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 |
|---|
| 2020/09/01 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/01 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/07/05 |
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:PHENYLEPHRINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:10MG/ML (10MG/ML) 治疗等效代码:AP1
| 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 |
|---|
| 204300 |
001 |
NDA |
VAZCULEP |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP1 |
2014/06/27
|
EXELA PHARMA |
| 211079 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2018/07/05
|
AMNEAL |
| 208905 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2019/01/31
|
SANDOZ |
| 209967 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2020/01/16
|
SAGENT PHARMS INC |
| 213318 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2020/06/11
|
CAPLIN |
| 213237 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Discontinued |
No |
No |
AP1 |
2020/07/01
|
ACCORD HLTHCARE |
| 211081 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2020/07/17
|
PROVEPHARM SAS |
| 211920 |
003 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2021/04/08
|
GLAND PHARMA LTD |
| 217069 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2022/08/30
|
MANKIND PHARMA |
| 218412 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Discontinued |
No |
No |
AP1 |
2024/03/14
|
HAINAN POLY |
| 218110 |
001 |
ANDA |
PHENYLEPHRINE HYDROCHLORIDE |
PHENYLEPHRINE HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/ML (10MG/ML) |
Prescription |
No |
No |
AP1 |
2024/05/10
|
ASPIRO |