This page has been updated recently.
- Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 17KB)
Posted: 6/8/2017; Updated as of 6/8/2017 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 285KB)
Posted: 6/8/2017; Updated as of 6/6/2017 - Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 14KB)
Posted: 6/8/2017; Updated as of 6/6/2017 - Complete List of Licensed Products and Establishments
Posted: 6/8/2017; Updated as of 5/31/2017 - June 7, 2017 Approval Letter - FIBRYNA (PDF - 76KB)
Posted: 6/8/2017
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