This page has been updated recently.
- May 2, 2017 Approval Letter - ACAM2000 (PDF - 33KB)
Posted: 5/9/2017 - BK170019: IH-1000 V04.04.52
Posted: 5/9/2017 - BK170021: IH-Com V5.0
Posted: 5/9/2017 - May 8, 2017 Approval Letter - Crofab (PDF - 33KB)
Posted: 5/9/2017 - Application History
Updated: 5/9/2017 - Complete List of Licensed Products and Establishments
Posted: 5/9/2017; Updated as of 4/30/2017 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 271KB)
Posted: 5/9/2017; Updated as of 5/5/2017 - Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 16KB)
Posted: 5/9/2017; Updated as of 5/4/2017 - Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 17KB)
Posted: 5/9/2017; Updated as of 5/4/2017
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