01 1Lunan Pharmaceutical
01 1ELAGOLIX SODIUM
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-09
Pay. Date : 2023-09-19
DMF Number : 37696
Submission : 2022-12-25
Status : Active
Type : II
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Shandong New Time Pharmaceutical Co Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ELAGOLIX SODIUM, with a corresponding US DMF Number 37696.
Remarkably, this DMF maintains an Active status since its submission on December 25, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2024, and payment made on September 19, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
