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ACTIVE SUBSTANCE / INN

INSULIN GLARGINE

Brand name(s): Abasaglar (previously Abasria), Ondibta, BASAGLAR, SEMGLEE, SOLIQUA 100/33, Semglee, Lusduna, Lantus, Toujeo (previously Optisulin)
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
AUTHORISED
BLA205692
BLA210605
ACTIVE SUBSTANCE
Insulin Glargine
REGULATORS
FDA · EMA
SPONSORS / MAH
ELI LILLY AND CO, Sanofi-aventis Deutschland GmbH, Merck Sharp & Dohme B.V.
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SEMGLEEBLA210605MYLAN PHARMS INCPrescription
SOLIQUA 100/33BLA208673SANOFI-AVENTIS USPrescription
BASAGLARBLA205692ELI LILLY AND COPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Toujeo (previously Optisulin)Sanofi-aventis Deutschland GmbHAuthorised26/06/2000Diabetes Mellitus
Lantussanofi-aventis Deutschland GmbHAuthorised09/06/2000Diabetes Mellitus
SemgleeBiosimilar Collaborations Ireland LimitedAuthorised23/03/2018Diabetes Mellitus
Abasaglar (previously Abasria)Eli Lilly Nederland B.V.Authorised09/09/2014Diabetes Mellitus
OndibtaGan & Lee Pharmaceuticals Europe GmbHOpinionDiabetes Mellitus
LusdunaMerck Sharp & Dohme B.V.Withdrawn03/01/2017Diabetes Mellitus

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