Drug History: RENAGEL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	RENAGEL
FDA Application No:	(NDA) 021179
Active Ingredient(s):	SEVELAMER HYDROCHLORIDE
Company:	GENZYME

Label History

View the label approved on August 17, 2007 for RENAGEL, (NDA) 021179

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
8/14/2007	021	Labeling Revision	Letter Label
10/19/2007	020	Efficacy Supplement with Clinical Data to Support	Letter Label
7/25/2005	015	Labeling Revision	Letter
1/7/2003	003	Manufacturing Change or Addition
2/6/2004	002	New or Modified Indication	Letter
3/15/2002	001	Control Supplement
7/12/2000	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents