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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217003

Marketing Status: Prescription
Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 70MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217003
Product Number: 001
Approval Date: Aug 24, 2022
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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