药品注册申请号:021014
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 150MG Yes No AB 2000/01/14 2000/01/14 Prescription
002 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 300MG Yes No AB 2000/01/14 Prescription
003 TRILEPTAL OXCARBAZEPINE TABLET;ORAL 600MG Yes Yes AB 2000/01/14 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/01/04 SUPPL 43 Approval Labeling STANDARD
2018/03/22 SUPPL 42 Approval Labeling STANDARD
2017/11/17 SUPPL 41 Approval Labeling STANDARD
2017/03/23 SUPPL 36 Approval Labeling STANDARD
2016/06/17 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2016/05/06 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2015/04/14 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2014/07/03 SUPPL 33 Approval Labeling STANDARD
2014/06/06 SUPPL 35 Approval Labeling STANDARD
2014/05/08 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2013/02/08 SUPPL 29 Approval Labeling STANDARD
2011/10/30 SUPPL 31 Approval REMS N/A
2011/03/03 SUPPL 28 Approval Labeling STANDARD
2011/03/03 SUPPL 27 Approval Labeling STANDARD
2011/03/03 SUPPL 25 Approval Labeling STANDARD
2011/03/03 SUPPL 24 Approval Labeling STANDARD
2011/03/03 SUPPL 22 Approval Labeling STANDARD
2011/03/03 SUPPL 19 Approval Labeling STANDARD
2011/03/03 SUPPL 15 Approval Labeling STANDARD
2009/04/23 SUPPL 26 Approval Labeling 901 REQUIRED
2007/08/31 SUPPL 21 Approval Labeling STANDARD
2007/01/09 SUPPL 20 Approval Manufacturing (CMC) N/A
2005/11/09 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2005/10/28 SUPPL 13 Approval Efficacy PRIORITY
2005/03/25 SUPPL 12 Approval Labeling STANDARD
2003/08/07 SUPPL 3 Approval Efficacy STANDARD
2003/03/27 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2002/05/01 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2002/04/01 SUPPL 6 Approval Labeling STANDARD
2001/11/14 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2000/08/29 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2000/06/02 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2000/01/14 ORIG 1 Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 7037525 2018/02/12 U-724 PDF格式**本条是由Drugfuture回溯的历史信息**
7037525*PED 2018/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
002 7037525 2018/02/12 U-724 PDF格式**本条是由Drugfuture回溯的历史信息**
7037525*PED 2018/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
003 7037525 2018/02/12 U-724 PDF格式**本条是由Drugfuture回溯的历史信息**
7037525*PED 2018/08/12 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-478 2008/10/28**本条是由Drugfuture回溯的历史信息**
PED 2009/04/28**本条是由Drugfuture回溯的历史信息**
002 I-478 2008/10/28**本条是由Drugfuture回溯的历史信息**
PED 2009/04/28**本条是由Drugfuture回溯的历史信息**
003 I-478 2008/10/28**本条是由Drugfuture回溯的历史信息**
PED 2009/04/28**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;ORAL 规格:150MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021014 001 NDA TRILEPTAL OXCARBAZEPINE TABLET;ORAL 150MG Prescription Yes No AB 2000/01/14 NOVARTIS
077794 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/10/09 SUN PHARM INDS
077795 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/10/09 WEST-WARD PHARMS INT
077802 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/10/09 GLENMARK PHARMS LTD
077801 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/11/15 TARO
078005 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/12/11 ANI PHARMS INC
078069 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2008/01/11 BRECKENRIDGE PHARM
077747 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2008/04/09 APOTEX INC
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;ORAL 规格:300MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021014 002 NDA TRILEPTAL OXCARBAZEPINE TABLET;ORAL 300MG Prescription Yes No AB 2000/01/14 NOVARTIS
077794 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/10/09 SUN PHARM INDS
077795 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/10/09 WEST-WARD PHARMS INT
077802 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/10/09 GLENMARK PHARMS LTD
077801 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/11/15 TARO
078005 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/12/11 ANI PHARMS INC
078069 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2008/01/11 BRECKENRIDGE PHARM
077747 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2008/04/09 APOTEX INC
活性成分:OXCARBAZEPINE 剂型/给药途径:TABLET;ORAL 规格:600MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021014 003 NDA TRILEPTAL OXCARBAZEPINE TABLET;ORAL 600MG Prescription Yes Yes AB 2000/01/14 NOVARTIS
077794 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/10/09 SUN PHARM INDS
077795 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/10/09 WEST-WARD PHARMS INT
077802 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/10/09 GLENMARK PHARMS LTD
077801 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/11/15 TARO
078005 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/12/11 ANI PHARMS INC
078069 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2008/01/11 BRECKENRIDGE PHARM
077747 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2008/04/09 APOTEX INC
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