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

Dataset · US Food and Drug Administration · primary source ↗

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 agency
US Food and Drug Administration
License
CC0 / US public domain
Coverage
25,000 applications
API endpoint

Keywords

Drugs@FDANDAANDA genericBLA biologicdrug approvalFDA applicationdrug labeling

Provenance

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

For agents