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    List of Drug Master Files (DMF) for 25315 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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    BROENAC SODIUM

    PDF Supplier PDF
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    25315
    Active
    2011-11-15
    Complete
    2014-04-23
    2013-09-20
    II
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    Looking for Drug Master Files (DMF) for 25315 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 25315 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 BROENAC SODIUM, with a corresponding US DMF Number 25315.

    Remarkably, this DMF maintains an Active status since its submission on November 15, 2011, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2014, and payment made on September 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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