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ACTIVE SUBSTANCE / INN

IBRUTINIB

Brand name(s): IBRUTINIB, Imbruvica, IMBRUVICA
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA214498
ANDA211344
ACTIVE SUBSTANCE
Ibrutinib
REGULATORS
FDA · EMA
SPONSORS / MAH
ZYDUS LIFESCIENCES, Janssen-Cilag International NV, ALVOGEN INC
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
IBRUTINIBANDA214498ALVOGEN INCNone (Tentative Approval)
IMBRUVICANDA205552PHARMACYCLICS LLCPrescription
IBRUTINIBANDA211344ZYDUS LIFESCIENCESDiscontinued
IMBRUVICANDA210563PHARMACYCLICS LLCDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ImbruvicaJanssen-Cilag International NVAuthorised21/10/2014Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, Chronic, B-Cell

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