Visitor Monitoring Drug History: WELLBUTRIN SR
 
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Label and Approval History

Drug Name: WELLBUTRIN SR
FDA Application No: (NDA) 020358
Active Ingredient(s): BUPROPION HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on August 3, 2007 for WELLBUTRIN SR, (NDA) 020358


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
8/2/2007 043Labeling Revision Letter
Label 
1/29/2007 042Labeling Revision Letter
Label 
7/3/2006 040Labeling Revision Letter
Label 
7/3/2006 037Labeling Revision Letter
Label 
2/28/2006 035Labeling Revision Letter 
1/12/2005 034Labeling Revision Letter
Label 
5/27/2004 032Labeling Revision Letter
Review 
4/26/2004 030Labeling Revision Letter 
10/22/2002 029Labeling Revision Letter 
7/12/2002 028Manufacturing Change or Addition Letter 
6/14/2002 027Manufacturing Change or Addition Letter
Label
Review 
7/12/2002 026Package Change  
2/13/2002 025Manufacturing Change or Addition  
10/2/2002 024Labeling Revision Letter 
6/20/2002 023Labeling Revision Letter 
10/11/2000 022Manufacturing Change or Addition  
10/11/2000 021Control Supplement  
10/11/2000 020Formulation Revision  
6/11/2001 019Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
6/20/2002 018Labeling Revision Letter 
8/4/2000 017Control Supplement  
4/10/2000 016Labeling Revision  
4/10/2000 015Labeling Revision  
4/10/2000 014Labeling Revision  
4/10/2000 013Labeling Revision  
4/10/2000 012Labeling Revision  
4/6/1999 011Manufacturing Change or Addition  
4/6/1999 010Package Change  
4/6/1999 009Expiration Date Change  
4/10/2000 008Labeling Revision  
4/10/2000 007Labeling Revision  
11/30/1998 006Manufacturing Change or Addition  
11/30/1998 005Control Supplement  
11/30/1998 004Package Change  
12/16/1997 003Labeling Revision Review 
1/26/1999 002Labeling Revision  
12/16/1997 001Labeling Revision Review 
10/4/1996 000Approval Other Important Information from FDA 
 
There are no Therapeutic Equivalents
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