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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 16658 | LEVOFLOXACIN HEMIHYDRATE USP | 2003-06-24 | Active | II | Complete | 2020-08-14 | 2020-08-10 |
25/04/2025 | Chromo Laboratories |
India |
CHROMO LABORATORIES INDIA PRIVATE LTD | 38449 | LEVOFLOXACIN HEMIHYDRATE USP | 2024-07-30 | Active | II | N/A |