01 1Lek Pharmaceuticals
01 1CLAVULANATE POTASSIUM DILUTED WITH SILICON DIOXIDE 1:1
01 1Slovenia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-24
Pay. Date : 2018-05-17
DMF Number : 32777
Submission : 2018-05-17
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 CLAVULANATE POTASSIUM DILUTED WITH SILICON DIOXIDE 1:1, with a corresponding US DMF Number 32777.
Remarkably, this DMF maintains an Active status since its submission on May 17, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 24, 2019, and payment made on May 17, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
