| 药品名称 | FLOMAX | | 申请号 | 020579 | 产品号 | 001 | | 活性成分 | TAMSULOSIN HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 0.4MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1997/04/15 | 申请机构 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| | 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 | | 020579 | 029 | AP | Label | 2014/10/21 | 下载 | | 020579 | 029 | AP | Letter | 2014/10/22 | 下载 | | 020579 | 028 | AP | Label | 2014/07/24 | 下载 | | 020579 | 028 | AP | Letter | 2014/07/24 | 下载 | | 020579 | 027 | AP | Label | 2011/07/27 | 下载 | | 020579 | 027 | AP | Letter | 2011/07/27 | 下载 | | 020579 | 026 | AP | Letter | 2009/12/29 | 下载 | | 020579 | 026 | AP | Label | 2010/01/04 | 下载 | | 020579 | 025 | AP | Label | 2009/10/30 | 下载 | | 020579 | 025 | AP | Letter | 2009/11/19 | 下载 | | 020579 | 024 | AP | Letter | 2008/12/04 | 下载 | | 020579 | 023 | AP | Letter | 2008/05/05 | 下载 | | 020579 | 021 | AP | Label | 2007/02/21 | 下载 | | 020579 | 021 | AP | Letter | 2007/02/23 | 下载 | | 020579 | 020 | AP | Label | 2007/01/16 | 下载 | | 020579 | 020 | AP | Letter | 2007/01/16 | 下载 | | 020579 | 016 | AP | Label | 2005/10/24 | 下载 | | 020579 | 016 | AP | Letter | 2005/10/25 | 下载 | | 020579 | 000 | AP | Review | 2010/03/16 | 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 | | 020579 | 032 | AP | 2016/09/09 | Manufacturing Change or Addition | | 020579 | 031 | AP | 2016/01/21 | Manufacturing Change or Addition | | 020579 | 029 | AP | 2014/10/21 | Labeling Revision | | 020579 | 028 | AP | 2014/07/20 | Labeling Revision | | 020579 | 027 | AP | 2011/07/25 | Labeling Revision | | 020579 | 026 | AP | 2009/12/22 | Efficacy Supplement with Clinical Data to Support | | 020579 | 025 | AP | 2009/10/29 | Labeling Revision | | 020579 | 024 | AP | 2008/12/02 | Labeling Revision | | 020579 | 023 | AP | 2008/04/29 | Labeling Revision | | 020579 | 021 | AP | 2007/02/16 | Labeling Revision | | 020579 | 020 | AP | 2007/01/11 | Labeling Revision | | 020579 | 016 | AP | 2005/10/18 | Labeling Revision | | 020579 | 012 | AP | 2001/12/17 | Control Supplement | | 020579 | 011 | AP | 2001/08/20 | Manufacturing Change or Addition | | 020579 | 010 | AP | 2001/06/06 | Control Supplement | | 020579 | 009 | AP | 2000/07/26 | Package Change | | 020579 | 008 | AP | 2000/06/30 | Manufacturing Change or Addition | | 020579 | 007 | AP | 2001/05/01 | Labeling Revision | | 020579 | 006 | AP | 1999/09/02 | Manufacturing Change or Addition | | 020579 | 005 | AP | 1999/02/23 | Control Supplement | | 020579 | 004 | AP | 1999/01/19 | Manufacturing Change or Addition | | 020579 | 003 | AP | 1998/12/08 | Control Supplement | | 020579 | 002 | AP | 1998/05/26 | Labeling Revision | | 020579 | 001 | AP | 1997/08/25 | Control Supplement | | 020579 | 000 | AP | 1997/04/15 | Approval |
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