Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205552

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IMBRUVICA (IBRUTINIB)
70MG
Marketing Status: Prescription

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 70MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205552
Product Number: 002
Approval Date: Dec 20, 2017
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information