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    List of Drug Master Files (DMF) for 10294 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 OXYTOCIN (1)

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    ASPEN OSS BV

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    OXYTOCIN

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    10294
    Active
    1993-06-14
    Complete
    2020-09-23
    2020-09-21
    II
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    Looking for Drug Master Files (DMF) for 10294 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 10294 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 OXYTOCIN, with a corresponding US DMF Number 10294.

    Remarkably, this DMF maintains an Active status since its submission on June 14, 1993, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2020, and payment made on September 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II

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