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    List of Drug Master Files (DMF) for 23191 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    OXCARBAZEPINE USP

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    23191
    Active
    2009-10-20
    Complete
    2017-11-16
    2017-10-16
    II
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    Looking for Drug Master Files (DMF) for 23191 of Amoli Organics Pvt Ltd

    Looking for Drug Master Files (DMF) for 23191 of Amoli Organics Pvt Ltd 1

    20

    Amoli Organics Pvt 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 OXCARBAZEPINE USP, with a corresponding US DMF Number 23191.

    Remarkably, this DMF maintains an Active status since its submission on October 20, 2009, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 16, 2017, and payment made on October 16, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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