Visitor Monitoring Drug History: IMITREX STATDOSE
 
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Label and Approval History

Drug Name: IMITREX STATDOSE
FDA Application No: (NDA) 020080
Active Ingredient(s): SUMATRIPTAN SUCCINATE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on February 7, 2006 for IMITREX STATDOSE, (NDA) 020080


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
2/1/2006 036New Dosage Regimen Letter
Label 
7/28/2003 030Labeling Revision Letter
Review 
1/3/2003 029Labeling Revision Letter 
2/2/2001 027Labeling Revision  
2/2/2001 026Labeling Revision  
2/2/2001 025Labeling Revision  
2/2/2001 024Labeling Revision  
11/26/1997 023Control Supplement  
12/16/1997 022Manufacturing Change or Addition  
2/2/2001 021Labeling Revision  
3/28/1996 020Manufacturing Change or Addition  
11/29/1995 018Manufacturing Change or Addition  
10/5/1995 017Control Supplement  
6/7/1995 014Manufacturing Change or Addition  
12/23/1996 005Package Change Review 
5/22/1996 004New or Modified Indication  
8/17/1994 003Labeling Revision  
9/30/1993 002Manufacturing Change or Addition  
12/28/1992 000Approval Other Important Information from FDA 
 
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