DAPAGLIFLOZIN AND SAXAGLIPTIN
Drug Details
- Generic Name
- DAPAGLIFLOZIN AND SAXAGLIPTIN
- Brand Names
- DAPAGLIFLOZIN AND SAXAGLIPTIN
- Application Number
- ANDA211533
- Sponsor
- Novadoz Pharmaceuticals LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- DAPAGLIFLOZIN, SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS (5.1) ]. Dapagliflozin and saxagliptin tablets is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor and saxagliptin a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )