01 1Xellia Pharmaceuticals ApS
01 1DALBAVANCIN HYDROCHLORIDE
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-01-29
DMF Number : 39378
Submission : 2024-03-27
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 DALBAVANCIN HYDROCHLORIDE, with a corresponding US DMF Number 39378.
Remarkably, this DMF maintains an Active status since its submission on March 27, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2024, and payment made on January 29, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
