Drug History: SINGULAIR

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	SINGULAIR
FDA Application No:	(NDA) 021409
Active Ingredient(s):	MONTELUKAST SODIUM
Company:	MERCK

Label History

View the label approved on December 14, 2006 for SINGULAIR, (NDA) 021409

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
12/8/2006	019	Labeling Revision	Letter Label
5/19/2006	018	Labeling Revision	Letter Label
6/27/2005	017	Labeling Revision	Letter Label
4/13/2007	016	New or Modified Indication	Letter Label
5/26/2005	015	Labeling Revision	Letter Label
11/30/2005	014	Efficacy Supplement with Clinical Data to Support	Letter Label
7/27/2005	012	New or Modified Indication	Letter Label
12/29/2004	011	Labeling Revision
11/15/2004	010	Labeling Revision	Letter Label
12/19/2003	007	Labeling Revision	Letter Label Review
10/2/2003	005	Labeling Revision	Letter Label Review
12/31/2002	003	New or Modified Indication	Letter Label
7/26/2002	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents