01 1Lek Pharmaceuticals
01 1POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-07
Pay. Date : 2022-11-23
DMF Number : 37008
Submission : 2023-09-27
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 POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1, with a corresponding US DMF Number 37008.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 07, 2023, and payment made on November 23, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
