Details for New Drug Application (NDA): 021078

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NDA 021078 describes MALARONE PEDIATRIC, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers. Additional details are available on the MALARONE PEDIATRIC profile page.

The generic ingredient in MALARONE PEDIATRIC is atovaquone; proguanil hydrochloride. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.

Summary for 021078

Tradename:	MALARONE PEDIATRIC
Applicant:	Glaxosmithkline
Ingredient:	atovaquone; proguanil hydrochloride
Patents:	0

Pharmacology for NDA: 021078

Mechanism of Action	Dihydrofolate Reductase Inhibitors

Suppliers and Packaging for NDA: 021078

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078	NDA	GlaxoSmithKline LLC	0173-0675	0173-0675-01	100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01)
MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078	NDA	GlaxoSmithKline LLC	0173-0675	0173-0675-02	24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG;100MG
Approval Date:	Jul 14, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	62.5MG;25MG
Approval Date:	Jul 14, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021078

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	MALARONE PEDIATRIC	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-002	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline	MALARONE	atovaquone; proguanil hydrochloride	TABLET;ORAL	021078-001	Jul 14, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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