| 药品名称 | GLUCOVANCE | | 申请号 | 021178 | 产品号 | 001 | | 活性成分 | GLYBURIDE; METFORMIN HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2000/07/31 | 申请机构 | BRISTOL MYERS SQUIBB
| | 化学类型 | | 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 | | M-37 | 2007/03/15 | | PED | 2007/09/15 |
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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 | | 021178 | 015 | AP | Letter | 2013/10/16 | 下载 | | 021178 | 015 | AP | Label | 2013/10/22 | 下载 | | 021178 | 012 | AP | Letter | 2010/11/30 | 下载 | | 021178 | 012 | AP | Label | 2010/12/01 | 下载 | | 021178 | 011 | AP | Label | 2009/12/02 | 下载 | | 021178 | 010 | AP | Letter | 2008/09/17 | 下载 | | 021178 | 010 | AP | Label | 2008/09/19 | 下载 | | 021178 | 009 | AP | Label | 2006/12/26 | 下载 | | 021178 | 009 | AP | Letter | 2006/12/28 | 下载 | | 021178 | 007 | AP | Letter | 2004/03/19 | 下载 | | 021178 | 007 | AP | Label | 2004/04/05 | 下载 | | 021178 | 004 | AP | Letter | 2002/09/30 | 下载 | | 021178 | 004 | AP | Label | 2002/09/30 | 下载 | | 021178 | 004 | AP | Review | 2003/10/29 | 下载 | | 021178 | 000 | AP | Review | 2003/12/31 | 下载 | | 021178 | 000 | AP | Letter | 2000/07/31 | 下载 | | 021178 | 000 | AP | Label | 2000/07/31 | 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 | | 021178 | 015 | AP | 2013/10/15 | Labeling Revision | | 021178 | 014 | AP | 2013/08/15 | Manufacturing Change or Addition | | 021178 | 013 | AP | 2013/03/14 | Manufacturing Change or Addition | | 021178 | 012 | AP | 2010/11/24 | Labeling Revision | | 021178 | 011 | AP | 2009/11/24 | Labeling Revision | | 021178 | 010 | AP | 2008/09/16 | Labeling Revision | | 021178 | 009 | AP | 2006/12/14 | Labeling Revision | | 021178 | 007 | AP | 2004/03/15 | Patient Population Altered | | 021178 | 005 | AP | 2002/07/02 | Expiration Date Change | | 021178 | 004 | AP | 2002/09/30 | New or Modified Indication | | 021178 | 003 | AP | 2002/07/08 | Control Supplement | | 021178 | 002 | AP | 2001/02/28 | Labeling Revision | | 021178 | 001 | AP | 2000/12/13 | Manufacturing Change or Addition | | 021178 | 000 | AP | 2000/07/31 | Approval |
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