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 |
|---|
| 2018/10/25 |
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 |
|---|
| 2025/01/22 |
SUPPL-5（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:PROCHLORPERAZINE EDISYLATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 5MG 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 |
|---|
| 089903 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
1989/08/29
|
HIKMA |
| 040540 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2004/05/28
|
SAGENT |
| 204147 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
Yes |
AP |
2013/10/15
|
AVET LIFESCIENCES |
| 210710 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2018/10/25
|
MYLAN LABS LTD |
| 204860 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Discontinued |
No |
No |
AP |
2019/02/15
|
NEXUS |
| 214379 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2021/04/22
|
CAPLIN |
| 214107 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2021/09/22
|
GLAND |
| 213626 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2021/09/28
|
VIWIT PHARM |
| 213873 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2022/07/14
|
EUGIA PHARMA |
| 213630 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Discontinued |
No |
No |
AP |
2022/11/22
|
HIKMA |
| 214192 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2022/11/28
|
AMNEAL |
| 212257 |
001 |
ANDA |
PROCHLORPERAZINE EDISYLATE |
PROCHLORPERAZINE EDISYLATE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2024/09/13
|
SOMERSET THERAPS LLC |