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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Polpharma |
Poland |
ZAKLADY FARMACEUTYCZNE POLPHARMA SA | 38964 | ISAVUCONAZONIUM SULFATE | 2023-10-04 | Active | II | N/A | ||
28/03/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 38781 | ISAVUCONAZONIUM SULFATE | 2023-09-22 | Active | II | Complete | 2023-11-08 | 2023-09-28 |