Visitor Monitoring Drug History: KETEK
 
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Label and Approval History

Drug Name: KETEK
FDA Application No: (NDA) 021144
Active Ingredient(s): TELITHROMYCIN
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on February 12, 2007 for KETEK, (NDA) 021144


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
2/12/2007 012Labeling Revision Letter
Label 
6/29/2006 011Labeling Revision Letter
Label 
4/8/2005 005Control Supplement Letter 
11/2/2005 004Labeling Revision Letter
Label 
2/3/2005 003Labeling Revision Letter
Label 
2/9/2005 001Efficacy Supplement with Clinical Data to Support Letter
Label 
4/1/2004 000Approval Letter
Label
Review
Other Important Information from FDA 
 
There are no Therapeutic Equivalents
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