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    List of Drug Master Files (DMF) for 14813 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Antibiotice SA

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    NYSTATIN

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    14813
    Active
    2000-03-31
    Complete
    2013-01-18
    2012-12-21
    II
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    Looking for Drug Master Files (DMF) for 14813 of Antibiotice Sa

    Looking for Drug Master Files (DMF) for 14813 of Antibiotice Sa 1

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    Antibiotice Sa, based in Romania, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is NYSTATIN, with a corresponding US DMF Number 14813.

    Remarkably, this DMF maintains an Active status since its submission on March 31, 2000, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 21, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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