药品名称MUCOMYST
申请号013601产品号001
活性成分ACETYLCYSTEINE市场状态停止上市
剂型或给药途径SOLUTION;INHALATION, ORAL规格20%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构APOTHECON INC DIV BRISTOL MYERS SQUIBB
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
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
013601029APReview2012/06/26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
013601053AP2001/09/24Manufacturing Change or Addition
013601052AP1997/03/19Labeling Revision
013601051AP1997/04/21Manufacturing Change or Addition
013601050AP1991/04/05Manufacturing Change or Addition
013601048AP1993/07/13Package Change
013601044AP1987/01/16Control Supplement
013601041AP1986/06/18Control Supplement
013601039AP1983/03/02Control Supplement
013601036AP1981/11/20Control Supplement
013601035AP1985/01/31General Efficacy (MarkIV)
013601034AP1980/01/10Control Supplement
013601033AP1979/06/18Control Supplement
013601032AP1979/04/23Control Supplement
013601031AP1978/09/19Control Supplement
013601030AP1978/08/14Control Supplement
013601029AP1978/09/01Labeling Revision
013601028AP1980/02/08Control Supplement
013601026AP1977/12/08Manufacturing Change or Addition
013601025AP1977/10/06Package Change
013601024AP1977/09/15Control Supplement
013601022AP1975/09/02Control Supplement
013601020AP1975/04/18Control Supplement
013601019AP1975/04/10Control Supplement
013601018AP1974/08/19Supplement
013601000AP1963/09/14Approval