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 |
|---|
| 2023/11/30 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2023/07/17 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2015/01/12 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/12 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2002/03/14 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/02/16 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/06/16 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1999/08/31 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/01/22 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/11/19 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/01/17 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/08/29 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1989/07/18 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1988/10/21 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/12/11 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/08/26 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1986/10/21 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1986/07/24 |
SUPPL-7（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
|
|
|
| 1984/01/17 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1983/10/24 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1983/05/10 |
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: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 |
