药品名称DEXTROSE 50% IN PLASTIC CONTAINER
申请号017521产品号001
活性成分DEXTROSE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格50GM/100ML
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BAXTER HEALTHCARE CORP
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
017521068APLetter2014/12/24下载
017521068APLabel2015/01/09下载
017521063APLetter2003/07/31下载
017521063APReview2007/09/24下载
017521062APLetter2003/07/31下载
017521062APReview2007/09/24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
017521072AP2016/03/23Manufacturing Change or Addition
017521071AP2016/01/15Manufacturing Change or Addition
017521070AP2015/02/03Manufacturing Change or Addition
017521068AP2014/12/22Labeling Revision
017521064AP2001/08/14Manufacturing Change or Addition
017521063AP2002/11/14Labeling Revision
017521062AP2002/11/14Labeling Revision
017521061AP2000/12/07Efficacy Supplement with Clinical Data to Support
017521060AP1999/11/24Manufacturing Change or Addition
017521059AP1999/05/25Manufacturing Change or Addition
017521058AP1998/06/22Control Supplement
017521057AP1997/04/29Package Change
017521056AP1994/02/18Control Supplement
017521055AP1994/09/30Control Supplement
017521052AP1993/07/13Manufacturing Change or Addition
017521051AP1991/03/26Control Supplement
017521050AP1995/01/05Labeling Revision
017521049AP1995/01/05Control Supplement
017521048AP1990/05/18Control Supplement
017521047AP1991/02/15Control Supplement
017521042AP1989/07/26Control Supplement
017521041AP1989/01/12Control Supplement
017521039AP1987/12/09Package Change
017521038AP1985/04/23Labeling Revision
017521037AP1985/04/15Control Supplement
017521036AP1984/09/21Control Supplement
017521035AP1985/06/13Control Supplement
017521034AP1984/09/22Control Supplement
017521033AP1984/08/24Practioner Draft Labeling
017521032AP1984/02/28Control Supplement
017521028AP1984/03/16Control Supplement
017521027AP1985/01/24Control Supplement
017521025AP1982/02/16Control Supplement
017521024AP1981/11/20Control Supplement
017521022AP1982/06/03Control Supplement
017521021AP1981/11/09Control Supplement
017521018AP1982/04/16Control Supplement
017521017AP1981/08/26Labeling Revision
017521016AP1981/12/21Control Supplement
017521015AP1982/03/26Labeling Revision
017521014AP1982/03/26Control Supplement
017521012AP1981/06/29Control Supplement
017521011AP1981/01/21Control Supplement
017521010AP1980/09/09Labeling Revision
017521009AP1980/09/09Control Supplement
017521008AP1980/07/31Control Supplement
017521007AP1980/08/06Control Supplement
017521006AP1981/04/16Control Supplement
017521005AP1980/02/11Control Supplement
017521004AP1980/06/18Control Supplement
017521003AP1980/05/30Control Supplement
017521002AP1980/07/18Labeling Revision
017521001AP1980/07/18Control Supplement
017521000AP1979/08/28Approval