药品名称ZERIT
申请号020412产品号004
活性成分STAVUDINE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格30MG
治疗等效代码AB参比药物
批准日期1994/06/24申请机构BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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
49786552008/06/24U-94PDF格式
4978655*PED2008/12/24U-94PDF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
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
020412038APLetter2011/11/22下载
020412038APMedication Guide2011/11/22下载
020412038APLabel2011/11/22下载
020412037APLetter2011/05/16下载
020412036APMedication Guide2010/12/23下载
020412036APLabel2010/12/23下载
020412036APLetter2010/12/28下载
020412034APLabel2009/07/09下载
020412034APLetter2009/07/15下载
020412033APLetter2009/02/18下载
020412033APLabel2009/02/20下载
020412032APLetter2008/12/18下载
020412032APLabel2009/01/02下载
020412030APLabel2008/04/23下载
020412030APLetter2008/04/16下载
020412029APLabel2008/04/23下载
020412029APLetter2008/04/16下载
020412027APLetter2007/04/25下载
020412027APLetter2007/06/14下载
020412024APLabel2007/02/05下载
020412023APLetter2004/06/07下载
020412023APLabel2004/06/07下载
020412018APLetter2002/02/20下载
020412017APLetter2002/02/20下载
020412016APLetter2002/03/29下载
020412016APLabel2002/03/29下载
020412015APLabel2003/04/22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
020412039AP2015/07/14Manufacturing Change or Addition
020412038AP2011/11/18Labeling Revision
020412037AP2011/05/11Labeling Revision
020412036AP2010/12/10Labeling Revision
020412034AP2009/07/08Labeling Revision
020412033AP2009/02/13Labeling Revision
020412032AP2008/12/11Labeling Revision
020412030AP2008/04/14Labeling Revision
020412029AP2008/04/14Labeling Revision
020412027AP2007/04/20Labeling Revision
020412027AP2007/06/06Labeling Revision
020412027AP2007/06/13Labeling Revision
020412027AP2007/06/21Labeling Revision
020412024AP2005/12/20Labeling Revision
020412023AP2004/06/04Labeling Revision
020412018AP2002/02/20Labeling Revision
020412017AP2002/02/20Labeling Revision
020412016AP2002/03/29Efficacy Supplement with Clinical Data to Support
020412015AP2001/10/16Labeling Revision
020412014AP2001/04/17Control Supplement
020412013AP2000/09/27Labeling Revision
020412012AP1999/06/10Manufacturing Change or Addition
020412011AP1998/09/16Labeling Revision
020412010AP1999/07/01New or Modified Indication
020412009AP1998/08/19Control Supplement
020412008AP1998/01/16Manufacturing Change or Addition
020412007AP1998/02/03Control Supplement
020412006AP1997/09/26Manufacturing Change or Addition
020412005AP1998/02/04Labeling Revision
020412004AP1996/09/06Patient Population Altered
020412003AP1996/02/09Control Supplement
020412002AP1995/12/21New or Modified Indication
020412001AP1994/08/02Control Supplement
020412000AP1994/06/24Approval