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    List of Drug Master Files (DMF) for 14540 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 TESTOSTERONE UNDECANOATE (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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    TESTOSTERONE UNDECANOATE

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    URL Supplier Web Content
    14540
    Active
    1999-11-18
    Complete
    2018-04-26
    2015-09-24
    II
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    Looking for Drug Master Files (DMF) for 14540 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 14540 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 TESTOSTERONE UNDECANOATE, with a corresponding US DMF Number 14540.

    Remarkably, this DMF maintains an Active status since its submission on November 18, 1999, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of April 26, 2018, and payment made on September 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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