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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021078."



Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: MALARONE
Applicant: GLAXOSMITHKLINE
Strength: 250MG;100MG
Application Number: N021078
Product Number: 001
Approval Date: Jul 14, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: MALARONE PEDIATRIC
Applicant: GLAXOSMITHKLINE
Strength: 62.5MG;25MG
Application Number: N021078
Product Number: 002
Approval Date: Jul 14, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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