药品名称STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
申请号018632产品号002
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1988/04/19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
018632051APLetter2016/05/31下载
018632051APLabel2016/06/01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
018632051AP2016/05/26Labeling Revision
018632050AP2014/09/26Manufacturing Change or Addition
018632033AP2001/08/29Microbiology
018632032AP2000/01/28Package Change
018632031AP1999/07/02Labeling
018632030AP1998/07/28Labeling
018632029AP1997/07/15Chemistry
018632028AP1997/04/29Chemistry
018632027AP1995/02/07Labeling
018632026AP1994/02/18Chemistry
018632025AP1994/09/30Chemistry
018632024AP1993/12/08Chemistry
018632022AP1991/03/26Chemistry
018632021AP1992/12/11Labeling
018632020AP1990/05/18Chemistry
018632019AP1991/02/15Chemistry
018632018AP1989/07/26Chemistry
018632017AP1989/01/12Chemistry
018632016AP1988/04/19Labeling
018632014AP1987/07/25Chemistry
018632013AP1987/11/16Labeling
018632012AP1987/11/16Chemistry
018632011AP1987/05/28Chemistry
018632010AP1986/09/09Labeling
018632009AP1986/09/09Chemistry
018632008AP1986/02/27Chemistry
018632007AP1985/04/26Chemistry
018632006AP1985/01/26Labeling
018632005AP1985/06/13Chemistry
018632004AP1984/09/22Chemistry
018632003AP1984/02/28Chemistry
018632002AP1984/03/14Labeling
018632000AP1982/06/30Approval