药品名称CEFZIL
申请号050664产品号002
活性成分CEFPROZIL市场状态停止上市
剂型或给药途径TABLET;ORAL规格500MG
治疗等效代码参比药物
批准日期1991/12/23申请机构CORDEN PHARMA LATINA SPA
化学类型New molecular entity (NME)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
050664024APLabel2007/09/19下载
050664024APLetter2007/09/25下载
050664023APLetter2004/06/25下载
050664023APLabel2004/06/25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
050664024AP2007/09/14Labeling Revision
050664023AP2004/06/23Labeling Revision
050664022AP2001/04/19Control Supplement
050664021AP2000/08/10Control Supplement
050664020AP2001/10/01Labeling Revision
050664019AP1999/02/18Control Supplement
050664018AP1998/11/06Control Supplement
050664017AP1997/05/29Labeling Revision
050664016AP1997/04/23Labeling Revision
050664015AP1997/08/26Labeling Revision
050664014AP1996/09/05New or Modified Indication
050664013AP1995/12/26Labeling Revision
050664012AP1995/04/10Control Supplement
050664011AP1995/02/08Labeling Revision
050664010AP1994/11/10Manufacturing Change or Addition
050664009AP1994/07/06Manufacturing Change or Addition
050664008AP1994/03/21Manufacturing Change or Addition
050664007AP1995/08/31Labeling Revision
050664006AP1995/08/31Labeling Revision
050664005AP1993/07/23Control Supplement
050664004AP1995/05/17Patient Population Altered
050664002AP1992/12/31Patient Population Altered
050664000AP1991/12/23Approval