Visitor Monitoring Drug History: TEKTURNA
 
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Label and Approval History

Drug Name: TEKTURNA
FDA Application No: (NDA) 021985
Active Ingredient(s): ALISKIREN HEMIFUMARATE
Company: NOVARTIS
 
Label History
 
View the label approved on March 7, 2007 for TEKTURNA, (NDA) 021985


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
8/7/2007 002Labeling Revision Letter 
3/5/2007 000Approval Letter
Label
Review 
 
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