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 |
|---|
| 2017/01/27 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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:EPHEDRINE SULFATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:50MG/ML (50MG/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 |
|---|
| 208289 |
001 |
NDA |
AKOVAZ |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
Yes |
Yes |
AP |
2016/04/29
|
EXELA PHARMA |
| 208943 |
001 |
NDA |
CORPHEDRA |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2017/01/27
|
ENDO OPERATIONS |
| 208609 |
001 |
NDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Discontinued |
No |
No |
AP |
2017/03/01
|
RENEW PHARMS |
| 209784 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2017/08/23
|
SANDOZ |
| 212932 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2019/10/23
|
AMNEAL |
| 209646 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2020/08/04
|
FRESENIUS KABI USA |
| 212649 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2020/10/03
|
DR REDDYS |
| 214334 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2020/12/15
|
HIKMA |
| 214579 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2021/06/14
|
EUGIA PHARMA |
| 216146 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2022/02/25
|
GLAND PHARMA LTD |
| 216129 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2022/04/14
|
MANKIND PHARMA |
| 215825 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2022/04/21
|
XIROMED |
| 214528 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2023/03/09
|
SAGENT PHARMS INC |
| 217276 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Discontinued |
No |
No |
AP |
2023/05/16
|
ZYDUS PHARMS |
| 219050 |
001 |
ANDA |
EPHEDRINE SULFATE |
EPHEDRINE SULFATE |
SOLUTION;INTRAVENOUS |
50MG/ML (50MG/ML) |
Prescription |
No |
No |
AP |
2024/07/18
|
CAPLIN |
