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 | Cambrex Corporation |
U.S.A |
CAMBREX KARLSKOGA AB | 12679 | ISOSORBIDE-5-MONONITRATE/LACTOSE | 1997-10-02 | Inactive | II | N/A | ||
| 28/10/2024 | Dipharma |
Italy |
DIPHARMA FRANCIS SRL | 6778 | ISOSORBIDE-5-MONONITRATE (5-ISMN) | 1987-01-09 | Active | II | Complete | 2013-01-15 | 2012-12-24 |
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