药品名称ROBAXIN
申请号011790产品号001
活性成分METHOCARBAMOL市场状态处方药
剂型或给药途径SOLUTION;IM-IV规格1GM/10ML (100MG/ML)
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
化学类型New dosage form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
011790046APLabel2004/05/04下载
011790046APLetter2004/05/04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
011790051AP2014/08/12Manufacturing Change or Addition
011790050AP2014/04/29Manufacturing Change or Addition
011790046AP2004/05/04Labeling Revision
011790042AP2001/02/28Control Supplement
011790041AP1999/12/29Manufacturing Change or Addition
011790040AP1998/04/22Manufacturing Change or Addition
011790038AP1990/12/11Package Change
011790037AP1988/12/02Control Supplement
011790036AP1987/01/22Control Supplement
011790035AP1987/01/07Control Supplement
011790034AP1986/01/03Manufacturing Change or Addition
011790033AP1982/12/16Manufacturing Change or Addition
011790032AP1983/06/20Labeling Revision
011790030AP1982/09/03Manufacturing Change or Addition
011790029AP1981/09/29Control Supplement
011790028AP1982/01/22Labeling Revision
011790027AP1981/06/10Labeling Revision
011790026AP1980/01/03Expiration Date Change
011790025AP1980/05/23Formulation Revision
011790024AP1980/05/23Manufacturing Change or Addition
011790023AP1980/05/01Manufacturing Change or Addition
011790022AP1979/09/17Manufacturing Change or Addition
011790012AP1976/03/11Control Supplement
011790000AP1959/06/10Approval