Drug History: PROZAC

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	PROZAC
FDA Application No:	(NDA) 020101
Active Ingredient(s):	FLUOXETINE HYDROCHLORIDE
Company:	LILLY

Label History

View the label approved on August 3, 2007 for PROZAC, (NDA) 020101

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
8/2/2007	037	Labeling Revision	Letter Label
3/15/2007	036	Labeling Revision	Letter
9/20/2006	035	Labeling Revision	Label
4/11/2006	034	Labeling Revision	Letter
2/18/2005	033	Labeling Revision	Letter
12/1/2005	032	Labeling Revision	Letter
8/19/2004	031	Labeling Revision	Letter
5/25/2004	029	Manufacturing Change or Addition	Letter
7/29/2002	027	Efficacy Supplement with Clinical Data to Support
6/16/1999	026	Labeling Revision
10/7/1999	024	Labeling Revision	Review
8/4/1998	023	Control Supplement
8/4/1998	022	Manufacturing Change or Addition
3/13/1998	021	Labeling Revision
4/23/1998	020	Control Supplement
4/1/1996	014	Package Change
9/12/1995	012	Labeling Revision
9/12/1995	011	Labeling Revision
3/1/1995	010	Labeling Revision
3/25/1997	009	Labeling Revision
7/6/1994	007	Labeling Revision
5/22/1995	006	Control Supplement
3/25/1993	005	Labeling Revision
8/18/1993	004	Labeling Revision
8/20/1992	003	Labeling Revision
1/21/1992	002	Labeling Revision
1/21/1992	001	Labeling Revision
4/24/1991	000	Approval	Other Important Information from FDA

Therapeutic Equivalents