Biologics Products & Establishments
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
Product / Manufacturer Lists
Biological Approvals by Year 510(k) Blood Establishment Computer Software Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays Testing 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 (PDF - 265KB)Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 16KB)Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 17KB)Vaccines Licensed for Use in the United States Devices Regulated by the Center for Biologics Evaluation and Research Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Reports
Related Resources
Compliance Actions (Biologics) Risk Evaluation and Mitigation Strategies 3/27/08 Federal Register Notice
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 2007National Drug Code Directory
Search commercially distributed prescription drugs and insulin productsTransfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
Other Product Approval Information
Drug Approvals and Databases Drug-Related Databases from FDA; Information on Drug Approvals Device Approvals, Denials and Clearances
Center for Devices and Radiological HealthRadiation-Emitting Products and Procedures Medical Imaging, Surgical & Therapeutic, Home, Business, & Entertainment Products Information about Approved Animal Drug Products, Animal Food/Feed (including Pet Food), Imports & Exports, and the Generally Recognized as Safe (GRAS) Notification Program