药品名称DTIC-DOME
申请号017575产品号002
活性成分DACARBAZINE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格200MG/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BAYER HEALTHCARE 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
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
017575020AP1998/09/24Control Supplement
017575019AP1996/05/24Control Supplement
017575016AP1991/07/29Control Supplement
017575015AP1996/11/07Manufacturing Change or Addition
017575013AP1989/04/19Manufacturing Change or Addition
017575012AP1988/12/02Manufacturing Change or Addition
017575009AP1986/05/22Labeling Revision
017575007AP1983/04/05Labeling Revision
017575006AP1985/07/15Manufacturing Change or Addition
017575004AP1980/10/27Manufacturing Change or Addition
017575003AP1981/04/29General Efficacy (MarkIV)
017575002AP1979/05/24Control Supplement
017575001AP1975/11/10Control Supplement
017575000AP1975/05/27Approval