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    List of Drug Master Files (DMF) for 5404 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    DIPHARMA FRANCIS SRL

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    DOXEPIN HCl

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    5404
    Active
    1984-04-10
    Complete
    2014-03-31
    2014-03-24
    II
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    Looking for Drug Master Files (DMF) for 5404 of Dipharma Francis Srl

    Looking for Drug Master Files (DMF) for 5404 of Dipharma Francis Srl 1

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    Dipharma Francis Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is DOXEPIN HCl, with a corresponding US DMF Number 5404.

    Remarkably, this DMF maintains an Active status since its submission on April 10, 1984, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on March 24, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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