药品名称DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
申请号017512产品号011
活性成分CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE市场状态处方药
剂型或给药途径SOLUTION;INTRAPERITONEAL规格25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML
治疗等效代码参比药物
批准日期1985/11/18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
017512123APLabel2016/08/17下载
017512123APLetter2016/08/18下载
017512122APLetter2015/09/04下载
017512122APLabel2015/09/04下载
017512121APLabel2015/07/30下载
017512121APLetter2015/07/31下载
017512120APLabel2015/07/30下载
017512120APLetter2015/07/31下载
017512118APLetter2015/02/10下载
017512118APLabel2015/02/10下载
017512113APLabel2013/04/23下载
017512113APLetter2013/04/24下载
017512108APLetter2008/12/24下载
017512108APLabel2009/01/02下载
017512106APLetter2005/08/11下载
017512104APLetter2005/08/11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
017512124AP2016/08/01Manufacturing Change or Addition
017512123AP2016/08/16Labeling Revision
017512122AP2015/09/01Labeling Revision
017512121AP2015/07/29Manufacturing Change or Addition
017512120AP2015/07/29Manufacturing Change or Addition
017512119AP2015/05/22Manufacturing Change or Addition
017512118AP2015/02/09Labeling Revision
017512117AP2014/09/30Manufacturing Change or Addition
017512116AP2013/04/26Manufacturing Change or Addition
017512113AP2013/04/19Labeling Revision
017512108AP2008/12/19Labeling Revision
017512106AP2005/08/09Labeling Revision
017512104AP2005/08/09Labeling Revision
017512099AP2002/09/20Package Change
017512098AP2001/08/22Control Supplement
017512097AP2000/09/20Package Change
017512096AP1997/04/29Package Change
017512095AP1997/01/17Package Change
017512094AP1996/07/02Package Change
017512093AP1994/02/18Control Supplement
017512092AP1994/09/30Control Supplement
017512091AP1994/07/01Control Supplement
017512089AP1995/07/21Package Change
017512088AP1992/11/23Control Supplement
017512086AP1991/04/29Control Supplement
017512085AP1993/06/14Manufacturing Change or Addition
017512084AP1992/06/12Manufacturing Change or Addition
017512083AP1990/11/28Labeling Revision
017512082AP1991/02/15Control Supplement
017512081AP1990/07/11Labeling Revision
017512080AP1990/07/11Formulation Revision
017512079AP1989/07/26Control Supplement
017512078AP1989/01/12Control Supplement
017512077AP1989/01/10Labeling Revision
017512076AP1989/01/10Formulation Revision
017512075AP1987/07/25Package Change
017512074AP1987/01/14Control Supplement
017512073AP1989/10/16Labeling Revision
017512072AP1989/10/16Control Supplement
017512071AP1987/05/28Control Supplement
017512070AP1986/05/27Manufacturing Change or Addition
017512069AP1986/09/04Package Change
017512068AP1985/11/18Labeling Revision
017512067AP1985/11/18Package Change
017512066AP1986/02/27Package Change
017512065AP1985/04/15Control Supplement
017512064AP1985/07/16Labeling Revision
017512063AP1985/07/16Control Supplement
017512062AP1985/08/29Practioner Draft Labeling
017512061AP1985/08/29Practioner Draft Labeling
017512058AP1985/04/10Labeling Revision
017512055AP1985/06/13Control Supplement
017512054AP1984/09/22Control Supplement
017512053AP1984/07/09Labeling Revision
017512052AP1984/07/09Package Change
017512050AP1984/02/28Control Supplement
017512049AP1983/11/07Labeling Revision
017512048AP1983/11/07Control Supplement
017512046AP1985/08/28Control Supplement
017512045AP1985/08/28Control Supplement
017512044AP1984/03/16Control Supplement
017512043AP1985/01/24Control Supplement
017512041AP1982/12/08Labeling Revision
017512040AP1982/12/08Control Supplement
017512039AP1982/12/08Labeling Revision
017512038AP1982/12/08Control Supplement
017512037AP1982/12/03Labeling Revision
017512036AP1982/02/16Control Supplement
017512035AP1981/12/15Control Supplement
017512034AP1981/11/20Control Supplement
017512032AP1982/04/09Labeling Revision
017512031AP1982/04/09Control Supplement
017512030AP1982/06/03Control Supplement
017512029AP1982/04/16Control Supplement
017512028AP1981/08/26Labeling Revision
017512027AP1981/12/21Control Supplement
017512026AP1981/11/13Control Supplement
017512025AP1981/10/05Labeling Revision
017512024AP1981/10/05Formulation Revision
017512022AP1981/06/29Control Supplement
017512021AP1981/01/21Control Supplement
017512019AP1980/07/31Control Supplement
017512018AP1985/07/16Labeling Revision
017512017AP1985/07/16Control Supplement
017512016AP1980/08/06Control Supplement
017512015AP1981/04/16Control Supplement
017512014AP1980/06/18Control Supplement
017512013AP1980/06/02Labeling Revision
017512012AP1980/06/02Labeling Revision
017512011AP1980/06/02Control Supplement
017512010AP1980/05/30Control Supplement
017512009AP1980/06/02Package Change
017512008AP1980/06/02Labeling Revision
017512007AP1980/06/02Control Supplement
017512006AP1980/08/07Control Supplement
017512004AP1980/06/28Control Supplement
017512003AP1979/02/27Labeling Revision
017512002AP1979/08/02Control Supplement
017512001AP1978/11/21Formulation Revision
017512000AP1978/09/27Approval