Visitor Monitoring Drug History: TEGRETOL
 
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Label and Approval History

Drug Name: TEGRETOL
FDA Application No: (NDA) 016608
Active Ingredient(s): CARBAMAZEPINE
Company: NOVARTIS
 
Label History
 
View the label approved on August 17, 2007 for TEGRETOL, (NDA) 016608


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 096Labeling Revision Letter
Label 
1/28/2002 094Control Supplement  
11/15/2001 093Manufacturing Change or Addition  
11/19/2001 092Manufacturing Change or Addition  
5/18/2000 091Manufacturing Change or Addition  
3/7/2001 090Labeling Revision Letter
Label
Review 
4/11/2000 089Manufacturing Change or Addition  
4/10/2000 088Labeling Revision  
6/7/1999 087Manufacturing Change or Addition  
4/21/1999 086Package Change  
7/15/1998 085Labeling Revision  
4/10/2000 084Labeling Revision  
7/15/1998 083Labeling Revision  
3/6/1997 082Expiration Date Change  
7/15/1998 081Labeling Revision  
7/15/1998 080Labeling Revision  
10/5/1995 079Package Change  
10/6/1993 077Control Supplement  
3/14/1991 071Control Supplement  
6/1/1990 070Control Supplement  
3/26/1990 068Labeling Revision  
3/28/1990 066Manufacturing Change or Addition  
3/28/1990 065Manufacturing Change or Addition  
3/27/1990 064Manufacturing Change or Addition  
7/21/1989 063Labeling Revision  
4/7/1989 062Package Change  
8/1/1988 061Labeling Revision  
8/8/1988 060Control Supplement  
10/11/1995 059Patient Population Altered  
7/31/1987 058Labeling Revision  
2/3/1986 056Labeling Revision  
1/10/1986 055Labeling Revision  
6/2/1986 054General Efficacy (MarkIV)  
1/10/1986 053Labeling Revision  
5/6/1985 052Control Supplement  
3/8/1985 051Manufacturing Change or Addition  
7/31/1984 050Manufacturing Change or Addition  
9/14/1983 049Control Supplement  
7/31/1987 048Patient Population Altered  
7/8/1982 047Package Change  
2/9/1982 046Package Change  
12/8/1981 045Labeling Revision  
2/1/1980 043Manufacturing Change or Addition  
3/25/1980 042Labeling Revision  
4/9/1979 041Manufacturing Change or Addition  
11/22/1978 039Control Supplement  
11/22/1978 038Control Supplement  
8/9/1978 037Labeling Revision  
8/9/1978 036Labeling Revision  
4/4/1977 035Control Supplement  
4/4/1977 034Control Supplement  
4/4/1977 033Package Change  
12/12/1975 032Control Supplement  
12/9/1975 029Control Supplement  
11/8/1976 028Labeling Revision  
7/2/1975 027Control Supplement  
3/31/1975 026Control Supplement  
12/12/1974 025Control Supplement  
11/15/1974 024Control Supplement  
3/28/1975 023Distributor  
8/20/1974 022Control Supplement  
11/8/1974 021Control Supplement  
8/29/1974 020Control Supplement  
8/29/1974 019Control Supplement  
8/29/1974 018Control Supplement  
8/29/1974 017Control Supplement  
8/29/1974 016Control Supplement  
8/29/1974 015Control Supplement  
8/29/1974 014Control Supplement  
7/15/1974 012Labeling Revision  
3/11/1968 000Approval Review 
 
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