U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

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: 
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
Back to Top