Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205552

IMBRUVICA (IBRUTINIB)
140MG Marketing Status: Prescription

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 140MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205552
Product Number: 001
Approval Date: Nov 13, 2013
Applicant Holder Full Name: PHARMACYCLICS INC
Marketing Status:  Prescription
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