Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210563

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IMBRUVICA (IBRUTINIB)
140MG
Marketing Status: Prescription

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 140MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210563
Product Number: 001
Approval Date: Feb 16, 2018
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

IMBRUVICA (IBRUTINIB)
280MG
Marketing Status: Prescription

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 280MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210563
Product Number: 002
Approval Date: Feb 16, 2018
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

IMBRUVICA (IBRUTINIB)
420MG
Marketing Status: Prescription

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 420MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210563
Product Number: 003
Approval Date: Feb 16, 2018
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

IMBRUVICA (IBRUTINIB)
560MG
Marketing Status: Discontinued

Active Ingredient: IBRUTINIB
Proprietary Name: IMBRUVICA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 560MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210563
Product Number: 004
Approval Date: Feb 16, 2018
Applicant Holder Full Name: PHARMACYCLICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information