| NDC Code | 33342-409-06 |
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| Package Description | 3 BLISTER PACK in 1 CARTON (33342-409-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-409-66) |
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| Product NDC | 33342-409 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
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| Non-Proprietary Name | Dapagliflozin And Metformin Hydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20260406 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA211559 |
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| Manufacturer | Macleods Pharmaceuticals Limited |
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| Substance Name | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
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| Strength | 10; 1000 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |
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