美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 9 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 |
| HYDROXYUREA |
074476 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
1995/08/18
|
1995/08/18
|
ROXANE |
Discontinued |
| HYDROXYUREA |
075020 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
1998/07/30
|
1998/07/30
|
BARR LABS INC |
Discontinued |
| HYDROXYUREA |
075020 |
002 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
250MG |
No
|
No
|
1998/07/30
|
2000/06/26
|
BARR LABS INC |
Discontinued |
| HYDROXYUREA |
075143 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
1998/10/16
|
1998/10/16
|
BARR |
Prescription |
| HYDROXYUREA |
075143 |
002 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
250MG |
No
|
No
|
1998/10/16
|
2000/09/21
|
BARR |
Discontinued |
| HYDROXYUREA |
075340 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
1999/02/24
|
1999/02/24
|
ENDO OPERATIONS |
Prescription |
| HYDROXYUREA |
075734 |
001 |
ANDA |
HYDROXYUREA |
TABLET;ORAL |
1GM |
No
|
No
|
2000/08/29
|
2000/08/29
|
BARR |
Discontinued |
| HYDROXYUREA |
213438 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
2020/04/08
|
2020/04/08
|
LEADING |
Prescription |
| HYDROXYUREA |
218021 |
001 |
ANDA |
HYDROXYUREA |
CAPSULE;ORAL |
500MG |
No
|
No
|
2024/03/06
|
2024/03/06
|
QILU |
Prescription |