药品名称TAXOTERE
申请号020449产品号004
活性成分DOCETAXEL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格80MG/4ML (20MG/ML)
治疗等效代码AP参比药物
批准日期2010/08/02申请机构SANOFI AVENTIS US LLC
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
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
PED2013/11/13
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
020449075APLetter2015/12/15下载
020449075APLabel2015/12/15下载
020449075APReview2016/07/27下载
020449073APLetter2014/11/17下载
020449073APLabel2014/11/20下载
020449071APLetter2013/12/16下载
020449071APLabel2013/12/17下载
020449069APLetter2013/06/27下载
020449069APLabel2013/07/08下载
020449065APLabel2011/12/20下载
020449065APLetter2011/12/20下载
020449064APLetter2011/09/12下载
020449064APLabel2011/09/16下载
020449063APLabel2015/04/14下载
020449059APLabel2010/05/17下载
020449059APLetter2010/05/18下载
020449054APReview2012/10/15下载
020449053APLabel2010/05/03下载
020449053APLetter2010/04/23下载
020449045APLetter2007/10/04下载
020449045APLabel2007/10/04下载
020449044APLetter2010/04/23下载
020449044APLabel2010/05/03下载
020449043APLetter2010/06/08下载
020449043APReview2014/07/07下载
020449039APReview2011/09/22下载
020449039APLabel2006/10/18下载
020449039APLetter2006/10/23下载
020449036APLetter2006/06/08下载
020449036APPatient Information Sheet2006/06/08下载
020449036APLabel2006/06/08下载
020449035APLetter2006/04/05下载
020449035APLabel2006/04/05下载
020449035APReview2014/07/07下载
020449034APLetter2005/11/18下载
020449033APLetter2005/08/15下载
020449033APLabel2005/08/15下载
020449031APLetter2005/01/11下载
020449029APLabel2004/08/19下载
020449029APLetter2004/08/25下载
020449029APReview2005/04/27下载
020449028APReview2005/04/15下载
020449028APLabel2004/05/19下载
020449028APLetter2004/05/26下载
020449022APLetter2003/01/30下载
020449022APLabel2003/01/30下载
020449019APLetter2003/01/30下载
020449019APLabel2004/06/18下载
020449018APReview2003/07/08下载
020449018APLetter2002/11/27下载
020449018APLabel2002/11/27下载
020449017APLabel2004/06/18下载
020449017APLetter2003/01/30下载
020449016APLabel2003/04/28下载
020449016APLetter2003/05/29下载
020449011APReview2001/07/05下载
020449011APLetter1999/12/23下载
020449011APLabel1999/12/23下载
020449006APLetter1998/06/22下载
020449005APLetter1998/06/22下载
020449004APReview2000/07/11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
020449075AP2015/12/11Labeling Revision
020449074AP2016/05/17Manufacturing Change or Addition
020449073AP2014/11/14Labeling Revision
020449072AP2014/05/15Manufacturing Change or Addition
020449071AP2013/12/13Labeling Revision
020449070AP2013/08/15Manufacturing Change or Addition
020449069AP2013/06/26Labeling Revision
020449068AP2012/11/21Manufacturing Change or Addition
020449065AP2011/12/15Labeling Revision
020449064AP2011/09/07Labeling Revision
020449063AP2012/04/13Manufacturing Change or Addition
020449059AP2010/05/13Patient Population Altered
020449054AP2010/08/02Manufacturing Change or Addition
020449053AP2010/04/20Labeling Revision
020449045AP2007/09/28New or Modified Indication
020449044AP2010/04/20Labeling Revision
020449043AP2010/06/03Labeling Revision
020449039AP2006/10/17New or Modified Indication
020449036AP2006/06/07Labeling Revision
020449035AP2006/03/22New or Modified Indication
020449034AP2005/11/05Labeling Revision
020449033AP2005/08/11Labeling Revision
020449031AP2005/01/06Labeling Revision
020449029AP2004/08/18New or Modified Indication
020449028AP2004/05/19New or Modified Indication
020449022AP2003/01/03Labeling Revision
020449019AP2002/07/30Labeling Revision
020449018AP2002/11/27New or Modified Indication
020449017AP2002/07/09Labeling Revision
020449016AP2003/04/24Labeling Revision
020449015AP2000/11/30Manufacturing Change or Addition
020449014AP2000/09/28Control Supplement
020449013AP2000/09/28Manufacturing Change or Addition
020449011AP1999/12/23New or Modified Indication
020449010AP1999/03/31Manufacturing Change or Addition
020449009AP1999/05/18Control Supplement
020449008AP1999/12/06Control Supplement
020449007AP1999/02/23Manufacturing Change or Addition
020449006AP1998/06/22Labeling Revision
020449005AP1998/06/22Accelerated Approval
020449004AP1998/01/06Labeling Revision
020449003AP1998/05/15Manufacturing Change or Addition
020449002AP1999/11/22Formulation Revision
020449001AP1997/04/28Control Supplement
020449000AP1996/05/14Approval