Visitor Monitoring Drug History: NEORAL
 
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: NEORAL
FDA Application No: (NDA) 050716
Active Ingredient(s): CYCLOSPORINE
Company: NOVARTIS
 
Label History
 
View the label approved on August 2, 2007 for NEORAL, (NDA) 050716


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
8/1/2007 026Labeling Revision Letter
Label 
3/6/2006 025Labeling Revision Letter
Label 
7/19/2005 024Labeling Revision Letter
Label 
2/6/2004 021Labeling Revision Letter
Label 
2/6/2004 020Labeling Revision Letter
Label 
6/12/2002 018Labeling Revision Letter
Label 
4/12/2002 017Manufacturing Change or Addition  
2/22/2002 016Control Supplement  
5/3/2001 015Manufacturing Change or Addition  
6/12/2002 014Labeling Revision Letter
Label 
11/29/2000 013Manufacturing Change or Addition  
12/21/1999 012Labeling Revision  
10/4/2000 011Labeling Revision  
5/13/1999 010Manufacturing Change or Addition  
7/24/1998 008Manufacturing Change or Addition  
7/27/1998 007Control Supplement  
1/30/1998 006Control Supplement  
3/30/1998 005Manufacturing Change or Addition  
6/19/1997 004Labeling Revision  
3/5/1997 001Control Supplement  
7/14/1995 000Approval  
 
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