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    • Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    Metadata Updated: July 11, 2025

    The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). (For more information, see the Orange Book Preface.)

    Access & Use Information

    Public: This dataset is intended for public access and use. License: See this page for license information.

    Downloads & Resources

    References

    http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

    Dates

    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date November 10, 2020
    Metadata Updated Date July 11, 2025
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier c7b84420-8e01-44eb-92de-c5e7f975ab28
    Data First Published 2021-02-25
    Data Last Modified 2013-10-31
    Category FDA
    Public Access Level public
    Bureau Code 009:10
    Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
    Metadata Catalog ID https://healthdata.gov/data.json
    Schema Version https://project-open-data.cio.gov/v1.1/schema
    Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
    Harvest Object Id 5f9e09b9-2cd2-4e4a-8c88-d377b3783bb7
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
    License http://opendefinition.org/licenses/odc-odbl/
    Program Code 009:002
    Related Documents http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
    Source Datajson Identifier True
    Source Hash eff555c5ec12998656dd86b6035740b04b3e8122a83cc70fd8a66e395f553210
    Source Schema Version 1.1

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