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 |
|---|
| 2016/12/22 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/06/26 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/12 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/06/15 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/06/23 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/11/19 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/09/30 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/29 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/10/23 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/03/15 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/06/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/01/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/01/17 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/10/27 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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% 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 |
|---|
| 018233 |
001 |
NDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
ICU MEDICAL INC |
| 018632 |
001 |
NDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
1982/06/30
|
BAXTER HLTHCARE |
| 018802 |
001 |
NDA |
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
1982/10/27
|
HOSPIRA |
| 088400 |
001 |
ANDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
No |
No |
AP |
1984/01/16
|
FRESENIUS KABI USA |
| 019633 |
001 |
NDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
1988/02/29
|
B BRAUN |
| 018632 |
002 |
NDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
1988/04/19
|
BAXTER HLTHCARE |
| 019869 |
001 |
NDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
Yes |
Yes |
AP |
1989/12/26
|
ICU MEDICAL INC |
| 077393 |
001 |
ANDA |
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
No |
No |
AP |
2006/08/11
|
TARO |
| 209689 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
No |
No |
AP |
2017/11/24
|
FRESENIUS KABI USA |
| 212735 |
001 |
ANDA |
STERILE WATER FOR INJECTION |
STERILE WATER FOR INJECTION |
LIQUID;N/A |
100% |
Prescription |
No |
No |
AP |
2023/01/31
|
HIKMA |