药品注册申请号：209677
申请类型：ANDA (仿制药申请)
申请人：SOLA PHARMS
申请人全名：SOLA PHARMACEUTICALS
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 TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG No No AB;AB 2020/06/17 2020/06/17 Prescription
002 TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG No No AB;AB 2023/09/28 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
2023/09/28 ORIG-2（原始申请） Approval STANDARD
2020/06/17 ORIG-1（原始申请） Approval 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
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:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:14MG 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
202992 002 NDA AUBAGIO TERIFLUNOMIDE TABLET;ORAL 14MG Prescription Yes Yes AB 2012/09/12 SANOFI AVENTIS US
209700 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/09/04 TEVA PHARMS USA
209613 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2018/09/28 AMNEAL PHARMS CO
209638 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/10/26 AUROBINDO PHARMA
209601 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/02 APOTEX
209663 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/15 GLENMARK SPECLT
209668 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/30 ZYDUS PHARMS
209710 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/01/03 SANDOZ
209690 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/01/07 ACCORD HLTHCARE
209572 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/04/19 ALEMBIC
209623 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/04/24 MSN
209702 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2020/02/28 MYLAN
209677 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2020/06/17 SOLA PHARMS
209639 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/03/13 BIOCON PHARMA
209598 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/03/13 HETERO LABS LTD V
209555 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/05/15 NATCO
209697 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2024/04/04 TORRENT
活性成分:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:14MG 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
202992 002 NDA AUBAGIO TERIFLUNOMIDE TABLET;ORAL 14MG Prescription Yes Yes AB 2012/09/12 SANOFI AVENTIS US
209700 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/09/04 TEVA PHARMS USA
209613 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2018/09/28 AMNEAL PHARMS CO
209638 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/10/26 AUROBINDO PHARMA
209601 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/02 APOTEX
209663 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/15 GLENMARK SPECLT
209668 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2018/11/30 ZYDUS PHARMS
209710 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/01/03 SANDOZ
209690 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/01/07 ACCORD HLTHCARE
209572 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/04/19 ALEMBIC
209623 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2019/04/24 MSN
209702 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2020/02/28 MYLAN
209677 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2020/06/17 SOLA PHARMS
209639 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/03/13 BIOCON PHARMA
209598 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/03/13 HETERO LABS LTD V
209555 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Prescription No No AB 2023/05/15 NATCO
209697 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG Discontinued No No AB 2024/04/04 TORRENT
活性成分:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:7MG 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
202992 001 NDA AUBAGIO TERIFLUNOMIDE TABLET;ORAL 7MG Prescription Yes No AB 2012/09/12 SANOFI AVENTIS US
209700 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/09/04 TEVA PHARMS USA
209613 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2018/09/28 AMNEAL PHARMS CO
209638 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/10/26 AUROBINDO PHARMA
209601 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/02 APOTEX
209663 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/15 GLENMARK SPECLT
209668 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/30 ZYDUS PHARMS
209710 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/01/03 SANDOZ
209690 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/01/07 ACCORD HLTHCARE
209572 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/04/19 ALEMBIC
209623 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/04/24 MSN
209702 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2020/02/28 MYLAN
209639 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/03/13 BIOCON PHARMA
209598 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/03/13 HETERO LABS LTD V
209555 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/05/15 NATCO
209677 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/09/28 SOLA PHARMS
209697 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2024/04/04 TORRENT
活性成分:TERIFLUNOMIDE 剂型/给药途径:TABLET;ORAL 规格:7MG 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
202992 001 NDA AUBAGIO TERIFLUNOMIDE TABLET;ORAL 7MG Prescription Yes No AB 2012/09/12 SANOFI AVENTIS US
209700 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/09/04 TEVA PHARMS USA
209613 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2018/09/28 AMNEAL PHARMS CO
209638 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/10/26 AUROBINDO PHARMA
209601 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/02 APOTEX
209663 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/15 GLENMARK SPECLT
209668 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2018/11/30 ZYDUS PHARMS
209710 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/01/03 SANDOZ
209690 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/01/07 ACCORD HLTHCARE
209572 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/04/19 ALEMBIC
209623 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2019/04/24 MSN
209702 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2020/02/28 MYLAN
209639 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/03/13 BIOCON PHARMA
209598 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/03/13 HETERO LABS LTD V
209555 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/05/15 NATCO
209677 002 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Prescription No No AB 2023/09/28 SOLA PHARMS
209697 001 ANDA TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG Discontinued No No AB 2024/04/04 TORRENT
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药品NDC数据与药品包装、标签说明书
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