Visitor Monitoring Drug History: JANUVIA
 
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Label and Approval History

Drug Name: JANUVIA
FDA Application No: (NDA) 021995
Active Ingredient(s): SITAGLIPTIN PHOSPHATE
Company: MERCK CO INC
 
Label History
 
View the label approved on October 18, 2006 for JANUVIA, (NDA) 021995


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
10/12/2007 006Labeling Revision Letter 
10/12/2007 004Labeling Revision Letter 
10/12/2007 003Efficacy Supplement with Clinical Data to Support Letter 
10/12/2007 002Efficacy Supplement with Clinical Data to Support Letter 
10/16/2006 000Approval Letter
Label
Review
Patient Information Sheet 
 
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