| 药品名称 | CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER | | 申请号 | 020678 | 产品号 | 001 | | 活性成分 | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 1997/03/26 | 申请机构 | BAXTER HEALTHCARE CORP
| | 化学类型 | New combination | 审评分类 | Standard review drug |
|
|
| 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 |
|
| 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 |
|
| 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 | | 020678 | 027 | AP | Label | 2016/09/29 | 下载 | | 020678 | 027 | AP | Letter | 2016/09/30 | 下载 | | 020678 | 021 | AP | Letter | 2010/01/20 | 下载 | | 020678 | 014 | AP | Letter | 2004/02/02 | 下载 | | 020678 | 013 | AP | Letter | 2003/06/08 | 下载 | | 020678 | 011 | AP | Letter | 2002/07/25 | 下载 | | 020678 | 010 | AP | Letter | 2002/07/25 | 下载 | | 020678 | 003 | AP | Letter | 2000/04/12 | 下载 | | 020678 | 003 | AP | Review | 2000/04/12 | 下载 | | 020678 | 000 | AP | Review | 2010/01/05 | 下载 |
|
| 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 | | 020678 | 033 | AP | 2016/09/09 | Manufacturing Change or Addition | | 020678 | 031 | AP | 2015/09/01 | Manufacturing Change or Addition | | 020678 | 030 | AP | 2015/02/09 | Manufacturing Change or Addition | | 020678 | 029 | AP | 2014/09/30 | Manufacturing Change or Addition | | 020678 | 028 | AP | 2014/08/29 | Manufacturing Change or Addition | | 020678 | 027 | AP | 2016/09/27 | Labeling Revision | | 020678 | 024 | AP | 2014/09/15 | Manufacturing Change or Addition | | 020678 | 021 | AP | 2009/11/02 | Labeling Revision | | 020678 | 014 | AP | 2004/01/23 | Labeling Revision | | 020678 | 013 | AP | 2003/05/21 | Control Supplement | | 020678 | 011 | AP | 2002/07/25 | Labeling Revision | | 020678 | 010 | AP | 2002/07/25 | Control Supplement | | 020678 | 009 | AP | 2002/02/15 | Package Change | | 020678 | 007 | AP | 2001/04/04 | Control Supplement | | 020678 | 006 | AP | 2000/10/19 | Package Change | | 020678 | 005 | AP | 2000/03/24 | Control Supplement | | 020678 | 004 | AP | 2000/02/25 | Package Change | | 020678 | 003 | AP | 2000/04/12 | Efficacy Supplement with Clinical Data to Support | | 020678 | 002 | AP | 1999/05/25 | Manufacturing Change or Addition | | 020678 | 001 | AP | 1999/04/15 | Control Supplement | | 020678 | 000 | AP | 1997/03/26 | Approval |
|