Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213036

Marketing Status: Prescription
Active Ingredient: ARTESUNATE
Proprietary Name: ARTESUNATE
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 110MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213036
Product Number: 001
Approval Date: May 26, 2020
Applicant Holder Full Name: AMIVAS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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