01 1Fresenius Kabi AB Brunna
01 1ICATIBANT ACETATE
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-10
Pay. Date : 2024-05-21
DMF Number : 38190
Submission : 2024-06-24
Status : Active
Type : II
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Fresenius Kabi Ipsum Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ICATIBANT ACETATE, with a corresponding US DMF Number 38190.
Remarkably, this DMF maintains an Active status since its submission on June 24, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 10, 2024, and payment made on May 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
