药品注册申请号：021447
申请类型：NDA (新药申请)
申请人：LEGACY PHARMA USA
申请人全名：LEGACY PHARMA 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 ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Yes No AB 2002/08/29 2002/08/29 Prescription
002 ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Yes No AB 2002/08/29 Prescription
003 ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Yes Yes AB 2002/08/29 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
2024/11/22 SUPPL-17（补充） Approval Labeling STANDARD
2020/12/18 SUPPL-15（补充） Approval Labeling STANDARD
2014/08/29 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2013/11/07 SUPPL-11（补充） Approval Labeling UNKNOWN
2013/03/08 SUPPL-5（补充） Approval Labeling STANDARD
2006/07/28 SUPPL-2（补充） Approval Labeling STANDARD
2002/08/29 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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
001 6455557 2021/11/28 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6455557 2021/11/28 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6455557 2021/11/28 PDF格式**本条是由Drugfuture回溯的历史信息**
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: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 LEGACY PHARMA USA
078868 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2012/02/03 APOTEX INC
208622 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
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
213223 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2020/01/13 ALEMBIC
213544 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2020/03/24 AUROBINDO PHARMA LTD
213798 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2020/05/27 RUBICON
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 LEGACY PHARMA USA
078868 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2012/02/03 APOTEX INC
208622 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
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
213223 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2020/01/13 ALEMBIC
213544 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2020/03/24 AUROBINDO PHARMA LTD
213798 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2020/05/27 RUBICON
213365 001 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 4MG BASE Prescription No No AB 2024/05/13 SOMERSET THERAPS LLC
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 LEGACY PHARMA USA
078868 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2012/02/03 APOTEX INC
208622 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2017/03/03 ZYDUS PHARMS
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
213223 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2020/01/13 ALEMBIC
213544 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2020/03/24 AUROBINDO PHARMA LTD
213798 003 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2020/05/27 RUBICON
213365 002 ANDA TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE CAPSULE;ORAL EQ 6MG BASE Prescription No No AB 2024/05/13 SOMERSET THERAPS LLC
更多信息
药品NDC数据与药品包装、标签说明书
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