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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Egis Pharmaceuticals PLC |
Hungary |
EGIS PHARMACEUTICALS PLC | 7882 | PROMETHAZINE HCL | 1989-01-24 | Active | II | Complete | 2021-06-10 | 2021-06-07 |
| 31/10/2025 | Sanofi |
France |
SANOFI WINTHROP INDUSTRIE | 1949 | PROMETHAZINE HCL | 1972-06-09 | Active | II | Complete | 2013-02-26 | 2013-02-13 |
