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    List of Drug Master Files (DMF) for 33410 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    URSODIOL USP

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    33410
    Active
    2018-12-17
    Complete
    2021-03-25
    2020-12-24
    II
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    Looking for Drug Master Files (DMF) for 33410 of Arch Pharmalabs Ltd

    Looking for Drug Master Files (DMF) for 33410 of Arch Pharmalabs Ltd 1

    20

    Arch Pharmalabs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is URSODIOL USP, with a corresponding US DMF Number 33410.

    Remarkably, this DMF maintains an Active status since its submission on December 17, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2021, and payment made on December 24, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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