药品名称ZANTAC 150
申请号018703产品号001
活性成分RANITIDINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 150MG BASE
治疗等效代码AB参比药物
批准日期1983/06/09申请机构GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
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
018703068APLabel2009/10/06下载
018703068APLetter2009/11/12下载
018703067APLetter2009/02/19下载
018703067APLabel2009/03/27下载
018703066APLetter2006/07/21下载
018703065APLetter2005/05/02下载
018703065APLabel2005/05/02下载
018703061APLetter2002/01/07下载
018703056APReview2003/04/30下载
018703056APLetter2004/07/01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
018703068AP2009/09/04Labeling Revision
018703067AP2009/02/17Labeling Revision
018703066AP2006/07/12Labeling Revision
018703065AP2005/04/28Labeling Revision
018703062AP2002/01/15Control Supplement
018703061AP2002/01/07Labeling Revision
018703060AP2001/05/09Labeling Revision
018703059AP1999/10/29Labeling Revision
018703058AP1999/10/22Labeling Revision
018703057AP1999/10/22Labeling Revision
018703056AP1999/10/29Efficacy Supplement with Clinical Data to Support
018703055AP1996/11/27Labeling Revision
018703053AP1994/11/03Labeling Revision
018703052AP1996/01/26Manufacturing Change or Addition
018703051AP1994/10/19Manufacturing Change or Addition
018703050AP1995/03/29New or Modified Indication
018703049AP1993/06/03Package Change
018703048AP1993/04/05Labeling Revision
018703047AP1994/11/03New or Modified Indication
018703046AP1994/02/28New Dosage Regimen
018703045AP1992/07/22Control Supplement
018703044AP1992/07/02Package Change
018703042AP1992/05/19New or Modified Indication
018703041AP1990/12/20Manufacturing Change or Addition
018703040AP1990/11/21Labeling Revision
018703039AP1990/12/12Manufacturing Change or Addition
018703037AP1990/07/16Labeling Revision
018703036AP1991/11/25Labeling Revision
018703035AP1991/01/04Control Supplement
018703034AP1991/01/04Control Supplement
018703033AP1989/05/18Labeling Revision
018703032AP1990/02/06Manufacturing Change or Addition
018703031AP1989/08/08Manufacturing Change or Addition
018703030AP1988/10/25Labeling Revision
018703029AP1989/02/03Labeling Revision
018703028AP1988/09/29Control Supplement
018703027AP1988/09/30Control Supplement
018703026AP1988/05/20Labeling Revision
018703025AP1988/05/20Labeling Revision
018703024AP1987/10/29Labeling Revision
018703023AP1987/08/27Manufacturing Change or Addition
018703022AP1987/04/24Expiration Date Change
018703020AP1987/03/06Labeling Revision
018703019AP1986/10/27Package Change
018703018AP1986/10/27Control Supplement
018703017AP1986/08/08Control Supplement
018703016AP1985/12/09Labeling Revision
018703015AP1986/02/20Control Supplement
018703014AP1985/11/20Package Change
018703013AP1985/08/23Package Change
018703012AP1985/12/09Control Supplement
018703011AP1985/02/22Control Supplement
018703010AP1985/02/04Expiration Date Change
018703008AP1986/05/30New or Modified Indication
018703007AP1984/09/13Package Change
018703006AP1985/12/09New Dosage Regimen
018703005AP1984/08/27Labeling Revision
018703004AP1986/05/30New or Modified Indication
018703003AP1984/02/28Control Supplement
018703002AP1985/06/28General Efficacy (MarkIV)
018703001AP1984/01/05Manufacturing Change or Addition
018703000AP1983/06/09Approval