Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Additional information and resources for the Orange Book

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Find Approved Drugs

Search by Proprietary Name, Active Ingredient or Application Number

Search by Applicant (Company)

OR

Select one or more names from the menu below.
Either Start Typing or Click to open menu and then Ctrl+Click to select multiples

 

Search by Dosage Form (for example: TABLET)

Search by Route of Administration (for example: ORAL)

 

To download the Orange Book product information into a spreadsheet that can be searched by additional fields see the download Instructions.

Find Patent Information

Search by Patent Number

View Newly Added Patents or Delisted Patents

Newly Added Patents

Delisted Patents

 

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. If you wish to report an error or discrepancy in drug data, please send a brief description of the problem to: orangebook@fda.hhs.gov.

Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: druginfo@fda.hhs.gov.

Current through October 2024.
For more information on the Orange Book update frequency, see the Orange Book FAQs.