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    List of Drug Master Files (DMF) for 15521 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 FEXOFENADINE HYDROCHLORIDE (1)

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    FEXOFENADINE HYDROCHLORIDE

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    URL Supplier Web Content
    15521
    Active
    2001-06-22
    Complete
    2014-07-07
    2014-03-06
    II
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    Looking for Drug Master Files (DMF) for 15521 of Farmhispania Sa

    Looking for Drug Master Files (DMF) for 15521 of Farmhispania Sa 1

    20

    Farmhispania Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is FEXOFENADINE HYDROCHLORIDE, with a corresponding US DMF Number 15521.

    Remarkably, this DMF maintains an Active status since its submission on June 22, 2001, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of July 07, 2014, and payment made on March 06, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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