药品名称DOXIL (LIPOSOMAL)
申请号050718产品号002
活性成分DOXORUBICIN HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE, LIPOSOMAL;INJECTION规格50MG/25ML (2MG/ML)
治疗等效代码AB参比药物
批准日期2000/06/13申请机构JANSSEN RESEARCH AND DEVELOPMENT LLC
化学类型New dosage form审评分类Standard review drug
罕用药/孤儿药
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
50135562009/10/20YU-940PDF格式
50135562009/10/20YU-941PDF格式
50135562009/10/20YU-942PDF格式
52138042009/10/20YU-940PDF格式
52138042009/10/20YU-941PDF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
ODE2014/05/17
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
050718050APLetter2015/12/29下载
050718048APLetter2015/04/17下载
050718048APLabel2015/04/17下载
050718046APLabel2015/01/29下载
050718045APLetter2013/09/04下载
050718045APLabel2013/09/09下载
050718043APLabel2012/09/20下载
050718043APLetter2012/09/24下载
050718033APLetter2008/06/13下载
050718033APLabel2008/06/19下载
050718033APSummary Review2008/07/17下载
050718029APLetter2007/05/29下载
050718029APLabel2007/05/18下载
050718028APLetter2007/05/29下载
050718028APLabel2007/05/29下载
050718020APLetter2005/02/03下载
050718020APLabel2005/02/03下载
050718019APLetter2004/10/29下载
050718019APLabel2004/11/01下载
050718019APReview2011/10/10下载
050718010APLetter2004/06/02下载
050718006APLetter1999/06/28下载
050718006APLabel1999/06/28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
050718052AP2016/04/25Manufacturing Change or Addition
050718051AP2016/03/29Manufacturing Change or Addition
050718050AP2015/12/28Manufacturing Change or Addition
050718049AP2015/10/09Manufacturing Change or Addition
050718048AP2015/04/16Efficacy Supplement with Clinical Data to Support
050718047AP2014/04/14Manufacturing Change or Addition
050718046AP2015/01/22Manufacturing Change or Addition
050718045AP2013/08/30Labeling Revision
050718043AP2012/09/19Labeling Revision
050718033AP2008/06/10Accelerated Approval
050718031AP2013/12/12Manufacturing Change or Addition
050718029AP2007/05/17New or Modified Indication
050718028AP2007/05/17Labeling Revision
050718020AP2005/01/28Accelerated Approval
050718019AP2004/10/27Efficacy Supplement with Clinical Data to Support
050718016AP2002/12/17Control Supplement
050718014AP2002/08/09Package Change
050718012AP2002/04/18Control Supplement
050718010AP2002/01/10Labeling Revision
050718008AP2000/06/13Package Change
050718007AP2000/03/30Manufacturing Change or Addition
050718006AP1999/06/28New or Modified Indication
050718005AP1998/03/31Control Supplement
050718004AP1997/07/31Labeling Revision
050718002AP1996/07/10Expiration Date Change
050718001AP1996/03/08Labeling Revision
050718000AP1995/11/17Approval