药品注册申请号:213146
申请类型:ANDA (仿制药申请)
申请人:NORVIUM BIOSCIENCE
申请人全名:NORVIUM BIOSCIENCE LLC
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 GRANULE;ORAL 90MG No No AB 2024/05/03 2024/05/03 Discontinued
002 DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG No No AB 2024/05/03 Discontinued
003 DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG No No AB 2024/05/03 Discontinued
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
2024/05/03 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
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
与本品治疗等效的药品
活性成分:DEFERASIROX 剂型/给药途径:GRANULE;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
207968 001 NDA JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 90MG Prescription Yes No AB 2017/05/18 NOVARTIS
213374 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2020/07/14 ALKEM LABS LTD
214559 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2021/03/09 AUCTA
214180 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2021/11/19 TEVA PHARMS USA
215026 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2022/02/23 CIPLA
214650 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2022/04/20 MSN
216229 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Prescription No No AB 2023/03/16 ANNORA PHARMA
213146 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 90MG Discontinued No No AB 2024/05/03 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:GRANULE;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
207968 002 NDA JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 180MG Prescription Yes No AB 2017/05/18 NOVARTIS
213374 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2020/07/14 ALKEM LABS LTD
214194 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Discontinued No No AB 2021/02/09 AMNEAL
214559 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2021/03/09 AUCTA
214650 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2021/03/17 MSN
214180 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2021/11/19 TEVA PHARMS USA
215026 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2022/02/23 CIPLA
216229 001 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Prescription No No AB 2022/09/22 ANNORA PHARMA
213146 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 180MG Discontinued No No AB 2024/05/03 NORVIUM BIOSCIENCE
活性成分:DEFERASIROX 剂型/给药途径:GRANULE;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
207968 003 NDA JADENU SPRINKLE DEFERASIROX GRANULE;ORAL 360MG Prescription Yes Yes AB 2017/05/18 NOVARTIS
213374 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2020/07/14 ALKEM LABS LTD
214194 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Discontinued No No AB 2021/02/09 AMNEAL
214559 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2021/03/09 AUCTA
214650 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2021/03/17 MSN
214180 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2021/11/19 TEVA PHARMS USA
215026 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2022/02/23 CIPLA
216229 002 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Prescription No No AB 2022/09/22 ANNORA PHARMA
213146 003 ANDA DEFERASIROX DEFERASIROX GRANULE;ORAL 360MG Discontinued No No AB 2024/05/03 NORVIUM BIOSCIENCE
更多信息
药品NDC数据与药品包装、标签说明书
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