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 one Drugs@FDA application. Returns chron…

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 one Drugs@FDA application. Returns chronological list of all submissions (original, supplements, labeling changes) with dates, review priority (STANDARD/PRIORITY), submission types (ORIG/SUPPL), and every linked FDA review document. A drug name commonly matches several applications; the response describes the first and lists the others in other_matching_applications, so pass application_number to choose one. Useful for tracking a drug’s regulatory history from initial approval through all subsequent changes.

Parameters:

  • operation (string) (optional) Operation type

  • drug_name ([‘string’, ‘null’]) (optional) Drug name (brand or generic, e.g., ‘warfarin’, ‘Eliquis’, ‘pembrolizumab’). Provide either drug_name or application_number, not both.

  • 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": {
    }
}
result = tu.run(query)

OpenFDA_get_approved_products (Type: OpenFDAApprovalTool)#

Get FDA-approved product details for one Drugs@FDA application including all marketed formulation…

OpenFDA_get_approved_products tool specification

Tool Information:

  • Name: OpenFDA_get_approved_products

  • Type: OpenFDAApprovalTool

  • Description: Get FDA-approved product details for one Drugs@FDA application 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 the application. A drug name commonly matches several applications; the response describes the first and lists the others in other_matching_applications, so pass application_number to choose one. Useful for comparing available formulations, checking generic equivalence, or identifying all strengths of a drug.

Parameters:

  • operation (string) (optional) Operation type

  • drug_name ([‘string’, ‘null’]) (optional) Drug name (brand or generic, e.g., ‘atorvastatin’, ‘Lipitor’). Provide either drug_name or application_number, not both.

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

Example Usage:

query = {
    "name": "OpenFDA_get_approved_products",
    "arguments": {
    }
}
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. drug_name is matched against both the resolved openfda name fields and the authoritative per-product name fields, so applications whose openfda block is empty upstream are still findable by brand name. One brand name commonly covers several applications with different formulations and approval dates; check total and compare application numbers before assuming a single answer. Pagination is exact: continue with metadata.next_offset while has_more is true; broad queries beyond openFDA’s 26,000-record window are marked upstream_window_exhausted. Summary arrays retain every brand name, generic name, and strength.

Parameters:

  • operation (string) (optional) 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 applications on this page (default: 5, max: 100)

  • offset (integer) (optional) openFDA skip offset; continue with metadata.next_offset

Example Usage:

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