| 药品名称 | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | | 申请号 | 020171 | 产品号 | 003 | | 活性成分 | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION;INTRAPERITONEAL | 规格 | 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | | 治疗等效代码 | AT | 参比药物 | 否 | | 批准日期 | 1992/08/19 | 申请机构 | FRESENIUS MEDICAL CARE NORTH AMERICA
| | 化学类型 | New formulation or new manufacturer | 审评分类 | Standard review drug |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 无 | | 历史专利信息 | | 无 |
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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 | | 020171 | 039 | AP | Letter | 2015/01/09 | 下载 | | 020171 | 039 | AP | Label | 2015/01/12 | 下载 | | 020171 | 033 | AP | Letter | 2014/04/25 | 下载 | | 020171 | 033 | AP | Label | 2014/04/28 | 下载 | | 020171 | 030 | AP | Label | 2013/04/19 | 下载 | | 020171 | 026 | AP | Label | 2013/02/01 | 下载 | | 020171 | 026 | AP | Letter | 2013/02/04 | 下载 | | 020171 | 015 | AP | Letter | 2009/11/13 | 下载 | | 020171 | 010 | AP | Letter | 2003/12/02 | 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 | | 020171 | 041 | AP | 2016/03/24 | Manufacturing Change or Addition | | 020171 | 039 | AP | 2015/01/08 | Labeling Revision | | 020171 | 036 | AP | 2014/04/23 | Manufacturing Change or Addition | | 020171 | 035 | AP | 2014/01/24 | Manufacturing Change or Addition | | 020171 | 034 | AP | 2014/01/13 | Manufacturing Change or Addition | | 020171 | 033 | AP | 2014/04/24 | Labeling Revision | | 020171 | 030 | AP | 2013/04/18 | Manufacturing Change or Addition | | 020171 | 029 | AP | 2013/02/22 | Manufacturing Change or Addition | | 020171 | 026 | AP | 2013/01/30 | Labeling Revision | | 020171 | 015 | AP | 2009/09/14 | Labeling Revision | | 020171 | 010 | AP | 2003/11/26 | Control Supplement | | 020171 | 008 | AP | 2001/09/26 | Package Change | | 020171 | 007 | AP | 1999/05/18 | Package Change | | 020171 | 006 | AP | 1997/02/24 | Control Supplement | | 020171 | 005 | AP | 1996/06/14 | Control Supplement | | 020171 | 004 | AP | 1996/02/22 | Control Supplement | | 020171 | 003 | AP | 1996/01/19 | Control Supplement | | 020171 | 002 | AP | 1996/03/08 | Control Supplement | | 020171 | 001 | AP | 1994/03/10 | Control Supplement | | 020171 | 000 | AP | 1992/08/19 | Approval |
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