Products
Approval Documents - (letters, labeling, reviews)
Approvals for Current Year
- Recent Biological License Application Approvals
- Recent Biological License Application Supplement Approvals
- Recent Biological Device Approvals
- Recent Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Previous years:
2008,
2007,
2006,
2005,
2004,
2003,
2002,
2001,
2000,
1999,
1998,
1997,
1996
Product / Manufacturer Lists
- 510(k) Blood Establishment Computer Software
- Blood Donor Screening / HIV Test Kits
- HCT/P Donor Screening Tests
- HCT/P Registered Establishments
- Immune Globulin Intravenous (IGIV)
- Licensed Products and Establishments
- New Drug Applications
- Premarket Approval (PMA) Devices
- Substantially Equivalent 510(k) Devices
- Vaccines Licensed for Immunization and Distribution in the US
Reports
- Fast Track Designation Request Performance
- Postmarketing Study Commitments
- User Fee Billable Products Approved Under Section 351 of the PHS Act
Other Resources
- Compliance and Surveillance
- Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of 2007 - 3/27/2008
- National Drug Code (NDC) Directory for Prescription Products (CDER)
- Pediatric Research Equity Act of 2007 (PREA)
- Pregnancy and Lactation Labeling
- Transfer of Therapeutic Products to CDER