药品名称 | CAPOZIDE 50/15 | 申请号 | 018709 | 产品号 | 004 | 活性成分 | CAPTOPRIL; HYDROCHLOROTHIAZIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1984/10/12 | 申请机构 | APOTHECON INC DIV BRISTOL MYERS SQUIBB
| 化学类型 | New combination | 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 | 018709 | 035 | AP | Letter | 2009/03/03 | 下载 | 018709 | 033 | AP | Letter | 2006/05/21 | 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 | 018709 | 035 | AP | 2009/02/26 | Labeling Revision | 018709 | 033 | AP | 2006/05/16 | Labeling Revision | 018709 | 031 | AP | 1997/05/20 | Control Supplement | 018709 | 030 | AP | 1998/06/03 | Labeling Revision | 018709 | 029 | AP | 1996/06/26 | Manufacturing Change or Addition | 018709 | 028 | AP | 1996/03/04 | Control Supplement | 018709 | 027 | AP | 1996/07/31 | Labeling Revision | 018709 | 026 | AP | 1996/07/31 | Labeling Revision | 018709 | 025 | AP | 1995/10/06 | Manufacturing Change or Addition | 018709 | 024 | AP | 1993/05/12 | Package Change | 018709 | 023 | AP | 1992/10/15 | Labeling Revision | 018709 | 022 | AP | 1992/06/25 | Labeling Revision | 018709 | 021 | AP | 1994/07/25 | Labeling Revision | 018709 | 020 | AP | 1992/03/05 | Package Change | 018709 | 019 | AP | 1991/12/10 | Manufacturing Change or Addition | 018709 | 018 | AP | 1990/09/05 | Package Change | 018709 | 017 | AP | 1991/03/21 | Labeling Revision | 018709 | 016 | AP | 1990/09/27 | Labeling Revision | 018709 | 015 | AP | 1989/05/03 | Labeling Revision | 018709 | 014 | AP | 1989/10/19 | Labeling Revision | 018709 | 012 | AP | 1988/06/22 | Labeling Revision | 018709 | 011 | AP | 1987/10/06 | Control Supplement | 018709 | 010 | AP | 1987/01/06 | Package Change | 018709 | 009 | AP | 1991/10/24 | New or Modified Indication | 018709 | 008 | AP | 1986/01/17 | Labeling Revision | 018709 | 007 | AP | 1985/08/02 | Labeling Revision | 018709 | 006 | AP | 1985/07/15 | Package Change | 018709 | 005 | AP | 1986/11/10 | Control Supplement | 018709 | 004 | AP | 1985/07/03 | Package Change | 018709 | 003 | AP | 1985/08/01 | Package Change | 018709 | 002 | AP | 1985/02/07 | Package Change | 018709 | 001 | AP | 1984/11/20 | Control Supplement | 018709 | 000 | AP | 1984/10/12 | Approval |
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