Drug History: PAXIL CR

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	PAXIL CR
FDA Application No:	(NDA) 020936
Active Ingredient(s):	PAROXETINE HYDROCHLORIDE
Company:	GLAXOSMITHKLINE

Label History

View the label approved on August 3, 2007 for PAXIL CR, (NDA) 020936

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 Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
8/22/2006	031	Labeling Revision	Letter
8/22/2006	030	Labeling Revision	Letter
8/2/2007	029	Labeling Revision	Letter Label
2/6/2006	027	Labeling Revision	Letter
2/6/2006	026	Labeling Revision	Letter
8/22/2006	023	Labeling Revision	Letter
2/6/2006	022	Labeling Revision	Letter
3/9/2006	021	Labeling Revision	Letter
1/12/2005	020	Labeling Revision	Letter Label
5/21/2004	019	Supplement	Letter
7/13/2005	018	Labeling Revision	Letter
1/27/2004	013	New Dosage Regimen	Letter Label
10/16/2003	012	New or Modified Indication	Letter Label Review
8/28/2003	011	New or Modified Indication	Letter Label Review
7/22/2002	009	Control Supplement
2/12/2002	008	Labeling Revision	Letter Label Review
4/30/2001	007	Manufacturing Change or Addition
4/30/2001	006	Manufacturing Change or Addition
12/6/2000	005	Manufacturing Change or Addition
7/18/2000	004	Manufacturing Change or Addition
9/21/2000	003	Control Supplement
8/17/2000	002	Manufacturing Change or Addition
7/2/1999	001	Manufacturing Change or Addition
2/16/1999	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents