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    List of Drug Master Files (DMF) for 22958 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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    FELBAMATE USP

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    22958
    Active
    2009-07-15
    Complete
    2015-01-29
    2015-01-19
    II
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    Looking for Drug Master Files (DMF) for 22958 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 22958 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 FELBAMATE USP, with a corresponding US DMF Number 22958.

    Remarkably, this DMF maintains an Active status since its submission on July 15, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2015, and payment made on January 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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