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    List of Drug Master Files (DMF) for 3164 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    F.I.S. Fabbrica Italiana Sintetici

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    01 F.I.S. Fabbrica Italiana Sintetici (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    DIAZEPAM

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    3164
    Active
    1978-02-28
    Complete
    2012-10-24
    2013-05-13
    II
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    Looking for Drug Master Files (DMF) for 3164 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 3164 of Fis Fabbrica Italiana Sintetici Spa 1

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    Fis Fabbrica Italiana Sintetici Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is DIAZEPAM, with a corresponding US DMF Number 3164.

    Remarkably, this DMF maintains an Active status since its submission on February 28, 1978, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2012, and payment made on May 13, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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