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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 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 15486 | ZOLPIDEM TARTRATE | 2001-06-21 | Active | II | Complete | 2019-04-11 | 2019-04-05 |
28/03/2025 | Sanofi |
France |
SANOFI WINTHROP INDUSTRIE | 20984 | ZOLPIDEM TARTRATE | 2007-10-30 | Active | II | N/A |