药品名称ZARONTIN
申请号012380产品号001
活性成分ETHOSUXIMIDE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格250MG
治疗等效代码AB参比药物是
批准日期Approved Prior to Jan 1, 1982申请机构PARKE DAVIS DIV WARNER LAMBERT 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
无
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
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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
012380036APLetter2016/05/20下载
012380036APLabel2016/05/20下载
012380034APLabel2012/05/07下载
012380034APMedication Guide2012/05/07下载
012380034APLetter2012/05/09下载
012380033APLetter2011/06/17下载
012380032APLetter2010/09/20下载
012380032APLabel2010/09/20下载
012380031APLabel2009/04/28下载
012380031APLetter2009/04/29下载
012380030APLetter2006/09/18下载
012380029APLetter2002/04/19下载
012380025APLetter2001/04/09下载
012380023APLetter2001/04/09下载
012380022APLetter2001/04/09下载
012380000APMedication Guide2010/09/30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
012380036AP2016/05/17Labeling Revision
012380034AP2012/05/03Labeling Revision
012380033AP2011/06/15Labeling Revision
012380032AP2010/09/14Labeling Revision
012380031AP2009/04/23Labeling Revision
012380030AP2006/09/01Labeling Revision
012380029AP2002/04/19Labeling Revision
012380028AP2000/09/22Manufacturing Change or Addition
012380027AP2000/06/28Manufacturing Change or Addition
012380025AP2001/04/09Labeling Revision
012380024AP1996/02/22Control Supplement
012380023AP2001/04/09Labeling Revision
012380022AP2001/04/09Labeling Revision
012380021AP1991/01/08Manufacturing Change or Addition
012380020AP1984/07/31Control Supplement
012380019AP1983/11/08Package Change
012380018AP1982/09/03Formulation Revision
012380017AP1981/12/09Manufacturing Change or Addition
012380016AP1981/05/28Manufacturing Change or Addition
012380015AP1981/05/28Formulation Revision
012380014AP1981/02/03Manufacturing Change or Addition
012380012AP1980/12/11Manufacturing Change or Addition
012380011AP1980/06/02Control Supplement
012380000AP1960/11/02Approval