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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204410

OPSUMIT (MACITENTAN)
10MG
Marketing Status: Prescription
Active Ingredient: MACITENTAN
Proprietary Name: OPSUMIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N204410
Product Number: 001
Approval Date: Oct 18, 2013
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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