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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 | PMC Isochem |
France |
PMC ISOCHEM | 7617 | AMIODARONE HYDROCHLORIDE | 1988-08-02 | Active | II | Complete | 2013-02-26 | 2013-02-13 |
| 31/10/2025 | Alivus Life Sciences |
India |
ALIVUS LIFE SCIENCES LTD | 16787 | AMIODARONE HYDROCHLORIDE USP | 2003-08-27 | Active | II | Complete | 2019-03-28 | 2019-03-25 |
