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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 | CHEMO IBERICA SA |
Spain |
QUIMICA SINTETICA SA | 17367 | ISRADIPINE | 2004-05-05 | Active | II | Complete | 2014-10-10 | 2014-03-20 |
| 31/10/2025 | Magle Chemoswed |
Sweden |
CHEMOSWED AB | 19376 | ISRADIPINE | 2006-04-19 | Active | II | N/A |
