药品通用名或有效成分Drug Generic Name / Active ingredient |
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药品专利药名或商品名Drug Brand Name / Proprietary Name |
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药品注册申请号New Drug Application (NDA) Number |
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产品号Product Number |
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药物剂型或给药途径Dosage Form / Route of Administration |
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药品规格或剂量Strength |
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药品的市场状态Product Market Status |
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药品治疗等效性代码Therapeutic Equivalence (TE) Code |
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是否作为仿制药参比药物:Reference Listed Drug |
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药品注册申请机构Applicant |
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活性成分之化学类型Chemical Type |
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药品注册审评分类Review classification |
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药品是否为罕用药\孤儿药Orphan Drug |
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获得美国FDA批准日期Approval Date |
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