药品名称CORTROSYN
申请号016750产品号001
活性成分COSYNTROPIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.25MG/VIAL
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AMPHASTAR PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
016750018APLetter2002/11/08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
016750028AP2014/09/29Manufacturing Change or Addition
016750018AP2002/11/05Labeling Revision
016750017AP2000/12/07Control Supplement
016750016AP1999/03/18Control Supplement
016750015AP1998/01/09Labeling Revision
016750014AP1997/01/29Manufacturing Change or Addition
016750013AP1997/04/08Control Supplement
016750012AP1994/02/18Manufacturing Change or Addition
016750010AP1989/04/28Labeling Revision
016750009AP1988/10/28Manufacturing Change or Addition
016750008AP1988/05/09Control Supplement
016750007AP1987/02/26Control Supplement
016750006AP1987/05/08Control Supplement
016750005AP1987/02/10Control Supplement
016750004AP1986/04/02Labeling Revision
016750003AP1982/10/26Manufacturing Change or Addition
016750002AP1982/04/28Control Supplement
016750000AP1970/04/22Approval