01 1Royal DSM
01 1COLESEVELAM HYDROCHLORIDE
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-04
Pay. Date : 2015-01-14
DMF Number : 28945
Submission : 2014-12-19
Status : Active
Type : II
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Patheon Austria Gmbh And Co Kg, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Royal DSM- Growth & Value: Purpose-led, Performance-driven.
One of their notable products is COLESEVELAM HYDROCHLORIDE, with a corresponding US DMF Number 28945.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2015, and payment made on January 14, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
