01 1Fresenius Kabi AB Brunna
01 1AVIBACTAM SODIUM STERILE
01 1Sweden
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-20
Pay. Date : 2024-02-08
DMF Number : 39510
Submission : 2024-02-09
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 AVIBACTAM SODIUM STERILE, with a corresponding US DMF Number 39510.
Remarkably, this DMF maintains an Active status since its submission on February 09, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 20, 2024, and payment made on February 08, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
