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the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons.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.
CONTENTS PAGE PREFACE TO FORTY SECOND EDITION iv
1.0 INTRODUCTION vi
1.1 Content and Exclusion vi
1.2 Therapeutic Equivalence-Related Terms vii
1.3 Further Guidance on Bioequivalenceix
1.4 Reference Listed Drug and Reference Standard x
1.5 General Policies and Legal Status xi
1.6 Practitioner/User Responsibilities xi
1.7 Therapeutic Equivalence Evaluations Codes xii
1.8 Description of Certain Special Situations xx
1.9 Therapeutic Equivalence Code Change for a Category of Multisource Drug Products xxiii
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product xxiii
1.11 Discontinued Section xxiv
1.12 Changes to the Orange Book xxiv
1.13 Availability of the Edition xxv
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 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
This official information is intended for use by those in the pharmaceutical industry.
