Visitor Monitoring Drug History: STARLIX
 
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Label and Approval History

Drug Name: STARLIX
FDA Application No: (NDA) 021204
Active Ingredient(s): NATEGLINIDE
Company: NOVARTIS
 
Label History
 
View the label approved on November 13, 2006 for STARLIX, (NDA) 021204


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
11/9/2006 010Labeling Revision Letter
Label 
7/1/2004 009Labeling Revision Letter
Label 
10/20/2003 006New or Modified Indication Letter
Label
Review 
11/26/2002 005Labeling Revision Letter
Label 
9/25/2002 004Control Supplement  
2/27/2002 003Manufacturing Change or Addition  
1/3/2002 002Manufacturing Change or Addition  
5/1/2001 001Control Supplement  
12/22/2000 000Approval Letter
Label
Review
Consumer Information Sheet 
 
Therapeutic Equivalents
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