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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 | Seqens |
France |
WAVELENGTH ENTERPRISES LTD | 24798 | PALONOSETRON HYDROCHLORIDE | 2011-03-23 | Active | II | Complete | 2013-07-08 | 2013-01-16 |
28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 23590 | PALONOSETRON HYDROCHLORIDE USP | 2010-03-01 | Active | II | N/A |