Biologics Products & Establishments
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This page contains a listing of biological product approvals and clearances with supporting documents; product/manufacturer lists; reports; related resources; and other product approval information.
- Biological Approvals by Year
- 510k Blood Establishment Computer Software
- Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
- Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
- Immune Globulins
- FDA Online Label Repository
- Complete List of Licensed Products and Establishments
- Complete List of Substantially Equivalent 510(k) Device Applications
- Complete List of Currently Approved Premarket Approvals (PMAs)
- Complete List of Currently Approved NDA and ANDA Application Submissions
- Vaccines Licensed for Use in the United States
- Devices Regulated by the Center for Biologics Evaluation and Research
- Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
- Compliance Actions (Biologics)
- National Drug Code Directory
Search commercially distributed prescription drugs and insulin products - Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER) - Archived
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
- Drug Approvals and Databases
CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. - Device Approvals, Denials and Clearances
Center for Devices and Radiological Health - Radiation-Emitting Products and Procedures
Introduction to all radiation-emitting products and procedures. - Products
Information about Approved Animal Drug Products, Animal Food/Feed (including Pet Food), Imports & Exports, and the Generally Recognized as Safe (GRAS) Notification Program