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 |
2020/06/25 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/09/09 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2017/02/23 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/10/15 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |
Prescription |
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 PHARMA LTD |
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 |