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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