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 |
|---|
| 2024/06/21 |
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 PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/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 |
|---|
| 209997 |
001 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) |
Prescription |
No |
Yes |
AP |
2022/03/30
|
FRESENIUS KABI USA |
| 218314 |
001 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) |
Prescription |
No |
No |
AP |
2024/06/21
|
AM REGENT |
活性成分:SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/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 |
|---|
| 018892 |
001 |
NDA |
SODIUM PHOSPHATES IN PLASTIC CONTAINER |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) |
Prescription |
Yes |
Yes |
AP |
1983/05/10
|
HOSPIRA |
| 209997 |
002 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) |
Prescription |
No |
No |
AP |
2022/03/30
|
FRESENIUS KABI USA |
| 218314 |
002 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) |
Prescription |
No |
No |
AP |
2024/06/21
|
AM REGENT |
活性成分:SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/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 |
|---|
| 209997 |
003 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) |
Prescription |
No |
Yes |
AP |
2022/03/30
|
FRESENIUS KABI USA |
| 218314 |
003 |
ANDA |
SODIUM PHOSPHATES |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SOLUTION;INTRAVENOUS |
13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) |
Prescription |
No |
No |
AP |
2024/06/21
|
AM REGENT |