Fda Orange Book ToolsĀ¶

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 ToolsĀ¶

FDA_OrangeBook_check_generic_availability (Type: FDAOrangeBookTool)Ā¶

Check if generic versions are FDA-approved for a brand-name drug. Returns reference drug info, apā€¦

FDA_OrangeBook_check_generic_availability tool specification

Tool Information:

  • Name: FDA_OrangeBook_check_generic_availability

  • Type: FDAOrangeBookTool

  • Description: Check if generic versions are FDA-approved for a brand-name drug. Returns reference drug info, approved generics count, and TE codes. Example: Query ā€˜LIPITORā€™ to find atorvastatin generics. Use for competitive landscape analysis.

Parameters:

  • operation (unknown) (required) 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": {
        "operation": "example_value"
    }
}
result = tu.run(query)

FDA_OrangeBook_get_approval_history (Type: FDAOrangeBookTool)Ā¶

Get complete approval history for a drug application including original approval date, supplementā€¦

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) (required) Operation type (fixed)

  • application_number (string) (required) FDA application number (e.g., ā€˜NDA020402ā€™)

Example Usage:

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

FDA_OrangeBook_get_exclusivity (Type: FDAOrangeBookTool)Ā¶

Get drug exclusivity information (NCE, orphan, pediatric). Note: Specific expiration dates requirā€¦

FDA_OrangeBook_get_exclusivity tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_exclusivity

  • Type: FDAOrangeBookTool

  • Description: Get drug exclusivity information (NCE, orphan, pediatric). Note: Specific expiration dates require Orange Book data files. Returns exclusivity types (5-year NCE, 3-year clinical study, 7-year orphan, 180-day generic). Use for generic launch planning.

Parameters:

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

  • application_number (string) (optional) FDA application number

  • brand_name (string) (optional) Brand name of drug

Example Usage:

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

FDA_OrangeBook_get_patent_info (Type: FDAOrangeBookTool)Ā¶

Get patent information for approved drugs. Note: Full patent details (numbers, expiration dates) ā€¦

FDA_OrangeBook_get_patent_info tool specification

Tool Information:

  • Name: FDA_OrangeBook_get_patent_info

  • Type: FDAOrangeBookTool

  • Description: Get patent information for approved drugs. Note: Full patent details (numbers, expiration dates) require Orange Book data files download. Returns guidance on accessing complete patent data. Use for regulatory exclusivity planning.

Parameters:

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

  • application_number (string) (optional) FDA application number

  • brand_name (string) (optional) Brand name of drug

Example Usage:

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

FDA_OrangeBook_get_te_code (Type: FDAOrangeBookTool)Ā¶

Get therapeutic equivalence (TE) codes for drug products. AB=bioequivalent/substitutable, AT=topiā€¦

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) (required) 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": {
        "operation": "example_value"
    }
}
result = tu.run(query)

FDA_OrangeBook_search_drug (Type: FDAOrangeBookTool)Ā¶

Search FDA Drugs@FDA database by brand name, generic name, or application number. Returns approvaā€¦

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=ā€™ADVILā€™ finds all Advil products with NDA numbers.

Parameters:

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

  • brand_name (string) (optional) Brand/trade name of drug (e.g., ā€˜ADVILā€™, ā€˜LIPITORā€™)

  • generic_name (string) (optional) Generic/active ingredient name (e.g., ā€˜IBUPROFENā€™, ā€˜ATORVASTATINā€™)

  • application_number (string) (optional) FDA application number (e.g., ā€˜NDA020402ā€™, ā€˜ANDA078394ā€™)

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

Example Usage:

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