Visitor Monitoring Drug History: FACTIVE
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: FACTIVE
FDA Application No: (NDA) 021158
Active Ingredient(s): GEMIFLOXACIN MESYLATE
Company: OSCIENT
 
Label History
 
View the label approved on May 7, 2007 for FACTIVE, (NDA) 021158


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/1/2007 007New Dosage Regimen Letter
Label 
10/26/2006 005Labeling Revision Letter
Label 
9/7/2004 003Labeling Revision Letter
Label 
7/28/2004 002Labeling Revision Letter
Label 
7/25/2003 001New or Modified Indication Letter
Label 
4/4/2003 000Approval Letter
Label
Review
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