药品名称XYLOCAINE 4% PRESERVATIVE FREE
申请号010417产品号001
活性成分LIDOCAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格4%
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构FRESENIUS KABI USA LLC
化学类型New dosage form审评分类Priority 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
010417027APLetter2010/02/25下载
010417027APLabel2010/02/25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
010417032AP2013/03/28Manufacturing Change or Addition
010417031AP2013/03/28Labeling Revision
010417027AP2010/02/19Labeling Revision
010417022AP1999/03/12Labeling Revision
010417021AP1996/03/11Manufacturing Change or Addition
010417020AP1995/07/11Control Supplement
010417019AP1996/09/13Expiration Date Change
010417018AP1994/11/22Manufacturing Change or Addition
010417017AP1993/02/18Manufacturing Change or Addition
010417016AP1989/07/11Control Supplement
010417015AP1987/09/16Manufacturing Change or Addition
010417014AP1984/06/20Manufacturing Change or Addition
010417013AP1982/06/28Manufacturing Change or Addition
010417012AP1982/03/25Control Supplement
010417011AP1985/03/25Practioner Draft Labeling
010417010AP1982/08/09Labeling Revision
010417009AP1982/08/09Control Supplement
010417008AP1980/11/03Labeling Revision
010417007AP1980/12/04Labeling Revision
010417006AP1980/12/04Package Change
010417005AP1980/11/03Control Supplement
010417004AP1979/08/29Labeling Revision
010417003AP1980/06/13Labeling Revision
010417002AP1973/02/01Labeling Revision
010417000AP1959/05/07Approval