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    List of Drug Master Files (DMF) for 33459 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Clarochem Ireland

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    DROXIDOPA

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    33459
    Active
    2019-01-04
    Complete
    2019-03-20
    2019-01-31
    II
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    Looking for Drug Master Files (DMF) for 33459 of Clarochem Ireland Ltd

    Looking for Drug Master Files (DMF) for 33459 of Clarochem Ireland Ltd 1

    20

    Clarochem Ireland Ltd, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is DROXIDOPA, with a corresponding US DMF Number 33459.

    Remarkably, this DMF maintains an Active status since its submission on January 04, 2019, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 20, 2019, and payment made on January 31, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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