Drug History: RAZADYNE

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	RAZADYNE
FDA Application No:	(NDA) 021169
Active Ingredient(s):	GALANTAMINE HYDROBROMIDE
Company:	JANSSEN PHARMA

Label History

View the label approved on February 28, 2001 for RAZADYNE, (NDA) 021169

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
4/27/2006	014	Labeling Revision	Letter
4/27/2006	013	Labeling Revision	Letter
4/27/2006	012	Labeling Revision	Letter
5/2/2005	011	Labeling Revision	Letter
4/27/2006	010	Labeling Revision	Letter
9/3/2003	007	Labeling Revision	Letter
7/31/2002	004	Manufacturing Change or Addition
4/19/2002	003	Labeling Revision	Letter
8/15/2001	001	Manufacturing Change or Addition
2/28/2001	000	Approval	Letter Label Review Other Important Information from FDA

Therapeutic Equivalents