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Athena Athena

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List of Drug Master Files (DMF) for 3829 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 ESTRADIOL (1)

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01 Netherlands (1)

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01 Active (1)

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01 Complete (1)

3829
Active
1980-05-21
Complete
2012-12-24
2012-11-20
II

Looking for Drug Master Files (DMF) for 3829 of Aspen Oss Bv

Looking for Drug Master Files (DMF) for 3829 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 ESTRADIOL, with a corresponding US DMF Number 3829.

Remarkably, this DMF maintains an Active status since its submission on May 21, 1980, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 24, 2012, and payment made on November 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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