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 |
2024/07/22 |
ORIG-1(原始申请) |
Approval |
|
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 |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
Yes |
Yes |
AP |
1996/06/21
|
PFIZER |
091404 |
001 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
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 |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
Yes |
Yes |
AP |
1996/06/21
|
PFIZER |
091404 |
002 |
ANDA |
MEROPENEM |
MEROPENEM |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
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 |