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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 | FARMAK, a.s |
Czech Republic |
FARMAK AS | 35433 | REGADENOSON | 2021-01-04 | Active | II | Complete | 2021-02-18 | 2021-01-13 |
28/03/2025 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 30834 | REGADENOSON | 2016-09-13 | Active | II | Complete | 2016-12-08 | 2016-09-16 |