药品名称PROCALAMINE
申请号018582产品号001
活性成分AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML
治疗等效代码参比药物
批准日期1982/05/08申请机构B BRAUN MEDICAL INC
化学类型New dosage form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
018582031APLetter2004/01/09下载
018582031APLabel2004/01/15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
018582047AP2013/08/21Manufacturing Change or Addition
018582042AP2013/03/19Manufacturing Change or Addition
018582031AP2003/12/24Control Supplement
018582030AP2000/06/20Control Supplement
018582029AP2000/04/12Control Supplement
018582028AP1999/05/04Control Supplement
018582027AP1996/06/14Control Supplement
018582026AP1995/09/13Control Supplement
018582024AP1994/10/28Manufacturing Change or Addition
018582023AP1993/06/08Control Supplement
018582022AP1992/09/28Manufacturing Change or Addition
018582021AP1991/12/11Manufacturing Change or Addition
018582020AP1990/04/11Control Supplement
018582017AP1987/12/08Labeling Revision
018582016AP1987/07/09Labeling Revision
018582014AP1986/11/13Control Supplement
018582012AP1986/05/21Labeling Revision
018582010AP1985/06/14Control Supplement
018582009AP1988/04/11Labeling Revision
018582008AP1988/03/07Package Change
018582006AP1985/06/27Package Change
018582005AP1985/09/10Labeling Revision
018582004AP1985/09/10Formulation Revision
018582003AP1982/07/01Control Supplement
018582002AP1982/08/26Control Supplement
018582001AP1982/07/19Control Supplement
018582000AP1982/05/06Approval