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    List of Drug Master Files (DMF) for 32340 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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    PONATINIB HYDROCHLORIDE

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    32340
    Active
    2018-01-07
    Complete
    2022-07-22
    2022-06-06
    II
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    Looking for Drug Master Files (DMF) for 32340 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 32340 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 PONATINIB HYDROCHLORIDE, with a corresponding US DMF Number 32340.

    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 July 22, 2022, and payment made on June 06, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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