药品名称DROXIA
申请号016295产品号004
活性成分HYDROXYUREA市场状态处方药
剂型或给药途径CAPSULE;ORAL规格400MG
治疗等效代码参比药物否
批准日期1998/02/25申请机构BRISTOL MYERS SQUIBB CO
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
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历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
无
历史市场独占权保护信息
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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
016295048APLabel2016/03/28下载
016295047APLetter2016/03/25下载
016295047APLabel2016/03/28下载
016295046APLetter2015/07/20下载
016295046APLabel2015/07/17下载
016295045APLetter2015/07/20下载
016295045APLabel2015/07/17下载
016295042APLabel2012/01/31下载
016295042APLetter2012/01/30下载
016295041APLabel2012/01/31下载
016295041APLetter2012/01/30下载
016295040APLetter2010/05/12下载
016295040APLabel2010/05/17下载
016295039APLetter2006/09/20下载
016295039APLabel2006/09/20下载
016295037APLetter2004/03/02下载
016295037APLabel2004/04/05下载
016295036APReview2004/04/14下载
016295036APLetter2003/07/06下载
016295036APLabel2003/07/08下载
016295034APLetter2001/04/04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
016295048AP2016/03/23Labeling Revision
016295047AP2016/03/23Labeling Revision
016295046AP2015/07/16Labeling Revision
016295045AP2015/07/16Labeling Revision
016295042AP2012/01/26Labeling Revision
016295041AP2012/01/26Labeling Revision
016295040AP2010/05/07Labeling Revision
016295039AP2006/09/19Labeling Revision
016295037AP2004/02/19Labeling Revision
016295036AP2003/06/26New Dosage Regimen
016295035AP2001/02/20Labeling Revision
016295034AP2001/04/04Labeling Revision
016295033AP2000/01/12Labeling Revision
016295031AP1998/11/10Manufacturing Change or Addition
016295030AP1998/02/25Control Supplement
016295029AP1998/02/25New or Modified Indication
016295028AP1997/05/23Manufacturing Change or Addition
016295027AP1997/04/07Manufacturing Change or Addition
016295026AP1999/08/11Labeling Revision
016295025AP1996/11/25Package Change
016295024AP1996/10/15Control Supplement
016295023AP1996/09/24Labeling Revision
016295022AP1993/03/09Formulation Revision
016295020AP1992/07/31Control Supplement
016295019AP1995/09/05Control Supplement
016295018AP1988/08/25Control Supplement
016295017AP1988/05/10Formulation Revision
016295015AP1987/03/19Control Supplement
016295014AP1985/07/16Manufacturing Change or Addition
016295013AP1987/03/19Control Supplement
016295011AP1996/09/24Labeling Revision
016295009AP1980/02/19Control Supplement
016295008AP1977/05/03Control Supplement
016295000AP1967/12/07Approval