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 |
2022/05/25 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/03 |
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 |
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 | RLD | RS | TE 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 | RLD | RS | TE 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
|
APPCO |
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 | RLD | RS | TE 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
|
APPCO |