Visitor Monitoring Drug History: BEXTRA
 
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Label and Approval History

Drug Name: BEXTRA
FDA Application No: (NDA) 021341
Active Ingredient(s): VALDECOXIB
Company: GD SEARLE
 
Label History
 
View the label approved on December 3, 2004 for BEXTRA, (NDA) 021341


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
11/24/2004 006Labeling Revision Letter
Label 
4/23/2004 003Efficacy Supplement with Clinical Data to Support Letter
Label 
11/1/2002 002Labeling Revision Letter
Review 
11/16/2001 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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