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GEMIFLOXACIN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

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 | Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision | Gemifloxacin Mesylate Tablets, Orchid Healthcare, Tentative Approval | Factive (gemifloxacin mesylate) Tablets, Cornerstone Therapeutics, Inc., Labeling Revision | Factive (gemifloxacin mesylate) Tablets, Cornerstone Therapeutics, Inc., Labeling Revision

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

                                                                   

 

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