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FARXIGA (nda202293)- (5MG,10MG)

DAPAGLIFLOZIN ASTRAZENECA AB
5MG,10MG
Yes No
2030-Nov-26 Expired
None None
None No
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV). • to reduce the risk of sustained eGFR decline, end stage kidney disease cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
0 18 0
Total Other Developers 29
Drugs with Suitability No
5MG ** ** Up - -
10MG ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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