药品名称REGONOL
申请号017398产品号001
活性成分PYRIDOSTIGMINE BROMIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5MG/ML
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SANDOZ CANADA INC
化学类型New formulation or new manufacturer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
017398015APLetter2004/09/29下载
017398015APLabel2004/09/29下载
017398014APLetter2003/10/22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
017398021AP2016/05/18Manufacturing Change or Addition
017398018AP2013/07/22Manufacturing Change or Addition
017398015AP2004/09/21Manufacturing Change or Addition
017398014AP2003/10/17Manufacturing Change or Addition
017398013AP1999/07/12Labeling Revision
017398012AP1999/03/15Manufacturing Change or Addition
017398011AP1997/03/04Control Supplement
017398010AP1994/02/28Manufacturing Change or Addition
017398009AP1992/10/06Manufacturing Change or Addition
017398008AP1990/10/05Manufacturing Change or Addition
017398007AP1988/03/30Control Supplement
017398006AP1987/02/10Control Supplement
017398005AP1999/03/05Labeling Revision
017398004AP1982/05/18Labeling Revision
017398003AP1982/05/18Manufacturing Change or Addition
017398002AP1980/11/13Labeling Revision
017398001AP1980/11/13Control Supplement
017398000AP1973/08/14Approval