药品名称CELEXA
申请号020822产品号003
活性成分CITALOPRAM HYDROBROMIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 40MG BASE
治疗等效代码AB参比药物
批准日期1998/07/17申请机构FOREST LABORATORIES 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
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
020822046APLetter2014/07/10下载
020822046APLabel2014/07/21下载
020822045APLetter2014/04/17下载
020822045APLabel2014/05/12下载
020822043APLabel2012/12/03下载
020822043APLetter2012/12/05下载
020822042APReview2013/09/11下载
020822042APLabel2012/03/28下载
020822042APLetter2012/03/29下载
020822040APLetter2011/08/17下载
020822040APReview2011/10/11下载
020822040APLabel2011/08/16下载
020822038APLetter2011/08/17下载
020822038APLabel2011/08/16下载
020822038APReview2011/10/11下载
020822037APLetter2009/02/03下载
020822037APLabel2009/02/04下载
020822035APLetter2008/09/19下载
020822035APLabel2008/09/19下载
020822034APLabel2007/08/03下载
020822034APLetter2007/08/07下载
020822029APLetter2005/02/23下载
020822029APLabel2005/02/28下载
020822027APLetter2004/05/26下载
020822023APLetter2004/04/20下载
020822019APLetter2002/11/19下载
020822019APReview2006/05/18下载
020822000APLetter1998/07/17下载
020822000APReview1998/07/17下载
020822000APLabel1998/07/17下载
020822000APMedication Guide2009/11/16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
020822046AP2014/07/08Labeling Revision
020822045AP2014/04/16Labeling Revision
020822044AP2013/06/17Manufacturing Change or Addition
020822043AP2012/12/03Labeling Revision
020822042AP2012/03/27Labeling Revision
020822040AP2011/08/12Labeling Revision
020822038AP2011/08/12Labeling Revision
020822037AP2009/01/30Labeling Revision
020822035AP2008/09/17Labeling Revision
020822034AP2007/08/02Labeling Revision
020822029AP2005/02/18Labeling Revision
020822027AP2004/05/20Labeling Revision
020822023AP2004/04/08Labeling Revision
020822019AP2002/11/19Labeling Revision
020822015AP2002/05/30Manufacturing Change or Addition
020822014AP2001/07/10Manufacturing Change or Addition
020822013AP2001/05/17Manufacturing Change or Addition
020822012AP2000/11/22Manufacturing Change or Addition
020822011AP2001/06/27Labeling Revision
020822010AP2000/06/27Manufacturing Change or Addition
020822008AP2000/04/27Manufacturing Change or Addition
020822007AP2000/07/13Control Supplement
020822006AP1999/12/07Control Supplement
020822005AP1999/12/07Control Supplement
020822003AP1999/10/21Package Change
020822002AP1999/08/13Manufacturing Change or Addition
020822001AP1999/10/19Control Supplement
020822000AP1998/07/17Approval