药品名称DIPENTUM
申请号019715产品号001
活性成分OLSALAZINE SODIUM市场状态处方药
剂型或给药途径CAPSULE;ORAL规格250MG
治疗等效代码参比药物
批准日期1990/07/31申请机构MEDA PHARMACEUTICALS INC
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
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
019715027APLabel2009/08/13下载
019715027APLetter2009/11/12下载
019715025APLetter2007/07/16下载
019715021APLetter2002/08/09下载
019715018APLetter2002/01/18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
019715027AP2009/08/05Labeling Revision
019715025AP2007/07/10Labeling Revision
019715022AP2002/11/12Manufacturing Change or Addition
019715021AP2002/08/09Package Change
019715020AP2001/02/14Package Change
019715019AP2000/09/08Labeling Revision
019715018AP2002/01/18Labeling Revision
019715017AP1999/06/30Labeling Revision
019715016AP1996/06/06Package Change
019715015AP1996/09/11Manufacturing Change or Addition
019715014AP1996/01/29Control Supplement
019715013AP1995/02/08Labeling Revision
019715012AP1996/01/31Package Change
019715011AP1996/06/12Manufacturing Change or Addition
019715010AP1995/03/23Manufacturing Change or Addition
019715009AP1996/06/04Manufacturing Change or Addition
019715008AP1994/09/22Control Supplement
019715007AP1994/05/26Manufacturing Change or Addition
019715006AP1994/05/24Manufacturing Change or Addition
019715005AP1993/12/08Labeling Revision
019715004AP1995/01/26Formulation Revision
019715003AP1993/03/15Labeling Revision
019715002AP1993/01/05Labeling Revision
019715001AP1993/08/09Control Supplement
019715000AP1990/07/31Approval