Application Nr Approved Date Route Status External Links
NDA202293 2014-01-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Farxiga (dapagliflozin) Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [see Clinical Studies (14)]. Farxiga Is A Sodium-Glucose Cotransporter 2 (sglt2) Inhibitor Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. (1) Limitation Of Use: •not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. (1.1) 1.1 Limitation Of Use Farxiga Is Not Recommended For Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dapagliflozin Propanediol

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