药品注册申请号:215908
申请类型:ANDA (仿制药申请)
申请人:TORRENT
申请人全名:TORRENT PHARMA 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 NITISINONE NITISINONE CAPSULE;ORAL 2MG No No AB 2023/01/09 2023/01/09 Discontinued
002 NITISINONE NITISINONE CAPSULE;ORAL 5MG No No AB 2023/01/09 Discontinued
003 NITISINONE NITISINONE CAPSULE;ORAL 10MG No No AB 2023/01/09 Discontinued
004 NITISINONE NITISINONE CAPSULE;ORAL 20MG No No AB 2023/01/09 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
2023/01/09 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:NITISINONE 剂型/给药途径:CAPSULE;ORAL 规格:2MG 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
021232 001 NDA ORFADIN NITISINONE CAPSULE;ORAL 2MG Prescription Yes No AB 2002/01/18 SWEDISH ORPHAN
211041 001 ANDA NITISINONE NITISINONE CAPSULE;ORAL 2MG Prescription No No AB 2019/08/26 NOVITIUM PHARMA
212390 001 ANDA NITISINONE NITISINONE CAPSULE;ORAL 2MG Prescription No No AB 2022/05/26 MEDUNIK
215908 001 ANDA NITISINONE NITISINONE CAPSULE;ORAL 2MG Discontinued No No AB 2023/01/09 TORRENT
216201 001 ANDA NITISINONE NITISINONE CAPSULE;ORAL 2MG Prescription No No AB 2023/05/25 ETON
活性成分:NITISINONE 剂型/给药途径:CAPSULE;ORAL 规格:5MG 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
021232 002 NDA ORFADIN NITISINONE CAPSULE;ORAL 5MG Prescription Yes No AB 2002/01/18 SWEDISH ORPHAN
211041 002 ANDA NITISINONE NITISINONE CAPSULE;ORAL 5MG Prescription No No AB 2019/08/26 NOVITIUM PHARMA
212390 002 ANDA NITISINONE NITISINONE CAPSULE;ORAL 5MG Prescription No No AB 2022/05/26 MEDUNIK
215908 002 ANDA NITISINONE NITISINONE CAPSULE;ORAL 5MG Discontinued No No AB 2023/01/09 TORRENT
216201 002 ANDA NITISINONE NITISINONE CAPSULE;ORAL 5MG Prescription No No AB 2023/05/25 ETON
活性成分:NITISINONE 剂型/给药途径:CAPSULE;ORAL 规格:10MG 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
021232 003 NDA ORFADIN NITISINONE CAPSULE;ORAL 10MG Prescription Yes No AB 2002/01/18 SWEDISH ORPHAN
211041 003 ANDA NITISINONE NITISINONE CAPSULE;ORAL 10MG Prescription No No AB 2019/08/26 NOVITIUM PHARMA
212390 003 ANDA NITISINONE NITISINONE CAPSULE;ORAL 10MG Prescription No No AB 2022/05/26 MEDUNIK
215908 003 ANDA NITISINONE NITISINONE CAPSULE;ORAL 10MG Discontinued No No AB 2023/01/09 TORRENT
216201 003 ANDA NITISINONE NITISINONE CAPSULE;ORAL 10MG Prescription No No AB 2023/05/25 ETON
活性成分:NITISINONE 剂型/给药途径:CAPSULE;ORAL 规格:20MG 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
021232 004 NDA ORFADIN NITISINONE CAPSULE;ORAL 20MG Prescription Yes Yes AB 2016/06/13 SWEDISH ORPHAN
215908 004 ANDA NITISINONE NITISINONE CAPSULE;ORAL 20MG Discontinued No No AB 2023/01/09 TORRENT
212390 004 ANDA NITISINONE NITISINONE CAPSULE;ORAL 20MG Prescription No No AB 2023/04/27 MEDUNIK
216201 004 ANDA NITISINONE NITISINONE CAPSULE;ORAL 20MG Prescription No No AB 2023/05/25 ETON
更多信息
药品NDC数据与药品包装、标签说明书
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