01 1Xellia Pharmaceuticals ApS
01 1TOBRAMYCIN SULPHATE, NON-STERILE BULK
01 1Denmark
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-06
Pay. Date : 2012-10-31
DMF Number : 15021
Submission : 2000-09-12
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, NON-STERILE BULK, with a corresponding US DMF Number 15021.
Remarkably, this DMF maintains an Active status since its submission on September 12, 2000, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 06, 2013, and payment made on October 31, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
