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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217686

TRYVIO (APROCITENTAN)
12.5MG
Marketing Status: Prescription
Active Ingredient: APROCITENTAN
Proprietary Name: TRYVIO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217686
Product Number: 001
Approval Date: Mar 19, 2024
Applicant Holder Full Name: IDORSIA PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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