Visitor Monitoring Drug History: PAXIL
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: PAXIL
FDA Application No: (NDA) 020031
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on August 3, 2007 for PAXIL, (NDA) 020031


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
8/22/2006 055Labeling Revision Letter 
8/22/2006 054Labeling Revision Letter 
8/2/2007 053Labeling Revision Letter
Label 
2/6/2006 052Labeling Revision Letter 
2/6/2006 051Labeling Revision Letter 
8/22/2006 049Labeling Revision Letter 
2/6/2006 048Labeling Revision Letter 
3/9/2006 046Labeling Revision Letter 
1/12/2005 045Labeling Revision Letter
Label 
5/21/2004 043Supplement Letter 
7/13/2005 042Labeling Revision Letter 
4/8/2004 040Labeling Revision Letter 
4/8/2004 039Labeling Revision Letter 
10/2/2002 035Efficacy Supplement with Clinical Data to Support Letter 
4/30/2001 034Manufacturing Change or Addition  
5/22/2001 033Package Change  
4/30/2001 032Manufacturing Change or Addition  
2/15/2001 031Labeling Revision Review 
9/28/2000 030Labeling Revision Review 
12/14/2001 029New or Modified Indication Letter
Label
Review 
9/21/2000 028Control Supplement Review 
9/20/2000 027Manufacturing Change or Addition Review 
4/13/2001 026New or Modified Indication Letter
Label
Review 
5/17/2000 025Manufacturing Change or Addition Review 
5/11/1999 023New or Modified Indication Letter
Label 
2/19/1998 022Control Supplement  
2/19/1998 021Control Supplement  
12/16/1997 020Manufacturing Change or Addition  
7/22/1997 019Control Supplement  
7/14/1997 018Control Supplement  
5/19/1997 017Labeling Revision  
12/13/1996 016Control Supplement  
10/17/1996 015Labeling Revision  
6/24/1997 013Formulation Revision  
7/11/1996 012Control Supplement  
7/2/1996 011Control Supplement  
3/5/1996 010Control Supplement  
5/7/1996 009New or Modified Indication  
2/23/1995 008Labeling Revision  
5/7/1996 007New or Modified Indication  
5/10/1995 006Manufacturing Change or Addition  
2/23/1995 005Labeling Revision  
9/22/1994 004Formulation Revision  
2/23/1995 003Labeling Revision  
6/22/1994 002Expiration Date Change  
11/29/1994 001Control Supplement  
12/29/1992 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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