药品名称THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
申请号018649产品号003
活性成分THEOPHYLLINE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格160MG/100ML
治疗等效代码参比药物
批准日期1982/07/26申请机构BAXTER HEALTHCARE CORP
化学类型New combination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
018649043APLetter2008/10/21下载
018649040APLetter2004/01/09下载
018649040APLabel2004/01/15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
018649043AP2008/10/17Packaging Addition
018649040AP2003/12/31Labeling Revision
018649038AP1999/11/23Package Change
018649037AP1999/07/16Manufacturing Change or Addition
018649036AP1997/12/22Manufacturing Change or Addition
018649035AP1997/05/02Package Change
018649034AP1996/09/04Labeling Revision
018649033AP1994/07/27Manufacturing Change or Addition
018649032AP1994/02/25Control Supplement
018649031AP1994/09/26Control Supplement
018649030AP1993/05/27Manufacturing Change or Addition
018649028AP1991/08/30Control Supplement
018649027AP1992/11/03Control Supplement
018649026AP1992/10/16Package Change
018649025AP1989/07/26Control Supplement
018649024AP1989/01/12Control Supplement
018649022AP1987/11/18Package Change
018649021AP1987/07/25Package Change
018649019AP1987/05/28Control Supplement
018649015AP1986/02/27Package Change
018649014AP1985/04/26Control Supplement
018649013AP1985/09/14Expiration Date Change
018649011AP1985/04/10Labeling Revision
018649010AP1985/11/13Labeling Revision
018649009AP1985/11/13Control Supplement
018649008AP1985/06/13Control Supplement
018649007AP1984/04/30Control Supplement
018649006AP1984/10/04Control Supplement
018649005AP1986/04/15Practioner Draft Labeling
018649004AP1984/02/28Control Supplement
018649003AP1984/04/30Labeling Revision
018649001AP1982/09/02Expiration Date Change
018649000AP1982/07/26Approval