药品名称OPHTHOCORT
申请号050201产品号002
活性成分CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE市场状态停止上市
剂型或给药途径OINTMENT;OPHTHALMIC规格10MG/GM;5MG/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PARKEDALE 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
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
050201026AP1996/08/27Labeling Revision
050201025AP1988/03/25Labeling Revision
050201024AP1983/04/19Manufacturing Change or Addition
050201023AP1982/07/07Practioner Draft Labeling
050201022AP1980/12/12Practioner Draft Labeling
050201021AP1980/12/08Labeling Revision
050201019AP1980/01/22Labeling Revision
050201018AP1979/12/20Manufacturing Change or Addition
050201017AP1978/08/29Labeling Revision
050201016AP1978/06/05Manufacturing Change or Addition
050201015AP1973/07/18Labeling Revision
050201014AP1972/08/30Labeling Revision
050201013AP1972/08/30Labeling Revision
050201012AP1970/11/09Labeling Revision
050201011AP1963/12/10Labeling Revision
050201008AP1961/05/19Package Change
050201007AP1961/05/19Package Change
050201006AP1992/06/17Manufacturing Change or Addition
050201005AP1986/09/29Control Supplement
050201004AP1988/11/08Labeling Revision
050201003AP1983/08/15Labeling Revision
050201002AP1983/07/22Manufacturing Change or Addition
050201001AP1983/04/19Manufacturing Change or Addition
050201000AP1958/06/25Approval