Visitor Monitoring Drug History: LAMICTAL CD
 
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Label and Approval History

Drug Name: LAMICTAL CD
FDA Application No: (NDA) 020764
Active Ingredient(s): LAMOTRIGINE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on September 25, 2006 for LAMICTAL CD, (NDA) 020764


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 022Labeling Revision  
9/22/2006 020New or Modified Indication Letter
Label
Label 
9/25/2006 020Labeling Revision Letter
Label
Label 
9/22/2006 019New or Modified Indication Letter
Label
Label 
9/25/2006 019Labeling Revision Letter
Label
Label 
9/22/2006 018New or Modified Indication Letter
Label
Label 
9/25/2006 018Labeling Revision Letter
Label
Label 
9/22/2006 014New or Modified Indication Letter
Label
Label 
9/25/2006 014Labeling Revision Letter
Label
Label 
6/20/2003 011New or Modified Indication Letter
Label
Review 
1/14/2004 009Efficacy Supplement with Clinical Data to Support Letter 
2/23/2001 008Labeling Revision  
9/8/2000 006Formulation Revision  
5/25/2001 005Efficacy Supplement with Clinical Data to Support Label
Review 
6/8/1999 004Manufacturing Change or Addition  
9/22/2006 003New or Modified Indication Letter
Label
Label 
9/25/2006 003Labeling Revision Letter
Label
Label 
1/17/2003 002New or Modified Indication Label 
12/14/1998 001New or Modified Indication Letter
Label
Review
Dear Health Professional Letter 
8/24/1998 000Approval Letter
Label
Review
Dear Health Professional Letter
Other Important Information from FDA 
 
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