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    List of Drug Master Files (DMF) for 19226 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Aurobindo Pharma Limited

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    AMPICILLIN TRIHYDRATE, USP

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    19226
    Active
    2006-02-28
    Complete
    2021-07-26
    2021-07-15
    II
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    Looking for Drug Master Files (DMF) for 19226 of Aurobindo Pharma Ltd

    Looking for Drug Master Files (DMF) for 19226 of Aurobindo Pharma Ltd 1

    20

    Aurobindo Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is AMPICILLIN TRIHYDRATE, USP, with a corresponding US DMF Number 19226.

    Remarkably, this DMF maintains an Active status since its submission on February 28, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 26, 2021, and payment made on July 15, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II

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