Visitor Monitoring Drug History: WELLBUTRIN XL
 
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Label and Approval History

Drug Name: WELLBUTRIN XL
FDA Application No: (NDA) 021515
Active Ingredient(s): BUPROPION HYDROCHLORIDE
Company: SMITHKLINE BEECHAM
 
Label History
 
View the label approved on August 3, 2007 for WELLBUTRIN XL, (NDA) 021515


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 020Labeling Revision Letter
Label 
6/12/2006 018Labeling Revision Letter
Label 
7/3/2006 014Labeling Revision Letter
Label 
2/28/2006 012Labeling Revision Letter 
6/12/2006 010New or Modified Indication Letter
Label 
1/12/2005 009Labeling Revision Letter
Label 
5/27/2004 007Labeling Revision Letter
Review 
10/28/2004 002Labeling Revision Letter 
8/29/2003 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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