FDA Drug Approvals Scraper

Free-plan limit: Apify free-plan runs can return at most 5 dataset records per run from this Actor, even if you request more.

Extract structured FDA drug approval actions from the official Drugs@FDA dataset. The Actor is designed for pharmaceutical research, regulatory intelligence, competitive monitoring, and data pipelines that need application-level approval history without parsing FDA pages manually.

The Actor uses the public openFDA Drugs@FDA endpoint, which is sourced from Drugs@FDA and updated on FDA business days. One dataset item represents one approved original or supplement submission—not one product package. This distinction keeps dates, review priority, submission class, and public approval documents attached to the regulatory action they describe.

What it extracts

Field	Description
applicationNumber, applicationType	NDA, ANDA, or BLA identifier and type
approvalDate, approvalStatus	FDA submission status date and AP/TA status
submissionType, submissionNumber	Original or supplement action and its number
reviewPriority	Standard or priority review when FDA supplies it
submissionClassCode	FDA submission classification and description
sponsorName	Application sponsor
products	Brand, ingredient/strength, dosage form, route, marketing status, RLD/RS flags, and TE code
brandNames, genericNames, substanceNames	Harmonized openFDA names
manufacturerNames, productNdcs, rxcuis	Harmonized identifiers
applicationDocuments	Public labels, letters, reviews, and other submission documents when available
applicationUrl, apiUrl	Official FDA and openFDA source links
sourceLastUpdated, fetchedAt	Source freshness and extraction timestamp

When to use it

Use this Actor to monitor approvals by date, build a sponsor or drug approval history, retrieve exact applications, analyze original versus supplement actions, or feed FDA regulatory data into a spreadsheet, database, or AI agent.

Do not use it for medical advice, adverse-event analysis, recalls, drug labels as full text, patents/exclusivity, or a complete list of CBER-regulated vaccines, blood products, and cell or gene therapies. Drugs@FDA coverage and harmonized fields vary by product and year.

Input

Input	Default	Purpose
query	Ozempic	Search brand names, ingredients, sponsors, and application numbers
applicationNumbers	[]	Retrieve exact NDA, ANDA, or BLA applications
brandName	empty	Match an FDA product brand name
activeIngredient	empty	Match an FDA active ingredient
sponsorName	empty	Match an application sponsor
applicationType	all	Limit to NDA, ANDA, or BLA
approvalType	original	Return originals, supplements, or both
approvalDateFrom, approvalDateTo	empty	Bound approval status dates in YYYY-MM-DD
includeTentativeApprovals	false	Include TA records alongside AP approvals
sortBy	newest	Sort approval actions by date
maxResults	25	Cap records and result-event charges (1–5,000)
maxRequestRetries	2	Retry bounded 429, 5xx, timeout, and network errors
apiKey	empty	Optional openFDA key for higher official API limits

At least one search criterion is required. Clear the default query when you want only exact filters to apply.

Recent original approvals

{
  "query": "",
  "approvalDateFrom": "2026-01-01",
  "approvalDateTo": "2026-12-31",
  "approvalType": "original",
  "sortBy": "newest",
  "maxResults": 100
}

Exact applications with supplement history

{
  "query": "",
  "applicationNumbers": ["NDA209637", "NDA213051"],
  "approvalType": "all",
  "maxResults": 250
}

API call

curl -X POST "https://api.apify.com/v2/acts/USERNAME~fda-drug-approvals-scraper/runs?token=APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"query":"semaglutide","approvalType":"original","maxResults":10}'

With Apify's MCP server, call the Actor with the same JSON input, wait for completion, then read results from the default dataset or summary from the output links.

Output example

{
  "approvalId": "NDA209637:ORIG:1:2017-12-05",
  "applicationNumber": "NDA209637",
  "applicationType": "NDA",
  "sponsorName": "NOVO",
  "submissionType": "ORIG",
  "submissionNumber": "1",
  "approvalStatus": "AP",
  "approvalStatusLabel": "Approved",
  "approvalDate": "2017-12-05",
  "reviewPriority": "STANDARD",
  "submissionClassCode": "TYPE 1",
  "submissionClassDescription": "Type 1 - New Molecular Entity",
  "brandNames": ["OZEMPIC"],
  "genericNames": [],
  "applicationUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209637",
  "sourceLastUpdated": "2026-08-28",
  "fetchedAt": "2026-08-31T12:00:00.000Z"
}

The full record also contains products, ingredients and strengths, harmonized identifiers, routes, manufacturers, and public documents. Optional FDA fields are represented as null or empty arrays rather than invented values.

Pricing

This Actor uses pay-per-event pricing. These are the current Apify Store event prices:

Event	Price (USD)	When it is charged
apify-actor-start	$0.0005	Actor Start — Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event). — Charged once per run.
fda-approval-action	$0.001	FDA approval action — One schema-valid FDA drug approval action written to the default dataset.

Apify platform usage for this Actor run is included alongside the event prices above; no separate per-run platform-usage fee is passed to users.

This covers Apify platform usage for this Actor run. Other Apify products or usage outside this Actor run may still follow your account plan.

Reliability and limits

• The source is the official public openFDA Drugs@FDA endpoint; no third-party provider is used.
• Requests use bounded timeouts, retry 429 and transient 5xx/network failures, and honor Retry-After when supplied.
• openFDA accepts at most 99 application records per request and restricts deep paging. The Actor paginates automatically and reports a warning if the source's 25,000-record deep-page boundary is reached. Narrow filters for larger studies.
• openFDA returns whole application records when a nested submission matches. The Actor re-filters every nested submission locally so unrelated dates or action types are not emitted.
• Drug-name text filters must use printable ASCII because openFDA rejects some Unicode search syntax; exact FDA application numbers remain available as a language-neutral lookup.
• A valid search with no approval actions returns an empty dataset plus a truthful SUMMARY. Invalid input is rejected before billable result work.
• Public API limits are stricter without an openFDA API key. Supply your own optional key for frequent or large runs.

Data responsibility

The data is public U.S. government regulatory information. Respect the openFDA terms and license, use reasonable request volumes, and retain source links when redistributing records. FDA and openFDA warn that the data should not be used alone for medical-care decisions. Verify material regulatory conclusions against the linked FDA documents and application page.

For support, open an issue from the Actor's Apify Console page and include the run ID, redacted input, expected outcome, and the SUMMARY record. Never include API keys or tokens.