| NDC Code | 33342-406-07 |
|---|
| Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-07) |
|---|
| Product NDC | 33342-406 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
|---|
| Non-Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20260406 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA211559 |
|---|
| Manufacturer | Macleods Pharmaceuticals Limited |
|---|
| Substance Name | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
|---|
| Strength | 5; 500 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |
|---|