药品名称DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
申请号016683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;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
016683100APLabel2013/09/11下载
016683100APLetter2013/09/12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
016683102AP2014/08/22Manufacturing Change or Addition
016683101AP2013/10/31Manufacturing Change or Addition
016683100AP2013/09/10Labeling Revision
016683094AP2004/06/02Labeling Revision
016683092AP2001/08/14Manufacturing Change or Addition
016683091AP1999/11/24Manufacturing Change or Addition
016683090AP2000/11/29Labeling Revision
016683089AP1997/04/29Package Change
016683088AP1996/10/11Package Change
016683087AP1994/02/18Control Supplement
016683086AP1994/09/30Control Supplement
016683083AP1991/04/29Control Supplement
016683082AP1991/03/26Control Supplement
016683081AP1991/02/15Control Supplement
016683080AP1989/07/26Control Supplement
016683079AP1989/01/12Control Supplement
016683078AP1987/07/25Package Change
016683077AP1987/05/28Control Supplement
016683074AP1985/04/15Control Supplement
016683073AP1985/07/03Labeling Revision
016683071AP1985/06/13Control Supplement
016683070AP1984/09/22Control Supplement
016683069AP1984/02/28Control Supplement
016683067AP1985/08/28Control Supplement
016683066AP1985/08/28Control Supplement
016683065AP1984/03/16Control Supplement
016683064AP1985/01/24Control Supplement
016683062AP1982/02/16Control Supplement
016683061AP1983/07/11Practioner Draft Labeling
016683060AP1981/11/20Control Supplement
016683058AP1982/06/03Control Supplement
016683057AP1981/11/09Control Supplement
016683056AP1982/04/16Control Supplement
016683055AP1981/08/26Labeling Revision
016683054AP1981/12/21Control Supplement
016683053AP1981/10/23Labeling Revision
016683052AP1981/10/23Control Supplement
016683050AP1981/06/29Control Supplement
016683049AP1981/01/21Control Supplement
016683048AP1980/07/31Control Supplement
016683047AP1980/08/06Control Supplement
016683046AP1981/04/16Control Supplement
016683044AP1980/06/18Control Supplement
016683043AP1980/05/30Control Supplement
016683042AP1980/08/07Control Supplement
016683040AP1980/06/28Control Supplement
016683039AP1979/08/02Control Supplement
016683037AP1978/10/12Control Supplement
016683036AP1978/10/20Control Supplement
016683035AP1978/08/07Control Supplement
016683034AP1978/08/02Control Supplement
016683033AP1978/04/25Labeling Revision
016683032AP1978/03/22Control Supplement
016683031AP1980/02/25Control Supplement
016683030AP1978/06/20Control Supplement
016683029AP1978/03/24Control Supplement
016683028AP1978/02/28Control Supplement
016683027AP1977/12/14Control Supplement
016683026AP1977/06/06Control Supplement
016683025AP1977/02/07Package Change
016683024AP1976/07/13Final Printed Labeling - MarkIV
016683023AP1976/06/17Control Supplement
016683021AP1976/01/02Labeling Revision
016683020AP1976/07/01Control Supplement
016683019AP1976/01/05Control Supplement
016683018AP1976/10/29Labeling Revision
016683017AP1975/09/23Control Supplement
016683016AP1976/05/11Labeling Revision
016683015AP1975/09/17Control Supplement
016683014AP1975/09/25Control Supplement
016683012AP1975/07/10Control Supplement
016683000AP1971/03/22Approval