Visitor Monitoring Drug History: TEGRETOL-XR
 
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Label and Approval History

Drug Name: TEGRETOL-XR
FDA Application No: (NDA) 020234
Active Ingredient(s): CARBAMAZEPINE
Company: NOVARTIS
 
Label History
 
View the label approved on August 17, 2007 for TEGRETOLXR, (NDA) 020234


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 025Labeling Revision Letter
Label 
1/28/2002 022Control Supplement  
5/6/2002 021Manufacturing Change or Addition  
11/15/2001 020Manufacturing Change or Addition  
2/22/2001 019Control Supplement  
1/11/2001 018Control Supplement  
3/7/2001 017Labeling Revision Letter
Label
Review 
4/11/2000 016Manufacturing Change or Addition  
3/7/2000 015Control Supplement  
4/10/2000 014Labeling Revision  
2/14/2000 013Manufacturing Change or Addition  
6/29/1999 012Expiration Date Change  
4/22/1999 011Package Change  
1/4/1999 010Manufacturing Change or Addition  
9/17/1998 009Manufacturing Change or Addition  
7/15/1998 008Labeling Revision  
4/10/2000 007Labeling Revision  
7/15/1998 006Labeling Revision  
7/15/1998 005Labeling Revision  
7/26/1996 004Control Supplement  
9/24/1996 003Package Change  
7/15/1998 002Labeling Revision  
6/24/1996 001Control Supplement  
3/25/1996 000Approval Letter
Label
Review 
 
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