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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021078

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MALARONE (ATOVAQUONE; PROGUANIL HYDROCHLORIDE)
250MG;100MG
Marketing Status: Prescription
Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Proprietary Name: MALARONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG;100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021078
Product Number: 001
Approval Date: Jul 14, 2000
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information
MALARONE PEDIATRIC (ATOVAQUONE; PROGUANIL HYDROCHLORIDE)
62.5MG;25MG
Marketing Status: Prescription
Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Proprietary Name: MALARONE PEDIATRIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 62.5MG;25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021078
Product Number: 002
Approval Date: Jul 14, 2000
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information
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