Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
McKesson
Chinese Patent Office
Healthtrust
Moodys
US Department of Justice
Cerilliant
Baxter

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021078

« Back to Dashboard

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. Eleven 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
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline MALARONE PEDIATRIC atovaquone; proguanil hydrochloride TABLET;ORAL 021078-002 Jul 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline MALARONE atovaquone; proguanil hydrochloride TABLET;ORAL 021078-001 Jul 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Moodys
Dow
Queensland Health
Covington
US Army
QuintilesIMS
Farmers Insurance
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.