ML @ COVIS PHARMA SARL EQ 15MG BASE/ML CEPHALEXIN CAPSULE; ORAL CEPHALEXIN ALKEM LABS LTD AB AB KEFLEX + SHIONOGI INC CETIRIZINE HYDROCHLORIDE SYRUP; ORAL CETIRIZINE HYDROCHLORIDE @ APOTEX INC 5MG/5ML @ AUROBINDO PHARMA LTD 5MG/5ML AA BIO PHARM INC CARACO SUN PHARM INDS INC CETRORELIX INJECTABLE; INJECTION CETROTIDE + EMD SERONO @ EMD SERONO INC CEVIMELINE HYDROCHLORIDE CAPSULE; ORAL CEVIMELINE HYDROCHLORIDE ROXANE 30MG CHLORHEXIDINE GLUCONATE SOLUTION; DENTAL CHLORHEXIDINE GLUCONATE @ APOTEX INC 0.12% AT PAROEX SUNSTAR AMERICAS CHLOROTHIAZIDE TABLET; ORAL DIURIL @ OAK PHARMS AKORN @ CHLOROTHIAZIDE SODIUM INJECTABLE; INJECTION CHLOROTHIAZIDE SODIUM LUITPOLD 0.12% 5MG/5ML 5MG/5ML 5MG/5ML

N050643 001 Apr 28, 1989 Jun N050643 001 Apr 28, 1989 Jun

DISC DISC

EQ 333MG BASE EQ 750MG BASE EQ 750MG BASE

A090836 003 Mar 29, 2013 Mar A090836 004 Mar 29, 2013 Mar N050405 005 May 12, 2006 Mar

NEWA NEWA CTEC

A078412 001 Jun 18, 2008 Apr A090751 001 Dec 16, 2009 Feb A078870 001 Apr 27, 2009 May A090191 001 Nov 12, 2009 Jun A090191 001 Nov 12, 2009 Jun

DISC DISC CAHN CAHN CAHN

>A> >D>

AA AA

>D> >A>

EQ 3MG BASE/ML EQ 3MG BASE/ML

N021197 002 Aug 11, 2000 Jun N021197 002 Aug 11, 2000 Jun

DISC DISC

>A>

AB

A091591 001 Jul 08, 2013 Jun

NEWA

A075561 001 Nov 14, 2000 Apr A076434 001 Nov 29, 2005 Apr

DISC CTNA

250MG 500MG

N011145 004 N011145 002

Jan Jan

CAHN CAHN

>A>

AP

EQ 500MG BASE/VIAL

A202561 001 Apr 22, 2013 Jun

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-18

>D>

AP AP AP

INJECTABLE; INJECTION CHLOROTHIAZIDE SODIUM PHARMAFORCE DIURIL + OAK PHARMS AKORN

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

A202561 001 Apr 22, 2013 Jun A202561 001 Apr 22, 2013 Apr N011145 005 Jan

CAHN NEWA CAHN

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE SOLUTION; ORAL VITUZ + CYPRESS PHARM CHLORPROPAMIDE TABLET; ORAL CHLORPROPAMIDE @ WATSON LABS INC @ CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE; ORAL FENOFIBRIC ACID MYLAN PHARMS INC EQ 45MG FENOFIBRIC ACID EQ 135MG FENOFIBRIC ACID TRILIPIX ABBVIE + CICLOPIROX SOLUTION; TOPICAL CICLOPIROX @ APOTEX INC @ TEVA PHARMS AT AT PENLAC + VALEANT BERMUDA + VALEANT INTL EQ 45MG FENOFIBRIC ACID EQ 135MG FENOFIBRIC ACID

4MG/5ML;5MG/5ML

N204307 001 Feb 20, 2013 Feb

NEWA

100MG 250MG

A088852 001 Sep 26, 1984 Jan A088826 001 Sep 26, 1984 Jan

DISC DISC

AB AB AB AB

A200913 001 Mar 25, 2013 Mar A200913 002 Mar 25, 2013 Mar N022224 001 Dec 15, 2008 Mar N022224 002 Dec 15, 2008 Mar

NEWA NEWA CFTG CFTG

8% 8% 8% 8%

A078172 001 Sep 18, 2007 Apr A078079 001 Sep 18, 2007 Jan N021022 001 Dec 17, 1999 May N021022 001 Dec 17, 1999 Feb

DISC DISC CAHN CAHN

CIMETIDINE TABLET; ORAL CIMETIDINE WATSON LABS @ WATSON LABS INC @ >A> @ @ CIMETIDINE HYDROCHLORIDE SOLUTION; ORAL CIMETIDINE HYDROCHLORIDE @ APOTEX INC EQ 300MG BASE/5ML CIPROFLOXACIN INJECTABLE; INJECTION CIPROFLOXACIN @ TEVA PHARMS USA @

>D>

AB

800MG 200MG 300MG 400MG 800MG

A074316 001 Feb 28, 1996 Jun A074349 001 Aug 30, 1996 May A074349 002 Aug 30, 1996 May A074349 003 Aug 30, 1996 May A074316 001 Feb 28, 1996 Jun

DISC DISC DISC DISC DISC

A075560 001 Mar 15, 2000 Apr

DISC

400MG/40ML (10MG/ML) 200MG/20ML (10MG/ML)

A077782 002 Aug 28, 2006 Apr A077782 001 Aug 28, 2006 Apr

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-19

CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC CIPROFLOXACIN HYDROCHLORIDE @ APOTEX INC EQ 0.3% BASE CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL CIPRO XR @ BAYER HLTHCARE 212.6MG;EQ 287.5MG BASE @ >D> >A> AB AB + + AB 425.2MG;EQ 574.9MG BASE CIPROFLOXACIN EXTENDED RELEASE DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE @ MYLAN PHARMS INC 212.6MG;EQ 287.5MG BASE 212.6MG;EQ 287.5MG BASE 425.2MG;EQ 574.9MG BASE

A075928 001 Jun 09, 2004 Apr

DISC

N021473 001 Dec 13, 2002 May N021473 002 Aug 28, 2003 May A077701 002 Oct 31, 2007 Jun A077701 002 Oct 31, 2007 Jun A078183 001 Mar 22, 2007 May A078183 002 Mar 22, 2007 May

DISC DISC DISC DISC CRLD CRLD

CISPLATIN INJECTABLE; INJECTION PLATINOL @ HQ SPCLT PHARMA @ PLATINOL-AQ @ HQ SPCLT PHARMA @ CITALOPRAM HYDROBROMIDE SOLUTION; ORAL CITALOPRAM HYDROBROMIDE @ APOTEX INC EQ 10MG BASE/5ML TABLET; ORAL CITALOPRAM HYDROBROMIDE @ COREPHARMA EQ 10MG BASE @ EQ 20MG BASE @ >D> >A> >D> >A> AB @ AB @ CLARITHROMYCIN TABLET; ORAL CLARITHROMYCIN ALLIED PHARMA INC NATCO PHARMA LTD EQ 40MG BASE EQ 20MG BASE EQ 20MG BASE EQ 40MG BASE EQ 40MG BASE

10MG/VIAL 50MG/VIAL 0.5MG/ML 1MG/ML

N018057 001 N018057 002

Jan Jan

CAHN CAHN CAHN CAHN

N018057 003 Jul 18, 1984 Jan N018057 004 Nov 08, 1988 Jan

A077601 001 Nov 15, 2005 Apr

DISC

A077036 001 Oct 28, 2004 Feb A077036 002 Oct 28, 2004 Feb A077036 003 Oct 28, 2004 Feb A077141 002 Apr 10, 2008 Jun A077141 002 Apr 10, 2008 Jun A077141 001 Apr 10, 2008 Jun A077141 001 Apr 10, 2008 Jun

DISC DISC DISC DISC DISC DISC DISC

AB AB

250MG 500MG

A202710 001 Jun 10, 2013 May A202710 002 Jun 10, 2013 May

NEWA NEWA

CLEMASTINE FUMARATE SYRUP; ORAL CLEMASTINE FUMARATE @ APOTEX INC @ SILARX

EQ 0.5MG BASE/5ML EQ 0.5MG BASE/5ML

A075703 001 Nov 27, 2000 Apr A074884 001 Dec 17, 1997 Mar

DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-20

CLEVIDIPINE EMULSION; INTRAVENOUS CLEVIPREX + MEDICINES CO +

25MG/50ML (0.5MG/ML) 50MG/100ML (0.5MG/ML)

N022156 001 Aug 01, 2008 Feb N022156 002 Aug 01, 2008 Feb

CAIN CAIN

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR SOLUTION; ORAL CLINDAMYCIN PALMITATE HYDROCHLORIDE AUROBINDO PHARMA LTD EQ 75MG BASE/5ML CLINDAMYCIN PHOSPHATE INJECTABLE; INJECTION CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER AKORN INC EQ 6MG BASE/ML A203048 001 Apr 04, 2013 Mar EQ 12MG BASE/ML A203048 002 Apr 04, 2013 Mar EQ 18MG BASE/ML A203048 003 Apr 04, 2013 Mar SOLUTION; TOPICAL CLINDAMYCIN PHOSPHATE @ ACTAVIS MID ATLANTIC @ PERRIGO NEW YORK CLOBETASOL PROPIONATE AEROSOL, FOAM; TOPICAL OLUX E + DELCOR ASSET + STIEFEL LABS INC CREAM; TOPICAL CLOBETASOL PROPIONATE TEVA PHARMS @ TEVA PHARMS USA CLONAZEPAM TABLET; ORAL CLONAZEPAM ACCORD HLTHCARE

AA

A202409 001 Apr 30, 2013 Apr

NEWA

AP AP AP

NEWA NEWA NEWA

EQ 1% BASE EQ 1% BASE

A062811 001 Sep 01, 1988 May A064050 001 Nov 30, 1995 Feb

CAHN DISC

>A> >D>

AB2 AB2

0.05% 0.05%

N022013 001 Jan 12, 2007 Jun N022013 001 Jan 12, 2007 Jun

CAHN CAHN

>D> >A>

AB1

0.05% 0.05%

A074087 001 Feb 16, 1994 Jun A074087 001 Feb 16, 1994 Jun

DISC DISC

AB AB AB

0.5MG 1MG 2MG

A077147 001 May 02, 2005 Apr A077147 002 May 02, 2005 Apr A077147 003 May 02, 2005 Apr A075468 001 Oct 06, 2000 Feb A075468 002 Oct 06, 2000 Feb A075468 003 Oct 06, 2000 Feb

CAHN CAHN CAHN DISC DISC DISC

@ APOTEX INC @ @ CLONIDINE HYDROCHLORIDE

0.5MG 1MG 2MG

AB AB AB

TABLET; ORAL CLONIDINE HYDROCHLORIDE CARLSBAD 0.1MG 0.2MG 0.3MG TABLET, EXTENDED RELEASE; ORAL JENLOGA @ CONCORDIA PHARMS INC 0.1MG @ KAPVAY + CONCORDIA PHARMS INC 0.2MG 0.1MG

A202297 001 Jun 13, 2013 May A202297 002 Jun 13, 2013 May A202297 003 Jun 13, 2013 May

NEWA NEWA NEWA

N022331 001 Sep 30, 2009 May N022331 002 May 25, 2010 May N022331 003 Sep 28, 2010 May

CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-21

TABLET, EXTENDED RELEASE; ORAL KAPVAY CONCORDIA PHARMS INC 0.2MG CLOPIDOGREL BISULFATE TABLET; ORAL CLOPIDOGREL BISULFATE ACCORD HLTHCARE ACTAVIS TOTOWA MUTUAL PHARM CLORAZEPATE DIPOTASSIUM CAPSULE; ORAL TRANXENE @ RECORDATI RARE @ @ TABLET; ORAL TRANXENE RECORDATI RARE + TRANXENE SD @ RECORDATI RARE @ CLOZAPINE SUSPENSION; ORAL VERSACLOZ + DOUGLAS PHARMS + JAZZ PHARMS III

N022331 004 Sep 28, 2010 May

CAHN

AB AB AB AB

EQ 75MG BASE EQ 300MG BASE EQ 75MG BASE EQ 75MG BASE

A202925 001 Mar 27, 2013 Mar A202925 002 Mar 27, 2013 Mar A090307 001 May 28, 2013 May A078133 001 Jun 10, 2013 May

NEWA NEWA NEWA NEWA

3.75MG 7.5MG 15MG

N017105 001 N017105 002 N017105 003

May May May

CAHN CAHN CAHN

AB AB AB

3.75MG 7.5MG 15MG 11.25MG 22.5MG

N017105 006 N017105 007 N017105 008 N017105 005 N017105 004

May May May May May

CAHN CAHN CAHN CAHN CAHN

50MG/ML 50MG/ML

N203479 001 Feb 06, 2013 Feb N203479 001 Feb 06, 2013 Mar

NEWA CAHN

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE AMNEAL PHARMS 10MG/5ML;6.25MG/5ML CARACO COSYNTROPIN INJECTABLE; INJECTION COSYNTROPIN MYLAN LLC CROMOLYN SODIUM CONCENTRATE; ORAL CROMOLYN SODIUM MICRO LABS LTD INDIA SOLUTION; INHALATION CROMOLYN SODIUM @ APOTEX INC 10MG/5ML;6.25MG/5ML

AA AA

A200894 001 Apr 24, 2013 Apr A090180 001 Mar 17, 2010 May

NEWA CAHN

AP

0.25MG/VIAL

A090574 001 Dec 17, 2009 Feb

CAHN

AA

100MG/5ML

A202745 001 Apr 04, 2013 Mar

NEWA

10MG/ML

A075333 001 Apr 30, 2002 Apr

DISC

SOLUTION/DROPS; OPHTHALMIC CROMOLYN SODIUM @ APOTEX INC 4%

A075615 001 Jan 26, 2001 Apr

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-22

CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL AMRIX IVAX INTL 15MG + 30MG CYCLOBENZAPRINE HYDROCHLORIDE TWI PHARMS INC 15MG 30MG TABLET; ORAL CYCLOBENZAPRINE HYDROCHLORIDE MYLAN PHARMS INC 7.5MG @ PROSAM LABS 5MG @ SANDOZ @ CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC AKPENTOLATE @ AKORN 2% CYCLOGYL + ALCON LABS INC CYCLOPHOSPHAMIDE INJECTABLE; INJECTION CYTOXAN (LYOPHILIZED) + BAXTER HLTHCARE @ AP AP + @ + @ CYCLOSPORINE SOLUTION; ORAL CYCLOSPORINE @ APOTEX INC CYPROHEPTADINE HYDROCHLORIDE SYRUP; ORAL CYPROHEPTADINE HYDROCHLORIDE PHARM ASSOC 2MG/5ML CYSTEAMINE BITARTRATE CAPSULE, DELAYED RELEASE; ORAL PROCYSBI RAPTOR PHARMS EQ 25MG BASE + CYTARABINE INJECTABLE; INJECTION CYTOSAR-U TEVA PARENTERAL + + EQ 75MG BASE 2% 5MG 10MG

AB AB AB AB

N021777 001 Feb 01, 2007 Jan N021777 002 Feb 01, 2007 Jan A091281 001 Jan 31, 2013 Jan A091281 002 Jan 31, 2013 Jan

CAHN CAHN NEWA NEWA

AB

A073144 003 Mar 25, 2013 Mar A077291 001 Feb 03, 2006 Mar A072854 002 Feb 03, 2006 Apr A072854 001 Nov 19, 1991 Apr

NEWA DISC DISC DISC

A040165 001 Jan 13, 1997 Mar A084108 001 Mar

DISC CTEC

AP

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

N012142 003

Mar

CTNA CTNA CTNA CTNA CTNA CTNA

N012142 008 Jan 04, 1984 Jan N012142 004 Aug 30, 1982 Mar N012142 010 Sep 24, 1985 Jan N012142 005 Aug 30, 1982 Mar N012142 009 Dec 10, 1985 Jan

100MG/ML

A065167 001 Jan 05, 2005 Apr

DISC

AA

A091295 001 Mar 28, 2013 Mar

NEWA

N203389 001 Apr 30, 2013 Apr N203389 002 Apr 30, 2013 Apr

NEWA NEWA

>D> >D> >D>

AP AP AP

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

A075206 001 Dec 30, 1998 Jun A075206 002 Dec 30, 1998 Jun A075206 004 Dec 30, 1998 Jun

CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-23

>D> >A> >A> >A> >A>

AP AP AP AP AP

INJECTABLE; INJECTION CYTOSAR-U + TEVA PARENTERAL TEVA PHARMS USA + + + DABRAFENIB MESYLATE CAPSULE; ORAL TAFINLAR GLAXOSMITHKLINE + DACARBAZINE INJECTABLE; INJECTION DACARBAZINE TEVA PHARMS USA + DACTINOMYCIN INJECTABLE; INJECTION COSMEGEN + RECORDATI RARE DALTEPARIN SODIUM INJECTABLE; SUBCUTANEOUS FRAGMIN EISAI INC @ @ DAUNORUBICIN HYDROCHLORIDE

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

A075206 003 Dec 30, 1998 Jun A075206 001 Dec 30, 1998 Jun A075206 002 Dec 30, 1998 Jun A075206 004 Dec 30, 1998 Jun A075206 003 Dec 30, 1998 Jun

CAHN CAHN CAHN CAHN CAHN

EQ 50MG BASE EQ 75MG BASE

N202806 001 May 29, 2013 May N202806 002 May 29, 2013 May

NEWA NEWA

AP AP

200MG/VIAL 500MG/VIAL

A075259 002 Aug 27, 1998 Apr A075259 001 Sep 22, 2000 Apr

CAHN CAHN

AP

0.5MG/VIAL

N050682 001

May

CAHN

>D> >A> >D> >A>

10,000IU/0.4ML (25,000IU/ML) 10,000IU/0.4ML (25,000IU/ML) 95,000IU/9.5ML (10,000IU/ML) 95,000IU/9.5ML (10,000IU/ML)

N020287 002 May 01, 2007 Jun N020287 002 May 01, 2007 Jun N020287 007 Apr 04, 2002 Jun N020287 007 Apr 04, 2002 Jun

DISC DISC DISC DISC

AP

INJECTABLE; INJECTION DAUNORUBICIN HYDROCHLORIDE TEVA PHARMS USA EQ 5MG BASE/ML DESMOPRESSIN ACETATE INJECTABLE; INJECTION DESMOPRESSIN ACETATE SUN PHARM INDS LTD TEVA PHARMS USA

A065035 001 Jan 24, 2000 Apr

CAHN

AP AP

0.004MG/ML 0.004MG/ML

A091280 001 Jan 25, 2013 Jan A074888 001 Oct 15, 1997 Apr

NEWA CAHN

DESOGESTREL; ETHINYL ESTRADIOL TABLET; ORAL-28 ENSKYCE LUPIN LTD DESONIDE GEL; TOPICAL DESONATE + BAYER HLTHCARE + BHP DERMATOLOGY

AB

0.15MG;0.03MG

A201887 001 Mar 07, 2013 Feb

NEWA

>A> >D>

0.05% 0.05%

N021844 001 Oct 20, 2006 Jun N021844 001 Oct 20, 2006 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-24

DESOXIMETASONE SPRAY; TOPICAL TOPICORT + TARO DESVENLAFAXINE TABLET, EXTENDED RELEASE; ORAL DESVENLAFAXINE + ALEMBIC PHARMS LTD 50MG 50MG + DEXAMETHASONE ELIXIR; ORAL DEXAMETHASONE WOCKHARDT EU OPERATN 100MG

0.25%

N204141 001 Apr 11, 2013 Apr

NEWA

N204150 001 Mar 04, 2013 Apr N204150 001 Mar 04, 2013 Mar N204150 002 Mar 04, 2013 Mar

CRLD NEWA NEWA

AA

0.5MG/5ML

A088254 001 Jul 27, 1983 May

CRLD

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND FERA PHARMS 0.1%;EQ 3.5MG UNITS/GM PERRIGO CO TENNESSEE 0.1%;EQ 3.5MG UNITS/GM SUSPENSION/DROPS; OPHTHALMIC NEOMYCIN AND POLYMYXIN B SULFATES AND @ ALCON PHARMS LTD 0.1%;EQ 3.5MG UNITS/ML DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE; INJECTION PRECEDEX + HOSPIRA +

>D> >A>

AT AT

DEXAMETHASONE BASE/GM;10,000 BASE/GM;10,000

A062938 001 Jul 31, 1989 Jun A062938 001 Jul 31, 1989 Jun

CAHN CAHN

DEXAMETHASONE BASE/ML;10,000

A062721 001 Nov 17, 1986 Jan

DISC

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

N021038 002 Mar 13, 2013 Mar N021038 003 Mar 13, 2013 Mar

NEWA NEWA

DEXRAZOXANE HYDROCHLORIDE INJECTABLE; INJECTION TOTECT + BIOCODEX INC DEXTROAMPHETAMINE SULFATE SOLUTION; ORAL DEXTROAMPHETAMINE SULFATE + OUTLOOK PHARMS 5MG/5ML TRIS PHARMA INC DEXTROSE; POTASSIUM CHLORIDE INJECTABLE; INJECTION POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER @ B BRAUN 5GM/100ML;220MG/100ML N018744 003 Nov 09, 1982 Jan DIAZEPAM INJECTABLE; INJECTION DIAZEPAM WATSON LABS 5MG/5ML

EQ 500MG BASE/VIAL

N022025 001 Sep 06, 2007 May

CAHN

AA AA

A040776 001 Jan 29, 2008 May A203644 001 May 29, 2013 May

CFTG NEWA

DISC

>D>

AP

5MG/ML

A070296 001 Feb 12, 1986 Jun

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-25

>A>

INJECTABLE; INJECTION DIAZEPAM @ WATSON LABS DIAZOXIDE SUSPENSION; ORAL PROGLYCEM + TEVA BRANDED PHARM DICLOFENAC SODIUM

5MG/ML

A070296 001 Feb 12, 1986 Jun

DISC

50MG/ML

N017453 001

Apr

CAHN

SOLUTION/DROPS; OPHTHALMIC DICLOFENAC SODIUM @ APOTEX INC 0.1% DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE; ORAL DICLOFENAC SODIUM AND MISOPROSTOL SANDOZ 50MG;0.2MG 75MG;0.2MG DIDANOSINE TABLET, FOR SUSPENSION; ORAL DIDANOSINE AUROBINDO 100MG 150MG + DIFLORASONE DIACETATE CREAM; TOPICAL DIFLORASONE DIACETATE @ FOUGERA PHARMS BX >D> >A> + TARO PSORCON @ TARO @ TARO PHARMS NORTH DIGOXIN TABLET; ORAL DIGOXIN CARACO @ AB @ DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL DILTIAZEM HYDROCHLORIDE PAR PHARM 120MG 180MG 240MG 300MG SANDOZ 120MG 180MG 240MG 300MG 200MG

A077600 001 Nov 13, 2008 Apr

DISC

AB AB

A200158 001 May 09, 2013 Apr A200158 002 May 09, 2013 Apr

NEWA NEWA

A077275 001 Aug 14, 2012 Apr A077275 002 Aug 14, 2012 Apr A077275 003 Aug 14, 2012 Apr

CDFR CDFR CDFR

0.05% 0.05% 0.05% 0.05%

A075187 001 Mar 30, 1998 May A075508 001 Apr 24, 2000 May N020205 001 Nov 20, 1992 Jun N020205 001 Nov 20, 1992 Jun

DISC CRLD CAHN CAHN

>D> >A> >D> >A>

AB

0.125MG 0.125MG 0.25MG 0.25MG

A076363 001 Jan 31, 2003 Jun A076363 001 Jan 31, 2003 Jun A076363 002 Jan 31, 2003 Jun A076363 002 Jan 31, 2003 Jun

DISC DISC DISC DISC

AB3 AB3 AB3 AB3 AB4 AB4 AB4 AB4

A074984 001 Dec 20, 1999 Jan A074984 002 Dec 20, 1999 Jan A074984 003 Dec 20, 1999 Jan A074984 004 Dec 20, 1999 Jan A091022 001 Sep 28, 2012 Feb A091022 002 Sep 28, 2012 Feb A091022 003 Sep 28, 2012 Feb A091022 004 Sep 28, 2012 Feb

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-26

AB4 AB4

CAPSULE, EXTENDED RELEASE; ORAL DILTIAZEM HYDROCHLORIDE SANDOZ 360MG 420MG INJECTABLE; INJECTION DILTIAZEM HYDROCHLORIDE @ APOTEX INC 5MG/ML @ TEVA PHARMS USA + 5MG/ML 10MG/ML

A091022 005 Sep 28, 2012 Feb A091022 006 Sep 28, 2012 Feb

CAHN CAHN

A075375 001 Sep 30, 1999 Apr A074894 001 Aug 26, 1997 Apr A074894 002 Apr 19, 2002 Apr

DISC CAHN CAHN

TABLET; ORAL DILTIAZEM HYDROCHLORIDE @ DAVA PHARMS INC 30MG @ 60MG @ @ DIMENHYDRINATE INJECTABLE; INJECTION DIMENHYDRINATE + FRESENIUS KABI USA @ WATSON LABS DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE; ORAL TECFIDERA BIOGEN IDEC INC 120MG + 240MG DIPHENHYDRAMINE HYDROCHLORIDE INJECTABLE; INJECTION DIPHENHYDRAMINE HYDROCHLORIDE @ WATSON LABS INC 10MG/ML @ AP 50MG/ML DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE BD RX 50MG/ML @ WATSON LABS INC DIPYRIDAMOLE INJECTABLE; INJECTION DIPYRIDAMOLE @ APOTEX INC @ TEVA PHARMS USA TABLET; ORAL DIPYRIDAMOLE PROSAM LABS @ AB @ AB @ DIVALPROEX SODIUM TABLET, EXTENDED RELEASE; ORAL DIVALPROEX SODIUM @ TEVA PHARMS USA EQ 500MG VALPROIC ACID 50MG/ML 90MG 120MG

A074093 001 Nov 05, 1992 Jan A074093 002 Nov 05, 1992 Jan A074093 003 Nov 05, 1992 Jan A074093 004 Nov 05, 1992 Jan

DISC DISC DISC DISC

50MG/ML 50MG/ML

A040519 001 Jun 23, 2004 Apr A080615 001 Apr

CRLD DISC

N204063 001 Mar 27, 2013 Mar N204063 002 Mar 27, 2013 Mar

NEWA NEWA

A080873 001 A080873 002

Mar Mar

DISC DISC NEWA DISC

A091526 001 Mar 26, 2013 Mar A080873 003 Mar

5MG/ML 5MG/ML

A075769 001 Nov 27, 2002 Apr A074952 001 Nov 26, 1997 May

DISC CAHN

>D> >A> >D> >A> >D> >A>

AB

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

A040542 001 Apr 21, 2006 Jun A040542 001 Apr 21, 2006 Jun A040542 002 Apr 21, 2006 Jun A040542 002 Apr 21, 2006 Jun A040542 003 Apr 21, 2006 Jun A040542 003 Apr 21, 2006 Jun

DISC DISC DISC DISC DISC DISC

A078700 001 Aug 03, 2009 Mar

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-27

DOCETAXEL INJECTABLE; INJECTION DOCETAXEL ACTAVIS INC

AP AP

20MG/ML (20MG/ML) 80MG/4ML (20MG/ML) 140MG/7ML (20MG/ML) 20MG/0.5ML (40MG/ML) 80MG/2ML (40MG/ML)

N203551 001 Apr 12, 2013 Apr N203551 002 Apr 12, 2013 Apr N203551 003 Apr 12, 2013 Apr N022312 001 Jan 11, 2012 May N022312 002 Jan 11, 2012 May

NEWA NEWA NEWA DISC DISC

@ APOTEX INC @ DONEPEZIL HYDROCHLORIDE

TABLET; ORAL DONEPEZIL HYDROCHLORIDE @ ACCORD HLTHCARE 5MG @ AB AB AB >A> >A> AB AB AB DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC DORZOLAMIDE HYDROCHLORIDE @ APOTEX INC EQ 2% BASE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS; OPHTHALMIC DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE @ APOTEX INC EQ 2% BASE;EQ 0.5% BASE DOXAZOSIN MESYLATE TABLET; ORAL DOXAZOSIN MESYLATE @ WATSON LABS INC @ @ @ DOXEPIN HYDROCHLORIDE CAPSULE; ORAL DOXEPIN HYDROCHLORIDE + MYLAN PHARMS INC + + @ PAR PHARM @ @ @ @ @ WATSON LABS @ ALEMBIC PHARMS LTD ALVOGEN PINE BROOK ACTAVIS GRP PTC 10MG 5MG 10MG 5MG 10MG 5MG 10MG

A201335 001 Aug 29, 2011 Jan A201335 002 Aug 29, 2011 Jan A090551 001 May 31, 2011 Apr A090551 002 May 31, 2011 Apr A201724 001 Feb 25, 2013 Feb A201724 002 Feb 25, 2013 Feb A202114 001 Jul 05, 2013 Jun A202114 002 Jul 05, 2013 Jun

DISC DISC CAHN CAHN NEWA NEWA NEWA NEWA

A078395 001 Oct 28, 2008 Apr

DISC

A078201 001 Oct 28, 2008 Apr

DISC

EQ 1MG BASE EQ 2MG BASE EQ 4MG BASE EQ 8MG BASE

A075426 001 Oct 18, 2000 Jan A075426 002 Oct 18, 2000 Jan A075426 003 Oct 18, 2000 Jan A075426 004 Oct 18, 2000 Jan

DISC DISC DISC DISC

>D> >A> >D> >A>

AB AB AB AB AB

EQ 10MG BASE EQ 10MG BASE EQ 10MG BASE EQ 25MG BASE EQ 25MG BASE EQ 10MG BASE EQ 25MG BASE EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE EQ 10MG BASE EQ 25MG BASE

A070791 002 May 13, 1986 Jun A070791 002 May 13, 1986 Jun A070791 002 May 13, 1986 May A070791 003 May 13, 1986 Jun A070791 003 May 13, 1986 Jun A071697 001 Nov 09, 1987 May A071437 001 Nov 09, 1987 May A071595 001 Nov 09, 1987 May A071608 001 Nov 09, 1987 May A071422 001 Nov 09, 1987 May A071485 001 Apr 30, 1987 May A071486 001 Apr 30, 1987 May

CRLD CRLD CRLD CRLD CRLD DISC DISC DISC DISC DISC DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-28

CAPSULE; ORAL DOXEPIN HYDROCHLORIDE @ WATSON LABS @ @ CONCENTRATE; ORAL DOXEPIN HYDROCHLORIDE @ PHARM ASSOC TABLET; ORAL SILENOR PERNIX THERAPS LLC + DOXORUBICIN HYDROCHLORIDE

EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE

A071238 001 Apr 30, 1987 May A071326 001 Apr 30, 1987 May A071239 001 Apr 30, 1987 May

DISC DISC DISC

EQ 10MG BASE/ML

A075924 001 Jan 15, 2004 Mar

DISC

EQ 3MG BASE EQ 6MG BASE

N022036 001 Mar 17, 2010 Apr N022036 002 Mar 17, 2010 Apr

CAHN CAHN

AP >D> >D> >A> >A> AP AP AP AP

INJECTABLE; INJECTION DOXORUBICIN HYDROCHLORIDE SAGENT PHARMS 2MG/ML TEVA PARENTERAL TEVA PHARMS USA 2MG/ML 200MG/100ML 2MG/ML 200MG/100ML INJECTABLE, LIPOSOMAL; INJECTION DOXIL + JANSSEN RES AND DEV 20MG/10ML (2MG/ML) + DOXIL (LIPOSOMAL) + JANSSEN RES AND DEV + + + 50MG/25ML (2MG/ML) 20MG/10ML (2MG/ML) 20MG/10ML (2MG/ML) 20MG/10ML (2MG/ML) 50MG/25ML (2MG/ML) 50MG/25ML (2MG/ML) 50MG/25ML (2MG/ML) DOXORUBICIN HYDROCHLORIDE SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) 50MG/25ML (2MG/ML) DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) + 20MG/10ML (2MG/ML) 20MG/10ML (2MG/ML) + 50MG/25ML (2MG/ML) 50MG/25ML (2MG/ML) 50MG/25ML (2MG/ML) DOXYCYCLINE FOR SUSPENSION; ORAL DOXYCYCLINE LUPIN LTD DOXYCYCLINE HYCLATE CAPSULE; ORAL DOXYCYCLINE HYCLATE HIKMA PHARMS TABLET; ORAL DOXYCYCLINE HYCLATE @ BLU CARIBE INC

A091495 001 Mar 18, 2013 Mar A064140 001 Jul 28, 1995 Jun A064140 002 Jul 28, 1995 Jun A064140 001 Jul 28, 1995 Jun A064140 002 Jul 28, 1995 Jun

NEWA CAHN CAHN CAHN CAHN

AB AB >D> >A> >D> >A> AB AB AB AB AB AB AB AB >D> >A> >D> >A> AB AB AB AB AB AB

N050718 001 Nov 17, 1995 Jan N050718 002 Jun 13, 2000 Jan N050718 001 Nov 17, 1995 Jun N050718 001 Nov 17, 1995 Jun N050718 001 Nov 17, 1995 Apr N050718 002 Jun 13, 2000 Jun N050718 002 Jun 13, 2000 Jun N050718 002 Jun 13, 2000 Apr A203263 001 Feb 04, 2013 Jan A203263 002 Feb 04, 2013 Jan A203263 001 Feb 04, 2013 Jun A203263 001 Feb 04, 2013 Jun A203263 001 Feb 04, 2013 Apr A203263 002 Feb 04, 2013 Jun A203263 002 Feb 04, 2013 Jun A203263 002 Feb 04, 2013 Apr

CFTG CFTG CRLD CRLD CTNA CRLD CRLD CTNA NEWA NEWA CRLD CRLD CTNA CRLD CRLD CTNA

AB

EQ 25MG BASE/5ML

A201678 001 Mar 18, 2013 Mar

NEWA

AB AB

EQ 50MG BASE EQ 100MG BASE

A062396 002 Nov 07, 1984 May A062396 001 May 07, 1984 May

CAHN CAHN

EQ 50MG BASE

A062269 003

Mar

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-29

TABLET; ORAL DOXYCYCLINE HYCLATE @ BLU CARIBE INC AB + HIKMA PHARMS

EQ 100MG BASE EQ 100MG BASE

A062269 002 Nov 08, 1982 Mar A065095 001 Jul 02, 2003 May

CAHN CAHN

TABLET, DELAYED RELEASE; ORAL DORYX MAYNE PHARMA EQ 80MG BASE EQ 200MG BASE AB AB AB DOXYCYCLINE HYCLATE HERITAGE PHARMS INC EQ 75MG BASE EQ 100MG BASE EQ 150MG BASE DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE; ORAL DICLEGIS + DUCHESNAY 10MG;10MG DUTASTERIDE CAPSULE; ORAL DUTASTERIDE BANNER PHARMACAPS ECONAZOLE NITRATE CREAM; TOPICAL ECONAZOLE NITRATE IGI LABS INC ENALAPRILAT INJECTABLE; INJECTION ENALAPRILAT TEVA PHARMS USA ENTACAPONE TABLET; ORAL ENTACAPONE MYLAN PHARMS INC EPIRUBICIN HYDROCHLORIDE INJECTABLE; INJECTION EPIRUBICIN HYDROCHLORIDE @ MYLAN LLC 50MG/25ML (2MG/ML) @ AP AP EPOPROSTENOL SODIUM INJECTABLE; INJECTION EPOPROSTENOL SODIUM TEVA PHARMS USA TEVA PHARMS USA 200MG/100ML (2MG/ML) 50MG/25ML (2MG/ML) 200MG/100ML (2MG/ML)

N050795 004 Apr 11, 2013 Apr N050795 005 Apr 11, 2013 Apr A200856 001 Apr 30, 2013 Apr A200856 002 Apr 30, 2013 Apr A200856 003 Apr 30, 2013 Apr

NEWA NEWA NEWA NEWA NEWA

N021876 001 Apr 08, 2013 Apr

NEWA

AB

0.5MG

A200899 001 May 30, 2013 May

NEWA

AB

1%

A076574 001 Dec 17, 2004 Mar

CAHN

AP

1.25MG/ML

A075578 001 Aug 22, 2000 May

CAHN

AB

200MG

A202394 001 May 13, 2013 Apr

NEWA

A065371 001 Nov 28, 2007 Feb A065371 002 Nov 28, 2007 Feb A065331 001 Aug 09, 2007 Apr A065331 002 Aug 09, 2007 Apr

DISC DISC CAHN CAHN

AP AP

EQ 0.5MG BASE/VIAL EQ 1.5MG BASE/VIAL

A078396 001 Apr 23, 2008 Apr A078396 002 Apr 23, 2008 Apr

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-30

ERTAPENEM SODIUM INJECTABLE; INTRAMUSCULAR, IV (INFUSION) INVANZ + MERCK EQ 1GM BASE/VIAL + MERCK SHARP DOHME EQ 1GM BASE/VIAL ERYTHROMYCIN CAPSULE, DELAYED REL PELLETS; ORAL ERYC + MAYNE PHARMA 250MG @ WARNER CHILCOTT LLC OINTMENT; OPHTHALMIC ERYTHROMYCIN + FERA PHARMS + PERRIGO CO TENNESSEE SOLUTION; TOPICAL SANSAC @ DOW PHARM ESCITALOPRAM OXALATE SOLUTION; ORAL ESCITALOPRAM OXALATE SILARX PHARMS INC ESOMEPRAZOLE SODIUM INJECTABLE; INTRAVENOUS ESOMEPRAZOLE SODIUM SUN PHARMA GLOBAL NEXIUM IV ASTRAZENECA 250MG

>D> >A>

N021337 001 Nov 21, 2001 Jun N021337 001 Nov 21, 2001 Jun

CAHN CAHN

AB

N050536 001 A062338 001

Mar Apr

CAHN DISC

>D> >A>

AT AT

0.5% 0.5%

A062447 001 Sep 26, 1983 Jun A062447 001 Sep 26, 1983 Jun

CAHN CAHN

2%

A062522 001 Jan 24, 1985 Apr

CAHN

AA

EQ 5MG BASE/5ML

A090477 001 Jun 12, 2013 May

NEWA

AP AP AP AP

EQ 20MG BASE/VIAL EQ 40MG BASE/VIAL EQ 20MG BASE/VIAL EQ 40MG BASE/VIAL

A200882 001 Mar 18, 2013 Mar A200882 002 Mar 18, 2013 Mar N021689 001 Mar 31, 2005 Mar N021689 002 Mar 31, 2005 Mar

NEWA NEWA CFTG CFTG

+ +

ESTRADIOL VALERATE INJECTABLE; INJECTION ESTRADIOL VALERATE WATSON LABS @ @ WATSON LABS INC ESTRONE INJECTABLE; INJECTION ESTRONE + WATSON LABS @ ESTROPIPATE TABLET; ORAL ORTHO-EST @ CARACO @

>D> >D> >A> >A> >D> >D> >D> >D> >A>

AO AO

20MG/ML 40MG/ML 40MG/ML 20MG/ML

A083547 001 A083714 001 A083714 001 A083547 001

Jun Jun Jun Jun

DISC DISC DISC DISC

5MG/ML 5MG/ML

A085239 001 A085239 001

Jun Jun

DISC DISC

0.75MG 1.5MG

A089567 001 Feb 27, 1991 Apr A089582 001 Jul 17, 1991 Apr

DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-31

ESZOPICLONE TABLET; ORAL ESZOPICLONE MYLAN PHARMS INC

AB AB AB AB AB AB AB AB AB

1MG 2MG 3MG 1MG 2MG 3MG

A091151 001 Mar 26, 2013 Mar A091151 002 Mar 26, 2013 Mar A091151 003 Mar 26, 2013 Mar A091103 001 Apr 03, 2013 Mar A091103 002 Apr 03, 2013 Mar A091103 003 Apr 03, 2013 Mar N021476 001 Dec 15, 2004 Mar N021476 002 Dec 15, 2004 Mar N021476 003 Dec 15, 2004 Mar

NEWA NEWA NEWA NEWA NEWA NEWA CTEC CTEC CTEC

SUN PHARMA GLOBAL

LUNESTA SUNOVION PHARMS INC +

1MG 2MG 3MG

ETHINYL ESTRADIOL; LEVONORGESTREL TABLET; ORAL DAYSEE LUPIN LTD QUARTETTE + TEVA BRANDED PHARM

AB

0.03MG,0.01MG;0.15MG,N/A

A091467 001 Apr 10, 2013 Mar

NEWA NEWA

0.02MG,0.15MG;0.025MG,0.15MG;0.03 N204061 001 Mar 28, 2013 Mar MG,0.15MG;0.01MG,N/A

AB1

TABLET; ORAL-28 LEVONORGESTREL AND ETHINYL ESTRADIOL LUPIN LTD 0.02MG;0.1MG ETHINYL ESTRADIOL; NORETHINDRONE TABLET; ORAL-28 PIRMELLA 1/35 LUPIN LTD PIRMELLA 7/7/7 LUPIN LTD

A091425 001 Jan 18, 2013 Jan

NEWA

AB AB

0.035MG;1MG

A201512 001 Apr 24, 2013 Apr

NEWA NEWA

0.035MG,0.035MG,0.035MG;0.5MG,0.7 A201510 001 Apr 24, 2013 Apr 5MG,1MG

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE; ORAL MINASTRIN 24 FE + WARNER CHILCOTT

0.02MG;1MG

N204426 001 Apr 19, 2013 Apr

NEWA DISC

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE @ WARNER CHILCOTT 0.02MG;1MG N204426 001 Apr 19, 2013 May TABLET; ORAL FEMHRT @ WARNER CHILCOTT LLC +

0.005MG;1MG

N021065 002 Oct 15, 1999 Jan A076221 001 Nov 06, 2009 Jan

DISC CRLD

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL BARR LABS INC 0.005MG;1MG

TABLET, CHEWABLE; ORAL NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE + WARNER CHILCOTT LLC 0.02MG;1MG N203667 001 May 08, 2003 May ETHINYL ESTRADIOL; NORGESTIMATE TABLET; ORAL-28 ESTARYLLA SANDOZ TRI LO SPRINTEC @ BARR LABS INC

NEWA

AB

0.035MG;0.25MG

A090794 001 Jan 30, 2013 Jan

NEWA DISC

0.025MG,0.025MG,0.025MG;0.18MG,0. A076784 001 Jun 29, 2009 Apr 215MG,0.25MG

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-32

AB

TABLET; ORAL-28 TRI-ESTARYLLA SANDOZ

0.035MG,0.035MG,0.035MG;0.18MG,0. A090793 001 Jan 30, 2013 Jan 215MG,0.25MG

NEWA

ETHOTOIN TABLET; ORAL PEGANONE + RECORDATI RARE ETODOLAC TABLET; ORAL ETODOLAC @ PROSAM LABS @ ETOPOSIDE INJECTABLE; INJECTION ETOPOSIDE ACCORD HLTHCARE @ PHARMACHEMIE AP AP FAMOTIDINE INJECTABLE; INJECTION FAMOTIDINE @ APOTEX INC AP TEVA PHARMS USA

250MG

N010841 001

May

CAHN

400MG 500MG

A074819 001 Feb 28, 1997 Mar A074819 002 Apr 28, 1998 Mar

DISC DISC

AP

20MG/ML 20MG/ML 20MG/ML 20MG/ML

A074513 001 Mar 14, 1996 Apr A074227 001 Feb 22, 1996 Apr A074284 001 Feb 10, 1994 May A074529 001 Jul 24, 1996 Apr

CAHN DISC CAHN CAHN

10MG/ML

A075942 001 Aug 02, 2002 Apr A076324 001 Nov 27, 2002 Mar A076324 001 Nov 27, 2002 Apr A076322 001 Nov 27, 2002 Mar A076322 001 Nov 27, 2002 Apr N020249 001 Feb 18, 1994 Apr

DISC CAHN DISC CAHN DISC CAHN

FAMOTIDINE PRESERVATIVE FREE AKORN INC 10MG/ML @ APOTEX INC 10MG/ML FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK) AKORN INC 10MG/ML @ APOTEX INC 10MG/ML PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER @ MERCK SHARP DOHME 0.4MG/ML FENOFIBRIC ACID TABLET; ORAL FIBRICOR MUTUAL PHARM CO INC + FENOPROFEN CALCIUM TABLET; ORAL FENOPROFEN CALCIUM @ IVAX SUB TEVA PHARMS + MYLAN PHARMS INC FENTANYL CITRATE FILM; BUCCAL ONSOLIS @ MEDA PHARMS @ @ @

AP

35MG 105MG

N022418 001 Aug 14, 2009 Feb N022418 002 Aug 14, 2009 Feb

CAHN CAHN

EQ 600MG BASE EQ 600MG BASE

A072557 001 Aug 29, 1988 Mar A072267 001 Aug 17, 1988 Mar

DISC CTEC

EQ 0.2MG BASE EQ 0.4MG BASE EQ 0.6MG BASE EQ 0.8MG BASE

N022266 001 Jul 16, 2009 May N022266 002 Jul 16, 2009 May N022266 003 Jul 16, 2009 May N022266 004 Jul 16, 2009 May

DISC DISC DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-33

FILM; BUCCAL ONSOLIS @ MEDA PHARMS

EQ 1.2MG BASE

N022266 005 Jul 16, 2009 May

DISC

AB AB

TABLET; BUCCAL, SUBLINGUAL FENTORA CEPHALON EQ 0.1MG BASE EQ 0.2MG BASE @ + EQ 0.3MG BASE EQ 0.4MG BASE EQ 0.6MG BASE EQ 0.8MG BASE TABLET; SUBLINGUAL ABSTRAL GALENA BIOPHARMA

N021947 001 Sep 25, 2006 Feb N021947 002 Sep 25, 2006 Feb N021947 006 Mar 02, 2007 Feb N021947 003 Sep 25, 2006 Feb N021947 004 Sep 25, 2006 Feb N021947 005 Sep 25, 2006 Feb

CDFR CDFR CDFR CDFR CDFR CDFR

AB AB AB

EQ 0.1MG BASE EQ 0.2MG BASE EQ 0.3MG BASE

N022510 001 Jan 07, 2011 May N022510 002 Jan 07, 2011 May N022510 003 Jan 07, 2011 May N022510 004 Jan 07, 2011 May N022510 005 Jan 07, 2011 May N022510 006 Jan 07, 2011 May

CAHN CAHN CAHN CAHN CAHN CAHN

EQ 0.4MG BASE EQ 0.6MG BASE EQ 0.8MG BASE

FERUMOXSIL SUSPENSION; ORAL GASTROMARK @ AMAG PHARMS INC FINASTERIDE TABLET; ORAL FINASTERIDE ACCORD HLTHCARE HETERO LABS LTD III SUN PHARMA GLOBAL FLECAINIDE ACETATE TABLET; ORAL FLECAINIDE ACETATE @ APOTEX INC @ @ AB + ROXANE TAMBOCOR @ MEDICIS @ @ FLUCONAZOLE FOR SUSPENSION; ORAL FLUCONAZOLE @ TARO PHARM INDS @

EQ 0.175MG IRON/ML

N020410 001 Dec 06, 1996 Feb

DISC

>A> >A>

AB AB AB AB

5MG 1MG 5MG 1MG

A090121 001 Feb 23, 2010 Apr A090060 001 Jul 01, 2013 Jun A090061 001 Jun 07, 2010 Apr A090508 001 Jul 01, 2013 Jun

CAHN NEWA CAHN NEWA

50MG 100MG 150MG 150MG 50MG 100MG 150MG

A079164 001 Jul 09, 2009 Apr A079164 002 Jul 09, 2009 Apr A079164 003 Jul 09, 2009 Apr A076278 003 Jan 14, 2003 May N018830 004 Aug 23, 1988 May N018830 001 Oct 31, 1985 May N018830 003 Jun 03, 1988 May

DISC DISC DISC CRLD DISC DISC DISC

50MG/5ML 200MG/5ML

A076918 001 Dec 18, 2006 Mar A076918 002 Dec 18, 2006 Mar

DISC DISC

INJECTABLE; INJECTION FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER @ APOTEX INC 200MG/100ML (2MG/ML) @ 400MG/200ML (2MG/ML) AP FLUCONAZOLE IN SODIUM CHLORIDE 0.9% TEVA PHARMS USA 200MG/100ML (2MG/ML)

A076888 001 Mar 25, 2005 Apr A076888 002 Mar 25, 2005 Apr A076653 001 Jul 29, 2004 May

DISC DISC CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-34

AP

INJECTABLE; INJECTION FLUCONAZOLE IN SODIUM CHLORIDE 0.9% TEVA PHARMS USA 400MG/200ML (2MG/ML) FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER @ APOTEX INC 200MG/100ML (2MG/ML) @ 400MG/200ML (2MG/ML) FLUDARABINE PHOSPHATE INJECTABLE; INJECTION FLUDARABINE PHOSPHATE + FRESENIUS KABI USA TEVA PARENTERAL TEVA PHARMS USA

A076653 002 Jul 29, 2004 May A076889 001 Mar 25, 2005 Apr A076889 002 Mar 25, 2005 Apr

CAHN DISC DISC

AP AP AP AP

50MG/2ML (25MG/ML) 50MG/2ML (25MG/ML) 50MG/2ML (25MG/ML) 50MG/VIAL

A078393 001 Oct 15, 2007 Jan A076661 001 Apr 28, 2004 Jan A076661 001 Apr 28, 2004 Apr A076349 001 Aug 28, 2003 Apr

CRLD CRLD CAHN CAHN

FLUDEOXYGLUCOSE F-18 INJECTABLE; INTRAVENOUS FLUDEOXYGLUCOSE F18 HOUSTON CYCLOTRON + + UCLA BIOMEDICAL

>D> >A> >A>

20-500mCi/ML 20-500mCi/ML 20-500mCi/ML 4-40mCi/ML

A203665 001 Feb 14, 2013 Jun A203665 001 Feb 14, 2013 Jun A203665 001 Feb 14, 2013 Jan A203811 001 Jun 27, 2013 Jun

CRLD CRLD NEWA NEWA

FLUMAZENIL INJECTABLE; INJECTION FLUMAZENIL @ APOTEX INC @ @ TEVA PHARMS USA @ FLUOCINONIDE CREAM; TOPICAL LIDEX @ CNTY LINE PHARMS LIDEX-E @ CNTY LINE PHARMS GEL; TOPICAL FLUOCINONIDE + TARO LIDEX @ CNTY LINE PHARMS OINTMENT; TOPICAL FLUOCINONIDE + TARO LIDEX @ CNTY LINE PHARMS SOLUTION; TOPICAL FLUOCINONIDE ACTAVIS MID ATLANTIC + TARO LIDEX @ CNTY LINE PHARMS @ MEDICIS

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

A076755 002 Oct 12, 2004 Apr A076755 001 Oct 12, 2004 Apr A076589 002 Oct 12, 2004 Apr A076589 001 Oct 12, 2004 Apr

DISC DISC CAHN CAHN

0.05% 0.05%

N016908 002 N016908 003

Jan Jan

CAHN CAHN

AB

0.05% 0.05%

A074935 001 Jul 29, 1997 Jan N017373 001 Jan

CRLD CAHN

AB

0.05% 0.05%

A075008 001 Jun 30, 1999 Jan N016909 002 Jan

CRLD CAHN

AT AT

0.05% 0.05% 0.05% 0.05%

A071535 001 Dec 02, 1988 May A074799 001 Dec 31, 1996 Jan N018849 001 Apr 06, 1984 May N018849 001 Apr 06, 1984 Jan

CAHN CRLD CAHN DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-35

FLUOROURACIL INJECTABLE; INJECTION FLUOROURACIL + MYLAN LLC + + + + FLUOXETINE HYDROCHLORIDE CAPSULE; ORAL FLUOXETINE HYDROCHLORIDE @ CARLSBAD EQ 10MG BASE @ @ CR DOUBLE CRANE AB1 @ AB1 @ WOCKHARDT LTD @ @ EQ 20MG BASE EQ 10MG BASE EQ 10MG BASE EQ 20MG BASE EQ 20MG BASE EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE TEVA PHARMS USA

AP AP AP AP AP

500MG/10ML (50MG/ML) 1GM/20ML (50MG/ML) 500MG/10ML (50MG/ML) 2.5GM/50ML (50MG/ML) 5GM/100ML (50MG/ML)

A040743 002 Apr 26, 2007 Feb A040743 001 Apr 26, 2007 Feb A040333 001 Jan 27, 2000 May A040334 001 Feb 25, 2000 May A040334 002 Feb 25, 2000 May

CAHN CAHN CAHN CAHN CAHN

A076022 001 Jan 30, 2002 Mar A076022 002 Jan 30, 2002 Mar A076165 001 Feb 01, 2002 Apr A076165 001 Feb 01, 2002 Mar A076165 002 Feb 01, 2002 Apr A076165 002 Feb 01, 2002 Mar A078143 001 Jan 16, 2008 Feb A078143 002 Jan 16, 2008 Feb A078143 003 Jan 16, 2008 Feb

DISC DISC DISC CAHN DISC CAHN DISC DISC DISC

SOLUTION; ORAL FLUOXETINE HYDROCHLORIDE @ APOTEX INC EQ 20MG BASE/5ML FLUOXETINE HYDROCHLORIDE; OLANZAPINE CAPSULE; ORAL OLANZAPINE AND FLUOXETINE HYDROCHLORIDE TEVA PHARMS EQ 25MG BASE;EQ 3MG BASE FLUPHENAZINE DECANOATE INJECTABLE; INJECTION FLUPHENAZINE DECANOATE @ APOTEX INC

A075292 001 Feb 07, 2002 Apr

DISC

AB

A202074 001 Mar 25, 2013 Mar

NEWA

25MG/ML

A075918 001 Aug 17, 2001 Apr

DISC

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE POWDER; INHALATION BREO ELLIPTA + GLAXO GRP LTD FLUTICASONE PROPIONATE POWDER; INHALATION FLOVENT DISKUS 100 + GLAXO GRP LTD FLOVENT DISKUS 250 + GLAXO GRP LTD FLOVENT DISKUS 50 + GLAXO GRP LTD

0.1MG/INH;EQ 0.025MG BASE/INH

N204275 001 May 10, 2013 May

NEWA

0.1MG/INH 0.25MG/INH 0.05MG/INH

N020833 002 Sep 29, 2000 May N020833 003 Sep 29, 2000 May N020833 001 Sep 29, 2000 May

CAHN CAHN CAHN

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AEROSOL, METERED; INHALATION ADVAIR HFA + GLAXO GRP LTD 0.045MG/INH;EQ 0.021MG BASE/INH + 0.115MG/INH;EQ 0.021MG BASE/INH

N021254 001 Jun 08, 2006 May N021254 002 Jun 08, 2006 May

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-36

AEROSOL, METERED; INHALATION ADVAIR HFA + GLAXO GRP LTD 0.23MG/INH;EQ 0.021MG BASE/INH POWDER; INHALATION ADVAIR DISKUS 100/50 + GLAXO GRP LTD ADVAIR DISKUS 250/50 + GLAXO GRP LTD ADVAIR DISKUS 500/50 + GLAXO GRP LTD FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE; ORAL FLUVOXAMINE MALEATE ACTAVIS ELIZABETH 100MG ANCHEN PHARMS 100MG 150MG LUVOX CR JAZZ PHARMS + TABLET; ORAL FLUVOXAMINE MALEATE CARACO @ AB @ AB @ FOSINOPRIL SODIUM TABLET; ORAL FOSINOPRIL SODIUM @ WATSON LABS @ @ FOSPHENYTOIN SODIUM INJECTABLE; INJECTION FOSPHENYTOIN SODIUM AMNEAL PHARMS @ APOTEX INC @ TEVA PHARMS USA FUROSEMIDE INJECTABLE; INJECTION FUROSEMIDE @ INTL MEDICATION TABLET; ORAL FUROSEMIDE @ DAVA PHARMS INC @ @ 100MG 150MG

N021254 003 Jun 08, 2006 May

CAHN

0.1MG/INH;EQ 0.05MG BASE/INH 0.25MG/INH;EQ 0.05MG BASE/INH 0.5MG/INH;EQ 0.05MG BASE/INH

N021077 001 Aug 24, 2000 May N021077 002 Aug 24, 2000 May N021077 003 Aug 24, 2000 May

CAHN CAHN CAHN

AB AB AB AB AB

A091482 001 Apr 23, 2013 Apr A091476 001 Mar 13, 2013 Mar A091476 002 Mar 13, 2013 Mar N022033 001 Feb 28, 2008 Mar N022033 002 Feb 28, 2008 Mar

NEWA NEWA NEWA CFTG CFTG

>D> >A> >D> >A> >D> >A>

AB

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

A075900 001 Feb 23, 2006 Jun A075900 001 Feb 23, 2006 Jun A075900 002 Feb 23, 2006 Jun A075900 002 Feb 23, 2006 Jun A075900 003 Feb 23, 2006 Jun A075900 003 Feb 23, 2006 Jun

DISC DISC DISC DISC DISC DISC

10MG 20MG 40MG

A076987 001 Dec 23, 2004 Mar A076987 002 Dec 23, 2004 Mar A076987 003 Dec 23, 2004 Mar

DISC DISC DISC

AP

EQ 50MG PNENYTOIN NA/ML EQ 50MG PHENYTOIN NA/ML EQ 50MG PHENYTOIN NA/ML

A078476 001 Mar 18, 2008 May A078126 001 Aug 06, 2007 Apr A076886 001 Aug 06, 2007 May

CAHN DISC CAHN

10MG/ML

N018025 001

Jan

DISC

20MG 40MG 80MG

N018415 001 Jul 27, 1982 Feb N018415 002 Jul 27, 1982 Feb N018415 003 Nov 26, 1984 Feb

DISC DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-37

GABAPENTIN SOLUTION; ORAL GABAPENTIN TARO GABAPENTIN ENACARBIL TABLET, EXTENDED RELEASE; ORAL HORIZANT XENOPORT INC 300MG + GADOTERATE MEGLUMINE SOLUTION; INTRAVENOUS DOTAREM + GUERBET + + + GADOXETATE DISODIUM SOLUTION; INTRAVENOUS EOVIST BAYER HLTHCARE GANCICLOVIR IMPLANT; IMPLANTATION VITRASERT @ BAUSCH AND LOMB GATIFLOXACIN SOLUTION/DROPS; OPHTHALMIC GATIFLOXACIN @ APOTEX INC 0.3% GEMCITABINE HYDROCHLORIDE INJECTABLE; INJECTION GEMCITABINE HYDROCHLORIDE DR REDDYS LABS LTD EQ 2GM BASE/VIAL JIANGSU HANSOH PHARM EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL PHARMAFORCE SAGENT PHARMS EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL EQ 200MG BASE/VIAL EQ 1GM BASE/VIAL GEMFIBROZIL TABLET; ORAL GEMFIBROZIL CARACO SUN PHARM INDS INC 600MG

>A>

AA

250MG/5ML

A076672 001 Jul 03, 2013 Jun

NEWA

N022399 002 Dec 13, 2011 May N022399 001 Apr 06, 2011 May

CAHN CAHN

37.69GM/100ML (376.9MG/ML) 3.769GM/10ML (376.9MG/ML) 5.6535GM/15ML (376.9MG/ML) 7.538GM/20ML (376.9MG/ML)

N204781 001 Mar 20, 2013 Mar N204781 002 Mar 20, 2013 Mar N204781 003 Mar 20, 2013 Mar N204781 004 Mar 20, 2013 Mar

NEWA NEWA NEWA NEWA

2.72145GM/15ML (181.43MG/ML)

N022090 002 Feb 04, 2013 Feb

NEWA

4.5MG

N020569 001 Mar 04, 1996 May

DISC

A079084 001 Aug 19, 2011 Apr

DISC

AP AP AP AP AP AP AP

A202997 001 May 07, 2013 Apr A202485 001 May 07, 2013 Apr A202485 002 May 07, 2013 Apr A202031 001 May 07, 2013 Apr A202031 002 May 07, 2013 Apr A091597 001 May 07, 2013 Apr A091597 002 May 07, 2013 Apr

NEWA NEWA NEWA NEWA NEWA NEWA NEWA

>A> >D>

AB AB

600MG 600MG

A079239 001 Dec 29, 2008 Jun A079239 001 Dec 29, 2008 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-38

GENTAMICIN SULFATE OINTMENT; OPHTHALMIC GENTAMICIN SULFATE FERA PHARMS PERRIGO CO TENNESSEE

>D> >A>

AT AT

EQ 0.3% BASE EQ 0.3% BASE

A065024 001 Jul 30, 2004 Jun A065024 001 Jul 30, 2004 Jun

CAHN CAHN

>D> >A>

AT AT

SOLUTION/DROPS; OPHTHALMIC GENTAMICIN SULFATE FERA PHARMS EQ 0.3% BASE PERRIGO CO TENNESSEE GLATIRAMER ACETATE FOR SOLUTION; SUBCUTANEOUS COPAXONE @ TEVA PHARMS USA 20MG/VIAL INJECTABLE; SUBCUTANEOUS COPAXONE + TEVA PHARMS USA GLIMEPIRIDE TABLET; ORAL GLIMEPIRIDE @ COREPHARMA @ @ EQ 0.3% BASE

A065121 001 Jan 30, 2004 Jun A065121 001 Jan 30, 2004 Jun

CAHN CAHN

N020622 001 Dec 20, 1996 Apr

CAHN

20MG/ML

N020622 002 Feb 12, 2002 Apr

CAHN

1MG 2MG 4MG

A077274 001 Oct 06, 2005 Feb A077274 002 Oct 06, 2005 Feb A077274 003 Oct 06, 2005 Feb A202112 001 Apr 17, 2013 Apr A202112 002 Apr 17, 2013 Apr A202112 003 Apr 17, 2013 Apr

DISC DISC DISC NEWA NEWA NEWA

AB AB AB

INDOCO REMEDIES

1MG 2MG 4MG

GLIPIZIDE TABLET; ORAL GLIPIZIDE ACCORD HLTHCARE @ BARR LABS INC @ GLYCEROL PHENYLBUTYRATE LIQUID; ORAL RAVICTI + HYPERION THERAP INC GLYCOPYRROLATE INJECTABLE; INJECTION ROBINUL + HIKMA MAPLE TABLET; ORAL GLYCOPYRROLATE AUROLIFE PHARMA LLC @ COREPHARMA @

AB AB

5MG 10MG 5MG 10MG

A074550 001 Sep 11, 1997 Apr A074550 002 Sep 11, 1997 Apr A074619 001 Apr 04, 1997 May A074619 002 Apr 04, 1997 May

CAHN CAHN CAHN CAHN

1.1GM/ML

N203284 001 Feb 01, 2013 Feb

NEWA

AP

0.2MG/ML

N017558 001

Apr

CAHN

AA

1MG 1MG 2MG

A202675 001 Apr 15, 2013 Apr A040568 001 Dec 22, 2004 Mar A040568 002 Dec 22, 2004 Mar

NEWA DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-39

GRANISETRON HYDROCHLORIDE INJECTABLE; INJECTION GRANISETRON HYDROCHLORIDE @ APOTEX INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) @ EQ 1MG BASE/ML (EQ 1MG BASE/ML) @ @ EBEWE PHARMA AP AP AP + + + TEVA PHARMS USA EQ 4MG BASE/4ML (EQ 1MG BASE/ML) EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) EQ 1MG BASE/ML (EQ 1MG BASE/ML) EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

A078197 001 Dec 31, 2007 Apr A078198 001 Jun 30, 2008 Apr A078198 002 Jun 30, 2008 Apr A078808 001 Apr 29, 2008 Feb A078392 001 Dec 31, 2007 May A077963 001 Jan 03, 2008 May A077297 001 Jun 30, 2008 May A077165 001 Dec 31, 2007 May

DISC DISC DISC DISC CAHN CAHN CAHN CAHN

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE @ TEVA PHARMS USA EQ 1MG BASE/ML (EQ 1MG BASE/ML) GRISEOFULVIN, MICROSIZE SUSPENSION; ORAL GRIFULVIN V + VALEANT LUXEMBOURG GUANFACINE HYDROCHLORIDE TABLET; ORAL GUANFACINE HYDROCHLORIDE EPIC PHARMA EQ 1MG BASE @ EPIC PHARMA LLC @ HALOBETASOL PROPIONATE OINTMENT; TOPICAL HALOBETASOL PROPIONATE @ FOUGERA PHARMS @ G AND W LABS INC @ TARO >D> @ VENUS PHARMS HALOPERIDOL DECANOATE INJECTABLE; INJECTION HALOPERIDOL DECANOATE @ APOTEX INC @ >D> >D> >A> >A> AO AO AO AO HALOPERIDOL LACTATE INJECTABLE; INJECTION HALOPERIDOL @ APOTEX INC @ >D> >A> AP AP TEVA PARENTERAL TEVA PHARMS USA TEVA PARENTERAL TEVA PHARMS USA EQ 2MG BASE EQ 1MG BASE EQ 2MG BASE

AB

125MG/5ML

A062483 001 Jan 26, 1984 Apr

CAHN

>D> >D> >A> >A>

AB AB

A074673 001 Feb 28, 1997 Jun A074673 002 Feb 28, 1997 Jun A074673 001 Feb 28, 1997 Jun A074673 002 Feb 28, 1997 Jun

DISC DISC DISC DISC

>A>

0.05% 0.05% 0.05% 0.05%

A076903 001 Dec 16, 2004 Apr A077109 001 Jun 14, 2005 Jun A076994 001 Dec 16, 2004 Mar A077109 001 Jun 14, 2005 Jun

DISC CAHN DISC CAHN

EQ 50MG BASE/ML EQ 100MG BASE/ML EQ 50MG BASE/ML EQ 100MG BASE/ML EQ 50MG BASE/ML EQ 100MG BASE/ML

A075440 001 Feb 28, 2000 Apr A075440 002 Feb 28, 2000 Apr A075393 001 May 11, 1999 Jun A075393 002 May 11, 1999 Jun A075393 001 May 11, 1999 Jun A075393 002 May 11, 1999 Jun

DISC DISC CAHN CAHN CAHN CAHN

EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML

A076791 001 Aug 25, 2004 Apr A076828 001 Aug 25, 2004 Apr A076035 001 Aug 29, 2001 Jun A076035 001 Aug 29, 2001 Jun

DISC DISC CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-40

HYALURONIDASE INJECTABLE; INJECTION VITRASE + BAUSCH AND LOMB @ HYDRALAZINE HYDROCHLORIDE INJECTABLE; INJECTION HYDRALAZINE HYDROCHLORIDE NAVINTA LLC 20MG/ML TABLET; ORAL HYDRALAZINE HYDROCHLORIDE 10MG ACTAVIS GRP PTC 25MG 50MG 100MG ACTAVIS PHARMA 10MG 25MG 50MG 100MG ALKEM LABS LTD 10MG 25MG 50MG 100MG HETERO LABS LTD III 10MG 25MG 50MG STRIDES ARCOLAB LTD 100MG 25MG 50MG 100MG ZYDUS PHARMS USA @ AA @ AA @ AA @ HYDROCHLOROTHIAZIDE TABLET; ORAL HYDROCHLOROTHIAZIDE @ WATSON LABS 10MG 10MG 25MG 25MG 50MG 50MG 100MG 100MG

200 UNITS/VIAL 6,200 UNITS/VIAL

N021640 002 Dec 02, 2004 May N021640 001 May 05, 2004 May

CAHN CAHN

AP

A202938 001 Mar 28, 2013 Mar

NEWA

AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA AA >D> >A> >D> >A> >D> >A> >D> >A> AA

A091679 001 Mar 04, 2013 Apr A091679 002 Mar 04, 2013 Apr A091679 003 Mar 04, 2013 Apr A091679 004 Mar 04, 2013 Apr A091679 001 Mar 04, 2013 Feb A091679 002 Mar 04, 2013 Feb A091679 003 Mar 04, 2013 Feb A091679 004 Mar 04, 2013 Feb A200737 001 Dec 07, 2012 Apr A200737 002 Dec 07, 2012 Apr A200737 003 Dec 07, 2012 Apr A200737 004 Dec 07, 2012 Apr A040901 001 Sep 12, 2008 Apr A040901 002 Sep 12, 2008 Apr A040901 003 Sep 12, 2008 Apr A040901 004 Sep 12, 2008 Apr A200770 001 May 03, 2013 Apr A200770 002 May 03, 2013 Apr A200770 003 May 03, 2013 Apr A040858 001 Feb 26, 2010 Jun A040858 001 Feb 26, 2010 Jun A040858 002 Feb 26, 2010 Jun A040858 002 Feb 26, 2010 Jun A040858 003 Feb 26, 2010 Jun A040858 003 Feb 26, 2010 Jun A040858 004 Feb 26, 2010 Jun A040858 004 Feb 26, 2010 Jun

CAHN CAHN CAHN CAHN NEWA NEWA NEWA NEWA CTEC CTEC CTEC CTEC CAHN CAHN CAHN CAHN NEWA NEWA NEWA DISC DISC DISC DISC DISC DISC DISC DISC

25MG

A081189 001 Jan 24, 1992 Mar

DISC

HYDROCHLOROTHIAZIDE; IRBESARTAN TABLET; ORAL IRBESARTAN AND HYDROCHLOROTHIAZIDE AUROBINDO PHARMA LTD 12.5MG;150MG 12.5MG;300MG LUPIN LTD 12.5MG;150MG 12.5MG;300MG

AB AB AB AB

A203630 001 Feb 22, 2013 Feb A203630 002 Feb 22, 2013 Feb A201524 001 Feb 27, 2013 Feb A201524 002 Feb 27, 2013 Feb

NEWA NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-41

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET; ORAL LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE IPCA LABS LTD 12.5MG;50MG 12.5MG;100MG 25MG;100MG HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE TABLET; ORAL QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE APOTEX CORP 12.5MG;EQ 10MG BASE 12.5MG;EQ 20MG BASE 25MG;EQ 20MG BASE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET; ORAL MAXZIDE + MYLAN PHARMS INC MAXZIDE-25 MYLAN PHARMS INC

AB AB AB

A201682 001 Mar 01, 2013 Feb A201682 002 Mar 01, 2013 Feb A201682 003 Mar 01, 2013 Feb

NEWA NEWA NEWA

AB AB AB

A091524 001 Mar 12, 2013 Mar A091524 002 Mar 12, 2013 Mar A091524 003 Mar 12, 2013 Mar

NEWA NEWA NEWA

AB AB

50MG;75MG 25MG;37.5MG

N019129 001 Oct 22, 1984 May N019129 003 May 13, 1988 May A071969 001 Apr 17, 1988 Jan

CAHN CAHN DISC

TRIAMTERENE AND HYDROCHLOROTHIAZIDE @ WATSON LABS 50MG;75MG HYDROCHLOROTHIAZIDE; VALSARTAN TABLET; ORAL VALSARTAN AND HYDROCHLOROTHIAZIDE ALEMBIC LTD 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG 25MG;320MG APOTEX INC 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG 25MG;320MG AUROBINDO PHARMA LTD 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG 25MG;320MG LUPIN LTD 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG MACLEODS PHARMS LTD 25MG;320MG 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG 25MG;320MG WATSON LABS INC 12.5MG;80MG 12.5MG;160MG 12.5MG;320MG 25MG;160MG

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

A201662 001 Mar 21, 2013 Mar A201662 002 Mar 21, 2013 Mar A201662 003 Mar 21, 2013 Mar A201662 004 Mar 21, 2013 Mar A201662 005 Mar 21, 2013 Mar A203026 001 Mar 21, 2013 Mar A203026 002 Mar 21, 2013 Mar A203026 003 Mar 21, 2013 Mar A203026 004 Mar 21, 2013 Mar A203026 005 Mar 21, 2013 Mar A202519 001 Mar 21, 2013 Mar A202519 002 Mar 21, 2013 Mar A202519 003 Mar 21, 2013 Mar A202519 004 Mar 21, 2013 Mar A202519 005 Mar 21, 2013 Mar A078946 003 Mar 21, 2013 Mar A078946 004 Mar 21, 2013 Mar A078946 001 Mar 21, 2013 Mar A078946 005 Mar 21, 2013 Mar A078946 002 Mar 21, 2013 Mar A203145 001 Apr 19, 2013 Apr A203145 002 Apr 19, 2013 Apr A203145 003 Apr 19, 2013 Apr A203145 004 Apr 19, 2013 Apr A203145 005 Apr 19, 2013 Apr A091519 001 Mar 21, 2013 Mar A091519 002 Mar 21, 2013 Mar A091519 003 Mar 21, 2013 Mar A091519 004 Mar 21, 2013 Mar

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-42

AB

TABLET; ORAL VALSARTAN AND HYDROCHLOROTHIAZIDE WATSON LABS INC 25MG;320MG HYDROCODONE BITARTRATE; IBUPROFEN TABLET; ORAL HYDROCODONE BITARTRATE AND IBUPROFEN SUN PHARM INDS INC 2.5MG;200MG 5MG;200MG 7.5MG;200MG 10MG;200MG REPREXAIN AMNEAL PHARMS NY 2.5MG;200MG 10MG;200MG HYDROCORTISONE LOTION; TOPICAL STIE-CORT @ PERRIGO CO OINTMENT; TOPICAL HYDROCORTISONE @ TARO HYDROCORTISONE ACETATE PASTE; TOPICAL ORABASE HCA @ COLGATE HYDROCORTISONE VALERATE OINTMENT; TOPICAL HYDROCORTISONE VALERATE @ FOUGERA PHARMS 0.2% + TARO WESTCORT @ RANBAXY HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE; ORAL EXALGO MALLINCKRODT INC 16MG + 32MG HYDROXYUREA CAPSULE; ORAL HYDROXYUREA @ BARR LABS INC @ @ DURAMED PHARMS BARR @ HYDROXYZINE HYDROCHLORIDE TABLET; ORAL HYDROXYZINE HYDROCHLORIDE CARACO 10MG 25MG 0.2% 0.2%

A091519 005 Mar 21, 2013 Mar

NEWA

AB AB AB AB AB AB

A091633 001 May 28, 2013 May A091633 002 May 28, 2013 May A091633 003 May 28, 2013 May A091633 004 May 28, 2013 May A076642 003 Oct 19, 2007 May A076642 004 Oct 19, 2007 May

NEWA NEWA NEWA NEWA CFTG CFTG

1%

A089066 001 Nov 25, 1985 Feb

DISC

2.5%

A040310 001 Dec 29, 2000 Mar

DISC

0.5%

A083205 001

Mar

DISC

A075085 001 Jul 31, 2001 Feb A075043 001 Aug 25, 1998 Feb N018726 001 Aug 08, 1983 Feb

DISC CRLD DISC

N021217 003 Mar 01, 2010 Jan N021217 004 Aug 24, 2012 Jan

CRLD CRLD

>A> >A> >D> >D>

250MG 500MG 250MG 500MG

A075020 002 Jun 26, 2000 Jun A075020 001 Jul 30, 1998 Jun A075020 002 Jun 26, 2000 Jun A075020 001 Jul 30, 1998 Jun

CAHN CAHN CAHN CAHN

>A> >A>

AB AB

A040899 001 Jun 10, 2008 Jun A040899 002 Jun 10, 2008 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-43

>A>

AB AB AB AB

TABLET; ORAL HYDROXYZINE HYDROCHLORIDE CARACO 50MG HETERO LABS LTD III 10MG 25MG 50MG SUN PHARM INDS INC 10MG 25MG 50MG HYDROXYZINE PAMOATE CAPSULE; ORAL HYDROXYZINE PAMOATE EMCURE PHARMS USA

A040899 003 Jun 10, 2008 Jun A040805 001 May 29, 2008 Apr A040805 002 May 29, 2008 Apr A040805 003 May 29, 2008 Apr A040899 001 Jun 10, 2008 Jun A040899 002 Jun 10, 2008 Jun A040899 003 Jun 10, 2008 Jun

CAHN CAHN CAHN CAHN CAHN CAHN CAHN

>D> >D> >D>

AB AB AB

AB AB

25MG 50MG

A201507 001 Jun 03, 2013 May A201507 002 Jun 03, 2013 May

NEWA NEWA

IBUPROFEN SOLUTION; INTRAVENOUS CALDOLOR @ CUMBERLAND PHARMS IBUPROFEN LYSINE INJECTABLE; INTRAVENOUS NEOPROFEN + RECORDATI RARE

400MG/4ML (100MG/ML)

N022348 001 Jun 11, 2009 May

DISC

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

N021903 001 Apr 13, 2006 May

CAHN

>A> >A> >A> >A> >A>

ICOSAPENT ETHYL CAPSULE; ORAL VASCEPA + AMARIN PHARMS + IDARUBICIN HYDROCHLORIDE INJECTABLE; INJECTION IDARUBICIN HYDROCHLORIDE PFS TEVA PHARMS USA 1MG/ML IFOSFAMIDE INJECTABLE; INJECTION IFOSFAMIDE + TEVA PHARMS USA + IFOSFAMIDE; MESNA INJECTABLE; INTRAVENOUS IFOSFAMIDE/MESNA KIT + TEVA PHARMS USA +

1GM 1GM

N202057 001 Jul 26, 2012 Jun N202057 001 Jul 26, 2012 Jun

NEWA NEWA

AP

A065036 001 May 01, 2002 Apr

CAHN

AP AP

1GM/20ML (50MG/ML) 3GM/60ML (50MG/ML)

A076657 001 Apr 04, 2007 May A076657 002 Apr 04, 2007 May

CAHN CAHN

1GM/20ML;1GM/10ML (50MG/ML;100MG/ML) 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)

A075874 001 Feb 26, 2002 May A075874 002 Feb 26, 2002 May

CAHN CAHN

IMIPRAMINE HYDROCHLORIDE TABLET; ORAL IMIPRAMINE HYDROCHLORIDE @ PROSAM LABS 10MG @ 25MG

A040753 001 Feb 28, 2008 Mar A040752 001 Feb 28, 2008 Mar

DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-44

TABLET; ORAL IMIPRAMINE HYDROCHLORIDE @ PROSAM LABS 50MG IMIPRAMINE PAMOATE CAPSULE; ORAL IMIPRAMINE PAMOATE MYLAN PHARMS INC

A040751 001 Feb 28, 2008 Mar

DISC

>A> >A> >A> >A>

AB AB AB AB

EQ 75MG HCL EQ 100MG HCL EQ 125MG HCL EQ 150MG HCL

A202338 001 Jun 28, 2013 Jun A202338 002 Jun 28, 2013 Jun A202338 003 Jun 28, 2013 Jun A202338 004 Jun 28, 2013 Jun

NEWA NEWA NEWA NEWA

INDINAVIR SULFATE CAPSULE; ORAL CRIXIVAN MERCK SHARP DOHME @ INDOMETHACIN CAPSULE; ORAL INDOCIN @ ICEUTICA OPERATIONS @ >A> >A> AB AB AB AB >D> >D> AB AB AB AB INDOMETHACIN SODIUM INJECTABLE; INJECTION INDOCIN + RECORDATI RARE IPRATROPIUM BROMIDE SOLUTION; INHALATION IPRATROPIUM BROMIDE @ APOTEX INC @ TEVA PHARMS USA SPRAY, METERED; NASAL IPRATROPIUM BROMIDE @ APOTEX INC @ IRON SUCROSE INJECTABLE; INTRAVENOUS VENOFER LUITPOLD SUN PHARM INDS INC INDOMETHACIN CARACO HETERO LABS LTD III

>D> >A>

EQ 100MG BASE EQ 100MG BASE

N020685 006 Apr 19, 2000 Jun N020685 006 Apr 19, 2000 Jun

DISC DISC

25MG 50MG 25MG 50MG 25MG 50MG 25MG 25MG 50MG 50MG

N016059 001 N016059 002

Mar Mar

CAHN CAHN CAHN CAHN CAHN CAHN CAHN NEWA CAHN NEWA

A091401 001 Mar 28, 2013 Jun A091401 002 Mar 28, 2013 Jun A091240 001 Apr 12, 2011 Apr A091240 002 Apr 12, 2011 Apr A091401 001 Mar 28, 2013 Jun A091401 001 Mar 28, 2013 Mar A091401 002 Mar 28, 2013 Jun A091401 002 Mar 28, 2013 Mar

AP

EQ 1MG BASE/VIAL

N018878 001 Jan 30, 1985 May

CAHN

0.02% 0.02%

A075441 001 Mar 28, 2001 Apr A075313 001 Feb 07, 2000 Mar

DISC DISC

0.021MG/SPRAY 0.042MG/SPRAY

A076156 001 Apr 18, 2003 Apr A076155 001 Apr 18, 2003 Apr

DISC DISC

EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)

N021135 005 Mar 29, 2013 Mar

NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-45

ISONIAZID TABLET; ORAL ISONIAZID WATSON LABS @ ISONIAZID; RIFAMPIN CAPSULE; ORAL RIFAMATE + SANOFI AVENTIS US RIFAMPIN AND ISONIAZID @ WEST WARD PHARM CORP ISOPROTERENOL HYDROCHLORIDE INJECTABLE; INJECTION ISOPROTERENOL HYDROCHLORIDE @ INTL MEDICATION 0.2MG/ML ISUPREL + HOSPIRA ISOSORBIDE DINITRATE CAPSULE, EXTENDED RELEASE; ORAL DILATRATE-SR + ACTIENT PHARMS 40MG TABLET; ORAL ISORDIL VALEANT BERMUDA 0.2MG/ML

>D> >A>

AA

300MG 300MG

A080521 001 A080521 001

Jun Jun

DISC DISC

150MG;300MG 150MG;300MG

A061884 001

Apr

CTEC DISC

A065221 001 Jul 29, 2005 Apr

A083724 001 N010515 001

Mar Mar

DISC CTEC

N019790 001 Sep 02, 1988 May

CAHN

AB AB AB AB AB AB AB AB

5MG 10MG 20MG

N012093 007 Jul 29, 1988 Apr N012093 002 Jul 29, 1988 Apr N012093 006 Jul 29, 1988 Apr N012093 005 Jul 29, 1988 Apr N012093 001 Jul 29, 1988 Apr N012093 007 Jul 29, 1988 Mar N012093 002 Jul 29, 1988 Mar N012093 006 Jul 29, 1988 Mar N012093 005 Jul 29, 1988 Mar N012093 001 Jul 29, 1988 Mar A086923 001 Mar 12, 1987 Apr A086923 001 Mar 12, 1987 Feb A086034 001 Jan 06, 1988 Apr A086032 001 Jan 07, 1988 Apr

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CMFD DISC DISC DISC

+ + VALEANT PHARM NORTH

30MG 40MG 5MG 10MG 20MG 30MG 40MG ISOSORBIDE DINITRATE PAR PHARM @ @ WATSON LABS @ 5MG 5MG 5MG 10MG

+ +

AB

>D> >A> >D> >A> >D> >A>

AB AB AB AB

TABLET; SUBLINGUAL ISOSORBIDE DINITRATE WATSON LABS @ + @ WEST WARD + WEST WARD PHARM CORP

2.5MG 2.5MG 5MG 5MG 5MG 5MG

A086033 001 Feb 26, 1988 Jun A086033 001 Feb 26, 1988 Jun A086031 001 Sep 29, 1987 Jun A086031 001 Sep 29, 1987 Jun A086055 001 Nov 02, 1987 Jun A086055 001 Nov 02, 1987 Jun

DISC DISC DISC DISC CRLD CRLD

ISOTRETINOIN CAPSULE; ORAL ABSORICA RANBAXY

BX BX

10MG 20MG

N021951 001 May 25, 2012 Feb N021951 002 May 25, 2012 Feb

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-46

BX BX AB AB AB AB AB AB AB

CAPSULE; ORAL ABSORICA RANBAXY AMNESTEEM MYLAN PHARMS INC CLARAVIS TEVA PHARMS USA + ZENATANE DR REDDYS LABS LTD

30MG 40MG 20MG 10MG 30MG 40MG 10MG 20MG 40MG

N021951 003 May 25, 2012 Feb N021951 004 May 25, 2012 Feb A075945 002 Nov 08, 2002 Apr A076356 001 Apr 11, 2003 May A076135 003 May 11, 2006 Apr A076135 001 Apr 11, 2003 Apr A202099 001 Mar 25, 2013 Mar A202099 002 Mar 25, 2013 Mar A202099 003 Mar 25, 2013 Mar

CAHN CAHN CRLD CAHN CRLD CRLD NEWA NEWA NEWA

ISRADIPINE TABLET, EXTENDED RELEASE; ORAL DYNACIRC CR GLAXOSMITHKLINE LLC 5MG 5MG @ + @ KETOROLAC TROMETHAMINE INJECTABLE; INJECTION KETOROLAC TROMETHAMINE @ APOTEX INC @ @ @ >D> >A> >D> >A> AP @ AP @ LUITPOLD 10MG 10MG

>D> >A> >D> >A>

N020336 001 Jun 01, 1994 Jun N020336 001 Jun 01, 1994 Jun N020336 002 Jun 01, 1994 Jun N020336 002 Jun 01, 1994 Jun

DISC DISC DISC DISC

15MG/ML 30MG/ML 30MG/ML 30MG/ML 15MG/ML 15MG/ML 30MG/ML 30MG/ML

A075631 002 Jun 29, 2001 Apr A075626 001 Jul 24, 2001 Apr A077201 001 Oct 14, 2005 Apr A075631 001 Jun 29, 2001 Apr A078145 001 Jan 14, 2008 Jun A078145 001 Jan 14, 2008 Jun A078145 002 Jan 14, 2008 Jun A078145 002 Jan 14, 2008 Jun

DISC DISC DISC DISC DISC DISC DISC DISC

SOLUTION/DROPS; OPHTHALMIC ACULAR PRESERVATIVE FREE @ ALLERGAN 0.5% LABETALOL HYDROCHLORIDE INJECTABLE; INJECTION LABETALOL HYDROCHLORIDE @ APOTEX INC 5MG/ML TABLET; ORAL LABETALOL HYDROCHLORIDE + SANDOZ 200MG TRANDATE @ PROMETHEUS LABS @ LACTULOSE SOLUTION; ORAL LACTULOSE @ APOTEX INC SOLUTION; ORAL, RECTAL LACTULOSE @ APOTEX INC 100MG 200MG

N020811 001 Nov 03, 1997 May

DISC

A076051 001 Jul 05, 2002 Apr

DISC

AB

A075113 002 Aug 04, 1998 Jan N018716 001 May 24, 1985 Jan N018716 002 Aug 01, 1984 Jan

CRLD DISC DISC

10GM/15ML

A075911 001 Feb 21, 2002 Apr

DISC

10GM/15ML

A076645 001 Jul 28, 2003 Apr

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-47

LAMOTRIGINE TABLET; ORAL LAMICTAL + GLAXOSMITHKLINE LLC @

AB AB AB AB

25MG 50MG 100MG 150MG 200MG

N020241 005 Dec 27, 1994 Mar N020241 006 Dec 27, 1994 Mar N020241 001 Dec 27, 1994 Mar N020241 002 Dec 27, 1994 Mar N020241 003 Dec 27, 1994 Mar N020241 004 Dec 27, 1994 Mar A200694 001 Jun 14, 2013 Jun A200694 002 Jun 14, 2013 Jun A200694 003 Jun 14, 2013 Jun A200694 004 Jun 14, 2013 Jun

CAHN CAHN CAHN CAHN CAHN CAHN NEWA NEWA NEWA NEWA

@ >A> >A> >A> >A> AB AB AB AB TABLET, CHEWABLE; ORAL LAMICTAL CD GLAXOSMITHKLINE LLC + @ LAMOTRIGINE ALKEM LABS LTD

250MG 25MG 100MG 150MG 200MG

AB AB AB

2MG 5MG 25MG 100MG

N020764 004 Sep 08, 2000 Mar N020764 001 Aug 24, 1998 Mar N020764 002 Aug 24, 1998 Mar N020764 003 Aug 24, 1998 Mar

CAHN CAHN CAHN CAHN

AB AB AB AB AB AB >A> >A> >A> >A> >A> AB AB AB AB AB AB AB AB AB AB AB >A> >A> >A> >A> AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL LAMICTAL XR GLAXOSMITHKLINE LLC 25MG + 50MG 100MG 200MG 250MG 300MG LAMOTRIGINE DR REDDYS LABS LTD 25MG 50MG 100MG 200MG 300MG PAR PHARM 25MG 50MG 100MG 200MG 250MG 300MG WILSHIRE PHARMS INC 25MG 50MG 100MG 200MG TABLET, ORALLY DISINTEGRATING; ORAL LAMICTAL ODT GLAXOSMITHKLINE LLC 25MG + 50MG 100MG 200MG LATANOPROST SOLUTION/DROPS; OPHTHALMIC LATANOPROST @ APOTEX INC 0.005%

N022115 001 May 29, 2009 Mar N022115 002 May 29, 2009 Mar N022115 003 May 29, 2009 Mar N022115 004 May 29, 2009 Mar N022115 006 Jun 21, 2011 Mar N022115 005 Apr 14, 2010 Mar A202383 001 Jun 19, 2013 Jun A202383 002 Jun 19, 2013 Jun A202383 003 Jun 19, 2013 Jun A202383 004 Jun 19, 2013 Jun A202383 005 Jun 19, 2013 Jun A201791 001 Jan 18, 2013 Jan A201791 002 Jan 18, 2013 Jan A201791 003 Jan 18, 2013 Jan A201791 004 Jan 18, 2013 Jan A201791 005 Jan 18, 2013 Jan A201791 006 Jan 18, 2013 Jan A202887 001 Jun 17, 2013 Jun A202887 002 Jun 17, 2013 Jun A202887 003 Jun 17, 2013 Jun A202887 004 Jun 17, 2013 Jun

CAHN CAHN CAHN CAHN CAHN CAHN NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

N022251 001 May 08, 2009 Mar N022251 002 May 08, 2009 Mar N022251 003 May 08, 2009 Mar N022251 004 May 08, 2009 Mar

CAHN CAHN CAHN CAHN

A077697 001 Mar 22, 2011 Apr

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-48

AT

SOLUTION/DROPS; OPHTHALMIC LATANOPROST DR REDDYS LABS LTD 0.005% LENALIDOMIDE CAPSULE; ORAL REVLIMID CELGENE LEPIRUDIN RECOMBINANT INJECTABLE; INJECTION REFLUDAN + BAYER HLTHCARE @ LETROZOLE TABLET; ORAL LETROZOLE JIANGSU HENGRUI MED LEUCOVORIN CALCIUM INJECTABLE; INJECTION LEUCOVORIN CALCIUM TEVA PHARMS USA

A202077 001 Feb 11, 2013 Jan

NEWA

>A> >D> >D> >D> >D> >A>

20MG

N021880 006 Jun 05, 2013 Jun

NEWA

50MG/VIAL 50MG/VIAL

N020807 001 Mar 06, 1998 Jun N020807 001 Mar 06, 1998 Jun

DISC DISC

AB

2.5MG

A202716 001 May 16, 2013 Apr

NEWA

AP AP >D> >A> AP

EQ 100MG BASE/VIAL EQ 350MG BASE/VIAL

A081277 001 Sep 28, 1993 Mar A040174 001 Jun 12, 1997 Mar A040338 001 Jan 31, 2001 Jun A040338 001 Jan 31, 2001 Jun

CAHN CAHN DISC DISC

LEUCOVORIN CALCIUM PRESERVATIVE FREE LUITPOLD EQ 50MG BASE/VIAL @ LEUPROLIDE ACETATE INJECTABLE; INJECTION LEUPROLIDE ACETATE TEVA PHARMS USA LUPRON DEPOT + ABBVIE ENDOCRINE INC LEVALBUTEROL HYDROCHLORIDE SOLUTION; INHALATION LEVALBUTEROL HYDROCHLORIDE DEY EQ 0.0103% BASE EQ 0.021% BASE EQ 0.042% BASE TEVA PHARMS USA EQ 0.0103% BASE EQ 0.021% BASE EQ 0.042% BASE LEVETIRACETAM INJECTABLE; IV (INFUSION) LEVETIRACETAM SAGENT PHARMS 500MG/5ML (100MG/ML) SOLUTION; ORAL LEVETIRACETAM @ APOTEX INC HETERO DRUGS LTD HETERO LABS LTD III EQ 50MG BASE/VIAL

AP

1MG/0.2ML 3.75MG/VIAL

A075471 001 Oct 25, 2000 Mar N020011 001 Oct 22, 1990 Apr

CAHN CAHN

AN AN AN AN AN AN

A077800 001 Mar 15, 2013 Mar A077800 002 Mar 15, 2013 Mar A077800 003 Mar 15, 2013 Mar A090297 001 Apr 26, 2013 Apr A090297 002 Apr 26, 2013 Apr A090297 003 Apr 26, 2013 Apr

NEWA NEWA NEWA NEWA NEWA NEWA

>A>

AP

A091627 001 Jun 26, 2013 Jun

NEWA

AA AA

100MG/ML 100MG/ML 100MG/ML

A090187 001 Aug 05, 2011 Apr A203052 001 Feb 28, 2013 Feb A203052 001 Feb 28, 2013 Apr

DISC NEWA CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-49

AA

SOLUTION; ORAL LEVETIRACETAM ORIT LABS LLC TABLET; ORAL LEVETIRACETAM HETERO LABS LTD III

100MG/ML

A203067 001 May 09, 2013 Apr

NEWA

AB AB AB AB AB AB AB AB

250MG 500MG 750MG 1GM

A090515 001 Oct 08, 2010 Apr A090515 002 Oct 08, 2010 Apr A090515 003 Oct 08, 2010 Apr A090515 004 Oct 08, 2010 Apr A078106 001 Feb 10, 2009 Apr A078106 002 Feb 10, 2009 Apr A078106 003 Feb 10, 2009 Apr A078106 004 Feb 10, 2009 Apr

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN

PRINSTON INC

250MG 500MG 750MG 1GM

TABLET, EXTENDED RELEASE; ORAL LEVETIRACETAM @ SANDOZ 500MG @ AB AB LEVOBUNOLOL HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC LEVOBUNOLOL HYDROCHLORIDE @ APOTEX INC 0.25% @ LEVOCARNITINE INJECTABLE; INJECTION LEVOCARNITINE TEVA PHARMS USA 0.5% VINTAGE PHARMS LLC 750MG 500MG 750MG

A091668 001 Nov 01, 2012 Mar A091668 002 Nov 01, 2012 Mar A202533 001 Jul 20, 2012 Jan A202533 002 Jul 20, 2012 Jan

DISC DISC NEWA NEWA

A075473 001 Aug 03, 2000 Apr A075475 001 Aug 03, 2000 Apr

DISC DISC

AP

200MG/ML

A075881 001 Mar 29, 2001 May

CAHN

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET; ORAL LEVOCETIRIZINE DIHYDROCHLORIDE SANDOZ 5MG SUN PHARMA GLOBAL LEVOFLOXACIN INJECTABLE; INJECTION LEVOFLOXACIN AUROBINDO PHARMA LTD CLARIS LIFESCIENCES EMCURE PHARMS LTD 5MG

AB AB

A090486 001 Mar 26, 2013 Mar A090362 001 Jan 31, 2013 Jan

NEWA NEWA

AP AP AP AP AP >A> >A> >A> AP AP AP

EQ 500MG/20ML (EQ 25MG/ML) EQ 750MG/30ML (EQ 25MG/ML) EQ 500MG/20ML (EQ 25MG/ML) EQ 500MG/20ML (EQ 25MG/ML) EQ 750MG/30ML (EQ 25MG/ML)

A202328 001 Jan 24, 2013 Jan A202328 002 Jan 24, 2013 Jan A091436 001 Jun 05, 2013 May A202590 001 Jan 24, 2013 Jan A202590 002 Jan 24, 2013 Jan A200674 001 Jun 19, 2013 Jun A200674 002 Jun 19, 2013 Jun A200674 003 Jun 19, 2013 Jun

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER FRESENIUS KABI USA EQ 250MG/50ML (EQ 5MG/ML) EQ 500MG/100ML (EQ 5MG/ML) EQ 750MG/150ML (EQ 5MG/ML) SOLUTION/DROPS; OPHTHALMIC LEVOFLOXACIN @ APOTEX INC 0.5%

A078282 001 Dec 20, 2010 Apr

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-50

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE INJECTABLE; INJECTION ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN NOVOCOL 0.05MG/ML;2% @ 0.05MG/ML;2% SCANDONEST L DEPROCO + LEVONORGESTREL INTRAUTERINE DEVICE; INTRAUTERINE SKYLA + BAYER HLTHCARE 13.5MG TABLET; ORAL LEVONORGESTREL LUPIN LTD NOVEL LABS INC + PLAN B ONE-STEP TEVA BRANDED PHARM 0.05MG/ML;2% 0.05MG/ML;2%

>D> >D> >A> >D> >A>

AP

A084697 001 A084697 001

Jun Jun

DISC DISC CRLD CRLD

AP

A088388 001 Oct 10, 1984 Jun A088388 001 Oct 10, 1984 Jun

N203159 001 Jan 09, 2013 Jan

NEWA

AB AB AB

0.75MG 1.5MG 1.5MG

A091328 001 Jan 23, 2013 Jan A202508 001 Feb 22, 2013 Feb N021998 001 Jul 10, 2009 Apr

NEWA NEWA CAHN

LEVOTHYROXINE SODIUM** **Refer to Annual Edition Preface Section 1.8 Levothyroxine Sodium for amplifying information TABLET; ORAL LEVOXYL AB1, KING PHARMS R AND D AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, AB3 AB1, + AB3 @ LIDOCAINE HYDROCHLORIDE INJECTABLE; INJECTION LIDOCAINE HYDROCHLORIDE @ LUITPOLD 2% AP AP AP AP LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE AUROBINDO PHARMA LTD 1% 1% 2% 2%

0.025MG 0.05MG 0.075MG 0.088MG 0.1MG 0.112MG 0.125MG 0.137MG 0.15MG 0.175MG 0.2MG 0.3MG

N021301 001 May 25, 2001 Mar N021301 002 May 25, 2001 Mar N021301 003 May 25, 2001 Mar N021301 004 May 25, 2001 Mar N021301 005 May 25, 2001 Mar N021301 006 May 25, 2001 Mar N021301 007 May 25, 2001 Mar N021301 008 May 25, 2001 Mar N021301 009 May 25, 2001 Mar N021301 010 May 25, 2001 Mar N021301 011 May 25, 2001 Mar N021301 012 May 25, 2001 Mar

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN

A083198 001

Mar

DISC NEWA NEWA NEWA NEWA

A203040 001 Mar 14, 2013 Mar A203082 001 Mar 14, 2013 Mar A203040 002 Mar 14, 2013 Mar A203082 002 Mar 14, 2013 Mar

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-51

JELLY; TOPICAL ANESTACON @ POLYMEDICA >D> >A> AT

2%

A080429 001

May

DISC DISC DISC

LIDOCAINE HYDROCHLORIDE TEVA PHARMS 2% @ TEVA PHARMS USA 2% LIOTHYRONINE SODIUM TABLET; ORAL CYTOMEL KING PHARMS R AND D + LISINOPRIL TABLET; ORAL LISINOPRIL @ SANDOZ @ @ @ @ @ LITHIUM CARBONATE CAPSULE; ORAL LITHIUM CARBONATE @ APOTEX INC

A081318 001 Apr 29, 1993 Jun A081318 001 Apr 29, 1993 Jun

AB AB AB

EQ 0.005MG BASE EQ 0.025MG BASE EQ 0.05MG BASE

N010379 001 N010379 002 N010379 003

Mar Mar Mar

CAHN CAHN CAHN

2.5MG 5MG 10MG 20MG 30MG 40MG

A075999 001 Jul 01, 2002 Jan A075999 002 Jul 01, 2002 Jan A075999 003 Jul 01, 2002 Jan A075999 004 Jul 01, 2002 Jan A075999 005 Jul 01, 2002 Jan A075999 006 Jul 01, 2002 Jan

CAHN CAHN CAHN CAHN CAHN CAHN

300MG 150MG 300MG 600MG

A076795 001 Nov 22, 2004 Feb A090702 001 Sep 25, 2009 Apr A090702 002 Sep 25, 2009 Apr A090702 003 Sep 25, 2009 Apr

DISC CAHN CAHN CAHN

AB AB AB

HETERO LABS LTD III

LOMUSTINE CAPSULE; ORAL CEENU CORDEN PHARMA + LORAZEPAM CONCENTRATE; ORAL LORAZEPAM LUPIN LTD TABLET; ORAL LORAZEPAM @ SANDOZ @ @ LOSARTAN POTASSIUM TABLET; ORAL LOSARTAN POTASSIUM ACTAVIS GRP PTC

10MG 40MG 100MG

N017588 001 N017588 002 N017588 003

Apr Apr Apr

CAHN CAHN CAHN

AA

2MG/ML

A091407 001 Feb 19, 2013 Feb

NEWA

0.5MG 1MG 2MG

A071193 001 Apr 15, 1988 Apr A071194 001 Apr 15, 1988 Apr A071195 001 Apr 15, 1988 Apr

DISC DISC DISC

AB AB AB

25MG 50MG 100MG

A090382 001 Oct 06, 2010 Mar A090382 002 Oct 06, 2010 Mar A090382 003 Oct 06, 2010 Mar

CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-52

LOVASTATIN TABLET; ORAL LOVASTATIN + CARLSBAD MEVACOR @ MERCK @ LOXAPINE SUCCINATE CAPSULE; ORAL LOXAPINE SUCCINATE MIKAH PHARMA

AB

40MG 20MG 40MG

A075991 003 Jun 05, 2002 Feb N019643 003 Aug 31, 1987 Feb N019643 004 Dec 14, 1988 Feb

CRLD DISC DISC

AB AB AB AB

EQ 5MG BASE EQ 10MG BASE EQ 25MG BASE EQ 50MG BASE

A076868 001 Aug 04, 2005 May A076868 002 Aug 04, 2005 May A076868 003 Aug 04, 2005 May A076868 004 Aug 04, 2005 May

CMFD CMFD CMFD CMFD

MAFENIDE ACETATE CREAM; TOPICAL SULFAMYLON + MYLAN INSTITUTIONAL FOR SOLUTION; TOPICAL MAFENIDE ACETATE PAR FORM SULFAMYLON + MYLAN INSTITUTIONAL + MYLAN LLC

EQ 85MG BASE/GM

N016763 001

May

CAHN

AB AB AB

5% 5% 5%

A201511 001 Feb 12, 2013 Jan N019832 003 Jun 05, 1998 May N019832 003 Jun 05, 1998 Jan

NEWA CAHN CFTG

MAGNESIUM SULFATE, POTASSIUM SULFATE, SODIUM SULFATE; POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE SOLUTION, FOR SOLUTION;ORAL, ORAL SUCLEAR + BRAINTREE LABS 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N N203595 001 Jan 18, 2013 Jan /A,N/A,N/A,N/A;N/A,N/A,N/A,210GM, 0.74GM,2.86GM,5.6GM MANNITOL INJECTABLE; INJECTION MANNITOL 20% @ B BRAUN MECAMYLAMINE HYDROCHLORIDE TABLET; ORAL MECAMYLAMINE HYDROCHLORIDE NEXGEN PHARMA 2.5MG MECHLORETHAMINE HYDROCHLORIDE INJECTABLE; INJECTION MUSTARGEN + RECORDATI RARE MEDROXYPROGESTERONE ACETATE INJECTABLE; INJECTION MEDROXYPROGESTERONE ACETATE TEVA PHARMS USA 150MG/ML @ 150MG/ML

NEWA

20GM/100ML

N014738 001

Jan

DISC

A204054 001 Mar 19, 2013 Mar

NEWA

10MG/VIAL

N006695 001

May

CAHN

AB

A076553 001 Jul 28, 2004 May A076552 001 Oct 27, 2004 May

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-53

MEFENAMIC ACID CAPSULE; ORAL MEFENAMIC ACID CYPRESS PHARM MEFLOQUINE HYDROCHLORIDE TABLET; ORAL MEFLOQUINE HYDROCHLORIDE WEST WARD 250MG @ WEST WARD PHARM CORP MEGESTROL ACETATE SUSPENSION; ORAL MEGESTROL ACETATE @ APOTEX INC MELOXICAM TABLET; ORAL MELOXICAM @ COREPHARMA @ @ CR DOUBLE CRANE AB @ AB MEPROBAMATE TABLET; ORAL MEPROBAMATE @ TARO @ MESALAMINE CAPSULE, DELAYED RELEASE; ORAL DELZICOL + WARNER CHILCOTT LLC 400MG SUPPOSITORY; RECTAL CANASA + APTALIS PHARMA US MESNA INJECTABLE; INTRAVENOUS MESNA TEVA PHARMS USA METAPROTERENOL SULFATE SOLUTION; INHALATION METAPROTERENOL SULFATE @ APOTEX INC @ SYRUP; ORAL METAPROTERENOL SULFATE @ APOTEX INC @ NOVEX 250MG

AB

250MG

A090359 001 Feb 05, 2013 Jan

NEWA

>D> >A>

AB

A077699 001 Apr 21, 2010 Jun A077699 001 Apr 21, 2010 Jun

DISC DISC

40MG/ML

A077404 001 Feb 16, 2006 Apr

DISC

7.5MG 15MG 7.5MG 7.5MG 15MG 15MG

A077930 001 Jul 19, 2006 Feb A077930 002 Jul 19, 2006 Feb A078039 001 Dec 14, 2006 Apr A078039 001 Dec 14, 2006 Mar A078039 002 Dec 14, 2006 Apr A078039 002 Dec 14, 2006 Mar

DISC DISC DISC CAHN DISC CAHN

200MG 400MG

A200998 001 May 23, 2011 Jan A200998 002 May 23, 2011 Jan

DISC DISC

N204412 001 Feb 01, 2013 Feb

NEWA

1GM

N021252 002 Nov 05, 2004 Feb

CRLD

AP

100MG/ML

A075764 001 Apr 27, 2001 May

CAHN

0.4% 0.6%

A075402 001 Feb 28, 2001 Apr A075403 001 Feb 28, 2001 Apr

DISC DISC

10MG/5ML 10MG/5ML

A075235 001 Jan 27, 2000 Apr A075235 001 Jan 27, 2000 Feb

DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-54

SYRUP; ORAL METAPROTERENOL SULFATE + SILARX TABLET; ORAL METAPROTERENOL SULFATE PAR PHARM + @ WATSON LABS @ METAXALONE TABLET; ORAL METAXALONE AMNEAL PHARMS METFORMIN HYDROCHLORIDE

10MG/5ML

A073632 001 Jul 22, 1992 Feb

CTEC

10MG 20MG 10MG 20MG

A072024 001 Jun 28, 1988 Mar A072025 001 Jun 28, 1988 Mar A073013 001 Jan 31, 1991 Mar A072795 001 Jan 31, 1991 Mar

CTEC CTEC DISC DISC

>A>

AB

800MG

A203399 001 Jun 21, 2013 Jun

NEWA

AB AB

TABLET; ORAL METFORMIN HYDROCHLORIDE SANDOZ 500MG @ 500MG 850MG @ 850MG 1GM 1GM

A075965 001 Jan 25, 2002 May A075965 001 Jan 25, 2002 Mar A075965 002 Jan 25, 2002 May A075965 002 Jan 25, 2002 Mar A075965 003 Jan 25, 2002 May A075965 003 Jan 25, 2002 Mar

CMFD DISC CMFD DISC CMFD DISC

AB @

>D> >A>

AB

TABLET, EXTENDED RELEASE; ORAL METFORMIN HYDROCHLORIDE TORRENT PHARMS 750MG @ TORRENT PHARMS LTD @ WATSON LABS INC 750MG 500MG

A079226 001 Feb 18, 2010 Jun A079226 001 Feb 18, 2010 Jun A076818 001 Dec 14, 2004 Mar

DISC DISC DISC

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET; ORAL PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE AUROBINDO PHARMA LTD 500MG;EQ 15MG BASE 850MG;EQ 15MG BASE SANDOZ TORRENT PHARMS LTD 500MG;EQ 15MG BASE 850MG;EQ 15MG BASE 500MG;EQ 15MG BASE 850MG;EQ 15MG BASE METHADONE HYDROCHLORIDE TABLET, FOR SUSPENSION; ORAL METHADONE HYDROCHLORIDE MALLINCKRODT INC 40MG + ROXANE SANDOZ METHADOSE MALLINCKRODT 40MG 40MG 40MG

AB AB AB AB AB AB

A200823 001 Feb 13, 2013 Jan A200823 002 Feb 13, 2013 Jan A091273 001 Apr 16, 2013 Apr A091273 002 Apr 16, 2013 Apr A202001 001 Feb 13, 2013 Jan A202001 002 Feb 13, 2013 Jan

NEWA NEWA NEWA NEWA NEWA NEWA

AA AA AA AA

A077142 001 Jul 12, 2005 Mar N017058 001 Mar A075082 001 Mar 25, 1998 Mar A074184 001 Apr 29, 1993 Mar

CDFR CDFR CDFR CDFR

METHAMPHETAMINE HYDROCHLORIDE TABLET; ORAL DESOXYN + RECORDATI RARE

AA

5MG

N005378 002

May

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-55

METHOCARBAMOL TABLET; ORAL METHOCARBAMOL AUSTARPHARMA LLC @ @ AA AA AA AA @ SOLCO HLTHCARE METHOXSALEN CAPSULE; ORAL OXSORALEN-ULTRA + DOW PHARM METHYCLOTHIAZIDE TABLET; ORAL METHYCLOTHIAZIDE + MYLAN PHARMS INC @ WATSON LABS >D> >D> >D> >D> >A> PRINSTON INC HETERO LABS LTD III

AA AA

500MG 500MG 750MG 750MG 500MG 750MG 500MG 750MG 500MG

A200958 001 Oct 21, 2011 May A200958 001 Oct 21, 2011 Jan A200958 002 Oct 21, 2011 May A200958 002 Oct 21, 2011 Jan A090200 001 Nov 06, 2009 Apr A090200 002 Nov 06, 2009 Apr A086989 001 A086988 001 A086989 001 Feb Feb Jan

CMFD DISC CMFD DISC CAHN CAHN CMFD CAHN DISC

10MG

N019600 001 Oct 30, 1986 Apr

CAHN

5MG 5MG

A087672 001 Aug 17, 1982 Jan A088724 001 Sep 06, 1984 Jan

CTEC DISC

METHYL AMINOLEVULINATE HYDROCHLORIDE CREAM; TOPICAL METVIXIA + GALDERMA LABS LP @ METHYLDOPA TABLET; ORAL METHYLDOPA @ ACCORD HLTHCARE AB AB

EQ 16.8% BASE EQ 16.8% BASE

N021415 001 Jul 27, 2004 Jun N021415 001 Jul 27, 2004 Jun

DISC DISC

125MG 250MG 500MG

A070070 003 Oct 15, 1985 Apr A070084 001 Oct 15, 1985 Apr A070085 001 Oct 15, 1985 Apr

CAHN CAHN CAHN

METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL METHYLPHENIDATE HYDROCHLORIDE WATSON LABS INC 20MG 30MG 40MG TABLET; ORAL METHYLPHENIDATE HYDROCHLORIDE CARACO 5MG 10MG 20MG TABLET, EXTENDED RELEASE; ORAL CONCERTA JANSSEN PHARMS 18MG AB METHYLIN ER MALLINCKRODT INC 18MG 10MG

AB1 AB1 AB1

A078458 001 Dec 01, 2011 Apr A078458 002 Dec 01, 2011 Apr A078458 003 Dec 01, 2011 Apr

CAHN CAHN CAHN

AB AB AB

A090710 001 Mar 15, 2012 May A090710 002 Mar 15, 2012 May A090710 003 Mar 15, 2012 May

CAHN CAHN CAHN

>D> >A>

N021121 001 Aug 01, 2000 Jun N021121 001 Aug 01, 2000 Jun A075629 001 May 09, 2000 Feb

CTEC CTEC CTEC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-56

>A> >A>

AB AB

TABLET, EXTENDED RELEASE; ORAL METHYLPHENIDATE HYDROCHLORIDE KUDCO IRELAND 18MG 27MG METHYLPREDNISOLONE ACETATE INJECTABLE; INJECTION METHYLPREDNISOLONE ACETATE TEVA PHARMS USA 40MG/ML 40MG/ML 80MG/ML 80MG/ML METOCLOPRAMIDE HYDROCHLORIDE INJECTABLE; INJECTION METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE/ML BD RX @ TEVA PARENTERAL @ TEVA PHARMS USA METOLAZONE TABLET; ORAL METOLAZONE @ TEVA EQ 5MG BASE/ML EQ 5MG BASE/ML

A091695 001 Jul 09, 2013 Jun A091695 002 Jul 09, 2013 Jun

NEWA NEWA

AB AB AB AB

A040557 001 Feb 23, 2005 May A040620 001 Oct 27, 2006 May A040557 002 Feb 23, 2005 May A040620 002 Oct 27, 2006 May

CAHN CAHN CAHN CAHN

AP

A091392 001 Apr 19, 2013 Apr A073135 001 Nov 27, 1991 Feb A073135 001 Nov 27, 1991 May

NEWA DISC CAHN

2.5MG 5MG 5MG 10MG

A076600 001 Jan 06, 2004 Mar A076833 001 Mar 01, 2004 Jun A076833 001 Mar 01, 2004 Jun A075543 003 Dec 24, 2003 May

DISC DISC DISC DISC

>D> >A>

AB @ @ METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE; ORAL METOPROLOL SUCCINATE @ NESHER PHARMS EQ 25MG TARTRATE @ METOPROLOL TARTRATE INJECTABLE; INJECTION METOPROLOL TARTRATE CLARIS LIFESCIENCES @ WATSON LABS TABLET; ORAL METOPROLOL TARTRATE ALEMBIC PHARMS LTD EQ 50MG TARTRATE

A077779 001 Mar 20, 2008 Feb A077176 001 May 14, 2008 May

DISC DISC

AP

1MG/ML 1MG/ML

A078950 001 Apr 29, 2013 Apr A074032 001 Dec 21, 1993 Mar

NEWA DISC

AB AB AB

25MG 50MG 100MG

A202871 001 May 28, 2013 May A202871 002 May 28, 2013 May A202871 003 May 28, 2013 May A074453 001 Apr 27, 1995 Mar A074453 002 Apr 27, 1995 Mar

NEWA NEWA NEWA CAHN CAHN

@ PRINSTON INC @ METRONIDAZOLE TABLET; ORAL METRONIDAZOLE TEVA PHARMS USA

50MG 100MG

AB

250MG

A070027 001 Nov 06, 1984 Mar

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-57

METYROSINE CAPSULE; ORAL DEMSER + ATON PHARMA VPNA + BIOVAIL TECHNOLOGIES MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HYDROCHLORIDE @ APOTEX INC EQ 1MG BASE/ML @ @ CLARIS LIFESCIENCES @ >D> >A> >D> >A> AP @ AP @ @ INTL MEDICATION @ INTL MEDICATED EQ 5MG BASE/ML EQ 1MG BASE/ML EQ 5MG BASE/ML EQ 1MG BASE/ML EQ 1MG BASE/ML EQ 5MG BASE/ML EQ 5MG BASE/ML EQ 1MG BASE/ML EQ 5MG BASE/ML

>A> >D>

250MG 250MG

N017871 001 N017871 001

Jun Jun

CAHN CAHN

A075637 001 Oct 31, 2000 Apr A075637 002 Oct 31, 2000 Apr A075637 001 Oct 31, 2000 Jan A075637 002 Oct 31, 2000 Jan A076144 001 Jan 26, 2005 Jun A076144 001 Jan 26, 2005 Jun A076144 002 Jan 26, 2005 Jun A076144 002 Jan 26, 2005 Jun A076020 001 Jul 16, 2004 May A076020 002 Jul 16, 2004 May

DISC DISC DISC DISC DISC DISC DISC DISC DISC DISC

SYRUP; ORAL MIDAZOLAM HYDROCHLORIDE @ APOTEX INC EQ 2MG BASE/ML MILRINONE LACTATE INJECTABLE; INJECTION MILRINONE LACTATE @ APOTEX INC

A077115 001 Sep 09, 2005 Apr

DISC

EQ 1MG BASE/ML

A076427 001 Sep 21, 2004 Apr A077151 001 Jul 20, 2005 Apr

DISC DISC

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER @ APOTEX INC EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL MINOCYCLINE HYDROCHLORIDE CARACO EQ 50MG BASE EQ 75MG BASE EQ 100MG BASE CAPSULE, EXTENDED RELEASE; ORAL XIMINO @ RANBAXY LABS LTD EQ 45MG BASE @ @ @ @ EQ 67.5MG BASE EQ 90MG BASE EQ 112.5MG BASE EQ 135MG BASE

AB AB AB

A090867 001 May 13, 2013 Apr A090867 002 May 13, 2013 Apr A090867 003 May 13, 2013 Apr

NEWA NEWA NEWA

N201922 001 Jul 11, 2012 May N201922 002 Jul 11, 2012 May N201922 003 Jul 11, 2012 May N201922 004 Jul 11, 2012 May N201922 005 Jul 11, 2012 May

DISC DISC DISC DISC DISC

TABLET, EXTENDED RELEASE; ORAL SOLODYN @ MEDICIS EQ 45MG BASE + + @ MIPOMERSEN SODIUM SOLUTION; SUBCUTANEOUS KYNAMRO + GENZYME CORP EQ 55MG BASE EQ 80MG BASE EQ 135MG BASE

N050808 001 May 08, 2006 Apr N050808 008 Aug 27, 2010 Apr N050808 007 Aug 27, 2010 Apr N050808 003 May 08, 2006 Apr

DISC CRLD CRLD DISC

200MG/ML (200MG/ML)

N203568 001 Jan 29, 2013 Jan

NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-58

MIRTAZAPINE TABLET, ORALLY DISINTEGRATING; ORAL MIRTAZAPINE ACTAVIS ELIZABETH 15MG @ 15MG 30MG @ AB @ MITOXANTRONE HYDROCHLORIDE INJECTABLE; INJECTION MITOXANTRONE HYDROCHLORIDE ONCO THERAPIES LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) TEVA PHARMS USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) EQ 30MG BASE/15ML (EQ 2MG BASE/ML) MOMETASONE FUROATE CREAM; TOPICAL ELOCON MERCK SHARP DOHME OINTMENT; TOPICAL MOMETASONE FUROATE @ TARO MORPHINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL KADIAN WATSON LABS INC 10MG + + AB1 AB1 AB1 AB1 AB1 AB1 + 10MG 20MG 30MG 40MG 50MG 60MG 70MG 80MG 100MG 130MG 150MG AB1 + + AB1 AB1 AB1 AB1 AB1 AB1 AB1 AB1 UPSHER SMITH MORPHINE SULFATE PAR PHARM INC 200MG 200MG 20MG 30MG 50MG 60MG 80MG 100MG 10MG 20MG 30MG 45MG 45MG

>D> >A> >D> >A> >D> >A>

AB AB

A077959 001 Feb 14, 2011 Jun A077959 001 Feb 14, 2011 Jun A077959 002 Feb 14, 2011 Jun A077959 002 Feb 14, 2011 Jun A077959 003 Feb 14, 2011 Jun A077959 003 Feb 14, 2011 Jun

DISC DISC DISC DISC DISC DISC

AP AP AP AP

A201014 001 Dec 11, 2012 Mar A077356 001 Apr 11, 2006 May A077356 002 Apr 11, 2006 May A077356 003 Apr 11, 2006 May

CAIN CAHN CAHN CAHN

AB

0.1%

N019625 002 Apr 19, 2013 Apr

NEWA

0.1%

A076624 001 Dec 03, 2004 May

DISC

AB1

N020616 008 Apr 20, 2007 May N020616 008 Apr 20, 2007 Apr N020616 001 Jul 03, 1996 Apr N020616 004 Mar 09, 2001 Apr N020616 009 Jul 09, 2012 Apr N020616 002 Jul 03, 1996 Apr N020616 005 Mar 09, 2001 Apr N020616 010 Jul 09, 2012 Apr N020616 006 Oct 27, 2006 Apr N020616 003 Jul 03, 1996 Apr N020616 011 Jul 09, 2012 Apr N020616 012 Jul 09, 2012 Apr N020616 007 Feb 27, 2007 May N020616 007 Feb 27, 2007 Apr A200812 001 Nov 10, 2011 Apr A200812 002 Nov 10, 2011 Apr A200812 003 Nov 10, 2011 Apr A200812 004 Nov 10, 2011 Apr A200812 005 Nov 10, 2011 Apr A200812 006 Nov 10, 2011 Apr A202104 001 Jun 03, 2013 May A202104 002 Jun 03, 2013 May

CTEC CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CTEC CAHN CTEC CTEC CTEC CTEC CTEC CTEC NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-59

AB1 AB1 AB1 AB1 AB1

CAPSULE, EXTENDED RELEASE; ORAL MORPHINE SULFATE UPSHER SMITH 30MG 50MG 60MG 80MG 100MG MUPIROCIN CALCIUM CREAM; TOPICAL BACTROBAN + GLAXOSMITHKLINE MUPIROCIN GLENMARK GENERICS MYCOPHENOLATE MOFETIL CAPSULE; ORAL MYCOPHENOLATE MOFETIL ACCORD HLTHCARE ALKEM LABS LTD NABUMETONE TABLET; ORAL NABUMETONE @ DR REDDYS LABS LTD @ @ PROSAM LABS @ NAFTIFINE HYDROCHLORIDE GEL; TOPICAL NAFTIN + MERZ PHARMS NALTREXONE HYDROCHLORIDE TABLET; ORAL NALTREXONE HYDROCHLORIDE @ SANDOZ 50MG NAPROXEN TABLET; ORAL NAPROXEN WEST WARD PHARM CORP

A202104 003 Jun 03, 2013 May A202104 004 Jun 03, 2013 May A202104 005 Jun 03, 2013 May A202104 006 Jun 03, 2013 May A202104 007 Jun 03, 2013 May

NEWA NEWA NEWA NEWA NEWA

AB AB

EQ 2% BASE EQ 2% BASE

N050746 001 Dec 11, 1997 Jan A201587 001 Jan 24, 2013 Jan

CFTG NEWA

>A>

AB AB

250MG 250MG

A090253 001 May 04, 2009 Apr A200197 001 Jun 13, 2013 Jun

CAHN NEWA

500MG 750MG 500MG 750MG

A078420 001 Sep 24, 2008 Apr A078420 002 Sep 24, 2008 Apr A079093 001 Feb 27, 2009 Mar A079093 002 Feb 27, 2009 Mar

DISC DISC DISC DISC

>A>

2%

N204286 001 Jun 27, 2013 Jun

NEWA

A075434 001 Mar 08, 2000 Apr

DISC

AB AB AB

250MG 375MG 500MG

A076494 001 Jan 14, 2004 Apr A076494 002 Jan 14, 2004 Apr A076494 003 Jan 14, 2004 Apr

CAHN CAHN CAHN

NARATRIPTAN HYDROCHLORIDE TABLET; ORAL AMERGE GLAXOSMITHKLINE LLC +

AB AB

EQ 1MG BASE EQ 2.5MG BASE

N020763 002 Feb 10, 1998 Mar N020763 001 Feb 10, 1998 Mar

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-60

NELFINAVIR MESYLATE >D> >D> >D> >A> POWDER; ORAL VIRACEPT + AGOURON @ NEOMYCIN SULFATE POWDER; FOR RX COMPOUNDING NEO-RX @ X GEN PHARMS 100% NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE SUSPENSION/DROPS; OPHTHALMIC POLY-PRED @ ALLERGAN EQ 0.35% BASE;10,000 UNITS/ML;0.5% NEOSTIGMINE METHYLSULFATE SOLUTION; INTRAVENOUS BLOXIVERZ + ECLAT PHARMS LLC + NIFEDIPINE CAPSULE; ORAL NIFEDIPINE ACTAVIS ELIZABETH @ CATALENT EMCURE PHARMS USA

EQ 50MG BASE/SCOOPFUL EQ 50MG BASE/SCOOPFUL

N020778 001 Mar 14, 1997 Jun N020778 001 Mar 14, 1997 Jun

DISC DISC

A061579 001

Mar

DISC

N050081 002

May

DISC

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

N204078 001 May 31, 2013 May N204078 002 May 31, 2013 May

NEWA NEWA

AB AB AB

20MG 10MG 10MG 20MG

A072556 001 Sep 20, 1990 Apr A073250 001 Oct 08, 1991 Apr A202644 001 Apr 25, 2013 Apr A202644 002 Apr 25, 2013 Apr

CTEC DISC NEWA NEWA

NILUTAMIDE TABLET; ORAL NILANDRON @ COVIS PHARMA SARL + NIMODIPINE SOLUTION; ORAL NYMALIZE + ARBOR PHARMS INC NITISINONE CAPSULE; ORAL ORFADIN SWEDISH ORPHAN +

50MG 150MG

N020169 001 Sep 19, 1996 Apr N020169 002 Apr 30, 1999 Apr

CAHN CAHN

60MG/20ML

N203340 001 May 10, 2013 May

NEWA

2MG 5MG 10MG

N021232 001 Jan 18, 2002 May N021232 002 Jan 18, 2002 May N021232 003 Jan 18, 2002 May

CAHN CAHN CAHN

NITROFURANTOIN, MACROCRYSTALLINE CAPSULE; ORAL MACRODANTIN ALVOGEN INC AB AB

25MG 25MG 50MG

N016620 003 N016620 003 N016620 001

Mar Feb Feb

CTEC CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-61

AB

CAPSULE; ORAL MACRODANTIN + ALVOGEN INC NITROFURANTOIN @ WATSON LABS @ @

100MG 25MG 50MG 100MG

N016620 002

Feb

CAHN DISC DISC DISC

A073696 001 Dec 31, 1992 Mar A073696 002 Dec 31, 1992 Mar A073696 003 Dec 31, 1992 Mar

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE; ORAL MACROBID + ALVOGEN INC NITROGLYCERIN FILM, EXTENDED RELEASE; TRANSDERMAL NITRO-DUR + MERCK SHARP DOHME 0.1MG/HR + + + + + NIZATIDINE CAPSULE; ORAL NIZATIDINE @ APOTEX INC @ NOREPINEPHRINE BITARTRATE INJECTABLE; INJECTION NOREPINEPHRINE BITARTRATE TEVA PHARMS USA EQ 1MG BASE/ML NORETHINDRONE TABLET; ORAL-28 JENCYCLA LUPIN LTD NORETHINDRONE FAMY CARE LTD 0.2MG/HR 0.3MG/HR 0.4MG/HR 0.6MG/HR 0.8MG/HR

AB

75MG;25MG

N020064 001 Dec 24, 1991 Mar

CAHN

AB1 AB1 AB1 AB1

N020145 001 Apr 04, 1995 Mar N020145 002 Apr 04, 1995 Mar N020145 003 Apr 04, 1995 Mar N020145 004 Apr 04, 1995 Mar N020145 005 Apr 04, 1995 Mar N020145 006 Apr 04, 1995 Mar

CAHN CAHN CAHN CAHN CAHN CAHN

150MG 300MG

A076383 001 Jan 23, 2003 Feb A076383 002 Jan 23, 2003 Feb

DISC DISC

AP

A040455 001 Mar 03, 2003 May

CAHN

AB2 AB >A> AB1 AB2

0.35MG 0.35MG 0.35MG 0.35MG

A091323 001 Mar 28, 2013 Apr A091323 001 Mar 28, 2013 Mar A201483 001 Jun 24, 2013 Jun A200980 001 Jun 12, 2013 May

CTEC NEWA NEWA NEWA

NYSTATIN SUSPENSION; ORAL NILSTAT @ GLENMARK GENERICS OCTREOTIDE ACETATE INJECTABLE; INJECTION OCTREOTIDE ACETATE TEVA PHARMS USA

100,000 UNITS/ML

N050299 001

Feb

DISC

AP AP AP AP

EQ 0.05MG BASE/ML EQ 0.1MG BASE/ML EQ 0.2MG BASE/ML EQ 0.5MG BASE/ML

A075957 001 Oct 03, 2005 May A075957 002 Oct 03, 2005 May A075959 001 Nov 21, 2005 May A075957 003 Oct 03, 2005 May

CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-62

AP

INJECTABLE; INJECTION OCTREOTIDE ACETATE TEVA PHARMS USA OFLOXACIN

EQ 1MG BASE/ML

A075959 002 Nov 21, 2005 May

CAHN

AT

SOLUTION/DROPS; OPHTHALMIC OFLOXACIN ALTAIRE PHARMS INC 0.3% @ APOTEX INC 0.3% OMEPRAZOLE; SODIUM BICARBONATE FOR SUSPENSION; ORAL OMEPRAZOLE AND SODIUM BICARBONATE PAR PHARM 20MG/PACKET;1.68GM/PACKET 40MG/PACKET;1.68GM/PACKET ZEGERID SANTARUS + ONDANSETRON HYDROCHLORIDE INJECTABLE; INJECTION ONDANSETRON HYDROCHLORIDE @ APOTEX INC EQ 2MG BASE/ML 20MG/PACKET;1.68GM/PACKET 40MG/PACKET;1.68GM/PACKET

A202692 001 Apr 29, 2013 Apr A076513 001 May 14, 2004 Apr

NEWA DISC

AB AB AB AB

A079182 001 Apr 19, 2013 Apr A079182 002 Apr 19, 2013 Apr N021636 001 Jun 15, 2004 Apr N021636 002 Dec 21, 2004 Apr

NEWA NEWA CFTG CFTG

AP

CLARIS LIFESCIENCES @ LUITPOLD @ PLIVA HRVATSKA DOO

2MG/ML EQ 2MG BASE/ML EQ 2MG BASE/ML

A077368 001 Dec 26, 2006 Apr A078288 001 Feb 22, 2013 Feb A077582 001 Dec 26, 2006 Mar A077544 001 Dec 26, 2006 Feb

DISC NEWA DISC DISC DISC DISC DISC NEWA DISC

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER @ CLARIS LIFESCIENCES EQ 0.64MG BASE/ML A078308 001 Mar 17, 2008 Jan @ HOSPIRA EQ 0.64MG BASE/ML A077348 001 Feb 01, 2007 Jan A077343 001 Dec 26, 2006 Apr A078287 001 Feb 22, 2013 Feb A077387 001 Dec 26, 2006 Mar ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE @ APOTEX INC EQ 2MG BASE/ML AP CLARIS LIFESCIENCES @ LUITPOLD OSPEMIFENE TABLET; ORAL OSPHENA + SHIONOGI INC OXACILLIN SODIUM INJECTABLE; INJECTION OXACILLIN SODIUM AUROBINDO PHARMA LTD 2MG/ML EQ 2MG BASE/ML

60MG

N203505 001 Feb 26, 2013 Feb

NEWA

AP AP AP

EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL

A201539 001 Jan 18, 2013 Jan A201539 002 Jan 18, 2013 Jan A201538 001 Jan 18, 2013 Jan

NEWA NEWA NEWA

OXAPROZIN TABLET; ORAL OXAPROZIN @ CARACO OXCARBAZEPINE TABLET; ORAL OXCARBAZEPINE @ TEVA PHARMS USA

600MG

A075844 001 Jan 03, 2002 Jan

DISC

150MG

A078005 001 Dec 11, 2007 Mar

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-63

TABLET; ORAL OXCARBAZEPINE @ TEVA PHARMS USA @ OXYBUTYNIN

300MG 600MG

A078005 002 Dec 11, 2007 Mar A078005 003 Dec 11, 2007 Mar

DISC DISC

>D> >D> >A> >A>

GEL, METERED; TRANSDERMAL ANTUROL + WATSON LABS INC 3% GELNIQUE 3% + WATSON LABS INC OXYBUTYNIN CHLORIDE SYRUP; ORAL OXYBUTYNIN CHLORIDE @ APOTEX INC 3%

N202513 001 Dec 07, 2011 Jun N202513 001 Dec 07, 2011 Jun

CTNA CTNA

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

A074997 001 Oct 15, 1997 Apr A075039 001 Jan 29, 1999 Jun A075039 001 Jan 29, 1999 Jun

DISC DISC DISC

>D> >A>

AA @

MIKART TABLET; ORAL OXYBUTYNIN CHLORIDE TEVA PHARMS USA OXYCODONE HYDROCHLORIDE

AB

5MG

A071655 001 Nov 14, 1988 Mar

CAHN

>D> >A> >D> >A> >D> >A> >D> >A> >D> >A>

AB

TABLET; ORAL OXYCODONE HYDROCHLORIDE @ NESHER PHARMS 5MG 5MG @ @ 5MG 10MG 10MG 10MG 15MG 15MG 15MG 20MG 20MG 20MG 30MG 30MG @ OXYMORPHONE HYDROCHLORIDE TABLET; ORAL OXYMORPHONE HYDROCHLORIDE AVANTHI INC 5MG 10MG MALLINCKRODT INC 5MG 10MG 30MG

A077290 001 Dec 08, 2005 Jun A077290 001 Dec 08, 2005 Jun A077290 001 Dec 08, 2005 Mar A077290 002 Dec 08, 2005 Jun A077290 002 Dec 08, 2005 Jun A077290 002 Dec 08, 2005 Mar A077290 003 Dec 08, 2005 Jun A077290 003 Dec 08, 2005 Jun A077290 003 Dec 08, 2005 Mar A077290 004 Dec 08, 2005 Jun A077290 004 Dec 08, 2005 Jun A077290 004 Dec 08, 2005 Mar A077290 005 Dec 08, 2005 Jun A077290 005 Dec 08, 2005 Jun A077290 005 Dec 08, 2005 Mar

CMFD CMFD DISC CMFD CMFD DISC CMFD CMFD DISC CMFD CMFD DISC CMFD CMFD DISC

AB @ @ AB @ @ AB @ @ AB

AB AB AB AB

A203601 001 Jan 30, 2013 Jan A203601 002 Jan 30, 2013 Jan A202321 001 Apr 25, 2013 Apr A202321 002 Apr 25, 2013 Apr

NEWA NEWA NEWA NEWA

AB AB

TABLET, EXTENDED RELEASE; ORAL OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH 7.5MG 15MG

A079046 001 Dec 13, 2010 Apr A079046 002 Dec 13, 2010 Apr

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-64

OXYTOCIN INJECTABLE; INJECTION OXYTOCIN HIKMA FARMACEUTICA @ TEVA PHARMS USA @

AP

10USP UNITS/ML (10USP UNITS/ML) 10USP UNITS/ML (10USP UNITS/ML) 100USP UNITS/10ML (10USP UNITS/ML)

A200219 001 Feb 13, 2013 Jan A077453 001 Jan 24, 2008 May A077453 002 Jan 24, 2008 May

NEWA CAHN CAHN

PACLITAXEL INJECTABLE; INJECTION PACLITAXEL @ ACCORD HLTHCARE @ TEVA PHARMS USA AP TAXOL HQ SPCLT PHARMA @ PAMIDRONATE DISODIUM INJECTABLE; INJECTION PAMIDRONATE DISODIUM TEVA PHARMS USA

6MG/ML 6MG/ML 6MG/ML 6MG/ML

A075436 001 Nov 12, 2004 Apr A075297 001 Jan 25, 2002 May N020262 001 Dec 29, 1992 Apr N020262 001 Dec 29, 1992 Jan

DISC CAHN CMFD CAHN

AP AP

30MG/10ML (3MG/ML) 90MG/10ML (9MG/ML)

A076153 001 Mar 27, 2002 Mar A076153 002 Mar 27, 2002 Mar

CAHN CAHN

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) CAPSULE, DELAYED RELEASE; ORAL CREON ABBVIE 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS PANCURONIUM BROMIDE INJECTABLE; INJECTION PANCURONIUM BROMIDE + TEVA PHARMS USA + PAROXETINE HYDROCHLORIDE SUSPENSION; ORAL PAROXETINE HYDROCHLORIDE @ APOTEX INC EQ 10MG BASE/5ML PAROXETINE MESYLATE >A> >A> >A> CAPSULE; ORAL BRISDELLE + NOVEN THERAP PEGINESATIDE ACETATE SOLUTION; INTRAVENOUS, SUBCUTANEOUS OMONTYS @ TAKEDA PHARMS USA EQ 10MG BASE/ML (EQ 10MG BASE/ML) N202799 007 Mar 27, 2012 May + EQ 10MG BASE/ML (EQ 10MG BASE/ML) @ EQ 20MG BASE/2ML (EQ 10MG BASE/ML) + EQ 20MG BASE/2ML (EQ 10MG BASE/ML) OMONTYS PRESERVATIVE FREE @ TAKEDA PHARMS USA EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) N202799 007 Mar 27, 2012 Apr N202799 008 Mar 27, 2012 May N202799 008 Mar 27, 2012 Apr

N020725 005 Mar 14, 2013 Mar

NEWA

AP AP

1MG/ML 2MG/ML

A072759 001 Jul 31, 1990 May A072760 001 Jul 31, 1990 Mar

CAHN CAHN

A077395 001 Dec 05, 2006 Apr

DISC

EQ 7.5MG BASE

N204516 001 Jun 28, 2013 Jun

NEWA

DISC CAHN DISC CAHN

N202799 001 Mar 27, 2012 May

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-65

SOLUTION; INTRAVENOUS, SUBCUTANEOUS OMONTYS PRESERVATIVE FREE + TAKEDA PHARMS USA EQ 1MG BASE/0.5ML BASE/0.5ML) @ EQ 2MG BASE/0.5ML BASE/0.5ML) + EQ 2MG BASE/0.5ML BASE/0.5ML) @ EQ 3MG BASE/0.5ML BASE/0.5ML) + EQ 3MG BASE/0.5ML BASE/0.5ML) @ EQ 4MG BASE/0.5ML BASE/0.5ML) + EQ 4MG BASE/0.5ML BASE/0.5ML) @ EQ 5MG BASE/0.5ML BASE/0.5ML) + EQ 5MG BASE/0.5ML BASE/0.5ML) @ EQ 6MG BASE/0.5ML BASE/0.5ML) + EQ 6MG BASE/0.5ML BASE/0.5ML) PHENYLEPHRINE HYDROCHLORIDE SOLUTION/DROPS; OPHTHALMIC PHENYLEPHRINE HYDROCHLORIDE PARAGON BIOTECK 2.5% + PHENYTOIN SODIUM INJECTABLE; INJECTION PHENYTOIN SODIUM @ HOSPIRA PHYTONADIONE TABLET; ORAL MEPHYTON + VALEANT PHARMS + PINDOLOL TABLET; ORAL PINDOLOL MYLAN + MYLAN PHARMS INC + AB @ AB @ PIOGLITAZONE HYDROCHLORIDE TABLET; ORAL PIOGLITAZONE HYDROCHLORIDE ACCORD HLTHCARE EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE WATSON LABS 10%

(EQ 1MG (EQ 2MG (EQ 2MG (EQ 3MG (EQ 3MG (EQ 4MG (EQ 4MG (EQ 5MG (EQ 5MG (EQ 6MG (EQ 6MG

N202799 001 Mar 27, 2012 Apr N202799 002 Mar 27, 2012 May N202799 002 Mar 27, 2012 Apr N202799 003 Mar 27, 2012 May N202799 003 Mar 27, 2012 Apr N202799 004 Mar 27, 2012 May N202799 004 Mar 27, 2012 Apr N202799 005 Mar 27, 2012 May N202799 005 Mar 27, 2012 Apr N202799 006 Mar 27, 2012 May N202799 006 Mar 27, 2012 Apr

CAHN DISC CAHN DISC CAHN DISC CAHN DISC CAHN DISC CAHN

N203510 001 Mar 21, 2013 Mar N203510 002 Mar 21, 2013 Mar

NEWA NEWA

50MG/ML

A089744 001 Dec 18, 1987 Mar

DISC

>D> >A>

5MG 5MG

N010104 003 N010104 003

Jun Jun

CAHN CAHN

>D> >D> >A> >A> >D> >A> >D> >A>

AB AB

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

A074019 001 Sep 03, 1992 Jun A074019 002 Sep 03, 1992 Jun A074019 001 Sep 03, 1992 Jun A074019 002 Sep 03, 1992 Jun A074437 001 Feb 27, 1995 Jun A074437 001 Feb 27, 1995 Jun A074437 002 Feb 27, 1995 Jun A074437 002 Feb 27, 1995 Jun

CTEC CTEC CTEC CTEC DISC DISC DISC DISC

AB AB AB

A200044 001 Feb 13, 2013 Jan A200044 002 Feb 13, 2013 Jan A200044 003 Feb 13, 2013 Jan

NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-66

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

TABLET; ORAL PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD EQ 15MG BASE EQ 30MG BASE DR REDDYS LABS LTD EQ 45MG BASE EQ 15MG BASE EQ 30MG BASE MACLEODS PHARMS LTD EQ 45MG BASE EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE SANDOZ EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE SYNTHON PHARMS EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE TORRENT PHARMS LTD EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE ZYDUS PHARMS USA INC EQ 15MG BASE EQ 30MG BASE EQ 45MG BASE POLYMYXIN B SULFATE POWDER; FOR RX COMPOUNDING POLY-RX @ X GEN PHARMS 100,000,000 UNITS/BOT POMALIDOMIDE CAPSULE; ORAL POMALYST CELGENE

A200268 001 Feb 13, 2013 Jan A200268 002 Feb 13, 2013 Jan A200268 003 Feb 13, 2013 Jan A078383 001 Mar 12, 2013 Mar A078383 002 Mar 12, 2013 Mar A078383 003 Mar 12, 2013 Mar A202467 001 Feb 06, 2013 Jan A202467 002 Feb 06, 2013 Jan A202467 003 Feb 06, 2013 Jan A078670 001 Feb 13, 2013 Jan A078670 002 Feb 13, 2013 Jan A078670 003 Feb 13, 2013 Jan A078472 001 Feb 13, 2013 Jan A078472 002 Feb 13, 2013 Jan A078472 003 Feb 13, 2013 Jan A091298 001 Feb 13, 2013 Jan A091298 002 Feb 13, 2013 Jan A091298 003 Feb 13, 2013 Jan A202456 001 Feb 13, 2013 Jan A202456 002 Feb 13, 2013 Jan A202456 003 Feb 13, 2013 Jan

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

A061578 001

Mar

DISC

1MG 2MG 3MG 4MG

N204026 001 Feb 08, 2013 Feb N204026 002 Feb 08, 2013 Feb N204026 003 Feb 08, 2013 Feb N204026 004 Feb 08, 2013 Feb

NEWA NEWA NEWA NEWA

+ POTASSIUM CHLORIDE

AB

CAPSULE, EXTENDED RELEASE; ORAL POTASSIUM CHLORIDE AMNEAL PHARMS 10MEQ PRAMIPEXOLE DIHYDROCHLORIDE TABLET; ORAL PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS GRP PTC 0.125MG 0.25MG 0.5MG 0.75MG 1MG 1.5MG SUN PHARM INDS INC 0.125MG 0.25MG 0.5MG 0.75MG 1MG

A202128 001 Feb 22, 2013 Feb

NEWA

AB AB AB AB AB AB AB AB AB AB AB

A091254 001 Nov 30, 2010 Mar A091254 002 Nov 30, 2010 Mar A091254 003 Nov 30, 2010 Mar A091254 004 Nov 30, 2010 Mar A091254 005 Nov 30, 2010 Mar A091254 006 Nov 30, 2010 Mar A091683 001 Mar 27, 2013 Mar A091683 002 Mar 27, 2013 Mar A091683 003 Mar 27, 2013 Mar A091683 004 Mar 27, 2013 Mar A091683 005 Mar 27, 2013 Mar

CAHN CAHN CAHN CAHN CAHN CAHN NEWA NEWA NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-67

AB

TABLET; ORAL PRAMIPEXOLE DIHYDROCHLORIDE SUN PHARM INDS INC 1.5MG PRAMLINTIDE ACETATE INJECTABLE; SUBCUTANEOUS SYMLIN AMYLIN PHARMS

A091683 006 Mar 27, 2013 Mar

NEWA

>D>

>D>

+ +

>A> >A>

+ @

AMYLIN PHARMS LLC

EQ 1.5MG BASE/1.5ML BASE/ML) EQ 2.7MG BASE/2.7ML BASE/ML) EQ 2.7MG BASE/2.7ML BASE/ML) EQ 3MG BASE/5ML (EQ BASE/ML) EQ 3MG BASE/5ML (EQ BASE/ML) EQ 2.7MG BASE/2.7ML BASE/ML) EQ 3MG BASE/5ML (EQ BASE/ML)

(EQ 1MG (EQ 1MG (EQ 1MG 600MCG 600MCG (EQ 1MG 600MCG

N021332 002 Sep 25, 2007 Jan N021332 003 Sep 25, 2007 Jun N021332 003 Sep 25, 2007 Jan N021332 001 Mar 16, 2005 Jun N021332 001 Mar 16, 2005 Jan N021332 003 Sep 25, 2007 Jun N021332 001 Mar 16, 2005 Jun

CAHN CRLD CAHN DISC CAHN CRLD DISC

PRAZIQUANTEL TABLET; ORAL BILTRICIDE + BAYER HLTHCARE + BAYER PHARMA AG

>A> >D>

600MG 600MG

N018714 001 Dec 29, 1982 Jun N018714 001 Dec 29, 1982 Jun

CAHN CAHN

PREDNISOLONE SYRUP; ORAL PREDNISOLONE @ APOTEX INC @

5MG/5ML 15MG/5ML

A040570 001 Aug 25, 2005 Apr A040571 001 Aug 25, 2005 Apr

DISC DISC

PREDNISOLONE SODIUM PHOSPHATE SOLUTION; ORAL ORAPRED + CONCORDIA PHARMS INC

AA

EQ 15MG BASE/5ML

A075117 001 Dec 14, 2000 May A076988 001 May 24, 2005 May A076123 001 Dec 23, 2002 Mar A075250 001 Jul 12, 2002 Mar

CAHN DISC DISC DISC

PREDNISOLONE SODIUM PHOSPHATE @ NESHER PHARMS EQ 15MG BASE/5ML @ PHARM ASSOC @ WE PHARMS EQ 5MG BASE/5ML EQ 15MG BASE/5ML

AB AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL ORAPRED ODT CONCORDIA PHARMS INC EQ 10MG BASE + SHIONOGI INC + EQ 15MG BASE EQ 30MG BASE EQ 10MG BASE EQ 15MG BASE EQ 30MG BASE PREDNISOLONE SODIUM PHOSPHATE MYLAN PHARMS INC EQ 10MG BASE EQ 15MG BASE EQ 30MG BASE

N021959 001 Jun 01, 2006 May N021959 002 Jun 01, 2006 May N021959 003 Jun 01, 2006 May N021959 001 Jun 01, 2006 Mar N021959 002 Jun 01, 2006 Mar N021959 003 Jun 01, 2006 Mar A202179 001 Apr 10, 2013 Mar A202179 002 Apr 10, 2013 Mar A202179 003 Apr 10, 2013 Mar

CAHN CAHN CAHN CFTG CFTG CFTG NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-68

PREDNISONE TABLET; ORAL PREDNISONE HIKMA PHARMS

AB AB AB AB AB AB

1MG 2.5MG 5MG 10MG 20MG 50MG

A040890 001 Nov 01, 2010 May A040538 001 Jan 08, 2004 May A080292 001 May A088832 001 Dec 04, 1985 May May A083677 001 A088465 001 Jun 01, 1984 May

CAHN CAHN CAHN CAHN CAHN CAHN

PRIMIDONE TABLET; ORAL PRIMIDONE @ DR REDDYS LABS LTD @ PROBENECID TABLET; ORAL PROBENECID @ IVAX SUB TEVA PHARMS PROGESTERONE CAPSULE; ORAL PROMETRIUM ABBVIE INC + @ PROMETHAZINE HYDROCHLORIDE INJECTABLE; INJECTION PROMETHAZINE HYDROCHLORIDE + TEVA PHARMS USA 25MG/ML + 50MG/ML SYRUP; ORAL PROMETHAZINE HYDROCHLORIDE CARACO 6.25MG/5ML TABLET; ORAL PROMETHAZINE HYDROCHLORIDE CARACO 12.5MG 25MG 50MG PROPOFOL INJECTABLE; INJECTION PROPOFOL TEVA PHARMS USA PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL PROPRANOLOL HYDROCHLORIDE GLATT AIR 60MG 80MG 120MG 160MG

50MG 250MG

A040862 001 Oct 03, 2008 Apr A040862 002 Oct 03, 2008 Apr

DISC DISC

500MG

A083740 001 May 09, 1984 May

DISC

AB AB

100MG 200MG 300MG

N019781 001 May 14, 1998 May N019781 002 Oct 15, 1999 May N019781 003 Oct 15, 1999 May

CAHN CAHN CAHN

AP AP

A040454 001 Aug 22, 2002 Mar A040454 002 Aug 22, 2002 Mar

CAHN CAHN

AA

A040891 001 Mar 13, 2009 May

CAHN

AB AB AB

A040863 001 Dec 30, 2008 May A040863 002 Dec 30, 2008 May A040863 003 Dec 30, 2008 May

CAHN CAHN CAHN

AB

10MG/ML

A075102 001 Jan 04, 1999 Mar

CAHN

AB AB AB AB

A078065 001 Jan 26, 2007 Feb A078065 002 Jan 26, 2007 Feb A078065 003 Jan 26, 2007 Feb A078065 004 Jan 26, 2007 Feb

CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-69

PROTRIPTYLINE HYDROCHLORIDE TABLET; ORAL VIVACTIL @ TEVA WOMENS @ PYRIMETHAMINE TABLET; ORAL DARAPRIM + AMEDRA PHARMS QUAZEPAM TABLET; ORAL DORAL @ QUESTCOR PHARMS + @ SCIECURE PHARMA INC + QUETIAPINE FUMARATE TABLET; ORAL QUETIAPINE FUMARATE ACCORD HLTHCARE

5MG 10MG

N016012 001 N016012 002

Mar Mar

CAHN CAHN

25MG

N008578 001

Apr

CAHN

>D> >D> >A> >A>

7.5MG 15MG 7.5MG 15MG

N018708 003 Feb 26, 1987 Jun N018708 001 Dec 27, 1985 Jun N018708 003 Feb 26, 1987 Jun N018708 001 Dec 27, 1985 Jun

CAHN CAHN CAHN CAHN

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

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ 200MG BASE EQ 300MG BASE EQ 400MG BASE EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ 150MG BASE EQ 200MG BASE EQ 300MG BASE EQ 400MG BASE EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ 150MG BASE EQ 200MG BASE EQ 300MG BASE EQ 400MG BASE EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE EQ 150MG BASE EQ 200MG BASE EQ 300MG BASE EQ 400MG BASE

A202152 001 Mar 27, 2012 Apr A202152 002 Mar 27, 2012 Apr A202152 003 Mar 27, 2012 Apr A202152 004 Mar 27, 2012 Apr A202152 005 Mar 27, 2012 Apr A202152 006 Mar 27, 2012 Apr A201762 001 Feb 27, 2013 May A201762 002 Feb 27, 2013 May A201762 003 Feb 27, 2013 May A201762 004 Feb 27, 2013 May A201762 005 Feb 27, 2013 May A201762 006 Feb 27, 2013 May A201762 007 Feb 27, 2013 May A201762 001 Feb 27, 2013 Feb A201762 002 Feb 27, 2013 Feb A201762 003 Feb 27, 2013 Feb A201762 004 Feb 27, 2013 Feb A201762 005 Feb 27, 2013 Feb A201762 006 Feb 27, 2013 Feb A201762 007 Feb 27, 2013 Feb A201504 001 Feb 12, 2013 Jan A201504 002 Feb 12, 2013 Jan A201504 003 Feb 12, 2013 Jan A201504 004 Feb 12, 2013 Jan A201504 005 Feb 12, 2013 Jan A201504 006 Feb 12, 2013 Jan A201504 007 Feb 12, 2013 Jan

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

ACTAVIS GRP PTC

ACTAVIS PHARMA

ALKEM LABS LTD

QUINAPRIL HYDROCHLORIDE TABLET; ORAL QUINAPRIL HYDROCHLORIDE @ APOTEX INC EQ 5MG BASE @ EQ 10MG BASE

A076240 001 Jan 26, 2006 Mar A076240 002 Jan 26, 2006 Mar

DISC DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-70

TABLET; ORAL QUINAPRIL HYDROCHLORIDE @ APOTEX INC EQ 20MG BASE @ AB AB AB AB RABEPRAZOLE SODIUM CAPSULE, DELAYED RELEASE; ORAL ACIPHEX SPRINKLE EISAI INC 5MG + RADIUM RA-223 DICHLORIDE SOLUTION; INTRAVENOUS XOFIGO + BAYER HLTHCARE RANITIDINE HYDROCHLORIDE GRANULE, EFFERVESCENT; ORAL ZANTAC 150 @ GLAXO GRP LTD EQ 150MG BASE/PACKET @ GLAXOSMITHKLINE EQ 150MG BASE/PACKET INJECTABLE; INJECTION RANITIDINE HYDROCHLORIDE ZYDUS PHARMS USA INC 25MG/ML ZANTAC IN PLASTIC CONTAINER + COVIS PHARMA EQ 1MG BASE/ML @ COVIS PHARMA SARL EQ 1MG BASE/ML SYRUP; ORAL RANITIDINE HYDROCHLORIDE @ APOTEX INC EQ 15MG BASE/ML AA AA >A> >D> AA AA BIO PHARM INC CARACO ZANTAC + GLAXO GRP LTD + GLAXOSMITHKLINE EQ 15MG BASE/ML EQ 15MG BASE/ML EQ 15MG BASE/ML EQ 15MG BASE/ML 10MG AUROBINDO PHARMA LTD EQ 40MG BASE EQ 5MG BASE EQ 10MG BASE EQ 20MG BASE EQ 40MG BASE

A076240 003 Jan 26, 2006 Mar A076240 004 Jan 26, 2006 Mar A202725 001 Apr 29, 2013 Apr A202725 002 Apr 29, 2013 Apr A202725 003 Apr 29, 2013 Apr A202725 004 Apr 29, 2013 Apr

DISC DISC NEWA NEWA NEWA NEWA

N204736 001 Mar 26, 2013 Mar N204736 002 Mar 26, 2013 Mar

NEWA NEWA

162MCI/6ML (27MCI/ML)

N203971 001 May 15, 2013 May

NEWA

>A> >D>

N020251 002 Mar 31, 1994 Jun N020251 002 Mar 31, 1994 Jun

CAHN CAHN

AP >D> >D> >A>

A091534 001 Feb 22, 2013 Feb N019593 002 Sep 27, 1991 Jun N019593 002 Sep 27, 1991 Jun

NEWA DISC DISC

A077602 001 Sep 17, 2007 Apr A090102 001 May 26, 2009 Apr A091091 001 Sep 20, 2011 Apr N019675 001 Dec 30, 1988 Jun N019675 001 Dec 30, 1988 Jun

DISC CAHN CAHN CAHN CAHN

TABLET; ORAL RANITIDINE HYDROCHLORIDE @ WATSON LABS EQ 150MG BASE @ @ WATSON LABS INC @ >A> >D> >A> >D> AB AB AB AB + + ZANTAC 150 GLAXO GRP LTD GLAXOSMITHKLINE ZANTAC 300 GLAXO GRP LTD GLAXOSMITHKLINE EQ 300MG BASE EQ 150MG BASE EQ 300MG BASE EQ 150MG BASE EQ 150MG BASE EQ 300MG BASE EQ 300MG BASE

A074864 001 Oct 20, 1997 Jan A074864 002 Oct 20, 1997 Jan A077426 001 Dec 19, 2005 Mar A077426 002 Dec 19, 2005 Mar N018703 001 Jun 09, 1983 Jun N018703 001 Jun 09, 1983 Jun N018703 002 Dec 09, 1985 Jun N018703 002 Dec 09, 1985 Jun

DISC DISC DISC DISC CAHN CAHN CAHN CAHN

>A> >D>

TABLET, EFFERVESCENT; ORAL ZANTAC 150 @ GLAXO GRP LTD EQ 150MG BASE @ GLAXOSMITHKLINE EQ 150MG BASE

N020251 001 Mar 31, 1994 Jun N020251 001 Mar 31, 1994 Jun

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-71

>A> >D>

TABLET, EFFERVESCENT; ORAL ZANTAC 25 + GLAXO GRP LTD EQ 25MG BASE + GLAXOSMITHKLINE EQ 25MG BASE

N020251 003 Apr 01, 2004 Jun N020251 003 Apr 01, 2004 Jun

CAHN CAHN

RASAGILINE MESYLATE TABLET; ORAL AZILECT TEVA AB + AB AB AB RESERPINE TABLET; ORAL SERPALAN @ LANNETT @ RILUZOLE TABLET; ORAL RILUTEK + COVIS PHARMA SARL RILUZOLE APOTEX CORP GLENMARK GENERICS MYLAN PHARMS INC SUN PHARM INDS LTD RIMANTADINE HYDROCHLORIDE TABLET; ORAL RIMANTADINE HYDROCHLORIDE @ COREPHARMA 100MG RISPERIDONE SOLUTION; ORAL RISPERIDONE BIO PHARM INC + RASAGILINE MESYLATE WATSON LABS INC

>D> >A> >D> >A> >A> >A> >A>

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

N021641 001 May 16, 2006 Jun N021641 001 May 16, 2006 Jun N021641 002 May 16, 2006 Jun N021641 002 May 16, 2006 Jun A201823 001 Jul 01, 2013 Jun A201823 002 Jul 01, 2013 Jun

CFTG CFTG CFTG CFTG NEWA NEWA

0.1MG 0.25MG

N010124 001 N010124 002

May May

DISC DISC

AB >A> >A> >A> >A> AB AB AB AB

50MG 50MG 50MG 50MG 50MG

N020599 001 Dec 12, 1995 Apr A091300 001 Jun 18, 2013 Jun A091394 001 Jun 18, 2013 Jun A203042 001 Jul 01, 2013 Jun A091417 001 Jun 18, 2013 Jun

CAHN NEWA NEWA NEWA NEWA

A075916 001 Nov 02, 2001 Feb

DISC

AA

1MG/ML

A078909 001 Jul 29, 2009 May

CAHN

AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL RISPERIDONE 0.25MG MYLAN PHARMS INC PAR PHARM SUN PHARM INDS LTD 0.25MG 0.5MG 1MG 2MG 3MG 4MG RIVASTIGMINE TARTRATE CAPSULE; ORAL RIVASTIGMINE TARTRATE APOTEX INC

A091537 006 Feb 12, 2013 Feb A077494 001 Apr 30, 2009 Feb A078464 001 Apr 08, 2013 Mar A078464 002 Apr 08, 2013 Mar A078464 003 Apr 08, 2013 Mar A078464 004 Apr 08, 2013 Mar A078464 005 Apr 08, 2013 Mar

NEWA CTEC NEWA NEWA NEWA NEWA NEWA

AB

EQ 1.5MG BASE

A091072 001 May 16, 2013 Apr

NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-72

AB AB AB

CAPSULE; ORAL RIVASTIGMINE TARTRATE APOTEX INC

EQ 3MG BASE EQ 4.5MG BASE EQ 6MG BASE

A091072 002 May 16, 2013 Apr A091072 003 May 16, 2013 Apr A091072 004 May 16, 2013 Apr

NEWA NEWA NEWA

RIZATRIPTAN BENZOATE TABLET; ORAL RIZATRIPTAN BENZOATE CIPLA LTD INVAGEN PHARMS

AB AB >A> >A> AB AB

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

A077526 001 Mar 26, 2013 Mar A077526 002 Mar 26, 2013 Mar A204339 001 Jul 01, 2013 Jun A204339 002 Jul 01, 2013 Jun

NEWA NEWA NEWA NEWA

>A> >A> >A> >A> >A> >A> >A> >A> >A> >A>

AB AB AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL RIZATRIPTAN BENZOATE APOTEX INC EQ 5MG BASE EQ 10MG BASE AUROBINDO PHARMA LTD GLENMARK GENERICS NATCO PHARMA LTD SANDOZ EQ 5MG BASE EQ 10MG BASE EQ 5MG BASE EQ 10MG BASE EQ 5MG BASE EQ 10MG BASE EQ 5MG BASE EQ 10MG BASE ROCURONIUM BROMIDE INJECTABLE; INJECTION ZEMURON @ ORGANON USA INC

A202477 001 Jul 01, 2013 Jun A202477 002 Jul 01, 2013 Jun A203062 001 Jul 01, 2013 Jun A203062 002 Jul 01, 2013 Jun A201914 001 Jul 01, 2013 Jun A201914 002 Jul 01, 2013 Jun A203478 001 Jul 01, 2013 Jun A203478 002 Jul 01, 2013 Jun A078739 001 Jul 01, 2013 Jun A078739 002 Jul 01, 2013 Jun

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

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

N020214 002 Mar 17, 1994 Jan N020214 001 Mar 17, 1994 Jan N020214 003 Mar 17, 1994 Jan

CAHN CAHN CAHN

AP AP

+ + ROPINIROLE HYDROCHLORIDE TABLET; ORAL REQUIP + GLAXOSMITHKLINE LLC

AB AB AB AB AB AB AB

EQ 0.25MG BASE EQ 0.5MG BASE EQ 1MG BASE EQ 2MG BASE EQ 3MG BASE EQ 4MG BASE EQ 5MG BASE

N020658 001 Sep 19, 1997 Mar N020658 002 Sep 19, 1997 Mar N020658 003 Sep 19, 1997 Mar N020658 004 Sep 19, 1997 Mar N020658 006 Jan 27, 1999 Mar N020658 007 Jan 27, 1999 Mar N020658 005 Sep 19, 1997 Mar

CAHN CAHN CAHN CAHN CAHN CAHN CAHN

AB AB AB AB AB AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL REQUIP XL + GLAXOSMITHKLINE LLC EQ 2MG BASE @ EQ 3MG BASE EQ 4MG BASE EQ 6MG BASE EQ 8MG BASE EQ 12MG BASE ROPINIROLE HYDROCHLORIDE ACTAVIS ELIZABETH EQ 2MG BASE EQ 4MG BASE EQ 6MG BASE EQ 8MG BASE

N022008 001 Jun 13, 2008 Mar N022008 002 Jun 13, 2008 Mar N022008 003 Jun 13, 2008 Mar N022008 006 Apr 10, 2009 Mar N022008 004 Jun 13, 2008 Mar N022008 005 Oct 31, 2008 Mar A090869 001 May 17, 2012 Apr A090869 002 May 17, 2012 Apr A090869 003 May 17, 2012 Apr A090869 004 May 17, 2012 Apr

CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-73

AB AB AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL ROPINIROLE HYDROCHLORIDE ACTAVIS ELIZABETH EQ 12MG BASE ALEMBIC LTD EQ 2MG BASE EQ 4MG BASE EQ 6MG BASE EQ 8MG BASE EQ 12MG BASE ROSIGLITAZONE MALEATE TABLET; ORAL AVANDIA SB PHARMCO + ROSIGLITAZONE MALEATE TEVA

A090869 005 May 17, 2012 Apr A202786 001 Apr 22, 2013 Apr A202786 002 Apr 22, 2013 Apr A202786 003 Apr 22, 2013 Apr A202786 004 Apr 22, 2013 Apr A202786 005 Apr 22, 2013 Apr

CAHN NEWA NEWA NEWA NEWA NEWA

AB AB AB AB AB AB

EQ 2MG BASE EQ 4MG BASE EQ 8MG BASE EQ 2MG BASE EQ 4MG BASE EQ 8MG BASE

N021071 002 May 25, 1999 Jan N021071 003 May 25, 1999 Jan N021071 004 May 25, 1999 Jan A076747 001 Jan 25, 2013 Jan A076747 002 Jan 25, 2013 Jan A076747 003 Jan 25, 2013 Jan

CFTG CFTG CFTG NEWA NEWA NEWA

ROTIGOTINE FILM, EXTENDED RELEASE; TRANSDERMAL NEUPRO + UCB INC 2MG/24HR 8MG/24HR SAQUINAVIR MESYLATE TABLET; ORAL INVIRASE + HOFFMAN LA ROCHE SELEGILINE HYDROCHLORIDE TABLET; ORAL SELEGILINE HYDROCHLORIDE @ DAVA PHARMS INC 5MG SERTACONAZOLE NITRATE CREAM; TOPICAL ERTACZO + VALEANT INTL + VALEANT LUXEMBOURG SERTRALINE HYDROCHLORIDE TABLET; ORAL SERTRALINE HYDROCHLORIDE @ DR REDDYS LABS LTD EQ 25MG BASE @ EQ 50MG BASE @ SILDENAFIL CITRATE TABLET; ORAL SILDENAFIL CITRATE ACTAVIS GRP PTC ACTAVIS PHARMA AMNEAL PHARMS EQ 100MG BASE

N021829 001 May 09, 2007 May N021829 006 Apr 02, 2012 May

CRLD CRLD

EQ 500MG BASE

N021785 001 Dec 17, 2004 Feb

CAHN

A074641 001 Aug 02, 1996 Jan

DISC

>D> >A>

2% 2%

N021385 001 Dec 10, 2003 Jun N021385 001 Dec 10, 2003 Jun

CAHN CAHN

A076442 001 Apr 30, 2007 Apr A076442 002 Apr 30, 2007 Apr A076442 003 Apr 30, 2007 Apr

DISC DISC DISC

AB AB AB

EQ 20MG BASE EQ 20MG BASE EQ 20MG BASE

A200149 001 Feb 25, 2013 Apr A200149 001 Feb 25, 2013 Feb A202025 001 Feb 28, 2013 Feb

CAHN NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-74

SODIUM CHLORIDE INJECTABLE; INJECTION SODIUM CHLORIDE 0.9% MEDEFIL INC

18MG/2ML (9MG/ML) 22.5MG/2.5ML (9MG/ML) 27MG/3ML (9MG/ML) 45MG/5ML (9MG/ML) 90MG/10ML (9MG/ML)

N202832 002 Jan 06, 2012 Mar N202832 003 Jan 06, 2012 Mar N202832 004 Jan 06, 2012 Mar N202832 005 Jan 06, 2012 Mar N202832 006 Jan 06, 2012 Mar N202832 001 Jan 06, 2012 Mar

NEWA NEWA NEWA NEWA NEWA CPOT

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER MEDEFIL INC 9MG/ML (9MG/ML) SOLUTION; IRRIGATION SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER @ BAXTER HLTHCARE 450MG/100ML SODIUM FLUORIDE F-18 INJECTABLE; INTRAVENOUS SODIUM FLUORIDE F-18 + MCPRF SODIUM PHENYLBUTYRATE POWDER; ORAL BUPHENYL + MEDICIS SODIUM PHENYLBUTYRATE SIGMAPHARM LABS LLC

N017864 001

Jan

DISC

>A>

10-91.5MCI/ML

A203605 001 Jun 28, 2013 Jun

NEWA

AB AB

3GM/TEASPOONFUL 3GM/TEASPOONFUL

N020573 001 Apr 30, 1996 Mar A202819 001 Mar 22, 2013 Mar

CFTG NEWA

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS INJECTABLE; INJECTION SODIUM PHOSPHATES IN PLASTIC CONTAINER HOSPIRA 142MG/ML;276MG/ML

>D>

N018892 001 May 10, 1983 Jun

CRLD

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS INJECTABLE; INJECTION SODIUM PHOSPHATES IN PLASTIC CONTAINER + HOSPIRA 142MG/ML;276MG/ML SODIUM POLYSTYRENE SULFONATE POWDER; ORAL, RECTAL KAYEXALATE + COVIS PHARMA SARL

>A>

N018892 001 May 10, 1983 Jun

CRLD

AA

453.6GM/BOT

N011287 001

Apr

CAHN

SUSPENSION; ORAL, RECTAL SODIUM POLYSTYRENE SULFONATE @ ROXANE 15GM/60ML STAVUDINE CAPSULE; ORAL STAVUDINE HETERO LABS LTD III

A089049 001 Nov 17, 1986 Mar

DISC

AB AB AB AB

15MG 20MG 30MG 40MG

A078957 001 Dec 29, 2008 Apr A078957 002 Dec 29, 2008 Apr A078957 003 Dec 29, 2008 Apr A078957 004 Dec 29, 2008 Apr

CAHN CAHN CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-75

STREPTOZOCIN INJECTABLE; INJECTION ZANOSAR + TEVA PHARMS USA SUCCIMER CAPSULE; ORAL CHEMET + RECORDATI RARE SULFACETAMIDE SODIUM LOTION; TOPICAL KLARON + VALEANT BERMUDA OINTMENT; OPHTHALMIC SULFACETAMIDE SODIUM FERA PHARMS PERRIGO CO TENNESSEE

1GM/VIAL

N050577 001 May 07, 1982 Apr

CAHN

100MG

N019998 002 Jan 30, 1991 May

CAHN

AB

10%

N019931 001 Dec 23, 1996 Feb

CAHN

>D> >A>

AT AT

10% 10%

A080029 001 A080029 001

Jun Jun

CAHN CAHN

SULFAMETHOXAZOLE; TRIMETHOPRIM INJECTABLE; INJECTION SULFAMETHOXAZOLE AND TRIMETHOPRIM + TEVA PHARMS USA 80MG/ML;16MG/ML TABLET; ORAL SULFAMETHOPRIM @ NOVEL LABS INC SULFAMETHOPRIM-DS @ NOVEL LABS INC >D> >A> AB

A073303 001 Oct 31, 1991 Mar

CAHN

400MG;80MG 800MG;160MG

A070022 001 Feb 15, 1985 Mar A070032 001 Feb 15, 1985 Mar N018598 004 May 19, 1982 Jun N018598 004 May 19, 1982 Jun

DISC DISC DISC DISC

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SANDOZ 800MG;160MG @ SULINDAC TABLET; ORAL SULINDAC HERITAGE PHARMS INC 800MG;160MG

AB AB

150MG 200MG

A073262 002 Sep 06, 1991 Apr A073262 001 Sep 06, 1991 Apr

CMFD CMFD

SUMATRIPTAN SUCCINATE INJECTABLE; SUBCUTANEOUS SUMATRIPTAN SUCCINATE AUROBINDO PHARMA LTD SAGENT AGILA TEVA PHARMS USA SYSTEM; IONTOPHORESIS ZECUITY + NUPATHE TABLET; ORAL SUMATRIPTAN SUCCINATE HIKMA PHARMS

AP AP AP

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

A202758 001 Apr 23, 2013 Apr A090641 001 Jul 28, 2010 Feb A077907 001 Feb 06, 2009 Mar

NEWA CAHN CAHN

EQ 6.5MG BASE/4HR

N202278 001 Jan 17, 2013 Jan

NEWA

AB AB AB

EQ 25MG BASE EQ 50MG BASE EQ 100MG BASE

A078298 001 May 21, 2013 May A078298 002 May 21, 2013 May A078298 003 May 21, 2013 May

NEWA NEWA NEWA

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-76

TACROLIMUS OINTMENT; TOPICAL PROTOPIC ASTELLAS + TAMSULOSIN HYDROCHLORIDE CAPSULE; ORAL TAMSULOSIN HYDROCHLORIDE AUROBINDO PHARMA LTD 0.4MG TECHNETIUM TC-99M TILMANOCEPT INJECTABLE; INJECTION LYMPHOSEEK KIT + NAVIDEA BIOPHARMS TENIPOSIDE INJECTABLE; INJECTION VUMON + CORDEN PHARMA TERBUTALINE SULFATE INJECTABLE; INJECTION TERBUTALINE SULFATE @ TEVA PHARMS USA TESTOSTERONE GEL; TRANSDERMAL TESTOSTERONE PERRIGO ISRAEL

>D> >A>

0.03% 0.03%

N050777 001 Dec 08, 2000 Jun N050777 001 Dec 08, 2000 Jun

CRLD CRLD

AB

A202433 001 Apr 30, 2013 Apr

NEWA

N/A

N202207 001 Mar 13, 2013 Mar

NEWA

10MG/ML

N020119 001 Jul 14, 1992 Apr

CAHN

1MG/ML

A076853 001 Jul 20, 2004 Mar

CAHN

25MG/2.5GM PACKET 50MG/5GM PACKET

N203098 002 Jan 31, 2013 Jan N203098 003 Jan 31, 2013 Jan

NEWA NEWA

GEL, METERED; TRANSDERMAL TESTOSTERONE PERRIGO ISRAEL 12.5MG/1.25GM ACTUATION TESTOSTERONE CYPIONATE INJECTABLE; INJECTION TESTOSTERONE CYPIONATE SUN PHARM INDS LTD

N203098 001 Jan 31, 2013 Jan

NEWA

AO AO

100MG/ML 200MG/ML

A201720 001 Jun 03, 2013 May A201720 002 Jun 03, 2013 May

NEWA NEWA

TESTOSTERONE ENANTHATE INJECTABLE; INJECTION DELATESTRYL + ENDO PHARMS @ THEOPHYLLINE TABLET, EXTENDED RELEASE; ORAL THEOPHYLLINE + TEVA PHARMS 450MG

AO

200MG/ML 200MG/ML

N009165 003 N009165 001

Jan Jan

CAHN CAHN

AB

A081236 001 Nov 09, 1992 Mar

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-77

THIABENDAZOLE SUSPENSION; ORAL MINTEZOL @ MERCK SHARP DOHME TABLET, CHEWABLE; ORAL MINTEZOL @ MERCK SHARP DOHME THIOGUANINE TABLET; ORAL THIOGUANINE + ASPEN GLOBAL INC >D> >D> >D> >D> >A> TILUDRONATE DISODIUM TABLET; ORAL SKELID + SANOFI AVENTIS US @ TIMOLOL MALEATE SOLUTION/DROPS; OPHTHALMIC ISTALOL + BAUSCH AND LOMB EQ 0.5% BASE TIMOLOL MALEATE AKORN @ @ APOTEX INC @ EQ 0.25% BASE EQ 0.25% BASE EQ 0.25% BASE EQ 0.5% BASE

500MG/5ML

N016097 001

May

CAHN

500MG

N016096 001

May

CAHN

40MG

N012429 001

Mar

CAHN

EQ 200MG BASE EQ 200MG BASE

N020707 001 Mar 07, 1997 Jun N020707 001 Mar 07, 1997 Jun

DISC DISC

BT >D> >A> AT

N021516 001 Jun 04, 2004 May A074515 001 Mar 25, 1997 Jun A074515 001 Mar 25, 1997 Jun A075411 001 Sep 08, 2000 Apr A075412 001 Sep 08, 2000 Apr

CAHN DISC DISC DISC DISC

AB AB

SOLUTION, GEL FORMING/DROPS; OPHTHALMIC TIMOPTIC-XE + VALEANT PHARMS LLC EQ 0.25% BASE + TIZANIDINE HYDROCHLORIDE CAPSULE; ORAL TIZANIDINE HYDROCHLORIDE MYLAN PHARMS INC EQ 2MG BASE EQ 4MG BASE EQ 6MG BASE TABLET; ORAL TIZANIDINE HYDROCHLORIDE @ MYLAN PHARMS INC EQ 2MG BASE @ EQ 4MG BASE TOBRAMYCIN POWDER; INHALATION TOBI PODHALER + NOVARTIS EQ 0.5% BASE

N020330 001 Nov 04, 1993 Jan N020330 002 Nov 04, 1993 Jan

CAHN CAHN

AB AB AB

A091502 001 Nov 09, 2012 May A091502 002 Nov 09, 2012 May A091502 003 Nov 09, 2012 May

CAHN CAHN CAHN

A076282 001 Dec 16, 2003 Feb A076282 002 Dec 16, 2003 Feb

DISC DISC

28MG

N201688 001 Mar 22, 2013 Mar

NEWA

SOLUTION/DROPS; OPHTHALMIC TOBRAMYCIN @ APOTEX INC 0.3%

A065087 001 Feb 25, 2002 Apr

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-78

TOLAZAMIDE TABLET; ORAL TOLAZAMIDE MYLAN PHARMS INC + @ WATSON LABS @ TOPIRAMATE TABLET; ORAL TOPAMAX JANSSEN PHARMS + TOPIRAMATE ACTIVIS TOTOWA LLC

250MG 500MG 250MG 500MG

A070259 001 Jan 02, 1986 Mar A070259 003 Mar 17, 1986 Mar A070514 001 Jan 09, 1986 Mar A070515 001 Jan 09, 1986 Mar

CTEC CTEC DISC DISC

AB AB AB AB AB AB AB >D> >A> >D> >A> >D> >A> >D> >A> AB AB

25MG 100MG 25MG 50MG 100MG 200MG 200MG 25MG 25MG 50MG 50MG 100MG 100MG 200MG 200MG

N020505 004 Dec 24, 1996 Apr N020505 001 Dec 24, 1996 Apr A078637 001 Feb 27, 2013 Feb A078637 002 Feb 27, 2013 Feb A078637 003 Feb 27, 2013 Feb A078637 004 Feb 27, 2013 Feb A090162 004 Feb 19, 2013 Feb A078499 001 Jan 07, 2010 Jun A078499 001 Jan 07, 2010 Jun A078499 002 Jan 07, 2010 Jun A078499 002 Jan 07, 2010 Jun A078499 003 Jan 07, 2010 Jun A078499 003 Jan 07, 2010 Jun A078499 004 Jan 07, 2010 Jun A078499 004 Jan 07, 2010 Jun

CRLD CRLD NEWA NEWA NEWA NEWA NEWA DISC DISC DISC DISC DISC DISC DISC DISC

UNICHEM LABS LTD UPSHER SMITH @

AB @ @ AB @ TOPOTECAN HYDROCHLORIDE

>A>

AP

INJECTABLE; INJECTION TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE EQ 4MG BASE/VIAL TOREMIFENE CITRATE TABLET; ORAL FARESTON + PROSTRAKAN INC TORSEMIDE TABLET; ORAL TORSEMIDE HETERO LABS LTD III

A202351 001 Jun 26, 2013 Jun

NEWA

EQ 60MG BASE

N020497 001 May 29, 1997 May

CAHN

AB AB AB AB

5MG 10MG 20MG 100MG

A079234 001 Jan 27, 2009 Apr A079234 002 Jan 27, 2009 Apr A079234 003 Jan 27, 2009 Apr A079234 004 Jan 27, 2009 Apr

CAHN CAHN CAHN CAHN

TRAMADOL HYDROCHLORIDE TABLET; ORAL TRAMADOL HYDROCHLORIDE ACCORD HLTHCARE INC CSPC OUYI PHARM CO

AB AB

50MG 50MG

A202390 001 May 16, 2013 Apr A091498 001 Mar 29, 2013 Mar

NEWA NEWA

TABLET, EXTENDED RELEASE; ORAL RYZOLT @ PURDUE PHARMA 100MG

N021745 001 Dec 30, 2008 Jan

DISC

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-79

TABLET, EXTENDED RELEASE; ORAL RYZOLT @ PURDUE PHARMA 200MG @ AB2 AB2 AB2 AB1 AB2 + PAR PHARM INC SUN PHARMA GLOBAL TRAMADOL HYDROCHLORIDE ACTAVIS ELIZABETH 300MG 100MG 200MG 300MG 100MG 100MG

N021745 002 Dec 30, 2008 Jan N021745 003 Dec 30, 2008 Jan A091609 001 Jun 27, 2012 Apr A091609 002 Jun 27, 2012 Apr A091609 003 Jun 27, 2012 Apr A078783 001 Nov 13, 2009 Feb A091607 001 Dec 30, 2011 Feb

DISC DISC CAHN CAHN CAHN CRLD CRLD

TRAMETINIB DIMETHYL SULFOXIDE TABLET; ORAL MEKINIST GLAXOSMITHKLINE LLC + TRANDOLAPRIL TABLET; ORAL TRANDOLAPRIL @ DR REDDYS LABS LTD @ @ TRANEXAMIC ACID INJECTABLE; INJECTION TRANEXAMIC ACID CUSTOPHARM INC TRAVOPROST SOLUTION/DROPS; OPHTHALMIC TRAVOPROST PAR PHARM 0.004% TRAZODONE HYDROCHLORIDE TABLET; ORAL TRAZODONE HYDROCHLORIDE TEVA PHARMS USA 50MG 100MG TABLET, EXTENDED RELEASE; ORAL OLEPTRO @ ANGELINI LLC 150MG @ 150MG @ @ >A> >A> TREPROSTINIL INJECTABLE; IV (INFUSION)-SC REMODULIN UNITED THERAP 1MG/ML 2.5MG/ML 5MG/ML + ANGELINI PHARMA 300MG 300MG 150MG 300MG

EQ 0.5MG NON-SOLVATED PARENT EQ 1MG NON-SOLVATED PARENT EQ 2MG NON-SOLVATED PARENT

N204114 001 May 29, 2013 May N204114 002 May 29, 2013 May N204114 003 May 29, 2013 May

NEWA NEWA NEWA

1MG 2MG 4MG

A078493 001 Aug 25, 2008 Apr A078493 002 Aug 25, 2008 Apr A078493 003 Aug 25, 2008 Apr

DISC DISC DISC

>A>

AP

100MG/ML

A201580 001 Jun 14, 2013 Jun

NEWA

A091340 001 Mar 01, 2013 Feb

NEWA

AB AB

A071523 001 Dec 11, 1987 Mar A071524 001 Dec 11, 1987 Mar

CAHN CAHN

>D> >D>

N022411 001 Feb 02, 2010 Jun N022411 001 Feb 02, 2010 May N022411 002 Feb 02, 2010 Jun N022411 002 Feb 02, 2010 May N022411 001 Feb 02, 2010 Jun N022411 002 Feb 02, 2010 Jun

CMFD DISC CMFD DISC CMFD CMFD

N021272 001 May 21, 2002 May N021272 002 May 21, 2002 May N021272 003 May 21, 2002 May

CAIN CAIN CAIN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-80

>A>

INJECTABLE; IV (INFUSION)-SC REMODULIN + UNITED THERAP 10MG/ML SOLUTION; INHALATION TYVASO + UNITED THERAP

N021272 004 May 21, 2002 Jun

CAIN

EQ 0.6MG BASE/ML

N022387 001 Jul 30, 2009 May

CAIN

>D> >D> >D> >D>

TREPROSTINIL SODIUM INJECTABLE; IV (INFUSION)-SC REMODULIN + UNITED THERAP 10MG/ML TRETINOIN CREAM; TOPICAL RETIN-A + VALEANT BERMUDA + + + + + GEL; TOPICAL ATRALIN + DOW PHARM TRIAMCINOLONE ACETONIDE CREAM; TOPICAL KENALOG @ APOTHECON @ TRIACET @ TEVA @ AT AT VALEANT INTL

N021272 004 May 21, 2002 Jun

CAIN

>A> >A> >A> >D> >D> >D>

AB AB1 AB AB AB1 AB

0.025% 0.05% 0.1% 0.025% 0.05% 0.1%

N019049 001 Sep 16, 1988 Jun N017522 001 N017340 001 Jun Jun

CAHN CAHN CAHN CAHN CAHN CAHN

N019049 001 Sep 16, 1988 Jun N017522 001 Jun N017340 001 Jun

0.05%

N022070 001 Jul 26, 2007 Apr

CAHN

0.025% 0.1% 0.025% 0.5%

N011601 003 N011601 006 A084908 001 A084908 003 A085692 001

Apr Apr Apr Apr Apr

DISC DISC DISC DISC CRLD CRLD DISC DISC DISC DISC

TRIAMCINOLONE ACETONIDE + FOUGERA PHARMS 0.025% + @ G AND W LABS @ TARO @ @ 0.1% 0.025% 0.025% 0.1% 0.5%

A085692 003 Apr A089797 001 May 31, 1991 May A086277 001 A086276 001 A086275 001 Apr Apr Apr

INJECTABLE; INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL TRIVARIS @ ALLERGAN 8MG/0.1ML (8MG/0.1ML) LOTION; TOPICAL TRIAMCINOLONE ACETONIDE VERSAPHARM INC 0.025% + WOCKHARDT EU OPERATN 0.1% 0.025%

N022220 001 Jun 16, 2008 May

DISC

AT AT AT

A202374 001 May 08, 2013 Apr A202374 002 May 08, 2013 Apr A088450 001 Apr 01, 1985 Apr

NEWA NEWA CAHN

OINTMENT; TOPICAL KENALOG @ APOTHECON @

0.025% 0.1%

N011600 003 N011600 001

Apr Apr

DISC DISC DISC DISC DISC

TRIAMCINOLONE ACETONIDE @ TARO 0.025% @ 0.025% @ 0.1%

A040040 001 Sep 30, 1994 May A040374 001 Jun 05, 2001 May A087902 001 Dec 27, 1982 May

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-81

OINTMENT; TOPICAL TRIAMCINOLONE ACETONIDE @ TARO 0.5% TRIMETHOPRIM TABLET; ORAL TRIMETHOPRIM + TEVA @ TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE; ORAL TROSPIUM CHLORIDE PADDOCK LLC 60MG URSODIOL TABLET; ORAL URSODIOL PAR PHARM @ TEVA PHARMS USA @ VALACYCLOVIR HYDROCHLORIDE TABLET; ORAL VALACYCLOVIR HYDROCHLORIDE ACTAVIS GRP PTC EQ 500MG BASE EQ 1GM BASE VALPROIC ACID CAPSULE; ORAL VALPROIC ACID SUN PHARM INDS LTD

A040386 001 Jun 05, 2001 May

DISC

>D> >A>

200MG 200MG

A071259 001 Jun 18, 1987 Jun A071259 001 Jun 18, 1987 Jun

DISC DISC

AB

A201291 001 May 24, 2013 May

NEWA

AB AB

250MG 500MG 250MG 500MG

A202540 001 Feb 14, 2013 Feb A202540 002 Feb 14, 2013 Feb A079184 001 May 13, 2009 Apr A079184 002 May 13, 2009 Apr

NEWA NEWA DISC DISC

AB AB

A090370 001 Mar 16, 2011 Mar A090370 002 Mar 16, 2011 Mar

CAHN CAHN

AB >D> >D> >D> >A> >D> >A> >D> >A>

250MG

A091037 001 Feb 22, 2013 Feb

NEWA

CAPSULE, DELAYED RELEASE; ORAL STAVZOR BANNER PHARMACAPS 125MG 125MG @ 250MG @ + @ VECURONIUM BROMIDE INJECTABLE; INJECTION VECURONIUM BROMIDE TEVA PHARMS USA 250MG 500MG 500MG

N022152 001 Jul 29, 2008 Jun N022152 001 Jul 29, 2008 Jun N022152 002 Jul 29, 2008 Jun N022152 002 Jul 29, 2008 Jun N022152 003 Jul 29, 2008 Jun N022152 003 Jul 29, 2008 Jun

DISC DISC DISC DISC DISC DISC

AP AP

10MG/VIAL 20MG/VIAL

A074688 001 Aug 25, 1999 Apr A074688 002 Aug 25, 1999 Apr

CAHN CAHN

VERAPAMIL HYDROCHLORIDE INJECTABLE; INJECTION VERAPAMIL HYDROCHLORIDE @ INTL MEDICATION 2.5MG/ML TABLET, EXTENDED RELEASE; ORAL VERAPAMIL HYDROCHLORIDE CARACO 120MG

A070451 001 Dec 16, 1985 Mar

DISC

AB

A090529 001 Dec 30, 2011 May

CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-82

AB AB

TABLET, EXTENDED RELEASE; ORAL VERAPAMIL HYDROCHLORIDE CARACO 180MG 240MG VERTEPORFIN INJECTABLE; INJECTION VISUDYNE + VALEANT PHARMS INC VINCRISTINE SULFATE INJECTABLE; INJECTION VINCRISTINE SULFATE PFS TEVA PHARMS USA 1MG/ML VINORELBINE TARTRATE INJECTABLE; INJECTION VINORELBINE TARTRATE TEVA PHARMS USA VORICONAZOLE FOR SUSPENSION; ORAL VFEND + PFIZER VORICONAZOLE MYLAN PHARMS INC WARFARIN SODIUM TABLET; ORAL WARFARIN SODIUM AMNEAL PHARMS

A090529 002 Dec 30, 2011 May A090529 003 Dec 30, 2011 May

CAHN CAHN

15MG/VIAL

N021119 001 Apr 12, 2000 Jan

CAHN

AP

A075493 001 Sep 01, 1999 Apr

CAHN

AP

EQ 10MG BASE/ML

A076028 001 Feb 03, 2003 Apr

CAHN

AB AB

200MG/5ML 200MG/5ML

N021630 001 Dec 19, 2003 May A202361 001 May 28, 2013 May

CFTG NEWA

AB AB AB AB AB AB AB AB AB >A> >A> >A> >A> >A> >A> >A> >A> >A> AB AB AB AB AB AB AB AB AB

1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG

A202202 001 Mar 04, 2013 Feb A202202 002 Mar 04, 2013 Feb A202202 003 Mar 04, 2013 Feb A202202 004 Mar 04, 2013 Feb A202202 005 Mar 04, 2013 Feb A202202 006 Mar 04, 2013 Feb A202202 007 Mar 04, 2013 Feb A202202 008 Mar 04, 2013 Feb A202202 009 Mar 04, 2013 Feb A200104 001 Jun 27, 2013 Jun A200104 002 Jun 27, 2013 Jun A200104 003 Jun 27, 2013 Jun A200104 004 Jun 27, 2013 Jun A200104 005 Jun 27, 2013 Jun A200104 006 Jun 27, 2013 Jun A200104 007 Jun 27, 2013 Jun A200104 008 Jun 27, 2013 Jun A200104 009 Jun 27, 2013 Jun

NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA

IPCA LABS LTD

1MG 2MG 2.5MG 3MG 4MG 5MG 6MG 7.5MG 10MG

ZALEPLON CAPSULE; ORAL SONATA PFIZER +

AB AB

5MG 10MG

N020859 001 Aug 13, 1999 Apr N020859 002 Aug 13, 1999 Apr

CAHN CAHN

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-83

ZIDOVUDINE TABLET; ORAL RETROVIR @ VIIV HLTHCARE AB AB + ZIDOVUDINE HEC PHARM USA INC @ HETERO LABS LTD III

300MG 300MG 300MG 300MG

N020518 002 Oct 04, 1996 Apr A202058 001 Oct 07, 2011 Feb A202058 001 Oct 07, 2011 Jan A090092 001 Apr 25, 2008 Apr

DISC CMFD DISC CRLD

ZOLEDRONIC ACID INJECTABLE; INJECTION ZOLEDRONIC ACID DR REDDYS LABS LTD EMCURE PHARMS LTD

AP AP

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

A091363 001 Mar 29, 2013 Mar A201801 001 Mar 29, 2013 Mar

NEWA NEWA

AP AP AP AP AP AP AP AP AP

INJECTABLE; IV (INFUSION) RECLAST + NOVARTIS EQ 5MG BASE/100ML ZOLEDRONIC ACID ACTAVIS INC AGILA SPECLTS DR REDDYS LABS LTD EMCURE PHARMS LTD HIKMA FARMACEUTICA HOSPIRA INC PHARMACEUTICS PHARMS + SUN PHARMA GLOBAL EQ 4MG BASE/5ML EQ 4MG BASE/5ML EQ 4MG BASE/5ML EQ 4MG BASE/5ML EQ 4MG BASE/5ML EQ 5MG BASE/100ML EQ 4MG BASE/5ML EQ 4MG BASE/5ML EQ 4MG BASE/VIAL EQ 4MG BASE/5ML ZOMETA + NOVARTIS ZOLMITRIPTAN TABLET; ORAL ZOLMITRIPTAN APOTEX INC GLENMARK GENERICS MYLAN PHARMS INC ZOMIG IPR + EQ 4MG BASE/5ML

N021817 001 Apr 16, 2007 Mar A202472 001 Mar 04, 2013 Feb A202650 001 Mar 04, 2013 Feb A091186 001 Mar 04, 2013 Feb A201783 001 Mar 12, 2013 Mar A202182 001 Jun 03, 2013 May A202837 001 Apr 05, 2013 Mar A091170 001 Mar 04, 2013 Feb A202571 001 May 07, 2013 Apr A090018 001 Mar 04, 2013 Feb A202746 001 Mar 04, 2013 Feb N021223 002 Mar 07, 2003 Feb

CTEC NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA NEWA CFTG

AP AP

AB AB AB AB AB AB AB AB

2.5MG 5MG 2.5MG 5MG 2.5MG 5MG 2.5MG 5MG

A202078 001 May 14, 2013 Apr A202078 002 May 14, 2013 Apr A201779 001 May 14, 2013 Apr A201779 002 May 14, 2013 Apr A203186 001 May 14, 2013 Apr A203186 002 May 14, 2013 Apr N020768 001 Nov 25, 1997 Apr N020768 002 Nov 25, 1997 Apr

NEWA NEWA NEWA NEWA NEWA NEWA CFTG CFTG

AB AB AB AB AB AB AB AB

TABLET, ORALLY DISINTEGRATING; ORAL ZOLMITRIPTAN APOTEX INC 2.5MG 5MG GLENMARK GENERICS ZYDUS PHARMS USA INC ZOMIG-ZMT ASTRAZENECA + 2.5MG 5MG 2.5MG 5MG 2.5MG 5MG

A202476 001 May 14, 2013 Apr A202476 002 May 14, 2013 Apr A202560 001 May 14, 2013 Apr A202560 002 May 14, 2013 Apr A202890 001 May 15, 2013 Apr A202890 002 May 15, 2013 Apr N021231 001 Feb 13, 2001 Apr N021231 002 Sep 17, 2001 Apr

NEWA NEWA NEWA NEWA NEWA NEWA CFTG CFTG

RX DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

1-84

ZOLPIDEM TARTRATE TABLET; ORAL ZOLPIDEM TARTRATE @ DR REDDYS LABS LTD @

5MG 10MG

A077985 001 Apr 23, 2007 Apr A077985 002 Apr 23, 2007 Apr

DISC DISC

AB AB AB AB

TABLET, EXTENDED RELEASE; ORAL ZOLPIDEM TARTRATE ACTAVIS ELIZABETH 6.25MG 12.5MG WATSON LABS INC FL 6.25MG 12.5MG ZONISAMIDE CAPSULE; ORAL ZONISAMIDE @ COREPHARMA @ @ @ DR REDDYS LABS LTD @ @

A078179 002 Oct 13, 2010 Apr A078179 001 Jun 06, 2011 Apr A090153 001 Mar 25, 2013 Mar A090153 002 Mar 25, 2013 Mar

CAHN CAHN NEWA NEWA

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

A077876 001 Feb 21, 2007 Feb A077876 002 Feb 21, 2007 Feb A077876 003 Feb 21, 2007 Feb A077645 002 Sep 29, 2006 Mar A077645 003 Sep 29, 2006 Mar A077645 001 Dec 22, 2005 Mar

DISC DISC DISC DISC DISC DISC

OTC DRUG PRODUCT LIST OTC DRUG PRODUCT LIST -

33RD EDITION 6 June 2013 2-1

CUMULATIVE SUPPLEMENT

ASPIRIN CAPSULE; ORAL ASPIRIN + PLX PHARMA CETIRIZINE HYDROCHLORIDE SYRUP; ORAL CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY @ APOTEX INC 5MG/5ML BIO PHARM INC 5MG/5ML CARACO 5MG/5ML CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF @ APOTEX INC 5MG/5ML BIO PHARM INC CARACO 5MG/5ML 5MG/5ML

325MG

N203697 001 Jan 14, 2013 Jan

NEWA

A090188 002 Apr 22, 2008 Apr A090474 002 Mar 30, 2009 May A091327 001 Oct 17, 2011 May A090188 001 Apr 22, 2008 Apr A090474 001 Mar 30, 2009 May A091327 002 Oct 17, 2011 May

DISC CAHN CAHN DISC CAHN CAHN

TABLET, CHEWABLE; ORAL CETIRIZINE HYDROCHLORIDE ALLERGY + SANDOZ 10MG CHILDREN'S ZYRTEC ALLERGY @ MCNEIL CONS 5MG + @ 5MG 10MG CHILDREN'S ZYRTEC HIVES RELIEF @ MCNEIL CONS 5MG + @ CHLORHEXIDINE GLUCONATE SOLUTION; TOPICAL DYNA-HEX BAJAJ MEDICAL LLC 5MG 10MG

A078692 002 Feb 14, 2008 Apr N021621 003 Nov 16, 2007 Apr N021621 003 Nov 16, 2007 Feb N021621 004 Nov 16, 2007 Feb N021621 005 Nov 16, 2007 Apr N021621 005 Nov 16, 2007 Feb N021621 006 Nov 16, 2007 Feb

CRLD DISC CRLD DISC DISC CRLD DISC

0.75%

N020111 001 Sep 11, 1997 Apr

CAHN

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SWAB; TOPICAL PREVANTICS MAXI SWABSTICK + PROF DSPLS 3.15%;70% (5.1ML) PREVANTICS SWAB + PROF DSPLS PREVANTICS SWABSTICK + PROF DSPLS 3.15%;70% (1ML) 3.15%;70% (1.6ML)

N021524 003 Jun 03, 2005 Mar N021524 001 Jun 03, 2005 Mar N021524 002 Jun 03, 2005 Mar

CTNA CTNA CTNA

DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE; ORAL DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE AVANTHI INC 6MG;120MG FEXOFENADINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING; ORAL CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY DR REDDYS LABS LTD 30MG CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES DR REDDYS LABS LTD 30MG

A078648 001 Feb 27, 2013 Feb

NEWA

A202978 001 Jan 18, 2013 Jan A202978 002 Jan 18, 2013 Jan

NEWA NEWA

OTC DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

2-2

KETOTIFEN FUMARATE SOLUTION/DROPS; OPHTHALMIC KETOTIFEN FUMARATE @ APOTEX INC EQ 0.025% BASE LEVONORGESTREL TABLET; ORAL LEVONORGESTREL LUPIN LTD AB + NOVEL LABS INC PLAN B ONE-STEP TEVA BRANDED PHARM

A077354 001 May 09, 2006 Apr

DISC

0.75MG 1.5MG 1.5MG

A091328 001 Jan 23, 2013 Jan A202508 001 Feb 22, 2013 Feb N021998 001 Jul 10, 2009 Apr

NEWA NEWA CAHN

LORATADINE SYRUP; ORAL LORATADINE @ APOTEX INC

1MG/ML

A075565 001 Oct 05, 2004 Apr

DISC

LORATADINE; PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE; ORAL LORATADINE AND PSEUDOEPHEDRINE SULFATE @ WATSON LABS INC FL 5MG;120MG MICONAZOLE NITRATE CREAM; VAGINAL MICONAZOLE NITRATE APHENA PHARMA MD MINOXIDIL SOLUTION; TOPICAL MINOXIDIL (FOR MEN) @ APOTEX INC MINOXIDIL (FOR WOMEN) @ APOTEX INC

A076208 001 Jan 28, 2004 Feb

DISC

2%

A074366 001 Feb 22, 1996 Jan

CAHN

2% 2%

A074924 001 Apr 29, 1998 Apr A074924 002 Apr 29, 1998 Apr A075839 001 Oct 01, 2001 Apr

DISC DISC DISC

MINOXIDIL EXTRA STRENGTH (FOR MEN) @ APOTEX INC 5% NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE SOLUTION/DROPS; OPHTHALMIC NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE AKORN INC 0.025%;0.3% OMEPRAZOLE; SODIUM BICARBONATE >A> >A> >A> FOR SUSPENSION; ORAL ZEGERID OTC + MSD CONSUMER OXYBUTYNIN FILM, EXTENDED RELEASE; TRANSDERMAL OXYTROL FOR WOMEN + MSD CONSUMER 3.9MG/24HR

A202795 001 Jan 24, 2013 Jan

NEWA

20MG/PACKET;1.68GM/PACKET

N022283 001 Jun 17, 2013 Jun

NEWA

N202211 001 Jan 25, 2013 Jan

NEWA

OTC DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT

June 2013

2-3

POLYETHYLENE GLYCOL 3350 FOR SOLUTION; ORAL POLYETHYLENE GLYCOL 3350 PAR PHARM 17GM/SCOOPFUL RANITIDINE HYDROCHLORIDE TABLET; ORAL RANITIDINE HYDROCHLORIDE @ WATSON LABS EQ 75MG BASE

A079214 001 Jan 31, 2013 Jan

NEWA

A075212 001 Jan 14, 2000 Mar

DISC

3-1 DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST CUMULATIVE SUPPLEMENT NUMBER 06 JUNE 2013

NO JUNE 2013 APPROVALS

4-1

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST

The list of List of Orphan Designations and Approvals is available at: http://www.fda.gov/orphan/designat/list.htm

5-1 DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO JUNE 2013 ADDITIONS

PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 33RD EDITION
A-1

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO
N021539 001

PATENT NO
8399445

PATENT CODES
U-1373

EXCLUSIVITY CODE(S)

ACETYLCYSTEINE - ACETADOTE Aug 24, 2025

ACYCLOVIR - SITAVIG N203791 001 ADAPALENE - DIFFERIN N022502 001 8435502 Sep 15, 2026 DP U-1078

NP

Apr

12, 2016

ADAPALENE; BENZOYL PEROXIDE - EPIDUO N022320 001 >A> 8445543 Jul 12, 2027 U-1078 NPP Feb 01, 2016

ALOGLIPTIN BENZOATE - NESINA N022271 001 6150383 6211205 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 ALOGLIPTIN BENZOATE - NESINA N022271 002 6150383 6211205 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 ALOGLIPTIN BENZOATE - NESINA N022271 003 6150383 6211205 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539

Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar

19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025

U-1330 U-1331 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 DS

NCE

Jan

25, 2018

Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar

19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS

U-1330 U-1331 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338

NCE

Jan

25, 2018

Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar

19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025

U-1330 U-1331 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 DS

NCE

Jan

25, 2018

A-2

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1339 U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1332 U-1333 U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 DS

EXCLUSIVITY CODE(S)
NCE NC

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO N203414 001 5965584 Jun 19, 2016 6150383 6150384 6166042 6166043 6172090 6211205 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025

Jan Jan

25, 2018 25, 2016

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO N203414 002 5965584 Jun 19, 2016 6150383 6150384 6166042 6166043 6172090 6211205 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025

U-1339 U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1332 U-1333 U-1334 U-1335 U-1335 U-1336

NCE NC

Jan Jan

25, 2018 25, 2016

DS DP U-1337 U-1338 DS

A-3

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NCE NC

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 001 5965584 Jun 19, 2016 DP U-1339 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338

Jan Jan

25, 2018 25, 2016

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 002 5965584 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS DP U-1339 U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 NCE NC Jan Jan 25, 2018 25, 2016

A-4

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NCE NC

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 003 5965584 Jun 19, 2016 DP U-1339 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338

Jan Jan

25, 2018 25, 2016

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 004 5965584 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS DP U-1339 U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 NCE NC Jan Jan 25, 2018 25, 2016

A-5

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
NCE NC

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 005 5965584 Jun 19, 2016 DP U-1339 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338

Jan Jan

25, 2018 25, 2016

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI N022426 006 5965584 6150383 6150384 6166042 6166043 6172090 6211205 6271243 6303640 6303661 6329404 6890898 7078381 7459428 7807689 8173663 8288539 AMBRISENTAN - LETAIRIS N022081 001 8349843 Oct 07, 2015 DS DP Jun Jun Jun Jun Jun Jun Jun Jun Aug Apr Jun Feb Feb Feb Jun Mar Mar 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 19, 2016 09, 2016 24, 2017 19, 2016 02, 2019 02, 2019 02, 2019 27, 2028 15, 2025 15, 2025 DS DP U-1339 U-1330 U-1340 U-1341 U-1342 U-1343 U-1331 U-1344 U-1332 U-1333 DP U-1334 U-1335 U-1335 U-1336 DS DP U-1337 U-1338 NCE NC Jan Jan 25, 2018 25, 2016

AMBRISENTAN - LETAIRIS N022081 002 8349843 Oct 07, 2015 DS DP

AMOXICILLIN - MOXATAG N050813 001 8357394 APIXABAN - ELIQUIS N202155 001 6413980 6967208 6967208

Dec

08, 2026

DP

Dec Feb Feb

22, 2019 03, 2023 03, 2023

DS DP U-1200 DS DP U-1323 DS DP U-1200

A-6

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-1200 DS DP U-1323 DS DP U-1200

EXCLUSIVITY CODE(S)

APIXABAN - ELIQUIS N202155 002 6413980 6967208 6967208 ARFORMOTEROL TARTRATE - BROVANA N021912 001 >A> 7348362 >A> 7462645 >A> 7465756 >A> 7473710 >A> 7541385

Dec Feb Feb

22, 2019 03, 2023 03, 2023

Jun Jun Jun Jun Jun

22, 2021 22, 2021 22, 2021 22, 2021 22, 2021

DP U-793 U-793 DP U-793 U-793

ARIPIPRAZOLE - ABILIFY MAINTENA KIT N202971 001 5006528 Apr 7807680 8030313 8338427 8338428 8399469 Oct Oct Mar Aug Dec

20, 2015 19, 2024 19, 2024 15, 2025 06, 2023 29, 2023

DS DP U-543 DP U-543 DP U-543 DP U-543 DS

NDF

Feb

28, 2016

ARIPIPRAZOLE - ABILIFY MAINTENA KIT N202971 002 5006528 7807680 8030313 8338427 8338428 8399469 ASENAPINE MALEATE - SAPHRIS N022117 001 5763476 Jun 09, 2020 DP U-326 Apr Oct Oct Mar Aug Dec 20, 2015 19, 2024 19, 2024 15, 2025 06, 2023 29, 2023 DS DS DP U-543 DP U-543 DP U-543 DP U-543 NDF Feb 28, 2016

ASENAPINE MALEATE - SAPHRIS N022117 002 5763476 Jun 09, 2020 DP U-326

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET N200153 001 5846966 Sep 21, 2013 5846966*PED RE42461 RE42461*PED Mar Oct Apr 21, 2014 25, 2016 25, 2017

DP U-1400 DS DP U-1400

NC

May

03, 2016

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET N200153 002 5846966 5846966*PED RE42461 RE42461*PED Sep Mar Oct Apr 21, 2013 21, 2014 25, 2016 25, 2017 DP U-1400 DS DP U-1400 NC May 03, 2016

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET N200153 003 5846966 Sep 21, 2013 5846966*PED RE42461 RE42461*PED Mar Oct Apr 21, 2014 25, 2016 25, 2017

DP U-1400 DS DP U-1400

NC

May

03, 2016

A-7

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-1400 DS DP U-1400

EXCLUSIVITY CODE(S)
NC

ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET N200153 004 5846966 Sep 21, 2013 5846966*PED RE42461 RE42461*PED Mar Oct Apr 21, 2014 25, 2016 25, 2017

May

03, 2016

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR N202331 002 AZTREONAM - CAYSTON N050814 001 8399496 Dec 20, 2021 DP U-1377 NCE NC Feb Dec 25, 2016 20, 2014

BEDAQUILINE FUMARATE - SIRTURO N204384 001 7498343

Oct

02, 2024

DS DP U-1321

ODE

Dec

28, 2019

BENDAMUSTINE HYDROCHLORIDE - TREANDA N022249 001 8436190 Oct 26, 2030 8436190*PED 8445524 8445524*PED Apr Mar Sep 26, 2031 26, 2029 26, 2029

DP DS DP U-1402

BENDAMUSTINE HYDROCHLORIDE - TREANDA N022249 002 8436190 8436190*PED 8445524 8445524*PED BEPOTASTINE BESILATE - BEPREVE N022288 001 >A> 6780877 Oct Apr Mar Sep 26, 2030 26, 2031 26, 2029 26, 2029 DP DS DP U-1402

Sep

19, 2019

DS DP

BESIFLOXACIN HYDROCHLORIDE - BESIVANCE N022308 001 8415342 Nov 07, 2030 U-80

BOCEPREVIR - VICTRELIS N202258 001 BRIMONIDINE TARTRATE; BRINZOLAMIDE - SIMBRINZA N204251 001 BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN N021398 001 8354409 Apr 19, 2022 BROMFENAC SODIUM - PROLENSA N203168 001 8129431 Sep 11, 2025 DS DP NP Apr 05, 2016 DP U-1371 NC Apr 19, 2016 M-126 NPP Feb Feb 27, 2016 13, 2016

BROMOCRIPTINE MESYLATE - CYCLOSET N020866 001 7888310 7888310 8137992 8137993 8137994 8431155 Jul Jul Jul Jul Jul Apr 25, 2023 25, 2023 25, 2023 25, 2023 25, 2023 30, 2032 U-976 U-1379 U-1380 U-1379 U-1379 DP U-1379

A-8

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-1325 DP DP DP U-1325

EXCLUSIVITY CODE(S)
NDF

BUDESONIDE - UCERIS N203634 001 7410651 7431943 8293273 RE43799

Jun Jun Jun Jun

09, 2020 09, 2020 09, 2020 09, 2020

Jan

14, 2016

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT N021929 001 8387615 >A> 8461211 Nov Sep 10, 2024 09, 2018 DP U-1118

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT N021929 002 8387615 Nov 10, 2024 DP

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N022410 001 >A> 8475832 Mar 02, 2030 DP U-1411

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N022410 002 Mar 02, 2030 DP U-1411 >A> 8475832 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N022410 003 >A> 8475832 Mar 02, 2030 DP U-1411

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE N022410 004 >A> 8475832 Mar 02, 2030 DP U-1411

CABOZANTINIB S-MALATE - COMETRIQ N203756 001 CABOZANTINIB S-MALATE - COMETRIQ N203756 002 CALCITONIN SALMON RECOMBINANT - FORTICAL N021406 001 RE43580 Feb 02, 2021 DP U-227 ODE Nov 29, 2019 ODE Nov 29, 2019

CANAGLIFLOZIN - INVOKANA N204042 001 7943582 7943788 8222219 CANAGLIFLOZIN - INVOKANA N204042 002 7943582 7943788 8222219 Feb Jul Jul 26, 2029 14, 2027 30, 2024 DS DP U-493 DS DP U-493 NCE Mar 29, 2018 Feb Jul Jul 26, 2029 14, 2027 30, 2024 DS DP U-493 DS DP U-493 NCE Mar 29, 2018

CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL A078702 001 CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL A078702 002 CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL A078702 003 CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL A078702 004 A090704 003 CARBINOXAMINE MALEATE - KARBINAL ER N022556 001 8062667 Mar 29, 2029 DP PC Jul 09, 2013 PC Jul 09, 2013 PC Jul 09, 2013

PC

Jul

09, 2013

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE PC Jun 02, 2013

A-9

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-247 U-1352 U-1351 U-1350 U-1349 U-1348

EXCLUSIVITY CODE(S)

CELECOXIB - CELEBREX N020998 001 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048*PED CELECOXIB - CELEBREX N020998 002 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048*PED CELECOXIB - CELEBREX N020998 003 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048*PED CELECOXIB - CELEBREX N020998 004 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048 RE44048*PED

Jun Jun Jun Jun Jun Jun Dec

02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015

Jun Jun Jun Jun Jun Jun Dec

02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015

U-247 U-1352 U-1351 U-1350 U-1349 U-1348

Jun Jun Jun Jun Jun Jun Dec

02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015

U-247 U-1352 U-1351 U-1350 U-1349 U-1348

Jun Jun Jun Jun Jun Jun Dec

02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015 02, 2015

U-247 U-1352 U-1351 U-1350 U-1349 U-1348

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT N020832 002 7422388 Apr 25, 2027 DP U-1397

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT N020832 005 7422388 Apr 25, 2027 DP U-1397

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT N020832 007 7422388 Apr 25, 2027 DP U-1397

CICLESONIDE - ALVESCO N021658 002 8371292 CICLESONIDE - ALVESCO N021658 003 8371292

Aug

25, 2027

U-1355

M-125

Dec

17, 2015

Aug

25, 2027

U-1355

M-125

Dec

17, 2015

CICLESONIDE - OMNARIS N022004 001 8371292 8383611 Aug Oct 25, 2027 20, 2020 DP U-1356

A - 10

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1357

EXCLUSIVITY CODE(S)

CICLESONIDE - ZETONNA N202129 001 8371292

Aug

25, 2027

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR N021473 001 >A> 8187632 Jun 23, 2021 DP

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR N021473 002 >A> 8187632 Jun 23, 2021 DP

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - PREPOPIK N202535 001 8450338 Oct 10, 2028 DP >A> 8481083 CLOBAZAM - ONFI N203993 001 CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE A201402 001 CLOBETASOL PROPIONATE - OLUX E N022013 001 >A> 8460641 Nov 05, 2028 DP U-1410 PC Jul 31, 2013 Oct 10, 2028 DP

ODE

Oct

21, 2018

COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - STRIBILD N203100 001 5814639*PED 5914331*PED 5922695*PED 5935946*PED 5977089*PED 6043230*PED 6642245*PED 6703396*PED 7635704 COLCHICINE - COLCRYS N022352 001 8415395 8415396 8440721 8440722 CYSTEAMINE BITARTRATE - PROCYSBI N203389 001 8026284 8129433 Sep Jan 22, 2027 26, 2027 U-1399 DP NDF Apr 30, 2016 Oct Oct Feb Feb 06, 2028 06, 2028 17, 2029 17, 2029 U-1007 U-1007 U-1007 U-1020 Mar Jan Jan Jan Jan Jan May Sep Oct 29, 2016 02, 2018 25, 2018 25, 2018 25, 2018 25, 2018 04, 2021 09, 2021 26, 2026 DS DP U-257

CYSTEAMINE BITARTRATE - PROCYSBI N203389 002 8026284 8129433 Sep Jan 22, 2027 26, 2027 U-1399 DP NDF Apr 30, 2016

DABRAFENIB MESYLATE - TAFINLAR N202806 001 >A> 7994185 >A> 8415345 Jan Jan 20, 2030 20, 2030 DS DP U-1406 DS DP U-1406 NCE >A> ODE May May 29, 2018 29, 2020

DABRAFENIB MESYLATE - TAFINLAR N202806 002 NCE >A> ODE May May 29, 2018 29, 2020

A - 11

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1030 U-1030 U-1030

EXCLUSIVITY CODE(S)

DALFAMPRIDINE - AMPYRA N022250 001 >A> 5540938 8354437 >A> 8440703 DARUNAVIR ETHANOLATE - PREZISTA N021976 001 DARUNAVIR ETHANOLATE - PREZISTA N021976 002 DARUNAVIR ETHANOLATE - PREZISTA N021976 003 DARUNAVIR ETHANOLATE - PREZISTA N021976 004 DARUNAVIR ETHANOLATE - PREZISTA N021976 005 DARUNAVIR ETHANOLATE - PREZISTA N021976 006 DARUNAVIR ETHANOLATE - PREZISTA N202895 001 DEFERASIROX - EXJADE N021882 001 DEFERASIROX - EXJADE N021882 002 DEFERASIROX - EXJADE N021882 003 DESONIDE - VERDESO N021978 001 >A> 8460641

Jul Dec Apr

30, 2018 22, 2026 08, 2025

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

D-135 PED

Feb Aug

01, 2016 01, 2016

I-665

Jan

23, 2016

I-665

Jan

23, 2016

I-665

Jan

23, 2016

Nov

05, 2028

DP U-1412

DESOXIMETASONE - TOPICORT N204141 001 >A> 5990100 >A> 8277780

Mar Apr

24, 2018 23, 2028

DP U-1408 DP U-1408

NDF

Apr

11, 2016

DESVENLAFAXINE SUCCINATE - PRISTIQ N021992 001 6673838 Feb 6673838 Feb

11, 2022 11, 2022

DS DP U-860 DS DP U-1364

DESVENLAFAXINE SUCCINATE - PRISTIQ N021992 002 6673838 Feb 6673838 DEXLANSOPRAZOLE - DEXILANT N022287 001 >A> 8461187 >A> 8461187*PED Feb

11, 2022 11, 2022

DS DP U-860 DS DP U-1364

Jan Jul

17, 2026 17, 2026

DP

A - 12

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

DEXLANSOPRAZOLE - DEXILANT N022287 002 >A> 8461187 >A> 8461187*PED

Jan Jul

17, 2026 17, 2026

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX Jul 15, 2013 N021038 001 4910214 4910214*PED Jan 15, 2014 6716867 6716867*PED Mar Oct 31, 2019 01, 2019

DS DP U-421 U-572

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX N021038 002 4910214 4910214*PED 6716867 6716867*PED 8242158 8242158*PED 8338470 8338470*PED 8455527 8455527*PED Jul Jan Mar Oct Jan Jul Jan Jul Jan Jul 15, 2013 15, 2014 31, 2019 01, 2019 04, 2032 04, 2032 04, 2032 04, 2032 04, 2032 04, 2032 U-421 DP DP DS DP U-421 U-572

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX N021038 003 4910214 4910214*PED 6716867 6716867*PED 8242158 8242158*PED 8338470 8338470*PED 8455527 8455527*PED DIFLUPREDNATE - DUREZOL N022212 001 6114319 6114319*PED Jul Jan Mar Oct Jan Jul Jan Jul Jan Jul 15, 2013 15, 2014 31, 2019 01, 2019 04, 2032 04, 2032 04, 2032 04, 2032 04, 2032 04, 2032 DP U-421 DP DS DP U-421 U-572

May Nov

18, 2019 18, 2019

DP

I-653 M-127 ODE PED PED PED

Jun Mar Jun Dec Sep Dec

13, 22, 13, 13, 22, 13,

2015 2016 2019 2019 2016 2015

DIMETHYL FUMARATE - TECFIDERA N204063 001 6509376 7320999 7619001 7803840 8399514 DIMETHYL FUMARATE - TECFIDERA N204063 002 6509376 7320999 7619001 7803840 8399514

Oct May Apr Apr Feb

29, 2019 18, 2020 01, 2018 01, 2018 07, 2028

DP U-1384 U-1384 U-1385 U-1384

NCE

Mar

27, 2018

Oct May Apr Apr Feb

29, 2019 18, 2020 01, 2018 01, 2018 07, 2028

DP U-1384 U-1384 U-1385 U-1384

NCE

Mar

27, 2018

A - 13

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

DONEPEZIL HYDROCHLORIDE - ARICEPT N022568 001 Oct >A> 8481565 DOXYCYCLINE - ORACEA N050805 001 >A> 8394405 >A> 8394406 >A> 8470364 Apr Apr Apr

04, 2026

07, 2024 07, 2024 07, 2024

DP U-925 DP U-925 DP U-925

DOXYCYCLINE HYCLATE - DORYX N050795 004 6958161 DOXYCYCLINE HYCLATE - DORYX N050795 005 6958161

Dec

15, 2022

DP U-918

Dec

15, 2022

DP U-918

D-136 NS

Apr Apr

11, 2016 11, 2016

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - DICLEGIS N021876 001 6340695 7560122 Jun Jan 21, 2021 25, 2019 DP U-1382 DP NP Apr 08, 2016

DRONEDARONE HYDROCHLORIDE - MULTAQ N022425 001 5223510 5223510 8410167 8410167 Jul Jul Apr Apr 26, 2016 26, 2016 16, 2029 16, 2029 DS DP U-992 DS DP U-1261 U-1388 U-1387

DROSPIRENONE; ETHINYL ESTRADIOL - YAZ N021676 001 RE43916 Jun 30, 2014 U-1326

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ N022532 001 RE43916 Jun 30, 2014 U-1326 DULOXETINE HYDROCHLORIDE - CYMBALTA N021427 001 DULOXETINE HYDROCHLORIDE - CYMBALTA N021427 002 DULOXETINE HYDROCHLORIDE - CYMBALTA N021427 004 EFAVIRENZ - SUSTIVA N020972 001 5519021 5519021*PED 5663169 5663169*PED 6238695 6238695*PED 6555133 6555133*PED 6639071 6639071*PED 6939964 6939964*PED May Nov Sep Mar Apr Oct Apr Oct Feb Aug Jan Jul 21, 2013 21, 2013 02, 2014 02, 2015 06, 2019 06, 2019 06, 2019 06, 2019 14, 2018 14, 2018 20, 2018 20, 2018 DS DS DP U-248 U-257 DS DP NPP PED May Nov 02, 2016 02, 2016 M-61 PED Oct Apr 18, 2015 18, 2016 M-61 PED Oct Apr 18, 2015 18, 2016 M-61 PED Oct Apr 18, 2015 18, 2016

A - 14

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-257 DP U-248 DS DS

EXCLUSIVITY CODE(S)

EFAVIRENZ - SUSTIVA N020972 002 5519021 5519021*PED 5663169 5663169*PED 6238695 6238695*PED 6555133 6555133*PED 6639071 6639071*PED 6939964 6939964*PED EFAVIRENZ - SUSTIVA N020972 003 5519021 5519021*PED 5663169 5663169*PED 6238695 6238695*PED 6555133 6555133*PED 6639071 6639071*PED 6939964 6939964*PED EFAVIRENZ - SUSTIVA N021360 001 5519021 5519021*PED 5663169 5663169*PED 6639071 6639071*PED 6939964 6939964*PED EFAVIRENZ - SUSTIVA N021360 002 5519021 5519021*PED 5663169 5663169*PED 6639071 6639071*PED 6939964 6939964*PED

May Nov Sep Mar Apr Oct Apr Oct Feb Aug Jan Jul

21, 2013 21, 2013 02, 2014 02, 2015 06, 2019 06, 2019 06, 2019 06, 2019 14, 2018 14, 2018 20, 2018 20, 2018

May Nov Sep Mar Apr Oct Apr Oct Feb Aug Jan Jul

21, 2013 21, 2013 02, 2014 02, 2015 06, 2019 06, 2019 06, 2019 06, 2019 14, 2018 14, 2018 20, 2018 20, 2018

DS DP U-257 DP U-248 DS DS

NPP PED

May Nov

02, 2016 02, 2016

May Nov Sep Mar Feb Aug Jan Jul

21, 2013 21, 2013 02, 2014 02, 2015 14, 2018 14, 2018 20, 2018 20, 2018 DS DS

May Nov Sep Mar Feb Aug Jan Jul

21, 2013 21, 2013 02, 2014 02, 2015 14, 2018 14, 2018 20, 2018 20, 2018

DS DP U-248 DS DS

NPP PED

May Nov

02, 2016 02, 2016

A - 15

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA N021937 001 5519021 May 21, 2013 DS DP 5519021*PED 5663169 5663169 5663169*PED 6639071 6639071*PED 6939964 6939964*PED EPINEPHRINE - AUVI-Q N201739 001 7731686 7731690 7749194 7918823 7947017 8016788 8206360 8361029 8425462 EPINEPHRINE - AUVI-Q N201739 002 7731686 7731690 7749194 7918823 7947017 8016788 8206360 8361029 8425462 EPOPROSTENOL SODIUM - VELETRI N022260 001 8318802 EPOPROSTENOL SODIUM - VELETRI N022260 002 8318802 Mar 15, 2027 DP Nov Sep Sep Mar Feb Aug Jan Jul 21, 2013 02, 2014 02, 2014 02, 2015 14, 2018 14, 2018 20, 2018 20, 2018 DS DS U-750 U-1170

Jun Jan Oct Nov Mar Mar Feb Nov Nov

01, 2026 15, 2025 30, 2028 23, 2024 12, 2028 21, 2025 27, 2027 23, 2024 23, 2024

DP DP DP DP DP DP DP DP DP

Jun Jan Oct Nov Mar Mar Feb Nov Nov

01, 2026 15, 2025 30, 2028 23, 2024 12, 2028 21, 2025 27, 2027 23, 2024 23, 2024

DP DP DP DP DP DP DP DP DP

Mar

15, 2027

DP

ERLOTINIB HYDROCHLORIDE - TARCEVA N021743 001 6900221 6900221 6900221 6900221 7087613 7087613 7087613 Nov Nov Nov Nov Nov Nov Nov 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 DS DP U-875 DS DP U-659 DS DP U-1403 DS DP U-1046 U-659 U-1403 U-1045 I-671 May 14, 2016

A - 16

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-875 DS DP U-659 DS DP U-1403 DS DP U-1046 U-659 U-1403 U-1045

EXCLUSIVITY CODE(S)
I-671

ERLOTINIB HYDROCHLORIDE - TARCEVA Nov N021743 002 6900221 Nov 6900221 6900221 6900221 7087613 7087613 7087613 Nov Nov Nov Nov Nov

09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020

May

14, 2016

ERLOTINIB HYDROCHLORIDE - TARCEVA N021743 003 6900221 6900221 6900221 6900221 7087613 7087613 7087613 ESTRADIOL - MINIVELLE N203752 001 5646286 6024976 8231906 ESTRADIOL - MINIVELLE N203752 002 5646286 6024976 8231906 ESTRADIOL - MINIVELLE N203752 003 5646286 6024976 8231906 ESTRADIOL - MINIVELLE N203752 004 5646286 6024976 8231906 ESZOPICLONE - LUNESTA N021476 001 ESZOPICLONE - LUNESTA N021476 002 ESZOPICLONE - LUNESTA N021476 003 ETHINYL ESTRADIOL; LEVONORGESTREL - QUARTETTE N204061 001 8415332 8450299 Mar Oct 11, 2029 07, 2025 DP U-1 NP Mar 28, 2016 M-61 PED Oct Apr 10, 2015 10, 2016 Aug Jan May 12, 2014 07, 2014 24, 2030 DS DP DS DP DS DP Aug Jan May 12, 2014 07, 2014 24, 2030 DS DP DS DP DS DP Aug Jan May 12, 2014 07, 2014 24, 2030 DS DP DS DP DS DP Nov Nov Nov Nov Nov Nov Nov 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 09, 2020 DS DP U-875 DS DP U-659 DS DP U-1403 DS DP U-1046 U-659 U-1403 U-1045 I-671 May 14, 2016

Aug Jan May

12, 2014 07, 2014 24, 2030

DS DP DS DP DS DP

M-61 PED

Oct Apr

10, 2015 10, 2016

M-61 PED

Oct Apr

10, 2015 10, 2016

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE N203667 001 5552394 Jul 22, 2014 U-1 NDF May 08, 2016

A - 17

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE N204426 001 5552394 Jul 22, 2014 U-1 6652880 EVEROLIMUS - AFINITOR N022334 001 8410131 8410131*PED 8436010 8436010*PED EVEROLIMUS - AFINITOR N022334 002 8410131 8410131*PED 8436010 8436010*PED EVEROLIMUS - AFINITOR N022334 003 8410131 8410131*PED 8436010 8436010*PED EVEROLIMUS - AFINITOR N022334 004 8410131 8410131*PED 8436010 8436010*PED EVEROLIMUS - ZORTRESS N021560 001 5665772 5665772 5665772*PED 6004973 6004973 6004973*PED 6440990 6440990 6440990*PED 6455518 6455518 6455518*PED Sep Sep Mar Jul Jul Jan Sep Sep Mar Jul Jul Jan 09, 2019 09, 2019 09, 2020 12, 2016 12, 2016 12, 2017 24, 2013 24, 2013 24, 2014 29, 2017 29, 2017 29, 2018 DS DP U-1365 DS DP U-1049 DP U-1365 DP U-1049 DP U-1365 DP U-1049 U-1365 U-1049 I-668 Feb 15, 2016 May Nov Feb Aug 22, 2025 22, 2025 22, 2022 22, 2022 DS DP U-1368 DS DP U-1396 May Nov Feb Aug 22, 2025 22, 2025 22, 2022 22, 2022 DS DP U-1368 DS DP U-1396 Mar 29, 2020 DP

May Nov Feb Aug

22, 2025 22, 2025 22, 2022 22, 2022

DS DP U-1368 DS DP U-1396

May Nov Feb Aug

22, 2025 22, 2025 22, 2022 22, 2022

DS DP U-1368 DS DP U-1396

A - 18

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-1365 DS DP U-1049 DP U-1365 DP U-1049 DP U-1365 DP U-1049 U-1365 U-1049

EXCLUSIVITY CODE(S)
I-668

EVEROLIMUS - ZORTRESS N021560 002 5665772 5665772 5665772*PED 6004973 6004973 6004973*PED 6440990 6440990 6440990*PED 6455518 6455518 6455518*PED EVEROLIMUS - ZORTRESS N021560 003 5665772 5665772 5665772*PED 6004973 6004973 6004973*PED 6440990 6440990 6440990*PED 6455518 6455518 6455518*PED EXENATIDE SYNTHETIC - BYDUREON N022200 001 8431685 >A> 8461105

Sep Sep Mar Jul Jul Jan Sep Sep Mar Jul Jul Jan

09, 2019 09, 2019 09, 2020 12, 2016 12, 2016 12, 2017 24, 2013 24, 2013 24, 2014 29, 2017 29, 2017 29, 2018

Feb

15, 2016

Sep Sep Mar Jul Jul Jan Sep Sep Mar Jul Jul Jan

09, 2019 09, 2019 09, 2020 12, 2016 12, 2016 12, 2017 24, 2013 24, 2013 24, 2014 29, 2017 29, 2017 29, 2018

DS DP U-1365 DS DP U-1049 DP U-1365 DP U-1049 DP U-1365 DP U-1049 U-1365 U-1049

I-668

Feb

15, 2016

Apr Apr

13, 2025 13, 2025

DP U-412 DP U-412

FAMOTIDINE; IBUPROFEN - DUEXIS N022519 001 FEBUXOSTAT - ULORIC N021856 001 5614520 8372872 FEBUXOSTAT - ULORIC N021856 002 5614520 8372872 FESOTERODINE FUMARATE - TOVIAZ N022030 001 8338478 May 11, 2019 DS DP U-913 Mar Sep 25, 2019 08, 2031 DS DP U-954 U-1346 Mar Sep 25, 2019 08, 2031 DS DP U-954 U-1346 8449910 Jul 18, 2026 DP

FESOTERODINE FUMARATE - TOVIAZ N022030 002 8338478 May 11, 2019 DS DP U-913

FLUTICASONE FUROATE - VERAMYST N022051 001 8347879

Apr

01, 2027

DP

A - 19

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA N204275 001 5873360 Feb 23, 2016 DP 6537983 6759398 6878698 7101866 7361787 7439393 7629335 7776895 8113199 8161968 Aug Aug Aug Aug Mar Sep Aug Sep Oct Feb 03, 2021 03, 2021 03, 2021 03, 2021 23, 2023 11, 2022 03, 2021 11, 2022 23, 2027 05, 2028 DP U-1401 DP U-1401 U-1401 DS DP U-1401 DS DP U-1401 DS DP U-1401 DP DP DP DP

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 001 5929028 5929028 7563763 7563763 7563763 Jan Jan Aug Aug Aug 14, 2018 14, 2018 23, 2019 23, 2019 23, 2019 DP U-567 DP U-1366 U-993 U-1367 U-1183

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 002 5929028 5929028 7563763 7563763 7563763 Jan Jan Aug Aug Aug 14, 2018 14, 2018 23, 2019 23, 2019 23, 2019 DP U-567 DP U-1366 U-993 U-1367 U-1183

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 003 5929028 5929028 7563763 7563763 7563763 Jan Jan Aug Aug Aug 14, 2018 14, 2018 23, 2019 23, 2019 23, 2019 DP U-567 DP U-1366 U-993 U-1367 U-1183

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021211 004 5929028 Jan 14, 2018 5929028 7563763 7563763 7563763 Jan Aug Aug Aug 14, 2018 23, 2019 23, 2019 23, 2019

DP U-567 DP U-1366 U-993 U-1367 U-1183

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021273 001 5767251 Jun 16, 2015 5929028 Jan 14, 2018

DS DP U-1366

FOLLITROPIN ALFA/BETA - FOLLISTIM AQ N021273 002 5767251 Jun 16, 2015 5929028 GABAPENTIN - GRALISE N022544 001 8333992 GABAPENTIN - GRALISE N022544 002 8333992 Oct 25, 2022 Jan 14, 2018

DS DP U-1366

Oct

25, 2022

DP U-1114

DP U-1114

A - 20

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1112

EXCLUSIVITY CODE(S)

GADOFOSVESET TRISODIUM - ABLAVAR N021711 001 8394356 Feb GADOFOSVESET TRISODIUM - ABLAVAR N021711 002 8394356 Feb

01, 2015

01, 2015

U-1112

GADOTERATE MEGLUMINE - DOTAREM N204781 001 GADOTERATE MEGLUMINE - DOTAREM N204781 002 GADOTERATE MEGLUMINE - DOTAREM N204781 003 GADOTERATE MEGLUMINE - DOTAREM N204781 004 GADOXETATE DISODIUM - EOVIST N022090 002 GANIRELIX ACETATE - GANIRELIX ACETATE INJECTION N021057 001 6653286 Jun 16, 2018 U-1354 NCE Mar 20, 2018 NCE Mar 20, 2018 NCE Mar 20, 2018

NCE

Mar

20, 2018

NCE

Jul

03, 2013

GLATIRAMER ACETATE - COPAXONE N020622 002 8367605 May 24, 2014 DS

GLYCEROL PHENYLBUTYRATE - RAVICTI N203284 001 5968979 Feb 8404215 GLYCOPYRROLATE - ROBINUL N012827 001 7091236 GLYCOPYRROLATE - ROBINUL FORTE N012827 002 7091236 IBUPROFEN LYSINE - NEOPROFEN N021903 001 8415337 Mar Mar

07, 2015 09, 2032

DS DP U-1378 U-1383

NE ODE

Feb Feb

01, 2016 01, 2020

Apr

24, 2024

U-877

Apr

24, 2024

U-877

02, 2032

DS DP

ICOSAPENT ETHYL - VASCEPA N202057 001 8357677 8367652 8377920 8399446 8415335 8426399 8431560 8440650 8445003 8445013 IMATINIB MESYLATE - GLEEVEC N021588 001 7544799 RE43932 RE43932*PED Jan Jan Jul 16, 2019 16, 2019 16, 2019 DS DP DS DP Y I-666 ODE Jan Jan 25, 2016 25, 2020 Feb Feb Feb Feb Feb Feb Feb Feb Apr Apr 09, 2030 09, 2030 09, 2030 09, 2030 09, 2030 09, 2030 09, 2030 09, 2030 29, 2030 29, 2030 U-1287 U-1287 U-1287 U-1287 U-1287 U-1287 U-1287 U-1287 U-1287 U-1287

A - 21

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP DS DP

EXCLUSIVITY CODE(S)
I-666 ODE

IMATINIB MESYLATE - GLEEVEC N021588 002 7544799 RE43932 RE43932*PED

Jan Jan Jul

16, 2019 16, 2019 16, 2019

Jan Jan

25, 2016 25, 2020

INDACATEROL MALEATE - ARCAPTA NEOHALER N022383 001 8067437 Jun 02, 2020 U-1168

INGENOL MEBUTATE - PICATO N202833 001 >A> 6844013 8372827 8372828 8377919 INGENOL MEBUTATE - PICATO N202833 002 >A> 6844013 8372827 8372828 8377919

Dec Dec Dec Dec

13, 2018 18, 2026 18, 2026 18, 2026

DS DP U-1221 DS DP DS DP DS DP

Dec Dec Dec Dec

13, 2018 18, 2026 18, 2026 18, 2026

DS DP U-1221 DS DP DS DP DS DP

IOBENGUANE SULFATE I-123 - ADREVIEW N022290 001 IRON SUCROSE - VENOFER N021135 005 ISOTRETINOIN - ABSORICA N021951 001 8367102 Sep 21, 2021 U-1347

I-669

Mar

20, 2016

NPP

Sep

21, 2015

ISOTRETINOIN - ABSORICA N021951 002 8367102 Sep 21, 2021 U-1347

ISOTRETINOIN - ABSORICA N021951 003 8367102 ISOTRETINOIN - ABSORICA N021951 004 8367102

Sep

21, 2021

U-1347

Sep

21, 2021

U-1347

IVACAFTOR - KALYDECO N203188 001 8410274 Dec 28, 2026 DP

KETOROLAC TROMETHAMINE - ACULAR LS N021528 001 8377982 May 8377982*PED Nov LENALIDOMIDE - REVLIMID N021880 001 >A> 7468363 8404717 LENALIDOMIDE - REVLIMID N021880 002 >A> 7468363 8404717 LENALIDOMIDE - REVLIMID N021880 003 >A> 7468363 8404717

28, 2024 28, 2024

U-1363

Oct Apr

07, 2023 11, 2023

U-1414 U-1215

>A> I-672 >A> ODE

Jun Jun

05, 2016 05, 2020

Oct Apr

07, 2023 11, 2023

U-1414 U-1215

>A> I-672 >A> ODE

Jun Jun

05, 2016 05, 2020

Oct Apr

07, 2023 11, 2023

U-1414 U-1215

>A> I-672 >A> ODE

Jun Jun

05, 2016 05, 2020

A - 22

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1414 U-1215

EXCLUSIVITY CODE(S)
>A> I-672 >A> ODE

LENALIDOMIDE - REVLIMID N021880 004 >A> 7468363 8404717 LENALIDOMIDE - REVLIMID N021880 005 >A> 7468363 8404717 LENALIDOMIDE - REVLIMID N021880 006 >A> 7468363

Oct Apr

07, 2023 11, 2023

Jun Jun

05, 2016 05, 2020

Oct Apr

07, 2023 11, 2023

U-1414 U-1215

>A> I-672 >A> ODE

Jun Jun

05, 2016 05, 2020

Oct

07, 2023

U-1414

>A> I-672 >A> NS >A> ODE

Jun Jun Jun

05, 2016 05, 2016 05, 2020

LEVALBUTEROL HYDROCHLORIDE - LEVALBUTEROL HYDROCHLORIDE A077756 001 LEVALBUTEROL HYDROCHLORIDE - LEVALBUTEROL HYDROCHLORIDE A077756 002 LEVALBUTEROL HYDROCHLORIDE - LEVALBUTEROL HYDROCHLORIDE A077756 003 LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 001 6500829 Mar LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 002 6500829 Mar 07, 2022 DS DP 07, 2022 DS DP

PC

Feb

16, 2013

PC

Feb

16, 2013

PC

Feb

16, 2013

LEVOLEUCOVORIN CALCIUM - FUSILEV N020140 003 6500829 Mar 07, 2022 DS DP

LEVONORGESTREL - SKYLA N203159 001 5785053 7252839 LEVOTHYROXINE SODIUM - LEVOXYL N021301 001 7101569 Oct 02, 2023 U-759 Dec Nov 05, 2015 13, 2023 DP DP NP Jan 09, 2016

LEVOTHYROXINE SODIUM - LEVOXYL N021301 002 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 003 7101569

Oct

02, 2023

U-759

Oct

02, 2023

U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 004 7101569 Oct 02, 2023 U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 005 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 006 7101569

Oct

02, 2023

U-759

Oct

02, 2023

U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 007 7101569 Oct 02, 2023 U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 008 7101569 Oct 02, 2023 U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 009 7101569

Oct

02, 2023

U-759

A - 23

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-759

EXCLUSIVITY CODE(S)

LEVOTHYROXINE SODIUM - LEVOXYL N021301 010 7101569 LEVOTHYROXINE SODIUM - LEVOXYL N021301 011 7101569

Oct

02, 2023

Oct

02, 2023

U-759

LEVOTHYROXINE SODIUM - LEVOXYL N021301 012 7101569 Oct 02, 2023 U-759

LOMITAPIDE MESYLATE - JUXTAPID N203858 001 5712279 7932268 LOMITAPIDE MESYLATE - JUXTAPID N203858 002 5712279 7932268 LOMITAPIDE MESYLATE - JUXTAPID N203858 003 5712279 7932268 LOPINAVIR; RITONAVIR - KALETRA N021906 001 8025899 8025899*PED 8377952 8377952*PED 8399015 8399015*PED LOPINAVIR; RITONAVIR - KALETRA N021906 002 8025899 8025899*PED 8377952 8377952*PED 8399015 8399015*PED LOTEPREDNOL ETABONATE - LOTEMAX N202872 001 LOXAPINE - ADASUVE N022549 001 6716416 7052679 7078020 7090830 7458374 7537009 7585493 7601337 8074644 8173107 8235037 8387612 5800807

Feb Aug

21, 2015 19, 2027

DS

U-1317 U-1316

ODE

Dec

21, 2019

Feb Aug

21, 2015 19, 2027

DS

U-1317 U-1316

ODE

Dec

21, 2019

Feb Aug

21, 2015 19, 2027

DS

U-1317 U-1316

ODE

Dec

21, 2019

Dec Jun Oct Apr Aug Feb

14, 2027 14, 2028 22, 2027 22, 2028 25, 2024 25, 2025

DP U-1372 DP

Dec Jun Oct Apr Aug Feb

14, 2027 14, 2028 22, 2027 22, 2028 25, 2024 25, 2025

DP U-1372 DP

Jan

29, 2017

DP

May Mar Oct Oct Aug Oct Oct Oct Oct Oct Oct Oct

20, 2022 20, 2022 26, 2021 26, 2021 18, 2024 26, 2021 26, 2021 26, 2021 26, 2021 26, 2021 26, 2021 23, 2026

DP DP DP U-1375 DP DP DP DP DP DP DP DP DP

A - 24

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-717 U-1392 U-1391 U-739 U-1404 DP U-1393 U-1203 U-1394 U-1214 DP U-1395 DP U-1345

EXCLUSIVITY CODE(S)
I-670

LUBIPROSTONE - AMITIZA N021908 001 6414016 6414016 6982283 7064148 7064148 8026393 8071613 8071613 8097653 8097653 8389542 8389542

Sep Sep Dec Aug Aug Oct Sep Sep Nov Nov Nov Nov

05, 2020 05, 2020 04, 2022 30, 2022 30, 2022 25, 2027 05, 2020 05, 2020 14, 2022 14, 2022 14, 2022 14, 2022

Apr

19, 2016

LURASIDONE HYDROCHLORIDE - LATUDA N200603 001 5532372 Jul 02, 2018 DS

LURASIDONE HYDROCHLORIDE - LATUDA N200603 002 5532372 Jul 02, 2018 DS

LURASIDONE HYDROCHLORIDE - LATUDA N200603 003 5532372 Jul 02, 2018 DS

LURASIDONE HYDROCHLORIDE - LATUDA N200603 004 5532372 Jul

02, 2018

DS

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE - SUCLEAR N203595 001 NC Jan 18, 2016 MEMANTINE HYDROCHLORIDE - NAMENDA XR N022525 001 8168209 8173708 8283379 8329752 8362085 Nov Nov Nov Nov Nov 22, 2025 22, 2025 22, 2025 22, 2025 22, 2025 DP U-539 DP U-539 U-539

MEMANTINE HYDROCHLORIDE - NAMENDA XR N022525 002 8168209 8173708 8283379 8329752 8362085 Nov Nov Nov Nov Nov 22, 2025 22, 2025 22, 2025 22, 2025 22, 2025 DP U-539 DP U-539 U-539

MEMANTINE HYDROCHLORIDE - NAMENDA XR N022525 003 8168209 8173708 8283379 8329752 8362085 Nov Nov Nov Nov Nov 22, 2025 22, 2025 22, 2025 22, 2025 22, 2025 DP U-539 DP U-539 U-539

A - 25

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP U-539 U-539 DP U-539

EXCLUSIVITY CODE(S)

MEMANTINE HYDROCHLORIDE - NAMENDA XR N022525 004 8168209 Nov 22, 2025 8173708 Nov 22, 2025 8283379 8329752 8362085 MESALAMINE - CANASA N021252 002 8217083 8436051 Jun Jun 06, 2028 06, 2028 Nov Nov Nov 22, 2025 22, 2025 22, 2025

DP DP

MESALAMINE - DELZICOL N204412 001 5541170 5541171 >A> 6649180 Jul Jul Apr 30, 2013 30, 2013 13, 2020 DP U-141 DP U-141 DP

METFORMIN HYDROCHLORIDE - FORTAMET N021574 001 Mar >A> 8475841 METFORMIN HYDROCHLORIDE - FORTAMET N021574 002 Mar >A> 8475841

20, 2018

U-604

20, 2018

U-604

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR N022024 001 >A> 8470368 >A> 8475841 Sep Mar 19, 2023 20, 2018 DP U-973

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR N022024 002 >A> 8470368 >A> 8475841 Sep Mar 19, 2023 20, 2018 DP U-973

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR N200678 001 RE44186 Jul 31, 2023 DS DP U-1097

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR N200678 002 RE44186 Jul 31, 2023 DS DP U-1097

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR N200678 003 RE44186 Jul 31, 2023 DS DP U-1097 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET N022044 001 7459428 8414921 Feb Jul 02, 2019 21, 2028 U-1036 DP U-1036

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET N022044 002 7459428 8414921 Feb Jul 02, 2019 21, 2028 U-1036 DP U-1036

METHYLNALTREXONE BROMIDE - RELISTOR N021964 001 8420663 Sep 30, 2029 U-1185

METHYLNALTREXONE BROMIDE - RELISTOR N021964 002 8420663 Sep 30, 2029 U-1185

METHYLNALTREXONE BROMIDE - RELISTOR N021964 003 8420663 Sep 30, 2029 U-1185

A - 26

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP DP U-1415

EXCLUSIVITY CODE(S)

METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR N202100 001 8062667 Mar 29, 2029 8287903 >A> 8465765 Feb Feb 15, 2031 15, 2031

MINOCYCLINE HYDROCHLORIDE - XIMINO N201922 001 5908838 7541347 7544373 7790705 7919483 8252776 8268804 Feb Apr Apr Jun Mar Jun Jun 19, 2018 02, 2027 02, 2027 24, 2025 07, 2027 24, 2025 24, 2025 DP U-124 U-124 U-124 U-124 U-1376 U-917

MINOCYCLINE HYDROCHLORIDE - XIMINO N201922 003 5908838 7541347 7544373 7790705 7919483 8252776 8268804 Feb Apr Apr Jun Mar Jun Jun 19, 2018 02, 2027 02, 2027 24, 2025 07, 2027 24, 2025 24, 2025 DP U-124 U-124 U-124 U-124 U-1376 U-917

MINOCYCLINE HYDROCHLORIDE - XIMINO N201922 005 5908838 Feb 7541347 7544373 7790705 7919483 8252776 8268804 MIPOMERSEN SODIUM - KYNAMRO N203568 001 5914396 6166197 6222025 6451991 7015315 7101993 7407943 7511131 MOMETASONE FUROATE - ELOCON N019625 002 MOXIFLOXACIN HYDROCHLORIDE - MOXEZA N022428 001 8450311 May MUPIROCIN CALCIUM - BACTROBAN N050703 001 5569672 Oct Jun Dec Mar Feb Mar Sep Aug Dec Apr Apr Jun Mar Jun Jun

19, 2018 02, 2027 02, 2027 24, 2025 07, 2027 24, 2025 24, 2025 DP

U-1376 U-917 U-124 U-124 U-124 U-124

22, 2016 26, 2017 06, 2015 11, 2017 21, 2023 05, 2023 01, 2021 13, 2025

DS DS DS DS DS DS U-1353 DS

NCE ODE

Jan Jan

29, 2018 29, 2020

NP

Apr

19, 2016

29, 2029

DP

29, 2013

U-1358

MUPIROCIN CALCIUM - BACTROBAN N050746 001 5569672 Oct 29, 2013 U-1358

MYCOPHENOLIC ACID - MYFORTIC N050791 001 6306900

Feb

27, 2018

DP

A - 27

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

MYCOPHENOLIC ACID - MYFORTIC N050791 002 6306900 NAFTIFINE HYDROCHLORIDE - NAFTIN N204286 001 NEPAFENAC - NEPAFENAC N203491 001 5475034 6403609 7947295 NEVIRAPINE - VIRAMUNE XR N201152 001 >A> 8460704

Feb

27, 2018

>A> NP

Jun

27, 2016

Jun Jul Jun

06, 2014 17, 2018 08, 2024 DP DP

U-100

Mar

12, 2029

U-1409

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER N019734 004 >A> 8455524 Sep 22, 2022 U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER N019734 003 Sep 22, 2022 U-1029 >A> 8455524 NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER N019734 002 >A> 8455524 Sep 22, 2022 U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER N019734 005 >A> 8455524 Sep 22, 2022 U-1029

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA N022068 001 8389537 >A> 8415363 Jul Jul 18, 2026 18, 2026 DS DP U-1374 DS DP U-1407

NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA N022068 002 8389537 >A> 8415363 NIMODIPINE - NYMALIZE N203340 001 NITRIC OXIDE - INOMAX N020845 002 8431163 8431163*PED NITRIC OXIDE - INOMAX N020845 003 8431163 8431163*PED Jun Dec 30, 2029 30, 2029 U-1286 ODE May 10, 2020 Jul Jul 18, 2026 18, 2026 DS DP U-1374 DS DP U-1407

Jun Dec

30, 2029 30, 2029

U-1286

OLOPATADINE HYDROCHLORIDE - PATANASE N021861 001 8399508 Sep 17, 2022 8399508*PED Mar 17, 2023

U-726

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID N021636 001 Jul 16, 2016 >A> 6489346 >A> 6645988 >A> 6699885 Jul Jul 16, 2016 16, 2016

DS DP U-588 DS DP U-588

Y Y Y

A - 28

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-624 DS DP U-623 DS DP U-624 U-623

EXCLUSIVITY CODE(S)

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID N021636 002 Jul 16, 2016 >A> 6489346 >A> 6489346 >A> 6645988 >A> 6699885 >A> 6699885 Jul Jul Jul Jul 16, 2016 16, 2016 16, 2016 16, 2016

Y Y Y Y Y

OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC N022281 001 6489346 6645988 6699885 OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 001 OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 002 OSELTAMIVIR PHOSPHATE - TAMIFLU N021087 003 OSELTAMIVIR PHOSPHATE - TAMIFLU N021246 001 OSELTAMIVIR PHOSPHATE - TAMIFLU N021246 002 OSPEMIFENE - OSPHENA N203505 001 6245819 8236861 8236861 OXYBUTYNIN - OXYTROL FOR WOMEN N202211 001 5601839 5834010 6743441 7081249 7081250 7081251 7081252 7179483 OXYCODONE HYDROCHLORIDE - OXECTA N202080 001 8409616 Nov 26, 2023 DP Apr Apr Apr Apr Apr Apr Apr Apr 26, 2015 26, 2015 26, 2020 26, 2020 26, 2020 26, 2020 26, 2020 26, 2020 DP U-1329 DP U-1329 DP U-1329 DP U-1329 DP U-1329 DP U-1329 DP U-1329 U-1329 NP Jan 25, 2016 Jul Aug Aug 21, 2020 11, 2026 11, 2026 U-1369 U-1370 U-1369 NCE Feb 26, 2018 NPP Dec 21, 2015 NPP Dec 21, 2015 NPP Dec 21, 2015 Jul Jul Jul 15, 2016 15, 2016 15, 2016 DP U-1025 DP DP Y Y Y

NPP

Dec

21, 2015

NPP

Dec

21, 2015

OXYCODONE HYDROCHLORIDE - OXECTA N202080 002 8409616 Nov 26, 2023 DP

OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE A079087 006 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - CREON N020725 005 PAROXETINE MESYLATE - BRISDELLE N204516 001 >A> 5874447 >A> 7598271 Jun Feb 10, 2017 12, 2023 DS DS

PC

Jul

07, 2013

M-93 NCE

Jul Apr

29, 2019 30, 2014

A - 29

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

PHENTERMINE HYDROCHLORIDE - SUPRENZA N202088 001 8440170 Mar 14, 2029 PHENTERMINE HYDROCHLORIDE - SUPRENZA N202088 002 8440170 Mar 14, 2029

DP

PHENTERMINE HYDROCHLORIDE - SUPRENZA N202088 003 8440170 Mar 14, 2029 DP

PITAVASTATIN CALCIUM - LIVALO N022363 001 5856336 PITAVASTATIN CALCIUM - LIVALO N022363 002 5856336

Jan

01, 2021

DS

U-998

Jan

01, 2021

DS

U-998

PITAVASTATIN CALCIUM - LIVALO N022363 003 5856336 Jan 01, 2021 DS U-998

PLERIXAFOR - MOZOBIL N022311 001 RE42152 Dec 10, 2018 DP

POMALIDOMIDE - POMALYST N204026 001 5635517 6045501 6315720 6316471 6476052 6561976 6561977 6755784 6908432 8158653 8198262 8204763 8315886 POMALIDOMIDE - POMALYST N204026 002 5635517 6045501 6315720 6316471 6476052 6561976 6561977 6755784 6908432 8158653 8198262 8204763 8315886

Jul Aug Oct Aug Jul Aug Oct Oct Aug Aug Oct Aug Oct

24, 2016 28, 2018 23, 2020 10, 2016 24, 2016 28, 2018 23, 2020 23, 2020 28, 2018 10, 2016 19, 2024 28, 2018 23, 2020 DP

U-1359 U-1361 U-1361 DP U-1360 DP U-1360 U-1361 U-1361 U-1361 U-1361 U-1360 U-1361 U-1361

NCE ODE

Feb Feb

08, 2018 08, 2020

Jul Aug Oct Aug Jul Aug Oct Oct Aug Aug Oct Aug Oct

24, 2016 28, 2018 23, 2020 10, 2016 24, 2016 28, 2018 23, 2020 23, 2020 28, 2018 10, 2016 19, 2024 28, 2018 23, 2020 DP

U-1359 U-1361 U-1361 DP U-1360 DP U-1360 U-1361 U-1361 U-1361 U-1361 U-1360 U-1361 U-1361

NCE ODE

Feb Feb

08, 2018 08, 2020

A - 30

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1359 U-1361 U-1361 DP U-1360 DP U-1360 U-1361 U-1361 U-1361 U-1361 DP U-1360 U-1361 U-1361

EXCLUSIVITY CODE(S)
NCE ODE

POMALIDOMIDE - POMALYST N204026 003 5635517 6045501 6315720 6316471 6476052 6561976 6561977 6755784 6908432 8158653 8198262 8204763 8315886 POMALIDOMIDE - POMALYST N204026 004 5635517 6045501 6315720 6316471 6476052 6561976 6561977 6755784 6908432 8158653 8198262 8204763 8315886

Jul Aug Oct Aug Jul Aug Oct Oct Aug Aug Oct Aug Oct

24, 2016 28, 2018 23, 2020 10, 2016 24, 2016 28, 2018 23, 2020 23, 2020 28, 2018 10, 2016 19, 2024 28, 2018 23, 2020

Feb Feb

08, 2018 08, 2020

Jul Aug Oct Aug Jul Aug Oct Oct Aug Aug Oct Aug Oct

24, 2016 28, 2018 23, 2020 10, 2016 24, 2016 28, 2018 23, 2020 23, 2020 28, 2018 10, 2016 19, 2024 28, 2018 23, 2020 DP

U-1359 U-1361 U-1361 DP U-1360 DP U-1360 U-1361 U-1361 U-1361 U-1361 U-1360 U-1361 U-1361

NCE ODE

Feb Feb

08, 2018 08, 2020

PONATINIB HYDROCHLORIDE - ICLUSIG N203469 001 PONATINIB HYDROCHLORIDE - ICLUSIG N203469 002 PRALATREXATE - FOLOTYN N022468 001 6028071 Jul 16, 2022 DS DP U-1004 ODE Dec 14, 2019

ODE

Dec

14, 2019

PRALATREXATE - FOLOTYN N022468 002 6028071 Jul 16, 2022 DS DP U-1004

PRASUGREL HYDROCHLORIDE - EFFIENT N022307 001 8404703 Mar PRASUGREL HYDROCHLORIDE - EFFIENT N022307 002 PREDNISONE - RAYOS N202020 001 PREDNISONE - RAYOS N202020 002 8394407 Apr 8394407 Apr 8404703 Mar

02, 2022

U-1381

02, 2022

U-1381

23, 2024

DP U-1362

M-128

Jul

26, 2015

23, 2024

DP U-1362

M-128

Jul

26, 2015

PREDNISONE - RAYOS N202020 003 8394407

Apr

23, 2024

DP U-1362

M-128

Jul

26, 2015

A - 31

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES

EXCLUSIVITY CODE(S)
I-651

PREGABALIN - LYRICA N022488 001 PROPOFOL - DIPRIVAN N019627 002 >A> 8476010 >A> 8476010*PED Dec Jun 01, 2024 01, 2025 DS DP

Jun

20, 2015

RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE N204736 001 5045552 5045552*PED May Nov 08, 2013 08, 2013 DS DP U-385 NDF PED Mar Sep 26, 2016 26, 2016

RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE N204736 002 5045552 5045552*PED May Nov 08, 2013 08, 2013 DS DP U-385 NDF PED Mar Sep 26, 2016 26, 2016

RADIUM RA-223 DICHLORIDE - XOFIGO N203971 001 6635234 Jan 03, 2020 U-1405 NCE May 15, 2018

REGORAFENIB - STIVARGA N203085 001 RITONAVIR - NORVIR N022417 001 8399015 8399015*PED Aug Feb 25, 2024 25, 2025 DP I-667 ODE Feb Feb 25, 2016 25, 2020

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE A078173 001 RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE A078173 002 ROFLUMILAST - DALIRESP N022522 001 8431154 Feb 19, 2023 DP PC Jun 29, 2013

PC

Jun

29, 2013

ROPIVACAINE HYDROCHLORIDE - NAROPIN N020533 001 5670524 Sep 23, 2014 DS DP U-833

ROPIVACAINE HYDROCHLORIDE - NAROPIN N020533 003 5670524 Sep ROPIVACAINE HYDROCHLORIDE - NAROPIN N020533 004 5670524 Sep

23, 2014

DS DP U-833

23, 2014

DS DP U-833

ROPIVACAINE HYDROCHLORIDE - NAROPIN N020533 005 5670524 Sep 23, 2014 DS DP U-833

RUXOLITINIB PHOSPHATE - JAKAFI N202192 001 8415362 Dec 24, 2027 DS DP

RUXOLITINIB PHOSPHATE - JAKAFI N202192 002 8415362 RUXOLITINIB PHOSPHATE - JAKAFI N202192 003 8415362

Dec

24, 2027

DS DP

Dec

24, 2027

DS DP

RUXOLITINIB PHOSPHATE - JAKAFI N202192 004 8415362 Dec 24, 2027 DS DP

RUXOLITINIB PHOSPHATE - JAKAFI N202192 005 8415362

Dec

24, 2027

DS DP

A - 32

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP

EXCLUSIVITY CODE(S)

SAPROPTERIN DIHYDROCHLORIDE - KUVAN N022181 001 8318745 Nov SAQUINAVIR MESYLATE - INVIRASE N020628 001 SAQUINAVIR MESYLATE - INVIRASE N021785 001 SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA N022350 001 RE44186 Jul

17, 2024

M-61 PED

Nov May

30, 2015 30, 2016

M-61 PED

Nov May

30, 2015 30, 2016

31, 2023

DS DP U-995

SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA N022350 002 RE44186 Jul 31, 2023 DS DP U-995

SERTRALINE HYDROCHLORIDE - ZOLOFT N020990 001 7067555 Oct 7067555*PED SODIUM OXYBATE - XYREM N021196 001 >A> 8457988 Apr

11, 2019 11, 2020

DP

Dec

17, 2022

U-1110

SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO N022239 001 8343130 Oct 18, 2022 DP

SUMATRIPTAN SUCCINATE - ZECUITY N202278 001 6745071 7973058 8155737 8366600 >A> 8470853 Feb Apr Apr Apr Apr 21, 2023 12, 2027 12, 2027 21, 2029 12, 2027 DP U-1328 U-1328 U-1327 U-1328 NDF Jan 17, 2016

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 001 8114383 8420056 Oct Nov 10, 2024 20, 2023 DP DP Y

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 002 8114383 8420056 Oct Nov 10, 2024 20, 2023 DP DP Y

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 003 8114383 8420056 Oct Nov 10, 2024 20, 2023 DP DP Y

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 004 8114383 8420056 Oct Nov 10, 2024 20, 2023 DP DP Y

TAPENTADOL HYDROCHLORIDE - NUCYNTA ER N200533 005 8114383 8420056 Oct Nov 10, 2024 20, 2023 DP DP Y

TECHNETIUM TC-99M TILMANOCEPT - LYMPHOSEEK KIT N202207 001 NCE Mar 13, 2018

A - 33

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DS DP U-1320 DP U-1320 U-1320

EXCLUSIVITY CODE(S)
ODE

TEDUGLUTIDE - GATTEX KIT N203441 001 5789379 7056886 7847061 TELAPREVIR - INCIVEK N201917 001 8431615

Apr Sep Nov

14, 2015 18, 2022 01, 2025

Dec

21, 2019

May

30, 2028

U-1398

TELAVANCIN HYDROCHLORIDE - VIBATIV N022110 001 6635618 Sep TELAVANCIN HYDROCHLORIDE - VIBATIV N022110 002 6635618 Sep

11, 2023

DS DP U-728

11, 2023

DS DP U-728

TELBIVUDINE - TYZEKA N022011 001 TELBIVUDINE - TYZEKA N022154 001 TEMSIROLIMUS - TORISEL N022088 001 >A> 8455539 Jul 25, 2023 DP M-124 Jan 28, 2016

M-124

Jan

28, 2016

TESTOSTERONE - ANDROGEL N022309 001 >A> 8446138 >A> 8466136 >A> 8466137 Oct Oct Oct 12, 2026 12, 2026 12, 2026 DP U-1103 U-1103

TESTOSTERONE - ANDROGEL N022309 002 >A> 8446138 >A> 8466136 >A> 8466137 Oct Oct Oct 12, 2026 12, 2026 12, 2026 U-1103 DP U-1103

TESTOSTERONE - ANDROGEL N022309 003 >A> 8446138 >A> 8466136 >A> 8466137 TESTOSTERONE - AXIRON N022504 001 8419307 8435944 TESTOSTERONE - TESTOSTERONE N203098 001 TESTOSTERONE - TESTOSTERONE N203098 002 TESTOSTERONE - TESTOSTERONE N203098 003 TICAGRELOR - BRILINTA N022433 001 8425934

Oct Oct Oct

12, 2026 12, 2026 12, 2026 DP

U-1103 U-1103

Feb Jul

26, 2027 05, 2027

U-1386 U-1390

NP

Jan

31, 2016

NP

Jan

31, 2016

NP

Jan

31, 2016

Dec

18, 2029

DP

TIGECYCLINE - TYGACIL N021821 001 8372995

Oct

08, 2030

DP

A - 34

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
DP DP U-1324

EXCLUSIVITY CODE(S)

TOBRAMYCIN - BETHKIS N201820 001 6987094 7696178 7939502 TOBRAMYCIN - TOBI PODHALER N201688 001 7097827 7368102 7442388 7516741 7559325 8069851 8349294 TOLTERODINE TARTRATE - DETROL LA N021228 001 6911217 6911217*PED

Sep Mar Jun

22, 2022 17, 2023 14, 2022

Jun Dec May Jan Oct Sep May

27, 2021 19, 2022 10, 2020 11, 2024 27, 2025 24, 2024 10, 2020

DP DP U-909 DP DP DP DP DP

NP

Mar

22, 2016

Nov May

11, 2019 11, 2020

DP U-544 DP U-544

TOLTERODINE TARTRATE - DETROL LA N021228 002 6911217 6911217*PED Nov May 11, 2019 11, 2020 DP U-544 DP U-544

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N204114 001 7378423 Sep 13, 2025 DS DP NCE >A> ODE May May 29, 2018 29, 2020

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N204114 002 7378423 Sep 13, 2025 DS DP NCE >A> ODE May May 29, 2018 29, 2020

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST N204114 003 7378423 Sep 13, 2025 DS DP NCE >A> ODE May May 29, 2018 29, 2020

TRANEXAMIC ACID - TRANEXAMIC ACID A202093 001 TRAVOPROST - TRAVATAN Z N021994 001 8388941 TREPROSTINIL - REMODULIN N021272 001 >A> 7999007 Mar 29, 2029 DP U-1413 Sep 20, 2027 DP PC Jul 02, 2013

TREPROSTINIL - REMODULIN N021272 002 >A> 7999007 Mar 29, 2029 DP U-1413

TREPROSTINIL - REMODULIN N021272 003 >A> 7999007 Mar 29, 2029 DP U-1413

TREPROSTINIL - REMODULIN N021272 004 >A> 7999007

Mar

29, 2029

DP U-1413

TROSPIUM CHLORIDE - TROSPIUM CHLORIDE A091289 001 ULIPRISTAL ACETATE - ELLA N022474 001 8426392 Jun 12, 2030 U-1389 PC Apr 10, 2013

UNOPROSTONE ISOPROPYL - RESCULA N021214 001 6770675 Nov

24, 2018

DP U-1322

A - 35

PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 6 - June 2013
See List footnote for information regarding List content PATENT EXPIRATION DATE PATENT DELIST REQUESTED EXCLUSIVITY EXPIRATION DATE

APPL/PROD NO

PATENT NO

PATENT CODES
U-1199

EXCLUSIVITY CODE(S)

ZOLEDRONIC ACID - RECLAST N021817 001 8052987

Oct

27, 2023

Footnote: 1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5). 2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. They may not be flagged with respect to other claims which may apply.

B-1

PATENT AND EXCLUSIVITY TERMS

Due to space limitations in the patent and exclusivity columns, abbreviations and references have been developed. Refer to the APPROVED DRUG rd PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 33 Edition for a full listing of patent and exclusivity terms (Abbreviations, Dosing Schedule, Indications, and Patent Use Codes). The current complete list of patent terms is available at http://www.accessdata.fda.gov/scripts/cder/ob/docs/pattermsall.cfm

The current complete list of patent terms is available at http://www.accessdata.fda.gov/scripts/cder/ob/docs/excltermsall.cfm