01 1Icrom
01 1BEPOTASTINE BESILATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-08-30
DMF Number : 27465
Submission : 2013-08-27
Status : Active
Type : II
20
Icrom Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is BEPOTASTINE BESILATE, with a corresponding US DMF Number 27465.
Remarkably, this DMF maintains an Active status since its submission on August 27, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2013, and payment made on August 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
