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
`
`KASHIV1065
`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
`
`KASHIV1065
`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
`General Policies and Legal Status .................................................................................. x
`1.5
`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
`
`KASHIV1065
`IPR of Patent No. 9,492,393
`
`

`

`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`DISCONTINUED DRUG PRODUCT LIST
`** See List Footnote
`
`6-258(of 375)
`
`MOMETASONE FUROATE
`CREAM; TOPICAL
`ELOCON
`MERCK SHARP DOHME
`OINTMENT;TOPICAL
`MOMETASONE FUROATE
`TARO
`MONOBENZONE
`CREAM; TOPICAL
`BEN OQUIN
`VALEANT PHARM INTL
`MONOCTANOIN
`LIQUID;PERFUSION, BILIARY
`MOCTANIN
`ETHITEK
`MORICIZINE HYDROCHLORIDE
`TABLET;ORAL
`ETHMOZINE
`SHIRE
`
`0.1%
`
`0.1%
`
`20%
`
`100%
`
`200MG
`250MG
`300MG
`
`MORPHINE SULFATE
`CAPSULE, EXTENDED RELEASE;ORAL
`AVINZA
`KING PHARMS LLC
`
`30MG
`45MG
`60MG
`75MG
`90MG
`120MG
`
`15MG/ML
`0.5MG/ML
`1MG/ML
`2MG/ML
`0.5MG/ML
`0.5MG/ML
`1MG/ML
`1MG/ML
`INJECTABLE, LIPOSOMAL;EPIDURAL
`DEPODUR
`PACIRA PHARMS INC
`
`N019625 001 May 06, 1987
`
`A076624 001 Dec 03, 2004
`
`N008173 003
`
`N019368 001 Oct 29, 1985
`
`N019753 001 Jun 19, 1990
`N019753 002 Jun 19, 1990
`N019753 003 Jun 19, 1990
`
`N021260 001 Mar 20, 2002
`N021260 005 Dec 18, 2008
`N021260 002 Mar 20, 2002
`N021260 006 Dec 18, 2008
`N021260 003 Mar 20, 2002
`N021260 004 Mar 20, 2002
`
`N202515 005 Nov 14, 2011
`N019917 001 Oct 30, 1992
`N020631 001 Jul 03, 1996
`N020631 002 Jul 03, 1996
`A073373 001 Sep 30, 1991
`A073375 001 Sep 30, 1991
`A073374 001 Sep 30, 1991
`A073376 001 Sep 30, 1991
`
`N021671 001 May 18, 2004
`N021671 002 May 18, 2004
`N021671 003 May 18, 2004
`
`A075656 001 Jan 30, 2001
`
`N019977 004 Nov 23, 1994
`N019977 001 Aug 15, 1991
`N019977 002 Aug 15, 1991
`N019977 003 Aug 15, 1991
`
`INJECTABLE; INJECTION
`MORPHINE SULFATE
`+
`HOSPIRA INC
`ICU MEDICAL INC
`SPECGX LLC
`
`WATSON LABS
`
`TABLET, EXTENDED RELEASE;ORAL
`MORPHINE SULFATE
`WATSON LABS
`ORAMORPH SR
`XANODYNE PHARMS INC
`
`MOXALACTAM DISODIUM
`INJECTABLE; INJECTION
`MOXAM
`
`LILLY
`
`10MG/ML
`(10MG/ML)
`15MG/1.5ML (10MG/ML)
`20MG/2ML
`(10MG/ML)
`
`100MG
`
`15MG
`30MG
`60MG
`100MG
`
`EQ 250MG BASE/VIAL
`EQ 500MG BASE/VIAL
`EQ 1GM BASE/VIAL
`EQ 2GM ·BASE/VIAL
`EQ 10GM BASE/VIAL
`
`N050550 001
`N050550 002
`N050550 003
`N050550 004
`N050550 008
`
`**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
`
`KASHIV1065
`IPR of Patent No. 9,492,393
`
`