FDA Drug Approvals Tracker

Track FDA drug approvals — NDA, BLA and ANDA application records with dates and manufacturers.

Public regulatory/health data — not medical advice.

📊 Sample Output

approval_id	application_number	drug_name	brand_name	generic_name	manufacturer
NDA215559-SUPPL-3	NDA215559	SOHONOS (PALOVAROTENE)	SOHONOS	PALOVAROTENE	IPSEN
NDA218881-SUPPL-1	NDA218881	INLURIYO (IMLUNESTRANT TOSYLATE)	INLURIYO	IMLUNESTRANT TOSYLATE	ELI LILLY AND CO
NDA219132-SUPPL-2	NDA219132	AQNEURSA (LEVACETYLLEUCINE)	AQNEURSA	LEVACETYLLEUCINE	INTRABIO
NDA208716-SUPPL-22	NDA208716	VERZENIO (ABEMACICLIB)	VERZENIO	ABEMACICLIB	ELI LILLY AND CO
ANDA217891-ORIG-1	ANDA217891	CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE)	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE	CIPLA
NDA211243-SUPPL-26	NDA211243	SPRAVATO (ESKETAMINE HYDROCHLORIDE)	SPRAVATO	ESKETAMINE HYDROCHLORIDE	JANSSEN PHARMS

Real rows from run 8nzUmu3hElSkhu2jj on build 0.0.8 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.

⚙️ Sample inputs

This is the Store example input — the same input Apify's automated check runs — so it is proven to return rows on the current build. Paste it into the input form, or send it through the API, CLI or a schedule:

{
  "date_range": "last_90d",
  "approval_type": "all",
  "has_special_designation": "all",
  "limit": 50
}

🔧 Input reference

Field	Type	Default	What it does
date_range	string (last_30d, last_90d, last_180d, last_365d, ytd, all)	"last_90d"	Filter by FDA approval date window. 'last_30d' = approvals in the last 30 calendar days (typical weekly desk pull); 'last_90d' = last 90 days (quarterly pipeline review window); '…
approval_type	string (all, NDA, BLA, ANDA, NME, SUPPL)	"all"	Filter by FDA application type. NDA = New Drug Application (small-molecule, CDER review); BLA = Biologics License Application (biologics, CBER/CDER); ANDA = Abbreviated NDA (gener…
manufacturer	string	""	Filter by FDA sponsor (applicant company) name. Case-insensitive substring match against the openFDA sponsor_name field. Examples: 'pfizer', 'merck', 'vertex', 'novartis', 'eli li…
therapeutic_class	string	""	Filter by therapeutic area or indication keyword. Case-insensitive match against drug name + active ingredient + dosage form. Examples: 'oncology', 'cancer', 'diabetes', 'cardiova…
has_special_designation	string (all, any, priority_review, breakthrough, accelerated, orphan, fast_track, none)	"all"	Filter approvals by FDA expedited program flag. 'priority_review' = 6-month FDA review clock (vs 10-month standard); 'breakthrough' = breakthrough therapy designation (substantial…
limit	integer	50	Maximum number of FDA approval records to emit. Set to 10 for a smoke test, 50 for a weekly desk pull, 200 for a full quarterly cohort. The openFDA index contains ~29,000 applicat…

🧾 JSON sample record

One real record from run 8nzUmu3hElSkhu2jj (emails/phones masked, long text shortened):

{
  "approval_id": "NDA215559-SUPPL-3",
  "application_number": "NDA215559",
  "drug_name": "SOHONOS (PALOVAROTENE)",
  "brand_name": "SOHONOS",
  "generic_name": "PALOVAROTENE",
  "manufacturer": "IPSEN",
  "approval_date": "2026-09-18",
  "approval_type": "SUPPL",
  "submission_type": "SUPPL",
  "submission_number": "3",
  "submission_class": "Labeling",
  "indication": "Retinoid [EPC]",
  "dosage_form": "CAPSULE",
  "route_of_administration": "ORAL",
  "therapeutic_class": null,
  "priority_review": false,
  "breakthrough_designation": false,
  "accelerated_approval": false,
  "orphan_drug": false,
  "fast_track": false,
  "fda_press_release_url": null,
  "fda_daf_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215559",
  "openfda_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA215559",
  "marketing_status": "Prescription",
  "data_source": "openFDA Drugs@FDA"
}

💰 Pricing

Event	Price (USD)	When it is charged
Actor Start (apify-actor-start)	$0.01	Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event).
FDA approval record (apify-default-dataset-item)	$0.1	Charged per FDA approval record returned with drug name, manufacturer, approval date / type, indication, dosage form, route, therapeutic cl…

Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.1 = $10.00 plus the start fee.

🔗 Related Actors

More from the NexGenData Healthcare & FDA family:

• Consumer Product Recall & Safety Intelligence — CPSC
• Doctor Directory Lead Finder — Provider Contacts API
• FDA Adverse Events — FAERS & MAUDE Records API
• FDA Drug Shortages Monitor — Current & Resolved API
• FDA Orange Book — Drug Patent & Exclusivity API
• FDA Pharma Pipeline Tracker — Milestone Data API

15 more in this family on the NexGenData Store page.

⏰ Run this as a monitoring subscription (recommended)

Regulatory data is monitoring data. Schedule a weekly sweep (0 8 * * 1) and catch new approvals as they post — an always-on official-records feed.

📊 What you get

Clean JSON, one record per approval (full output has 25 fields):

• approval_id — Approval id
• application_number — Application number
• drug_name — Drug name
• brand_name — Brand name
• generic_name — Generic name
• manufacturer — Manufacturer
• approval_date — Approval date
• approval_type — Approval type
• submission_type — Submission type
• submission_number — Submission number

Pricing: $0.10 per approval record returned to the dataset (Pay-Per-Event) — about 10 approvals per $1 — plus $0.01 per actor start (one event per GB of run memory, minimum one).

🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and pull official records on demand.

Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

🔗 Related regulatory actors

FDA & public-health records family:

OpenFDA Drug · Drug Shortages · Purple Book · Warning Letters/483 · Pharma Pipeline · Adverse Events · Medical Devices

Product-safety recalls: NHTSA Recalls · NHTSA Defects · NHTSA Safety · CPSC Recalls

Agent front door — Healthcare & FDA MCP: Healthcare & FDA MCP

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Public official records and enforcement data, assembled for research and monitoring.