| 药品名称 | FANAPT | | 申请号 | 022192 | 产品号 | 006 | | 活性成分 | ILOPERIDONE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 10MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2009/05/06 | 申请机构 | VANDA PHARMACEUTICALS INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | |
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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 | | M-180 | 2019/05/26 | | 历史市场独占权保护信息 | | NCE | 2014/05/06 |
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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 | | 022192 | 017 | AP | Letter | 2016/01/06 | 下载 | | 022192 | 017 | AP | Label | 2016/01/06 | 下载 | | 022192 | 015 | AP | Letter | 2016/05/27 | 下载 | | 022192 | 015 | AP | Label | 2016/06/01 | 下载 | | 022192 | 013 | AP | Letter | 2014/04/22 | 下载 | | 022192 | 013 | AP | Label | 2014/04/22 | 下载 | | 022192 | 009 | AP | Label | 2012/01/30 | 下载 | | 022192 | 009 | AP | Letter | 2012/01/31 | 下载 | | 022192 | 007 | AP | Label | 2013/02/01 | 下载 | | 022192 | 007 | AP | Letter | 2013/02/04 | 下载 | | 022192 | 006 | AP | Label | 2011/09/12 | 下载 | | 022192 | 006 | AP | Letter | 2011/09/12 | 下载 | | 022192 | 005 | AP | Label | 2011/09/12 | 下载 | | 022192 | 005 | AP | Letter | 2011/09/12 | 下载 | | 022192 | 004 | AP | Letter | 2011/03/24 | 下载 | | 022192 | 004 | AP | Label | 2011/03/28 | 下载 | | 022192 | 002 | AP | Label | 2010/12/04 | 下载 | | 022192 | 002 | AP | Letter | 2010/12/06 | 下载 | | 022192 | 001 | AP | Letter | 2010/08/26 | 下载 | | 022192 | 001 | AP | Label | 2010/08/27 | 下载 | | 022192 | 000 | AP | Label | 2009/05/11 | 下载 | | 022192 | 000 | AP | Letter | 2009/05/11 | 下载 | | 022192 | 000 | AP | Review | 2009/06/12 | 下载 | | 022192 | 000 | AP | Summary Review | 2009/06/12 | 下载 | | 022192 | 000 | AP | Other Important Information from FDA | 2011/12/22 | 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 | | 022192 | 017 | AP | 2016/01/05 | Labeling Revision | | 022192 | 016 | AP | 2016/03/29 | Manufacturing Change or Addition | | 022192 | 015 | AP | 2016/05/26 | Efficacy Supplement with Clinical Data to Support | | 022192 | 014 | AP | 2015/03/30 | Manufacturing Change or Addition | | 022192 | 013 | AP | 2014/04/21 | Labeling Revision | | 022192 | 012 | AP | 2013/07/19 | Manufacturing Change or Addition | | 022192 | 011 | AP | 2013/05/30 | Manufacturing Change or Addition | | 022192 | 010 | AP | 2013/07/12 | Manufacturing Change or Addition | | 022192 | 009 | AP | 2012/01/27 | Labeling Revision | | 022192 | 007 | AP | 2013/01/31 | Labeling Revision | | 022192 | 006 | AP | 2011/09/07 | Labeling Revision | | 022192 | 005 | AP | 2011/09/07 | Labeling Revision | | 022192 | 004 | AP | 2011/03/21 | Labeling Revision | | 022192 | 002 | AP | 2010/12/01 | Labeling Revision | | 022192 | 001 | AP | 2010/08/24 | Labeling Revision | | 022192 | 000 | AP | 2009/05/06 | Approval |
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