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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 30088 | NILOTINIB HYDROCHLORIDE | 2015-12-31 | Active | II | Complete | 2016-03-16 | 2016-02-04 |
24/02/2025 | Granules India Limited |
India |
GRANULES INDIA LTD (UNIT-V) | 37531 | NILOTINIB HYDROCHLORIDE MONOHYDRATE | 2022-09-30 | Active | II | N/A |