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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 | Alkem Laboratories |
India |
ALKEM LABORATORIES LTD | 27637 | DALFAMPRIDINE USP | 2013-11-01 | Active | II | Complete | 2014-01-24 | 2013-11-19 |
| 28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 27843 | DALFAMPRIDINE | 2014-01-09 | Active | II | Complete | 2014-02-26 | 2014-01-06 |
