Application Nr Approved Date Route Status External Links
NDA208658 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Synjardy Xr Is A Combination Of Empagliflozin And Metformin Hydrochloride Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus When Treatment With Both Empagliflozin And Metformin Hydrochloride Is Appropriate . 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) ] . However, The Effectiveness Of Synjardy Xr On Reducing The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Cardiovascular Disease Has Not Been Established. Synjardy Xr Is A Combination Of Empagliflozin, A Sodium-Glucose Co-Transporter 2 (Sglt2) Inhibitor And Metformin Hydrochloride, A Biguanide, Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus When Treatment With Both Empagliflozin And Metformin Hydrochloride Is Appropriate. Empagliflozin Is Indicated To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Established Cardiovascular Disease. However, The Effectiveness Of Synjardy Xr On Reducing The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes Mellitus And Cardiovascular Disease Has Not Been Established. ( 1 ) Limitations Of Use : Not For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis ( 1 ) Limitations Of Use Synjardy Xr Is Not Recommended For Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis [See Warnings And Precautions (5.3) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Comments