01 1Sandoz B2B
01 1CLAVULANATE POTASSIUM DILUTED WITH MICROCRYSTALLINE CELLULOSE 1:1
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-10
Pay. Date : 2015-08-19
DMF Number : 29292
Submission : 2015-08-20
Status : Active
Type : II
20
Lek Pharmaceuticals Dd, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for A global leader in antibiotics.
One of their notable products is CLAVULANATE POTASSIUM DILUTED WITH MICROCRYSTALLINE CELLULOSE 1:1, with a corresponding US DMF Number 29292.
Remarkably, this DMF maintains an Active status since its submission on August 20, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 10, 2016, and payment made on August 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
