| 药品名称 | INVEGA SUSTENNA | | 申请号 | 022264 | 产品号 | 005 | | 活性成分 | PALIPERIDONE PALMITATE | 市场状态 | 处方药 | | 剂型或给药途径 | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 规格 | 234MG/1.5ML (156MG/ML) | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2009/07/31 | 申请机构 | JANSSEN PHARMACEUTICALS INC
| | 化学类型 | New dosage form | 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 | | M-119 | 2015/08/29 | | I-698 | 2017/11/12 | | 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 | | 022264 | 019 | AP | Letter | 2016/03/03 | 下载 | | 022264 | 019 | AP | Label | 2016/03/03 | 下载 | | 022264 | 018 | AP | Letter | 2015/06/10 | 下载 | | 022264 | 018 | AP | Label | 2015/06/11 | 下载 | | 022264 | 014 | AP | Letter | 2014/11/14 | 下载 | | 022264 | 014 | AP | Label | 2014/12/20 | 下载 | | 022264 | 013 | AP | Letter | 2014/11/14 | 下载 | | 022264 | 013 | AP | Label | 2014/12/20 | 下载 | | 022264 | 010 | AP | Letter | 2014/05/01 | 下载 | | 022264 | 010 | AP | Label | 2014/05/02 | 下载 | | 022264 | 006 | AP | Letter | 2011/09/28 | 下载 | | 022264 | 006 | AP | Label | 2011/09/30 | 下载 | | 022264 | 005 | AP | Letter | 2012/08/30 | 下载 | | 022264 | 005 | AP | Label | 2012/08/31 | 下载 | | 022264 | 004 | AP | Label | 2010/12/04 | 下载 | | 022264 | 004 | AP | Letter | 2010/12/07 | 下载 | | 022264 | 002 | AP | Label | 2011/06/16 | 下载 | | 022264 | 002 | AP | Letter | 2011/06/24 | 下载 | | 022264 | 001 | AP | Label | 2010/05/17 | 下载 | | 022264 | 001 | AP | Letter | 2010/05/18 | 下载 | | 022264 | 000 | AP | Other Important Information from FDA | 2011/12/22 | 下载 | | 022264 | 000 | AP | Letter | 2009/08/17 | 下载 | | 022264 | 000 | AP | Label | 2009/10/01 | 下载 | | 022264 | 000 | AP | Review | 2010/05/13 | 下载 | | 022264 | 000 | AP | Summary Review | 2010/05/13 | 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 | | 022264 | 020 | AP | 2016/08/29 | Manufacturing Change or Addition | | 022264 | 019 | AP | 2016/03/01 | Labeling Revision | | 022264 | 018 | AP | 2015/06/09 | Labeling Revision | | 022264 | 017 | AP | 2015/06/16 | Manufacturing Change or Addition | | 022264 | 014 | AP | 2014/11/12 | General Efficacy (MarkIV) | | 022264 | 013 | AP | 2014/11/12 | General Efficacy (MarkIV) | | 022264 | 012 | AP | 2014/08/25 | Manufacturing Change or Addition | | 022264 | 011 | AP | 2013/08/26 | Manufacturing Change or Addition | | 022264 | 010 | AP | 2014/04/29 | Labeling Revision | | 022264 | 006 | AP | 2011/09/24 | Labeling Revision | | 022264 | 005 | AP | 2012/08/29 | Efficacy Supplement with Clinical Data to Support | | 022264 | 004 | AP | 2010/12/01 | Labeling Revision | | 022264 | 002 | AP | 2011/06/15 | Labeling Revision | | 022264 | 001 | AP | 2010/05/13 | Labeling Revision | | 022264 | 000 | AP | 2009/07/31 | Approval |
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