药品名称XYLOCAINE W/ EPINEPHRINE
申请号006488产品号005
活性成分EPINEPHRINE; LIDOCAINE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格0.02MG/ML;2%
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
化学类型审评分类
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
006488074APLabel2010/02/25下载
006488074APLetter2010/03/18下载
006488019APReview2012/01/27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
006488091AP2016/03/17Manufacturing Change or Addition
006488089AP2015/03/03Manufacturing Change or Addition
006488088AP2013/12/26Manufacturing Change or Addition
006488087AP2013/07/22Manufacturing Change or Addition
006488086AP2013/02/20Manufacturing Change or Addition
006488085AP2013/02/13Manufacturing Change or Addition
006488084AP2013/03/28Labeling Revision
006488083AP2013/02/16Manufacturing Change or Addition
006488079AP2013/10/29Manufacturing Change or Addition
006488078AP2013/04/09Manufacturing Change or Addition
006488076AP2013/06/11Manufacturing Change or Addition
006488074AP2010/02/19Labeling Revision
006488066AP2002/07/17Control Supplement
006488065AP2000/12/08Control Supplement
006488064AP2000/12/14Control Supplement
006488062AP1998/03/06Manufacturing Change or Addition
006488061AP1999/05/26Labeling Revision
006488060AP1996/05/02Control Supplement
006488059AP1996/05/31Manufacturing Change or Addition
006488058AP1996/01/03Manufacturing Change or Addition
006488057AP1997/12/08Package Change
006488056AP1995/07/18Expiration Date Change
006488055AP1995/07/11Control Supplement
006488054AP1994/11/21Manufacturing Change or Addition
006488053AP1993/04/13Control Supplement
006488052AP1993/02/18Manufacturing Change or Addition
006488051AP1993/10/20Expiration Date Change
006488050AP1990/10/02Control Supplement
006488049AP1989/07/11Package Change
006488048AP1988/12/02Labeling Revision
006488047AP1988/12/02Package Change
006488046AP1987/09/11Labeling Revision
006488045AP1987/09/11Control Supplement
006488044AP1987/03/18Labeling Revision
006488043AP1987/09/16Manufacturing Change or Addition
006488042AP1986/05/19Labeling Revision
006488041AP1986/02/27Labeling Revision
006488040AP1986/08/29Labeling Revision
006488039AP1986/08/29Control Supplement
006488038AP1986/11/13Labeling Revision
006488037AP1986/11/13Control Supplement
006488036AP1991/03/21Labeling Revision
006488035AP1991/03/21Control Supplement
006488034AP1985/03/22Labeling Revision
006488033AP1985/03/22Control Supplement
006488032AP1984/12/03Labeling Revision
006488031AP1982/06/28Manufacturing Change or Addition
006488030AP1982/03/25Control Supplement
006488029AP1986/02/22Labeling Revision
006488028AP1986/02/22Control Supplement
006488027AP1984/12/12Practioner Draft Labeling
006488026AP1981/10/01Labeling Revision
006488025AP1982/07/26Labeling Revision
006488024AP1982/07/26Control Supplement
006488023AP1981/10/01Control Supplement
006488022AP1980/04/17Control Supplement
006488021AP1979/08/29Labeling Revision
006488020AP1980/12/31Labeling Revision
006488019AP1979/02/27Control Supplement
006488018AP1979/04/09Labeling Revision
006488017AP1979/04/09Control Supplement
006488016AP1979/03/26Control Supplement
006488015AP1978/05/17Labeling Revision
006488013AP1976/02/02Manufacturing Change or Addition
006488011AP1975/10/09Labeling Revision
006488010AP1975/07/16Control Supplement
006488009AP1975/08/28Control Supplement
006488008AP1975/08/28Labeling Revision
006488006AP1974/06/24Supplement
006488005AP1974/05/20Control Supplement
006488002AP1972/12/04Labeling Revision
006488000AP1948/11/19Approval