Drug History: ZOLOFT

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	ZOLOFT
FDA Application No:	(NDA) 020990
Active Ingredient(s):	SERTRALINE HYDROCHLORIDE
Company:	PFIZER

Label History

View the label approved on October 10, 2007 for ZOLOFT, (NDA) 020990

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
10/4/2007	029	Labeling Revision	Letter Label
8/2/2007	027	Labeling Revision	Letter Label
9/14/2006	026	Labeling Revision	Letter Label
8/2/2007	025	Labeling Revision	Letter
9/14/2006	024	Labeling Revision	Letter Label
5/4/2006	023	Labeling Revision	Letter
7/26/2005	022	Labeling Revision	Letter
2/18/2005	020	Labeling Revision	Letter Label
2/18/2005	019	Labeling Revision	Letter Label
8/19/2004	017	Labeling Revision	Letter Label
8/19/2004	013	Efficacy Supplement with Clinical Data to Support	Letter Label
2/7/2003	011	New or Modified Indication	Letter Label
9/16/2003	010	Patient Population Altered	Letter Label Review
9/18/2002	009	Labeling Revision	Letter
5/16/2002	007	New or Modified Indication	Letter Label
11/16/2000	006	Labeling Revision
2/22/2001	005	Labeling Revision
9/20/2002	004	Efficacy Supplement with Clinical Data to Support	Letter
8/6/2001	003	Efficacy Supplement with Clinical Data to Support	Letter Label Review
9/20/2002	002	Efficacy Supplement with Clinical Data to Support	Letter
10/12/2001	001	Efficacy Supplement with Clinical Data to Support	Letter Label
12/7/1999	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents