药品注册申请号：213914
申请类型：ANDA (仿制药申请)
申请人：SUN PHARM
申请人全名：SUN PHARMACEUTICAL INDUSTRIES 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 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE No No AB 2021/08/16 2021/08/16 Prescription
002 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE No No AB 2021/08/16 Prescription
003 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE No No AB 2021/08/16 Prescription
004 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE No No AB 2021/08/16 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/08/16 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/08/21 SUPPL-1（补充） Approval Labeling-Package Insert,Labeling-Medication Guide 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:SUNITINIB MALATE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 12.5MG BASE; 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
021938 001 NDA SUTENT SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription Yes No AB 2006/01/26 CPPI CV
213914 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2021/08/16 SUN PHARM
213803 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2021/11/30 TEVA PHARMS USA
201275 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2021/12/06 MYLAN
215843 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2022/04/11 DR REDDYS
218012 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2023/08/21 FOSUN WANBANG
218024 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2023/10/24 NATCO PHARMA
218615 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2024/03/14 EUGIA PHARMA
214824 001 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE Prescription No No AB 2025/02/14 MSN
>>>活性成分:SUNITINIB MALATE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 25MG BASE; 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
021938 002 NDA SUTENT SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription Yes No AB 2006/01/26 CPPI CV
213914 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/08/16 SUN PHARM
213803 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/11/30 TEVA PHARMS USA
201275 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2021/12/06 MYLAN
215843 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2022/04/11 DR REDDYS
218012 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2023/08/21 FOSUN WANBANG
218024 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2023/10/24 NATCO PHARMA
218615 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2024/03/14 EUGIA PHARMA
214824 002 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE Prescription No No AB 2025/02/14 MSN
>>>活性成分:SUNITINIB MALATE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 37.5MG BASE; 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
021938 004 NDA SUTENT SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription Yes No AB 2009/03/31 CPPI CV
213914 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/08/16 SUN PHARM
213803 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/11/30 TEVA PHARMS USA
201275 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2021/12/06 MYLAN
215843 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2022/04/11 DR REDDYS
218012 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2023/08/21 FOSUN WANBANG
218024 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2023/10/24 NATCO PHARMA
218615 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2024/03/14 EUGIA PHARMA
214824 003 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE Prescription No No AB 2025/02/14 MSN
>>>活性成分:SUNITINIB MALATE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 50MG BASE; 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
021938 003 NDA SUTENT SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription Yes Yes AB 2006/01/26 CPPI CV
213914 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/08/16 SUN PHARM
213803 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/11/30 TEVA PHARMS USA
201275 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2021/12/06 MYLAN
215843 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2022/04/11 DR REDDYS
218012 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2023/08/21 FOSUN WANBANG
218024 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2023/10/24 NATCO PHARMA
218615 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2024/03/14 EUGIA PHARMA
214824 004 ANDA SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2025/02/14 MSN
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
©2006-2025 DrugFuture->U.S. FDA Drugs Database