01 1AK AND MN BIOFARM CO LTD
01 1ICOSAPENT ETHYL
01 1South Korea
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-25
Pay. Date : 2022-06-10
DMF Number : 36822
Submission : 2022-06-07
Status : Active
Type : II
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Ak Biopharm Co Ltd, based in South Korea, is a pharmaceutical company.
One of their notable products is ICOSAPENT ETHYL, with a corresponding US DMF Number 36822.
Remarkably, this DMF maintains an Active status since its submission on June 07, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 25, 2022, and payment made on June 10, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
