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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