01 1Huatai Biopharm
01 1ICOSAPENT ETHYL
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-10
Pay. Date : 2020-08-07
DMF Number : 34959
Submission : 2020-07-17
Status : Active
Type : II
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Huatai Pharma Inc, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ICOSAPENT ETHYL, with a corresponding US DMF Number 34959.
Remarkably, this DMF maintains an Active status since its submission on July 17, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 10, 2020, and payment made on August 07, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
