药品名称CORTISPORIN
申请号050169产品号001
活性成分HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE市场状态停止上市
剂型或给药途径SUSPENSION/DROPS;OPHTHALMIC规格1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MONARCH PHARMACEUTICALS INC
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
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
050169046APLetter2003/12/02下载
050169046APLabel2003/12/02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
050169046AP2003/11/25Labeling Revision
050169045AP1999/04/19Manufacturing Change or Addition
050169044AP1995/06/13Control Supplement
050169042AP1982/09/13Control Supplement
050169041AP1982/03/26Manufacturing Change or Addition
050169040AP1982/01/26Control Supplement
050169037AP1981/10/20Manufacturing Change or Addition
050169036AP1981/09/15Control Supplement
050169035AP1980/12/01Labeling Revision
050169034AP1981/01/16New or Modified Indication
050169031AP1972/11/20Labeling Revision
050169030AP1972/07/06Labeling Revision
050169028AP1972/06/21Labeling Revision
050169025AP1971/05/11Control Supplement
050169024AP1970/12/18Labeling Revision
050169023AP1970/10/09Labeling Revision
050169022AP1970/07/27Labeling Revision
050169020AP1969/03/17Package Change
050169019AP1969/03/25Control Supplement
050169017AP1969/03/24Control Supplement
050169016AP1967/07/13Labeling Revision
050169015AP1967/04/20Labeling Revision
050169014AP1967/04/10Labeling Revision
050169013AP1967/04/04Labeling Revision
050169012AP1966/10/19Labeling Revision
050169010AP1966/09/13Labeling Revision
050169009AP1994/05/10Labeling Revision
050169008AP1985/12/13Control Supplement
050169007AP1984/08/21Package Change
050169006AP1984/02/28Package Change
050169003AP1966/05/05Labeling Revision
050169002AP1965/09/30Labeling Revision
050169001AP1983/03/30Labeling Revision
050169000AP1964/12/18Approval