药品名称 | GABITRIL | 申请号 | 020646 | 产品号 | 004 | 活性成分 | TIAGABINE HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 20MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1997/09/30 | 申请机构 | CEPHALON INC
| 化学类型 | New molecular entity (NME) | 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 | 020646 | 021 | AP | Letter | 2016/08/10 | 下载![](pdf.jpg) | 020646 | 021 | AP | Label | 2016/08/10 | 下载![](pdf.jpg) | 020646 | 020 | AP | Letter | 2012/01/30 | 下载![](pdf.jpg) | 020646 | 018 | AP | Letter | 2015/11/09 | 下载![](pdf.jpg) | 020646 | 018 | AP | Label | 2015/11/12 | 下载![](pdf.jpg) | 020646 | 017 | AP | Label | 2010/10/11 | 下载![](pdf.jpg) | 020646 | 017 | AP | Letter | 2010/10/13 | 下载![](pdf.jpg) | 020646 | 016 | AP | Letter | 2009/05/04 | 下载![](pdf.jpg) | 020646 | 016 | AP | Label | 2009/05/12 | 下载![](pdf.jpg) | 020646 | 015 | AP | Label | 2005/12/05 | 下载![](pdf.jpg) | 020646 | 015 | AP | Letter | 2005/12/06 | 下载![](pdf.jpg) | 020646 | 014 | AP | Letter | 2005/02/17 | 下载![](pdf.jpg) | 020646 | 014 | AP | Label | 2005/02/17 | 下载![](pdf.jpg) | 020646 | 000 | AP | Other Important Information from FDA | 2005/04/15 | 下载 | 020646 | 000 | AP | Review | 2010/01/07 | 下载 | 020646 | 000 | AP | Medication Guide | 2010/10/13 | 下载![](pdf.jpg) |
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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 | 020646 | 021 | AP | 2016/08/09 | Labeling Revision | 020646 | 020 | AP | 2012/01/25 | Labeling Revision | 020646 | 018 | AP | 2015/11/04 | Labeling Revision | 020646 | 017 | AP | 2010/10/11 | Labeling Revision | 020646 | 016 | AP | 2009/04/23 | Labeling Revision | 020646 | 015 | AP | 2005/11/29 | Manufacturing Change or Addition | 020646 | 014 | AP | 2005/02/14 | Labeling Revision | 020646 | 011 | AP | 2001/10/03 | Manufacturing Change or Addition | 020646 | 010 | AP | 2001/10/03 | Package Change | 020646 | 009 | AP | 2001/07/27 | Manufacturing Change or Addition | 020646 | 008 | AP | 2000/05/16 | Manufacturing Change or Addition | 020646 | 007 | AP | 2000/05/17 | Control Supplement | 020646 | 006 | AP | 1999/08/23 | Expiration Date Change | 020646 | 005 | AP | 1999/04/16 | Labeling Revision | 020646 | 004 | AP | 1999/04/16 | Manufacturing Change or Addition | 020646 | 003 | AP | 1998/07/31 | Control Supplement | 020646 | 002 | AP | 1998/05/08 | Package Change | 020646 | 001 | AP | 1997/10/09 | Control Supplement | 020646 | 000 | AP | 1997/09/30 | Approval |
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