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    List of Drug Master Files (DMF) for 18306 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    BUPROPION HYDROCHLORIDE USP

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    18306
    Active
    2005-04-24
    Complete
    2013-03-15
    2013-02-27
    II
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    Looking for Drug Master Files (DMF) for 18306 of Divis Laboratories Ltd

    Looking for Drug Master Files (DMF) for 18306 of Divis Laboratories Ltd 1

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    Divis Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is BUPROPION HYDROCHLORIDE USP, with a corresponding US DMF Number 18306.

    Remarkably, this DMF maintains an Active status since its submission on April 24, 2005, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2013, and payment made on February 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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