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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1974/04/08 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2014/09/24 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/02/10 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/27 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/08/24 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/06/30 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/11/28 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/11/12 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/01/18 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/10/29 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/22 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/08/25 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/15 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/03/01 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1982/08/26 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 1982/06/10 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/11/06 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/07/21 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/03/03 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1980/10/06 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1980/10/01 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 1980/06/06 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/05/23 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/03/20 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/10/04 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/07/30 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/07/16 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/05/01 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1979/04/23 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1979/01/03 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1978/12/01 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/11/22 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1978/11/22 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/10/16 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1978/07/12 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1978/07/12 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/07/12 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1977/06/22 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1977/01/28 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1976/04/20 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1976/03/29 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1975/10/07 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/09/04 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/07/15 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1975/07/15 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
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 IRRIGATION; 剂型/给药途径:LIQUID;IRRIGATION; 规格:100%; 治疗等效代码:AT<<<
| 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 |
|---|
| 016734 |
001 |
NDA |
STERILE WATER IN PLASTIC CONTAINER |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
Yes |
No |
AT |
Approved Prior to Jan 1, 1982
|
B BRAUN |
| 017428 |
001 |
NDA |
STERILE WATER |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
Yes |
No |
AT |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 017513 |
001 |
NDA |
STERILE WATER IN PLASTIC CONTAINER |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
OTSUKA ICU MEDCL |
| 017866 |
001 |
NDA |
STERILE WATER IN PLASTIC CONTAINER |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
| 018313 |
001 |
NDA |
STERILE WATER IN PLASTIC CONTAINER |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
No |
No |
AT |
Approved Prior to Jan 1, 1982
|
OTSUKA ICU MEDCL |
| 216123 |
001 |
ANDA |
STERILE WATER FOR IRRIGATION |
STERILE WATER FOR IRRIGATION |
LIQUID;IRRIGATION |
100% |
Prescription |
No |
No |
AT |
2024/08/12
|
FRESENIUS KABI USA |