Visitor Monitoring Drug History: TEGRETOL
 
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: TEGRETOL
FDA Application No: (NDA) 018927
Active Ingredient(s): CARBAMAZEPINE
Company: NOVARTIS
 
Label History
 
View the label approved on August 17, 2007 for TEGRETOL, (NDA) 018927


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
8/16/2007 035Labeling Revision Letter
Label 
12/11/2002 034Manufacturing Change or Addition  
1/28/2002 033Control Supplement  
11/15/2001 032Manufacturing Change or Addition  
3/7/2001 031Labeling Revision Letter
Label 
4/11/2000 030Manufacturing Change or Addition  
3/8/2000 029Manufacturing Change or Addition  
4/10/2000 028Labeling Revision  
12/29/1998 027Control Supplement  
2/19/1999 026Manufacturing Change or Addition  
7/15/1998 025Labeling Revision  
4/10/2000 024Labeling Revision  
7/15/1998 023Labeling Revision  
1/2/1997 022Control Supplement  
7/15/1998 021Labeling Revision  
7/15/1998 020Labeling Revision  
8/9/1995 019Manufacturing Change or Addition  
10/11/1995 018Patient Population Altered  
10/6/1993 016Control Supplement  
3/14/1991 010Control Supplement  
3/26/1990 008Labeling Revision  
8/1/1989 006Manufacturing Change or Addition  
7/21/1989 005Labeling Revision  
4/7/1989 004Package Change  
8/1/1988 003Labeling Revision  
7/28/1988 002Manufacturing Change or Addition  
7/28/1988 001Manufacturing Change or Addition  
12/18/1987 000Approval  
 
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