Openfda Approval Tools

Configuration File: openfda_approval_tools.json Tool Type: Local Tools Count: 3

This page contains all tools defined in the openfda_approval_tools.json configuration file.

Available Tools

OpenFDA_get_approval_history (Type: OpenFDAApprovalTool)

Get the complete FDA submission and approval history for a specific drug. Returns chronological l…

OpenFDA_get_approval_history tool specification

Tool Information:

  • Name: OpenFDA_get_approval_history

  • Type: OpenFDAApprovalTool

  • Description: 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.

Parameters:

  • operation (string) (required) Operation type

  • drug_name ([‘string’, ‘null’]) (optional) Drug name (brand or generic, e.g., ‘warfarin’, ‘Eliquis’, ‘pembrolizumab’)

  • application_number ([‘string’, ‘null’]) (optional) FDA application number (e.g., ‘NDA021457’). More specific than drug_name.

Example Usage:

query = {
    "name": "OpenFDA_get_approval_history",
    "arguments": {
        "operation": "example_value"
    }
}
result = tu.run(query)

OpenFDA_get_approved_products (Type: OpenFDAApprovalTool)

Get FDA-approved product details for a drug including all marketed formulations, active ingredien…

OpenFDA_get_approved_products tool specification

Tool Information:

  • Name: OpenFDA_get_approved_products

  • Type: OpenFDAApprovalTool

  • Description: Get FDA-approved product details for a drug including all marketed formulations, active ingredients with strengths, dosage forms, administration routes, therapeutic equivalence (TE) codes, and marketing status. Returns the full list of products under an FDA application. Useful for comparing available formulations, checking generic equivalence, or identifying all strengths of a drug.

Parameters:

  • operation (string) (required) Operation type

  • drug_name ([‘string’, ‘null’]) (optional) Drug name (brand or generic, e.g., ‘atorvastatin’, ‘Lipitor’)

  • application_number ([‘string’, ‘null’]) (optional) FDA application number (e.g., ‘NDA020702’)

Example Usage:

query = {
    "name": "OpenFDA_get_approved_products",
    "arguments": {
        "operation": "example_value"
    }
}
result = tu.run(query)

OpenFDA_search_drug_approvals (Type: OpenFDAApprovalTool)

Search the FDA Drugs@FDA database for drug approval records by drug name, sponsor/manufacturer, o…

OpenFDA_search_drug_approvals tool specification

Tool Information:

  • Name: OpenFDA_search_drug_approvals

  • Type: OpenFDAApprovalTool

  • Description: Search the FDA Drugs@FDA database for drug approval records by drug name, sponsor/manufacturer, or application number. Returns FDA application details including NDA/ANDA/BLA numbers, sponsor names, approved dosage forms and strengths, active ingredients, original approval dates, and submission counts. Use this to find FDA-approved drugs, check approval status, or look up generic vs brand drug registrations.

Parameters:

  • operation (string) (required) Operation type

  • drug_name ([‘string’, ‘null’]) (optional) Drug name to search (brand or generic, e.g., ‘aspirin’, ‘metformin’, ‘Lipitor’, ‘atorvastatin’)

  • sponsor ([‘string’, ‘null’]) (optional) Sponsor/manufacturer name (e.g., ‘PFIZER’, ‘MERCK’, ‘NOVARTIS’)

  • application_number ([‘string’, ‘null’]) (optional) FDA application number (e.g., ‘NDA021457’, ‘ANDA078372’, ‘BLA125554’)

  • limit (integer) (optional) Maximum number of results (default: 5, max: 20)

Example Usage:

query = {
    "name": "OpenFDA_search_drug_approvals",
    "arguments": {
        "operation": "example_value"
    }
}
result = tu.run(query)