💊 FDA Drug Approvals Scraper

Export the FDA's Drugs@FDA record as flat rows: application number, sponsor, brand and generic name, dosage form, strength, marketing status and the status date of every submission. No API key, no registration, no login.

In a generics or specialty pharma deal, the asset being sold is the application. An ANDA or an NDA is what carries the right to market the product, and its submission history is what tells you whether the sponsor has kept it alive. The FDA publishes all of it through the openFDA Drugs@FDA endpoint, one JSON page at a time, nested several levels deep. This Actor flattens it into one row per product submission and writes it to a dataset you can open in a spreadsheet.

Who uses it	What they use the record for
💼 Buyers of pharma and generics businesses	Listing the seller's applications, and seeing which products are Prescription and which are Discontinued
🏭 Contract manufacturers and their acquirers	Matching a manufacturer name to the applications it appears on
🔬 Licensing and business development teams	Finding every sponsor holding an application for a given ingredient
📊 Analysts and researchers	Building a dated submission history for a molecule or a company

📋 What it does

💡 Why it matters: an asset schedule that lists "12 ANDAs" is a claim. The application numbers, their marketing status and their submission history are a public record you can check against it.

• 🔎 Queries openFDA directly. search takes the same query syntax the endpoint uses, for example submissions.submission_type:ORIG.
• 🧾 One row per product submission, so an application with several products and several supplements flattens into rows you can group and count.
• 🏢 Sponsor and manufacturer names side by side, which is how you connect a target company to the applications it holds.
• 💊 Product detail: brand name, generic name, substance, route, dosage form and strength.
• 🚦 Marketing status on every row, for example Prescription or Discontinued.
• 💾 Exports to CSV, Excel, JSON or XML, from the run page or the API.

📊 Output

Every product submission is one flat row with 22 fields. null means the FDA publishes no value for that field on that record; the openfda fields in particular are absent for many older applications.

Field	Type	Description
🆔 applicationNumber	string	FDA application number, for example ANDA078902 or NDA017864
🏢 sponsorName	string	The sponsor as Drugs@FDA records it, for example MYLAN
🏷 openfdaBrandName	string	Brand name from the openFDA block
🧪 openfdaGenericName	string	Generic name from the openFDA block
🏭 openfdaManufacturerName	string	Manufacturer name from the openFDA block
📦 openfdaProductType	string	Product type, for example HUMAN PRESCRIPTION DRUG
💉 openfdaRoute	string	Route of administration, for example ORAL
⚗️ openfdaSubstanceName	string	Active substance name
🔢 productNumber	string	Product number inside the application, for example 004
💊 dosageForm	string	Dosage form, for example TABLET or SOLUTION
📏 strength	string	Strength as published
🚦 marketingStatus	string	Marketing status, for example Prescription or Discontinued
📄 submissionType	string	Submission type, for example ORIG or SUPPL
🔖 submissionNumber	string	Sequence number of the submission
✅ submissionStatus	string	Submission status code, for example AP for approved
📅 submissionStatusDate	string	Date that status was set, as YYYYMMDD
🗂 submissionClassCode	string	Submission class code, for example LABELING or MANUF (CMC)
📝 submissionClassDescription	string	The same class in words, for example Manufacturing (CMC)
📚 submissionsCount	integer	How many submissions the parent application has in total
📦 productsCount	integer	How many products the parent application covers
🕒 scrapedAt	string	ISO timestamp of collection
⚠️ error	string	null on a normal row

Example rows

{
  "applicationNumber": "ANDA078902",
  "sponsorName": "MYLAN",
  "openfdaBrandName": "PAROXETINE",
  "openfdaGenericName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
  "openfdaManufacturerName": "Mylan Pharmaceuticals Inc.",
  "openfdaProductType": "HUMAN PRESCRIPTION DRUG",
  "openfdaRoute": "ORAL",
  "openfdaSubstanceName": "PAROXETINE HYDROCHLORIDE",
  "productNumber": "004",
  "dosageForm": "TABLET",
  "strength": "PAROXETINE HYDROCHLORIDE EQ 40MG BASE",
  "marketingStatus": "Prescription",
  "submissionType": "SUPPL",
  "submissionNumber": "7",
  "submissionStatus": "AP",
  "submissionStatusDate": "20100325",
  "submissionClassCode": "LABELING",
  "submissionClassDescription": "Labeling",
  "submissionsCount": 12,
  "productsCount": 4,
  "scrapedAt": "2026-09-14T16:31:15.682Z",
  "error": null
}

{
  "applicationNumber": "NDA017864",
  "sponsorName": "BAXTER HLTHCARE",
  "openfdaBrandName": null,
  "openfdaGenericName": null,
  "openfdaManufacturerName": null,
  "openfdaProductType": null,
  "openfdaRoute": null,
  "openfdaSubstanceName": null,
  "productNumber": "001",
  "dosageForm": "SOLUTION",
  "strength": "SODIUM CHLORIDE 450MG/100ML",
  "marketingStatus": "Discontinued",
  "submissionType": "SUPPL",
  "submissionNumber": "39",
  "submissionStatus": "AP",
  "submissionStatusDate": "19940218",
  "submissionClassCode": "MANUF (CMC)",
  "submissionClassDescription": "Manufacturing (CMC)",
  "submissionsCount": 37,
  "productsCount": 1,
  "scrapedAt": "2026-09-14T16:31:15.682Z",
  "error": null
}

✨ Why choose this Actor

	What you get
The FDA's own record	Data comes from the openFDA Drugs@FDA endpoint, not from a drug database that resells it.
Flat instead of nested	The endpoint nests products inside submissions inside applications. Here it is one row, 22 columns.
No credentials	openFDA is public. No API key, no account, no quota to negotiate.
The same fields every run	Append several searches into one dataset without cleaning columns.
You pay per row	No subscription. A search that returns nothing costs nothing.

🚀 How to use it

1. Create a free Apify account. New accounts start with $5 of credit.
2. Open the Actor and select Try for free.
3. Leave search empty for a general pull, or write an openFDA query to narrow it.
4. Set maxItems to cap the run.
5. Select Start, then export from the Dataset tab as CSV, Excel, JSON or XML.

A first run:

{
  "maxItems": 10
}

Original applications only, in volume:

{
  "search": "submissions.submission_type:ORIG",
  "maxItems": 500
}

One sponsor's record:

{
  "search": "sponsor_name:MYLAN",
  "maxItems": 500
}

⚙️ Input

Field	Required	Description
search	No	openFDA search query, for example submissions.submission_type:ORIG. Empty returns a general pull
maxItems	No	Maximum rows per run. Free plan is limited to 10 as a preview, paid plans up to 1,000,000

💰 Pricing

Pay per result. No subscription, and no Apify platform usage on top.

Apify plan	Free	Bronze	Silver	Gold	Platinum	Diamond
Per row	$0.021	$0.02033	$0.01967	$0.019	$0.019	$0.019

Rows collected	Cost on the Free plan
100	$2.10
1,000	$21.00
10,000	$210.00

Free plan runs return up to 10 rows as a preview. Any paid Apify plan lifts that to 1,000,000 per run.

🔌 Integrate with any app

The dataset is available through the Apify API as soon as the run finishes. Use run-sync-get-dataset-items for a one-shot call, webhooks to trigger what happens next, or the Make, Zapier, Airbyte and LangChain integrations listed on the Actor page.

🤖 Use with an AI agent

Give an agent live access to Drugs@FDA over the Model Context Protocol:

$claude mcp add --transport http apify "https://mcp.apify.com?tools=acquistion-automation/fda-drug-approvals-scraper"

Then ask it in plain language which applications a sponsor holds and have it read the rows back.

❓ Frequently asked questions

Why do I get several rows for the same application number? Because the row is a product submission, not an application. An application with four products and twelve submissions produces many rows. submissionsCount and productsCount tell you the size of the parent application on each row, so you can check you pulled all of it.

What does submissionStatusDate mean? It is the date the submission reached the status in submissionStatus, written as YYYYMMDD. For a row with submissionStatus of AP and submissionType of ORIG, that is the original approval date. On a SUPPL row it is the date that supplement was approved, not the date the drug first reached the market.

Why are the openfda fields empty on some rows? The openFDA block is matched from product labelling, and older or discontinued applications often have none. The Drugs@FDA fields on those rows, such as sponsorName, dosageForm and strength, are still populated.

What query syntax does search take? The openFDA syntax, field:value, with the field paths openFDA uses, for example sponsor_name:MYLAN or submissions.submission_type:ORIG. Leaving it empty returns a general pull.

Does this cover biologics, devices or supplements? No. Drugs@FDA covers drug applications. Biologics licensed under a BLA, medical devices and dietary supplements sit in other FDA datasets.

What can I export? CSV, Excel, JSON and XML from the run page, or JSON straight from the API.

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About Acquisition Automation Co.

We build automation for people buying businesses. The repetitive part of an acquisition search, checking listings, pulling public records, tracking owners and assets, is work a machine should do, so the buyer's time goes into judging deals instead of collecting them.

We add new Actors regularly. If there is a source you need and do not see here, tell us.

🆘 Support

Open an issue in the Issues tab of this Actor with your run ID, the input you used, and what you expected to get back.

⚠️ Disclaimer

This Actor is independent and is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration or any government agency. It collects only publicly available data. You are responsible for using that data in compliance with the source's terms of service and applicable law. Nothing here is medical, legal or investment advice.