Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

On March 23, 2020, FDA removed from the Orange Book the listings for “biological products” that have been approved in applications under section 505 of the FD&C Act because these products are no longer “listed drugs” (see section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009).
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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. 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 2020.
For more information on the Orange Book update frequency, see the Orange Book FAQs.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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