Application Nr Approved Date Route Status External Links
NDA212614 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Trijardy Xr Is A Combination Of Empagliflozin, Linagliptin, And Metformin Hydrochloride (Hcl) Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus . Empagliflozin Is Indicated To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease [See Clinical Studies (14.2) ] . Trijardy Xr Is A Combination Of Empagliflozin, A Sodium-Glucose Co-Transporter 2 (Sglt2) Inhibitor, Linagliptin, A Dipeptidyl Peptidase-4 (Dpp-4) Inhibitor, And Metformin Hydrochloride (Hcl), A Biguanide, Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Empagliflozin Is Indicated To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease. ( 1 ) Limitations Of Use Not Recommended For 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 Trijardy Xr Is Not Recommended For Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis [See Warnings And Precautions (5.5) ] . Trijardy Xr 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 Trijardy Xr [See Warnings And Precautions (5.2) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 3 Total)

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