| 药品名称 | CARBATROL | | 申请号 | 020712 | 产品号 | 002 | | 活性成分 | CARBAMAZEPINE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE, EXTENDED RELEASE;ORAL | 规格 | 300MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1997/09/30 | 申请机构 | SHIRE DEVELOPMENT 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 | | 020712 | 035 | AP | Letter | 2013/03/25 | 下载 | | 020712 | 035 | AP | Label | 2013/03/26 | 下载 | | 020712 | 035 | AP | Medication Guide | 2013/05/22 | 下载 | | 020712 | 034 | AP | Letter | 2011/09/06 | 下载 | | 020712 | 032 | AP | Letter | 2013/03/25 | 下载 | | 020712 | 032 | AP | Label | 2013/03/26 | 下载 | | 020712 | 032 | AP | Medication Guide | 2013/05/22 | 下载 | | 020712 | 031 | AP | Medication Guide | 2011/01/31 | 下载 | | 020712 | 031 | AP | Label | 2011/01/31 | 下载 | | 020712 | 031 | AP | Letter | 2011/02/03 | 下载 | | 020712 | 030 | AP | Label | 2009/04/28 | 下载 | | 020712 | 030 | AP | Letter | 2009/04/29 | 下载 | | 020712 | 029 | AP | Label | 2007/12/12 | 下载 | | 020712 | 029 | AP | Other | 2007/12/31 | 下载 | | 020712 | 029 | AP | Letter | 2008/01/09 | 下载 | | 020712 | 025 | AP | Label | 2006/07/03 | 下载 | | 020712 | 025 | AP | Letter | 2006/07/13 | 下载 | | 020712 | 024 | AP | Letter | 2006/01/30 | 下载 | | 020712 | 000 | AP | Review | 2007/04/17 | 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 | | 020712 | 035 | AP | 2013/03/22 | Labeling Revision | | 020712 | 034 | AP | 2011/08/22 | Labeling Revision | | 020712 | 032 | AP | 2013/03/22 | Labeling Revision | | 020712 | 031 | AP | 2011/01/26 | Labeling Revision | | 020712 | 030 | AP | 2009/04/23 | Labeling Revision | | 020712 | 029 | AP | 2007/12/11 | Labeling Revision | | 020712 | 025 | AP | 2006/06/30 | Labeling Revision | | 020712 | 024 | AP | 2006/01/24 | Labeling Revision | | 020712 | 016 | AP | 2002/08/07 | Manufacturing Change or Addition | | 020712 | 015 | AP | 2002/02/21 | Manufacturing Change or Addition | | 020712 | 014 | AP | 2001/10/30 | Manufacturing Change or Addition | | 020712 | 013 | AP | 2000/08/08 | Manufacturing Change or Addition | | 020712 | 012 | AP | 2000/08/08 | Manufacturing Change or Addition | | 020712 | 011 | AP | 2001/05/17 | Control Supplement | | 020712 | 010 | AP | 2000/06/14 | Manufacturing Change or Addition | | 020712 | 009 | AP | 2000/01/19 | Control Supplement | | 020712 | 008 | AP | 1999/11/08 | Package Change | | 020712 | 007 | AP | 1999/12/22 | Manufacturing Change or Addition | | 020712 | 006 | AP | 1999/06/28 | Package Change | | 020712 | 005 | AP | 1999/06/28 | Package Change | | 020712 | 003 | AP | 1999/01/27 | Manufacturing Change or Addition | | 020712 | 002 | AP | 1999/01/27 | Control Supplement | | 020712 | 001 | AP | 1998/07/24 | Control Supplement | | 020712 | 000 | AP | 1997/09/30 | Approval |
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