药品名称KEFLEX
申请号050405产品号004
活性成分CEPHALEXIN市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格EQ 333MG BASE
治疗等效代码参比药物
批准日期2006/05/12申请机构PRAGMA PHARMACEUTICALS 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
050405106APLetter2015/11/04下载
050405106APLabel2015/11/04下载
050405101APLetter2008/09/17下载
050405099APLetter2008/05/21下载
050405097APLabel2006/05/16下载
050405097APLetter2006/05/16下载
050405095APLetter2004/07/01下载
050405094APLetter2004/01/22下载
050405094APLabel2004/01/22下载
050405092APLetter2004/12/02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
050405106AP2015/10/30Labeling Revision
050405104AP2013/12/30Manufacturing Change or Addition
050405101AP2008/09/16Labeling Revision
050405099AP2008/05/21Labeling Revision
050405097AP2006/05/12Efficacy Supplement with Clinical Data to Support
050405095AP2004/06/25Labeling Revision
050405094AP2004/01/15Labeling Revision
050405093AP2002/10/23Control Supplement
050405092AP2004/11/19Labeling Revision
050405091AP2001/07/27Manufacturing Change or Addition
050405090AP1996/05/15Labeling Revision
050405089AP1995/02/13Labeling Revision
050405088AP1988/11/04Manufacturing Change or Addition
050405087AP1977/05/25Manufacturing Change or Addition
050405086AP1977/04/28Expiration Date Change
050405085AP1977/04/22Labeling Revision
050405084AP1977/03/15Control Supplement
050405083AP1977/03/09Control Supplement
050405082AP1977/02/28Labeling Revision
050405081AP1976/12/17Labeling Revision
050405080AP1976/12/10Control Supplement
050405079AP1976/12/10Control Supplement
050405078AP1976/09/08Labeling Revision
050405077AP1976/09/08Labeling Revision
050405076AP1976/09/02Labeling Revision
050405075AP1976/08/10Control Supplement
050405074AP1976/06/08Labeling Revision
050405073AP1976/04/22Labeling Revision
050405072AP1976/04/09Labeling Revision
050405071AP1976/03/10Control Supplement
050405070AP1976/03/10Control Supplement
050405069AP1975/11/17Labeling Revision
050405068AP1975/10/24Labeling Revision
050405065AP1975/09/16Labeling Revision
050405064AP1975/09/08Labeling Revision
050405063AP1975/09/04Labeling Revision
050405062AP1975/08/12Labeling Revision
050405061AP1975/08/04Labeling Revision
050405060AP1975/07/31Control Supplement
050405059AP1975/07/08Labeling Revision
050405057AP1975/04/07Expiration Date Change
050405056AP1974/12/13Labeling Revision
050405055AP1974/10/02Labeling Revision
050405054AP1974/09/03Labeling Revision
050405053AP1974/10/04New or Modified Indication
050405052AP1974/08/28Labeling Revision
050405051AP1974/08/22Labeling Revision
050405050AP1974/08/16Labeling Revision
050405049AP1974/07/10Formulation Revision
050405048AP1974/05/24Labeling Revision
050405047AP1974/06/28Labeling Revision
050405046AP1974/03/06Labeling Revision
050405045AP1974/02/20Expiration Date Change
050405044AP1974/01/24Control Supplement
050405043AP1974/01/15Control Supplement
050405042AP1973/11/08Expiration Date Change
050405041AP1973/10/02Labeling Revision
050405040AP1973/07/31Labeling Revision
050405039AP1973/07/25Control Supplement
050405038AP1973/06/25Labeling Revision
050405037AP1973/06/19Labeling Revision
050405036AP1973/06/04Labeling Revision
050405035AP1973/04/27Labeling Revision
050405034AP1973/02/15Control Supplement
050405033AP1973/01/18Control Supplement
050405032AP1972/12/13Labeling Revision
050405031AP1972/07/19Control Supplement
050405030AP1972/12/13Labeling Revision
050405029AP1972/02/24Labeling Revision
050405028AP1972/01/12Control Supplement
050405027AP1971/12/13Control Supplement
050405025AP1971/11/30Control Supplement
050405024AP1971/10/06Labeling Revision
050405023AP1971/10/19Expiration Date Change
050405022AP1971/07/01Labeling Revision
050405021AP1971/05/19Labeling Revision
050405020AP1971/05/13Labeling Revision
050405019AP1971/04/14Labeling Revision
050405018AP1971/01/07Manufacturing Change or Addition
050405016AP1991/10/09Control Supplement
050405015AP1992/08/27Labeling Revision
050405014AP1990/04/10Labeling Revision
050405013AP1988/09/21Labeling Revision
050405012AP1987/02/17New or Modified Indication
050405011AP1987/03/04Labeling Revision
050405010AP1987/03/04Manufacturing Change or Addition
050405009AP1986/08/29Labeling Revision
050405008AP1971/08/06Labeling Revision
050405007AP1971/07/07Labeling Revision
050405005AP1986/08/21New or Modified Indication
050405004AP1985/11/22Labeling Revision
050405003AP1985/11/04Control Supplement
050405002AP1971/02/08Control Supplement
050405001AP1984/09/05Control Supplement
050405000AP1971/01/04Approval