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    List of Drug Master Files (DMF) for 5674 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 CLOMIPHENE CITRATE (1)

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    FIS FABBRICA ITALIANA SINTETICI SPA

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    CLOMIPHENE CITRATE

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    5674
    Active
    1984-12-20
    Complete
    2014-10-21
    2013-07-05
    II
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    Looking for Drug Master Files (DMF) for 5674 of Fis Fabbrica Italiana Sintetici Spa

    Looking for Drug Master Files (DMF) for 5674 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 CLOMIPHENE CITRATE, with a corresponding US DMF Number 5674.

    Remarkably, this DMF maintains an Active status since its submission on December 20, 1984, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 21, 2014, and payment made on July 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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