药品名称ROBAXIN
申请号011011产品号004
活性成分METHOCARBAMOL市场状态处方药
剂型或给药途径TABLET;ORAL规格500MG
治疗等效代码AA参比药物
批准日期Approved Prior to Jan 1, 1982申请机构AUXILIUM PHARMACEUTICALS LLC
化学类型New molecular entity (NME)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
011011071APLabel2003/05/06下载
011011071APLetter2003/05/16下载
011011070APLabel2003/05/06下载
011011070APLetter2003/05/16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
011011077AP2015/03/09Manufacturing Change or Addition
011011071AP2003/05/01Labeling Revision
011011070AP2003/05/01Labeling Revision
011011069AP1998/04/22Manufacturing Change or Addition
011011066AP1990/08/21Manufacturing Change or Addition
011011064AP1989/01/06Manufacturing Change or Addition
011011063AP1987/01/28Control Supplement
011011062AP1986/04/16Control Supplement
011011061AP1986/04/16Control Supplement
011011060AP1985/10/25Labeling Revision
011011059AP1985/04/29Manufacturing Change or Addition
011011058AP1985/04/29Manufacturing Change or Addition
011011057AP1984/06/27Control Supplement
011011055AP1983/01/25Control Supplement
011011054AP1983/04/07Package Change
011011053AP1982/10/18Control Supplement
011011052AP1982/10/01Control Supplement
011011050AP1982/01/18Control Supplement
011011049AP1982/03/15Expiration Date Change
011011048AP1981/12/21Manufacturing Change or Addition
011011047AP1981/12/24Control Supplement
011011046AP1981/12/24Control Supplement
011011044AP1982/01/18Control Supplement
011011043AP1981/11/02Control Supplement
011011042AP1982/07/15Package Change
011011041AP1981/01/22Formulation Revision
011011040AP1981/01/22Formulation Revision
011011039AP1981/12/07Labeling Revision
011011038AP1981/10/28Labeling Revision
011011032AP1980/02/11Manufacturing Change or Addition
011011031AP1979/07/24Manufacturing Change or Addition
011011022AP1979/05/21Manufacturing Change or Addition
011011020AP1979/05/21Labeling Revision
011011019AP1979/05/21Labeling Revision
011011018AP1976/03/10Control Supplement
011011017AP1975/05/01Control Supplement
011011015AP1974/10/22Labeling Revision
011011013AP1975/04/29Control Supplement
011011012AP1975/04/29Control Supplement
011011011AP1974/12/09Distributor
011011008AP1974/10/17Control Supplement
011011000AP1957/07/16Approval