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 3 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 |
209102 |
004 |
ANDA |
BACLOFEN |
TABLET;ORAL |
15MG |
No
|
No
|
2017/11/28
|
2024/02/05
|
RUBICON |
Prescription |
| BACLOFEN |
209594 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
1MG/ML |
No
|
No
|
2018/03/06
|
2018/03/06
|
MYLAN LABS LTD |
Prescription |
| BACLOFEN |
209592 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
No
|
No
|
2018/03/21
|
2018/03/21
|
MYLAN LABS LTD |
Prescription |
| BACLOFEN |
209592 |
002 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
No
|
No
|
2018/03/21
|
2018/03/21
|
MYLAN LABS LTD |
Prescription |
| BACLOFEN |
211659 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2018/11/23
|
2018/11/23
|
ZYDUS LIFESCIENCES |
Prescription |
| BACLOFEN |
211659 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2018/11/23
|
2018/11/23
|
ZYDUS LIFESCIENCES |
Prescription |
| BACLOFEN |
211659 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2018/11/23
|
2020/04/17
|
ZYDUS LIFESCIENCES |
Prescription |
| BACLOFEN |
211659 |
004 |
ANDA |
BACLOFEN |
TABLET;ORAL |
15MG |
No
|
No
|
2018/11/23
|
2024/02/13
|
ZYDUS LIFESCIENCES |
Prescription |
| BACLOFEN |
211555 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2019/02/01
|
2019/02/01
|
HIBROW HLTHCARE |
Prescription |
| BACLOFEN |
211555 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2019/02/01
|
2019/02/01
|
HIBROW HLTHCARE |
Prescription |
| BACLOFEN |
211555 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2019/02/01
|
2021/11/30
|
HIBROW HLTHCARE |
Prescription |
| BACLOFEN |
210315 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
1MG/ML |
No
|
No
|
2019/07/30
|
2019/07/30
|
MAIA PHARMS INC |
Prescription |
| BACLOFEN |
210048 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
No
|
No
|
2019/09/11
|
2019/09/11
|
MAIA PHARMS INC |
Prescription |
| BACLOFEN |
210048 |
002 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
No
|
No
|
2019/09/11
|
2019/09/11
|
MAIA PHARMS INC |
Prescription |
| BACLOFEN |
212067 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2020/07/09
|
2020/07/09
|
UNICHEM |
Prescription |
| BACLOFEN |
212067 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2020/07/09
|
2020/07/09
|
UNICHEM |
Prescription |
| BACLOFEN |
212067 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2020/07/09
|
2023/03/09
|
UNICHEM |
Prescription |
| BACLOFEN |
212378 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2020/10/09
|
2020/10/09
|
ANDAS 5 HOLDING |
Prescription |
| BACLOFEN |
212378 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2020/10/09
|
2020/10/09
|
ANDAS 5 HOLDING |
Prescription |
| BACLOFEN |
212378 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2020/10/09
|
2021/04/30
|
ANDAS 5 HOLDING |
Prescription |