药品名称NITHIODOTE
申请号201444产品号001
活性成分SODIUM NITRITE; SODIUM THIOSULFATE市场状态处方药
剂型或给药途径SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS规格300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)
治疗等效代码参比药物是
批准日期2011/01/14申请机构HOPE PHARMACEUTICALS
化学类型New formulation or new manufacturer审评分类Priority review drug
罕用药/孤儿药是
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
84969732031/03/29YYU-1419PDF格式
85687932031/12/24YYPDF格式
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
ODE2018/01/14
历史市场独占权保护信息
无
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
201444000APLetter2011/01/20下载
201444000APLabel2011/01/20下载
201444000APReview2012/02/10下载
201444000APSummary Review2012/02/10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
201444018AP2016/04/22Manufacturing Change or Addition
201444017AP2016/06/14Manufacturing Change or Addition
201444016AP2015/02/03Manufacturing Change or Addition
201444015AP2015/01/26Manufacturing Change or Addition
201444013AP2014/11/24Manufacturing Change or Addition
201444012AP2014/06/03Manufacturing Change or Addition
201444011AP2013/11/14Manufacturing Change or Addition
201444010AP2013/04/08Manufacturing Change or Addition
201444009AP2013/03/28Manufacturing Change or Addition
201444000AP2011/01/14Approval