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ACTIVE SUBSTANCE / INN

PALBOCICLIB

Brand name(s): PALBOCICLIB CAPSULES, PALBOCICLIB, Ibrance, IBRANCE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Breast Neoplasms
ANDA213086
ACTIVE SUBSTANCE
Palbociclib
REGULATORS
FDA · EMA
SPONSORS / MAH
ZYDUS LIFESCIENCES, Pfizer Europe MA EEIG, EUGIA PHARMA SPECLTS
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PALBOCICLIBANDA215570ZYDUS LIFESCIENCESDiscontinued
IBRANCENDA212436PFIZERPrescription
PALBOCICLIBANDA213086EUGIA PHARMA SPECLTSNone (Tentative Approval)
PALBOCICLIB CAPSULESANDA217365CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.None (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
IbrancePfizer Europe MA EEIGAuthorised09/11/2016Breast Neoplasms

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