药品名称ZANTAC 75
申请号020520产品号001
活性成分RANITIDINE HYDROCHLORIDE市场状态非处方药
剂型或给药途径TABLET;ORAL规格EQ 75MG BASE
治疗等效代码参比药物
批准日期1995/12/19申请机构BOEHRINGER INGELHEIM
化学类型New dosage form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
020520033APLetter2016/07/28下载
020520033APLabel2016/08/23下载
020520032APLetter2016/02/17下载
020520032APLabel2016/02/23下载
020520030APLetter2015/11/23下载
020520030APLabel2015/11/25下载
020520028APLetter2015/02/03下载
020520028APLabel2015/02/17下载
020520015APLetter2005/03/03下载
020520015APReview2008/02/19下载
020520001APReview1998/06/08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
020520033AP2016/07/27Labeling Revision
020520032AP2016/01/26Labeling Revision
020520031AP2015/09/24Manufacturing Change or Addition
020520030AP2015/11/20Labeling Revision
020520028AP2015/01/30Labeling Revision
020520026AP2013/07/25Manufacturing Change or Addition
020520015AP2005/02/28Labeling Revision
020520013AP2002/12/03Manufacturing Change or Addition
020520012AP2002/05/30Manufacturing Change or Addition
020520010AP2001/05/29Labeling Revision
020520009AP2000/11/08Manufacturing Change or Addition
020520008AP2000/06/07Manufacturing Change or Addition
020520006AP2000/02/28Manufacturing Change or Addition
020520005AP1998/04/01Package Change
020520004AP1997/12/08Manufacturing Change or Addition
020520003AP1998/05/22Package Change
020520002AP1997/03/26Package Change
020520001AP1998/06/08New or Modified Indication
020520000AP1995/12/19Approval