药品注册申请号:021285
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 SUSPENSION;ORAL 300MG/5ML Yes Yes AB 2001/05/25 2001/05/25 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 36 Approval Labeling STANDARD
2018/03/22 SUPPL 35 Approval Labeling STANDARD
2017/11/17 SUPPL 34 Approval Labeling STANDARD
2017/03/23 SUPPL 31 Approval Labeling STANDARD
2014/07/03 SUPPL 27 Approval Labeling UNKNOWN
2014/06/06 SUPPL 30 Approval Labeling STANDARD
2014/05/08 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2014/02/28 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2013/02/08 SUPPL 23 Approval Labeling STANDARD
2011/10/30 SUPPL 25 Approval REMS N/A
2011/03/03 SUPPL 22 Approval Labeling STANDARD
2011/03/03 SUPPL 20 Approval Labeling STANDARD
2011/03/03 SUPPL 19 Approval Labeling STANDARD
2011/03/03 SUPPL 18 Approval Labeling STANDARD
2011/03/03 SUPPL 15 Approval Labeling STANDARD
2011/03/03 SUPPL 13 Approval Labeling STANDARD
2011/03/03 SUPPL 9 Approval Labeling STANDARD
2009/04/23 SUPPL 21 Approval Labeling 901 REQUIRED
2007/08/31 SUPPL 14 Approval Labeling STANDARD
2005/10/28 SUPPL 8 Approval Efficacy PRIORITY
2005/03/25 SUPPL 7 Approval Labeling STANDARD
2002/09/10 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2002/04/01 SUPPL 2 Approval Labeling STANDARD
2002/01/18 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2001/05/25 ORIG 1 Approval Type 3 - New Dosage Form 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 8119148 2020/12/19 Y U-724 2012/03/08 PDF格式
8119148*PED 2021/06/19 PDF格式
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**
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**
与本品治疗等效的药品
活性成分:OXCARBAZEPINE 剂型/给药途径:SUSPENSION;ORAL 规格:300MG/5ML 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
021285 001 NDA TRILEPTAL OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Prescription Yes Yes AB 2001/05/25 NOVARTIS
078734 001 ANDA OXCARBAZEPINE OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Prescription No No AB 2009/06/26 SUN PHARM INDS LTD
202961 001 ANDA OXCARBAZEPINE OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Prescription No No AB 2012/09/17 AMNEAL PHARMS
201193 001 ANDA OXCARBAZEPINE OXCARBAZEPINE SUSPENSION;ORAL 300MG/5ML Prescription No No AB 2012/10/03 WEST-WARD PHARMS INT
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