Drug History: RAPAMUNE

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	RAPAMUNE
FDA Application No:	(NDA) 021110
Active Ingredient(s):	SIROLIMUS
Company:	WYETH PHARMS INC

Label History

View the label approved on October 22, 2007 for RAPAMUNE, (NDA) 021110

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
10/17/2007	045	Labeling Revision	Letter Label
5/2/2007	039	Labeling Revision	Letter Label
1/12/2007	038	Labeling Revision	Letter Label
1/30/2007	037	Patient Population Altered	Letter
10/19/2006	036	Labeling Revision	Label
1/9/2007	035	Labeling Revision	Letter Label
6/2/2006	034	Labeling Revision	Letter Label
6/2/2006	032	Efficacy Supplement with Clinical Data to Support	Letter Label
10/7/2005	031	Labeling Revision	Letter Label
10/7/2005	030	Labeling Revision	Letter Label
6/30/2005	028	Labeling Revision	Letter Label
6/30/2005	027	Labeling Revision	Letter Label
3/11/2005	024	Patient Population Altered	Letter Label
7/20/2004	020	Labeling Revision	Letter Label
2/23/2004	018	Formulation Revision	Letter Label
10/2/2003	015	Labeling Revision	Letter Label
3/19/2003	014	Labeling Revision	Label
2/13/2003	013	Labeling Revision	Letter Label
1/31/2003	011	Labeling Revision	Letter Label
1/23/2003	010	Labeling Revision	Letter Label
1/23/2003	009	Labeling Revision	Letter Label
6/5/2002	008	Control Supplement
1/23/2003	007	Labeling Revision	Letter Label
5/7/2002	006	Control Supplement
1/23/2003	005	Labeling Revision	Letter Label
4/11/2003	004	New or Modified Indication	Letter Label
8/22/2002	003	Formulation Revision	Letter
9/6/2001	002	Control Supplement
1/23/2003	001	Labeling Revision	Letter Label
8/25/2000	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents