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 |
| RILUZOLE |
076173 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2003/01/29
|
2003/01/29
|
IMPAX LABS |
Prescription |
| RILUZOLE |
091300 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2013/06/18
|
2013/06/18
|
APOTEX CORP |
Discontinued |
| RILUZOLE |
091394 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2013/06/18
|
2013/06/18
|
GLENMARK PHARMS LTD |
Prescription |
| RILUZOLE |
091417 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2013/06/18
|
2013/06/18
|
SUN PHARM INDS LTD |
Discontinued |
| RILUZOLE |
203042 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2013/07/01
|
2013/07/01
|
MYLAN PHARMS INC |
Prescription |
| RILUZOLE |
204048 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
Yes
|
2016/03/30
|
2016/03/30
|
ALKEM LABS LTD |
Prescription |
| RILUZOLE |
204430 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2018/10/16
|
2018/10/16
|
DAITO PHARMS CO LTD |
Discontinued |
| RILUZOLE |
206045 |
001 |
ANDA |
RILUZOLE |
TABLET;ORAL |
50MG |
No
|
No
|
2019/12/09
|
2019/12/09
|
KENTON |
Prescription |
| RILUZOLE |
216035 |
001 |
ANDA |
RILUZOLE |
SUSPENSION;ORAL |
50MG/10ML |
No
|
No
|
2024/08/22
|
2024/08/22
|
ALKEM LABS LTD |
Prescription |