# US Drug Approvals — NDA, ANDA & BLA Application Tracker (`plaindata/us-drug-approvals`) Actor

US drug applications (NDA, ANDA, BLA): sponsor, brand and generic names, ingredients, dosage form, approval and latest submission dates, letter and label links. Filter by drug, sponsor, dates. Data: openFDA (CC0), not affiliated.

- **URL**: https://apify.com/plaindata/us-drug-approvals.md
- **Developed by:** [plaindata](https://apify.com/plaindata) (community)
- **Categories:** Developer tools, News, Other
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $1.50 / 1,000 result returneds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

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

## US Drug Approvals — NDA, ANDA & BLA Application Tracker

Search **FDA drug applications (NDA, ANDA, BLA)** from the official **openFDA Drugs@FDA** API: sponsor, brand and generic names, active ingredients and strengths, dosage forms, routes, marketing status, original approval date, latest submission (type, status, class, date) and links to the approval letter and label PDFs. Track new approvals by date, by company or by ingredient.

### Input examples

```json
{ "approvedFrom": "2026-01-01", "newApprovalsOnly": true, "maxItems": 100 }
{ "activeIngredient": "SEMAGLUTIDE" }
{ "sponsor": "PFIZER", "approvedFrom": "2026-06-01" }
```

### Output (one row per application)

| Field | Meaning |
|---|---|
| applicationNumber, sponsorName | NDA/ANDA/BLA number and company |
| brandNames, genericNames, activeIngredients | Product identity |
| dosageForms, routes, marketingStatuses | Product details |
| originalApprovalDate | First approval of the original application |
| latestSubmissionType/Number/Status/Date/Class, reviewPriority | Most recent submission in your date window |
| latestDocuments | Letter / label / review PDF links |
| pharmacologicClass, manufacturerNames, submissionsCount, drugsAtFdaUrl, source | Extra context |

### Data source & licence

openFDA (api.fda.gov). openFDA data are public domain (CC0): "You can copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission." Sponsors are companies — no personal data.

### Notes

Without an API key openFDA limits daily requests per IP; add your free key for heavy use. Not affiliated with or endorsed by the U.S. FDA. Do not rely on openFDA data for medical decisions.

# Actor input Schema

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

e.g. OZEMPIC

## `activeIngredient` (type: `string`):

e.g. SEMAGLUTIDE

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

e.g. PFIZER

## `applicationNumbers` (type: `array`):

e.g. NDA213051, BLA125057

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

YYYY-MM-DD

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

YYYY-MM-DD

## `newApprovalsOnly` (type: `boolean`):

Only original applications (new drugs/generics), not supplements.

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

Newest activity first.

## `apiKey` (type: `string`):

Free key from open.fda.gov raises daily limits. Not required.

## Actor input object example

```json
{
  "approvedFrom": "2026-01-01",
  "newApprovalsOnly": true,
  "maxItems": 100
}
```

# 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 = {
    "approvedFrom": "2026-01-01",
    "newApprovalsOnly": true,
    "maxItems": 100
};

// Run the Actor and wait for it to finish
const run = await client.actor("plaindata/us-drug-approvals").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 = {
    "approvedFrom": "2026-01-01",
    "newApprovalsOnly": True,
    "maxItems": 100,
}

# Run the Actor and wait for it to finish
run = client.actor("plaindata/us-drug-approvals").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 '{
  "approvedFrom": "2026-01-01",
  "newApprovalsOnly": true,
  "maxItems": 100
}' |
apify call plaindata/us-drug-approvals --silent --output-dataset

```

## MCP server setup

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

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/7ZndVr5HWUeOk0chr/builds/BQ8dQVm1kgrO0lNIo/openapi.json