Cortexa research tool·clinical·openfda_approvals

OpenFDA Get Approval History

Get the complete FDA submission and approval history for a specific drug. Returns chronological list of all submissions (original, supplements, labeling changes) with dates, review priority (STANDARD/PRIORITY), submission types (ORIG/SUPPL), and linked FDA review documents. Useful for tracking a drug's regulatory history from initial approval through all subsequent changes.

Livelast probed 2026-04-30 23:07Z· 113msCortexa

Status

The most recent probe succeeded. Safe to call from the agent today.

Last probed: 1d ago
Last success: 1d ago
Last latency: 113ms

Schema

JSON Schema the agent (or your API call) must match.

{
  "properties": {
    "application_number": {
      "description": "FDA application number (e.g., 'NDA021457'). More specific than drug_name.",
      "type": [
        "string",
        "null"
      ]
    },
    "drug_name": {
      "description": "Drug name (brand or generic, e.g., 'warfarin', 'Eliquis', 'pembrolizumab')",
      "type": [
        "string",
        "null"
      ]
    },
    "operation": {
      "description": "Operation type",
      "enum": [
        "get_approval_history"
      ],
      "type": "string"
    }
  },
  "required": [
    "operation"
  ],
  "type": "object"
}

Examples (1)

Default OpenFDA Get Approval History call

public-safeinput

{
  "operation": ""
}

Expected response keys: success

Anonymous-safe example. Rate-limited; no sign-in required.

Identifiers

Catalog ID: tu_OpenFDA_get_approval_history
Tool name: OpenFDA_get_approval_history
Added: 2026-04-30 22:47Z
Tags: tooluniverse

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