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ACTIVE SUBSTANCE / INN

REPAGLINIDE

Brand name(s): Repaglinide Teva, Repaglinide Sun, REPAGLINIDE, Prandin, NovoNorm, PRANDIN, REPAGLINIDE AND METFORMIN HYDROCHLORIDE, Enyglid, PRANDIMET, Repaglinide Krka, Repaglinide Accord
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
NDA020741
NDA022386
ACTIVE SUBSTANCE
Repaglinide
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, Krka, d.d., Novo mesto, Novo Nordisk A/S
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
REPAGLINIDEANDA078555CHARTWELL RXPrescription
REPAGLINIDEANDA090252QUAGENDiscontinued
REPAGLINIDEANDA077571SUN PHARM INDS INCNone (Tentative Approval)
PRANDIMETNDA022386NOVO NORDISK INCDiscontinued
PRANDINNDA020741GEMINI LABS LLCDiscontinued
REPAGLINIDE AND METFORMIN HYDROCHLORIDEANDA200624LUPIN LTDDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Repaglinide TevaTeva Pharma B.V.Authorised28/06/2009Diabetes Mellitus, Type 2
EnyglidKrka, d.d., Novo mestoAuthorised13/10/2009Diabetes Mellitus, Type 2
Repaglinide KrkaKrka, d.d., Novo mestoAuthorised03/11/2009Diabetes Mellitus, Type 2
Repaglinide AccordAccord Healthcare S.L.U.Authorised22/12/2011Diabetes Mellitus, Type 2
PrandinNovo Nordisk A/SAuthorised29/01/2001Diabetes Mellitus, Type 2
NovoNormNovo Nordisk A/SAuthorised16/08/1998Diabetes Mellitus, Type 2
Repaglinide SunSun Pharmaceutical Industries B.V.Application withdrawnDiabetes Mellitus, Type 2

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