药品名称ZOVIRAX
申请号018603产品号002
活性成分ACYCLOVIR SODIUM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1989/06/29申请机构GLAXOSMITHKLINE
化学类型审评分类Priority 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
018603027APLetter2004/05/27下载
018603027APLabel2004/05/27下载
018603025APLetter2002/01/29下载
018603024APLetter2002/01/29下载
018603023APLetter2002/01/29下载
018603019APLetter1998/06/02下载
018603019APLabel1998/06/02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
018603027AP2004/05/19Labeling Revision
018603025AP2002/01/29Labeling Revision
018603024AP2002/01/29Labeling Revision
018603023AP2002/01/29Labeling Revision
018603022AP2000/07/12Manufacturing Change or Addition
018603021AP1999/07/15Control Supplement
018603020AP1999/05/19Labeling Revision
018603019AP1998/06/02New or Modified Indication
018603018AP1996/10/29Control Supplement
018603017AP1995/06/07Manufacturing Change or Addition
018603015AP1994/04/14Labeling Revision
018603014AP1993/11/09Control Supplement
018603013AP1993/04/22Labeling Revision
018603012AP1992/07/17Control Supplement
018603011AP1989/06/29Package Change
018603010AP1993/04/22Labeling Revision
018603009AP1990/02/09New or Modified Indication
018603008AP1984/07/09Labeling Revision
018603007AP1984/05/31Manufacturing Change or Addition
018603006AP1984/08/14Expiration Date Change
018603005AP1984/05/08Manufacturing Change or Addition
018603004AP1983/08/30Manufacturing Change or Addition
018603003AP1990/02/09New or Modified Indication
018603002AP1983/01/05Expiration Date Change
018603001AP1982/12/14Control Supplement
018603000AP1982/10/22Approval