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    List of Drug Master Files (DMF) for 3803 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 ETHINYL ESTRADIOL (1)

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    ASPEN OSS BV

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    ETHINYL ESTRADIOL

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    3803
    Active
    1980-05-20
    Complete
    2012-11-04
    2012-11-14
    II
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    Looking for Drug Master Files (DMF) for 3803 of Aspen Oss Bv

    Looking for Drug Master Files (DMF) for 3803 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 ETHINYL ESTRADIOL, with a corresponding US DMF Number 3803.

    Remarkably, this DMF maintains an Active status since its submission on May 20, 1980, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of November 04, 2012, and payment made on November 14, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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