药品名称DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
申请号016697产品号001
活性成分DEXTROSE; SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2.5GM/100ML;450MG/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
016697096APLabel2013/09/11下载
016697096APLetter2013/09/12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
016697097AP2014/08/29Manufacturing Change or Addition
016697096AP2013/09/10Labeling Revision
016697091AP2004/06/02Labeling Revision
016697089AP2001/08/14Manufacturing Change or Addition
016697088AP1999/11/24Manufacturing Change or Addition
016697087AP2000/11/29Labeling Revision
016697086AP1997/04/29Package Change
016697085AP1994/02/18Control Supplement
016697084AP1994/09/30Control Supplement
016697082AP1991/02/25Control Supplement
016697081AP1991/04/29Control Supplement
016697080AP1991/03/26Control Supplement
016697079AP1991/02/15Control Supplement
016697078AP1989/07/26Control Supplement
016697077AP1989/01/12Control Supplement
016697076AP1987/07/25Package Change
016697075AP1987/05/28Control Supplement
016697073AP1986/02/27Package Change
016697072AP1985/04/15Control Supplement
016697071AP1985/07/03Labeling Revision
016697069AP1985/06/13Control Supplement
016697068AP1984/09/22Control Supplement
016697067AP1984/02/28Control Supplement
016697065AP1985/08/28Control Supplement
016697064AP1985/08/28Control Supplement
016697063AP1984/03/16Control Supplement
016697062AP1985/01/24Control Supplement
016697060AP1982/02/16Control Supplement
016697059AP1983/07/11Practioner Draft Labeling
016697058AP1981/11/20Control Supplement
016697056AP1982/06/03Control Supplement
016697055AP1981/11/09Control Supplement
016697054AP1982/04/16Control Supplement
016697053AP1981/08/26Labeling Revision
016697052AP1981/12/21Control Supplement
016697050AP1981/06/29Control Supplement
016697049AP1981/01/21Control Supplement
016697048AP1980/07/31Control Supplement
016697047AP1980/08/06Control Supplement
016697046AP1981/04/16Control Supplement
016697044AP1980/06/18Control Supplement
016697043AP1980/05/30Control Supplement
016697042AP1980/08/07Control Supplement
016697040AP1980/06/28Control Supplement
016697039AP1979/08/02Control Supplement
016697037AP1978/10/12Control Supplement
016697036AP1978/10/20Control Supplement
016697035AP1978/08/07Control Supplement
016697034AP1978/08/02Control Supplement
016697033AP1978/04/25Labeling Revision
016697032AP1978/03/22Control Supplement
016697031AP1980/02/25Control Supplement
016697030AP1978/06/20Control Supplement
016697029AP1978/03/24Control Supplement
016697028AP1978/02/28Control Supplement
016697027AP1977/12/14Control Supplement
016697026AP1977/06/06Control Supplement
016697025AP1977/02/07Package Change
016697024AP1976/07/13Final Printed Labeling - MarkIV
016697023AP1976/06/17Control Supplement
016697021AP1976/01/02Labeling Revision
016697020AP1976/07/01Control Supplement
016697019AP1976/01/05Control Supplement
016697018AP1976/10/29Labeling Revision
016697017AP1975/09/23Control Supplement
016697016AP1976/05/11Labeling Revision
016697015AP1975/09/17Control Supplement
016697014AP1975/06/16Control Supplement
016697012AP1975/07/10Control Supplement
016697000AP1971/03/22Approval