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ACTIVE SUBSTANCE / INN

SITAGLIPTIN

Brand name(s): SITAGLIPTIN, Tesavel, Xelevia, ZITUVIMET, Januvia, ZITUVIMET XR, SITAGLIPTIN AND METFORMIN HYDROCHLORIDE, ZITUVIO, Ristaben, Sitagliptin Accord, SITAGLIPTIN; METFORMIN HYDROCHLORIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA202426
ANDA218441
ACTIVE SUBSTANCE
Sitagliptin
REGULATORS
FDA · EMA
SPONSORS / MAH
ZYDUS LIFESCIENCES, Merck Sharp & Dohme B.V., Merck Sharp and Dohme B.V
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SITAGLIPTIN; METFORMIN HYDROCHLORIDEANDA202426APOTEX INCNone (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDEANDA215220AJANTA PHARMA LTDNone (Tentative Approval)
ZITUVIONDA211566ZYDUS LIFESCIENCESPrescription
SITAGLIPTINANDA218441BIOCON PHARMA LTDNone (Tentative Approval)
ZITUVIMET XRNDA216778ZYDUS LIFESCIENCESPrescription
ZITUVIMETNDA216743ZYDUS LIFESCIENCESPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
XeleviaMerck Sharp & Dohme B.V.Authorised21/03/2007Diabetes Mellitus, Type 2
TesavelMerck Sharp & Dohme B.V.Authorised10/01/2008Diabetes Mellitus, Type 2
JanuviaMerck Sharp and Dohme B.VAuthorised20/03/2007Diabetes Mellitus, Type 2
RistabenMerck Sharp & Dohme B.V.Authorised15/03/2010Diabetes Mellitus, Type 2
Sitagliptin AccordAccord Healthcare S.L.U.Authorised25/04/2022Diabetes Mellitus, Type 2

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