Application Nr Approved Date Route Status External Links
NDA201280 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tradjenta Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [See Clinical Studies (14.1) ]. Tradjenta Is A Dipeptidyl Peptidase-4 (Dpp-4) Inhibitor Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus ( 1 ) Limitations Of Use Should Not Be Used In Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis ( 1 ) Has Not Been Studied In Patients With A History Of Pancreatitis ( 1 ) Limitations Of Use Tradjenta Should Not Be Used In Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Tradjenta Has Not Been Studied In Patients With A History Of Pancreatitis. It Is Unknown Whether Patients With A History Of Pancreatitis Are At An Increased Risk For The Development Of Pancreatitis While Using Tradjenta [See Warnings And Precautions (5.1) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Linagliptin LINAGLIPTIN ZINC3820029

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