药品名称DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
申请号016689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5GM/100ML;200MG/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
016689105APLabel2013/09/11下载
016689105APLetter2013/09/12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
016689106AP2014/09/26Manufacturing Change or Addition
016689105AP2013/09/10Labeling Revision
016689098AP2004/06/02Labeling Revision
016689096AP2001/08/14Manufacturing Change or Addition
016689095AP1999/11/24Manufacturing Change or Addition
016689094AP2000/11/29Labeling Revision
016689093AP1997/04/29Package Change
016689092AP1996/10/11Package Change
016689091AP1994/02/18Control Supplement
016689090AP1994/09/30Control Supplement
016689087AP1991/04/29Control Supplement
016689086AP1991/03/26Control Supplement
016689085AP1991/02/15Control Supplement
016689084AP1989/07/26Control Supplement
016689083AP1989/01/12Control Supplement
016689082AP1987/07/25Package Change
016689081AP1987/05/28Control Supplement
016689078AP1986/02/27Package Change
016689077AP1985/04/15Control Supplement
016689076AP1985/07/03Labeling Revision
016689074AP1985/06/13Control Supplement
016689073AP1984/09/22Control Supplement
016689072AP1984/02/28Control Supplement
016689070AP1985/08/28Control Supplement
016689069AP1985/08/28Control Supplement
016689068AP1984/03/16Control Supplement
016689067AP1985/01/24Control Supplement
016689065AP1982/02/16Control Supplement
016689064AP1983/07/11Practioner Draft Labeling
016689063AP1981/11/20Control Supplement
016689061AP1982/06/03Control Supplement
016689060AP1981/11/09Control Supplement
016689059AP1982/04/16Control Supplement
016689058AP1981/08/26Labeling Revision
016689057AP1981/12/21Control Supplement
016689056AP1981/05/20Control Supplement
016689054AP1981/06/29Control Supplement
016689053AP1981/01/21Control Supplement
016689052AP1980/07/31Control Supplement
016689051AP1980/08/06Control Supplement
016689050AP1981/04/16Control Supplement
016689048AP1980/06/18Control Supplement
016689047AP1980/05/30Control Supplement
016689046AP1980/02/22Control Supplement
016689045AP1980/08/07Control Supplement
016689043AP1980/06/28Control Supplement
016689042AP1979/08/02Control Supplement
016689040AP1978/10/12Control Supplement
016689039AP1978/10/20Control Supplement
016689038AP1978/08/07Control Supplement
016689037AP1978/08/02Control Supplement
016689036AP1978/11/03Control Supplement
016689035AP1978/04/25Labeling Revision
016689034AP1978/03/22Control Supplement
016689033AP1980/02/25Control Supplement
016689032AP1978/06/20Control Supplement
016689031AP1978/03/24Control Supplement
016689030AP1978/02/28Control Supplement
016689029AP1977/12/14Control Supplement
016689028AP1977/06/06Control Supplement
016689027AP1977/02/07Package Change
016689026AP1976/10/20Labeling Revision
016689025AP1976/07/13Final Printed Labeling - MarkIV
016689024AP1976/06/17Control Supplement
016689022AP1976/01/02Labeling Revision
016689021AP1976/07/01Control Supplement
016689020AP1976/01/05Control Supplement
016689019AP1976/11/26Labeling Revision
016689018AP1975/09/23Control Supplement
016689017AP1976/05/11Labeling Revision
016689016AP1975/09/17Control Supplement
016689015AP1975/09/25Control Supplement
016689013AP1975/07/10Control Supplement
016689000AP1970/12/08Approval