药品名称MESANTOIN
申请号006008产品号001
活性成分MEPHENYTOIN市场状态停止上市
剂型或给药途径TABLET;ORAL规格100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构NOVARTIS PHARMACEUTICALS 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
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
006008049AP2001/04/02Manufacturing Change or Addition
006008048AP1999/04/23Package Change
006008046AP1997/07/15Control Supplement
006008045AP1996/02/21Control Supplement
006008044AP1995/02/15Control Supplement
006008043AP1995/08/14Control Supplement
006008042AP1994/12/14Labeling Revision
006008041AP1994/12/14Labeling Revision
006008040AP1994/11/23Package Change
006008039AP1996/07/23Formulation Revision
006008038AP1994/07/01Control Supplement
006008035AP1987/11/10Labeling Revision
006008034AP1986/08/27Control Supplement
006008033AP1984/12/05Manufacturing Change or Addition
006008032AP1986/08/27Control Supplement
006008031AP1983/08/08Control Supplement
006008030AP1981/07/20Manufacturing Change or Addition
006008027AP1981/03/06Package Change
006008026AP1980/07/24Labeling Revision
006008025AP1979/06/14Package Change
006008024AP1978/09/28Package Change
006008023AP1978/02/13Package Change
006008022AP1977/02/18Package Change
006008021AP1976/07/20Package Change
006008020AP1976/07/23Package Change
006008019AP1976/05/04Package Change
006008018AP1976/05/04Control Supplement
006008017AP1975/07/01Control Supplement
006008015AP1975/11/10Labeling Revision
006008014AP1974/09/20Control Supplement
006008011AP1974/08/29Control Supplement
006008000AP1946/10/23Approval