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    List of Drug Master Files (DMF) for 4435 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 COSMA S.p.A (1)

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    01 HYDROXYZINE HYDROCHLORIDE (1)

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    HYDROXYZINE HYDROCHLORIDE

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    4435
    Active
    1982-01-29
    Complete
    2014-05-15
    2014-01-28
    II
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    Looking for Drug Master Files (DMF) for 4435 of Cosma Spa

    Looking for Drug Master Files (DMF) for 4435 of Cosma Spa 1

    20

    Cosma Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is HYDROXYZINE HYDROCHLORIDE, with a corresponding US DMF Number 4435.

    Remarkably, this DMF maintains an Active status since its submission on January 29, 1982, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 15, 2014, and payment made on January 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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