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 |
|---|
| 2021/06/09 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/01/30 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/02/27 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/03/11 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/04 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2008/04/28 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 2002/09/19 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/09/19 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/09/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/09/03 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/02/14 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/12/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/06/01 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/06/01 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/06/01 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/06/01 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/12/21 |
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 TARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/ML 治疗等效代码:AP
| 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 |
|---|
| 074133 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Discontinued |
No |
No |
AP |
1993/12/21
|
HOSPIRA |
| 075160 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Discontinued |
No |
No |
AP |
1998/07/06
|
HOSPIRA |
| 076495 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2003/07/07
|
HIKMA |
| 077761 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2007/05/30
|
HIKMA FARMACEUTICA |
| 077360 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2007/10/02
|
SANDOZ |
| 078085 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
Yes |
AP |
2008/04/29
|
HOSPIRA |
| 091045 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2010/10/25
|
FRESENIUS KABI USA |
| 078950 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2013/04/29
|
BAXTER HLTHCARE CORP |
| 204205 |
001 |
ANDA |
METOPROLOL TARTRATE |
METOPROLOL TARTRATE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2014/08/27
|
GLAND PHARMA LTD |