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List of Drug Master Files (DMF) for 11826 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 TESTOSTERONE (1)

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01 Netherlands (1)

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01 Active (1)

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01 Complete (1)

11826
Active
1996-01-03
Complete
2014-10-31
2014-10-23
II

Looking for Drug Master Files (DMF) for 11826 of Aspen Oss Bv

Looking for Drug Master Files (DMF) for 11826 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 TESTOSTERONE, with a corresponding US DMF Number 11826.

Remarkably, this DMF maintains an Active status since its submission on January 03, 1996, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2014, and payment made on October 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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