01 1Lek Pharmaceuticals
01 1DOLUTEGRAVIR SODIUM
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2016-11-25
DMF Number : 30933
Submission : 2016-12-19
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 DOLUTEGRAVIR SODIUM, with a corresponding US DMF Number 30933.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 06, 2017, and payment made on November 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
