| 药品名称 | FAZACLO ODT | | 申请号 | 021590 | 产品号 | 004 | | 活性成分 | CLOZAPINE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET, ORALLY DISINTEGRATING;ORAL | 规格 | 12.5MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2007/05/30 | 申请机构 | JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
| | 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 | | 021590 | 028 | AP | Letter | 2015/10/02 | 下载 | | 021590 | 028 | AP | Label | 2015/10/22 | 下载 | | 021590 | 027 | AP | Letter | 2015/09/16 | 下载 | | 021590 | 027 | AP | Label | 2015/09/16 | 下载 | | 021590 | 024 | AP | Label | 2012/01/09 | 下载 | | 021590 | 024 | AP | Letter | 2012/01/12 | 下载 | | 021590 | 021 | AP | Letter | 2013/07/22 | 下载 | | 021590 | 021 | AP | Label | 2013/07/23 | 下载 | | 021590 | 018 | AP | Label | 2010/12/04 | 下载 | | 021590 | 018 | AP | Letter | 2010/12/06 | 下载 | | 021590 | 017 | AP | Label | 2010/09/10 | 下载 | | 021590 | 017 | AP | Letter | 2010/09/13 | 下载 | | 021590 | 016 | AP | Label | 2010/07/12 | 下载 | | 021590 | 016 | AP | Letter | 2010/07/14 | 下载 | | 021590 | 015 | AP | Label | 2010/07/12 | 下载 | | 021590 | 015 | AP | Letter | 2010/07/14 | 下载 | | 021590 | 014 | AP | Letter | 2015/09/16 | 下载 | | 021590 | 014 | AP | Label | 2015/09/16 | 下载 | | 021590 | 013 | AP | Letter | 2008/08/19 | 下载 | | 021590 | 011 | AP | Letter | 2008/07/17 | 下载 | | 021590 | 010 | AP | Letter | 2007/06/04 | 下载 | | 021590 | 010 | AP | Label | 2007/06/04 | 下载 | | 021590 | 009 | AP | Label | 2006/02/22 | 下载 | | 021590 | 009 | AP | Letter | 2006/02/22 | 下载 | | 021590 | 008 | AP | Letter | 2005/08/16 | 下载 | | 021590 | 008 | AP | Label | 2005/08/15 | 下载 | | 021590 | 007 | AP | Letter | 2005/06/10 | 下载 | | 021590 | 007 | AP | Label | 2005/06/10 | 下载 | | 021590 | 003 | AP | Letter | 2005/08/15 | 下载 | | 021590 | 002 | AP | Letter | 2004/09/07 | 下载 | | 021590 | 001 | AP | Letter | 2004/06/23 | 下载 | | 021590 | 000 | AP | Letter | 2004/02/27 | 下载 | | 021590 | 000 | AP | Label | 2004/03/03 | 下载 | | 021590 | 000 | AP | Review | 2005/10/06 | 下载 | | 021590 | 000 | AP | Other | 2015/09/16 | 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 | | 021590 | 029 | AP | 2016/04/25 | Manufacturing Change or Addition | | 021590 | 028 | AP | 2015/09/30 | Labeling Revision | | 021590 | 027 | AP | 2015/09/15 | Labeling Revision | | 021590 | 025 | AP | 2012/11/07 | Manufacturing Change or Addition | | 021590 | 024 | AP | 2012/01/09 | Labeling Revision | | 021590 | 021 | AP | 2013/07/19 | Labeling Revision | | 021590 | 018 | AP | 2010/12/01 | Labeling Revision | | 021590 | 017 | AP | 2010/09/08 | Labeling Revision | | 021590 | 016 | AP | 2010/07/09 | Manufacturing Change or Addition | | 021590 | 015 | AP | 2010/07/09 | Labeling Revision | | 021590 | 014 | AP | 2015/09/15 | Supplement | | 021590 | 013 | AP | 2008/08/14 | Labeling Revision | | 021590 | 011 | AP | 2008/07/15 | Labeling Revision | | 021590 | 010 | AP | 2007/05/30 | Manufacturing Change or Addition | | 021590 | 009 | AP | 2006/02/16 | Labeling Revision | | 021590 | 008 | AP | 2005/08/12 | Labeling Revision | | 021590 | 007 | AP | 2005/06/08 | Labeling Revision | | 021590 | 003 | AP | 2005/08/12 | Labeling Revision | | 021590 | 002 | AP | 2004/08/27 | Labeling Revision | | 021590 | 001 | AP | 2004/06/17 | Labeling Revision | | 021590 | 000 | AP | 2004/02/09 | Approval |
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