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 |
|---|
| 2015/04/27 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/12/06 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/12/06 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/03/17 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/03/09 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/24 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1996/10/11 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 1995/05/16 |
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:MEXILETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:150MG 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 |
|---|
| 074377 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
1995/05/16
|
TEVA |
| 074450 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
1996/05/16
|
ANI PHARMS |
| 213500 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2020/07/22
|
CROSSMEDIKA SA |
| 214352 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2021/01/25
|
NOVAST LABS |
| 214089 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2021/10/01
|
SENORES PHARMS |
| 215315 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2022/08/26
|
ZENARA |
| 216463 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2022/11/09
|
ANNORA PHARMA |
| 215876 |
001 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
150MG |
Prescription |
No |
No |
AB |
2023/02/27
|
CHEMISTRY HLTH |
活性成分:MEXILETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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 |
|---|
| 074377 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
1995/05/16
|
TEVA |
| 074450 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
1996/05/16
|
ANI PHARMS |
| 213500 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/07/22
|
CROSSMEDIKA SA |
| 214352 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/01/25
|
NOVAST LABS |
| 214089 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/10/01
|
SENORES PHARMS |
| 215315 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/08/26
|
ZENARA |
| 216463 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/11/09
|
ANNORA PHARMA |
| 215876 |
002 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/02/27
|
CHEMISTRY HLTH |
活性成分:MEXILETINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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 |
|---|
| 074377 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
Yes |
AB |
1995/05/16
|
TEVA |
| 074450 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
1996/05/16
|
ANI PHARMS |
| 213500 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/07/22
|
CROSSMEDIKA SA |
| 214352 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2021/01/25
|
NOVAST LABS |
| 214089 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2021/10/01
|
SENORES PHARMS |
| 215315 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2022/08/26
|
ZENARA |
| 216463 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2022/11/09
|
ANNORA PHARMA |
| 215876 |
003 |
ANDA |
MEXILETINE HYDROCHLORIDE |
MEXILETINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2023/02/27
|
CHEMISTRY HLTH |