药品名称AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
申请号021277产品号001
活性成分MOXIFLOXACIN HYDROCHLORIDE市场状态处方药
剂型或给药途径SOLUTION;IV (INFUSION)规格400MG/250ML (1.6MG/ML)
治疗等效代码参比药物
批准日期2001/11/30申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
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
58497522016/12/05U-298PDF格式
65480792020/07/25YU-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
021277059APLabel2016/07/26下载
021277059APLetter2016/07/26下载
021277058APLabel2016/09/29下载
021277058APLetter2016/09/30下载
021277057APLetter2016/09/30下载
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021277056APLetter2015/05/13下载
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021277055APLetter2014/11/24下载
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021277054APLabel2013/08/15下载
021277054APLetter2013/08/16下载
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021277053APLetter2012/12/26下载
021277052APLetter2012/08/28下载
021277052APLabel2012/09/11下载
021277050APLabel2011/10/20下载
021277050APLetter2011/10/20下载
021277049APMedication Guide2011/08/05下载
021277049APLetter2011/08/08下载
021277046APLetter2011/10/20下载
021277046APLabel2011/10/20下载
021277041APLetter2011/03/02下载
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021277040APLabel2010/03/05下载
021277040APLetter2010/04/09下载
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021277039APLetter2010/01/25下载
021277038APLabel2010/10/25下载
021277038APLetter2010/11/02下载
021277036APLetter2009/05/05下载
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021277035APLetter2009/06/29下载
021277034APLetter2008/10/07下载
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021277033APLetter2008/12/31下载
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021277031APLetter2008/02/20下载
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021277030APLetter2007/06/04下载
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021277025APLabel2005/11/30下载
021277025APLetter2005/11/30下载
021277024APLetter2005/11/30下载
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021277022APLetter2005/06/14下载
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021277019APLetter2004/07/30下载
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021277018APLetter2004/03/10下载
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021277017APLetter2004/05/26下载
021277017APLabel2004/05/27下载
021277017APReview2008/02/19下载
021277011APLetter2003/10/06下载
021277011APLabel2003/10/10下载
021277009APLetter2003/03/10下载
021277009APLabel2003/02/28下载
021277007APLabel2003/02/28下载
021277007APReview2008/02/19下载
021277007APLetter2003/03/10下载
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021277006APLetter2003/03/10下载
021277003APLetter2002/05/16下载
021277003APLabel2002/05/16下载
021277002APLetter2002/06/12下载
021277002APLabel2002/06/12下载
021277001APLetter2002/05/22下载
021277000APLetter2001/11/30下载
021277000APLabel2001/11/30下载
021277000APReview2004/05/27下载
021277000APMedication 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
021277059AP2016/07/26Labeling Revision
021277058AP2016/09/27Labeling Revision
021277057AP2016/09/27Efficacy Supplement with Clinical Data to Support
021277056AP2015/05/08Efficacy Supplement with Clinical Data to Support
021277055AP2014/11/20Labeling Revision
021277054AP2013/08/14Labeling Revision
021277053AP2012/12/18Labeling Revision
021277052AP2012/08/24Labeling Revision
021277050AP2011/10/18Labeling Revision
021277049AP2011/08/03Labeling Revision
021277046AP2011/10/18Labeling Revision
021277041AP2011/02/25Labeling Revision
021277040AP2010/03/02Labeling Revision
021277039AP2009/11/24Labeling Revision
021277038AP2010/10/25Labeling Revision
021277036AP2009/04/27Labeling Revision
021277035AP2009/06/24Labeling Revision
021277034AP2008/10/03Labeling Revision
021277033AP2008/12/29Labeling Revision
021277031AP2008/02/15Labeling Revision
021277030AP2007/05/31Labeling Revision
021277025AP2005/11/22Labeling Revision
021277024AP2005/11/22New or Modified Indication
021277022AP2005/06/13New or Modified Indication
021277019AP2004/07/28Labeling Revision
021277018AP2004/03/06Labeling Revision
021277017AP2004/05/18New or Modified Indication
021277011AP2003/10/06Labeling Revision
021277009AP2003/02/28Labeling Revision
021277007AP2003/02/28New or Modified Indication
021277006AP2003/02/28Labeling Revision
021277005AP2002/12/10Control Supplement
021277003AP2002/05/16Labeling Revision
021277002AP2002/06/12Labeling Revision
021277001AP2002/05/22Labeling Revision
021277000AP2001/11/30Approval