药品注册申请号：211383
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA INC
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;ORAL 90MG No No AB;AB 2019/11/20 2019/11/20 Prescription
002 DEFERASIROX DEFERASIROX TABLET;ORAL 360MG No No AB;AB 2019/11/20 Prescription
003 DEFERASIROX DEFERASIROX TABLET;ORAL 180MG No No AB;AB 2020/06/15 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
2024/03/05 SUPPL-6（补充） Approval Labeling STANDARD
2023/06/23 SUPPL-4（补充） Approval Labeling STANDARD
2023/06/23 SUPPL-3（补充） Approval Labeling STANDARD
2023/06/23 SUPPL-2（补充） Approval Labeling STANDARD
2020/06/18 SUPPL-1（补充） Approval Labeling STANDARD
2020/06/15 ORIG-2（原始申请） Approval STANDARD
2019/11/20 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:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:90MG 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
206910 001 NDA JADENU DEFERASIROX TABLET;ORAL 90MG Prescription Yes No AB 2015/03/30 NOVARTIS PHARMS CORP
210945 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 MSN
211383 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 ZYDUS PHARMS
211824 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 ALEMBIC
209223 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Discontinued No No AB 2019/11/25 TEVA PHARMS USA
208697 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
212995 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/12/30 PIRAMAL
211641 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2020/01/02 SUN PHARM
211852 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Discontinued No No AB 2020/02/11 CIPLA
210555 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2020/03/30 ALKEM LABS LTD
214341 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:90MG 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
206910 001 NDA JADENU DEFERASIROX TABLET;ORAL 90MG Prescription Yes No AB 2015/03/30 NOVARTIS PHARMS CORP
210945 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 MSN
211383 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 ZYDUS PHARMS
211824 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/11/20 ALEMBIC
209223 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Discontinued No No AB 2019/11/25 TEVA PHARMS USA
208697 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
212995 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2019/12/30 PIRAMAL
211641 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2020/01/02 SUN PHARM
211852 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Discontinued No No AB 2020/02/11 CIPLA
210555 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2020/03/30 ALKEM LABS LTD
214341 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 001 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 90MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:360MG 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
206910 003 NDA JADENU DEFERASIROX TABLET;ORAL 360MG Prescription Yes Yes AB 2015/03/30 NOVARTIS PHARMS CORP
210945 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 MSN
211383 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 ZYDUS PHARMS
211824 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 ALEMBIC
209223 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Discontinued No No AB 2019/11/25 TEVA PHARMS USA
208697 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
212995 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/12/30 PIRAMAL
211641 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2020/01/02 SUN PHARM
211852 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Discontinued No No AB 2020/02/11 CIPLA
210555 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2020/03/30 ALKEM LABS LTD
214341 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:360MG 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
206910 003 NDA JADENU DEFERASIROX TABLET;ORAL 360MG Prescription Yes Yes AB 2015/03/30 NOVARTIS PHARMS CORP
210945 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 MSN
211383 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 ZYDUS PHARMS
211824 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/11/20 ALEMBIC
209223 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Discontinued No No AB 2019/11/25 TEVA PHARMS USA
208697 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
212995 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2019/12/30 PIRAMAL
211641 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2020/01/02 SUN PHARM
211852 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Discontinued No No AB 2020/02/11 CIPLA
210555 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2020/03/30 ALKEM LABS LTD
214341 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 360MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:180MG 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
206910 002 NDA JADENU DEFERASIROX TABLET;ORAL 180MG Prescription Yes No AB 2015/03/30 NOVARTIS PHARMS CORP
208697 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
209223 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Discontinued No No AB 2020/04/24 TEVA PHARMS USA
211641 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 SUN PHARM
211824 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 ALEMBIC
211852 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Discontinued No No AB 2020/06/15 CIPLA
211383 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 ZYDUS PHARMS
212995 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 PIRAMAL
210945 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/16 MSN
210555 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/07/02 ALKEM LABS LTD
214341 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:TABLET;ORAL 规格:180MG 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
206910 002 NDA JADENU DEFERASIROX TABLET;ORAL 180MG Prescription Yes No AB 2015/03/30 NOVARTIS PHARMS CORP
208697 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2019/12/13 ACTAVIS ELIZABETH
209223 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Discontinued No No AB 2020/04/24 TEVA PHARMS USA
211641 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 SUN PHARM
211824 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 ALEMBIC
211852 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Discontinued No No AB 2020/06/15 CIPLA
211383 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 ZYDUS PHARMS
212995 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/15 PIRAMAL
210945 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/06/16 MSN
210555 003 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2020/07/02 ALKEM LABS LTD
214341 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2021/05/14 ANNORA PHARMA
212669 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2021/05/27 CHARTWELL RX
214474 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2023/10/16 AUROBINDO PHARMA LTD
211395 002 ANDA DEFERASIROX DEFERASIROX TABLET;ORAL 180MG Prescription No No AB 2024/03/22 NORVIUM BIOSCIENCE
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药品NDC数据与药品包装、标签说明书
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