| NDC Code | 59368-381-01 |
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| Package Description | 1 BOTTLE in 1 CARTON (59368-381-01) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
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| Product NDC | 59368-381 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Jentadueto Xr |
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| Non-Proprietary Name | Linagliptin And Metformin Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20160527 |
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| Marketing Category Name | NDA |
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| Application Number | NDA208026 |
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| Manufacturer | Praxis, LLC |
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| Substance Name | LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
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| Strength | 5; 1000 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |
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