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 |
|---|
| 2022/08/18 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 2025/03/13 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
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:MEROPENEM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:500MG/VIAL; 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 |
|---|
| 050706 |
003 |
NDA |
MERREM IV |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Discontinued |
Yes |
No |
AP |
1996/06/21
|
PFIZER |
| 091404 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
Yes |
AP |
2011/10/26
|
ACS DOBFAR |
| 204854 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Discontinued |
No |
No |
AP |
2015/12/18
|
DAEWOONG PHARM CO |
| 205883 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/04/12
|
AMNEAL PHARMS |
| 206086 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/04/19
|
SAVIOR LIFETEC CORP |
| 206141 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/06/08
|
GLAND |
| 204139 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/06/09
|
ACS DOBFAR SPA |
| 205835 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2017/03/27
|
EUGIA PHARMA |
| 210773 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2019/08/16
|
HQ SPCLT PHARMA |
| 216154 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2022/08/18
|
BROOKS STERISCIENCE |
| 216424 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2024/07/22
|
QILU |
>>>活性成分:MEROPENEM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:1GM/VIAL; 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 |
|---|
| 050706 |
001 |
NDA |
MERREM IV |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Discontinued |
Yes |
No |
AP |
1996/06/21
|
PFIZER |
| 091404 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
Yes |
AP |
2011/10/26
|
ACS DOBFAR |
| 204854 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Discontinued |
No |
No |
AP |
2015/12/18
|
DAEWOONG PHARM CO |
| 205883 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2016/04/12
|
AMNEAL PHARMS |
| 206086 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2016/04/19
|
SAVIOR LIFETEC CORP |
| 206141 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2016/06/08
|
GLAND |
| 204139 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2016/06/09
|
ACS DOBFAR SPA |
| 205835 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2017/03/27
|
EUGIA PHARMA |
| 210773 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2019/08/16
|
HQ SPCLT PHARMA |
| 216154 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2022/08/18
|
BROOKS STERISCIENCE |
| 216424 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2024/07/22
|
QILU |