| 药品名称 | VERSED | | 申请号 | 018654 | 产品号 | 001 | | 活性成分 | MIDAZOLAM HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 5MG BASE/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1985/12/20 | 申请机构 | HLR TECHNOLOGY
| | 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 | | 018654 | 030 | AP | Review | 1997/11/20 | 下载 | | 018654 | 029 | AP | Review | 1997/11/20 | 下载 | | 018654 | 018 | AP | Review | 1997/11/20 | 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 | | 018654 | 038 | AP | 2001/09/04 | Labeling Revision | | 018654 | 037 | AP | 1999/12/20 | Control Supplement | | 018654 | 036 | AP | 1998/08/25 | Labeling Revision | | 018654 | 033 | AP | 1998/12/17 | Control Supplement | | 018654 | 032 | AP | 1998/10/23 | Control Supplement | | 018654 | 031 | AP | 1998/05/11 | Manufacturing Change or Addition | | 018654 | 030 | AP | 1997/03/18 | New Dosage Regimen | | 018654 | 029 | AP | 1996/12/31 | New Dosage Regimen | | 018654 | 028 | AP | 1999/02/19 | Labeling Revision | | 018654 | 027 | AP | 1994/04/26 | New or Modified Indication | | 018654 | 026 | AP | 1995/07/06 | Manufacturing Change or Addition | | 018654 | 025 | AP | 1993/07/22 | Control Supplement | | 018654 | 024 | AP | 1999/02/19 | Labeling Revision | | 018654 | 023 | AP | 1993/02/26 | Control Supplement | | 018654 | 022 | AP | 1993/02/26 | Control Supplement | | 018654 | 021 | AP | 1993/03/12 | Manufacturing Change or Addition | | 018654 | 020 | AP | 1991/09/19 | Labeling Revision | | 018654 | 018 | AP | 1996/12/31 | Labeling Revision | | 018654 | 017 | AP | 1990/10/04 | Manufacturing Change or Addition | | 018654 | 016 | AP | 1990/10/04 | Manufacturing Change or Addition | | 018654 | 015 | AP | 1991/09/19 | Labeling Revision | | 018654 | 014 | AP | 1989/09/29 | Control Supplement | | 018654 | 012 | AP | 1988/02/25 | Labeling Revision | | 018654 | 011 | AP | 1987/08/20 | Control Supplement | | 018654 | 010 | AP | 1987/05/26 | Control Supplement | | 018654 | 009 | AP | 1987/05/26 | Labeling Revision | | 018654 | 008 | AP | 1987/02/25 | Labeling Revision | | 018654 | 005 | AP | 1988/10/17 | Labeling Revision | | 018654 | 004 | AP | 1986/05/28 | Control Supplement | | 018654 | 001 | AP | 1986/05/28 | Manufacturing Change or Addition | | 018654 | 000 | AP | 1985/12/20 | Approval |
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