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    List of Drug Master Files (DMF) for 21574 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Signa S.A. de C.V. (1)

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    01 ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE USP (1)

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    ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE USP

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    21574
    Active
    2008-04-29
    Complete
    2012-11-23
    2012-11-05
    II
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    Looking for Drug Master Files (DMF) for 21574 of Signa Sa De Cv

    Looking for Drug Master Files (DMF) for 21574 of Signa Sa De Cv 1

    20

    Signa Sa De Cv, based in Mexico, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE USP, with a corresponding US DMF Number 21574.

    Remarkably, this DMF maintains an Active status since its submission on April 29, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 23, 2012, and payment made on November 05, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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