美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 88 条
共 5 页，当前第 4 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 |
212378 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2020/10/09
|
2021/04/30
|
ANDAS 5 HOLDING |
Prescription |
| BACLOFEN |
210777 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.05MG/ML |
No
|
No
|
2021/01/15
|
2021/01/15
|
MAIA PHARMS INC |
Prescription |
| BACLOFEN |
214374 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2021/03/05
|
2021/03/05
|
RISING |
Prescription |
| BACLOFEN |
214374 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2021/03/05
|
2021/03/05
|
RISING |
Prescription |
| BACLOFEN |
214374 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2021/03/05
|
2021/03/05
|
RISING |
Prescription |
| BACLOFEN |
214099 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2021/07/13
|
2021/07/13
|
AUROBINDO PHARMA LTD |
Prescription |
| BACLOFEN |
214099 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2021/07/13
|
2021/07/13
|
AUROBINDO PHARMA LTD |
Prescription |
| BACLOFEN |
214099 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2021/07/13
|
--
|
AUROBINDO PHARMA LTD |
Prescription |
| BACLOFEN |
214114 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2021/07/16
|
2021/07/16
|
REGCON HOLDINGS |
Prescription |
| BACLOFEN |
214114 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2021/07/16
|
2021/07/16
|
REGCON HOLDINGS |
Prescription |
| BACLOFEN |
214114 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2021/07/16
|
2023/09/19
|
REGCON HOLDINGS |
Prescription |
| BACLOFEN |
215885 |
001 |
ANDA |
BACLOFEN |
TABLET;ORAL |
5MG |
No
|
No
|
2022/01/25
|
2022/01/25
|
MANKIND PHARMA |
Prescription |
| BACLOFEN |
215885 |
002 |
ANDA |
BACLOFEN |
TABLET;ORAL |
10MG |
No
|
No
|
2022/01/25
|
2022/01/25
|
MANKIND PHARMA |
Prescription |
| BACLOFEN |
215885 |
003 |
ANDA |
BACLOFEN |
TABLET;ORAL |
20MG |
No
|
No
|
2022/01/25
|
2022/01/25
|
MANKIND PHARMA |
Prescription |
| BACLOFEN |
217324 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
No
|
No
|
2023/02/22
|
2023/02/22
|
RUBICON RESEARCH |
Prescription |
| BACLOFEN |
217324 |
002 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
1MG/ML |
No
|
No
|
2023/02/22
|
2023/02/22
|
RUBICON RESEARCH |
Prescription |
| BACLOFEN |
217324 |
003 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
No
|
No
|
2023/02/22
|
2023/02/22
|
RUBICON RESEARCH |
Prescription |
| BACLOFEN |
217252 |
001 |
ANDA |
BACLOFEN |
SUSPENSION;ORAL |
25MG/5ML |
No
|
No
|
2023/06/08
|
2023/06/08
|
ANI PHARMS |
Prescription |
| BACLOFEN |
216309 |
001 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
0.5MG/ML |
No
|
No
|
2023/08/10
|
2023/08/10
|
HERITAGE |
Discontinued |
| BACLOFEN |
216309 |
002 |
ANDA |
BACLOFEN |
INJECTABLE;INTRATHECAL |
2MG/ML |
No
|
No
|
2023/08/10
|
2023/08/10
|
HERITAGE |
Discontinued |