Drugs
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
The Orange Book data files are current through July 2009. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files. However, if you detect an error or discrepancy in drug data, please send a brief description of the data problem to the following e-mail address: DRUGPRODUCTS@CDER.FDA.GOV.
General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Drug Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information Staff at:
Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500
The CDER Freedom of Information Office Electronic Reading Room provides background information about the FOI process.
Database Information and Help files
- Orange Book Query
The Electronic Orange Book Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. - Orange Book Annual Edition (PDF - 22844KB)
29th Edition - The publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. - Orange Book Current Cumulative Supplement (PDF - 2274KB)
The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data. - Electronic Orange Book (EOB) Query data files
This page describes the Approved Drug Products EOB Query web files. The files are ASCII text tilde (~) delimited. They are zipped into a self-extracting file, EOBZIP.ZIP. Allow for approximately 5 megabytes for the unzip process. - Frequently Asked Questions on The Orange Book
- Frequently Asked Questions on Patents and Exclusivity
- Orange Book Preface
- Additions/Deletions for Prescription and OTC Drug Product Lists
Changes to the annual edition are listed separately by month.