ZOVIRAX(ACYCLOVIR SODIUM) - 美国FDA药品数据库

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剂型或给药途径	INJECTABLE;INJECTION	规格	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	否
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
无
历史专利信息
无

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
018603	027	AP	2004/05/19	Labeling Revision
018603	025	AP	2002/01/29	Labeling Revision
018603	024	AP	2002/01/29	Labeling Revision
018603	023	AP	2002/01/29	Labeling Revision
018603	022	AP	2000/07/12	Manufacturing Change or Addition
018603	021	AP	1999/07/15	Control Supplement
018603	020	AP	1999/05/19	Labeling Revision
018603	019	AP	1998/06/02	New or Modified Indication
018603	018	AP	1996/10/29	Control Supplement
018603	017	AP	1995/06/07	Manufacturing Change or Addition
018603	015	AP	1994/04/14	Labeling Revision
018603	014	AP	1993/11/09	Control Supplement
018603	013	AP	1993/04/22	Labeling Revision
018603	012	AP	1992/07/17	Control Supplement
018603	011	AP	1989/06/29	Package Change
018603	010	AP	1993/04/22	Labeling Revision
018603	009	AP	1990/02/09	New or Modified Indication
018603	008	AP	1984/07/09	Labeling Revision
018603	007	AP	1984/05/31	Manufacturing Change or Addition
018603	006	AP	1984/08/14	Expiration Date Change
018603	005	AP	1984/05/08	Manufacturing Change or Addition
018603	004	AP	1983/08/30	Manufacturing Change or Addition
018603	003	AP	1990/02/09	New or Modified Indication
018603	002	AP	1983/01/05	Expiration Date Change
018603	001	AP	1982/12/14	Control Supplement
018603	000	AP	1982/10/22	Approval