| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALKERAN | 014691 | 002 | NDA | MELPHALAN | TABLET;ORAL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1964/01/17 | Approved Prior to Jan 1, 1982 | APOTEX | Discontinued |
| ALKERAN | 020207 | 001 | NDA | MELPHALAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1992/11/18 | 1992/11/18 | APOTEX | Discontinued |