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    List of Drug Master Files (DMF) for 19422 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    CURIA ITALY SRL

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    AZELASTINE HYDROCHLORIDE

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    19422
    Active
    2006-05-05
    Complete
    2014-01-27
    2014-01-16
    II
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    Looking for Drug Master Files (DMF) for 19422 of Curia Italy Srl

    Looking for Drug Master Files (DMF) for 19422 of Curia Italy Srl 1

    20

    Curia Italy Srl, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

    One of their notable products is AZELASTINE HYDROCHLORIDE, with a corresponding US DMF Number 19422.

    Remarkably, this DMF maintains an Active status since its submission on May 05, 2006, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 27, 2014, and payment made on January 16, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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