药品名称 | MODURETIC 5-50 | 申请号 | 018201 | 产品号 | 001 | 活性成分 | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 5MG ANHYDROUS;50MG | 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 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| 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 | 018201 | 040 | AP | Letter | 2003/03/10 | 下载 | 018201 | 037 | AP | Letter | 2002/03/21 | 下载 | 018201 | 037 | AP | Label | 2002/03/21 | 下载 | 018201 | 037 | AP | Review | 2002/05/30 | 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 | 018201 | 040 | AP | 2003/02/25 | Labeling Revision | 018201 | 039 | AP | 2002/06/24 | Manufacturing Change or Addition | 018201 | 038 | AP | 2002/04/05 | Manufacturing Change or Addition | 018201 | 037 | AP | 2002/03/21 | Labeling Revision | 018201 | 036 | AP | 2001/09/18 | Labeling Revision | 018201 | 035 | AP | 1998/02/12 | Control Supplement | 018201 | 034 | AP | 1998/08/24 | Labeling Revision | 018201 | 033 | AP | 1995/11/29 | Manufacturing Change or Addition | 018201 | 032 | AP | 1993/12/09 | Labeling Revision | 018201 | 031 | AP | 1992/10/01 | Labeling Revision | 018201 | 030 | AP | 1992/09/17 | Labeling Revision | 018201 | 029 | AP | 1992/03/26 | Control Supplement | 018201 | 026 | AP | 1991/05/14 | Control Supplement | 018201 | 025 | AP | 1989/04/12 | Labeling Revision | 018201 | 024 | AP | 1988/03/29 | Manufacturing Change or Addition | 018201 | 023 | AP | 1988/04/21 | Manufacturing Change or Addition | 018201 | 022 | AP | 1987/07/10 | Package Change | 018201 | 021 | AP | 1987/06/01 | Manufacturing Change or Addition | 018201 | 020 | AP | 1987/03/09 | Control Supplement | 018201 | 019 | AP | 1987/08/26 | Labeling Revision | 018201 | 018 | AP | 1988/08/15 | Control Supplement | 018201 | 017 | AP | 1986/01/21 | Labeling Revision | 018201 | 016 | AP | 1985/11/01 | Labeling Revision | 018201 | 015 | AP | 1988/05/05 | Labeling Revision | 018201 | 014 | AP | 1985/09/10 | Control Supplement | 018201 | 013 | AP | 1985/06/14 | Labeling Revision | 018201 | 012 | AP | 1986/07/16 | Labeling Revision | 018201 | 011 | AP | 1985/02/07 | Labeling Revision | 018201 | 010 | AP | 1984/08/28 | Labeling Revision | 018201 | 009 | AP | 1984/04/19 | Labeling Revision | 018201 | 007 | AP | 1984/01/04 | Formulation Revision | 018201 | 006 | AP | 1983/12/23 | Manufacturing Change or Addition | 018201 | 005 | AP | 1983/03/01 | Package Change | 018201 | 004 | AP | 1982/07/08 | Package Change | 018201 | 003 | AP | 1982/06/04 | Control Supplement | 018201 | 002 | AP | 1982/03/03 | Manufacturing Change or Addition | 018201 | 001 | AP | 1982/02/08 | Control Supplement | 018201 | 000 | AP | 1981/10/05 | Approval |
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