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    List of Drug Master Files (DMF) for 25633 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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    CLOFARABINE

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    25633
    Active
    2012-02-15
    Complete
    2015-10-01
    2015-09-18
    II
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    Looking for Drug Master Files (DMF) for 25633 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 25633 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 CLOFARABINE, with a corresponding US DMF Number 25633.

    Remarkably, this DMF maintains an Active status since its submission on February 15, 2012, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 01, 2015, and payment made on September 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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