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    List of Drug Master Files (DMF) for 7548 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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    01 CLOTRIMAZOLE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    CLOTRIMAZOLE

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    7548
    Active
    1988-06-21
    Complete
    2015-01-07
    2014-12-18
    II
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    Looking for Drug Master Files (DMF) for 7548 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 7548 of Fis Fabbrica Italiana Sintetici Spa 1

    20

    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 CLOTRIMAZOLE, with a corresponding US DMF Number 7548.

    Remarkably, this DMF maintains an Active status since its submission on June 21, 1988, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 07, 2015, and payment made on December 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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