药品名称XYLOCAINE
申请号008816产品号001
活性成分LIDOCAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径JELLY;TOPICAL规格2%
治疗等效代码AT参比药物
批准日期Approved Prior to Jan 1, 1982申请机构OAK PHARMACEUTICALS INC
化学类型New dosage form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
008816032APLetter2004/07/28下载
008816032APLabel2004/07/28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
008816038AP2013/10/24Manufacturing Change or Addition
008816037AP2013/09/24Manufacturing Change or Addition
008816036AP2012/11/28Manufacturing Change or Addition
008816032AP2004/07/23Labeling Revision
008816031AP2000/06/02Package Change
008816030AP1999/07/29Package Change
008816029AP1996/05/31Manufacturing Change or Addition
008816028AP1998/04/07Package Change
008816027AP1993/02/18Manufacturing Change or Addition
008816024AP1990/11/07Package Change
008816017AP1987/06/08Package Change
008816016AP1987/06/08Control Supplement
008816015AP1987/09/16Manufacturing Change or Addition
008816014AP1984/06/20Manufacturing Change or Addition
008816013AP1984/07/11Labeling Revision
008816012AP1984/07/11Formulation Revision
008816009AP1982/03/25Control Supplement
008816008AP1984/11/20Practioner Draft Labeling
008816007AP1981/02/23Labeling Revision
008816006AP1981/02/23General Efficacy (MarkIV)
008816005AP1979/02/16Package Change
008816004AP1977/02/02Labeling Revision
008816003AP1977/01/12Control Supplement
008816002AP1977/02/02Labeling Revision
008816001AP1973/03/06Labeling Revision
008816000AP1953/03/12Approval