药品名称CYTOVENE
申请号019661产品号001
活性成分GANCICLOVIR SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 500MG BASE/VIAL
治疗等效代码AP参比药物
批准日期1989/06/23申请机构ROCHE PALO ALTO LLC
化学类型New molecular entity (NME)审评分类
罕用药/孤儿药
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
019661030APLabel2006/02/02下载
019661030APLetter2006/02/02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
019661035AP2016/03/17Manufacturing Change or Addition
019661034AP2013/04/08Manufacturing Change or Addition
019661030AP2006/01/31Labeling Revision
019661029AP2002/10/25Control Supplement
019661028AP2002/09/23Manufacturing Change or Addition
019661027AP2002/03/21Control Supplement
019661026AP2000/05/11Control Supplement
019661025AP2000/03/30Expiration Date Change
019661024AP2000/12/01Labeling Revision
019661023AP1999/08/27Manufacturing Change or Addition
019661022AP1997/11/14Labeling Revision
019661021AP1997/05/23Manufacturing Change or Addition
019661020AP1996/05/29Labeling Revision
019661019AP1996/05/08Labeling Revision
019661018AP1996/08/08Control Supplement
019661017AP1995/07/20Control Supplement
019661016AP1995/04/28Package Change
019661015AP1995/01/20Labeling Revision
019661014AP1994/09/13Package Change
019661013AP1994/09/30Control Supplement
019661012AP1992/09/30Control Supplement
019661011AP1992/10/09Control Supplement
019661010AP1993/01/15Control Supplement
019661008AP1992/05/15New or Modified Indication
019661007AP1992/06/19Manufacturing Change or Addition
019661006AP1992/07/17Control Supplement
019661004AP1990/07/24Labeling Revision
019661003AP1993/02/09Control Supplement
019661002AP1990/01/11Labeling Revision
019661000AP1989/06/23Approval