美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 20 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 |
| ROFLUMILAST |
208257 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2018/07/13
|
2018/07/13
|
MYLAN |
Prescription |
| ROFLUMILAST |
208272 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2018/08/06
|
2018/08/06
|
TORRENT |
Discontinued |
| ROFLUMILAST |
208236 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2018/10/03
|
2018/10/03
|
BRECKENRIDGE |
Discontinued |
| ROFLUMILAST |
208236 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2018/10/03
|
2023/10/19
|
BRECKENRIDGE |
Prescription |
| ROFLUMILAST |
208213 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2018/11/23
|
2018/11/23
|
HETERO LABS LTD III |
Prescription |
| ROFLUMILAST |
208213 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2018/11/23
|
2023/04/18
|
HETERO LABS LTD III |
Prescription |
| ROFLUMILAST |
208180 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2019/03/22
|
2019/03/22
|
MICRO LABS |
Prescription |
| ROFLUMILAST |
208180 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2019/03/22
|
2023/04/18
|
MICRO LABS |
Prescription |
| ROFLUMILAST |
208247 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2020/03/30
|
2020/03/30
|
STRIDES PHARMA |
Prescription |
| ROFLUMILAST |
208247 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2020/03/30
|
2023/06/20
|
STRIDES PHARMA |
Prescription |
| ROFLUMILAST |
208303 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2022/02/10
|
2022/02/10
|
ZYDUS PHARMS |
Prescription |
| ROFLUMILAST |
208303 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2022/02/10
|
2023/04/18
|
ZYDUS PHARMS |
Prescription |
| ROFLUMILAST |
208299 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2022/05/10
|
2022/05/10
|
PRINSTON INC |
Prescription |
| ROFLUMILAST |
208256 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2022/09/07
|
2022/09/07
|
MSN |
Prescription |
| ROFLUMILAST |
208256 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2022/09/07
|
2022/09/07
|
MSN |
Prescription |
| ROFLUMILAST |
213298 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2023/04/17
|
2023/04/17
|
AUROBINDO PHARMA LTD |
Prescription |
| ROFLUMILAST |
208303 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2023/04/18
|
2022/02/10
|
ZYDUS PHARMS |
Prescription |
| ROFLUMILAST |
208303 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2023/04/18
|
2023/04/18
|
ZYDUS PHARMS |
Prescription |
| ROFLUMILAST |
212490 |
001 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
250MCG |
No
|
No
|
2023/04/18
|
2023/04/18
|
ALKEM LABS LTD |
Prescription |
| ROFLUMILAST |
212490 |
002 |
ANDA |
ROFLUMILAST |
TABLET;ORAL |
500MCG |
No
|
No
|
2023/04/18
|
2023/04/18
|
ALKEM LABS LTD |
Prescription |