| 药品名称 | DOPRAM | | 申请号 | 014879 | 产品号 | 001 | | 活性成分 | DOXAPRAM HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 20MG/ML | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard 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 | | 014879 | 044 | AP | Letter | 2005/03/23 | 下载 | | 014879 | 044 | AP | Label | 2005/03/23 | 下载 | | 014879 | 044 | AP | Review | 2007/07/09 | 下载 | | 014879 | 040 | AP | Letter | 2004/04/20 | 下载 | | 014879 | 040 | AP | Label | 2004/05/03 | 下载 | | 014879 | 037 | AP | Letter | 2006/04/05 | 下载 | | 014879 | 036 | AP | Letter | 2001/08/23 | 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 | | 014879 | 044 | AP | 2005/03/17 | Labeling Revision | | 014879 | 040 | AP | 2004/04/16 | Labeling Revision | | 014879 | 037 | AP | 2006/03/29 | Labeling Revision | | 014879 | 036 | AP | 2001/08/23 | Labeling Revision | | 014879 | 035 | AP | 1998/02/13 | Manufacturing Change or Addition | | 014879 | 034 | AP | 1989/01/13 | Control Supplement | | 014879 | 033 | AP | 1988/05/31 | Control Supplement | | 014879 | 031 | AP | 1987/01/14 | Labeling Revision | | 014879 | 030 | AP | 1987/01/14 | Labeling Revision | | 014879 | 029 | AP | 1986/06/18 | Control Supplement | | 014879 | 028 | AP | 1986/07/24 | Control Supplement | | 014879 | 027 | AP | 1984/05/16 | Control Supplement | | 014879 | 026 | AP | 1983/03/02 | Control Supplement | | 014879 | 025 | AP | 1985/09/17 | Practioner Draft Labeling | | 014879 | 024 | AP | 1982/03/04 | Manufacturing Change or Addition | | 014879 | 023 | AP | 1982/08/06 | Labeling Revision | | 014879 | 022 | AP | 1982/08/06 | Other Amendment | | 014879 | 021 | AP | 1982/08/06 | Labeling Revision | | 014879 | 020 | AP | 1982/08/06 | Control Supplement | | 014879 | 019 | AP | 1981/09/24 | Control Supplement | | 014879 | 018 | AP | 1980/02/15 | Control Supplement | | 014879 | 017 | AP | 1978/11/30 | Control Supplement | | 014879 | 016 | AP | 1978/11/27 | Labeling Revision | | 014879 | 015 | AP | 1979/02/15 | Labeling Revision | | 014879 | 014 | AP | 1979/02/15 | Manufacturing Change or Addition | | 014879 | 013 | AP | 1977/06/20 | Manufacturing Change or Addition | | 014879 | 012 | AP | 1977/04/06 | Control Supplement | | 014879 | 010 | AP | 1976/05/03 | Control Supplement | | 014879 | 009 | AP | 1979/09/11 | Control Supplement | | 014879 | 008 | AP | 1976/11/01 | Control Supplement | | 014879 | 007 | AP | 1976/04/05 | Labeling Revision | | 014879 | 000 | AP | 1965/06/23 | Approval |
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