药品名称PEPCID AC
申请号020325产品号002
活性成分FAMOTIDINE市场状态非处方药
剂型或给药途径TABLET;ORAL规格20MG
治疗等效代码参比药物
批准日期2003/09/23申请机构JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
化学类型New formulation or new manufacturer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
NP2006/09/23
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
020325030APLetter2016/06/09下载
020325030APLabel2016/06/13下载
020325024APLabel2016/04/11下载
020325019APLetter2006/06/12下载
020325017APLetter2004/10/29下载
020325015APReview2007/05/29下载
020325015APLetter2003/09/30下载
020325015APLabel2003/09/30下载
020325013APLetter2002/03/01下载
020325003APLetter2002/03/01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
020325031AP2016/08/01Manufacturing Change or Addition
020325030AP2016/06/08Labeling Revision
020325029AP2016/05/05Manufacturing Change or Addition
020325028AP2015/07/09Manufacturing Change or Addition
020325027AP2015/05/06Manufacturing Change or Addition
020325026AP2015/04/20Manufacturing Change or Addition
020325025AP2013/04/01Manufacturing Change or Addition
020325024AP2012/10/11Labeling Revision
020325019AP2006/06/09Labeling Revision
020325017AP2004/10/27Labeling Revision
020325015AP2003/09/23New Dosage Regimen
020325013AP2002/03/01Labeling Revision
020325011AP2000/04/05Package Change
020325010AP2000/02/10Manufacturing Change or Addition
020325009AP1998/11/05Control Supplement
020325008AP1998/04/15Package Change
020325007AP1998/11/09New Dosage Regimen
020325006AP1997/09/26Package Change
020325004AP1996/04/23Manufacturing Change or Addition
020325003AP1996/05/03Package Change
020325002AP1995/10/02Manufacturing Change or Addition
020325001AP1996/05/31Control Supplement
020325000AP1995/04/28Approval