药品名称DURANEST
申请号017751产品号005
活性成分ETIDOCAINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ASTRAZENECA LP
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
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
017751013AP1999/03/02Labeling Revision
017751012AP1996/05/31Manufacturing Change or Addition
017751011AP1999/03/02Labeling Revision
017751010AP1990/10/04Formulation Revision
017751009AP1987/04/08Labeling Revision
017751008AP1986/03/06Labeling Revision
017751007AP1985/08/07Labeling Revision
017751006AP1985/08/07Control Supplement
017751005AP1982/06/28Manufacturing Change or Addition
017751004AP1987/01/29Practioner Draft Labeling
017751003AP1982/07/13Labeling Revision
017751002AP1982/07/13Control Supplement
017751001AP1979/08/29Labeling Revision
017751000AP1976/08/30Approval