| 药品名称 | HALCION | | 申请号 | 017892 | 产品号 | 001 | | 活性成分 | TRIAZOLAM | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.25MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1982/11/15 | 申请机构 | PHARMACIA AND UPJOHN 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 | | 017892 | 047 | AP | Label | 2014/09/22 | 下载 | | 017892 | 047 | AP | Letter | 2014/09/23 | 下载 | | 017892 | 038 | AP | Letter | 2008/02/14 | 下载 | | 017892 | 038 | AP | Label | 2008/02/14 | 下载 | | 017892 | 034 | AP | Letter | 2003/07/06 | 下载 | | 017892 | 034 | AP | Review | 2006/05/08 | 下载 | | 017892 | 000 | AP | Other Important Information from FDA | 2007/03/16 | 下载 | | 017892 | 000 | AP | Medication Guide | 2009/11/19 | 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 | | 017892 | 048 | AP | 2015/12/15 | Manufacturing Change or Addition | | 017892 | 047 | AP | 2014/09/18 | Labeling Revision | | 017892 | 045 | AP | 2014/01/21 | Manufacturing Change or Addition | | 017892 | 044 | AP | 2013/01/25 | Manufacturing Change or Addition | | 017892 | 038 | AP | 2008/02/12 | Labeling Revision | | 017892 | 035 | AP | 1999/11/04 | Package Change | | 017892 | 034 | AP | 2003/06/25 | Labeling Revision | | 017892 | 033 | AP | 1996/04/04 | Labeling Revision | | 017892 | 032 | AP | 1994/11/04 | Control Supplement | | 017892 | 031 | AP | 1994/07/13 | Manufacturing Change or Addition | | 017892 | 030 | AP | 1993/09/14 | Labeling Revision | | 017892 | 026 | AP | 1993/05/25 | Control Supplement | | 017892 | 024 | AP | 1992/02/21 | Package Change | | 017892 | 023 | AP | 1991/11/13 | Labeling Revision | | 017892 | 022 | AP | 1991/01/17 | Labeling Revision | | 017892 | 021 | AP | 1993/05/21 | Control Supplement | | 017892 | 019 | AP | 1990/08/16 | Labeling Revision | | 017892 | 018 | AP | 1990/08/16 | Labeling Revision | | 017892 | 017 | AP | 1990/08/16 | Labeling Revision | | 017892 | 016 | AP | 1989/03/20 | Labeling Revision | | 017892 | 015 | AP | 1988/05/06 | Labeling Revision | | 017892 | 014 | AP | 1988/05/05 | Labeling Revision | | 017892 | 013 | AP | 1988/07/26 | Manufacturing Change or Addition | | 017892 | 012 | AP | 1988/03/25 | Package Change | | 017892 | 011 | AP | 1987/10/23 | Labeling Revision | | 017892 | 010 | AP | 1987/10/23 | Labeling Revision | | 017892 | 009 | AP | 1988/08/24 | Control Supplement | | 017892 | 008 | AP | 1987/10/23 | Labeling Revision | | 017892 | 007 | AP | 1987/10/23 | Labeling Revision | | 017892 | 005 | AP | 1985/12/06 | Manufacturing Change or Addition | | 017892 | 004 | AP | 1985/04/26 | Labeling Revision | | 017892 | 002 | AP | 1987/10/23 | Labeling Revision | | 017892 | 001 | AP | 1985/04/26 | Formulation Revision | | 017892 | 000 | AP | 1982/11/15 | Approval |
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