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U.S. Department of Health and Human Services

Drugs

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Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

 

About the Orange Book

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 Act). (For more information, see the Orange Book Preface.)

 

The Approved Drug Products list first appeared as a print publication in 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.

 

The Orange Book Search was added to the FDA website October 31, 1997. 

Orange Book with jack-o'-lanterns

Did you ever wonder how the Orange Book got its nickname?

When the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, "It's almost Halloween. How about orange?"

Before long, The Orange Book had become a popular short title for this important publication.

To send comments or questions about the Orange Book or drug data, please see the contact information below. 


  • Orange Book Search
    You can search by active ingredient, proprietary name, applicant, or application number.

 

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Orange Book Publications

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Downloadable Files

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Contact Us

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: 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, Division of Drug Information: DRUGINFO@FDA.HHS.GOV.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.

All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:

Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857

Requests may be sent via fax to: fax number (301) 827-9267.
If you experience difficulty sending a fax, please call (301) 796-3900.

The CDER Freedom of Information Office Electronic Reading Room page provides background information about the FOIA process.