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) 020710
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on August 3, 2007 for PAXIL, (NDA) 020710


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 019Labeling Revision Letter 
8/22/2006 018Labeling Revision Letter 
8/2/2007 017Labeling Revision Letter
Label 
2/6/2006 016Labeling Revision Letter 
2/6/2006 015Labeling Revision Letter 
11/8/2001 012Control Supplement  
4/30/2001 011Manufacturing Change or Addition  
4/30/2001 010Manufacturing Change or Addition  
2/15/2001 009Labeling Revision  
9/28/2000 008Labeling Revision  
7/18/2000 007Manufacturing Change or Addition  
9/21/2000 006Control Supplement  
6/27/2000 005Manufacturing Change or Addition  
2/23/1999 004Control Supplement Review 
2/20/1998 002Control Supplement Review 
11/6/1997 001Control Supplement Review 
6/25/1997 000Approval Other Important Information from FDA 
 
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