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    List of Drug Master Files (DMF) for 24334 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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    ZILEUTON USP

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    24334
    Active
    2011-04-01
    Complete
    2016-03-03
    2015-09-18
    II
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    Looking for Drug Master Files (DMF) for 24334 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 24334 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 ZILEUTON USP, with a corresponding US DMF Number 24334.

    Remarkably, this DMF maintains an Active status since its submission on April 01, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2016, and payment made on September 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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