药品名称NORVASC
申请号019787产品号002
活性成分AMLODIPINE BESYLATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 5MG BASE
治疗等效代码AB参比药物
批准日期1992/07/31申请机构PFIZER 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
45729092006/07/31YYU-683PDF格式
4572909*PED2007/01/31PDF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
I-4722008/09/28
NPP2007/01/08
PED2007/07/08
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
019787059APLetter2015/03/25下载
019787059APLabel2015/04/09下载
019787054APLabel2013/01/07下载
019787054APLetter2013/01/08下载
019787053APLetter2013/01/08下载
019787053APLabel2013/01/07下载
019787052APLetter2011/11/02下载
019787052APLabel2011/10/31下载
019787047APLabel2011/05/09下载
019787047APLetter2011/05/11下载
019787045APLetter2010/02/22下载
019787045APLabel2010/02/23下载
019787042APLabel2007/11/07下载
019787042APLetter2007/11/08下载
019787038APLabel2005/09/30下载
019787038APLetter2005/10/20下载
019787037APLabel2005/07/15下载
019787037APLetter2005/07/15下载
019787032APLetter2002/05/28下载
019787031APLetter2003/08/28下载
019787030APLetter2004/01/09下载
019787030APReview2007/03/02下载
019787027APLetter2003/12/08下载
019787022APReview1999/12/15下载
019787021APReview2000/02/01下载
019787020APLetter2000/07/12下载
019787020APReview2000/07/12下载
019787019APLetter2004/06/10下载
019787019APReview2003/08/05下载
019787018APReview1999/06/04下载
019787017APReview2000/07/12下载
019787017APLetter2000/07/12下载
019787016APReview2003/08/05下载
019787015APReview2003/08/05下载
019787014APReview2003/08/05下载
019787013APReview1997/01/08下载
019787012APReview2003/08/05下载
019787011APReview2003/08/05下载
019787010APReview2003/08/05下载
019787009APReview2003/08/05下载
019787008APReview2003/08/05下载
019787007APReview2002/04/30下载
019787006APReview2003/08/05下载
019787005APReview2003/08/05下载
019787004APReview2003/08/05下载
019787003APReview2003/08/05下载
019787002APReview2003/08/05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
019787059AP2015/03/23Labeling Revision
019787058AP2014/07/28Manufacturing Change or Addition
019787057AP2013/07/24Manufacturing Change or Addition
019787056AP2013/09/12Manufacturing Change or Addition
019787055AP2012/11/16Manufacturing Change or Addition
019787054AP2013/01/07Labeling Revision
019787053AP2013/01/07Labeling Revision
019787052AP2011/10/31Labeling Revision
019787047AP2011/05/09Labeling Revision
019787045AP2010/02/17Labeling Revision
019787042AP2007/10/31Labeling Revision
019787038AP2005/09/28New or Modified Indication
019787037AP2005/07/13Labeling Revision
019787032AP2002/05/28Labeling Revision
019787031AP2003/08/20Labeling Revision
019787030AP2004/01/08Patient Population Altered
019787029AP2001/08/13Manufacturing Change or Addition
019787028AP2001/08/10Manufacturing Change or Addition
019787027AP2003/12/03Labeling Revision
019787025AP2000/02/23Manufacturing Change or Addition
019787024AP2000/09/06Control Supplement
019787023AP2000/03/14Labeling Revision
019787022AP1999/12/15Control Supplement
019787021AP2000/02/01Package Change
019787020AP2000/07/12Efficacy Supplement with Clinical Data to Support
019787019AP1999/09/07Manufacturing Change or Addition
019787018AP1999/06/04Manufacturing Change or Addition
019787017AP2000/07/12Labeling Revision
019787016AP1998/03/09Control Supplement
019787015AP1997/05/16Manufacturing Change or Addition
019787014AP1997/04/18Control Supplement
019787013AP1997/01/08Labeling Revision
019787012AP1996/06/28Control Supplement
019787011AP1996/02/07Manufacturing Change or Addition
019787010AP1996/02/08Manufacturing Change or Addition
019787009AP1995/12/05Labeling Revision
019787008AP1995/11/02Control Supplement
019787007AP1996/06/14Patient Population Altered
019787006AP1995/06/19Control Supplement
019787005AP1995/02/07Manufacturing Change or Addition
019787004AP1994/05/03Control Supplement
019787003AP1994/03/03Control Supplement
019787002AP1995/01/12Labeling Revision
019787000AP1992/07/31Approval