药品名称 | PROSCAR | 申请号 | 020180 | 产品号 | 001 | 活性成分 | FINASTERIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1992/06/19 | 申请机构 | MERCK AND CO INC
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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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 | 020180 | 044 | AP | Letter | 2014/03/13 | 下载 | 020180 | 044 | AP | Label | 2014/03/13 | 下载 | 020180 | 043 | AP | Letter | 2013/01/22 | 下载 | 020180 | 043 | AP | Label | 2013/01/22 | 下载 | 020180 | 042 | AP | Label | 2012/04/11 | 下载 | 020180 | 042 | AP | Letter | 2012/04/12 | 下载 | 020180 | 041 | AP | Label | 2012/04/11 | 下载 | 020180 | 041 | AP | Letter | 2012/04/12 | 下载 | 020180 | 040 | AP | Letter | 2012/04/12 | 下载 | 020180 | 040 | AP | Label | 2012/04/11 | 下载 | 020180 | 039 | AP | Letter | 2011/06/10 | 下载 | 020180 | 039 | AP | Label | 2011/06/10 | 下载 | 020180 | 037 | AP | Label | 2010/10/04 | 下载 | 020180 | 037 | AP | Letter | 2010/10/07 | 下载 | 020180 | 035 | AP | Letter | 2011/06/17 | 下载 | 020180 | 033 | AP | Label | 2010/03/26 | 下载 | 020180 | 033 | AP | Letter | 2010/03/29 | 下载 | 020180 | 029 | AP | Review | 2007/07/24 | 下载 | 020180 | 029 | AP | Letter | 2004/04/29 | 下载 | 020180 | 029 | AP | Label | 2004/05/04 | 下载 | 020180 | 027 | AP | Review | 2006/05/08 | 下载 | 020180 | 027 | AP | Letter | 2003/09/25 | 下载 | 020180 | 027 | AP | Label | 2003/09/25 | 下载 | 020180 | 026 | AP | Label | 2004/04/14 | 下载 | 020180 | 026 | AP | Letter | 2004/04/20 | 下载 | 020180 | 026 | AP | Review | 2007/07/24 | 下载 | 020180 | 025 | AP | Review | 2007/07/06 | 下载 | 020180 | 025 | AP | Letter | 2003/07/06 | 下载 | 020180 | 024 | AP | Review | 2007/07/24 | 下载 | 020180 | 023 | AP | Review | 2007/07/24 | 下载 | 020180 | 022 | AP | Review | 2008/08/04 | 下载 | 020180 | 020 | AP | Letter | 2003/09/30 | 下载 | 020180 | 020 | AP | Review | 2007/07/06 | 下载 | 020180 | 019 | AP | Review | 2008/08/04 | 下载 | 020180 | 018 | AP | Review | 2008/08/08 | 下载 | 020180 | 017 | AP | Review | 1997/12/19 | 下载 | 020180 | 016 | AP | Review | 1998/03/20 | 下载 | 020180 | 015 | AP | Review | 1998/03/20 | 下载 | 020180 | 014 | AP | Review | 2006/05/10 | 下载 | 020180 | 013 | AP | Review | 1997/05/12 | 下载 | 020180 | 011 | AP | Review | 2003/08/07 | 下载 | 020180 | 010 | AP | Review | 2006/05/10 | 下载 | 020180 | 000 | AP | Other Important Information from FDA | 2011/12/20 | 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 | 020180 | 045 | AP | 2015/07/06 | Manufacturing Change or Addition | 020180 | 044 | AP | 2014/03/11 | Labeling Revision | 020180 | 043 | AP | 2013/01/16 | Labeling Revision | 020180 | 042 | AP | 2012/04/11 | Labeling Revision | 020180 | 041 | AP | 2012/04/11 | Labeling Revision | 020180 | 040 | AP | 2012/04/11 | Labeling Revision | 020180 | 039 | AP | 2011/06/09 | Labeling Revision | 020180 | 037 | AP | 2010/10/04 | Labeling Revision | 020180 | 035 | AP | 2011/06/10 | Labeling Revision | 020180 | 033 | AP | 2010/03/23 | Labeling Revision | 020180 | 029 | AP | 2004/04/23 | Labeling Revision | 020180 | 027 | AP | 2003/09/09 | Labeling Revision | 020180 | 026 | AP | 2004/04/12 | Efficacy Supplement with Clinical Data to Support | 020180 | 025 | AP | 2003/06/26 | Labeling Revision | 020180 | 024 | AP | 2002/11/26 | Control Supplement | 020180 | 023 | AP | 2002/10/28 | Control Supplement | 020180 | 022 | AP | 2001/01/30 | Labeling Revision | 020180 | 020 | AP | 2003/09/23 | Labeling Revision | 020180 | 019 | AP | 2001/01/17 | Labeling Revision | 020180 | 018 | AP | 1999/08/02 | Labeling Revision | 020180 | 017 | AP | 1997/12/19 | Labeling Revision | 020180 | 016 | AP | 1998/03/20 | New or Modified Indication | 020180 | 015 | AP | 1998/03/20 | Patient Population Altered | 020180 | 014 | AP | 1997/05/16 | Control Supplement | 020180 | 013 | AP | 1997/05/12 | Manufacturing Change or Addition | 020180 | 011 | AP | 1996/08/28 | Labeling Revision | 020180 | 010 | AP | 1996/07/24 | Manufacturing Change or Addition | 020180 | 009 | AP | 1994/12/30 | Labeling Revision | 020180 | 008 | AP | 1994/05/18 | Labeling Revision | 020180 | 007 | AP | 1994/05/18 | Labeling Revision | 020180 | 006 | AP | 1993/09/16 | Package Change | 020180 | 005 | AP | 1993/09/01 | Manufacturing Change or Addition | 020180 | 004 | AP | 1993/04/05 | Package Change | 020180 | 003 | AP | 1992/12/22 | Labeling Revision | 020180 | 002 | AP | 1992/12/22 | Manufacturing Change or Addition | 020180 | 001 | AP | 1992/08/20 | Labeling Revision | 020180 | 000 | AP | 1992/06/19 | Approval |
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