Drugs@FDA Applications (NDA / ANDA / BLA registry)

Dataset · US Food and Drug Administration · source URL ↗

Every FDA drug application — 25k most recent of 29k total. Each application carries its full products[] list (different strengths + dosage forms under one app number) and submissions[] history (original approval + supplements + amendments). Application types: NDA (innovator new drug), ANDA (generic), BLA (biologic), NADA (animal). Joins to fda_ndc via application_number.

Source organization
US Food and Drug Administration
License / terms
Coverage
25,000 applications
Latest local indexed-row date
2026-05-18
API endpoint

Keywords

Drugs@FDANDAANDA genericBLA biologicdrug approvalFDA applicationdrug labeling

Provenance

The listed URL identifies a referenced source; it does not by itself document the ingestion endpoint. Referenced source URL: https://open.fda.gov/apis/drug/drugsfda/. 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.

For agents