`fda_drug_approvals`

Pack: openfda · Endpoint: https://gateway.pipeworx.io/openfda/mcp

Find FDA-approved drugs by brand name, active ingredient, or application number. To find generic versions of a drug, search by active ingredient using products.active_ingredients.name (NOT openfda.generic_name — that field only works in the label endpoint). IMPORTANT: drug names in the FDA database are stored in UPPERCASE — always pass ingredient and brand names in uppercase (e.g. “APIXABAN” not “apixaban”) or you will get 0 results. Returns approval status, sponsor, application number (ANDA = generic, NDA = brand), and application details. There is NO queryable “application_type” field — never add application_type:“ANDA” (it returns 0 results). To limit to generics, search by active ingredient and read the ANDA/NDA prefix on application_number in the results. This endpoint has NO indication/disease field — for “drugs approved to treat ” use fda_drug_labels (which searches indications_and_usage); an indication phrase passed here is silently ignored and matches by drug name only. The response total can exceed the 100-row cap on a single page — use skip to page past it, and sort to get genuinely-newest-first ordering (“most recently approved” is not the default order).

Parameters

Name	Type	Required	Description
`query`	string	yes	OpenFDA drugsfda search query. Drug names MUST be UPPERCASE in quotes. To find all generics for a drug: ‘products.active_ingredients.name:“APIXABAN”’ (returns all ANDA + NDA approvals). By brand: ‘openfda.brand_name:“KEYTRUDA”’. By original submission: ‘submissions.submission_type:“ORIG”’. Do NOT use application_type (no such field — returns 0); ANDA vs NDA is read from the application_number prefix in the results, not filtered in the query. NOTE: use products.active_ingredients.name (not openfda.generic_name which is a label-API field and returns 0 here).
`limit`	number	no	Number of results (1-100, default 10)
`skip`	number	no	Offset for pagination (default 0). The reported `total` is often larger than one page — pass skip=100 to reach the 101st+ result of a large query instead of assuming the first page is everything.
`sort`	string	no	Order results by each drug’s original FDA approval date instead of openFDA’s default (unordered/relevance) order. approval_date_desc puts the genuinely most-recently-approved drug first — needed for “most recent approval” questions, which are wrong without it. Computed client-side from each record’s own ORIG+approved submission (openFDA’s native sort on this field is unreliable — it reads any submission in a drug’s history, so an old drug with a recent label supplement can outrank a real new approval). Sorting is exact over up to 1000 matching records per call; a `sort_note` in the response says if the query matched more than that.

Example call

Arguments

{
  "query": "openfda.brand_name:\"KEYTRUDA\""
}

curl

curl -X POST https://gateway.pipeworx.io/openfda/mcp \
  -H 'Content-Type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call","params":{"name":"fda_drug_approvals","arguments":{"query":"openfda.brand_name:\"KEYTRUDA\""}}}'

TypeScript (@pipeworx/sdk)

import { Pipeworx } from '@pipeworx/sdk';
const pipeworx = new Pipeworx();

const result = await pipeworx.call('fda_drug_approvals', {
  "query": "openfda.brand_name:\"KEYTRUDA\""
});

More examples

{
  "query": "products.active_ingredients.name:\"SEMAGLUTIDE\"",
  "sort": "approval_date_desc",
  "limit": 10
}

{
  "query": "products.active_ingredients.name:\"pembrolizumab\"",
  "limit": 20
}

{
  "query": "products.active_ingredients.name:\"AMOXICILLIN\"",
  "limit": 5,
  "skip": 100
}

{
  "query": "products.active_ingredients.name:\"AMOXICILLIN\"",
  "limit": 10,
  "sort": "approval_date_desc"
}

Response shape

Always returns: total, results

Field	Type	Description
`total`	number	Total count of matching FDA-approved drugs
`results`	array	Array of drug approval objects

Full JSON Schema

{
  "type": "object",
  "properties": {
    "total": {
      "type": "number",
      "description": "Total count of matching FDA-approved drugs"
    },
    "results": {
      "type": "array",
      "description": "Array of drug approval objects",
      "items": {
        "type": "object"
      }
    }
  },
  "required": [
    "total",
    "results"
  ]
}

Connect

Add this to your MCP client config, or use one-click install buttons:

{
  "mcpServers": {
    "openfda": {
      "url": "https://gateway.pipeworx.io/openfda/mcp"
    }
  }
}

See Getting Started for client-specific install steps.

fda_drug_approvals