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    List of Drug Master Files (DMF) for 15102 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 NALTREXONE HYDROCHLORIDE (1)

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    01 Netherlands (1)

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    ASPEN OSS BV

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    • FDA
    • EDQM
    Virtual BoothAspen API. More than just an API.
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    NALTREXONE HYDROCHLORIDE

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    NA Not Available For Sales
    15102
    Active
    2000-10-18
    Complete
    2015-06-16
    2012-12-20
    II
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    Looking for Drug Master Files (DMF) for 15102 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 15102 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 NALTREXONE HYDROCHLORIDE, with a corresponding US DMF Number 15102.

    Remarkably, this DMF maintains an Active status since its submission on October 18, 2000, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2015, and payment made on December 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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