药品名称DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
申请号018008产品号002
活性成分DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;75MG/100ML;450MG/100ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BAXTER HEALTHCARE CORP
化学类型New formulation or new manufacturer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
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
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
018008070APLabel2013/09/11下载
018008070APLetter2013/09/12下载
018008066APLabel2007/04/25下载
018008066APLetter2007/05/01下载
018008065APLabel2005/08/31下载
018008065APLetter2005/08/31下载
018008063APLetter2004/06/07下载
018008059APLetter2003/05/29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
018008071AP2014/09/26Manufacturing Change or Addition
018008070AP2013/09/10Labeling Revision
018008066AP2007/04/20Labeling Revision
018008065AP2005/08/26Package Change
018008063AP2004/06/02Labeling Revision
018008060AP2001/08/14Manufacturing Change or Addition
018008059AP2003/04/14Labeling Revision
018008058AP1999/11/24Manufacturing Change or Addition
018008057AP1997/04/29Package Change
018008056AP1994/02/18Control Supplement
018008055AP1994/09/30Control Supplement
018008054AP1993/04/22Labeling Revision
018008053AP1991/12/11Control Supplement
018008051AP1991/04/29Control Supplement
018008050AP1991/03/26Control Supplement
018008049AP1991/02/15Control Supplement
018008048AP1989/07/26Control Supplement
018008047AP1987/07/25Package Change
018008046AP1987/05/28Control Supplement
018008044AP1986/02/27Package Change
018008043AP1985/04/15Control Supplement
018008042AP1985/07/03Labeling Revision
018008041AP1985/06/13Control Supplement
018008040AP1984/10/23Control Supplement
018008039AP1984/02/28Control Supplement
018008037AP1985/08/28Control Supplement
018008036AP1985/08/28Control Supplement
018008035AP1984/03/16Control Supplement
018008034AP1985/01/24Control Supplement
018008032AP1982/05/25Labeling Revision
018008031AP1982/04/28Labeling Revision
018008029AP1983/07/11Practioner Draft Labeling
018008028AP1981/11/20Control Supplement
018008026AP1982/06/03Control Supplement
018008025AP1981/11/09Control Supplement
018008024AP1982/04/16Control Supplement
018008023AP1981/08/26Labeling Revision
018008022AP1981/12/21Control Supplement
018008020AP1981/06/29Control Supplement
018008019AP1981/05/29Control Supplement
018008018AP1981/01/21Control Supplement
018008017AP1980/07/31Control Supplement
018008014AP1980/08/06Control Supplement
018008013AP1981/04/16Control Supplement
018008012AP1980/02/22Labeling Revision
018008010AP1980/06/18Control Supplement
018008008AP1980/05/28Control Supplement
018008007AP1980/05/30Control Supplement
018008006AP1980/08/07Control Supplement
018008005AP1979/08/02Control Supplement
018008003AP1980/06/28Control Supplement
018008002AP1979/06/14Control Supplement
018008001AP1980/02/25Control Supplement
018008000AP1979/02/02Approval