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 |
|---|
| 2023/05/26 |
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:VASOPRESSIN 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:20UNITS/ML (20UNITS/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 |
|---|
| 204485 |
001 |
NDA |
VASOSTRICT |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
Yes |
Yes |
AP |
2014/04/17
|
ENDO OPERATIONS |
| 211538 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2021/12/15
|
EAGLE PHARMS |
| 211857 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2022/07/18
|
AMPHASTAR PHARMS INC |
| 212944 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2022/08/05
|
AMNEAL |
| 214314 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2022/08/15
|
EUGIA PHARMA |
| 213206 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2023/05/26
|
FRESENIUS KABI USA |
| 216963 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2024/02/09
|
GLAND PHARMA LTD |
| 213988 |
001 |
ANDA |
VASOPRESSIN |
VASOPRESSIN |
SOLUTION;INTRAVENOUS |
20UNITS/ML (20UNITS/ML) |
Prescription |
No |
No |
AP |
2024/05/08
|
DR REDDYS |