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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 26479 | DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG | 2013-05-02 | Active | II | Complete | 2013-11-01 | 2013-05-07 |
| 28/03/2025 | Sanofi |
France |
SANOFI WINTHROP INDUSTRIE | 18409 | DRONEDARONE HYDROCHLORIDE | 2005-06-08 | Active | II | N/A |
