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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213217

BRUKINSA (ZANUBRUTINIB)
80MG
Marketing Status: Prescription
Active Ingredient: ZANUBRUTINIB
Proprietary Name: BRUKINSA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213217
Product Number: 001
Approval Date: Nov 14, 2019
Applicant Holder Full Name: BEIGENE USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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