FDA DRUG INTELLIGENCE
FDA Drug Approvals & Applications
Every drug FDA has approved or has under application — brand and generic name, the sponsor, dosage form and route, the full approval history, and current marketing status. Drawn from Drugs@FDA, each record links to live shortage and recall signals. Every value is FDA's own application data.
29,417 applications · 5,908 NDA · 23,024 ANDA · 485 BLA
New Drug Application — a brand/innovator drug approved on its own safety and efficacy data.
Abbreviated New Drug Application — a generic shown to be bioequivalent to an approved reference drug.
Biologics License Application — a biologic (vaccine, antibody, cell/gene therapy) licensed under the PHS Act.
Recently approved
The most recent FDA approval actions across all application types. Filter by application type, sponsor or approval year; search by product, sponsor or application number.