| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FUSILEV | 020140 | 001 | NDA | LEVOLEUCOVORIN CALCIUM | POWDER;INTRAVENOUS | EQ 50MG BASE/VIAL | Yes | No | 2008/03/07 | 2008/03/07 | ACROTECH BIOPHARMA | Discontinued |
| FUSILEV | 020140 | 002 | NDA | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/03/07 | 2011/04/29 | ACROTECH BIOPHARMA | Discontinued |
| FUSILEV | 020140 | 003 | NDA | LEVOLEUCOVORIN CALCIUM | SOLUTION;INTRAVENOUS | EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/03/07 | 2011/04/29 | ACROTECH BIOPHARMA | Discontinued |