药品注册申请号:210721
申请类型:ANDA (仿制药申请)
申请人:APOTEX
申请人全名:APOTEX 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 CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG No No AB1 2019/07/10 2019/07/10 Prescription
002 CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 50MG No No AB1 2019/07/10 Prescription
003 CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG No No AB1 2019/07/10 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
2019/07/10 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:CYCLOSPORINE 剂型/给药途径:CAPSULE;ORAL 规格:25MG 治疗等效代码:AB1
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
050715 001 NDA NEORAL CYCLOSPORINE CAPSULE;ORAL 25MG Prescription Yes No AB1 1995/07/14 NOVARTIS
065017 002 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2000/01/13 SANDOZ
065003 001 ANDA GENGRAF CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2000/05/12 ABBVIE
065044 002 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2000/12/20 DR REDDYS LABS SA
065110 003 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2005/03/29 IVAX SUB TEVA PHARMS
210721 001 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2019/07/10 APOTEX
216046 001 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG Prescription No No AB1 2022/08/02 STRIDES PHARMA
活性成分:CYCLOSPORINE 剂型/给药途径:CAPSULE;ORAL 规格:50MG 治疗等效代码:AB1
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
065110 001 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 50MG Prescription No No AB1 2005/03/29 IVAX SUB TEVA PHARMS
210721 002 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 50MG Prescription No No AB1 2019/07/10 APOTEX
216046 002 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 50MG Prescription No No AB1 2022/08/02 STRIDES PHARMA
活性成分:CYCLOSPORINE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 治疗等效代码:AB1
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
050715 002 NDA NEORAL CYCLOSPORINE CAPSULE;ORAL 100MG Prescription Yes Yes AB1 1995/07/14 NOVARTIS
065017 001 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2000/01/13 SANDOZ
065003 003 ANDA GENGRAF CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2000/05/12 ABBVIE
065044 001 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2000/12/20 DR REDDYS LABS SA
065110 002 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2005/03/29 IVAX SUB TEVA PHARMS
210721 003 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2019/07/10 APOTEX
216046 003 ANDA CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG Prescription No No AB1 2022/08/02 STRIDES PHARMA
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药品NDC数据与药品包装、标签说明书
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