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GEMIFLOXACIN

 
 
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Title 21 Code of Federal Regulations
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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

^ FDA's latest approval appears at the bottom of this list. ^


 

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