美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 36 条
共 2 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 |
| APREMILAST |
211756 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2023/07/14
|
2023/07/14
|
DR REDDYS |
Discontinued |
| APREMILAST |
211716 |
001 |
ANDA |
APREMILAST |
TABLET;ORAL |
10MG |
No
|
No
|
2023/07/19
|
2023/07/19
|
AUROBINDO PHARMA LTD |
Discontinued |
| APREMILAST |
211716 |
002 |
ANDA |
APREMILAST |
TABLET;ORAL |
20MG |
No
|
No
|
2023/07/19
|
2023/07/19
|
AUROBINDO PHARMA LTD |
Discontinued |
| APREMILAST |
211716 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2023/07/19
|
2023/07/19
|
AUROBINDO PHARMA LTD |
Discontinued |
| APREMILAST |
211878 |
001 |
ANDA |
APREMILAST |
TABLET;ORAL |
10MG |
No
|
No
|
2023/07/26
|
2023/07/26
|
ANNORA |
Prescription |
| APREMILAST |
211878 |
002 |
ANDA |
APREMILAST |
TABLET;ORAL |
20MG |
No
|
No
|
2023/07/26
|
2023/07/26
|
ANNORA |
Prescription |
| APREMILAST |
211878 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2023/07/26
|
2023/07/26
|
ANNORA |
Prescription |
| APREMILAST |
211674 |
001 |
ANDA |
APREMILAST |
TABLET;ORAL |
10MG |
No
|
No
|
2023/10/16
|
2023/10/16
|
GLENMARK PHARMS LTD |
Prescription |
| APREMILAST |
211674 |
002 |
ANDA |
APREMILAST |
TABLET;ORAL |
20MG |
No
|
No
|
2023/10/16
|
2023/10/16
|
GLENMARK PHARMS LTD |
Prescription |
| APREMILAST |
211674 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2023/10/16
|
2023/10/16
|
GLENMARK PHARMS LTD |
Prescription |
| APREMILAST |
211734 |
001 |
ANDA |
APREMILAST |
TABLET;ORAL |
10MG |
No
|
No
|
2024/02/07
|
2024/02/07
|
MANKIND PHARMA |
Prescription |
| APREMILAST |
211734 |
002 |
ANDA |
APREMILAST |
TABLET;ORAL |
20MG |
No
|
No
|
2024/02/07
|
2024/02/07
|
MANKIND PHARMA |
Prescription |
| APREMILAST |
211734 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2024/02/07
|
2024/02/07
|
MANKIND PHARMA |
Prescription |
| APREMILAST |
211788 |
001 |
ANDA |
APREMILAST |
TABLET;ORAL |
10MG |
No
|
No
|
2024/11/25
|
2024/11/25
|
MACLEODS PHARMS LTD |
Prescription |
| APREMILAST |
211788 |
002 |
ANDA |
APREMILAST |
TABLET;ORAL |
20MG |
No
|
No
|
2024/11/25
|
2024/11/25
|
MACLEODS PHARMS LTD |
Prescription |
| APREMILAST |
211788 |
003 |
ANDA |
APREMILAST |
TABLET;ORAL |
30MG |
No
|
No
|
2024/11/25
|
2024/11/25
|
MACLEODS PHARMS LTD |
Prescription |