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.

Live API

This dataset is served via a live REST API at api.ai-analytics.org. The card you're reading exists so HuggingFace's index can route AI agents + researchers to the canonical source.

API endpoint: https://api.ai-analytics.org/api/v1/drug-approvals/recent
Dataset landing page: https://api.ai-analytics.org/datasets/drug-approvals
DataCatalog (JSON-LD): https://api.ai-analytics.org/.well-known/dataset.json
DCAT-US (data.gov-compatible): https://api.ai-analytics.org/data.json

Quick start

# Recent records (JSON)
curl 'https://api.ai-analytics.org/api/v1/drug-approvals/recent?limit=10'

# Browse on the web
open 'https://api.ai-analytics.org/datasets/drug-approvals'

MCP (Model Context Protocol)

This dataset is also accessible via MCP at https://api.ai-analytics.org/mcp — Claude, ChatGPT, and other MCP-compatible agents can call it directly.

Source

Agency: US Food and Drug Administration
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/
License: CC0 1.0 Universal (derived data). Underlying federal works are US public domain under 5 USC 105 / 17 USC 105.
Update cadence: Per agency (most refresh daily via Cloudflare Cron Trigger)

Keywords

FDA drug approval, Drugs@FDA, NDA, ANDA, BLA, generic drugs, biologics, drug application, Orange Book, Purple Book, active ingredient

Citation

@misc{ai_analytics_drug_approvals_2026,
  title  = {{name}},
  author = {AI Analytics},
  year   = {2026},
  url    = {https://api.ai-analytics.org/datasets/drug-approvals},
  note   = {Derived from US Food and Drug Administration. License: CC0 1.0.}
}

Maintained by AI Analytics. Data is CC0; please cite the upstream agency.

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