01 1Xellia Pharmaceuticals ApS
01 1DAPTOMYCIN NON-STERILE
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-19
Pay. Date : 2013-06-25
DMF Number : 27179
Submission : 2013-07-16
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 DAPTOMYCIN NON-STERILE, with a corresponding US DMF Number 27179.
Remarkably, this DMF maintains an Active status since its submission on July 16, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on June 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
