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    List of Drug Master Files (DMF) for 14034 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 NALOXONE 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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    NALOXONE HYDROCHLORIDE

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    NA Not Available For Sales
    14034
    Active
    1999-03-19
    Complete
    2015-09-21
    2015-09-10
    II
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    Looking for Drug Master Files (DMF) for 14034 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 14034 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 NALOXONE HYDROCHLORIDE, with a corresponding US DMF Number 14034.

    Remarkably, this DMF maintains an Active status since its submission on March 19, 1999, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2015, and payment made on September 10, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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