药品名称FELBATOL
申请号020189产品号002
活性成分FELBAMATE市场状态处方药
剂型或给药途径TABLET;ORAL规格600MG
治疗等效代码AB参比药物
批准日期1993/07/29申请机构MEDA PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
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
49786802009/09/26U-83PDF格式
50828612009/09/26U-83PDF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
020189027APLetter2012/09/05下载
020189027APLabel2012/09/06下载
020189027APMedication Guide2012/09/06下载
020189023APLetter2011/07/07下载
020189023APLabel2011/07/07下载
020189023APMedication Guide2011/07/07下载
020189022APLetter2009/05/01下载
020189022APLabel2009/05/13下载
020189018APLetter2002/11/19下载
020189000APHealthcare Professional Sheet2008/02/01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
020189027AP2012/08/31Labeling Revision
020189023AP2011/07/06Labeling Revision
020189022AP2009/04/23Labeling Revision
020189019AP2002/06/26Manufacturing Change or Addition
020189018AP2002/11/19Labeling Revision
020189012AP1995/08/28Control Supplement
020189011AP1995/06/26Control Supplement
020189010AP1995/01/24Expiration Date Change
020189009AP1994/11/29Labeling Revision
020189008AP1994/11/01Labeling Revision
020189006AP1994/11/01Labeling Revision
020189005AP1994/05/31Formulation Revision
020189004AP1994/03/02Labeling Revision
020189003AP1993/12/21Manufacturing Change or Addition
020189002AP1993/12/20Manufacturing Change or Addition
020189001AP1993/09/17Manufacturing Change or Addition
020189000AP1993/07/29Approval