Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | PMC Isochem |
France |
PMC ISOCHEM | 7617 | AMIODARONE HYDROCHLORIDE | 1988-08-02 | Active | II | Complete | 2013-02-26 | 2013-02-13 |
| 28/10/2024 | Taro Pharmaceutical Industries |
U.S.A |
TARO PHARMACEUTICAL INDUSTRIES LTD | 15794 | AMIODARONE HCL USP | 2001-12-27 | Active | II | N/A |
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