药品名称MONOPRIL
申请号019915产品号004
活性成分FOSINOPRIL SODIUM市场状态停止上市
剂型或给药途径TABLET;ORAL规格40MG
治疗等效代码参比药物
批准日期1995/03/28申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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
50063442009/07/10PDF格式
5006344*PED2010/01/10PDF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
PED2006/11/27
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
019915042APLetter2009/02/13下载
019915038APLetter2003/11/05下载
019915037APLetter2003/06/08下载
019915037APLabel2003/06/08下载
019915032APReview2003/07/08下载
019915032APLetter2002/08/29下载
019915000APOther Important Information from FDA2006/06/09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
019915042AP2009/02/09Labeling Revision
019915038AP2003/10/29Labeling Revision
019915037AP2003/05/27Patient Population Altered
019915034AP2000/09/21Control Supplement
019915033AP2000/06/26Control Supplement
019915032AP2002/08/29Labeling Revision
019915031AP1999/11/16Manufacturing Change or Addition
019915030AP1999/05/24Manufacturing Change or Addition
019915029AP1999/05/21Control Supplement
019915028AP1999/03/11Manufacturing Change or Addition
019915027AP1998/08/11Manufacturing Change or Addition
019915026AP1998/01/28Manufacturing Change or Addition
019915025AP1997/10/01Manufacturing Change or Addition
019915024AP1997/09/12Manufacturing Change or Addition
019915023AP1997/02/21Manufacturing Change or Addition
019915022AP1997/01/14Manufacturing Change or Addition
019915021AP1997/01/08Labeling Revision
019915020AP1996/08/02Manufacturing Change or Addition
019915019AP1996/03/20Manufacturing Change or Addition
019915018AP1995/09/29Control Supplement
019915017AP1996/07/24Labeling Revision
019915016AP1995/03/27Manufacturing Change or Addition
019915015AP1994/12/30Manufacturing Change or Addition
019915014AP1995/02/08Manufacturing Change or Addition
019915013AP1995/03/28Manufacturing Change or Addition
019915012AP1994/12/30Manufacturing Change or Addition
019915011AP1994/06/14Manufacturing Change or Addition
019915010AP1994/05/19Labeling Revision
019915009AP1995/05/02New or Modified Indication
019915008AP1993/04/05Manufacturing Change or Addition
019915007AP1992/10/07Labeling Revision
019915006AP1992/07/10Manufacturing Change or Addition
019915005AP1992/09/22Formulation Revision
019915004AP1992/06/25Labeling Revision
019915003AP1991/09/09Manufacturing Change or Addition
019915002AP1991/06/27Control Supplement
019915001AP1991/06/27Control Supplement
019915000AP1991/05/16Approval