药品名称NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
申请号017609产品号001
活性成分DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOSPIRA INC
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
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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
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
017609127AP2013/09/05Manufacturing Change or Addition
017609110AP2000/06/15Labeling Revision
017609109AP1998/10/29Control Supplement
017609108AP1997/06/11Manufacturing Change or Addition
017609107AP2000/06/20Labeling Revision
017609106AP1996/08/06Control Supplement
017609105AP1996/03/04Control Supplement
017609104AP1995/08/18Manufacturing Change or Addition
017609103AP1996/08/29Control Supplement
017609102AP1996/08/27Control Supplement
017609099AP1991/08/30Package Change
017609098AP1992/01/28Package Change
017609097AP1991/09/10Control Supplement
017609095AP1990/01/11Manufacturing Change or Addition
017609094AP1990/02/22Manufacturing Change or Addition
017609091AP1987/07/30Control Supplement
017609090AP1986/11/26Control Supplement
017609089AP1986/08/08Control Supplement
017609088AP1986/01/31Control Supplement
017609087AP1985/06/10Control Supplement
017609085AP1986/01/31Control Supplement
017609084AP1985/05/14Control Supplement
017609082AP1985/10/26Labeling Revision
017609081AP1985/05/03Control Supplement
017609080AP1984/11/16Labeling Revision
017609079AP1984/11/16Control Supplement
017609078AP1985/10/26Control Supplement
017609077AP1984/11/09Resubmission - Chemistry (MarkIV)
017609074AP1984/10/22Control Supplement
017609073AP1985/09/26Package Change
017609071AP1985/11/29Labeling Revision
017609070AP1985/11/29Control Supplement
017609069AP1985/10/29Package Change
017609068AP1984/11/28Control Supplement
017609067AP1989/06/22Control Supplement
017609066AP1984/04/09Control Supplement
017609065AP1983/10/25Expiration Date Change
017609064AP1984/10/17Control Supplement
017609063AP1984/03/21Control Supplement
017609062AP1983/10/17Control Supplement
017609061AP1983/12/08Control Supplement
017609060AP1984/02/17Control Supplement
017609059AP1984/10/10Labeling Revision
017609058AP1984/10/10Package Change
017609057AP1982/07/26Control Supplement
017609056AP1984/03/01Control Supplement
017609055AP1983/02/15Manufacturing Change or Addition
017609054AP1982/06/18Control Supplement
017609053AP1982/07/08Control Supplement
017609052AP1982/02/01Control Supplement
017609051AP1982/01/08Control Supplement
017609050AP1982/06/09Control Supplement
017609049AP1981/10/07Control Supplement
017609048AP1981/03/02Labeling Revision
017609047AP1982/07/08Practioner Draft Labeling
017609046AP1980/10/31Control Supplement
017609045AP1981/03/02Labeling Revision
017609044AP1981/03/02Control Supplement
017609043AP1981/01/07Control Supplement
017609042AP1980/09/15Control Supplement
017609041AP1980/06/10Control Supplement
017609040AP1980/04/08Labeling Revision
017609039AP1979/10/10Control Supplement
017609038AP1979/11/29Control Supplement
017609037AP1980/01/22Control Supplement
017609036AP1979/11/27Control Supplement
017609035AP1979/12/03Control Supplement
017609034AP1979/12/03Control Supplement
017609033AP1979/07/17Labeling Revision
017609032AP1979/01/05Control Supplement
017609031AP1979/02/01Supplement
017609030AP1978/12/29Control Supplement
017609029AP1978/11/08Control Supplement
017609028AP1978/11/22Control Supplement
017609027AP1978/10/11Control Supplement
017609026AP1979/03/29Control Supplement
017609025AP1978/11/22Control Supplement
017609024AP1979/02/06Control Supplement
017609023AP1978/08/02Control Supplement
017609022AP1978/08/15Control Supplement
017609021AP1978/06/26Control Supplement
017609020AP1978/05/01Control Supplement
017609018AP1978/02/08Labeling Revision
017609016AP1978/03/30Control Supplement
017609015AP1978/06/14Formulation Revision
017609013AP1977/09/28Labeling Revision
017609012AP1978/03/15Control Supplement
017609011AP1978/01/23Control Supplement
017609010AP1977/05/20Control Supplement
017609009AP1976/11/24Labeling Revision
017609008AP1978/06/14Control Supplement
017609007AP1977/04/29Manufacturing Change or Addition
017609006AP1976/03/17Control Supplement
017609005AP1976/11/08Package Change
017609004AP1975/10/17Labeling Revision
017609003AP1975/11/20Control Supplement
017609002AP1975/11/03Control Supplement
017609001AP1975/10/15Control Supplement
017609000AP1975/08/13Approval