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 |
|---|
| 2015/06/29 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/29 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 2014/05/15 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2009/08/03 |
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:METOPROLOL SUCCINATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 50MG TARTRATE 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 |
|---|
| 019962 |
001 |
NDA |
TOPROL-XL |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
Yes |
Yes |
AB |
1992/01/10
|
TOPROL |
| 076862 |
001 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2009/08/03
|
ACTAVIS LABS FL INC |
| 090615 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2010/07/22
|
WOCKHARDT |
| 202033 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2011/12/15
|
MYLAN PHARMS INC |
| 090617 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2012/08/01
|
DR REDDYS LABS LTD |
| 204161 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2016/11/25
|
ACTAVIS ELIZABETH |
| 204106 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2018/02/06
|
NOVAST LABS |
| 203894 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2018/03/23
|
ZYDUS PHARMS |
| 207465 |
001 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2018/10/26
|
CIPLA |
| 207206 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2018/12/19
|
VISUM PHARM |
| 203028 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2020/03/31
|
PHARMADAX INC |
| 205541 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2020/11/06
|
HETERO LABS LTD III |
| 211143 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2020/11/25
|
ALKEM LABS LTD |
| 213854 |
003 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2021/11/08
|
YICHANG HUMANWELL |
| 214004 |
001 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2022/09/26
|
SUNSHINE |
| 215637 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Discontinued |
No |
No |
AB |
2022/10/18
|
ACCORD HLTHCARE |
| 216916 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2023/06/12
|
GRANULES |
| 216509 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Discontinued |
No |
No |
AB |
2023/08/07
|
GRANULES |
| 209272 |
002 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Discontinued |
No |
No |
AB |
2023/08/15
|
LUPIN |
| 214110 |
001 |
ANDA |
METOPROLOL SUCCINATE |
METOPROLOL SUCCINATE |
TABLET, EXTENDED RELEASE;ORAL |
EQ 50MG TARTRATE |
Prescription |
No |
No |
AB |
2024/07/26
|
ZHEJIANG JUTAI PHARM |