药品名称POLY-PRED
申请号050081产品号002
活性成分NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE市场状态停止上市
剂型或给药途径SUSPENSION/DROPS;OPHTHALMIC规格EQ 0.35% BASE;10,000 UNITS/ML;0.5%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALLERGAN PHARMACEUTICAL
化学类型审评分类
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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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
050081036AP2002/04/12Control Supplement
050081035AP2002/02/21Manufacturing Change or Addition
050081032AP2001/04/12Manufacturing Change or Addition
050081031AP2000/10/02Manufacturing Change or Addition
050081030AP1998/05/19Control Supplement
050081029AP1982/08/02Package Change
050081028AP1981/06/30Formulation Revision
050081025AP1980/03/18Control Supplement
050081024AP1979/11/16Labeling Revision
050081018AP1965/12/02Labeling Revision
050081015AP1995/08/03Control Supplement
050081013AP1994/03/07Manufacturing Change or Addition
050081011AP1987/08/17Control Supplement
050081010AP1964/06/23Expiration Date Change
050081009AP1985/12/12Manufacturing Change or Addition
050081008AP1985/09/04Manufacturing Change or Addition
050081007AP1963/10/23Labeling Revision
050081006AP1984/02/10Expiration Date Change
050081005AP1985/11/01Package Change
050081004AP1983/10/18Control Supplement
050081003AP1984/05/15Labeling Revision
050081001AP1982/10/26Expiration Date Change
050081000AP1963/05/10Approval