美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 85 条
共 5 页，当前第 2 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 |
| BACLOFEN |
077241 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2005/12/20
|
2007/07/06
|
LANNETT CO INC |
Prescription |
| BACLOFEN |
077241 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2005/12/20
|
2021/09/22
|
LANNETT CO INC |
Prescription |
| BACLOFEN |
077862 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2006/08/14
|
2006/08/14
|
SUN PHARM INDS INC |
Discontinued |
| BACLOFEN |
077862 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2006/08/14
|
2006/08/14
|
SUN PHARM INDS INC |
Discontinued |
| BACLOFEN |
077971 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2007/10/26
|
2007/10/26
|
IMPAX |
Discontinued |
| BACLOFEN |
077971 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2007/10/26
|
2007/10/26
|
IMPAX |
Discontinued |
| BACLOFEN |
077971 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2007/10/26
|
2021/07/07
|
IMPAX |
Discontinued |
| BACLOFEN |
077088 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2007/10/31
|
2007/10/31
|
OXFORD PHARMS |
Prescription |
| BACLOFEN |
077088 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2007/10/31
|
2007/10/31
|
OXFORD PHARMS |
Prescription |
| BACLOFEN |
078401 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2009/09/18
|
2009/09/18
|
NORTHSTAR HLTHCARE |
Prescription |
| BACLOFEN |
078401 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2009/09/18
|
2009/09/18
|
NORTHSTAR HLTHCARE |
Prescription |
| BACLOFEN |
078504 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2009/09/18
|
--
|
NORTHSTAR HLTHCARE |
Prescription |
| BACLOFEN |
090334 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2010/02/18
|
2010/02/18
|
APPCO |
Discontinued |
| BACLOFEN |
090334 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2010/02/18
|
2010/02/18
|
APPCO |
Discontinued |
| BACLOFEN |
091193 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
No
|
No
|
2016/05/03
|
2016/05/03
|
AMNEAL |
Prescription |
| BACLOFEN |
091193 |
002 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
No
|
No
|
2016/05/03
|
2016/05/03
|
AMNEAL |
Prescription |
| BACLOFEN |
091193 |
003 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
No
|
No
|
2016/05/03
|
2016/05/03
|
AMNEAL |
Prescription |
| BACLOFEN |
209102 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
Yes
|
2017/11/28
|
2017/11/28
|
RUBICON |
Prescription |
| BACLOFEN |
209102 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2017/11/28
|
2017/11/28
|
RUBICON |
Prescription |
| BACLOFEN |
209102 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2017/11/28
|
2017/11/28
|
RUBICON |
Prescription |