Drug History: FLUOXETINE HYDROCHLORIDE

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	FLUOXETINE HYDROCHLORIDE
FDA Application No:	(ANDA) 075049
Active Ingredient(s):	FLUOXETINE HYDROCHLORIDE
Company:	SANDOZ

Label History

View the label approved on June 4, 2004 for FLUOXETINE HYDROCHLORIDE, (ANDA) 075049

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
1/29/2002	010	Labeling	Letter
1/29/2002	009	Control Supplement	Letter
1/29/2002	008	Labeling	Letter
1/29/2002	007	Packaging Addition	Letter
1/29/2002	005	Formulation Revision	Letter
1/29/2002	004	Control Supplement	Letter
1/29/2002	003	Labeling	Letter
1/29/2002	002	Chemistry New Strength	Letter
8/22/2001	001	Labeling	Letter
8/2/2001	000	Approval	Letter Label Review Other Important Information from FDA
6/15/1999	000	Tentative Approval	Letter Label Review Other Important Information from FDA
4/30/2001	000	Tentative Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents