Visitor Monitoring Drug History: MAXALT
 
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Label and Approval History

Drug Name: MAXALT
FDA Application No: (NDA) 020864
Active Ingredient(s): RIZATRIPTAN BENZOATE
Company: MERCK
 
Label History
 
View the label approved on June 29, 1998 for MAXALT, (NDA) 020864


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
12/6/2001 009Manufacturing Change or Addition  
4/22/2002 008Labeling Revision Letter 
12/11/2000 007Labeling Revision Review 
1/25/2001 006Manufacturing Change or Addition  
12/11/2000 005Efficacy Supplement with Clinical Data to Support Review 
12/11/2000 004Labeling Revision Review 
11/16/1999 003Efficacy Supplement with Clinical Data to Support Letter 
6/21/2000 002Efficacy Supplement with Clinical Data to Support Review 
6/29/1998 000Approval Letter
Label
Review
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