FDA Approval Activities for this Drug
Factive (gemifloxacin mesylate) Tablets, 320 mg, GeneSoft NDA 21-158/S1 7/25/03 8/15/03 8/15/03
Factive (gemifloxacin mesylate) Tablets, 320 mg, LG Life Sciences, Ltd NDA 21-158 FACTIVE (gemifloxacin mesylate) Tablets, Parexel International, Labeling Revision FACTIVE (gemifloxacin mesylate) Tablets, Parexel International, Labeling Revision | Factive (gemifloxacin mesylate) Tablets, Oscient Pharma, Labeling Revision | Factive (gemifloxacin mesylate) Tablets, Oscient Pharma, New Dosage Regimen | Factive (gemifloxacin) Tablets, Oscient Pharma, Labeling Revision | Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision | Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Package Change