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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021290

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TRACLEER (BOSENTAN)
62.5MG
Marketing Status: Prescription
Active Ingredient: BOSENTAN
Proprietary Name: TRACLEER
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 62.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021290
Product Number: 001
Approval Date: Nov 20, 2001
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRACLEER (BOSENTAN)
125MG
Marketing Status: Prescription
Active Ingredient: BOSENTAN
Proprietary Name: TRACLEER
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021290
Product Number: 002
Approval Date: Nov 20, 2001
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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