Visitor Monitoring Drug History: LAMICTAL
 
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Label and Approval History

Drug Name: LAMICTAL
FDA Application No: (NDA) 020241
Active Ingredient(s): LAMOTRIGINE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on September 25, 2006 for LAMICTAL, (NDA) 020241


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
3/17/2006 029Labeling Revision  
9/22/2006 027New or Modified Indication Letter
Label
Label 
9/25/2006 027Labeling Revision Letter
Label
Label 
9/22/2006 026New or Modified Indication Letter
Label
Label 
9/25/2006 026Labeling Revision Letter
Label
Label 
9/22/2006 025New or Modified Indication Letter
Label 
9/25/2006 025Labeling Revision Letter
Label 
9/22/2006 021New or Modified Indication Letter
Label
Label 
9/25/2006 021Labeling Revision Letter
Label
Label 
4/4/2003 018Labeling Revision Letter 
6/20/2003 017New or Modified Indication Letter
Label
Review 
1/14/2004 016Efficacy Supplement with Clinical Data to Support Letter 
2/23/2001 015Labeling Revision  
9/8/2000 014Labeling Revision  
6/12/2000 012Manufacturing Change or Addition  
5/25/2001 011Efficacy Supplement with Clinical Data to Support Label
Review 
9/22/2006 010New or Modified Indication Letter
Label
Label 
9/25/2006 010Labeling Revision Letter
Label
Label 
6/8/1999 009Manufacturing Change or Addition  
1/17/2003 008New or Modified Indication Label 
5/10/1999 007Manufacturing Change or Addition  
3/16/1998 006Labeling Revision  
3/16/1998 005Control Supplement  
3/11/1997 004Labeling Revision  
12/14/1998 003New or Modified Indication Letter
Label
Review
Dear Health Professional Letter 
8/24/1998 002New or Modified Indication Letter
Label
Review
Dear Health Professional Letter 
12/27/1994 000Approval Other Important Information from FDA 
 
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