药品注册申请号：209782
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 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG No No AB 2019/11/20 2019/11/20 Prescription
002 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG No No AB 2019/11/20 Prescription
003 DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG No No AB 2019/11/20 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
2019/11/20 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
2023/11/14 SUPPL-11（补充） Approval Labeling-Medication Guide,Labeling-Patient Package Insert STANDARD
2023/11/14 SUPPL-10（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2023/11/14 SUPPL-9（补充） Approval Labeling-Package Insert,Labeling-Medication Guide,Labeling-Patient Package Insert STANDARD
2023/11/14 SUPPL-6（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2023/11/14 SUPPL-5（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2023/11/14 SUPPL-4（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2023/11/14 SUPPL-3（补充） Approval Labeling-Medication Guide,Labeling-Patient Package Insert 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:DEFERASIROX; 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL; 规格:125MG; 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
021882 001 NDA EXJADE DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription Yes No AB 2005/11/02 NOVARTIS
203560 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2016/01/26 ACTAVIS ELIZABETH
209782 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2019/11/20 SUN PHARM
209878 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2019/11/20 MSN
210060 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2019/11/20 ALEMBIC
210519 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2019/11/20 ALKEM LABS LTD
210920 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2019/11/20 BIONPHARMA
209433 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2020/01/06 GLENMARK SPECLT
207124 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Prescription No No AB 2022/09/23 TEVA PHARMS USA
206585 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Discontinued No No AB 2024/05/17 PHARMOBEDIENT
209426 001 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 125MG Discontinued No No AB 2024/11/05 TORRENT
>>>活性成分:DEFERASIROX; 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL; 规格:250MG; 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
021882 002 NDA EXJADE DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription Yes No AB 2005/11/02 NOVARTIS
203560 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2016/01/26 ACTAVIS ELIZABETH
209782 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2019/11/20 SUN PHARM
209878 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2019/11/20 MSN
210060 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2019/11/20 ALEMBIC
210519 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2019/11/20 ALKEM LABS LTD
210920 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2019/11/20 BIONPHARMA
209433 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2020/01/06 GLENMARK SPECLT
207124 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Prescription No No AB 2022/09/23 TEVA PHARMS USA
206585 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Discontinued No No AB 2024/05/17 PHARMOBEDIENT
209426 002 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 250MG Discontinued No No AB 2024/11/05 TORRENT
>>>活性成分:DEFERASIROX; 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL; 规格:500MG; 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
021882 003 NDA EXJADE DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription Yes Yes AB 2005/11/02 NOVARTIS
203560 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2016/01/26 ACTAVIS ELIZABETH
209782 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2019/11/20 SUN PHARM
209878 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2019/11/20 MSN
210060 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2019/11/20 ALEMBIC
210519 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2019/11/20 ALKEM LABS LTD
210920 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2019/11/20 BIONPHARMA
209433 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2020/01/06 GLENMARK SPECLT
207124 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Prescription No No AB 2022/09/23 TEVA PHARMS USA
206585 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Discontinued No No AB 2024/05/17 PHARMOBEDIENT
209426 003 ANDA DEFERASIROX DEFERASIROX TABLET, FOR SUSPENSION;ORAL 500MG Discontinued No No AB 2024/11/05 TORRENT
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