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ACTIVE SUBSTANCE / INN

EMPAGLIFLOZIN

Brand name(s): Jardiance, EMPAGLIFLOZIN AND LINAGLIPTIN, GLYXAMBI, EMPAGLIFLOZIN, EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE, TRIJARDY XR, EMPAGLIFLOZIN; LINAGLIPTIN, SYNJARDY, JARDIANCE, EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA213654
ANDA212138
ACTIVE SUBSTANCE
Empagliflozin
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, CIPLA LTD, BOEHRINGER INGELHEIM
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
GLYXAMBINDA206073BOEHRINGER INGELHEIMPrescription
EMPAGLIFLOZINANDA212365ANNORA PHARMANone (Tentative Approval)
TRIJARDY XRNDA212614BOEHRINGER INGELHEIMPrescription
EMPAGLIFLOZIN AND LINAGLIPTINANDA212359MSN LABS PVT LTDNone (Tentative Approval)
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDEANDA213654LUPIN LTDNone (Tentative Approval)
EMPAGLIFLOZINANDA212138ZYDUS PHARMSDiscontinued
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDEANDA212243CIPLA LTDNone (Tentative Approval)
JARDIANCENDA204629BOEHRINGER INGELHEIMPrescription
EMPAGLIFLOZIN; LINAGLIPTINANDA212366ALKEM LABS LTDNone (Tentative Approval)
SYNJARDYNDA206111BOEHRINGER INGELHEIMPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
JardianceBoehringer Ingelheim International GmbHAuthorised22/05/2014Diabetes Mellitus, Type 2;Heart Failure;Renal Insufficiency, Chronic

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