Visitor Monitoring Drug History: FANSIDAR
 
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Label and Approval History

Drug Name: FANSIDAR
FDA Application No: (NDA) 018557
Active Ingredient(s): PYRIMETHAMINE; SULFADOXINE
Company: ROCHE
 
Label History
 
View the label approved on April 5, 2004 for FANSIDAR, (NDA) 018557


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
4/27/2003 016Labeling Revision Letter 
2/26/2004 015Labeling Revision Letter
Label
Review 
8/14/1998 014Package Change  
6/9/1993 013Manufacturing Change or Addition  
11/3/1987 012Labeling Revision  
4/30/1987 011Labeling Revision  
7/24/1985 010Labeling Revision  
7/24/1985 009Labeling Revision  
7/24/1985 008Labeling Revision  
7/24/1985 007Labeling Revision  
10/26/1983 006Control Supplement  
7/26/1983 005Manufacturing Change or Addition  
7/21/1983 003Manufacturing Change or Addition  
7/21/1983 002Control Supplement  
10/28/1981 000Approval  
 
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