Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Effective November 21, 2017, the Orange Book search results and drug listings will display patent submission dates where available. More information
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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:

Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information:

Current through October 2017.
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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