药品名称STATROL
申请号050344产品号002
活性成分NEOMYCIN SULFATE; POLYMYXIN B SULFATE市场状态停止上市
剂型或给药途径OINTMENT;OPHTHALMIC规格EQ 3.5MG BASE/GM;10,000 UNITS/GM
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALCON LABORATORIES 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
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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
050344018AP1999/09/28Package Change
050344017AP1999/02/05Manufacturing Change or Addition
050344016AP1997/09/09Labeling Revision
050344015AP1996/11/29Control Supplement
050344014AP1996/03/18Control Supplement
050344013AP1993/09/28Labeling Revision
050344010AP1984/08/08Labeling Revision
050344009AP1983/11/23Control Supplement
050344008AP1983/11/23Labeling Revision
050344007AP1992/08/24Package Change
050344006AP1988/03/22Manufacturing Change or Addition
050344005AP1981/04/13Control Supplement
050344004AP1987/06/16Manufacturing Change or Addition
050344003AP1989/03/03Control Supplement
050344002AP1992/02/03Control Supplement
050344001AP1991/12/31Labeling Revision
050344000AP1974/03/12Approval