Drug History: MALARONE PEDIATRIC

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:	MALARONE PEDIATRIC
FDA Application No:	(NDA) 021078
Active Ingredient(s):	ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Company:	GLAXOSMITHKLINE

Label History

View the label approved on March 3, 2005 for MALARONE PEDIATRIC, (NDA) 021078

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
2/27/2005	009	Labeling Revision	Letter Label
2/27/2005	008	Labeling Revision	Letter Label
11/24/2004	007	Labeling Revision	Letter Label
12/2/2003	006	Patient Population Altered	Letter Label
5/9/2003	005	Supplement	Review
5/13/2002	004	Control Supplement	Review
8/2/2002	003	Efficacy Supplement with Clinical Data to Support	Letter Label Review
9/3/2004	002	Labeling Revision	Letter Label
2/28/2002	001	Labeling Revision	Letter Review
7/14/2000	000	Approval	Letter Label Review

There are no Therapeutic Equivalents