| 药品名称 | DOBUTREX | | 申请号 | 017820 | 产品号 | 002 | | 活性成分 | DOBUTAMINE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 12.5MG BASE/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ELI LILLY AND CO
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
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| 与本品相关的市场独占权保护信息 | | 独占权代码 | 失效日期 | | 无 | | 历史市场独占权保护信息 | | 无 |
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| 与药品注册相关的信息 | | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | | 017820 | 037 | AP | Letter | 2002/07/23 | 下载 | | 017820 | 037 | AP | Review | 2002/07/23 | 下载 | | 017820 | 036 | AP | Review | 1998/07/29 | 下载 |
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| 药品注册审批历史信息 | | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | | 017820 | 037 | AP | 2002/07/23 | Labeling Revision | | 017820 | 036 | AP | 1998/07/29 | Labeling Revision | | 017820 | 034 | AP | 1997/01/08 | Control Supplement | | 017820 | 033 | AP | 1996/03/06 | Labeling Revision | | 017820 | 032 | AP | 1995/11/09 | Manufacturing Change or Addition | | 017820 | 031 | AP | 1996/01/11 | Control Supplement | | 017820 | 030 | AP | 1995/03/10 | Manufacturing Change or Addition | | 017820 | 029 | AP | 1995/03/30 | Labeling Revision | | 017820 | 027 | AP | 1994/04/20 | Labeling Revision | | 017820 | 026 | AP | 1993/02/09 | Control Supplement | | 017820 | 025 | AP | 1993/02/01 | Control Supplement | | 017820 | 024 | AP | 1990/12/20 | Labeling Revision | | 017820 | 023 | AP | 1991/04/26 | Labeling Revision | | 017820 | 022 | AP | 1989/12/07 | Labeling Revision | | 017820 | 021 | AP | 1989/04/18 | Labeling Revision | | 017820 | 020 | AP | 1989/06/23 | Labeling Revision | | 017820 | 019 | AP | 1988/04/21 | Labeling Revision | | 017820 | 018 | AP | 1987/05/27 | Labeling Revision | | 017820 | 017 | AP | 1987/01/21 | Control Supplement | | 017820 | 016 | AP | 1987/05/27 | Labeling Revision | | 017820 | 015 | AP | 1987/01/21 | Labeling Revision | | 017820 | 013 | AP | 1986/03/07 | Manufacturing Change or Addition | | 017820 | 011 | AP | 1986/03/07 | Control Supplement | | 017820 | 010 | AP | 1985/07/25 | Control Supplement | | 017820 | 008 | AP | 1983/06/24 | Formulation Revision | | 017820 | 007 | AP | 1982/02/24 | Control Supplement | | 017820 | 006 | AP | 1986/09/08 | Labeling Revision | | 017820 | 005 | AP | 1981/06/17 | Manufacturing Change or Addition | | 017820 | 004 | AP | 1981/02/03 | Control Supplement | | 017820 | 003 | AP | 1980/08/13 | Control Supplement | | 017820 | 002 | AP | 1978/09/12 | Expiration Date Change | | 017820 | 001 | AP | 1978/09/12 | Labeling Revision | | 017820 | 000 | AP | 1978/07/18 | Approval |
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