APPROVED
`DRUG
`PRODUCTS
`
`WITH
`
`THERAPEUTIC
`EQUIVALENCE
`EVALUATIONS
`38th EDITION
`
`THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF GENERIC DRUGS
`OFFICE OF GENERIC DRUG POLICY
`
`2018
`
`KASHIV1064
`IPR of Patent No. 9,492,393
`
`
`DRUG
`PRODUCTS
`
`WITH
`
`THERAPEUTIC
`EQUIVALENCE
`EVALUATIONS
`38th EDITION
`
`THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF GENERIC DRUGS
`OFFICE OF GENERIC DRUG POLICY
`
`2018
`
`KASHIV1064
`IPR of Patent No. 9,492,393
`
`
`
`APPROVED DRUG PRODUCTS
`with
`THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`The products in this list have been approved under section 505 of the
`Federal Food, Drug, and Cosmetic Act. This volume is current through
`December 31, 2017.
`
`38th EDITION
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF GENERIC DRUGS
`OFFICE OF GENERIC DRUG POLICY
`
`2018
`
`KASHIV1064
`IPR of Patent No. 9,492,393
`
`
`
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`APPROVED DRUG PRODUCTS
`With
`Therapeutic Equivalence Evaluations
`
`CONTENTS
`
`PAGE
`
`PREFACE TO THIRTY EIGHTH EDITION ................................................................ iv
`
`INTRODUCTION ............................................................ ..... .. ........................................ vi
`1.0
`Content and Exclusion ................................................................................................... vi
`1.1
`Therapeutic Equivalence-Related Terms ............ ........................................................... vi
`1.2
`Further Guidance on Bioequivalence ............................................................................. ix
`1.3
`Reference Listed Drug and Reference Standard ............................................................ ix
`1.4
`1.5
`General Policies and Legal Status .................................................................................. x
`Practitioner/User Responsibilities .................................................................................. xi
`1.6
`Therapeutic Equivalence Evaluations Codes ................................................................ xiii
`1.7
`Description of Certain Special Situations ...................................................................... xx
`1.8
`Therapeutic Equivalence Code Change for a Drug Entity ........................................... xxiii
`1.9
`1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product .................... xxiv
`1.11 Discontinued Section ........................................................................... .................... ... xxiv
`1.12 Changes to the Orange Book ...................................................................................... xxiv
`1.13 Availability of the Edition .............................................................................................. xxv
`
`2.0
`2.1
`2.2
`2.3
`
`HOW TO USE THE DRUG PRODUCTS LISTS ............................................................. 2-1
`Key Sections for Using the Drug Product Lists ..................................................... 2-1
`Drug Product Illustration ................................................................................. 2-3
`Therapeutic Equivalence Evaluations Illustration ................................................. 2-4
`
`DRUG PRODUCT LISTS
`Prescription Drug Product List ................................................................................... 3-1
`OTC Drug Product List ............................................................................................. 4-1
`Drug Products with Approval under Section 505 of the FD&C Act Administered
`by the Center for Biologics Evaluation and Research List ......................................... 5-1
`Discontinued Drug Product List .................................................................................. 6-1
`Orphan Products Designations and Approvals List ........................................................ 7-1
`Drug Products Which Must Demonstrate in vivo Bioavailability
`Only if Product Fails to Achieve Adequate Dissolution .................................................... 8-1
`
`APPENDICES
`A. Product Name Index .................................................................................. A-1
`B. Product Name Index Listed by Applicant ................................ ........................ B-1
`C. Uniform Terms .......................................................................................... C-1
`
`PATENT AND EXCLUSIVITY INFORMATION ADDENDUM .............................................. AD1
`A. Patent and Exclusivity Lists ...................................................................... ADA 1
`B. Patent and Exclusivity Terms ... .. ............................................................... ADB1
`
`KASHIV1064
`IPR of Patent No. 9,492,393
`
`
`
`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`PRESCRIPTION DRUG PRODUCT LIST
`
`3-299 (of 436)
`
`MORPHINE SULFATE
`TABLET, EXTENDED RELEASE;ORAL
`MORPHINE SQLFATE
`
`NOVEL LABS INC
`
`RHODES PHARMS
`
`SPECGX LLC
`
`SUN PHARM INDS LTD
`
`SUN PHARM
`INDUSTRIES
`
`VINTAGE PHARMS LLC
`
`.l.Q.QMG
`.2..Q.QMG.
`~
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`~
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`~
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`~
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`~
`
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`~
`.3..QMG
`..6..QMG
`.l.Q.QMG
`.2..Q.QMG.
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`A077855 ..Q..Q1. Sep 27, 2007
`A077855 QQ.£ Sep 27, 2007
`A203602 ..Q..Q1. Dec 16, 2015
`A203602 QQ.£ Dec 16, 2015
`A203602 .Q..Q.3. Dec 16, 2015
`A203602 .Q..QA Dec 16, 2015
`A203602 QQ.5. Dec 16, 2015
`A074862 ..Q..Q1. Jul 07, 1998
`A074862 QQ.£ Jul 07, 1998
`A074862 .Q..Q.3. Jul 07, 1998
`A074769 ..Q..Q1. Jul 02, 1998
`A074769 QQ.£ Jul 02, 1998
`A076412 ..Q..Q1. Jul 31, 2003
`A076412 .Q..Q2. Jul 31, 2003
`A076412 .Q..Q.3. Jul 31, 2003
`A076438 ..Q..Q1. Jul 03, 2003
`A076438 Q.Q2. Jul 03, 2003
`A078761 ..Q..Q1. May 11, 2012
`A078761 QQ.£ May 11, 2012
`A078761 .Q..Q.3. May 11, 2012
`A078761 .Q..QA May 11, 2012
`A078761 QQ.5. May 11, 2012
`A205634 ..Q..Q1. Aug 25, 2016
`
`A205634 QQ.£ Aug 25, 2016
`A205634 .Q..Q.3. Aug 25, 2016
`A205634 .Q..QA Aug 25, 2016
`A205634 QQ.5. Aug 25, 2016
`A075295 ..Q..Q1. Oct 28, 1998
`A075295 QQ.£ Oct 28, 1998
`A075295 QQ.3. Oct 28, 1998
`A075295 .Q..QA Sep 15, 2000
`A075295 QQ.5. Sep 15, 2000
`
`15MG
`30MG
`60MG
`
`20MG;0.8MG
`30MG;1.2MG
`50MG;2MG
`60MG; 2. 4MG
`80MG;3.2MG
`100MG; 4MG
`
`N019516 .Q_Q_l Sep 12, 1989
`N019516 ..Q..Q1. May 29, 1987
`N019516 QQ.£ Apr 08, 1988
`N019516 .Q..QA Jan 16, 1990
`N019516 QQ.5. Nov 08, 1993
`
`N208603 001 Jan 09, 2017
`N208603 002 Jan 09, 2017
`N208603 003 Jan 09, 2017
`
`N206544 001 Oct 02, 2015
`N206544 002 Oct 02, 2015
`N206544 003 Oct 02, 2015
`N206544 004 Oct 02, 2015
`
`N022321 001 Aug 13, 2009
`N022321 002 Aug 13, 2009
`N022321 003 Aug 13, 2009
`N022321 004 Aug 13, 2009
`N022321 005 Aug 13, 2009
`N022321 006 Aug 13, 2009
`
`AB
`AB
`AB
`AB
`AB
`
`ALPHARMA PHARMS
`
`MS CONTIN
`+
`PURDUE PHARMA LP
`+
`+
`+!
`+
`ARYMO ER
`+
`EGALET
`+
`+
`MORPHABOND ER
`+
`15MG
`DAIICHI SANKYO INC
`30MG
`+
`+
`60MG
`+!
`100MG
`MORPHINE SULFATE· NALTREXONE HYDROCHLORIDE
`CAPSULE, EXTENDED RELEASE;ORAL
`EMBEDA
`+
`+
`+
`+!
`+
`+
`MOXIFLOXACIN HYDROCHLORIDE
`SOLUTION;IV (INFUSION)
`MOXIFLOXACIN HYDROCHLORIDE
`+!
`N205572 001 Apr 03, 2015
`(EQ 1.6MG BASE/ML)
`EQ 400MG BASE/250ML
`FRESENIUS KABI USA
`MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
`MYLAN LABS LTD
`400MG/250ML
`(1.6MG/ML)
`A205833 001 May 05, 2017
`SOLUTION/DROPS;OPHTHALMIC
`MOXIFLOXACIN HYDROCHLORIDE
`AKORN
`APOTEX INC
`AUROBINDO PHARMA
`LTD
`
`ATl
`ATl
`ATl
`
`EO 0 5% BASE
`EO 0 5% BASE
`EO 0 5% BASE
`
`A202916 ..Q..Q.l Nov 09, 2017
`A090080 ..Q..Q.l Jun 30, 2017
`A206242 ..Q..Q.l Oct 04, 2017
`
`KASHIV1064
`IPR of Patent No. 9,492,393
`
`
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