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Last Updated: August 12, 2020

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. Ten suppliers are listed for this compound. Additional details are available on the atovaquone; proguanil hydrochloride profile page.
Summary for 021078
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 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)
Paragraph IV (Patent) Challenges for 021078
Tradename Dosage Ingredient NDA Submissiondate
MALARONE PEDIATRIC TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2010-09-14
MALARONE TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2010-09-14
MALARONE TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2009-04-03
MALARONE PEDIATRIC TABLET;ORAL atovaquone; proguanil hydrochloride 021078 2009-04-03

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

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