# FDA Drug Approvals Scraper - Drugs@FDA NDA ANDA BLA (`scrapers_lat/fda-drug-approvals-scraper`) Actor

Extract FDA drug approvals from Drugs@FDA: NDA, ANDA (generic) and BLA (biologic) applications, sponsor, brand and generic names, active ingredients, dosage form, route, marketing status, approval dates and the full submission history. Export JSON, CSV or Excel.

- **URL**: https://apify.com/scrapers\_lat/fda-drug-approvals-scraper.md
- **Developed by:** [Scrapers Lat](https://apify.com/scrapers_lat) (community)
- **Categories:** Automation, Developer tools, Other
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $8.32 / 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/platform/actors/running/actors-in-store#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
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.
Actors are written with capital "A".

## 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.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

[![FDA Drug Approvals Scraper - Drugs@FDA NDA ANDA BLA](https://scrapers.lat/banners/fda-drug-approvals-scraper.png)](https://apify.com/scrapers_lat/fda-drug-approvals-scraper)

## FDA Drug Approvals Scraper (Drugs@FDA)

Pull the official **Drugs@FDA** approvals database: every US drug application (NDA, ANDA and BLA), its sponsor, products, active ingredients, marketing status, and the full approval and supplement history. Search by sponsor, brand, generic ingredient, application type, marketing status, route, dosage form or approval date, and export clean rows to JSON, CSV or Excel.

This is the **approvals / applications registry**, distinct from drug labeling or adverse-event data. One row per product gives you a richer, more granular dataset than the raw application feed.

Here is one real result with every field the actor returns:

```json
{
  "applicationNumber": "BLA125514",
  "applicationType": "BLA - Biologic",
  "sponsorName": "MERCK SHARP DOHME",
  "brandName": "KEYTRUDA",
  "genericName": "PEMBROLIZUMAB",
  "activeIngredients": [
    { "name": "PEMBROLIZUMAB", "strength": "100MG/4ML (25MG/ML)" }
  ],
  "dosageForm": "SOLUTION",
  "route": "INTRAVENOUS",
  "marketingStatus": "Prescription",
  "referenceDrug": false,
  "productNumber": "001",
  "originalApprovalDate": "2014-09-04",
  "latestSubmissionDate": "2026-07-10",
  "submissionCount": 127,
  "pharmClass": ["Programmed Death Receptor-1 Blocking Antibody [EPC]"],
  "rxcui": ["1657746", "1657749", "1657750", "1657751"],
  "drugsFdaUrl": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514",
  "approvalHistory": null,
  "aiSummary": null,
  "observedAt": "2026-08-16T00:00:00.000Z",
  "error": null
}
```

### What you can search

| Input | Type | Description |
|-------|------|-------------|
| `sponsor` | text | Applicant / holder, for example Pfizer, Teva, Novartis. |
| `brandName` | text | Trade name, for example Lipitor, Humira, Ozempic. |
| `genericName` | text | Active ingredient (generic), for example atorvastatin, adalimumab. |
| `applicationNumber` | text | Exact application, for example NDA021436, ANDA076277, BLA761363. |
| `applicationType` | select | NDA (brand), ANDA (generic) or BLA (biologic). |
| `marketingStatus` | select | Prescription, Over-the-counter, Discontinued or None (tentative). |
| `route` | text | Route of administration, for example ORAL, INTRAVENOUS, TOPICAL. |
| `dosageForm` | text | Dosage form, for example TABLET, CAPSULE, INJECTION. |
| `approvedFrom` / `approvedTo` | date | Approval / action date range (YYYY-MM-DD). |
| `searchQuery` | text | Advanced raw Drugs@FDA field expression. |
| `maxResults` | integer | Maximum product rows to return (free plans capped at 10). |
| `includeApprovalHistory` | boolean | Paid add-on: full submission timeline per application. |
| `withAiSummary` | boolean | Paid add-on: plain-English AI summary per application. |

### What you get

| Field | Description |
|-------|-------------|
| `applicationNumber` | Drugs@FDA application number (NDA/ANDA/BLA prefix). |
| `applicationType` | Derived type: New Drug, Generic or Biologic. |
| `sponsorName` | Company holding the application. |
| `brandName` | Product trade name. |
| `genericName` | Active ingredient names, joined. |
| `activeIngredients` | Array of `{ name, strength }`. |
| `dosageForm`, `route` | Product formulation and route. |
| `marketingStatus` | Prescription, Over-the-counter, Discontinued or None. |
| `referenceDrug` | Whether the product is a reference listed drug. |
| `originalApprovalDate` | Earliest original approval date (YYYY-MM-DD). |
| `latestSubmissionDate` | Most recent submission / action date. |
| `submissionCount` | Number of submissions (approvals plus supplements). |
| `pharmClass` | Pharmacologic class (EPC) when available. |
| `rxcui` | RxNorm concept IDs when available. |
| `drugsFdaUrl` | Direct link to the Drugs@FDA overview page. |
| `approvalHistory` | Full timeline when the add-on is enabled. |
| `aiSummary` | Plain-English summary when the add-on is enabled. |
| `observedAt` | Timestamp of the pull. |

### Use cases

- **Pharma competitive intelligence**: track which sponsors win FDA drug approvals and when.
- **Generic drug and patent cliff tracking**: monitor new ANDA approvals against reference brands to time generic entry.
- **Regulatory affairs**: follow the full submission and supplement history for any NDA, ANDA or BLA.
- **Biotech and pharma investing**: watch BLA biologic approvals, new molecular entities and marketing status changes.
- **Market research and drug databases**: build a clean, structured catalog of approved US drugs, ingredients and dosage forms.
- **Portfolio and lifecycle monitoring**: spot discontinuations, tentative approvals and label supplements over time.

### Billing

This actor uses pay-per-event pricing. You only pay for what you collect.

| Event | Price (USD) | When it is charged |
|-------|-------------|--------------------|
| `result` | $0.008 | Per product row returned. |
| `approval_history` | $0.008 | Once per application, only when the submission timeline is produced (enable `includeApprovalHistory`). |
| `ai_summary` | $0.012 | Once per application, only on a usable AI summary (enable `withAiSummary`). |

Add-ons are opt-in and off by default. They are disabled on free Apify plans, and no add-on is ever charged when it produces no data. Free plans are capped at 10 rows per run.

### Notes and limitations

- Data comes from the official openFDA Drugs@FDA dataset and is only as complete and current as FDA publishes. Fields like `pharmClass` and `rxcui` are present only when FDA provides them.
- A query that matches zero applications returns an empty dataset, not an error.
- Very large result sets are paginated; narrow with a filter for the fastest, most complete pulls.

# Actor input Schema

## `sponsor` (type: `string`):

Company that holds the application, for example Pfizer, Teva or Novartis. Matches the sponsor name on the Drugs@FDA application. Leave empty for all sponsors.

## `brandName` (type: `string`):

Trade / brand name of the drug product, for example Lipitor, Humira or Ozempic. Leave empty to ignore.

## `genericName` (type: `string`):

Active ingredient (generic name), for example atorvastatin, adalimumab or semaglutide. Leave empty to ignore.

## `applicationNumber` (type: `string`):

Exact Drugs@FDA application number with its prefix, for example NDA021436, ANDA076277 or BLA761363. Returns just that one application.

## `applicationType` (type: `string`):

Restrict to New Drug Applications (NDA, brand), Abbreviated New Drug Applications (ANDA, generic) or Biologics License Applications (BLA, biologic). Leave as Any for all types.

## `marketingStatus` (type: `string`):

Restrict products to a marketing status. Prescription and Over-the-counter are actively marketed; Discontinued is no longer marketed; None covers tentative approvals.

## `route` (type: `string`):

Restrict to a route, for example ORAL, INTRAVENOUS, TOPICAL, SUBCUTANEOUS or OPHTHALMIC. Leave empty for all routes.

## `dosageForm` (type: `string`):

Restrict to a dosage form, for example TABLET, CAPSULE, INJECTION or SOLUTION. Leave empty for all forms.

## `approvedFrom` (type: `string`):

Only applications with an approval / submission action on or after this date. Format YYYY-MM-DD, for example 2024-01-01.

## `approvedTo` (type: `string`):

Only applications with an approval / submission action on or before this date. Format YYYY-MM-DD, for example 2024-12-31.

## `searchQuery` (type: `string`):

Advanced: a raw Drugs@FDA search expression that already names a field, for example products.dosage\_form:TABLET or sponsor\_name:TEVA. Combined with the filters above.

## `maxResults` (type: `integer`):

Maximum number of product rows to return. One approved application can yield several product rows. Free Apify plans are capped at 10.

## `includeApprovalHistory` (type: `boolean`):

Add-on: emit the full submission / approval timeline for each application (every original approval and supplement with its type, number, status, date, class and review priority). Billed once per application on success. Disabled for free plans.

## `withAiSummary` (type: `boolean`):

Add-on: generate a short plain-English summary of each application (what it is, drug class, approval status, generic or brand). Uses AI, billed once per application only on usable output. Disabled for free plans.

## `proxyConfiguration` (type: `object`):

Optional. The FDA source does not require a proxy; you can leave this off.

## Actor input object example

```json
{
  "applicationType": "",
  "marketingStatus": "",
  "maxResults": 50,
  "includeApprovalHistory": false,
  "withAiSummary": false,
  "proxyConfiguration": {
    "useApifyProxy": false
  }
}
```

# 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 = {
    "maxResults": 50
};

// Run the Actor and wait for it to finish
const run = await client.actor("scrapers_lat/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 = { "maxResults": 50 }

# Run the Actor and wait for it to finish
run = client.actor("scrapers_lat/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 '{
  "maxResults": 50
}' |
apify call scrapers_lat/fda-drug-approvals-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,scrapers_lat/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/0JkWYNSPibGSDgEW4/builds/o8q3H5sgkndEpupfM/openapi.json