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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2019/01/04 SUPPL-43(补充) Approval Labeling STANDARD
2018/03/22 SUPPL-42(补充) Approval Labeling STANDARD
2017/11/17 SUPPL-41(补充) Approval Labeling STANDARD
2017/03/23 SUPPL-36(补充) Approval Labeling STANDARD
2016/06/17 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2016/05/06 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
2015/04/14 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2014/07/03 SUPPL-33(补充) Approval Labeling STANDARD
2014/06/06 SUPPL-35(补充) Approval Labeling STANDARD
2014/05/08 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
2013/02/08 SUPPL-29(补充) Approval Labeling STANDARD
2011/10/30 SUPPL-31(补充) Approval REMS N/A
2011/03/03 SUPPL-28(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-27(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-25(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-24(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-22(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-19(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-15(补充) Approval Labeling STANDARD
2009/04/23 SUPPL-26(补充) Approval Labeling 901 REQUIRED
2007/08/31 SUPPL-21(补充) Approval Labeling STANDARD
2007/01/09 SUPPL-20(补充) Approval Manufacturing (CMC) N/A
2005/11/09 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2005/10/28 SUPPL-13(补充) Approval Efficacy PRIORITY
2005/03/25 SUPPL-12(补充) Approval Labeling STANDARD
2003/08/07 SUPPL-3(补充) Approval Efficacy STANDARD
2003/03/27 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2002/05/01 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2002/04/01 SUPPL-6(补充) Approval Labeling STANDARD
2001/11/14 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
2000/08/29 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2000/06/02 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
2000/01/14 ORIG-1(原始申请) 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
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
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 RUBICON
215939 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2022/01/11 ANNORA PHARMA
211747 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Discontinued No No AB 2023/07/03 ZYDUS
207717 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2024/03/05 RUBICON
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
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
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 RUBICON
215939 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2022/01/11 ANNORA PHARMA
211747 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Discontinued No No AB 2023/07/03 ZYDUS
207717 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2024/03/05 RUBICON
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
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
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 RUBICON
215939 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2022/01/11 ANNORA PHARMA
211747 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Discontinued No No AB 2023/07/03 ZYDUS
207717 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2024/03/05 RUBICON
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