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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Seqens |
France |
CU CHEMIE UETIKON GMBH | 17860 | DALFAMPRIDINE | 2004-11-29 | Active | II | N/A | ||
| 25/04/2025 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 27637 | DALFAMPRIDINE USP | 2013-11-01 | Active | II | Complete | 2014-01-24 | 2013-11-19 |
