| 药品名称 | PRIMATENE MIST | | 申请号 | 016126 | 产品号 | 001 | | 活性成分 | EPINEPHRINE | 市场状态 | 停止上市 | | 剂型或给药途径 | AEROSOL, METERED;INHALATION | 规格 | 0.2MG/INH | | 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 | WYETH CONSUMER HEALTHCARE
| | 化学类型 | New formulation or new manufacturer | 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 | | 016126 | 029 | AP | Review | 2007/07/06 | 下载 | | 016126 | 028 | AP | Review | 2007/07/06 | 下载 | | 016126 | 027 | AP | Review | 2007/07/06 | 下载 | | 016126 | 025 | AP | Review | 2007/07/06 | 下载 | | 016126 | 025 | AP | Letter | 2001/08/30 | 下载 | | 016126 | 025 | AP | Label | 2003/06/10 | 下载 | | 016126 | 024 | AP | Review | 2007/07/06 | 下载 | | 016126 | 023 | AP | Review | 2007/07/06 | 下载 | | 016126 | 020 | AP | Review | 2007/07/06 | 下载 | | 016126 | 017 | AP | Review | 2007/07/06 | 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 | | 016126 | 029 | AP | 2004/01/15 | Supplement | | 016126 | 028 | AP | 2004/01/13 | Supplement | | 016126 | 027 | AP | 2002/01/25 | Control Supplement | | 016126 | 025 | AP | 2001/08/30 | Labeling Revision | | 016126 | 024 | AP | 1999/11/24 | Manufacturing Change or Addition | | 016126 | 023 | AP | 1999/11/24 | Control Supplement | | 016126 | 021 | AP | 1998/05/01 | Manufacturing Change or Addition | | 016126 | 020 | AP | 1999/11/24 | Manufacturing Change or Addition | | 016126 | 018 | AP | 1995/11/17 | Manufacturing Change or Addition | | 016126 | 017 | AP | 1999/12/01 | Control Supplement | | 016126 | 016 | AP | 1996/01/19 | Control Supplement | | 016126 | 013 | AP | 1993/10/22 | Manufacturing Change or Addition | | 016126 | 012 | AP | 1991/08/09 | Manufacturing Change or Addition | | 016126 | 011 | AP | 1994/03/24 | Labeling Revision | | 016126 | 010 | AP | 1994/03/24 | Labeling Revision | | 016126 | 009 | AP | 1994/03/24 | Labeling Revision | | 016126 | 008 | AP | 1988/04/22 | Labeling Revision | | 016126 | 007 | AP | 1988/05/19 | Labeling Revision | | 016126 | 005 | AP | 1980/10/03 | Labeling Revision | | 016126 | 004 | AP | 1977/05/25 | Manufacturing Change or Addition | | 016126 | 003 | AP | 1980/10/03 | Labeling Revision | | 016126 | 000 | AP | 1967/11/08 | Approval |
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