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    List of Drug Master Files (DMF) for 28438 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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    COBICISTAT ON SILICON DIOXIDE

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    28438
    Active
    2014-08-08
    Complete
    2014-10-20
    2014-07-28
    II
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    Looking for Drug Master Files (DMF) for 28438 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 28438 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 COBICISTAT ON SILICON DIOXIDE, with a corresponding US DMF Number 28438.

    Remarkably, this DMF maintains an Active status since its submission on August 08, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 20, 2014, and payment made on July 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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