01 1Lek Pharmaceuticals
01 1ENTECAVIR MONOHYDRATE
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2013-11-21
DMF Number : 27719
Submission : 2013-12-17
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 ENTECAVIR MONOHYDRATE, with a corresponding US DMF Number 27719.
Remarkably, this DMF maintains an Active status since its submission on December 17, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 23, 2014, and payment made on November 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
