药品名称LOTRONEX
申请号021107产品号002
活性成分ALOSETRON HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 0.5MG BASE
治疗等效代码AB参比药物
批准日期2003/12/23申请机构SEBELA IRELAND LTD
化学类型New molecular entity (NME)审评分类Priority 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
53608002013/01/13YYU-405PDF格式
62847702018/10/05U-405PDF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
D-1132011/04/01
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
021107027APLetter2016/01/11下载
021107027APLabel2016/01/26下载
021107026APLetter2016/01/11下载
021107025APLetter2015/07/27下载
021107024APLetter2014/05/12下载
021107016APLetter2010/09/07下载
021107016APLabel2010/09/07下载
021107014APLetter2010/09/07下载
021107014APLabel2010/10/01下载
021107013APLetter2008/04/09下载
021107013APLabel2008/05/06下载
021107012APLabel2006/03/14下载
021107012APLetter2006/03/23下载
021107011APLetter2005/02/23下载
021107011APLabel2005/02/23下载
021107010APLabel2005/02/04下载
021107010APLetter2005/02/08下载
021107008APLetter2003/12/24下载
021107008APLabel2003/12/29下载
021107007APLetter2003/03/26下载
021107006APReview2007/11/19下载
021107005APReview2007/11/19下载
021107005APLetter2002/06/07下载
021107005APLabel2002/06/07下载
021107002APReview2007/11/19下载
021107001APReview2007/11/19下载
021107000APLetter2000/02/09下载
021107000APReview2000/08/29下载
021107000APLabel2000/02/09下载
021107000APOther Important Information from FDA2003/12/17下载
021107000APMedication Guide2010/09/15下载
021107000APOther2010/10/01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
021107028AP2016/09/20Manufacturing Change or Addition
021107027AP2016/01/07Labeling Revision
021107026AP2016/01/07Efficacy Supplement with Clinical Data to Support
021107025AP2015/07/24Supplement
021107024AP2014/05/08Labeling Revision
021107021AP2013/04/19Manufacturing Change or Addition
021107016AP2010/09/02Labeling Revision
021107014AP2010/09/02Labeling Revision
021107013AP2008/04/01New Dosage Regimen
021107012AP2006/03/10Labeling Revision
021107011AP2005/02/18Labeling Revision
021107010AP2005/02/04Labeling Revision
021107008AP2003/12/23Formulation Revision
021107007AP2003/03/20Labeling Revision
021107006AP2002/06/03Package Change
021107005AP2002/06/07Efficacy Supplement with Clinical Data to Support
021107002AP2000/08/11Labeling Revision
021107001AP2000/03/07Manufacturing Change or Addition
021107000AP2000/02/09Approval