PLEASE NOTE: On January 25, 2017, The Orange Book data will be updated to reflect the recent publication of the draft guidance for industry 'Referencing Approved Drug Products in ANDA Submissions.'
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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: firstname.lastname@example.org.
Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: email@example.com.
Current through December 2016.
For more information on the Orange Book update frequency, see the Orange Book FAQs.