FDA Drugs@FDA Approved Drug Applications Scraper

Extract structured data from FDA Drugs@FDA, the authoritative database of FDA-approved drug applications maintained by the U.S. Food and Drug Administration. This Actor fetches comprehensive drug approval records from the openFDA API, providing powerful filtering, computed approval date fields, and clean JSON output ready for pharmaceutical research, regulatory compliance, and supply-chain intelligence pipelines.

Drugs@FDA contains all FDA-approved human drug applications approved since 1982 for all dosage forms and routes of administration. Pharmaceutical companies, researchers, regulatory professionals, and healthcare supply-chain managers rely on this data for market analysis, competitive intelligence, and pharmacovigilance workflows.

Key Features

• Complete Drugs@FDA database access — All FDA-approved drug applications searchable without authentication
• Sponsor/manufacturer filtering — Find drugs by the company that sponsors the application
• Brand name and generic name extraction — Clean separation of brand names, generic names, and active ingredients
• Marketing status filtering — Isolate Prescription, Over-the-Counter, Discontinued, or Withdrawn drugs
• Product-level detail — Dosage forms, routes of administration, NDC codes, manufacturer information
• Original approval dates — Computed from submission records (earliest ORIG/AP submission date)
• Active ingredients structured — Each ingredient listed with strength/dose information
• Pharmacological classifications — Extract therapeutic and chemical classes (pharm_class_epc)
• Batch-optimized output — One record per product (applications may have multiple product variations)
• No authentication required — Public openFDA API, no API keys or credentials needed
• Pagination support — Handle up to 25,000 results with configurable batch sizes

Output Data Fields

Field	Type	Description
applicationNumber	string	FDA application number (e.g., NDA021833, ANDA076232, BLA125023)
applicationType	string	Application type derived from application number (e.g., NDA, ANDA, BLA)
sponsorName	string	Company name that sponsored the application
brandName	string	Brand/trade name of the drug product
genericName	string	Generic/nonproprietary name (INN)
activeIngredients	string	Semicolon-separated list of active ingredients with strengths
dosageForm	string	Pharmaceutical form (e.g., Tablet, Capsule, Solution, Injectable)
route	string	Route of administration (e.g., Oral, Intravenous, Topical, Intramuscular)
marketingStatus	string	Market status (e.g., Prescription, Over-the-Counter, Discontinued)
manufacturerName	string	Manufacturing company names (comma-separated if multiple)
pharmClass	string	Pharmacological class/therapeutic category
substanceName	string	Active substance names from the openFDA database
productNdc	string	FDA NDC (National Drug Code) values
originalApprovalDate	string	Date of original FDA approval (YYYY-MM-DD format, or empty if not found)

How to Scrape FDA Approved Drugs

1. Navigate to the FDA Drugs@FDA Scraper Actor page on Apify Store.
2. Click Start to open the input configuration form.
3. (Optional) Enter a Sponsor Name to filter results by pharmaceutical company (e.g., "Pfizer", "Merck").
4. (Optional) Enter a Brand Name to search for a specific drug by brand (e.g., "Lipitor", "Advil").
5. (Optional) Enter a Marketing Status to filter by status (e.g., "Prescription", "Over-the-Counter", "Discontinued").
6. (Optional) Enter an Application Number to retrieve a specific FDA application.
7. Set Max Results to control the output size (default: 1000, max: 25000).
8. Click Start to run the Actor.
9. Download results as JSON, CSV, or Excel from the Dataset tab after execution.

Input Example

{
    "sponsorName": "Pfizer",
    "brandName": "",
    "marketingStatus": "Prescription",
    "applicationNumber": "",
    "maxResults": 100
}

Output Example

{
    "applicationNumber": "NDA021833",
    "applicationType": "NDA",
    "sponsorName": "Pfizer Inc",
    "brandName": "Lipitor",
    "genericName": "atorvastatin",
    "activeIngredients": "atorvastatin calcium 10 mg; atorvastatin calcium 20 mg",
    "dosageForm": "Tablet",
    "route": "Oral",
    "marketingStatus": "Prescription",
    "manufacturerName": "Pfizer Inc",
    "pharmClass": "HMG-CoA Reductase Inhibitors",
    "substanceName": "atorvastatin",
    "productNdc": "0071-0151-23; 0071-0152-23",
    "originalApprovalDate": "1997-12-17",
    "applicationType": "NDA"
}

Pricing

This Actor fetches data from the free public openFDA API using simple HTTP requests with no browser automation required.

• Cost per run: ~$0.0001 (minimal API overhead, fast queries)
• Actor start event: Default platform rate
• Per-result pricing: $0.003/result (each product record emitted)

Typical run times:

• Empty filters (all drugs): 30-60 seconds for 1000 results
• Filtered queries (by sponsor/brand): 5-15 seconds
• Specific application number: <2 seconds

Use Cases

• Pharmaceutical market research — Analyze competitive drug portfolios by sponsor, therapeutic class, and approval timeline
• Regulatory compliance tracking — Monitor FDA approvals, track withdrawal/discontinuation status, validate product marketing claims
• Supply-chain intelligence — Identify active manufacturers, track NDC codes, verify product formulations
• Clinical data enrichment — Supplement patient records with structured drug approval and formulation data
• Patent and IP analysis — Correlate FDA approvals with patent databases to track product life-cycle
• Pharmacovigilance workflows — Feed approval records into adverse-event tracking systems
• Healthcare provider onboarding — Validate formularies against Drugs@FDA data for accuracy
• RAG pipeline ingestion — Clean structured output ready for LLM-based drug information queries
• Competitive intelligence — Track competitor product approvals, dosage forms, and market entries
• Historical trend analysis — Analyze approval trends by therapeutic class, manufacturer, or application type

FAQ

Is it legal to scrape FDA Drugs@FDA data?

Yes. This Actor accesses publicly available data from the openFDA API, which is published by the U.S. Food and Drug Administration as open government data. No authentication is required and no terms of service are violated. The data is freely available for any use, including commercial use.

How often is Drugs@FDA data updated?

The openFDA database is updated quarterly with new FDA approvals. New drug applications may appear in Drugs@FDA within a few days of FDA approval. You can schedule this Actor to run weekly or monthly to stay current with new approvals.

What does "Marketing Status" mean?

Marketing Status indicates whether a drug is actively available for sale:

• Prescription — Requires a prescription; typically OTC equivalents do not have this status
• Over-the-Counter (OTC) — Available for purchase without a prescription
• Discontinued — No longer manufactured/marketed but was previously approved
• Withdrawn — Approval was voluntarily withdrawn or revoked by FDA

Can I export FDA Drugs@FDA data to Excel or CSV?

Yes. Apify supports exporting results in JSON, CSV, Excel, XML, and other formats directly from the Dataset tab after a run completes. You can also download raw data for bulk import into databases or analytics tools.

Why do some applications have multiple product records?

Each FDA application can contain multiple drug products (different dosage forms, strengths, or routes). For example, a single application for "Aspirin" may include tablets in 100mg, 325mg, and 500mg strengths. This Actor emits one record per product variation to enable detailed analysis. If you need application-level records only, you can deduplicate by applicationNumber downstream.

What is an Application Number (NDA, ANDA, BLA)?

• NDA (New Drug Application) — Standard approval pathway for a new chemical entity
• ANDA (Abbreviated New Drug Application) — Approval for generic equivalent of an existing drug
• BLA (Biologics License Application) — Approval for biological products (vaccines, monoclonal antibodies, etc.)

What is an NDC code?

NDC (National Drug Code) is a unique identifier assigned to each drug product strength/dosage combination and packaging size. It has 10 digits in 5-4-2 format: LLLLL-LLLL-LL. NDCs are used in pharmacy records, insurance claims, and supply-chain tracking.

How do I filter by therapeutic class?

Use the Brand Name or Sponsor Name filter to narrow results, then filter by pharmacClass in your downstream analysis. Alternatively, you can schedule multiple runs targeting specific therapeutic classes (e.g., "statin", "antibiotic", "immunosuppressant") using the generic name or pharm_class fields.

Can I get approval dates for generic/ANDA drugs?

Yes. This Actor computes originalApprovalDate from submission records. For ANDA (generic) drugs, this is typically the date the generic formulation was approved, not the date the original brand drug was approved.

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Legal Disclaimer

This Actor extracts publicly available data from the openFDA Drugs@FDA database, which is published as open government data by the U.S. Food and Drug Administration. No authentication bypass, credential usage, or terms-of-service violation is involved. Users are responsible for ensuring their use of extracted data complies with applicable laws and regulations, including HIPAA (for health information), FDA regulations, and state pharmacy/medical practice laws.

For regulatory questions about Drugs@FDA data, consult the official FDA Drugs@FDA Documentation. For Actor support, contact the developer through the Apify Store.