Drug History: PEPCID

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:	PEPCID
FDA Application No:	(NDA) 019527
Active Ingredient(s):	FAMOTIDINE
Company:	SALIX PHARMS

Label History

View the label approved on December 3, 2004 for PEPCID, (NDA) 019527

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
11/24/2004	027	Labeling Revision	Letter Label
3/14/2001	025	Labeling Revision
6/6/2002	024	Efficacy Supplement with Clinical Data to Support	Letter Label Review
4/25/2001	023	Labeling Revision
11/27/2000	022	Labeling Revision
10/13/1999	021	Manufacturing Change or Addition
3/18/1999	020	Labeling Revision	Review
10/8/1998	019	Labeling Revision
10/28/1997	018	Control Supplement
8/22/1997	017	Labeling Revision
8/12/1998	016	Labeling Revision
2/1/1996	015	Control Supplement
3/29/1996	014	Labeling Revision
3/29/1996	013	Labeling Revision
3/29/1996	012	Labeling Revision
11/30/1990	009	Labeling Revision
8/22/1997	008	Labeling Revision
12/10/1991	007	Labeling Revision
11/30/1990	005	Labeling Revision
11/30/1990	004	Labeling Revision
10/28/1988	003	Labeling Revision
9/29/1995	002	Manufacturing Change or Addition
11/23/1988	001	Labeling Revision
2/2/1987	000	Approval

There are no Therapeutic Equivalents