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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Inke S.A |
Spain |
INKE SA | 16317 | ONDANSETRON HYDROCHLORIDE | 2002-12-13 | Active | II | N/A | ||
28/10/2024 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 15436 | ONDANSETRON HYDROCHLORIDE DIHYDRATE USP | 2001-05-15 | Active | II | Complete | 2015-09-23 | 2015-09-09 |
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