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    List of Drug Master Files (DMF) for 16918 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    PHENYLEPHRINE HYDROCHLORIDE USP

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    16918
    Active
    2003-10-19
    Complete
    2015-01-07
    2014-12-26
    II
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    Looking for Drug Master Files (DMF) for 16918 of Divi's Labotatories Ltd

    Looking for Drug Master Files (DMF) for 16918 of Divi's Labotatories Ltd 1

    20

    Divi's Labotatories 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 PHENYLEPHRINE HYDROCHLORIDE USP, with a corresponding US DMF Number 16918.

    Remarkably, this DMF maintains an Active status since its submission on October 19, 2003, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of January 07, 2015, and payment made on December 26, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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