The Orange Book
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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 Act) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.
One-time report on marketing status for all ANDAs and NDAs required by FDARA section 506I(c) was due February 14, 2018. More information
Orange Book Publications
- Orange Book Annual Edition
- Orange Book Current Cumulative Supplement
- Appendix A: Product Name Index
- Appendix B: Product Name Sorted by Applicant
- Appendix C: Uniform Terms
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Orange Book Data Files (compressed)
For more information, including the descriptions of data fields in the Orange Book Search, see Orange Book Data Files.
- Reference Listed Drugs by ANDA Reference Standard List
- Orange Book Patent Listing Dispute List
- BPCIA Orange Book Transition Edition
- Frequently Asked Questions on The Orange Book
- Frequently Asked Questions on Patents and Exclusivity
- Orange Book Preface
- FDA introduces reference standard data updates to the Orange Book
The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to email@example.com.
General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information firstname.lastname@example.org.
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.