Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208627

Marketing Status: Prescription
Active Ingredient: TECOVIRIMAT
Proprietary Name: TPOXX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208627
Product Number: 001
Approval Date: Jul 13, 2018
Applicant Holder Full Name: SIGA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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