- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB)
Posted: 10/4/2018; Updated through 9/30/2018 - Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB)
Posted: 10/4/2018; Updated through 9/30/2018 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 747KB)
Posted: 10/4/2018; Updated through 9/30/2018 - Complete List of Licensed Products and Establishments
Posted: 10/4/2018; Updated through 9/30/2018 - Influenza Virus Vaccine for the 2018-2019 Season
Updated: 10/4/2018 - October 4, 2018 Approval Letter - IXIARO (PDF - 35KB)
Posted: 10/4/2018
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