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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 | Cayman Pharma s.r.o |
Czech Republic |
CAYMAN PHARMA SRO | 21584 | EPOPROSTENOL SODIUM | 2008-04-28 | Active | II | Complete | 2019-09-27 | 2019-09-13 |
| 28/03/2025 | EUROAPI |
France |
EUROAPI HUNGARY LTD | 19539 | EPOPROSTENAL SODIUM DRUG SUBSTANCE | 2006-06-22 | Active | II | N/A |
