Visitor Monitoring Drug History: SANDIMMUNE
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: SANDIMMUNE
FDA Application No: (NDA) 050574
Active Ingredient(s): CYCLOSPORINE
Company: NOVARTIS
 
Label History
 
View the label approved on March 10, 2006 for SANDIMMUNE, (NDA) 050574


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
3/6/2006 040Labeling Revision Letter
Label 
7/19/2005 039Labeling Revision Letter
Label 
2/6/2004 037Labeling Revision Letter
Label 
2/6/2004 035Labeling Revision Letter
Label 
4/12/2002 033Manufacturing Change or Addition  
6/14/2002 032Manufacturing Change or Addition  
1/16/2002 031Manufacturing Change or Addition  
2/22/2002 030Control Supplement  
2/14/2003 029Labeling Revision Letter
Label 
11/16/2001 028Manufacturing Change or Addition  
2/14/2003 027Labeling Revision Letter
Label 
12/21/1999 026Labeling Revision  
10/4/2000 025Labeling Revision  
5/13/1999 024Manufacturing Change or Addition  
10/20/1998 023Manufacturing Change or Addition  
7/27/1998 022Control Supplement  
1/30/1998 021Control Supplement  
3/30/1998 020Manufacturing Change or Addition  
3/22/1996 019Control Supplement  
8/9/1996 018Labeling Revision  
11/21/1995 017Labeling Revision  
4/28/1995 016Control Supplement  
11/10/1994 015Labeling Revision  
3/7/1995 014Manufacturing Change or Addition  
5/19/1994 013Formulation Revision  
5/9/1994 012Control Supplement  
5/9/1994 011Control Supplement  
3/19/1993 010Control Supplement  
2/11/1993 009Formulation Revision  
2/21/1992 008Control Supplement  
6/10/1991 006Labeling Revision  
3/14/1991 005Control Supplement  
2/24/1993 004Expiration Date Change  
2/16/1993 003Control Supplement  
11/14/1983 000Approval  
 
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