Pricing

Pay per usage

FDA Drug Approval Tracker (openFDA)

Searches the openFDA API for drug approval data including NDAs, ANDAs, and BLAs. Returns drug names, sponsors, approval dates, dosage forms, routes, active ingredients, and submission details.

Pricing

Pay per usage

Rating

0.0

(0)

Developer

Curt Smith

Actor stats

Bookmarked

Total users

Monthly active users

2 days ago

Last modified

What data do you get?

For each drug approval record, the actor returns:

Application number (e.g. NDA021457, ANDA078418)
Brand name and generic name
Sponsor/company name
Active ingredients with strengths
Dosage form (tablet, capsule, injection, etc.)
Route of administration (oral, intravenous, topical, etc.)
Approval date of the original submission
Submission type and status
Marketing status (prescription, OTC, discontinued)
Review priority (standard, priority)
Product type (human prescription drug, human OTC drug)

Use cases

Pharmaceutical researchers: Track competitor drug approvals, monitor pipeline activity
Investors: Identify newly approved drugs, track company approval rates
Regulatory professionals: Audit approval timelines and submission histories
Generic drug manufacturers: Find reference drugs eligible for ANDA submissions
Healthcare analysts: Study approval trends by therapeutic area or company

Input parameters

Parameter	Type	Description
keywords	string	Search brand name, generic name, or active ingredient
sponsorName	string	Filter by sponsor company (e.g. "PFIZER")
dateFrom	string	Start date (YYYY-MM-DD)
dateTo	string	End date (YYYY-MM-DD)
approvalType	string	NDA, ANDA, or BLA
maxResults	integer	Max records to return (default: 50)

Example output

{
    "applicationNumber": "NDA021457",
    "sponsorName": "PFIZER INC",
    "brandName": "CADUET",
    "genericName": "AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM",
    "activeIngredients": [
        { "name": "AMLODIPINE BESYLATE", "strength": "5MG" },
        { "name": "ATORVASTATIN CALCIUM", "strength": "10MG" }
    ],
    "dosageForm": "TABLET",
    "route": "ORAL",
    "approvalDate": "2004-02-12",
    "submissionType": "ORIG",
    "submissionStatus": "AP",
    "marketingStatus": "Prescription",
    "productType": "HUMAN PRESCRIPTION DRUG",
    "reviewPriority": "STANDARD"
}

Data source

All data comes from the openFDA Drugs@FDA endpoint, a free public API maintained by the U.S. Food and Drug Administration. The database contains most drug products approved since 1939, with mostly complete data from 1998 onward.

No API key is required for basic use (up to 240 requests/minute).

Rate limiting

The actor adds a 300ms delay between API requests to stay well within the openFDA rate limits. The openFDA API allows 240 requests per minute without an API key.

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