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 |
|---|
| 2022/05/19 |
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 |
|---|
| 2024/04/15 |
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:PANTOPRAZOLE SODIUM; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:EQ 40MG BASE/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 |
|---|
| 020988 |
001 |
NDA |
PROTONIX IV |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
Yes |
Yes |
AP |
2001/03/22
|
WYETH PHARMS |
| 079197 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/11/08
|
EPIC PHARMA LLC |
| 090296 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2015/07/14
|
SANDOZ |
| 205675 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/03/30
|
EUGIA PHARMA |
| 077674 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2019/08/19
|
SUN PHARM |
| 209524 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/08/30
|
HANGZHOU ZHONGMEI |
| 213778 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/05/18
|
ASPIRO |
| 204400 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/05/18
|
GLAND |
| 216171 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/05/18
|
BE PHARMS |
| 214680 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/05/19
|
KNACK |
| 215860 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/08/29
|
MEITHEAL |
| 219230 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2025/03/31
|
ALEMBIC |
| 215074 |
001 |
ANDA |
PANTOPRAZOLE SODIUM |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
Prescription |
No |
No |
AP |
2025/05/16
|
DEVA HOLDING AS |