药品名称PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
申请号017378产品号001
活性成分MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML
治疗等效代码AP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
017378068APLetter2013/09/13下载
017378068APLabel2013/09/17下载
017378065APLetter2009/01/30下载
017378065APLabel2009/02/04下载
017378055APLetter2002/04/03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
017378072AP2016/04/28Manufacturing Change or Addition
017378071AP2016/01/26Manufacturing Change or Addition
017378069AP2015/02/03Manufacturing Change or Addition
017378068AP2013/09/11Labeling Revision
017378065AP2009/01/27Labeling Revision
017378059AP2001/08/14Manufacturing Change or Addition
017378058AP2001/02/01Labeling Revision
017378057AP1999/11/24Manufacturing Change or Addition
017378056AP1999/02/04Control Supplement
017378055AP2002/04/03Labeling Revision
017378054AP1997/04/29Package Change
017378053AP1994/02/18Control Supplement
017378052AP1994/09/30Control Supplement
017378050AP1991/04/29Control Supplement
017378049AP1990/05/24Control Supplement
017378048AP1991/03/26Control Supplement
017378047AP1991/02/15Control Supplement
017378046AP1989/07/26Control Supplement
017378045AP1987/07/25Package Change
017378044AP1987/05/28Control Supplement
017378042AP1986/02/27Package Change
017378041AP1985/04/15Control Supplement
017378040AP1985/01/26Labeling Revision
017378039AP1985/06/13Control Supplement
017378038AP1984/09/22Control Supplement
017378036AP1984/02/28Control Supplement
017378035AP1985/01/19Labeling Revision
017378033AP1985/08/28Control Supplement
017378032AP1985/08/28Control Supplement
017378031AP1984/03/16Control Supplement
017378030AP1982/11/22Labeling Revision
017378029AP1982/11/22Control Supplement
017378028AP1985/01/24Control Supplement
017378026AP1982/02/16Control Supplement
017378025AP1983/07/11Practioner Draft Labeling
017378024AP1983/07/11Practioner Draft Labeling
017378023AP1981/11/20Control Supplement
017378021AP1982/06/03Control Supplement
017378020AP1982/04/16Control Supplement
017378019AP1981/08/26Labeling Revision
017378018AP1981/12/21Control Supplement
017378017AP1981/09/03Labeling Revision
017378016AP1981/09/03Control Supplement
017378014AP1981/06/29Control Supplement
017378013AP1981/01/21Control Supplement
017378012AP1980/07/31Control Supplement
017378011AP1981/04/16Control Supplement
017378009AP1980/06/18Control Supplement
017378007AP1980/05/30Control Supplement
017378006AP1980/08/07Control Supplement
017378005AP1979/08/02Control Supplement
017378003AP1980/06/28Control Supplement
017378002AP1979/06/14Control Supplement
017378001AP1980/02/25Control Supplement
017378000AP1979/02/02Approval