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    List of Drug Master Files (DMF) for 32339 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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    REGADENOSON

    PDF Supplier PDF
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    32339
    Active
    2018-01-07
    Complete
    2018-12-04
    2018-09-14
    II
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    Looking for Drug Master Files (DMF) for 32339 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 32339 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 REGADENOSON, with a corresponding US DMF Number 32339.

    Remarkably, this DMF maintains an Active status since its submission on January 07, 2018, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2018, and payment made on September 14, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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