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
`
`KASHIV1066
`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
`
`KASHIV1066
`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
`
`KASHIV1066
`IPR of Patent No. 9,492,393
`
`

`

`38TH EDITION - 2018 - APPROVED DRUG PRODUCT LIST
`DISCONTINUED DRUG PRODUCT LIST
`** See List Footnote
`
`6-277(of 375)
`
`QXTRIPHYLLINE
`SYRUP;ORAL
`CHOLEDYL
`PARKE DAVIS
`OXTRIPHYLLINE PEDIATRIC
`MORTON GROVE
`TABLET, DELAYED RELEASE;ORAL
`CHOLEDYL
`PARKE DAVIS
`
`OXTRIPHYLLINE
`WATSON LABS
`
`TABLET, EXTENDED RELEASE;ORAL
`CHOLEDYL SA
`WARNER CHILCOTT LLC
`QXYBUTYNIN
`GEL, METERED;TRANSDERMAL
`GELNIQUE 3%
`+
`ALLERGAN SALES LLC
`QXYBUTYNIN CHLQRIDE
`SYRUP;ORAL
`DITROPAN
`+
`OR THO MCNEIL JANSSEN
`OXYBUTYNIN CHLORIDE
`APOTEX INC
`MIKART
`TABLET;ORAL
`DITROPAN
`+
`JANSSEN PHARMS
`OXYBUTYNIN CHLORIDE
`QUANTUM PHARMICS
`USL PHARMA
`WATSON LABS
`QXYCQDQNE HYDRQCHLQRIDE
`TABLET, EXTENDED RELEASE;ORAL
`ROXICODONE
`ROXANE
`
`50MG/5ML
`
`50MG/5ML
`
`100MG
`200MG
`
`100MG
`200MG
`
`600MG
`
`3%
`
`5MG/5ML
`
`**
`
`5MG/5ML
`5MG/5ML
`
`5MG
`
`5MG
`5MG
`5MG
`
`10MG
`30MG
`
`QXYMETAZQLINE HYDRQCHLQRIDE
`SOLUTION/DROPS;OPHTHALMIC
`OCUCLEAR
`BAYER HEALTH CARE LLC 0 . 0 2 5%
`QX¥MQRPHQNE HYDRQCHLQRIDE
`INJECTABLE; INJECTION
`OPANA
`+
`
`ENDO PHARMS
`
`SUPPOSITORY;RECTAL
`NUMORPHAN
`ENDO PHARMS
`TABLET, EXTENDED RELEASE;ORAL
`OPANA ER
`ENDO PHARMS
`
`+
`
`+
`
`+
`
`+
`
`+
`
`+
`
`+
`
`1MG/ML
`1. 5MG/ML
`
`5MG
`
`5MG **
`5MG
`7.5MG **
`7.5MG
`10MG **
`10MG
`15MG **
`15MG
`20MG **
`20MG
`30MG **
`30MG
`40MG **
`40MG
`
`N009268 011
`
`A088242 001 Dec 05, 1983
`
`N009268 003
`N009268 007
`
`A087866 001 Aug 25, 1983
`A087835 001 Aug 25, 1983
`
`A086742 001
`
`N202513 001 Dec 07, 2011
`
`N018211 001
`
`A074997 001 Oct 15, 1997
`A075039 001 Jan 29, 1999
`
`N017577 001
`
`A072296 001 Dec 08, 1988
`A070746 001 Mar 10, 1988
`A072485 001 Apr 19, 1989
`
`N020932 001 Oct 26, 1998
`N020932 002 Oct 26, 1998
`
`N018471 001 May 30, 1986
`
`NOll 707 002
`N011707 001
`
`N011738 004
`
`N021610 001 Jun 22, 2006
`N201655 001 Dec 09, 2011
`N021610 005 Feb 29, 2008
`N201655 002 Dec 09, 2011
`N021610 002 Jun 22, 2006
`N201655 003 Dec 09, 2011
`N021610 006 Feb 29, 2008
`N201655 004 Dec 09, 2011
`N021610 003 Jun 22, 2006
`N201655 005 Dec 09, 2011
`N021610 007 Feb 29, 2008
`N201655 006 Dec 09, 2011
`N021610 004 Jun 22, 2006
`N201655 007 Dec 09, 2011
`
`**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
`
`KASHIV1066
`IPR of Patent No. 9,492,393
`
`