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ACTIVE SUBSTANCE / INN

ABEMACICLIB

Brand name(s): VERZENIO, ABEMACICLIB, Verzenios
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA220238
NDA208716
ACTIVE SUBSTANCE
Abemaciclib
REGULATORS
FDA · EMA
SPONSORS / MAH
QILU PHARMACEUTICAL CO., LTD., Eli Lilly Nederland B.V., ELI LILLY AND CO
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
VERZENIONDA208716ELI LILLY AND COPrescription
ABEMACICLIBANDA220238QILU PHARMACEUTICAL CO., LTD.None (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
VerzeniosEli Lilly Nederland B.V.Authorised26/09/2018Breast Neoplasms

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