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    List of Drug Master Files (DMF) for 4395 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Chemische Fabrik Berg

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    01 Chemische Fabrik Berg (1)

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    01 BUTALBITAL (1)

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    01 Germany (1)

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    CHEMISCHE FABRIK BERG GMBH

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    BUTALBITAL

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    4395
    Active
    1981-11-25
    Complete
    2013-03-06
    2013-02-20
    II
    Moehs Chemische Fabrik Berg

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    Looking for Drug Master Files (DMF) for 4395 of Chemische Fabrik Berg Gmbh

    Looking for Drug Master Files (DMF) for 4395 of Chemische Fabrik Berg Gmbh 1

    20

    Chemische Fabrik Berg Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is BUTALBITAL, with a corresponding US DMF Number 4395.

    Remarkably, this DMF maintains an Active status since its submission on November 25, 1981, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 06, 2013, and payment made on February 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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