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    List of Drug Master Files (DMF) for 28194 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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    TETRABENAZINE

    PDF Supplier PDF
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    28194
    Active
    2014-06-15
    Complete
    2014-10-28
    2014-06-12
    II
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    Looking for Drug Master Files (DMF) for 28194 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 28194 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 TETRABENAZINE, with a corresponding US DMF Number 28194.

    Remarkably, this DMF maintains an Active status since its submission on June 15, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 28, 2014, and payment made on June 12, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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