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the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons.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 FORTIETH EDITION iv1.0 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 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 Drug Entity xxiii 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
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 Products 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 Lists 6-1
Orphan Products Designations and Approvals List 7-1
Only if Product Fails to Achieve Adequate Dissolution 8-1
This official information is intended for use by those in the pharmaceutical industry.
