药品名称PRIMAXIN
申请号050587产品号002
活性成分CILASTATIN SODIUM; IMIPENEM市场状态处方药
剂型或给药途径POWDER;INTRAVENOUS规格EQ 500MG BASE/VIAL;500MG/VIAL
治疗等效代码AP参比药物
批准日期1985/11/26申请机构MERCK AND CO INC
化学类型审评分类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
51478682009/09/15YYU-928PDF格式
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
050587076APLetter2014/12/17下载
050587076APLabel2014/12/17下载
050587073APLabel2012/04/16下载
050587073APLetter2012/04/18下载
050587072APLabel2009/09/22下载
050587072APLetter2009/11/20下载
050587070APLetter2008/12/19下载
050587065APLabel2008/04/01下载
050587065APLetter2008/04/02下载
050587064APLetter2006/08/07下载
050587061APLetter2004/05/26下载
050587061APReview2008/02/19下载
050587059APReview2008/08/01下载
050587058APReview2008/02/19下载
050587058APLetter2003/03/10下载
050587055APReview2007/11/19下载
050587054APReview2007/11/19下载
050587053APLetter2001/11/30下载
050587052APReview2007/11/19下载
050587048APLetter1998/04/08下载
050587048APLabel1998/04/08下载
050587046APReview2008/02/19下载
050587045APReview2008/08/11下载
050587041APReview2008/02/19下载
050587039APReview2008/02/19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
050587079AP2016/10/03Manufacturing Change or Addition
050587078AP2016/03/11Manufacturing Change or Addition
050587077AP2016/02/19Manufacturing Change or Addition
050587076AP2014/12/16Labeling Revision
050587075AP2014/08/26Manufacturing Change or Addition
050587073AP2012/04/16Labeling Revision
050587072AP2009/08/26Labeling Revision
050587070AP2008/05/08Labeling Revision
050587065AP2008/03/28Labeling Revision
050587064AP2006/08/04Labeling Revision
050587061AP2004/05/20Labeling Revision
050587059AP2002/07/09Package Change
050587058AP2003/03/04Labeling Revision
050587056AP2002/05/28Manufacturing Change or Addition
050587055AP2001/08/29Control Supplement
050587054AP2001/07/23Control Supplement
050587053AP2001/11/30Labeling Revision
050587052AP2000/08/28Labeling Revision
050587051AP1999/07/13Manufacturing Change or Addition
050587050AP1999/02/04Labeling Revision
050587049AP1998/07/24Package Change
050587048AP1998/04/08Patient Population Altered
050587047AP1997/06/30Labeling Revision
050587046AP1996/09/19Manufacturing Change or Addition
050587045AP1997/01/09Labeling Revision
050587044AP1995/03/10Control Supplement
050587042AP1994/09/27Manufacturing Change or Addition
050587041AP1995/03/21Labeling Revision
050587040AP1993/11/19Labeling Revision
050587039AP1996/09/12Labeling Revision
050587038AP1994/06/24Labeling Revision
050587037AP1992/07/17Package Change
050587036AP1992/11/23Labeling Revision
050587035AP1992/01/14Control Supplement
050587033AP1993/11/04Labeling Revision
050587028AP1991/08/26Control Supplement
050587026AP1994/03/07Labeling Revision
050587025AP1990/08/24Labeling Revision
050587024AP1989/03/30Control Supplement
050587022AP1988/12/12Control Supplement
050587021AP1988/06/17Control Supplement
050587020AP1988/05/20Labeling Revision
050587018AP1988/01/11Labeling Revision
050587017AP1988/01/25Labeling Revision
050587013AP1987/10/08Labeling Revision
050587009AP1986/10/29Control Supplement
050587004AP1987/10/08Labeling Revision
050587002AP1987/10/08Labeling Revision
050587000AP1985/11/26Approval