药品名称AVELOX
申请号021085产品号001
活性成分MOXIFLOXACIN HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 400MG BASE
治疗等效代码AB参比药物
批准日期1999/12/10申请机构BAYER HEALTHCARE PHARMACEUTICALS 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
58497522016/12/05U-298PDF格式
66103272019/10/29YU-298PDF格式
历史专利信息
49905172011/12/08YYU-298PDF格式
56079422014/03/04U-298PDF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
M-1852019/09/27
历史市场独占权保护信息
I-4772008/06/13
I-4792008/11/18
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
021085063APLabel2016/07/26下载
021085063APLetter2016/07/26下载
021085062APLabel2016/09/29下载
021085062APLetter2016/09/30下载
021085061APLetter2016/09/30下载
021085061APLabel2016/09/29下载
021085060APLetter2015/05/13下载
021085060APLabel2015/06/05下载
021085059APLetter2014/11/24下载
021085059APLabel2014/12/03下载
021085057APLabel2013/08/15下载
021085057APLetter2013/08/16下载
021085056APLabel2012/12/21下载
021085056APLetter2012/12/26下载
021085055APLetter2012/08/28下载
021085055APLabel2012/09/11下载
021085053APLetter2011/10/20下载
021085053APLabel2011/10/20下载
021085052APMedication Guide2011/08/05下载
021085052APLetter2011/08/08下载
021085050APLetter2011/10/20下载
021085050APLabel2011/10/20下载
021085047APLetter2011/03/02下载
021085047APLabel2011/03/04下载
021085046APLabel2010/03/05下载
021085046APLetter2010/04/09下载
021085045APLabel2009/12/02下载
021085045APLetter2010/01/25下载
021085044APLabel2010/10/25下载
021085044APLetter2010/11/02下载
021085042APLetter2009/05/05下载
021085042APLabel2009/05/15下载
021085041APLetter2009/06/29下载
021085040APLetter2008/10/07下载
021085040APLabel2008/10/09下载
021085039APLetter2008/12/31下载
021085039APLabel2009/01/02下载
021085038APLetter2008/02/20下载
021085038APLabel2008/02/25下载
021085036APLetter2007/06/04下载
021085036APLabel2007/06/04下载
021085029APLetter2005/11/30下载
021085029APLabel2005/11/30下载
021085027APLetter2005/11/30下载
021085027APLabel2005/11/30下载
021085026APLetter2005/06/14下载
021085026APLabel2005/06/14下载
021085024APLetter2004/07/30下载
021085024APLabel2004/07/30下载
021085023APLetter2004/03/10下载
021085023APLabel2004/04/05下载
021085022APLetter2004/05/26下载
021085022APLabel2004/05/27下载
021085022APReview2008/02/19下载
021085019APLetter2003/10/06下载
021085019APLabel2003/10/10下载
021085017APLabel2003/02/28下载
021085017APLetter2003/03/10下载
021085015APLabel2003/02/28下载
021085015APLetter2003/03/10下载
021085014APLabel2003/02/28下载
021085014APLetter2003/03/10下载
021085012APLetter2002/05/16下载
021085012APLabel2002/05/16下载
021085010APLetter2001/04/27下载
021085010APLabel2001/04/27下载
021085010APReview2004/05/27下载
021085007APLetter2002/06/12下载
021085007APLabel2002/06/12下载
021085006APLetter2002/06/12下载
021085006APLabel2002/06/12下载
021085000APLetter1999/12/10下载
021085000APLabel1999/12/10下载
021085000APReview2004/05/27下载
021085000APMedication Guide2013/01/03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
021085063AP2016/07/26Labeling Revision
021085062AP2016/09/27Labeling Revision
021085061AP2016/09/27Efficacy Supplement with Clinical Data to Support
021085060AP2015/05/08Efficacy Supplement with Clinical Data to Support
021085059AP2014/11/20Labeling Revision
021085058AP2014/11/19Manufacturing Change or Addition
021085057AP2013/08/14Labeling Revision
021085056AP2012/12/18Labeling Revision
021085055AP2012/08/24Labeling Revision
021085053AP2011/10/18Labeling Revision
021085052AP2011/08/03Labeling Revision
021085050AP2011/10/18Labeling Revision
021085047AP2011/02/25Labeling Revision
021085046AP2010/03/02Labeling Revision
021085045AP2009/11/23Labeling Revision
021085044AP2010/10/25Labeling Revision
021085042AP2009/04/27Labeling Revision
021085041AP2009/06/24Labeling Revision
021085040AP2008/10/03Labeling Revision
021085039AP2008/12/29Labeling Revision
021085038AP2008/02/15Labeling Revision
021085036AP2007/05/31Labeling Revision
021085029AP2005/11/22Labeling Revision
021085027AP2005/11/22New or Modified Indication
021085026AP2005/06/13New or Modified Indication
021085025AP2004/12/14Control Supplement
021085024AP2004/07/28Labeling Revision
021085023AP2004/03/06Labeling Revision
021085022AP2004/05/18New or Modified Indication
021085019AP2003/10/06Labeling Revision
021085017AP2003/02/28Labeling Revision
021085015AP2003/02/28New or Modified Indication
021085014AP2003/02/28Labeling Revision
021085013AP2002/12/10Control Supplement
021085012AP2002/05/16Labeling Revision
021085010AP2001/04/27Labeling Revision
021085008AP2001/02/02Control Supplement
021085007AP2002/06/12Labeling Revision
021085006AP2002/06/12Labeling Revision
021085005AP2001/05/17Labeling Revision
021085004AP2001/05/17Labeling Revision
021085002AP2000/04/21Manufacturing Change or Addition
021085001AP2000/05/04Labeling Revision
021085000AP1999/12/10Approval