# Drugs@FDA Search: FDA Drug Approvals (NDA, ANDA, BLA) (`smilemask/fda-drug-approvals-drugsfda`) Actor

Search Drugs@FDA approval applications (NDA, ANDA, BLA) by active ingredient, brand name, sponsor company or drug class. Returns application number, sponsor, brands, ingredients, strengths, forms, routes, marketing status, first approval date, review priority and submissions. Free CC0 openFDA data.

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

## Pricing

from $2.00 / 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.

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

## Drugs@FDA Search: FDA Drug Approvals (NDA, ANDA, BLA)

Search Drugs@FDA approval applications (NDA, ANDA, BLA) by active ingredient, brand name, sponsor company or drug class. Returns application number, sponsor, brands, ingredients, strengths, forms, routes, marketing status, first approval date, review priority and submissions. Free CC0 openFDA data.

### What does Drugs@FDA Search do?

Look up US FDA drug approval applications by ingredient, brand, sponsor or drug class with approval date and products.

### What can you use it for?

- Find every approved brand and generic application for an ingredient such as atorvastatin or semaglutide.
- List a pharma company's FDA approval portfolio for competitive or investment research.
- Check original approval dates and priority review status for a drug class.
- Spot generic (ANDA) competition for a branded product.

### Why use this Actor?

- **Fast and cheap:** lightweight HTTP-based Actor with no browser, so runs finish in seconds and cost very little.
- **No API keys or accounts needed** for the data source (see notes below).
- **Clean, structured JSON** that you can export as CSV, Excel, JSON or XML, or pull through the Apify API and integrations.
- **Scheduling, webhooks and integrations:** run it daily and send results to Google Sheets, Slack, Zapier, Make, n8n or your own API.

### Input

Configure the run in the **Input** tab (all fields have sensible defaults).

| Field | Type | Required | Default | Description |
|---|---|---|---|---|
| `query` | string | yes | - | e.g. semaglutide, LIPITOR, PFIZER, or a drug class such as GLP-1. |
| `searchField` | string (products.active_ingredients.name / products.brand_name / sponsor_name / openfda.pharm_class_epc / application_number) | no | `"products.active_ingredients.name"` | Which field to match. |
| `maxResults` | integer | no | `50` | Maximum number of applications. |
| `apiKey` | string | no | - | Free key from open.fda.gov raises the rate limit. Stored encrypted. |

#### Example input

```json
{
  "query": "semaglutide",
  "maxResults": 20
}
```

### Output

Results are stored in the default dataset. Download them from the **Output** tab or via the API.

#### Example result

```json
{
  "applicationNumber": "NDA213051",
  "sponsor": "NOVO",
  "brandNames": "OZEMPIC, RYBELSUS",
  "activeIngredients": "SEMAGLUTIDE",
  "strengths": "9MG, 1.5MG, 7MG, 4MG, 14MG, 3MG",
  "dosageForms": "TABLET",
  "routes": "ORAL",
  "marketingStatus": "Prescription",
  "productCount": 6,
  "originalActionDate": "2019-09-20T00:00:00.000Z",
  "originalStatus": "AP",
  "originalReviewPriority": "PRIORITY",
  "submissionCount": 13,
  "pharmClass": "GLP-1 Receptor Agonist [EPC]",
  "manufacturer": "Novo Nordisk Pharmaceutical Industries, LP",
  "scrapedAt": "2026-10-22T20:39:57.011Z"
}
```

#### Output fields

| Field | Type | Example |
|---|---|---|
| `applicationNumber` | string | "NDA213051" |
| `sponsor` | string | "NOVO" |
| `brandNames` | string | "OZEMPIC, RYBELSUS" |
| `activeIngredients` | string | "SEMAGLUTIDE" |
| `strengths` | string | "9MG, 1.5MG, 7MG, 4MG, 14MG, 3MG" |
| `dosageForms` | string | "TABLET" |
| `routes` | string | "ORAL" |
| `marketingStatus` | string | "Prescription" |
| `productCount` | number | 6 |
| `originalActionDate` | string | "2019-09-20T00:00:00.000Z" |
| `originalStatus` | string | "AP" |
| `originalReviewPriority` | string | "PRIORITY" |
| `submissionCount` | number | 13 |
| `pharmClass` | string | "GLP-1 Receptor Agonist \[EPC]" |
| `manufacturer` | string | "Novo Nordisk Pharmaceutical Industries, LP" |
| `scrapedAt` | string | "2026-10-22T20:39:57.011Z" |

### How much does it cost?

The Actor is billed by Apify according to the pricing shown on the **Pricing** tab of this page. Runs are small and fast, and the Apify Free plan includes monthly platform credits so you can try it at no cost. You can set a maximum cost per run, and the Actor stops cleanly when that limit is reached.

### Notes and limitations

- Source: openFDA Drugs@FDA endpoint (US FDA). One row per application; products of the same application are combined.
- originalStatus AP means approved, TA tentative approval (e.g. a generic waiting on patents); originalActionDate is the date of that action.
- Sponsor search matches the FDA spelling of the company name (e.g. PFIZER, NOVO NORDISK). pharmClass and manufacturer are only filled for applications openFDA could link to a current label. Informational only, not medical advice.

### Tips

- Start with a small test run, then scale up the input.
- Use **Schedules** to automate recurring runs and **Webhooks** or **Integrations** to deliver the data where you need it.
- Call the Actor from your code with the Apify API or the official JavaScript and Python clients.

### FAQ

**Can I use my own openFDA key?**

Yes, paste it in the optional API key field for higher rate limits.

**What do NDA, ANDA and BLA mean?**

NDA is a new (brand) drug, ANDA a generic, BLA a biologic. The prefix is part of applicationNumber.

**How fresh is the data?**

openFDA updates Drugs@FDA weekly.

### Feedback

Found a bug or need an extra field? Open an issue from the **Issues** tab of this Actor and it will be looked at quickly.

### More tools from the same author

- [NDC Drug Directory: FDA National Drug Code Lookup & Search](https://apify.com/SmileMask/fda-ndc-drug-directory-search) - Search the official FDA National Drug Code (NDC) Directory by NDC, brand, generic name, ingredient, labeler or drug class.
- [FDA Drug Label Search: Ingredients, Warnings & Indications](https://apify.com/SmileMask/fda-drug-label-search) - Search official FDA drug labels: active ingredients, indications, warnings, dosage and manufacturers.
- [Drug Shortages: FDA Drug Shortage Database Search & Tracker](https://apify.com/SmileMask/fda-drug-shortage-tracker) - Search the official US FDA drug shortage list by drug, company or therapeutic area with status, availability and reason.

# Changelog

This Actor's version history is a separate document: https://apify.com/smilemask/fda-drug-approvals-drugsfda/changelog.md

# Actor input Schema

## `query` (type: `string`):

e.g. semaglutide, LIPITOR, PFIZER, or a drug class such as GLP-1.

## `searchField` (type: `string`):

Which field to match.

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

Maximum number of applications.

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

Free key from open.fda.gov raises the rate limit. Stored encrypted.

## Actor input object example

```json
{
  "query": "semaglutide",
  "searchField": "products.active_ingredients.name",
  "maxResults": 20
}
```

# 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 = {
    "query": "semaglutide",
    "maxResults": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("smilemask/fda-drug-approvals-drugsfda").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 = {
    "query": "semaglutide",
    "maxResults": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("smilemask/fda-drug-approvals-drugsfda").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 '{
  "query": "semaglutide",
  "maxResults": 20
}' |
apify call smilemask/fda-drug-approvals-drugsfda --silent --output-dataset

```

## MCP server setup

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

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/JzhA8COcUwJVUoPix/builds/xExwkdb0EZJ6ht7ho/openapi.json