| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NILOTINIB HYDROCHLORIDE | 203640 | 001 | ANDA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No | 2024/01/05 | 2024/01/05 | APOTEX | Discontinued |
| NILOTINIB HYDROCHLORIDE | 203640 | 002 | ANDA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No | 2024/01/05 | 2024/01/05 | APOTEX | Discontinued |
| NILOTINIB HYDROCHLORIDE | 203640 | 003 | ANDA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | No | No | 2024/01/05 | 2024/01/05 | APOTEX | Discontinued |
| NILOTINIB HYDROCHLORIDE DIHYDRATE | 209651 | 001 | ANDA | NILOTINIB HYDROCHLORIDE DIHYDRATE | CAPSULE | 200MG | No | No | 2024/12/10 (TA) | -- | HETERO LABS LIMITED | Prescription |
| NILOTINIB HYDROCHLORIDE DIHYDRATE | 209651 | 002 | ANDA | NILOTINIB HYDROCHLORIDE DIHYDRATE | CAPSULE | 50MG | No | No | 2024/12/10 (TA) | -- | HETERO LABS LIMITED | Prescription |
| NILOTINIB HYDROCHLORIDE DIHYDRATE | 209651 | 003 | ANDA | NILOTINIB HYDROCHLORIDE DIHYDRATE | CAPSULE | 150MG | No | No | 2024/12/10 (TA) | -- | HETERO LABS LIMITED | Prescription |