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    • Isotretinoin

    Metadata Updated: February 18, 2026

    Isotretinoin is a prescription retinoid medication available as oral capsules in strengths of 10mg, 20mg, 30mg, and 40mg. Manufactured by Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited, it's used for treating certain skin conditions like severe acne. This generic drug (ANDA211568) was approved for marketing starting September 2023. This information was generated using AI and is provided for informational and research purposes only.

    Access & Use Information

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

    Downloads & Resources

    Dates

    Metadata Created Date February 18, 2026
    Metadata Updated Date February 18, 2026
    Data Update Frequency R/P1Y

    Metadata Source

    Harvested from Healthdata.gov

    Other Data Resources

    Additional Metadata

    Resource Type Dataset
    Metadata Created Date February 18, 2026
    Metadata Updated Date February 18, 2026
    Publisher U.S. Food and Drug Administration
    Maintainer
    Identifier ANDA213571
    Data First Published 2016-09-16
    Data Last Modified 2025-03-17
    Category FDA
    Public Access Level public
    Data Update Frequency R/P1Y
    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 d464fb0c-66f4-4963-acdc-0c8f35a4b62c
    Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
    Harvest Source Title Healthdata.gov
    Homepage URL https://www.fda.gov/drugs
    License https://open.fda.gov/license
    Program Code 009:002
    Source Datajson Identifier True
    Source Hash 6693e252c2a7658b70f7fb6e65c96d6eefb4cf87f33afb46e3e4359658ace9fa
    Source Schema Version 1.1

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