ACTIVE SUBSTANCE / INN

LINAGLIPTIN

Brand name(s): JENTADUETO XR, LINAGLIPTIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN AND LINAGLIPTIN, GLYXAMBI, TRIJARDY XR, EMPAGLIFLOZIN; LINAGLIPTIN, LINAGLIPTIN, EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE, JENTADUETO, LINAGLIPTIN; METFORMIN HYDROCHLORIDE, Trajenta
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA212366
ANDA208430
ACTIVE SUBSTANCE
Linagliptin
REGULATORS
FDA · EMA
SPONSORS / MAH
BOEHRINGER INGELHEIM, MSN LABS PVT LTD, ZYDUS PHARMS USA INC
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
JENTADUETONDA201281BOEHRINGER INGELHEIMPrescription
GLYXAMBINDA206073BOEHRINGER INGELHEIMPrescription
LINAGLIPTINANDA208415AUROBINDO PHARMA LTDPrescription
TRIJARDY XRNDA212614BOEHRINGER INGELHEIMPrescription
EMPAGLIFLOZIN AND LINAGLIPTINANDA212359MSN LABS PVT LTDNone (Tentative Approval)
LINAGLIPTIN; METFORMIN HYDROCHLORIDEANDA208430MYLAN PHARMS INCNone (Tentative Approval)
JENTADUETO XRNDA208026BOEHRINGER INGELHEIMPrescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDEANDA208459MSNPrescription
EMPAGLIFLOZIN; LINAGLIPTINANDA212366ALKEM LABS LTDNone (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDEANDA217049ZYDUS PHARMS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TrajentaBoehringer Ingelheim International GmbHAuthorised23/08/2011Diabetes Mellitus, Type 2

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