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    List of Drug Master Files (DMF) for 29615 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 (PROCESS-II)

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    29615
    Active
    2015-09-02
    Complete
    2015-10-14
    2015-08-31
    II
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    Looking for Drug Master Files (DMF) for 29615 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 29615 of Mylan Laboratories Ltd 1

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    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 (PROCESS-II), with a corresponding US DMF Number 29615.

    Remarkably, this DMF maintains an Active status since its submission on September 02, 2015, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2015, and payment made on August 31, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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