01 1Xellia Pharmaceuticals ApS
01 1TOBRAMYCIN SULPHATE, USP STERILE BULK
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2012-11-15
DMF Number : 15629
Submission : 2001-09-17
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 TOBRAMYCIN SULPHATE, USP STERILE BULK, with a corresponding US DMF Number 15629.
Remarkably, this DMF maintains an Active status since its submission on September 17, 2001, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 12, 2013, and payment made on November 15, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
