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Details for New Drug Application (NDA): 205552

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NDA 205552 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the IMBRUVICA profile page.

The generic ingredient in IMBRUVICA is ibrutinib. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

Summary for NDA: 205552

Tradename:
IMBRUVICA
Applicant:
Pharmacyclics Inc
Ingredient:
ibrutinib
Patents:14
Formulation / Manufacturing:see details

Pharmacology for NDA: 205552

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 205552

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA
ibrutinib
CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-140 57962-140-09 90 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09)
IMBRUVICA
ibrutinib
CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-140 57962-140-12 120 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG
Approval Date:Nov 13, 2013TE:RLD:Yes
Patent:7,514,444Patent Expiration:Dec 28, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:8,008,309Patent Expiration:Dec 28, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:8,697,711Patent Expiration:Dec 28, 2026Product Flag?YSubstance Flag?YDelist Request?


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