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    List of Drug Master Files (DMF) for 19549 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    MEMANTINE HYDROCHLORIDE

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    19549
    Active
    2006-06-20
    Complete
    2013-06-06
    2013-05-22
    II
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    Looking for Drug Master Files (DMF) for 19549 of Amsa Anonima Materie Sintetiche And Affini Spa

    Looking for Drug Master Files (DMF) for 19549 of Amsa Anonima Materie Sintetiche And Affini Spa 1

    20

    Amsa Anonima Materie Sintetiche And Affini Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is MEMANTINE HYDROCHLORIDE, with a corresponding US DMF Number 19549.

    Remarkably, this DMF maintains an Active status since its submission on June 20, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 06, 2013, and payment made on May 22, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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