| 药品名称 | XENICAL | | 申请号 | 020766 | 产品号 | 001 | | 活性成分 | ORLISTAT | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 120MG | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 1999/04/23 | 申请机构 | HOFFMANN LA ROCHE 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 | | M-29 | 2006/12/12 | | PED | 2007/06/12 |
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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 | | 020766 | 036 | AP | Letter | 2016/08/15 | 下载 | | 020766 | 035 | AP | Label | 2015/08/10 | 下载 | | 020766 | 035 | AP | Letter | 2015/08/11 | 下载 | | 020766 | 033 | AP | Letter | 2013/10/18 | 下载 | | 020766 | 033 | AP | Label | 2013/10/18 | 下载 | | 020766 | 030 | AP | Label | 2010/12/22 | 下载 | | 020766 | 030 | AP | Letter | 2010/12/22 | 下载 | | 020766 | 029 | AP | Label | 2012/01/24 | 下载 | | 020766 | 029 | AP | Letter | 2012/01/25 | 下载 | | 020766 | 028 | AP | Letter | 2010/05/25 | 下载 | | 020766 | 028 | AP | Label | 2010/05/25 | 下载 | | 020766 | 026 | AP | Label | 2009/02/12 | 下载 | | 020766 | 026 | AP | Letter | 2009/02/18 | 下载 | | 020766 | 022 | AP | Label | 2007/01/08 | 下载 | | 020766 | 022 | AP | Letter | 2007/01/12 | 下载 | | 020766 | 021 | AP | Label | 2005/09/08 | 下载 | | 020766 | 021 | AP | Letter | 2005/09/08 | 下载 | | 020766 | 021 | AP | Review | 2007/07/06 | 下载 | | 020766 | 020 | AP | Letter | 2004/07/14 | 下载 | | 020766 | 020 | AP | Label | 2004/07/14 | 下载 | | 020766 | 019 | AP | Letter | 2004/10/29 | 下载 | | 020766 | 019 | AP | Label | 2004/11/01 | 下载 | | 020766 | 019 | AP | Review | 2007/07/06 | 下载 | | 020766 | 018 | AP | Review | 2007/07/06 | 下载 | | 020766 | 018 | AP | Letter | 2003/12/19 | 下载 | | 020766 | 018 | AP | Label | 2003/12/29 | 下载 | | 020766 | 013 | AP | Review | 2007/07/06 | 下载 | | 020766 | 009 | AP | Review | 2007/07/06 | 下载 | | 020766 | 007 | AP | Label | 2001/04/23 | 下载 | | 020766 | 000 | AP | Letter | 1999/04/26 | 下载 | | 020766 | 000 | AP | Label | 1999/04/26 | 下载 | | 020766 | 000 | AP | Review | 1999/08/13 | 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 | | 020766 | 036 | AP | 2016/08/12 | Labeling Revision | | 020766 | 035 | AP | 2015/08/07 | Labeling Revision | | 020766 | 034 | AP | 2014/04/30 | Manufacturing Change or Addition | | 020766 | 033 | AP | 2013/10/16 | Labeling Revision | | 020766 | 032 | AP | 2013/04/02 | Manufacturing Change or Addition | | 020766 | 031 | AP | 2013/04/05 | Manufacturing Change or Addition | | 020766 | 030 | AP | 2010/12/17 | Manufacturing Change or Addition | | 020766 | 029 | AP | 2012/01/20 | Labeling Revision | | 020766 | 028 | AP | 2010/05/25 | Labeling Revision | | 020766 | 026 | AP | 2009/02/11 | Labeling Revision | | 020766 | 022 | AP | 2007/01/05 | Labeling Revision | | 020766 | 021 | AP | 2005/09/02 | Labeling Revision | | 020766 | 020 | AP | 2004/07/09 | Labeling Revision | | 020766 | 019 | AP | 2004/10/22 | Efficacy Supplement with Clinical Data to Support | | 020766 | 018 | AP | 2003/12/12 | Patient Population Altered | | 020766 | 014 | AP | 2002/02/27 | Manufacturing Change or Addition | | 020766 | 013 | AP | 2002/03/08 | Manufacturing Change or Addition | | 020766 | 012 | AP | 2002/02/21 | Control Supplement | | 020766 | 011 | AP | 2001/12/19 | Control Supplement | | 020766 | 010 | AP | 2001/12/19 | Control Supplement | | 020766 | 009 | AP | 2001/11/12 | Package Change | | 020766 | 007 | AP | 2001/06/25 | Labeling Revision | | 020766 | 006 | AP | 2001/01/29 | Package Change | | 020766 | 005 | AP | 2001/01/09 | Control Supplement | | 020766 | 004 | AP | 2000/04/06 | Labeling Revision | | 020766 | 003 | AP | 2000/04/06 | Labeling Revision | | 020766 | 001 | AP | 1999/08/31 | Labeling Revision | | 020766 | 000 | AP | 1999/04/23 | Approval |
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