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    List of Drug Master Files (DMF) for 23120 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II) (1)

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    MYLAN LABORATORIES LTD

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    ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II)

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    23120
    Active
    2009-09-16
    Complete
    2014-03-25
    2014-03-13
    II
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    Looking for Drug Master Files (DMF) for 23120 of Mylan Laboratories Ltd

    Looking for Drug Master Files (DMF) for 23120 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 ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II), with a corresponding US DMF Number 23120.

    Remarkably, this DMF maintains an Active status since its submission on September 16, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2014, and payment made on March 13, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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