01 1Fresenius Kabi Anti-Infectives
01 1DEGARELIX ACETATE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2022-12-05
DMF Number : 36499
Submission : 2023-01-19
Status : Active
Type : II
20
Fresenius Kabi Ipsum Srl, based in Italy, is a pharmaceutical company.
One of their notable products is DEGARELIX ACETATE, with a corresponding US DMF Number 36499.
Remarkably, this DMF maintains an Active status since its submission on January 19, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 27, 2023, and payment made on December 05, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
