药品名称GUANIDINE HYDROCHLORIDE
申请号001546产品号001
活性成分GUANIDINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格125MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MERCK SHARP AND DOHME CORP
化学类型审评分类
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
001546011APLetter2002/04/24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
001546022AP2015/08/03Manufacturing Change or Addition
001546021AP2014/09/30Manufacturing Change or Addition
001546015AP2000/06/16Manufacturing Change or Addition
001546014AP2000/02/14Manufacturing Change or Addition
001546013AP1998/12/23Manufacturing Change or Addition
001546012AP1992/10/28Manufacturing Change or Addition
001546011AP2002/04/24Labeling Revision
001546010AP1986/12/11Control Supplement
001546009AP1984/12/05Manufacturing Change or Addition
001546008AP1983/08/02Package Change
001546007AP1980/06/16Manufacturing Change or Addition
001546006AP1978/02/16Manufacturing Change or Addition
001546004AP1975/01/29Control Supplement
001546000AP1939/10/02Approval