药品名称PHYSIOLYTE IN PLASTIC CONTAINER
申请号019024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SOLUTION;IRRIGATION规格30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML
治疗等效代码参比药物
批准日期1984/06/08申请机构B BRAUN MEDICAL INC
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
019024015APLetter2003/10/28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
019024021AP2013/05/08Manufacturing Change or Addition
019024015AP2003/10/22Labeling Revision
019024014AP2002/07/08Control Supplement
019024013AP2002/04/03Control Supplement
019024012AP1999/05/04Control Supplement
019024011AP1998/03/25Control Supplement
019024010AP1995/10/26Control Supplement
019024009AP1995/09/13Control Supplement
019024008AP1999/03/18Control Supplement
019024007AP1990/09/11Package Change
019024005AP1988/04/19Control Supplement
019024002AP1987/03/05Control Supplement
019024001AP1985/09/18Control Supplement
019024000AP1984/06/08Approval