| NDC Code | 52958-034-01 |
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| Package Description | 10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
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| Product NDC | 52958-034 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Bivalirudin |
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| Non-Proprietary Name | Bivalirudin |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20191023 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA210031 |
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| Manufacturer | Hainan Shuangcheng Pharmaceuticals Co., Ltd. |
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| Substance Name | BIVALIRUDIN |
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| Strength | 250 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
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