药品名称ZOFRAN
申请号020007产品号001
活性成分ONDANSETRON HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 2MG BASE/ML
治疗等效代码参比药物
批准日期1991/01/04申请机构NOVARTIS PHARMACEUTICALS CORP
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
4753789*PED2006/12/24PDF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
D-972008/03/25
D-982008/03/25
PED2008/09/25
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
020007046APLabel2014/09/22下载
020007046APLetter2014/09/23下载
020007044APLabel2013/12/11下载
020007044APLetter2013/12/13下载
020007043APLabel2012/11/15下载
020007043APLetter2012/11/16下载
020007042APLetter2011/09/16下载
020007042APLabel2011/09/16下载
020007041APLetter2011/07/13下载
020007040APLetter2010/09/28下载
020007040APLabel2010/09/29下载
020007039APLabel2006/08/23下载
020007039APLetter2006/09/18下载
020007037APLabel2006/01/05下载
020007037APReview2009/09/16下载
020007035APLetter2005/03/30下载
020007035APLabel2005/03/30下载
020007034APLetter2004/12/02下载
020007034APLabel2004/12/03下载
020007030APReview2009/01/12下载
020007022APReview1997/10/31下载
020007000APOther2007/07/09下载
020007000APOther2011/12/20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
020007046AP2014/09/18Labeling Revision
020007044AP2013/12/10Labeling Revision
020007043AP2012/11/14Labeling Revision
020007042AP2011/09/14Labeling Revision
020007041AP2011/07/07Labeling Revision
020007040AP2010/09/22Labeling Revision
020007039AP2006/08/22Labeling Revision
020007037AP2005/12/27Labeling Revision
020007035AP2005/03/25Patient Population Altered
020007034AP2004/11/24Labeling Revision
020007032AP2000/12/08Labeling Revision
020007031AP2000/12/08Labeling Revision
020007030AP2000/04/11Labeling Revision
020007029AP1999/05/14Manufacturing Change or Addition
020007028AP1999/02/17Labeling Revision
020007027AP1999/03/10Labeling Revision
020007024AP1997/08/12Manufacturing Change or Addition
020007023AP1997/04/02Labeling Revision
020007022AP1997/10/31New Route of Administration
020007021AP1996/03/12Labeling Revision
020007020AP1996/05/16New or Modified Indication
020007019AP1996/07/29Package Change
020007018AP1995/02/14Manufacturing Change or Addition
020007016AP1994/04/27Labeling Revision
020007015AP1994/03/31Manufacturing Change or Addition
020007014AP1995/01/31Formulation Revision
020007013AP1993/04/28Labeling Revision
020007012AP1993/02/09Control Supplement
020007011AP1993/03/24Control Supplement
020007010AP1993/01/22Control Supplement
020007009AP1993/12/10Formulation Revision
020007008AP1993/02/02Labeling Revision
020007007AP1993/02/02Labeling Revision
020007006AP1992/08/18Control Supplement
020007005AP1993/08/13New or Modified Indication
020007004AP1993/02/02Labeling Revision
020007003AP1993/02/02New Dosage Regimen
020007002AP1993/02/02Labeling Revision
020007001AP1993/02/02Labeling Revision
020007000AP1991/01/04Approval