药品名称EMCYT
申请号018045产品号001
活性成分ESTRAMUSTINE PHOSPHATE SODIUM市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 140MG PHOSPHATE
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACIA AND UPJOHN CO
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
018045023APLabel2008/07/10下载
018045023APLetter2008/07/14下载
018045021APLetter2003/10/29下载
018045021APLabel2003/10/31下载
018045016APLetter2002/01/18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
018045028AP2013/02/14Manufacturing Change or Addition
018045023AP2008/07/09Labeling Revision
018045021AP2003/10/28Labeling Revision
018045020AP2001/09/07Control Supplement
018045019AP1999/02/10Manufacturing Change or Addition
018045018AP1999/02/10Manufacturing Change or Addition
018045017AP1998/10/15Manufacturing Change or Addition
018045016AP2002/01/18Labeling Revision
018045015AP1996/01/11Control Supplement
018045014AP1995/03/16Control Supplement
018045011AP1994/01/25Control Supplement
018045010AP1998/10/09Labeling Revision
018045009AP1994/02/18Manufacturing Change or Addition
018045008AP1995/10/05Manufacturing Change or Addition
018045007AP1994/03/16Package Change
018045006AP1993/04/28Control Supplement
018045005AP1987/08/17Labeling Revision
018045004AP1984/10/22Labeling Revision
018045003AP1986/04/25Control Supplement
018045001AP1982/06/30Control Supplement
018045000AP1981/12/24Approval