| 药品名称 | PEPCID | | 申请号 | 019462 | 产品号 | 002 | | 活性成分 | FAMOTIDINE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 40MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1986/10/15 | 申请机构 | VALEANT PHARMACEUTICALS NORTH AMERICA LLC
| | 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 | | 019462 | 038 | AP | Label | 2014/02/06 | 下载 | | 019462 | 038 | AP | Letter | 2014/02/10 | 下载 | | 019462 | 037 | AP | Letter | 2011/06/03 | 下载 | | 019462 | 037 | AP | Label | 2011/06/07 | 下载 | | 019462 | 035 | AP | Letter | 2010/03/25 | 下载 | | 019462 | 035 | AP | Label | 2010/03/26 | 下载 | | 019462 | 034 | AP | Label | 2007/11/07 | 下载 | | 019462 | 034 | AP | Letter | 2007/11/08 | 下载 | | 019462 | 031 | AP | Letter | 2001/03/14 | 下载 | | 019462 | 030 | AP | Letter | 2002/06/06 | 下载 | | 019462 | 030 | AP | Label | 2002/06/06 | 下载 | | 019462 | 030 | AP | Review | 2007/07/09 | 下载 | | 019462 | 029 | AP | Label | 2003/04/24 | 下载 | | 019462 | 027 | AP | Review | 1999/03/18 | 下载 | | 019462 | 000 | AP | Label | 2003/04/30 | 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 | | 019462 | 038 | AP | 2014/02/03 | Labeling Revision | | 019462 | 037 | AP | 2011/06/02 | Labeling Revision | | 019462 | 035 | AP | 2010/03/23 | Labeling Revision | | 019462 | 034 | AP | 2007/11/05 | Labeling Revision | | 019462 | 032 | AP | 2002/04/29 | Control Supplement | | 019462 | 031 | AP | 2001/03/14 | Labeling Revision | | 019462 | 030 | AP | 2002/06/06 | Efficacy Supplement with Clinical Data to Support | | 019462 | 029 | AP | 2001/04/25 | Labeling Revision | | 019462 | 028 | AP | 2000/11/27 | Labeling Revision | | 019462 | 027 | AP | 1999/03/18 | Labeling Revision | | 019462 | 026 | AP | 1998/10/08 | Labeling Revision | | 019462 | 025 | AP | 1999/02/08 | Control Supplement | | 019462 | 024 | AP | 1998/11/25 | Manufacturing Change or Addition | | 019462 | 023 | AP | 1997/08/22 | Labeling Revision | | 019462 | 022 | AP | 1998/08/12 | Labeling Revision | | 019462 | 021 | AP | 1997/01/09 | Control Supplement | | 019462 | 020 | AP | 1996/02/06 | Manufacturing Change or Addition | | 019462 | 019 | AP | 1996/11/13 | Package Change | | 019462 | 018 | AP | 1996/03/29 | Labeling Revision | | 019462 | 017 | AP | 1995/03/17 | Control Supplement | | 019462 | 016 | AP | 1996/03/29 | Labeling Revision | | 019462 | 015 | AP | 1996/03/29 | Labeling Revision | | 019462 | 012 | AP | 1990/11/30 | Labeling Revision | | 019462 | 011 | AP | 1997/08/22 | Labeling Revision | | 019462 | 010 | AP | 1991/12/10 | New or Modified Indication | | 019462 | 008 | AP | 1990/11/30 | Labeling Revision | | 019462 | 007 | AP | 1990/11/30 | Labeling Revision | | 019462 | 006 | AP | 1991/08/16 | Manufacturing Change or Addition | | 019462 | 005 | AP | 1988/11/23 | Labeling Revision | | 019462 | 004 | AP | 1988/08/18 | Package Change | | 019462 | 003 | AP | 1988/10/17 | New or Modified Indication | | 019462 | 002 | AP | 1987/04/01 | Labeling Revision | | 019462 | 001 | AP | 1986/12/12 | Labeling Revision | | 019462 | 000 | AP | 1986/10/15 | Approval |
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