Fda Orange Book Tools#

Configuration File: fda_orange_book_tools.json Tool Type: Local Tools Count: 6

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

Available Tools#

FDA_OrangeBook_check_generic_availability (Type: FDAOrangeBookTool)#

Check whether FDA-approved generic applications exist for a brand or ingredient. Scans every matc…

FDA_OrangeBook_check_generic_availability tool specification

Tool Information:

  • Name: FDA_OrangeBook_check_generic_availability

  • Type: FDAOrangeBookTool

  • Description: Check whether FDA-approved generic applications exist for a brand or ingredient. Scans every matching Drugs@FDA page. Generic means application_number starts with ANDA; reference means at least one product has reference_drug=’Yes’. Returns these defining criteria, applications_scanned, and counts_complete so the classification is auditable.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • brand_name (string) (optional) Brand name to check for generics

  • generic_name (string) (optional) Generic name to check

Example Usage:

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

FDA_OrangeBook_get_approval_history (Type: FDAOrangeBookTool)#

Get complete approval history for a drug application including original approval date, supplement…

FDA_OrangeBook_get_approval_history tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_approval_history

  • Type: FDAOrangeBookTool

  • Description: Get complete approval history for a drug application including original approval date, supplements, and review documents. Returns submission timeline and links to approval letters/labels. Example: NDA020402 shows all Advil approval actions.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • application_number (string) (required) FDA application number (e.g., ‘NDA020402’)

Example Usage:

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

FDA_OrangeBook_get_exclusivity (Type: FDAOrangeBookTool)#

Get the exclusivity codes and expiration dates FDA lists in the Orange Book for a drug product (e…

FDA_OrangeBook_get_exclusivity tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_exclusivity

  • Type: FDAOrangeBookTool

  • Description: Get the exclusivity codes and expiration dates FDA lists in the Orange Book for a drug product (e.g. NCE, ODE orphan, PED pediatric, I-nnn new indication), every listed date per code, per product. Reads FDA’s monthly Orange Book data files from a local copy: download the zip from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files and set TOOLUNIVERSE_ORANGE_BOOK_DATA to the zip or its extracted folder; returns an error when it is not set. The file date is returned in source.files_dated. Search by application_number (e.g. ‘NDA212306’) or exact brand_name. Covers NDA/ANDA drug products, not biologics. Use for generic launch planning. For product details and marketing status without local data files, use FDA_OrangeBook_search_drug; for therapeutic equivalence codes, use FDA_OrangeBook_get_te_code.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • application_number (string) (optional) FDA application number, e.g. NDA212306, N212306 or 212306

  • brand_name (string) (optional) Brand (trade) name of the drug, exact match, case-insensitive

Example Usage:

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

FDA_OrangeBook_get_patent_info (Type: FDAOrangeBookTool)#

Get the patents FDA lists in the Orange Book for a drug product: patent number, expiration date, …

FDA_OrangeBook_get_patent_info tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_patent_info

  • Type: FDAOrangeBookTool

  • Description: Get the patents FDA lists in the Orange Book for a drug product: patent number, expiration date, drug substance/drug product flags, every patent use code, delist request and submission date, per product. Reads FDA’s monthly Orange Book data files from a local copy: download the zip from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files and set TOOLUNIVERSE_ORANGE_BOOK_DATA to the zip or its extracted folder; returns an error when it is not set. The file date is returned in source.files_dated. Search by application_number (e.g. ‘NDA021695’, ‘N021695’ or ‘021695’) or exact brand_name. Covers NDA/ANDA drug products, not biologics. Use for patent expiry and generic entry questions. For product details and marketing status without local data files, use FDA_OrangeBook_search_drug; for therapeutic equivalence codes, use FDA_OrangeBook_get_te_code.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • application_number (string) (optional) FDA application number, e.g. NDA021695, N021695 or 021695

  • brand_name (string) (optional) Brand (trade) name of the drug, exact match, case-insensitive

Example Usage:

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

FDA_OrangeBook_get_te_code (Type: FDAOrangeBookTool)#

Get therapeutic equivalence (TE) codes for drug products. AB=bioequivalent/substitutable, AT=topi…

FDA_OrangeBook_get_te_code tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_te_code

  • Type: FDAOrangeBookTool

  • Description: Get therapeutic equivalence (TE) codes for drug products. AB=bioequivalent/substitutable, AT=topical equivalent, B*=NOT therapeutically equivalent. Returns TE codes with interpretation guide. Use for generic substitution decisions.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • brand_name (string) (optional) Brand name to check TE codes

  • generic_name (string) (optional) Generic name to check TE codes

Example Usage:

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

FDA_OrangeBook_search_drug (Type: FDAOrangeBookTool)#

Search FDA Drugs@FDA database by brand name, generic name, or application number. Returns approva…

FDA_OrangeBook_search_drug tool specification

Tool Information:

  • Name: FDA_OrangeBook_search_drug

  • Type: FDAOrangeBookTool

  • Description: Search FDA Drugs@FDA database by brand name, generic name, or application number. Returns approval status, products, and basic regulatory info. Example: brand_name=’ADVIL’ finds all Advil products with NDA numbers. A query that matches nothing returns status=’success’ with count=0 and an explanatory note – an ‘error’ status means the request itself failed, never that there were no matches. Results use native openFDA pagination: start with offset=0 and continue with next_offset while has_more is true.

Parameters:

  • operation (unknown) (optional) Operation type (fixed)

  • brand_name (string) (optional) Brand/trade name of drug (e.g., ‘ADVIL’, ‘LIPITOR’)

  • generic_name (string) (optional) Generic/active ingredient name (e.g., ‘IBUPROFEN’, ‘ATORVASTATIN’)

  • drug_name (string) (optional) Drug name of either kind when you do not know whether it is a brand or a generic name (e.g., ‘QUVIVIQ’, ‘IBUPROFEN’). Matches the brand name OR the active-ingredient name. Prefer brand_name or generic_name when you know which one you have.

  • application_number (string) (optional) FDA application number (e.g., ‘NDA020402’, ‘ANDA078394’)

  • limit (integer) (optional) Maximum number of results (1-100, default 10)

  • offset (integer) (optional) Zero-based Drugs@FDA result offset. Continue with next_offset while has_more is true.

Example Usage:

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