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

Dataset · US Food and Drug Administration · primary source ↗

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 agency
US Food and Drug Administration
License
CC0 / US public domain
Coverage
~29k drug applications
API endpoint

Keywords

FDA drug approvalDrugs@FDANDAANDABLAgeneric drugsbiologicsdrug applicationOrange BookPurple Bookactive ingredient

Provenance

Every record in this dataset can be traced back to its primary source at https://www.accessdata.fda.gov/scripts/cder/daf/. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.

For agents