FDA Drug Approvals — Drugs@FDA (29k applications: NDA + ANDA + BLA)

Dataset · US Food and Drug Administration · source URL ↗

Every drug application in the FDA Drugs@FDA database — the canonical record of every drug approved for US marketing. **NDA** (New Drug Application — brand-name innovators), **ANDA** (Abbreviated New Drug Application — generics), **BLA** (Biologics License Application — biotech drugs, vaccines, gene therapies). Each application has the FDA application number, sponsor (Pfizer, Merck, Teva, Hetero), brand name (Lipitor, Eliquis, Humira), generic name, active ingredients, dosage form, route of administration, marketing status, and first approval date. Source: api.fda.gov/drug/drugsfda.json (openFDA, no auth required). schema.org/Drug JSON-LD with nonProprietaryName, activeIngredient, dosageForm.

Source organization
US Food and Drug Administration
License / terms
Coverage
~29k drug applications
Latest local indexed-row date
2026-05-17
API endpoint

Keywords

FDA drug approvalDrugs@FDANDAANDABLAgeneric drugsbiologicsdrug applicationOrange BookPurple Bookactive ingredient

Provenance

The listed URL identifies a referenced source; it does not by itself document the ingestion endpoint. Referenced source URL: https://www.accessdata.fda.gov/scripts/cder/daf/. Source-specific terms apply. US federal employee-authored works are generally public domain under 17 USC 105; non-federal and third-party material retains source terms. Free or keyless access does not alter source terms. Metadata and normalization authored by MORVS (AI Analytics LLC) are CC0 only where expressly stated.

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