药品名称DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
申请号016687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;330MG/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
016687102APLabel2013/09/11下载
016687102APLetter2013/09/12下载
016687095APLetter2004/06/07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
016687103AP2014/09/26Manufacturing Change or Addition
016687102AP2013/09/10Labeling Revision
016687095AP2004/06/02Labeling Revision
016687093AP2001/08/14Manufacturing Change or Addition
016687092AP1999/11/24Manufacturing Change or Addition
016687091AP2000/11/29Labeling Revision
016687090AP1997/04/29Package Change
016687089AP1996/10/11Package Change
016687088AP1994/02/18Control Supplement
016687087AP1994/09/30Control Supplement
016687084AP1991/04/29Control Supplement
016687083AP1991/03/26Control Supplement
016687082AP1991/02/15Control Supplement
016687081AP1989/07/26Control Supplement
016687080AP1989/01/12Control Supplement
016687079AP1987/07/25Package Change
016687078AP1987/05/28Control Supplement
016687075AP1986/02/27Package Change
016687074AP1985/04/15Control Supplement
016687073AP1985/07/03Labeling Revision
016687071AP1985/06/13Control Supplement
016687070AP1984/09/22Control Supplement
016687069AP1984/02/28Control Supplement
016687067AP1985/08/28Control Supplement
016687066AP1985/08/28Control Supplement
016687065AP1984/03/16Control Supplement
016687064AP1985/01/24Control Supplement
016687062AP1982/02/16Control Supplement
016687061AP1983/07/11Practioner Draft Labeling
016687060AP1981/11/20Control Supplement
016687058AP1982/06/03Control Supplement
016687057AP1981/11/09Control Supplement
016687056AP1982/04/16Control Supplement
016687055AP1981/08/26Labeling Revision
016687054AP1981/12/21Control Supplement
016687053AP1981/10/23Labeling Revision
016687052AP1981/10/23Control Supplement
016687050AP1981/06/29Control Supplement
016687049AP1981/01/21Control Supplement
016687048AP1980/07/31Control Supplement
016687047AP1980/08/06Control Supplement
016687046AP1981/04/16Control Supplement
016687044AP1980/06/18Control Supplement
016687043AP1980/05/30Control Supplement
016687042AP1980/08/07Control Supplement
016687040AP1980/06/28Control Supplement
016687039AP1979/08/02Control Supplement
016687037AP1978/10/12Control Supplement
016687036AP1978/10/20Control Supplement
016687035AP1978/08/07Control Supplement
016687034AP1978/08/02Control Supplement
016687033AP1978/04/25Labeling Revision
016687032AP1978/03/22Control Supplement
016687031AP1980/02/25Control Supplement
016687030AP1978/06/20Control Supplement
016687029AP1978/03/24Control Supplement
016687028AP1978/02/28Control Supplement
016687027AP1977/12/14Control Supplement
016687026AP1977/06/06Control Supplement
016687025AP1977/02/07Package Change
016687024AP1976/07/13Final Printed Labeling - MarkIV
016687023AP1976/06/17Control Supplement
016687021AP1976/01/02Labeling Revision
016687020AP1976/07/01Control Supplement
016687019AP1976/01/05Control Supplement
016687018AP1976/11/16Labeling Revision
016687017AP1975/09/23Control Supplement
016687016AP1976/05/11Labeling Revision
016687015AP1975/09/17Control Supplement
016687014AP1975/09/25Control Supplement
016687012AP1975/07/10Control Supplement
016687008AP1973/04/26Supplement
016687000AP1971/03/22Approval