| 药品名称 | TAGAMET | | 申请号 | 017924 | 产品号 | 001 | | 活性成分 | CIMETIDINE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | SOLUTION;ORAL | 规格 | EQ 300MG BASE/5ML | | 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 | GLAXOSMITHKLINE
| | 化学类型 | New active ingredient | 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 | | 无 |
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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 | | 017924 | 059 | AP | 1997/04/15 | Control Supplement | | 017924 | 058 | AP | 1995/02/22 | Labeling Revision | | 017924 | 057 | AP | 1993/11/10 | Manufacturing Change or Addition | | 017924 | 056 | AP | 1993/06/08 | Manufacturing Change or Addition | | 017924 | 054 | AP | 1992/07/16 | Control Supplement | | 017924 | 053 | AP | 1992/01/07 | Labeling Revision | | 017924 | 052 | AP | 1992/08/27 | Control Supplement | | 017924 | 050 | AP | 1991/11/13 | Labeling Revision | | 017924 | 049 | AP | 1989/11/13 | Labeling Revision | | 017924 | 047 | AP | 1990/05/30 | Control Supplement | | 017924 | 046 | AP | 1991/03/07 | Labeling Revision | | 017924 | 045 | AP | 1989/06/26 | Labeling Revision | | 017924 | 044 | AP | 1989/06/26 | Labeling Revision | | 017924 | 042 | AP | 1988/06/15 | Labeling Revision | | 017924 | 041 | AP | 1988/05/20 | Labeling Revision | | 017924 | 040 | AP | 1988/03/31 | New Dosage Regimen | | 017924 | 038 | AP | 1986/04/23 | Labeling Revision | | 017924 | 037 | AP | 1986/01/13 | Labeling Revision | | 017924 | 036 | AP | 1985/05/15 | Labeling Revision | | 017924 | 035 | AP | 1985/04/18 | Labeling Revision | | 017924 | 034 | AP | 1985/02/07 | Labeling Revision | | 017924 | 033 | AP | 1986/04/29 | New Dosage Regimen | | 017924 | 032 | AP | 1984/06/14 | Labeling Revision | | 017924 | 031 | AP | 1984/07/19 | Labeling Revision | | 017924 | 030 | AP | 1984/12/05 | Package Change | | 017924 | 029 | AP | 1984/03/05 | Labeling Revision | | 017924 | 027 | AP | 1984/07/19 | Labeling Revision | | 017924 | 025 | AP | 1983/02/28 | Labeling Revision | | 017924 | 024 | AP | 1983/01/31 | General Efficacy (MarkIV) | | 017924 | 023 | AP | 1983/03/11 | Manufacturing Change or Addition | | 017924 | 022 | AP | 1982/08/25 | General Efficacy (MarkIV) | | 017924 | 019 | AP | 1982/01/22 | Labeling Revision | | 017924 | 018 | AP | 1982/12/30 | Labeling Revision | | 017924 | 017 | AP | 1981/11/02 | Labeling Revision | | 017924 | 016 | AP | 1981/07/13 | Labeling Revision | | 017924 | 014 | AP | 1981/06/12 | Formulation Revision | | 017924 | 013 | AP | 1981/01/22 | Labeling Revision | | 017924 | 012 | AP | 1981/01/22 | Labeling Revision | | 017924 | 011 | AP | 1982/12/30 | General Efficacy (MarkIV) | | 017924 | 010 | AP | 1980/07/08 | Labeling Revision | | 017924 | 008 | AP | 1980/01/08 | Control Supplement | | 017924 | 000 | AP | 1977/08/16 | Approval |
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