药品名称ZANOSAR
申请号050577产品号001
活性成分STREPTOZOCIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1GM/VIAL
治疗等效代码参比药物
批准日期1982/05/07申请机构TEVA PHARMACEUTICALS USA
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
050577016APLetter2003/01/22下载
050577014APLetter2003/07/30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
050577041AP2015/01/05Manufacturing Change or Addition
050577040AP2015/01/05Manufacturing Change or Addition
050577039AP2014/09/23Manufacturing Change or Addition
050577038AP2014/07/31Manufacturing Change or Addition
050577037AP2012/12/12Manufacturing Change or Addition
050577036AP2013/08/09Manufacturing Change or Addition
050577035AP2012/12/04Manufacturing Change or Addition
050577034AP2012/12/04Manufacturing Change or Addition
050577020AP2012/12/04Manufacturing Change or Addition
050577017AP2002/10/22Control Supplement
050577016AP2003/01/22Labeling Revision
050577015AP2000/04/03Control Supplement
050577014AP2002/12/30Labeling Revision
050577013AP1999/05/05Labeling Revision
050577012AP1995/06/29Control Supplement
050577011AP1994/09/27Manufacturing Change or Addition
050577010AP1993/06/14Control Supplement
050577007AP1994/08/11Control Supplement
050577006AP1988/04/22Labeling Revision
050577005AP1986/11/17Labeling Revision
050577000AP1982/05/07Approval