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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts

Generated: February 25, 2018

DrugPatentWatch Database Preview

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 five 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. Fifteen suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 021078
Ingredient:atovaquone; proguanil hydrochloride
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021078
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 N 0173-0675-02
MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078 NDA GlaxoSmithKline LLC 0173-0675 N 0173-0675-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG;100MG
Approval Date:Jul 14, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength62.5MG;25MG
Approval Date:Jul 14, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021078

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Express Scripts
Argus Health
Queensland Health

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