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) 021083
Active Ingredient(s):	SIROLIMUS
Company:	WYETH PHARMS INC

Label History

View the label approved on October 22, 2007 for RAPAMUNE, (NDA) 021083

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	034	Labeling Revision	Letter Label
5/2/2007	031	Labeling Revision	Letter Label
1/12/2007	030	Labeling Revision	Letter Label
1/30/2007	029	Patient Population Altered	Letter
10/19/2006	028	Labeling Revision	Label
1/9/2007	026	Labeling Revision	Letter Label
6/2/2006	025	Labeling Revision	Letter Label
6/2/2006	024	Efficacy Supplement with Clinical Data to Support	Letter Label
10/7/2005	023	Labeling Revision	Letter Label
10/7/2005	022	Labeling Revision	Letter Label
6/30/2005	021	Labeling Revision	Letter Label
6/30/2005	020	Labeling Revision	Letter Label
3/11/2005	019	Patient Population Altered	Letter Label
7/20/2004	017	Labeling Revision	Letter Label
10/2/2003	015	Labeling Revision	Letter Label
3/26/2003	014	Labeling Revision	Letter Label
1/23/2003	010	Labeling Revision	Letter Label
1/23/2003	009	Labeling Revision	Letter Label
1/23/2003	008	Labeling Revision	Letter Label
1/23/2003	007	Labeling Revision	Letter Label
4/11/2003	006	New or Modified Indication	Letter Label
1/23/2003	005	Labeling Revision	Letter Label
8/25/2000	004	Labeling Revision
5/3/2000	002	Labeling Revision
3/17/2000	001	Expiration Date Change
9/15/1999	000	Approval	Letter Review Consumer Information Sheet

There are no Therapeutic Equivalents