药品名称PONSTEL
申请号015034产品号003
活性成分MEFENAMIC ACID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
批准日期Approved Prior to Jan 1, 1982申请机构SHIONOGI INC
化学类型New molecular entity (NME)审评分类Standard 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
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
015034044APLetter2016/05/11下载
015034044APLabel2016/05/11下载
015034040APLabel2008/03/07下载
015034040APLetter2008/03/17下载
015034039APLabel2006/01/20下载
015034039APLetter2006/01/20下载
015034034APReview2008/08/04下载
015034032APReview2008/08/11下载
015034000APMedication Guide2009/11/20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
015034044AP2016/05/09Labeling Revision
015034043AP2015/01/05Manufacturing Change or Addition
015034040AP2008/03/06Labeling Revision
015034039AP2006/01/18Labeling Revision
015034035AP2001/07/31Manufacturing Change or Addition
015034034AP2001/10/04Labeling Revision
015034033AP1998/09/01Manufacturing Change or Addition
015034032AP1998/04/23Labeling Revision
015034031AP1996/04/05Manufacturing Change or Addition
015034029AP1993/10/04Control Supplement
015034028AP1989/06/14Labeling Revision
015034027AP1989/06/14Formulation Revision
015034025AP1984/05/29Manufacturing Change or Addition
015034024AP1986/01/31Control Supplement
015034023AP1984/08/13Control Supplement
015034022AP1983/04/19Manufacturing Change or Addition
015034021AP1983/03/31Labeling Revision
015034019AP1982/01/26Control Supplement
015034017AP1981/02/05Manufacturing Change or Addition
015034016AP1981/03/02Manufacturing Change or Addition
015034015AP1981/05/14Manufacturing Change or Addition
015034014AP1981/01/29Formulation Revision
015034013AP1981/02/17Labeling Revision
015034012AP1981/02/17Control Supplement
015034011AP1977/10/18Control Supplement
015034010AP1977/04/27Package Change
015034008AP1975/04/28Final Printed Labeling - MarkIV
015034000AP1967/03/28Approval