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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208383

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BEVYXXA (BETRIXABAN)
40MG
Marketing Status: Discontinued
Active Ingredient: BETRIXABAN
Proprietary Name: BEVYXXA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208383
Product Number: 001
Approval Date: Jun 23, 2017
Applicant Holder Full Name: PORTOLA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
BEVYXXA (BETRIXABAN)
80MG
Marketing Status: Discontinued
Active Ingredient: BETRIXABAN
Proprietary Name: BEVYXXA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208383
Product Number: 002
Approval Date: Jun 23, 2017
Applicant Holder Full Name: PORTOLA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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