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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214518

200MG/20ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: TECOVIRIMAT
Proprietary Name: TPOXX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 200MG/20ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214518
Product Number: 001
Approval Date: May 18, 2022
Applicant Holder Full Name: SIGA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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