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    List of Drug Master Files (DMF) for 33089 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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    DROXIDOPA

    PDF Supplier PDF
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    33089
    Active
    2018-09-18
    Complete
    2018-11-15
    2018-08-22
    II
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    Looking for Drug Master Files (DMF) for 33089 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 33089 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 DROXIDOPA, with a corresponding US DMF Number 33089.

    Remarkably, this DMF maintains an Active status since its submission on September 18, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 15, 2018, and payment made on August 22, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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