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 |
|---|
| 2020/06/10 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/08/17 |
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:SODIUM NITROPRUSSIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:25MG/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 |
|---|
| 071961 |
001 |
ANDA |
NITROPRESS |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Discontinued |
No |
No |
AP |
1988/08/01
|
VPNA |
| 207426 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2016/12/08
|
SAGENT PHARMS INC |
| 208635 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Discontinued |
No |
No |
AP |
2017/05/04
|
EPIC PHARMA LLC |
| 207499 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2017/05/25
|
NEXUS |
| 209493 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2017/11/07
|
AMNEAL |
| 209352 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
Yes |
AP |
2017/12/08
|
MICRO LABS |
| 210763 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2018/04/17
|
MYLAN LABS LTD |
| 209584 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2018/08/10
|
NORVIUM BIOSCIENCE |
| 210882 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2018/08/17
|
SOMERSET THERAPS LLC |
| 210114 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2019/04/10
|
DR REDDYS |
| 211016 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2019/11/29
|
CAPLIN |
| 214199 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2020/08/25
|
SLATE RUN PHARMA |
| 211277 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2020/10/29
|
XIROMED |
| 214971 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2021/07/12
|
BE PHARMS |
| 208923 |
001 |
ANDA |
SODIUM NITROPRUSSIDE |
SODIUM NITROPRUSSIDE |
INJECTABLE;INJECTION |
25MG/ML |
Discontinued |
No |
No |
AP |
2022/11/08
|
AVET LIFESCIENCES |