药品名称OCUCLEAR
申请号018471产品号001
活性成分OXYMETAZOLINE HYDROCHLORIDE市场状态非处方药
剂型或给药途径SOLUTION/DROPS;OPHTHALMIC规格0.025%
治疗等效代码参比药物
批准日期1986/05/30申请机构BAYER HEALTHCARE LLC
化学类型New dosage form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
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
018471016AP2001/06/06Control Supplement
018471015AP2001/01/24Control Supplement
018471014AP1997/07/14Control Supplement
018471013AP1996/11/13Manufacturing Change or Addition
018471012AP1990/05/16Control Supplement
018471011AP1989/08/24Labeling Revision
018471008AP1989/04/06Package Change
018471007AP1989/06/09Manufacturing Change or Addition
018471006AP1989/03/30Control Supplement
018471005AP1988/01/15Control Supplement
018471004AP1987/08/04Manufacturing Change or Addition
018471003AP1987/05/12Manufacturing Change or Addition
018471002AP1987/08/03Control Supplement
018471001AP1986/08/20Manufacturing Change or Addition
018471000AP1986/05/30Approval