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    List of Drug Master Files (DMF) for 31759 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    MYLAN LABORATORIES LTD

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    VORTIOXETINE HYDROBROMIDE

    PDF Supplier PDF
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    31759
    Active
    2017-06-24
    Complete
    2017-07-13
    2017-06-14
    II
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    Looking for Drug Master Files (DMF) for 31759 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 31759 of Mylan Laboratories Ltd 1

    20

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

    One of their notable products is VORTIOXETINE HYDROBROMIDE, with a corresponding US DMF Number 31759.

    Remarkably, this DMF maintains an Active status since its submission on June 24, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 13, 2017, and payment made on June 14, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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