药品名称ZINACEF
申请号050558产品号004
活性成分CEFUROXIME SODIUM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 7.5GM BASE/VIAL
治疗等效代码AP参比药物
批准日期1986/10/23申请机构IGI LABORATORIES INC
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
050558069APLetter2014/09/29下载
050558069APLabel2014/09/30下载
050558067APLetter2007/07/31下载
050558067APLabel2007/07/31下载
050558057APLetter2004/05/26下载
050558057APLabel2004/05/27下载
050558050APLabel2003/05/02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
050558073AP2015/03/16Manufacturing Change or Addition
050558072AP2013/08/14Manufacturing Change or Addition
050558069AP2014/09/25Labeling Revision
050558067AP2007/07/30Labeling Revision
050558057AP2004/05/19Labeling Revision
050558054AP2002/10/23Control Supplement
050558053AP2001/11/09Control Supplement
050558052AP2001/05/05Control Supplement
050558051AP2001/04/13Control Supplement
050558050AP2001/10/12Labeling Revision
050558049AP2001/07/12Labeling Revision
050558048AP1997/04/03Manufacturing Change or Addition
050558047AP1996/12/23Labeling Revision
050558046AP1995/10/31Manufacturing Change or Addition
050558045AP1996/09/11Labeling Revision
050558044AP1996/12/23Labeling Revision
050558043AP1995/09/29Labeling Revision
050558042AP1993/06/28Control Supplement
050558041AP1994/10/27Labeling Revision
050558040AP1992/12/31Labeling Revision
050558037AP1995/02/06Labeling Revision
050558036AP1993/02/18Manufacturing Change or Addition
050558035AP1992/09/23Control Supplement
050558033AP1991/08/14Manufacturing Change or Addition
050558032AP1992/02/13Package Change
050558031AP1995/10/23Labeling Revision
050558030AP1992/11/04Control Supplement
050558029AP1992/02/13Control Supplement
050558028AP1992/02/13Control Supplement
050558027AP1990/03/22Manufacturing Change or Addition
050558026AP1989/06/30Labeling Revision
050558025AP1989/03/24Control Supplement
050558024AP1987/09/25Package Change
050558023AP1987/08/28Labeling Revision
050558022AP1987/08/13Manufacturing Change or Addition
050558020AP1988/05/12Labeling Revision
050558019AP1986/10/23Labeling Revision
050558018AP1986/05/30Control Supplement
050558017AP1986/04/17Package Change
050558015AP1986/01/23Package Change
050558013AP1985/11/25Manufacturing Change or Addition
050558012AP1985/04/03Manufacturing Change or Addition
050558010AP1984/07/27Control Supplement
050558009AP1984/08/20Manufacturing Change or Addition
050558008AP1984/05/11Labeling Revision
050558007AP1984/04/18Labeling Revision
050558006AP1984/03/05Labeling Revision
050558005AP1984/02/17Labeling Revision
050558004AP1984/02/08Manufacturing Change or Addition
050558002AP1983/12/22Labeling Revision
050558001AP1983/12/07Labeling Revision
050558000AP1983/10/19Approval