Visitor Monitoring Drug History: MAXALT-MLT
 
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Label and Approval History

Drug Name: MAXALT-MLT
FDA Application No: (NDA) 020865
Active Ingredient(s): RIZATRIPTAN BENZOATE
Company: MERCK
 
Label History
 
View the label approved on June 29, 1998 for MAXALTMLT, (NDA) 020865


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 010Manufacturing Change or Addition  
4/22/2002 009Labeling Revision Letter 
3/23/2001 008Manufacturing Change or Addition  
12/11/2000 007Labeling Revision Review 
12/11/2000 006Efficacy Supplement with Clinical Data to Support Review 
12/11/2000 005Labeling Revision Review 
6/21/2000 004Efficacy Supplement with Clinical Data to Support Review 
3/28/2000 003Control Supplement  
6/21/2000 002Supplement Review 
11/16/1999 001Efficacy Supplement with Clinical Data to Support Letter 
6/29/1998 000Approval Letter
Label
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