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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022268

COARTEM (ARTEMETHER; LUMEFANTRINE)
20MG;120MG
Marketing Status: Prescription
Active Ingredient: ARTEMETHER; LUMEFANTRINE
Proprietary Name: COARTEM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022268
Product Number: 001
Approval Date: Apr 7, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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