药品名称NORMOSOL-R IN PLASTIC CONTAINER
申请号017586产品号001
活性成分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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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
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
017586129AP2016/03/22Manufacturing Change or Addition
017586127AP2013/09/05Manufacturing Change or Addition
017586107AP2000/06/15Labeling Revision
017586106AP1998/10/29Control Supplement
017586105AP1998/02/12Control Supplement
017586104AP1997/06/11Manufacturing Change or Addition
017586103AP1998/05/12Labeling Revision
017586102AP1996/08/06Control Supplement
017586101AP1996/03/04Control Supplement
017586100AP1996/08/29Control Supplement
017586099AP1996/08/27Control Supplement
017586096AP1991/08/30Package Change
017586095AP1992/01/28Package Change
017586094AP1991/09/10Control Supplement
017586092AP1990/01/11Manufacturing Change or Addition
017586091AP1990/02/22Manufacturing Change or Addition
017586088AP1987/07/30Control Supplement
017586087AP1986/11/26Control Supplement
017586086AP1986/08/08Control Supplement
017586085AP1986/08/04Expiration Date Change
017586084AP1986/01/31Control Supplement
017586083AP1985/06/10Control Supplement
017586081AP1986/01/31Control Supplement
017586080AP1985/05/14Control Supplement
017586078AP1985/10/26Labeling Revision
017586077AP1985/05/03Control Supplement
017586076AP1985/10/26Control Supplement
017586075AP1984/11/09Resubmission - Chemistry (MarkIV)
017586072AP1984/10/22Control Supplement
017586071AP1985/09/26Package Change
017586069AP1985/11/29Labeling Revision
017586068AP1985/11/29Control Supplement
017586067AP1985/10/29Package Change
017586066AP1989/06/22Control Supplement
017586065AP1984/04/09Control Supplement
017586064AP1983/10/25Expiration Date Change
017586063AP1984/10/17Control Supplement
017586062AP1984/03/21Control Supplement
017586061AP1983/12/08Control Supplement
017586060AP1984/01/17Labeling Revision
017586059AP1984/01/17Formulation Revision
017586058AP1984/10/10Labeling Revision
017586057AP1984/10/10Package Change
017586056AP1982/07/26Control Supplement
017586055AP1984/03/01Control Supplement
017586054AP1983/02/15Manufacturing Change or Addition
017586053AP1982/06/18Control Supplement
017586052AP1982/07/08Control Supplement
017586051AP1982/02/01Control Supplement
017586050AP1982/01/08Control Supplement
017586049AP1982/06/09Control Supplement
017586048AP1981/10/07Control Supplement
017586047AP1981/03/02Labeling Revision
017586046AP1982/07/08Practioner Draft Labeling
017586045AP1981/03/02Labeling Revision
017586044AP1981/03/02Control Supplement
017586043AP1980/09/11Control Supplement
017586042AP1981/01/07Control Supplement
017586041AP1980/09/15Control Supplement
017586040AP1980/06/10Control Supplement
017586039AP1980/04/08Labeling Revision
017586038AP1979/10/10Control Supplement
017586037AP1979/11/29Control Supplement
017586036AP1980/01/22Control Supplement
017586035AP1979/11/27Control Supplement
017586034AP1979/12/03Control Supplement
017586033AP1979/12/03Control Supplement
017586032AP1979/08/08Labeling Revision
017586031AP1979/01/05Control Supplement
017586030AP1979/02/01Supplement
017586029AP1978/12/29Control Supplement
017586028AP1978/11/22Control Supplement
017586027AP1978/10/11Control Supplement
017586026AP1978/11/22Control Supplement
017586025AP1979/02/06Control Supplement
017586024AP1978/08/02Control Supplement
017586023AP1978/08/15Control Supplement
017586022AP1978/06/26Control Supplement
017586020AP1978/07/12Control Supplement
017586019AP1978/02/08Labeling Revision
017586018AP1978/03/09Labeling Revision
017586017AP1978/03/09Control Supplement
017586015AP1978/03/30Control Supplement
017586014AP1978/06/14Formulation Revision
017586013AP1977/09/28Labeling Revision
017586011AP1978/04/11Control Supplement
017586010AP1978/01/23Control Supplement
017586009AP1977/05/20Control Supplement
017586008AP1977/01/28Labeling Revision
017586007AP1978/06/14Control Supplement
017586006AP1977/04/29Manufacturing Change or Addition
017586005AP1976/11/08Package Change
017586004AP1975/10/21Labeling Revision
017586003AP1975/11/20Control Supplement
017586002AP1975/11/03Control Supplement
017586001AP1975/10/15Control Supplement
017586000AP1975/08/13Approval