Approved Drug Products With Therapeutic Equivalence 39th Edition 2019

The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).  The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons.  Inclusion of products in the Orange Book is independent of any current regulatory action through administrative or judicial means against a drug product.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

DRUG PRODUCT LISTS Prescription Drug Product List ……………………………………….…………….………………...3-1

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

Drug Products with Approval under Section 505 of the FD&C Act Administered Drug Products Which Must Demonstrate in vivo Bioavailability 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

Only if Product Fails to Achieve Adequate Dissolution …………………..………………………..8-1

APPENDICES A. Product Name Index ……….…...………………………….………..……………………A-1

B. Product Name Index Listed by Applicant ………………….……..……………………..B-1

C. Uniform Terms …………………………………………….………..…………...………...C-1

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1

A. Patent and Exclusivity Lists …………………………….…..……..……………..……ADA1

B. Patent and Exclusivity Terms ...……………………….….………...…………………ADB1

Information and advice to state health agencies, prescribers, and pharmacists to promote public education.