药品名称TOPAMAX
申请号020505产品号002
活性成分TOPIRAMATE市场状态处方药
剂型或给药途径TABLET;ORAL规格200MG
治疗等效代码AB参比药物
批准日期1996/12/24申请机构JANSSEN PHARMACEUTICALS 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
59983802015/10/13U-598PDF格式
65038842015/10/13U-598PDF格式
70189832015/10/13U-723PDF格式
74983112015/10/13U-955PDF格式
5998380*PED2016/04/13PDF格式
6503884*PED2016/04/13PDF格式
7018983*PED2016/04/13PDF格式
7498311*PED2016/04/13PDF格式
历史专利信息
45130062008/09/26YYU-83PDF格式
4513006*PED2009/03/26PDF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
NPP2017/03/28
历史市场独占权保护信息
D-882006/12/16
I-412007/08/11
I-4672008/06/29
NPP2014/07/15
ODE2008/08/28
PED2008/12/29
PED2009/02/28
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
020505055APLabel2014/12/19下载
020505055APLetter2014/12/19下载
020505054APLetter2014/10/23下载
020505054APLabel2014/10/23下载
020505053APLetter2014/01/30下载
020505053APLabel2014/01/31下载
020505052APLabel2014/04/01下载
020505052APLetter2014/04/02下载
020505050APLabel2012/10/29下载
020505050APLetter2012/11/01下载
020505045APLetter2011/03/08下载
020505045APLabel2011/03/04下载
020505045APMedication Guide2011/03/04下载
020505042APMedication Guide2011/07/18下载
020505042APLabel2011/07/18下载
020505042APLetter2011/07/19下载
020505040APLetter2011/03/08下载
020505040APMedication Guide2011/03/04下载
020505040APLabel2011/03/04下载
020505039APLabel2009/05/12下载
020505039APLetter2009/05/04下载
020505038APLabel2009/05/12下载
020505038APLetter2009/05/04下载
020505037APLetter2009/12/30下载
020505037APLabel2010/01/04下载
020505036APLabel2009/04/28下载
020505032APLabel2010/01/04下载
020505032APLetter2009/12/30下载
020505031APLetter2009/12/30下载
020505031APLabel2010/01/04下载
020505029APPatient Information Sheet2006/10/23下载
020505029APLetter2006/10/23下载
020505026APLabel2005/07/05下载
020505026APLetter2005/07/08下载
020505025APLetter2004/08/12下载
020505025APLabel2004/08/12下载
020505023APLetter2003/05/29下载
020505022APLetter2004/08/12下载
020505022APLabel2004/08/12下载
020505021APLetter2003/05/29下载
020505020APLetter2003/06/22下载
020505019APLetter2003/12/19下载
020505019APLabel2003/12/29下载
020505018APLabel2005/07/05下载
020505018APLetter2005/07/08下载
020505018APReview2012/02/28下载
020505017APLabel2003/12/29下载
020505017APLetter2003/12/19下载
020505016APLetter2002/12/09下载
020505015APLetter2003/06/08下载
020505014APLabel2010/01/04下载
020505014APLetter2009/12/30下载
020505010APLabel2003/12/29下载
020505010APLetter2004/06/28下载
020505003APReview2000/07/03下载
020505003APLetter1999/10/01下载
020505003APLabel1999/10/01下载
020505002APLetter2001/08/28下载
020505002APLabel2001/08/28下载
020505002APReview2004/09/08下载
020505001APReview2000/07/03下载
020505001APLetter1999/07/23下载
020505001APLabel1999/07/23下载
020505000APReview2004/09/10下载
020505000APMedication Guide2009/09/30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
020505056AP2015/05/11Manufacturing Change or Addition
020505055AP2014/12/18Labeling Revision
020505054AP2014/10/21Labeling Revision
020505053AP2014/01/29Labeling Revision
020505052AP2014/03/28Efficacy Supplement with Clinical Data to Support
020505051AP2013/07/25Manufacturing Change or Addition
020505050AP2012/10/29Labeling Revision
020505045AP2011/03/04Labeling Revision
020505042AP2011/07/15Efficacy Supplement with Clinical Data to Support
020505040AP2011/03/04Labeling Revision
020505039AP2009/04/23Labeling Revision
020505038AP2009/04/23Labeling Revision
020505037AP2009/12/22Patient Population Altered
020505036AP2009/04/22Labeling Revision
020505032AP2009/12/22Labeling Revision
020505031AP2009/12/22Labeling Revision
020505029AP2006/10/19Labeling Revision
020505026AP2005/06/29Labeling Revision
020505025AP2004/08/11Labeling Revision
020505023AP2003/04/15Labeling Revision
020505022AP2004/08/11New or Modified Indication
020505021AP2003/04/15Labeling Revision
020505020AP2003/06/12Labeling Revision
020505019AP2003/12/16Labeling Revision
020505018AP2005/06/29New or Modified Indication
020505017AP2003/12/16New Dosage Regimen
020505016AP2002/11/26Labeling Revision
020505015AP2003/06/03Labeling Revision
020505014AP2009/12/22Labeling Revision
020505013AP2000/10/24Manufacturing Change or Addition
020505012AP2000/07/18Manufacturing Change or Addition
020505011AP2000/05/15Control Supplement
020505010AP2003/12/16Labeling Revision
020505009AP2000/01/04Manufacturing Change or Addition
020505008AP1999/12/07Manufacturing Change or Addition
020505007AP2000/03/02Manufacturing Change or Addition
020505005AP2000/05/01Labeling Revision
020505003AP1999/10/01New or Modified Indication
020505002AP2001/08/28New or Modified Indication
020505001AP1999/07/23New or Modified Indication
020505000AP1996/12/24Approval