# FDA Drug Approvals Scraper (`acquistion-automation/fda-drug-approvals-scraper`) Actor

Scrapes FDA drug approval records from the openFDA Drugs@FDA endpoint. Each row returns the application number, sponsor, active ingredients, and approval date.

- **URL**: https://apify.com/acquistion-automation/fda-drug-approvals-scraper.md
- **Developed by:** [Acquisition Automation Co.](https://apify.com/acquistion-automation) (community)
- **Categories:** Other, Lead generation
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $19.00 / 1,000 results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

![Acquisition Automation Co. Search less. Close more.](https://api.apify.com/v2/key-value-stores/AOdPHdOpeDpzEPS5f/records/banner.jpg)

## 💊 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

```json
{
  "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
}
```

```json
{
  "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](https://console.apify.com/sign-up). 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:

```json
{
  "maxItems": 10
}
```

Original applications only, in volume:

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

One sponsor's record:

```json
{
  "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:

```bash
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.

### 🔗 More from Acquisition Automation Co.

- [DrugBank Open Data Scraper](https://apify.com/acquistion-automation/drugbank-open-scraper)
- [IRS Exempt Organizations Scraper](https://apify.com/acquistion-automation/irs-eo-master-file-scraper)
- [SAM.gov Contract Opportunities Scraper](https://apify.com/acquistion-automation/sam-gov-contracts-scraper)
- [Clutch Agencies Scraper](https://apify.com/acquistion-automation/clutch-agencies-scraper)
- [BizBuySell Scraper](https://apify.com/acquistion-automation/bizbuysell-scraper)

### 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.

# Actor input Schema

## `search` (type: `string`):

openFDA search query (e.g. submissions.submission_type:ORIG)

## `maxItems` (type: `integer`):

Free users: Limited to 10 items (preview). Paid users: Optional, max 1,000,000

## Actor input object example

```json
{
  "maxItems": 10
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "maxItems": 10
};

// Run the Actor and wait for it to finish
const run = await client.actor("acquistion-automation/fda-drug-approvals-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = { "maxItems": 10 }

# Run the Actor and wait for it to finish
run = client.actor("acquistion-automation/fda-drug-approvals-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "maxItems": 10
}' |
apify call acquistion-automation/fda-drug-approvals-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,acquistion-automation/fda-drug-approvals-scraper"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/9UyhC56H9iH2iyIXd/builds/0UXu8TeaGaTv9rgtq/openapi.json