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) 018281
Active Ingredient(s): CARBAMAZEPINE
Company: NOVARTIS
 
Label History
 
View the label approved on August 17, 2007 for TEGRETOL, (NDA) 018281


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 044Labeling Revision Letter
Label 
3/5/2002 043Control Supplement  
1/28/2002 042Control Supplement  
11/15/2001 041Manufacturing Change or Addition  
5/18/2000 040Manufacturing Change or Addition  
3/7/2001 039Labeling Revision Letter
Label
Review 
4/11/2000 038Manufacturing Change or Addition  
4/10/2000 037Labeling Revision  
4/23/1999 036Package Change  
1/27/1999 035Manufacturing Change or Addition  
7/15/1998 034Labeling Revision  
4/10/2000 033Labeling Revision  
7/15/1998 032Labeling Revision  
7/15/1998 031Labeling Revision Review 
7/15/1998 030Labeling Revision  
10/6/1993 028Control Supplement  
3/14/1991 022Control Supplement  
11/23/1992 021Formulation Revision  
2/3/1995 020Control Supplement  
3/26/1990 018Labeling Revision  
3/29/1990 016Manufacturing Change or Addition  
3/29/1990 015Manufacturing Change or Addition  
3/27/1990 014Manufacturing Change or Addition  
7/21/1989 013Labeling Revision  
4/7/1989 012Package Change  
8/1/1988 011Labeling Revision  
10/11/1995 010Patient Population Altered  
7/31/1987 009Labeling Revision  
9/11/1986 008Manufacturing Change or Addition  
2/3/1986 006Package Change  
1/10/1986 005Labeling Revision  
1/10/1986 004Labeling Revision  
6/21/1983 003Package Change  
2/11/1982 001Labeling Revision  
12/14/1981 000Approval  
 
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