药品注册申请号:210267
申请类型:ANDA (仿制药申请)
申请人:NOVAST LABS
申请人全名:NOVAST LABORATORIES 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 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE No No AB 2019/03/12 2019/03/12 Prescription
002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE No No AB 2019/03/12 Prescription
003 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE No No AB 2019/03/12 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/03/12 ORIG 1 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:TIZANIDINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 2MG BASE 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
021447 001 NDA ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription Yes No AB 2002/08/29 COVIS PHARMA BV
078868 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2012/02/03 APOTEX INC
091502 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2012/11/09 MYLAN PHARMS INC
208622 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
207199 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2017/03/14 PAR PHARM INC
209605 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2017/08/04 JUBILANT GENERICS
210267 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2019/03/12 NOVAST LABS
210021 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2019/03/26 CADILA PHARMS LTD
212196 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2019/03/27 ALKEM LABS LTD
活性成分:TIZANIDINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 4MG BASE 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
021447 002 NDA ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription Yes No AB 2002/08/29 COVIS PHARMA BV
078868 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2012/02/03 APOTEX INC
091502 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2012/11/09 MYLAN PHARMS INC
208622 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
207199 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2017/03/14 PAR PHARM INC
209605 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2017/08/04 JUBILANT GENERICS
210267 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2019/03/12 NOVAST LABS
210021 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2019/03/26 CADILA PHARMS LTD
212196 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2019/03/27 ALKEM LABS LTD
活性成分:TIZANIDINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 6MG BASE 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
021447 003 NDA ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription Yes Yes AB 2002/08/29 COVIS PHARMA BV
078868 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2012/02/03 APOTEX INC
091502 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2012/11/09 MYLAN PHARMS INC
208622 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
207199 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/03/14 PAR PHARM INC
209605 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/08/04 JUBILANT GENERICS
210267 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2019/03/12 NOVAST LABS
210021 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2019/03/26 CADILA PHARMS LTD
212196 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2019/03/27 ALKEM LABS LTD
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