01 1Xellia Pharmaceuticals ApS
01 1COLISTIN SULFATE
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2012-11-15
DMF Number : 13362
Submission : 1998-09-01
Status : Active
Type : II
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Xellia Pharmaceuticals Aps, based in Denmark, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is COLISTIN SULFATE, with a corresponding US DMF Number 13362.
Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2014, and payment made on November 15, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
