01 1Zentiva
01 1ARTICAINE HYDROCHLORIDE
01 1Czech Republic
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-03
DMF Number : 20287
Submission : 2007-02-20
Status : Active
Type : II
20
Zentiva Ks, based in Czech Republic, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ARTICAINE HYDROCHLORIDE, with a corresponding US DMF Number 20287.
Remarkably, this DMF maintains an Active status since its submission on February 20, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 31, 2013, and payment made on January 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
