01 1Icrom
01 1EPINASTINE HYDROCHLORIDE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-27
Pay. Date : 2020-05-19
DMF Number : 21830
Submission : 2008-07-28
Status : Active
Type : II
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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 EPINASTINE HYDROCHLORIDE, with a corresponding US DMF Number 21830.
Remarkably, this DMF maintains an Active status since its submission on July 28, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 27, 2020, and payment made on May 19, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
