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.
Every record in this dataset can be traced back to its primary source at 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. AI Analytics-authored metadata and normalization are CC0 only where expressly stated.