| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GLEEVEC | 021335 | 001 | NDA | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2001/05/10 | 2001/05/10 | NOVARTIS | Discontinued |
| GLEEVEC | 021335 | 002 | NDA | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2001/05/10 | 2001/05/10 | NOVARTIS | Discontinued |
| GLEEVEC | 021588 | 001 | NDA | IMATINIB MESYLATE | TABLET;ORAL | EQ 100MG BASE | Yes | No | 2003/04/18 | 2003/04/18 | NOVARTIS | Prescription |
| GLEEVEC | 021588 | 002 | NDA | IMATINIB MESYLATE | TABLET;ORAL | EQ 400MG BASE | Yes | Yes | 2003/04/18 | 2003/04/18 | NOVARTIS | Prescription |