药品名称XYLOCAINE PRESERVATIVE FREE
申请号016801产品号005
活性成分LIDOCAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1%
治疗等效代码AP参比药物
批准日期1988/01/19申请机构FRESENIUS KABI USA LLC
化学类型New formulation or new manufacturer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
016801042AP2013/04/18Manufacturing Change or Addition
016801041AP2013/03/28Labeling Revision
016801035AP2000/12/08Control Supplement
016801034AP1997/02/20Expiration Date Change
016801033AP1997/02/04Labeling Revision
016801032AP1995/05/31Control Supplement
016801031AP1994/07/15Package Change
016801030AP1993/02/18Manufacturing Change or Addition
016801029AP1989/07/11Control Supplement
016801028AP1988/08/26Labeling Revision
016801027AP1988/01/19Labeling Revision
016801026AP1987/09/16Manufacturing Change or Addition
016801025AP1986/09/04Labeling Revision
016801024AP1986/09/04Control Supplement
016801023AP1986/04/03Expiration Date Change
016801022AP1983/09/02Labeling Revision
016801021AP1982/07/08Manufacturing Change or Addition
016801020AP1982/03/25Control Supplement
016801019AP1982/02/22Labeling Revision
016801018AP1983/04/27Practioner Draft Labeling
016801017AP1982/07/22Labeling Revision
016801016AP1982/07/22Control Supplement
016801015AP1980/12/15Labeling Revision
016801014AP1979/12/07Labeling Revision
016801013AP1979/12/07Control Supplement
016801011AP1979/12/28Control Supplement
016801010AP1978/10/12Control Supplement
016801009AP1978/09/29Labeling Revision
016801008AP1978/09/29Control Supplement
016801007AP1976/05/27Final Printed Labeling - MarkIV
016801006AP1976/04/15Control Supplement
016801004AP1975/02/12Labeling Revision
016801000AP1969/10/06Approval