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    List of Drug Master Files (DMF) for 28289 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    SODIUM OXYBATE

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    28289
    Active
    2014-06-19
    Complete
    2022-10-06
    2022-08-17
    II
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    Looking for Drug Master Files (DMF) for 28289 of Alkem Laboratories Ltd

    Looking for Drug Master Files (DMF) for 28289 of Alkem Laboratories Ltd 1

    20

    Alkem 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 SODIUM OXYBATE, with a corresponding US DMF Number 28289.

    Remarkably, this DMF maintains an Active status since its submission on June 19, 2014, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2022, and payment made on August 17, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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