药品名称STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
申请号018801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1982/10/27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
018801034APLetter2009/07/08下载
018801023APLetter2004/04/20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
018801039AP2016/03/29Manufacturing Change or Addition
018801038AP2014/06/12Manufacturing Change or Addition
018801036AP2014/08/01Manufacturing Change or Addition
018801034AP2009/07/02Control Supplement
018801023AP2004/04/07Control Supplement
018801020AP2001/02/16Package Change
018801019AP2000/05/04Control Supplement
018801018AP2000/06/16Package Change
018801017AP1999/05/28Package Change
018801016AP1999/05/27Control Supplement
018801015AP1999/08/31Package Change
018801014AP1998/08/14Package Change
018801013AP1998/05/13Labeling Revision
018801012AP1996/08/29Control Supplement
018801011AP1997/01/17Control Supplement
018801010AP1996/04/17Expiration Date Change
018801008AP1989/06/14Expiration Date Change
018801007AP1988/10/21Control Supplement
018801006AP1985/08/07Package Change
018801005AP1984/10/22Control Supplement
018801004AP1985/03/15Control Supplement
018801003AP1984/01/17Control Supplement
018801002AP1984/06/14Package Change
018801001AP1984/01/25Control Supplement
018801000AP1982/10/27Approval