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    List of Drug Master Files (DMF) for 24949 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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    CEVIMELINE HYDROCHLORIDE USP

    PDF Supplier PDF
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    24949
    Active
    2011-10-31
    Complete
    2013-09-21
    2013-09-12
    II
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    Looking for Drug Master Files (DMF) for 24949 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 24949 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 CEVIMELINE HYDROCHLORIDE USP, with a corresponding US DMF Number 24949.

    Remarkably, this DMF maintains an Active status since its submission on October 31, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2013, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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