药品名称CLAFORAN
申请号050547产品号003
活性成分CEFOTAXIME SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 2GM BASE/VIAL
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US PHARMACEUTICAL HOLDINGS II LLC
化学类型New molecular entity (NME)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
050547071APLetter2015/03/24下载
050547071APLabel2015/04/14下载
050547070APLetter2014/02/25下载
050547070APLabel2014/02/25下载
050547068APLetter2011/09/13下载
050547068APLabel2011/09/16下载
050547067APLetter2009/06/02下载
050547066APLabel2008/02/25下载
050547066APLetter2008/02/25下载
050547061APLetter2004/09/03下载
050547060APLetter2004/06/24下载
050547047APLetter2002/01/18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
050547071AP2015/03/23Labeling Revision
050547070AP2014/02/21Labeling Revision
050547068AP2011/09/09Labeling Revision
050547067AP2009/05/27Labeling Revision
050547066AP2008/02/21Labeling Revision
050547061AP2004/09/02Labeling Revision
050547060AP2004/06/23Approval
050547057AP2002/02/22Manufacturing Change or Addition
050547056AP2001/09/06Control Supplement
050547055AP2001/07/27Manufacturing Change or Addition
050547054AP2001/04/12Manufacturing Change or Addition
050547053AP2001/04/10Control Supplement
050547052AP2000/02/18Manufacturing Change or Addition
050547051AP1998/06/16Control Supplement
050547050AP1998/06/26Manufacturing Change or Addition
050547049AP1997/10/28Control Supplement
050547048AP1998/03/16Control Supplement
050547047AP2002/01/18Labeling Revision
050547045AP1997/04/24Labeling Revision
050547044AP1996/12/23Labeling Revision
050547042AP1996/09/27New Dosage Regimen
050547040AP1995/08/25Control Supplement
050547038AP1996/04/30Labeling Revision
050547035AP1982/06/29Labeling Revision
050547034AP1982/07/26Labeling Revision
050547033AP1982/02/23Labeling Revision
050547031AP1982/02/05Package Change
050547030AP1981/10/19Labeling Revision
050547029AP1981/10/05Labeling Revision
050547028AP1981/07/22Manufacturing Change or Addition
050547026AP1993/10/20Control Supplement
050547025AP1994/09/02Labeling Revision
050547024AP1994/09/14Labeling Revision
050547023AP1993/11/12Manufacturing Change or Addition
050547022AP1993/01/19Control Supplement
050547021AP1994/11/22Labeling Revision
050547020AP1995/08/17Manufacturing Change or Addition
050547019AP1992/06/30Package Change
050547018AP1994/05/19Manufacturing Change or Addition
050547015AP1996/09/24Labeling Revision
050547014AP1989/08/07Labeling Revision
050547013AP1988/06/20Formulation Revision
050547012AP1981/08/13Manufacturing Change or Addition
050547011AP1987/07/14Labeling Revision
050547010AP1985/10/25Control Supplement
050547009AP1985/06/24Manufacturing Change or Addition
050547008AP1985/09/16Manufacturing Change or Addition
050547007AP1984/12/14Expiration Date Change
050547005AP1984/02/29Labeling Revision
050547004AP1983/08/23Manufacturing Change or Addition
050547003AP1983/12/29Package Change
050547001AP1983/01/14Manufacturing Change or Addition
050547000AP1981/03/11Approval