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    List of Drug Master Files (DMF) for 15100 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Angelini Pharma

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    ANGELINI ACRAF SPA

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    METAXALONE

    PDF Supplier PDF
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    15100
    Active
    2000-10-19
    Complete
    2013-02-26
    2013-02-11
    II
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    Looking for Drug Master Files (DMF) for 15100 of Angelini Acraf Spa

    Looking for Drug Master Files (DMF) for 15100 of Angelini Acraf Spa 1

    20

    Angelini Acraf Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is METAXALONE, with a corresponding US DMF Number 15100.

    Remarkably, this DMF maintains an Active status since its submission on October 19, 2000, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of February 26, 2013, and payment made on February 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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