FDA Orange Book

The FDA Orange Book is a list of Approved Drug Products with Therapeutic Equivalence Evaluations. The website to access the homepage of the orange book is:

http://www.accessdata.fda.gov/scripts/cder/ob/default.cfmhttp://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

The FDA publishes the Annual Edition of the book or the current Cumulative Summary in electronic Portable Document Format (PDF). Since February of 2005, the FDA provides daily Electronic Orange Book (EOB) product information for new generic drug approvals. Daily generic updates provide the consumer with the current list of approved generic drugs, which is important for substitution purposes. The monthly EOB update goal is by the end of the following month’s second workweek.

The electronic Orange Book content includes:

• New Drug Application (NDA) approvals in the month they were approved. NDA applications are preceded with an “N”.
• Abbreviated NDA approvals (ANDA or Generic) as of the date of the daily update. Generic application numbers are preceded with an ”A”.
• All product changes received and processed as of the monthly update date. `The FDA will process discontinued products as of the date of publication.
• Patent information, also updated daily in the EOB, as of the date of the daily update.
• Exclusivity information updated monthly and current to the date of the monthly EOB update date.

Beginning with the 25^th edition, the FDA publishes everything in a PDF file available at the EOB home page. The Annual Edition and Cumulative Summary are also available in a paper version from the US Government Printing Office: www.bookstore.gpo.gov or 866.512.1800.

To find a generic drug with FDA approval go to the homepage of the FDA Orange Book.

• If you have a trade name, search the EOB Rx or OTC section using the Proprietary Name search.
• This determines the ingredients.
• Then use the Ingredient Search for all approved products that contain the ingredient.
• The resulting list contains approved products by dosage form and route.

Requests for more specific information are available through the Freedom of Information Act. Requests must be in writing or directed to the FDA’s Freedom of information Staff at:

• 5600 Fishers Lane, Rockville, Maryland 20857; or 301.827.6500.

The products in the FDA Orange Book were approved under section 505 of the Federal Food, Drug, and Cosmetic Act of 1938.

Written by: Margaret Stenerson

10 7 2010