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ACTIVE SUBSTANCE / INN

CANAGLIFLOZIN

Brand name(s): INVOKANA, INVOKAMET, CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE, Invokana, CANAGLIFLOZIN, INVOKAMET XR, CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA210297
NDA204353
ACTIVE SUBSTANCE
Canagliflozin
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, MACLEODS PHARMACEUTICALS LTD, ZYDUS PHARMS USA INC
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CANAGLIFLOZINANDA210297SANDOZ INCNone (Tentative Approval)
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDEANDA215255MACLEODS PHARMACEUTICALS LTDNone (Tentative Approval)
INVOKAMET XRNDA205879JANSSEN PHARMSPrescription
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDEANDA210542ZYDUS PHARMS USA INCNone (Tentative Approval)
INVOKAMETNDA204353JANSSEN PHARMSPrescription
INVOKANANDA204042JANSSEN PHARMSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
InvokanaJanssen-Cilag International NVAuthorised15/11/2013Diabetes Mellitus, Type 2

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