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    List of Drug Master Files (DMF) for 3849 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 Aspen API (1)

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    01 NORETHINDRONE (1)

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    01 Netherlands (1)

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    ASPEN OSS BV

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    Virtual BoothAspen API. More than just an API.
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    NORETHINDRONE

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    3849
    Active
    1980-05-22
    Complete
    2012-12-26
    2012-11-20
    II
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    Looking for Drug Master Files (DMF) for 3849 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 3849 of Aspen Oss Bv 1

    20

    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 NORETHINDRONE, with a corresponding US DMF Number 3849.

    Remarkably, this DMF maintains an Active status since its submission on May 22, 1980, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of December 26, 2012, and payment made on November 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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