01 1Icrom
01 1RISPERIDONE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-07-07
DMF Number : 35974
Submission : 2021-06-28
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 RISPERIDONE, with a corresponding US DMF Number 35974.
Remarkably, this DMF maintains an Active status since its submission on June 28, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2021, and payment made on July 07, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
