药品名称PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
申请号017385产品号001
活性成分DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;32MG/100ML;128MG/100ML;234MG/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
017385062APLetter2016/03/22下载
017385062APLabel2016/03/22下载
017385060APLetter2014/12/24下载
017385060APLabel2015/01/09下载
017385059APLetter2013/09/13下载
017385059APLabel2013/09/17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
017385062AP2016/03/18Labeling Revision
017385060AP2014/12/22Labeling Revision
017385059AP2013/09/11Labeling Revision
017385052AP2001/08/14Manufacturing Change or Addition
017385051AP2001/02/01Labeling Revision
017385050AP1999/11/24Manufacturing Change or Addition
017385049AP2000/11/29Labeling Revision
017385048AP1997/04/29Package Change
017385047AP1994/02/18Control Supplement
017385046AP1994/09/30Control Supplement
017385044AP1991/04/29Control Supplement
017385043AP1991/01/10Control Supplement
017385042AP1991/03/26Control Supplement
017385041AP1991/02/15Control Supplement
017385040AP1989/07/26Control Supplement
017385039AP1987/07/25Package Change
017385038AP1987/05/28Control Supplement
017385036AP1986/02/27Package Change
017385035AP1985/04/15Control Supplement
017385034AP1985/04/18Labeling Revision
017385033AP1985/06/13Control Supplement
017385032AP1984/09/22Control Supplement
017385031AP1984/02/28Control Supplement
017385029AP1985/08/28Control Supplement
017385028AP1985/08/28Control Supplement
017385027AP1984/03/16Control Supplement
017385026AP1985/01/24Control Supplement
017385024AP1982/02/16Control Supplement
017385023AP1983/07/11Practioner Draft Labeling
017385022AP1981/11/20Control Supplement
017385020AP1982/06/03Control Supplement
017385019AP1982/04/16Control Supplement
017385018AP1981/08/26Labeling Revision
017385017AP1981/12/21Control Supplement
017385015AP1981/06/29Control Supplement
017385014AP1981/01/21Control Supplement
017385013AP1980/07/31Control Supplement
017385012AP1980/08/06Control Supplement
017385011AP1981/04/16Control Supplement
017385010AP1980/05/30Control Supplement
017385008AP1980/06/18Control Supplement
017385006AP1979/08/10Control Supplement
017385005AP1980/08/07Control Supplement
017385004AP1979/08/02Control Supplement
017385002AP1980/06/28Control Supplement
017385001AP1980/02/25Control Supplement
017385000AP1979/02/01Approval