药品名称SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
申请号018016产品号001
活性成分SODIUM CHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格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
018016062APLetter2014/12/30下载
018016062APLabel2015/01/08下载
018016061APLetter2013/09/13下载
018016061APLabel2013/09/17下载
018016057APLabel2005/08/31下载
018016057APLetter2005/08/31下载
018016056APLetter2005/05/25下载
018016056APLabel2005/05/25下载
018016053APLetter2003/07/28下载
018016049APLetter2002/04/03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
018016062AP2014/12/22Labeling Revision
018016061AP2013/09/11Labeling Revision
018016057AP2005/08/26Package Change
018016056AP2005/05/23Labeling Revision
018016053AP2003/07/17Package Change
018016053AP2014/06/05Manufacturing Change or Addition
018016051AP2001/08/14Manufacturing Change or Addition
018016050AP1999/11/24Manufacturing Change or Addition
018016049AP2002/04/03Labeling Revision
018016048AP1997/04/29Package Change
018016047AP1994/02/18Control Supplement
018016046AP1994/09/30Control Supplement
018016044AP1991/04/29Control Supplement
018016043AP1991/03/26Control Supplement
018016042AP1990/05/24Control Supplement
018016041AP1991/02/15Control Supplement
018016040AP1989/07/26Control Supplement
018016039AP1987/07/25Package Change
018016038AP1987/05/28Control Supplement
018016036AP1986/02/27Package Change
018016035AP1985/04/15Control Supplement
018016034AP1985/04/18Labeling Revision
018016033AP1985/06/13Control Supplement
018016032AP1984/09/22Control Supplement
018016031AP1984/02/28Control Supplement
018016029AP1985/08/28Control Supplement
018016028AP1985/08/28Control Supplement
018016027AP1984/03/16Control Supplement
018016026AP1985/01/24Control Supplement
018016024AP1982/06/22Control Supplement
018016022AP1983/07/11Practioner Draft Labeling
018016021AP1981/11/20Control Supplement
018016019AP1982/06/03Control Supplement
018016018AP1982/04/16Control Supplement
018016017AP1981/08/26Labeling Revision
018016016AP1981/12/21Control Supplement
018016014AP1981/06/29Control Supplement
018016013AP1981/01/21Control Supplement
018016012AP1980/07/31Control Supplement
018016011AP1981/04/16Control Supplement
018016009AP1980/06/18Control Supplement
018016007AP1980/05/30Control Supplement
018016006AP1980/08/07Control Supplement
018016005AP1979/08/02Control Supplement
018016003AP1980/06/28Control Supplement
018016002AP1979/06/14Control Supplement
018016001AP1980/02/25Control Supplement
018016000AP1979/02/02Approval