FDA Drug Approvals Scraper (Drugs@FDA)

Pull the official Drugs@FDA approvals database: every US drug application (NDA, ANDA and BLA), its sponsor, products, active ingredients, marketing status, and the full approval and supplement history. Search by sponsor, brand, generic ingredient, application type, marketing status, route, dosage form or approval date, and export clean rows to JSON, CSV or Excel.

This is the approvals / applications registry, distinct from drug labeling or adverse-event data. One row per product gives you a richer, more granular dataset than the raw application feed.

Here is one real result with every field the actor returns:

{
  "applicationNumber": "BLA125514",
  "applicationType": "BLA - Biologic",
  "sponsorName": "MERCK SHARP DOHME",
  "brandName": "KEYTRUDA",
  "genericName": "PEMBROLIZUMAB",
  "activeIngredients": [
    { "name": "PEMBROLIZUMAB", "strength": "100MG/4ML (25MG/ML)" }
  ],
  "dosageForm": "SOLUTION",
  "route": "INTRAVENOUS",
  "marketingStatus": "Prescription",
  "referenceDrug": false,
  "productNumber": "001",
  "originalApprovalDate": "2014-09-04",
  "latestSubmissionDate": "2026-07-10",
  "submissionCount": 127,
  "pharmClass": ["Programmed Death Receptor-1 Blocking Antibody [EPC]"],
  "rxcui": ["1657746", "1657749", "1657750", "1657751"],
  "drugsFdaUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514",
  "approvalHistory": null,
  "aiSummary": null,
  "observedAt": "2026-08-16T00:00:00.000Z",
  "error": null
}

What you can search

Input	Type	Description
sponsor	text	Applicant / holder, for example Pfizer, Teva, Novartis.
brandName	text	Trade name, for example Lipitor, Humira, Ozempic.
genericName	text	Active ingredient (generic), for example atorvastatin, adalimumab.
applicationNumber	text	Exact application, for example NDA021436, ANDA076277, BLA761363.
applicationType	select	NDA (brand), ANDA (generic) or BLA (biologic).
marketingStatus	select	Prescription, Over-the-counter, Discontinued or None (tentative).
route	text	Route of administration, for example ORAL, INTRAVENOUS, TOPICAL.
dosageForm	text	Dosage form, for example TABLET, CAPSULE, INJECTION.
approvedFrom / approvedTo	date	Approval / action date range (YYYY-MM-DD).
searchQuery	text	Advanced raw Drugs@FDA field expression.
maxResults	integer	Maximum product rows to return (free plans capped at 10).
includeApprovalHistory	boolean	Paid add-on: full submission timeline per application.
withAiSummary	boolean	Paid add-on: plain-English AI summary per application.

What you get

Field	Description
applicationNumber	Drugs@FDA application number (NDA/ANDA/BLA prefix).
applicationType	Derived type: New Drug, Generic or Biologic.
sponsorName	Company holding the application.
brandName	Product trade name.
genericName	Active ingredient names, joined.
activeIngredients	Array of { name, strength }.
dosageForm, route	Product formulation and route.
marketingStatus	Prescription, Over-the-counter, Discontinued or None.
referenceDrug	Whether the product is a reference listed drug.
originalApprovalDate	Earliest original approval date (YYYY-MM-DD).
latestSubmissionDate	Most recent submission / action date.
submissionCount	Number of submissions (approvals plus supplements).
pharmClass	Pharmacologic class (EPC) when available.
rxcui	RxNorm concept IDs when available.
drugsFdaUrl	Direct link to the Drugs@FDA overview page.
approvalHistory	Full timeline when the add-on is enabled.
aiSummary	Plain-English summary when the add-on is enabled.
observedAt	Timestamp of the pull.

Use cases

• Pharma competitive intelligence: track which sponsors win FDA drug approvals and when.
• Generic drug and patent cliff tracking: monitor new ANDA approvals against reference brands to time generic entry.
• Regulatory affairs: follow the full submission and supplement history for any NDA, ANDA or BLA.
• Biotech and pharma investing: watch BLA biologic approvals, new molecular entities and marketing status changes.
• Market research and drug databases: build a clean, structured catalog of approved US drugs, ingredients and dosage forms.
• Portfolio and lifecycle monitoring: spot discontinuations, tentative approvals and label supplements over time.

Billing

This actor uses pay-per-event pricing. You only pay for what you collect.

Event	Price (USD)	When it is charged
result	$0.008	Per product row returned.
approval_history	$0.008	Once per application, only when the submission timeline is produced (enable includeApprovalHistory).
ai_summary	$0.012	Once per application, only on a usable AI summary (enable withAiSummary).

Add-ons are opt-in and off by default. They are disabled on free Apify plans, and no add-on is ever charged when it produces no data. Free plans are capped at 10 rows per run.

Notes and limitations

• Data comes from the official openFDA Drugs@FDA dataset and is only as complete and current as FDA publishes. Fields like pharmClass and rxcui are present only when FDA provides them.
• A query that matches zero applications returns an empty dataset, not an error.
• Very large result sets are paginated; narrow with a filter for the fastest, most complete pulls.