KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1ESTRADIOL VALERATE
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-12-22
DMF Number : 12268
Submission : 1996-12-16
Status : Active
Type : II
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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 VALERATE, with a corresponding US DMF Number 12268.
Remarkably, this DMF maintains an Active status since its submission on December 16, 1996, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2015, and payment made on December 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
