药品名称CERUMENEX
申请号011340产品号002
活性成分TROLAMINE POLYPEPTIDE OLEATE CONDENSATE市场状态停止上市
剂型或给药途径SOLUTION/DROPS;OTIC规格10%
治疗等效代码参比药物否
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACEUTICAL RESEARCH ASSOC INC
化学类型New molecular entity (NME)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
无
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
无
历史市场独占权保护信息
无
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
011340016APLetter2002/04/12下载
011340016APLabel2002/04/12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
011340016AP2002/04/17Labeling Revision
011340015AP2000/11/09Manufacturing Change or Addition
011340014AP2000/11/09Manufacturing Change or Addition
011340013AP2000/11/09Manufacturing Change or Addition
011340012AP2000/11/09Manufacturing Change or Addition
011340011AP2000/11/09Manufacturing Change or Addition
011340010AP2000/11/09Manufacturing Change or Addition
011340009AP2000/02/11Control Supplement
011340008AP1991/08/21Labeling Revision
011340007AP1988/12/02Labeling Revision
011340006AP1981/06/04Manufacturing Change or Addition
011340005AP1977/10/07Manufacturing Change or Addition
011340000AP1958/06/25Approval