| NDC Code | 0597-0300-20 |
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| Package Description | 1 BOTTLE in 1 CARTON (0597-0300-20) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE |
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| Product NDC | 0597-0300 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Synjardy |
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| Proprietary Name Suffix | Xr |
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| Non-Proprietary Name | Empagliflozin, Metformin Hydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20161210 |
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| Marketing Category Name | NDA |
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| Application Number | NDA208658 |
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| Manufacturer | Boehringer Ingelheim Pharmaceuticals, Inc. |
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| Substance Name | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
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| Strength | 12.5; 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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