美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 6 条
共 1 页，当前第 1 页
| 商品名 |
申请号 |
产品号 |
申请类型 |
活性成分 |
剂型/给药途径 |
规格/剂量 |
RLD |
RS |
申请号原始批准/暂定批准日期 |
产品号批准日期 |
申请人 |
市场状态 |
| OLPRUVA |
214860 |
001 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
2GM/PACKET |
Yes
|
No
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |
| OLPRUVA |
214860 |
002 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
3GM/PACKET |
Yes
|
No
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |
| OLPRUVA |
214860 |
003 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
4GM/PACKET |
Yes
|
No
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |
| OLPRUVA |
214860 |
004 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
5GM/PACKET |
Yes
|
No
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |
| OLPRUVA |
214860 |
005 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
6GM/PACKET |
Yes
|
No
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |
| OLPRUVA |
214860 |
006 |
NDA |
SODIUM PHENYLBUTYRATE |
FOR SUSPENSION;ORAL |
6.67GM/PACKET |
Yes
|
Yes
|
2022/12/22
|
2022/12/22
|
ACER |
Prescription |