药品名称THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
申请号019211产品号002
活性成分THEOPHYLLINE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格80MG/100ML
治疗等效代码参比药物
批准日期1984/12/14申请机构HOSPIRA INC
化学类型New formulation or new manufacturer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
019211042APLetter2009/04/01下载
019211042APLabel2009/04/03下载
019211040APLetter2008/11/03下载
019211040APLabel2008/11/07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
019211042AP2009/03/26Labeling Revision
019211040AP2008/10/31Labeling Revision
019211030AP2002/11/01Package Change
019211028AP1998/11/10Control Supplement
019211027AP1997/07/10Manufacturing Change or Addition
019211026AP1996/07/22Package Change
019211025AP1996/02/05Labeling Revision
019211024AP1996/02/13Package Change
019211022AP1995/08/21Manufacturing Change or Addition
019211020AP1996/07/09Control Supplement
019211019AP1996/07/09Control Supplement
019211018AP1996/02/02Labeling Revision
019211016AP1992/07/13Package Change
019211015AP1991/12/02Package Change
019211014AP1992/03/23Control Supplement
019211013AP1990/02/22Manufacturing Change or Addition
019211011AP1988/01/20Labeling Revision
019211010AP1988/01/20Control Supplement
019211008AP1986/10/31Labeling Revision
019211007AP1992/03/23Control Supplement
019211006AP1986/11/26Control Supplement
019211005AP1986/08/11Control Supplement
019211004AP1986/08/08Control Supplement
019211003AP1986/01/24Control Supplement
019211002AP1986/08/29Control Supplement
019211001AP1986/01/31Control Supplement
019211000AP1984/12/14Approval