| 药品名称 | TROKENDI XR | | 申请号 | 201635 | 产品号 | 002 | | 活性成分 | TOPIRAMATE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE, EXTENDED RELEASE;ORAL | 规格 | 50MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2013/08/16 | 申请机构 | SUPERNUS 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 | | 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 | | 201635 | 014 | AP | Letter | 2016/08/19 | 下载 | | 201635 | 014 | AP | Label | 2016/08/22 | 下载 | | 201635 | 011 | AP | Letter | 2016/08/19 | 下载 | | 201635 | 007 | AP | Letter | 2015/05/13 | 下载 | | 201635 | 007 | AP | Label | 2015/06/05 | 下载 | | 201635 | 000 | TA | Letter | 2012/06/26 | 下载 | | 201635 | 000 | TA | Letter | 2013/06/11 | 下载 | | 201635 | 000 | AP | Letter | 2013/08/20 | 下载 | | 201635 | 000 | AP | Label | 2013/08/21 | 下载 | | 201635 | 000 | TA | Medication Guide | 2013/08/30 | 下载 | | 201635 | 000 | AP | Review | 2014/06/24 | 下载 | | 201635 | 000 | AP | Summary Review | 2014/06/24 | 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 | | 201635 | 014 | AP | 2016/08/18 | Efficacy Supplement with Clinical Data to Support | | 201635 | 012 | AP | 2016/03/16 | Manufacturing Change or Addition | | 201635 | 011 | AP | 2016/08/18 | Tentative Approval | | 201635 | 010 | AP | 2015/10/12 | Manufacturing Change or Addition | | 201635 | 007 | AP | 2015/05/08 | Labeling Revision | | 201635 | 006 | AP | 2015/04/17 | Manufacturing Change or Addition | | 201635 | 004 | AP | 2014/04/18 | Manufacturing Change or Addition | | 201635 | 002 | AP | 2014/06/20 | Manufacturing Change or Addition | | 201635 | 001 | AP | 2014/04/18 | Manufacturing Change or Addition | | 201635 | 000 | AP | 2013/08/16 | Approval | | 201635 | 000 | TA | 2012/06/25 | Tentative Approval | | 201635 | 000 | TA | 2013/06/07 | Tentative Approval |
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