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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Curia |
U.S.A |
CURIA SPAIN SAU | 34802 | BREXANOLONE | 2020-04-24 | Active | II | Complete | 2020-06-03 | 2020-05-15 |
| 29/11/2025 | Zhejiang Xianju Pharmaceutical Co. Ltd |
China |
ZHEJIANG XIANJU PHARMACEUTICAL CO LTD | 39854 | BREXANOLONE | 2024-04-16 | Active | II | N/A |
