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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.

Product Approvals & Clearances with Supporting Documents

• Cleared 510(k) Submissions with Supporting Documents
• Licensed Biological Products with Supporting Documents
• New Drug Applications with Supporting Documents
• Premarket Approvals with Supporting Documents

Product / Manufacturer Lists

• 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 Globulin Intravenous (IGIV) Indications
• 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

Reports

• Fast Track Designation Request Performance
• Postmarketing Reports
• Biologics PREA Labeling Changes
• CBER Expanded Access Submission Receipt Reports

Related Resources

• 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)

Other Product Approval Information

• 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