药品名称BUTISOL SODIUM
申请号000793产品号002
活性成分BUTABARBITAL SODIUM市场状态停止上市
剂型或给药途径TABLET;ORAL规格15MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MEDA PHARMACEUTICALS INC
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
000793025APLetter2007/10/04下载
000793025APLabel2007/10/04下载
000793000APOther Important Information from FDA2007/03/16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
000793025AP2007/09/28Labeling Revision
000793024AP2002/10/23Manufacturing Change or Addition
000793023AP2000/04/10Manufacturing Change or Addition
000793022AP2000/01/21Manufacturing Change or Addition
000793021AP1998/11/13Manufacturing Change or Addition
000793020AP2000/05/02Labeling Revision
000793019AP1992/11/02Manufacturing Change or Addition
000793018AP1993/01/14Manufacturing Change or Addition
000793017AP1987/01/15Control Supplement
000793016AP1986/09/26Control Supplement
000793015AP1998/11/04Labeling Revision
000793014AP1984/02/29Manufacturing Change or Addition
000793013AP1984/06/15Package Change
000793012AP1983/11/22Package Change
000793011AP1983/11/22Labeling Revision
000793010AP1983/11/22Manufacturing Change or Addition
000793009AP1983/11/22Manufacturing Change or Addition
000793008AP1982/11/08Labeling Revision
000793007AP1982/02/26Labeling Revision
000793006AP1979/02/16Labeling Revision
000793005AP1979/02/16Labeling Revision
000793004AP1978/06/02Manufacturing Change or Addition
000793003AP1976/11/30Formulation Revision
000793000AP1939/06/05Approval