01 1Xellia Pharmaceuticals ApS
01 1POLYMYXIN B SULFATE, STERILE
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13536
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 POLYMYXIN B SULFATE, STERILE, with a corresponding US DMF Number 13536.
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 November 08, 2012, and payment made on October 31, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
