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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 Bristol Myers Squibb
U.S.A
BRISTOL MYERS SQUIBB CO 16546 GARENOXACIN MESYLATE (BMS-284756-01) DRUG SUBSTANCE 2003-04-22 Inactive II N/A
28/03/2025 Sumitomo Pharma
Japan
DAINIPPON PHARMACEUTICAL CO LTD 7252 ENOXACIN SESQUIHYDRATE 1987-12-09 Inactive II N/A