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    List of Drug Master Files (DMF) for 30295 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    5N Plus Lubeck GmbH

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    01 5N Plus Lubeck GmbH (1)

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    01 BISMUTH SUBCITRATE POTASSIUM (1)

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    BISMUTH SUBCITRATE POTASSIUM

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    30295
    Active
    2017-09-06
    Complete
    2022-05-09
    2022-02-22
    II
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    Looking for Drug Master Files (DMF) for 30295 of 5n Plus Lubeck Gmbh

    Looking for Drug Master Files (DMF) for 30295 of 5n Plus Lubeck Gmbh 1

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    5n Plus Lubeck Gmbh, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA.

    One of their notable products is BISMUTH SUBCITRATE POTASSIUM, with a corresponding US DMF Number 30295.

    Remarkably, this DMF maintains an Active status since its submission on September 06, 2017, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2022, and payment made on February 22, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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