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MALARONE PEDIATRIC Drug Profile

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Malarone Pediatric is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from three suppliers.

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

Summary for Tradename: MALARONE PEDIATRIC

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details

Pharmacology for Tradename: MALARONE PEDIATRIC

Clinical Trials for: MALARONE PEDIATRIC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 2000RXNo<disabled><disabled>
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Expired Patents for Tradename: MALARONE PEDIATRIC

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20005,053,432*PED<disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20006,166,046*PED<disabled>
Glaxosmithkline
MALARONE PEDIATRIC
atovaquone; proguanil hydrochloride
TABLET;ORAL021078-002Jul 14, 20005,998,449*PED<disabled>
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