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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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 16999 | MOXIFLOXACIN HYDROCHLORIDE USP | 2003-12-02 | Active | II | Complete | 2013-01-30 | 2013-01-02 |
28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 18789 | MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP | 2005-09-19 | Active | II | N/A |