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 |
|---|
| 2022/07/19 |
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:NOREPINEPHRINE BITARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/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 |
|---|
| 007513 |
001 |
NDA |
LEVOPHED |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HOSPIRA |
| 040455 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2003/03/03
|
MEITHEAL |
| 040462 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2003/10/31
|
HIKMA |
| 040859 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2012/03/27
|
BAXTER HLTHCARE CORP |
| 211242 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/10/04
|
MYLAN LABS LTD |
| 211359 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/10/18
|
SANDOZ |
| 203662 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/11/07
|
HIKMA |
| 210839 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/12/17
|
AMNEAL |
| 211382 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2020/11/03
|
FRESENIUS KABI USA |
| 214455 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2021/01/22
|
BRECKENRIDGE |
| 211980 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2021/01/29
|
SUN PHARM |
| 214323 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2021/05/06
|
GLAND PHARMA LTD |
| 216341 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Discontinued |
No |
No |
AP |
2022/07/19
|
ZYDUS PHARMS |
| 217575 |
001 |
ANDA |
NOREPINEPHRINE BITARTRATE |
NOREPINEPHRINE BITARTRATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2023/09/15
|
CAPLIN |