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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1995/04/27 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2025/09/03 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2025/09/03 |
SUPPL-4（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2025/09/03 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
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:METOPROLOL TARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:50MG; 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 |
|---|
| 017963 |
001 |
NDA |
LOPRESSOR |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALIDUS PHARMS |
| 074453 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1995/04/27
|
RENATA |
| 074644 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1996/12/10
|
SUN PHARM INDS INC |
| 076704 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2004/01/16
|
MYLAN |
| 077739 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2007/09/11
|
AUROBINDO PHARMA |
| 078459 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2008/06/17
|
IPCA LABS LTD |
| 202871 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/05/28
|
ALEMBIC PHARMS LTD |
| 200981 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/10/28
|
RUBICON RESEARCH |
| 208955 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/02/05
|
SCIEGEN PHARMS INC |
| 212402 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2023/04/19
|
ZYDUS PHARMS |
>>>活性成分:METOPROLOL TARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:100MG; 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 |
|---|
| 017963 |
002 |
NDA |
LOPRESSOR |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALIDUS PHARMS |
| 074453 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1995/04/27
|
RENATA |
| 074644 |
002 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1996/12/10
|
SUN PHARM INDS INC |
| 076704 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
Yes |
AB |
2004/01/16
|
MYLAN |
| 077739 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2007/09/11
|
AUROBINDO PHARMA |
| 078459 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2008/06/17
|
IPCA LABS LTD |
| 202871 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/05/28
|
ALEMBIC PHARMS LTD |
| 200981 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2014/10/28
|
RUBICON RESEARCH |
| 208955 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/02/05
|
SCIEGEN PHARMS INC |
| 212402 |
003 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2023/04/19
|
ZYDUS PHARMS |