Drug History: WELCHOL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	WELCHOL
FDA Application No:	(NDA) 021176
Active Ingredient(s):	COLESEVELAM HYDROCHLORIDE
Company:	DAIICHI SANKYO

Label History

View the label approved on August 30, 2007 for WELCHOL, (NDA) 021176

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
8/27/2007	019	Labeling Revision	Letter Label
7/10/2006	015	Labeling Revision	Letter Label
9/6/2006	014	Efficacy Supplement with Clinical Data to Support	Letter Label
11/17/2003	010	Control Supplement	Letter Label
10/10/2003	009	Labeling Revision	Letter Label
8/21/2003	008	Control Supplement	Letter Label
8/8/2002	006	Control Supplement
10/17/2002	005	Package Change	Letter Label
2/11/2003	004	Labeling Revision	Letter Label
5/10/2002	003	Control Supplement
5/3/2001	002	Control Supplement
1/16/2001	001	Package Change
5/26/2000	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents