01 1Pliva Hrvatska
01 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE
01 1Croatia
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 19050
Submission : 2005-12-20
Status : Active
Type : II
20
Pliva-lachema As, based in Croatia, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is IRINOTECAN HYDROCHLORIDE TRIHYDRATE, with a corresponding US DMF Number 19050.
Remarkably, this DMF maintains an Active status since its submission on December 20, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 23, 2012, and payment made on November 09, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
