药品名称STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
申请号018233产品号001
活性成分STERILE WATER FOR INJECTION市场状态处方药
剂型或给药途径LIQUID;N/A规格100%
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
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
018233068APLetter2007/11/08下载
018233063APLetter2005/01/26下载
018233062APLetter2003/01/24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
018233080AP2013/09/05Manufacturing Change or Addition
018233068AP2007/11/02Package Change
018233063AP2005/01/19Labeling Revision
018233062AP2003/01/24Control Supplement
018233061AP2002/10/15Expiration Date Change
018233060AP1999/06/04Control Supplement
018233059AP1998/10/29Control Supplement
018233058AP1997/06/11Manufacturing Change or Addition
018233057AP2000/06/14Labeling Revision
018233056AP1996/08/06Control Supplement
018233055AP1996/03/04Control Supplement
018233054AP1996/08/29Control Supplement
018233053AP1996/08/27Control Supplement
018233052AP1995/08/14Control Supplement
018233049AP1991/08/30Package Change
018233048AP1992/01/28Package Change
018233047AP1991/09/10Control Supplement
018233045AP1990/01/11Manufacturing Change or Addition
018233044AP1990/02/22Manufacturing Change or Addition
018233041AP1987/07/30Control Supplement
018233040AP1986/11/26Control Supplement
018233039AP1986/08/08Control Supplement
018233038AP1985/06/10Control Supplement
018233036AP1986/01/31Control Supplement
018233034AP1985/10/26Labeling Revision
018233033AP1985/05/03Control Supplement
018233032AP1985/10/26Control Supplement
018233029AP1984/10/22Control Supplement
018233028AP1985/09/26Package Change
018233026AP1985/11/29Labeling Revision
018233025AP1985/11/29Control Supplement
018233024AP1985/10/29Package Change
018233023AP1984/04/09Control Supplement
018233022AP1983/11/07Expiration Date Change
018233021AP1984/10/17Control Supplement
018233020AP1984/03/21Control Supplement
018233019AP1983/12/08Control Supplement
018233018AP1984/10/10Labeling Revision
018233017AP1984/10/10Package Change
018233016AP1982/07/26Control Supplement
018233015AP1984/03/01Control Supplement
018233014AP1983/02/15Manufacturing Change or Addition
018233013AP1982/07/08Control Supplement
018233012AP1982/01/08Control Supplement
018233011AP1982/06/09Control Supplement
018233010AP1981/10/07Control Supplement
018233009AP1981/03/02Labeling Revision
018233008AP1982/03/12Practioner Draft Labeling
018233007AP1981/03/02Labeling Revision
018233006AP1981/03/02Control Supplement
018233005AP1981/01/07Control Supplement
018233004AP1980/09/15Control Supplement
018233003AP1980/05/28Control Supplement
018233002AP1980/05/23Control Supplement
018233001AP1980/05/14Control Supplement
018233000AP1980/02/18Approval