美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 10 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 |
| METAXALONE |
040445 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2010/03/31
|
2010/03/31
|
SANDOZ |
Prescription |
| METAXALONE |
203399 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
Yes
|
2013/06/21
|
2013/06/21
|
AMNEAL PHARMS |
Prescription |
| METAXALONE |
040486 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
400MG |
No
|
No
|
2015/02/27
|
2015/02/27
|
MOUNTAIN |
Prescription |
| METAXALONE |
022503 |
001 |
NDA |
METAXALONE |
TABLET;ORAL |
640MG |
Yes
|
Yes
|
2015/06/01
|
2015/06/01
|
PRIMUS PHARMS |
Prescription |
| METAXALONE |
204770 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2016/11/22
|
2016/11/22
|
LANNETT CO INC |
Prescription |
| METAXALONE |
203695 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2017/06/15
|
2017/06/15
|
ACTAVIS LABS FL INC |
Prescription |
| METAXALONE |
207466 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2017/08/31
|
2017/08/31
|
SCIEGEN PHARMS INC |
Prescription |
| METAXALONE |
207466 |
002 |
ANDA |
METAXALONE |
TABLET;ORAL |
400MG |
No
|
No
|
2017/08/31
|
2020/03/13
|
SCIEGEN PHARMS INC |
Prescription |
| METAXALONE |
208774 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2018/09/24
|
2018/09/24
|
RISING |
Discontinued |
| METAXALONE |
213836 |
001 |
ANDA |
METAXALONE |
TABLET;ORAL |
800MG |
No
|
No
|
2020/10/21
|
2020/10/21
|
NOVAST LABS |
Discontinued |