01 1Lek Pharmaceuticals
01 1TACROLIMUS
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-28
Pay. Date : 2015-05-05
DMF Number : 19979
Submission : 2006-11-20
Status : Active
Type : II
20
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 TACROLIMUS, with a corresponding US DMF Number 19979.
Remarkably, this DMF maintains an Active status since its submission on November 20, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 28, 2015, and payment made on May 05, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
