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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
27/02/2026 Curia
U.S.A
CURIA SPAIN SAU 34802 BREXANOLONE 2020-04-24 Active II Complete 2020-06-03 2020-05-15
27/02/2026 Zhejiang Xianju Pharmaceutical Co. Ltd
China
ZHEJIANG XIANJU PHARMACEUTICAL CO LTD 39854 BREXANOLONE 2024-04-16 Active II N/A