Drug History: ACIPHEX

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:	ACIPHEX
FDA Application No:	(NDA) 020973
Active Ingredient(s):	RABEPRAZOLE SODIUM
Company:	EISAI MEDCL RES

Label History

View the label approved on June 7, 2005 for ACIPHEX, (NDA) 020973

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
6/3/2005	020	Labeling Revision	Letter Label
8/1/2003	016	Labeling Revision	Letter
9/30/2002	015	Formulation Revision	Letter
9/23/2002	014	Labeling Revision	Letter
11/8/2002	013	Efficacy Supplement with Clinical Data to Support	Letter Label Review
5/29/2002	012	Formulation Revision	Letter
10/2/2001	011	Package Change
10/2/2001	010	Control Supplement
2/12/2002	009	New or Modified Indication	Letter Label
8/15/2001	008	Labeling Revision	Label Review
12/15/2000	007	Manufacturing Change or Addition
9/20/2000	006	Package Change
2/28/2000	005	Control Supplement
5/8/2000	004	Manufacturing Change or Addition
2/16/2000	003	Manufacturing Change or Addition
2/16/2000	002	Manufacturing Change or Addition
10/21/1999	001	Control Supplement
8/19/1999	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents