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 |
|---|
| 2024/05/13 |
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 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
|
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 | 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
|
SOMERSET THERAPS LLC |