药品注册申请号:078005
申请类型:ANDA (仿制药申请)
申请人:ANI PHARMS
申请人全名:ANI PHARMACEUTICALS INC
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 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG No No AB 2007/12/11 2007/12/11 Prescription
002 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG No No AB 2007/12/11 Prescription
003 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG No No AB 2007/12/11 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
2020/10/27 SUPPL-7(补充) Approval Labeling STANDARD
2020/10/27 SUPPL-6(补充) Approval Labeling STANDARD
2012/01/20 SUPPL-4(补充) Approval Manufacturing (CMC)
2010/06/29 SUPPL-3(补充) Approval Labeling
2010/06/29 SUPPL-2(补充) Approval Labeling
2007/12/11 ORIG-1(原始申请) Approval
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
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
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
078005 001 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 150MG Prescription No No AB 2007/12/11 ANI PHARMS
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
078005 002 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG Prescription No No AB 2007/12/11 ANI PHARMS
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
078005 003 ANDA OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG Prescription No No AB 2007/12/11 ANI PHARMS
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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药品NDC数据与药品包装、标签说明书
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