01 1Lek Pharmaceuticals
01 1VORTIOXETINE HYDROBROMIDE
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-14
Pay. Date : 2017-03-03
DMF Number : 31314
Submission : 2017-03-01
Status : Active
Type : II
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Lek Pharmaceuticals Dd, based in Slovenia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is VORTIOXETINE HYDROBROMIDE, with a corresponding US DMF Number 31314.
Remarkably, this DMF maintains an Active status since its submission on March 01, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 14, 2017, and payment made on March 03, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
