- Complete List of Licensed Products and Establishments
Posted: 2/4/2019; Updated as of 1/31/2019 - Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 31KB)
Posted: 2/4/2019; Updated as of 1/31/2019 - Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB)
Posted: 2/4/2019; Updated as of 1/31/2019 - Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 697KB)
Posted: 2/4/2019; Updated as of 1/31/2019
Recently Added
- Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
Posted: 2/5/2019; Updated as of 2/1/2019 - Complete List of Licensed Products and Establishments
Posted: 2/4/2019; Updated as of 1/31/2019 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 31KB)
Posted: 2/4/2019; Updated as of 1/31/2019Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB)
Posted: 2/4/2019; Updated as of 1/31/2019Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 697KB)
Posted: 2/4/2019; Updated as of 1/31/2019- Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot L67530 through January 31, 2020
Posted: 2/1/2019 - BK180306 - MacoPress Smart Smarter and DMS Plus
Posted: 1/31/2019 - Fast Track Designation Request Performance
Updated: 1/30/2019 - Malaria gene activity findings could form basis of improved test for monitoring disease spread
Posted: 1/30/2019 - BK180258 - Vista Information System
Posted: 1/30/2019 - BK180280 - DG Gel Essential Control
Posted: 1/29/2019 - eSubmitter Application History
Updated: 1/29/2019 - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Information on TICE BCG - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Dialysis formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Pediatric/Adolescent formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on RECOMBIVAX HB - Adult formulation - CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Update on SHINGRIX CBER-Regulated Products: Current Shortages
Posted: 1/8/2019; Information on Cuvitru
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