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XIGDUO XR (nda205649)- (2.5MG;1GM,5MG;500MG,5MG;1GM,10MG;500MG,10MG;1GM)

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB
2.5MG;1GM,5MG;500MG,5MG;1GM,10MG;500MG,10MG;1GM
Yes No
2031-May-12 2019-Jan-08
None None
None No
XIGDUO XR is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Dapagliflozin is indicated to reduce: • The risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. • The risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. • 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 4 0
Total Other Developers 26
Drugs with Suitability No
2.5MG;1GM ** ** Up - -
5MG;500MG ** ** Up - -
5MG;1GM ** ** Up - -
10MG;500MG ** ** Up - -
10MG;1GM ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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