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 |
|---|
| 2020/10/22 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/08/24 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/08/24 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/02/07 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2007/01/31 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2003/08/13 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2003/07/31 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/03 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:TABLET;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 |
|---|
| 076286 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2002/07/03
|
DR REDDYS LABS INC |
| 076347 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2002/10/11
|
EPIC PHARMA LLC |
| 076280 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Discontinued |
No |
No |
AB |
2002/11/26
|
CHARTWELL RX |
| 076416 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2003/09/29
|
SUN PHARM INDS INC |
| 076281 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2003/10/20
|
OXFORD PHARMS |
| 076533 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2004/01/16
|
APOTEX |
| 091283 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2012/11/28
|
UNICHEM LABS LTD |
| 208187 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/03/09
|
CADILA |
| 211798 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2019/01/25
|
ALKEM LABS LTD |
| 218920 |
001 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/08/07
|
GRAVITI PHARMS |
活性成分:TIZANIDINE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 020397 |
001 |
NDA |
ZANAFLEX |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
Yes |
Yes |
AB |
1996/11/27
|
LEGACY PHARMA USA |
| 076280 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Discontinued |
No |
No |
AB |
2002/06/27
|
CHARTWELL RX |
| 076286 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2002/07/03
|
DR REDDYS LABS INC |
| 076347 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2002/10/11
|
EPIC PHARMA LLC |
| 076416 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2003/09/29
|
SUN PHARM INDS INC |
| 076281 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2003/10/20
|
OXFORD PHARMS |
| 076533 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2004/01/16
|
APOTEX |
| 091283 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2012/11/28
|
UNICHEM LABS LTD |
| 208187 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2018/03/09
|
CADILA |
| 211798 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2019/01/25
|
ALKEM LABS LTD |
| 218920 |
002 |
ANDA |
TIZANIDINE HYDROCHLORIDE |
TIZANIDINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 4MG BASE |
Prescription |
No |
No |
AB |
2024/08/07
|
GRAVITI PHARMS |