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 |
APREMILAST | 211887 | 001 | ANDA | APREMILAST | TABLET;ORAL | 10MG | No | No | 2024/12/16 | 2024/12/16 | MSN | Prescription |
APREMILAST | 211887 | 002 | ANDA | APREMILAST | TABLET;ORAL | 20MG | No | No | 2024/12/16 | 2024/12/16 | MSN | Prescription |
APREMILAST | 211887 | 003 | ANDA | APREMILAST | TABLET;ORAL | 30MG | No | No | 2024/12/16 | 2024/12/16 | MSN | Prescription |
APREMILAST | 211834 | 001 | ANDA | APREMILAST | TABLET | 30MG | No | No | 2024/12/19 (TA) | -- | TORRENT PHARMACEUTICALS LIMITED | None (Tentative Approval) |