药品注册申请号：077802
申请类型：ANDA (仿制药申请)
申请人：GLENMARK PHARMS LTD
申请人全名：GLENMARK PHARMACEUTICALS LTD
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 2007/10/09 2007/10/09 Prescription
002 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 300MG No No AB 2007/10/09 Prescription
003 OXCARBAZEPINE OXCARBAZEPINE TABLET;ORAL 600MG No No AB 2007/10/09 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
2020/08/25 SUPPL 17 Approval Labeling STANDARD
2020/08/25 SUPPL 15 Approval Labeling STANDARD
2020/08/25 SUPPL 13 Approval Labeling STANDARD
2015/01/20 SUPPL 11 Approval Labeling STANDARD
2015/01/20 SUPPL 8 Approval Labeling STANDARD
2012/01/19 SUPPL 5 Approval REMS
2011/12/28 SUPPL 4 Approval Labeling
2010/06/29 SUPPL 2 Approval Labeling
2007/10/09 ORIG 1 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
无
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
无
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
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
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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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