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    List of Drug Master Files (DMF) for 21833 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 DULOXETINE HYDROCHLORIDE USP (1)

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    DULOXETINE HYDROCHLORIDE USP

    PDF Supplier PDF
    URL Supplier Web Content
    21833
    Active
    2008-07-30
    Complete
    2017-06-16
    2017-05-19
    II
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    Looking for Drug Master Files (DMF) for 21833 of Signa Sa De Cv

    Looking for Drug Master Files (DMF) for 21833 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 DULOXETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 21833.

    Remarkably, this DMF maintains an Active status since its submission on July 30, 2008, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2017, and payment made on May 19, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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