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ACTIVE SUBSTANCE / INN

SAXAGLIPTIN

Brand name(s): DAPAGLIFLOZIN AND SAXAGLIPTIN, Onglyza, SAXAGLIPTIN, SAXAGLIPTIN;METFORMIN HYDROCHLORIDE
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Diabetes Mellitus, Type 2
ANDA211533
ACTIVE SUBSTANCE
Saxagliptin
REGULATORS
FDA · EMA
SPONSORS / MAH
MSN LABS PVT LTD, PAR PHARM, AMNEAL PHARMS
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SAXAGLIPTINANDA205959PAR PHARMNone (Tentative Approval)
SAXAGLIPTIN;METFORMIN HYDROCHLORIDEANDA205942AMNEAL PHARMSNone (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTINANDA211533MSN LABS PVT LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OnglyzaAstraZeneca ABAuthorised30/09/2009Diabetes Mellitus, Type 2

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