Drug History: FLUOXETINE

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	FLUOXETINE
FDA Application No:	(ANDA) 074803
Active Ingredient(s):	FLUOXETINE HYDROCHLORIDE
Company:	BARR

Label History

View the label approved on June 4, 2004 for FLUOXETINE, (ANDA) 074803

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
11/26/2002	010	Control Supplement
1/30/2002	009	Facility Addition	Letter
1/30/2002	008	Manufacturing Revision	Letter
1/30/2002	007	Facility Addition	Letter
1/30/2002	006	Packaging Addition	Letter
1/30/2002	005	Manufacturing Revision	Letter
1/30/2002	004	Labeling	Letter
12/13/2001	003	Facility Addition
12/13/2001	002	Manufacturing Revision
12/13/2001	001	Facility Addition
8/2/2001	000	Approval	Letter Letter Label Review Other Important Information from FDA
6/14/2000	000	Tentative Approval	Letter Letter Label Review Other Important Information from FDA

Therapeutic Equivalents