药品注册申请号：217281
申请类型：ANDA (仿制药申请)
申请人：NOVUGEN
申请人全名：NOVUGEN ONCOLOGY SDN BHD
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 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG No No AB 2024/09/11 2024/09/11 Prescription
002 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG No No AB 2024/09/11 Prescription
003 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG No No AB 2024/09/11 Prescription
004 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG No No AB 2024/09/11 Prescription
005 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG No No AB 2024/09/11 Prescription
006 LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG No No AB 2024/09/11 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
2024/09/11 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:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:2.5MG 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
021880 005 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription Yes No AB 2011/12/21 BRISTOL MYERS SQUIBB
209348 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2021/10/14 DR REDDYS
210154 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 ZYDUS PHARMS
210480 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 LOTUS PHARM CO LTD
201452 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 ARROW INTL
211846 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 SUN PHARM
213885 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 EUGIA PHARMA
213912 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 MYLAN
214618 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/06 CIPLA
211022 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/03/07 APOTEX
212414 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
217265 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Discontinued No No AB 2024/02/22 QILU
217281 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 2.5MG Prescription No No AB 2024/09/11 NOVUGEN
活性成分:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:5MG 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
021880 001 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 5MG Prescription Yes No AB 2005/12/27 BRISTOL MYERS SQUIBB
201452 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2021/05/21 ARROW INTL
209348 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/08/30 DR REDDYS
211022 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/08/30 APOTEX
213912 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/08/30 MYLAN
210480 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/08/31 LOTUS PHARM CO LTD
210435 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/09/06 CIPLA
210154 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2022/09/12 ZYDUS PHARMS
211846 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2023/02/08 SUN PHARM
213885 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2023/03/06 EUGIA PHARMA
212414 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
217265 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Discontinued No No AB 2024/02/22 QILU
217281 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 5MG Prescription No No AB 2024/09/11 NOVUGEN
活性成分:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:10MG 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
021880 002 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 10MG Prescription Yes No AB 2005/12/27 BRISTOL MYERS SQUIBB
201452 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2021/05/21 ARROW INTL
209348 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/08/30 DR REDDYS
211022 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/08/30 APOTEX
213912 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/08/30 MYLAN
210480 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/08/31 LOTUS PHARM CO LTD
210435 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/09/06 CIPLA
210154 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/09/12 ZYDUS PHARMS
211846 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/02/08 SUN PHARM
213405 001 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Discontinued No No AB 2023/02/17 TORRENT
213885 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/03/06 EUGIA PHARMA
212414 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
217265 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Discontinued No No AB 2024/02/22 QILU
217281 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 10MG Prescription No No AB 2024/09/11 NOVUGEN
活性成分:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:15MG 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
021880 003 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 15MG Prescription Yes No AB 2006/06/29 BRISTOL MYERS SQUIBB
201452 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2021/05/21 ARROW INTL
209348 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/08/30 DR REDDYS
211022 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/08/30 APOTEX
213912 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/08/30 MYLAN
210480 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/08/31 LOTUS PHARM CO LTD
210435 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/09/06 CIPLA
210154 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2022/09/12 ZYDUS PHARMS
211846 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2023/02/08 SUN PHARM
213885 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2023/03/06 EUGIA PHARMA
212414 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
217265 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Discontinued No No AB 2024/02/22 QILU
217281 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 15MG Prescription No No AB 2024/09/11 NOVUGEN
活性成分:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:20MG 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
021880 006 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 20MG Prescription Yes No AB 2013/06/05 BRISTOL MYERS SQUIBB
209348 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2021/10/14 DR REDDYS
210154 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 ZYDUS PHARMS
210435 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 CIPLA
210480 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 LOTUS PHARM CO LTD
201452 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 ARROW INTL
211846 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 SUN PHARM
213885 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 EUGIA PHARMA
213912 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/06 MYLAN
211022 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/03/07 APOTEX
212414 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
213405 003 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Discontinued No No AB 2023/08/03 TORRENT
217265 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Discontinued No No AB 2024/02/22 QILU
217281 005 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 20MG Prescription No No AB 2024/09/11 NOVUGEN
活性成分:LENALIDOMIDE 剂型/给药途径:CAPSULE;ORAL 规格:25MG 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
021880 004 NDA REVLIMID LENALIDOMIDE CAPSULE;ORAL 25MG Prescription Yes Yes AB 2006/06/29 BRISTOL MYERS SQUIBB
201452 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2021/05/21 ARROW INTL
209348 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/08/30 DR REDDYS
211022 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/08/30 APOTEX
213912 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/08/30 MYLAN
210480 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/08/31 LOTUS PHARM CO LTD
210435 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/09/06 CIPLA
210154 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2022/09/12 ZYDUS PHARMS
211846 004 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2023/02/08 SUN PHARM
213405 002 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Discontinued No No AB 2023/02/17 TORRENT
213885 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2023/03/06 EUGIA PHARMA
212414 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2023/05/11 HETERO LABS LTD V
217265 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Discontinued No No AB 2024/02/22 QILU
217281 006 ANDA LENALIDOMIDE LENALIDOMIDE CAPSULE;ORAL 25MG Prescription No No AB 2024/09/11 NOVUGEN
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药品NDC数据与药品包装、标签说明书
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