Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209279

TRACLEER (BOSENTAN)
32MG Marketing Status: Prescription

Active Ingredient: BOSENTAN
Proprietary Name: TRACLEER
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 32MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209279
Product Number: 001
Approval Date: Sep 5, 2017
Applicant Holder Full Name: ACTELION PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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