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    List of Drug Master Files (DMF) for 21054 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CURIA SPAIN SAU

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    FLUDROCORTISONE ACETATE USP

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    21054
    Active
    2007-11-20
    Complete
    2021-12-10
    2021-10-15
    II
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    Looking for Drug Master Files (DMF) for 21054 of Curia Spain Sau

    Looking for Drug Master Files (DMF) for 21054 of Curia Spain Sau 1

    20

    Curia Spain Sau, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

    One of their notable products is FLUDROCORTISONE ACETATE USP, with a corresponding US DMF Number 21054.

    Remarkably, this DMF maintains an Active status since its submission on November 20, 2007, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 10, 2021, and payment made on October 15, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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