Application Nr Approved Date Route Status External Links
NDA200678 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Kombiglyze Xr Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus When Treatment With Both Saxagliptin And Metformin Is Appropriate [ See Clinical Studies (14) ]. Kombiglyze Xr Is A Combination Of Saxagliptin, A Dipeptidyl Peptidase-4 (Dpp4) Inhibitor, And Metformin, 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 Saxagliptin And Metformin Is Appropriate. (1 , 14) Limitations Of Use: • Not Used For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. (1.1) 1.1 Limitations Of Use Kombiglyze Xr Is Not Indicated For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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