药品名称PROVIGIL
申请号020717产品号001
活性成分MODAFINIL市场状态处方药
剂型或给药途径TABLET;ORAL规格100MG
治疗等效代码AB参比药物
批准日期1998/12/24申请机构CEPHALON INC
化学类型New molecular entity (NME)审评分类
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
72973462023/11/29YPDF格式
7297346*PED2024/05/29PDF格式
历史专利信息
49278552007/05/22U-255PDF格式
4927855*PED2007/11/22PDF格式
RE375162014/10/06U-255PDF格式
RE37516*PED2015/04/06PDF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
I-4492007/01/23
PED2007/07/23
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
020717041APLetter2012/01/19下载
020717040APLetter2012/01/19下载
020717038APLabel2015/01/20下载
020717038APLetter2015/01/20下载
020717037APLetter2015/01/20下载
020717037APLabel2015/01/20下载
020717036APMedication Guide2010/10/25下载
020717036APLetter2010/10/25下载
020717036APLabel2010/10/25下载
020717034APLabel2010/10/25下载
020717034APMedication Guide2010/10/25下载
020717034APLetter2010/10/25下载
020717030APLetter2010/10/25下载
020717030APLabel2010/10/25下载
020717030APMedication Guide2010/10/25下载
020717020APLabel2007/08/21下载
020717020APLetter2007/08/22下载
020717018APLabel2007/08/21下载
020717013APLabel2007/08/21下载
020717009APReview2007/09/24下载
020717009APLetter2003/08/15下载
020717008APLetter2004/02/02下载
020717008APLabel2004/02/03下载
020717006APLetter2003/05/29下载
020717006APReview2007/09/24下载
020717004APReview2007/04/11下载
020717003APReview2007/04/11下载
020717002APReview2007/04/11下载
020717001APReview2007/04/11下载
020717000APLetter1998/12/24下载
020717000APReview1998/12/24下载
020717000APLabel1998/12/24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
020717042AP2014/04/24Manufacturing Change or Addition
020717041AP2012/01/13Labeling Revision
020717040AP2012/01/13Labeling Revision
020717038AP2015/01/15Labeling Revision
020717037AP2015/01/15Labeling Revision
020717036AP2010/10/21Labeling Revision
020717034AP2010/10/21Labeling Revision
020717030AP2010/10/21Labeling Revision
020717024AP2007/06/15Manufacturing Change or Addition
020717023AP2006/12/13Manufacturing Change or Addition
020717022AP2006/08/07Manufacturing Change or Addition
020717020AP2007/08/17Labeling Revision
020717018AP2007/08/17Supplement
020717017AP2006/03/08Manufacturing Change or Addition
020717016AP2005/03/08Manufacturing Change or Addition
020717015AP2005/01/26Control Supplement
020717014AP2004/10/27Manufacturing Change or Addition
020717013AP2007/08/17Supplement
020717012AP2004/04/06Package Change
020717011AP2004/06/22Control Supplement
020717010AP2003/11/10Manufacturing Change or Addition
020717009AP2003/07/29Formulation Revision
020717008AP2004/01/23New or Modified Indication
020717006AP2003/04/16Package Change
020717004AP2001/11/05Manufacturing Change or Addition
020717003AP2000/09/19Control Supplement
020717002AP2000/05/17Manufacturing Change or Addition
020717001AP1999/12/14Control Supplement
020717000AP1998/12/24Approval