药品名称MYSOLINE
申请号009170产品号003
活性成分PRIMIDONE市场状态处方药
剂型或给药途径TABLET;ORAL规格50MG
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VALEANT PHARMACEUTICALS INTERNATIONAL
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
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
009170038APLetter2011/08/12下载
009170036APLetter2009/05/01下载
009170036APLabel2009/05/13下载
009170035APLetter2010/07/23下载
009170035APMedication Guide2010/07/30下载
009170035APLabel2010/07/30下载
009170034APLabel2009/10/15下载
009170034APLetter2009/05/13下载
009170033APLetter2009/02/03下载
009170031APLetter2008/06/16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
009170039AP2016/02/19Manufacturing Change or Addition
009170038AP2011/08/10Labeling Revision
009170036AP2009/04/23Labeling Revision
009170035AP2010/07/21Labeling Revision
009170034AP2009/05/08Manufacturing Change or Addition
009170033AP2009/01/29Manufacturing Change or Addition
009170031AP2008/06/13Manufacturing Change or Addition
009170021AP2002/05/06Manufacturing Change or Addition
009170020AP2000/12/14Manufacturing Change or Addition
009170019AP2000/04/10Labeling Revision
009170018AP1994/03/18Control Supplement
009170017AP1989/10/25Manufacturing Change or Addition
009170016AP1988/07/28Package Change
009170014AP1987/09/02Control Supplement
009170013AP1989/08/11Formulation Revision
009170012AP1982/05/20Control Supplement
009170011AP1982/01/28Control Supplement
009170007AP1981/02/18Manufacturing Change or Addition
009170000AP1954/03/08Approval