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    List of Drug Master Files (DMF) for 7197 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 DESOGESTREL (1)

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    ASPEN OSS BV

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    Virtual BoothAspen API. More than just an API.
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    DESOGESTREL

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    7197
    Active
    1987-10-28
    Complete
    2013-08-13
    2013-08-01
    II
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    Looking for Drug Master Files (DMF) for 7197 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 7197 of Aspen Oss Bv 1

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    Aspen Oss Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Aspen API. More than just an API.

    One of their notable products is DESOGESTREL, with a corresponding US DMF Number 7197.

    Remarkably, this DMF maintains an Active status since its submission on October 28, 1987, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of August 13, 2013, and payment made on August 01, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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