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 |
|---|
| 2024/02/09 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2023/08/29 |
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:STERILE WATER FOR INJECTION 剂型/给药途径:LIQUID;N/A 规格:100% (10ML) 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 |
|---|
| 018801 |
002 |
NDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (10ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/27
|
HOSPIRA |
| 206369 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (10ML) |
Prescription |
No |
No |
AP |
2015/09/02
|
HIKMA |
| 211188 |
005 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (10ML) |
Prescription |
No |
No |
AP |
2019/12/02
|
MEDEFIL INC |
| 217536 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (10ML) |
Prescription |
No |
No |
AP |
2023/07/11
|
NEXUS |
| 217341 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (10ML) |
Prescription |
No |
No |
AP |
2023/08/29
|
AM REGENT |
活性成分:STERILE WATER FOR INJECTION 剂型/给药途径:LIQUID;N/A 规格:100% (20ML) 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 |
|---|
| 018801 |
003 |
NDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (20ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/27
|
HOSPIRA |
| 217536 |
002 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (20ML) |
Prescription |
No |
No |
AP |
2023/07/11
|
NEXUS |
| 217341 |
002 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (20ML) |
Prescription |
No |
No |
AP |
2023/08/29
|
AM REGENT |
活性成分:STERILE WATER FOR INJECTION 剂型/给药途径:LIQUID;N/A 规格:100% (5ML) 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 |
|---|
| 211188 |
004 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (5ML) |
Prescription |
No |
Yes |
AP |
2019/12/02
|
MEDEFIL INC |
| 211222 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (5ML) |
Prescription |
No |
No |
AP |
2021/02/10
|
NEPHRON |
| 217341 |
003 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% (5ML) |
Prescription |
No |
No |
AP |
2024/02/09
|
AM REGENT |