| 药品名称 | LOTRONEX | | 申请号 | 021107 | 产品号 | 002 | | 活性成分 | ALOSETRON HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 0.5MG BASE | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 2003/12/23 | 申请机构 | SEBELA IRELAND LTD
| | 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 | | D-113 | 2011/04/01 |
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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 | | 021107 | 027 | AP | Letter | 2016/01/11 | 下载 | | 021107 | 027 | AP | Label | 2016/01/26 | 下载 | | 021107 | 026 | AP | Letter | 2016/01/11 | 下载 | | 021107 | 025 | AP | Letter | 2015/07/27 | 下载 | | 021107 | 024 | AP | Letter | 2014/05/12 | 下载 | | 021107 | 016 | AP | Letter | 2010/09/07 | 下载 | | 021107 | 016 | AP | Label | 2010/09/07 | 下载 | | 021107 | 014 | AP | Letter | 2010/09/07 | 下载 | | 021107 | 014 | AP | Label | 2010/10/01 | 下载 | | 021107 | 013 | AP | Letter | 2008/04/09 | 下载 | | 021107 | 013 | AP | Label | 2008/05/06 | 下载 | | 021107 | 012 | AP | Label | 2006/03/14 | 下载 | | 021107 | 012 | AP | Letter | 2006/03/23 | 下载 | | 021107 | 011 | AP | Letter | 2005/02/23 | 下载 | | 021107 | 011 | AP | Label | 2005/02/23 | 下载 | | 021107 | 010 | AP | Label | 2005/02/04 | 下载 | | 021107 | 010 | AP | Letter | 2005/02/08 | 下载 | | 021107 | 008 | AP | Letter | 2003/12/24 | 下载 | | 021107 | 008 | AP | Label | 2003/12/29 | 下载 | | 021107 | 007 | AP | Letter | 2003/03/26 | 下载 | | 021107 | 006 | AP | Review | 2007/11/19 | 下载 | | 021107 | 005 | AP | Review | 2007/11/19 | 下载 | | 021107 | 005 | AP | Letter | 2002/06/07 | 下载 | | 021107 | 005 | AP | Label | 2002/06/07 | 下载 | | 021107 | 002 | AP | Review | 2007/11/19 | 下载 | | 021107 | 001 | AP | Review | 2007/11/19 | 下载 | | 021107 | 000 | AP | Letter | 2000/02/09 | 下载 | | 021107 | 000 | AP | Review | 2000/08/29 | 下载 | | 021107 | 000 | AP | Label | 2000/02/09 | 下载 | | 021107 | 000 | AP | Other Important Information from FDA | 2003/12/17 | 下载 | | 021107 | 000 | AP | Medication Guide | 2010/09/15 | 下载 | | 021107 | 000 | AP | Other | 2010/10/01 | 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 | | 021107 | 028 | AP | 2016/09/20 | Manufacturing Change or Addition | | 021107 | 027 | AP | 2016/01/07 | Labeling Revision | | 021107 | 026 | AP | 2016/01/07 | Efficacy Supplement with Clinical Data to Support | | 021107 | 025 | AP | 2015/07/24 | Supplement | | 021107 | 024 | AP | 2014/05/08 | Labeling Revision | | 021107 | 021 | AP | 2013/04/19 | Manufacturing Change or Addition | | 021107 | 016 | AP | 2010/09/02 | Labeling Revision | | 021107 | 014 | AP | 2010/09/02 | Labeling Revision | | 021107 | 013 | AP | 2008/04/01 | New Dosage Regimen | | 021107 | 012 | AP | 2006/03/10 | Labeling Revision | | 021107 | 011 | AP | 2005/02/18 | Labeling Revision | | 021107 | 010 | AP | 2005/02/04 | Labeling Revision | | 021107 | 008 | AP | 2003/12/23 | Formulation Revision | | 021107 | 007 | AP | 2003/03/20 | Labeling Revision | | 021107 | 006 | AP | 2002/06/03 | Package Change | | 021107 | 005 | AP | 2002/06/07 | Efficacy Supplement with Clinical Data to Support | | 021107 | 002 | AP | 2000/08/11 | Labeling Revision | | 021107 | 001 | AP | 2000/03/07 | Manufacturing Change or Addition | | 021107 | 000 | AP | 2000/02/09 | Approval |
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