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    List of Drug Master Files (DMF) for 23704 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BROENAC SODIUM

    PDF Supplier PDF
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    23704
    Active
    2010-04-12
    Complete
    2013-07-31
    2013-07-18
    II
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    Looking for Drug Master Files (DMF) for 23704 of Archimica Spa

    Looking for Drug Master Files (DMF) for 23704 of Archimica Spa 1

    20

    Archimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is BROENAC SODIUM, with a corresponding US DMF Number 23704.

    Remarkably, this DMF maintains an Active status since its submission on April 12, 2010, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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