| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | 022485 | 001 | NDA | ARGATROBAN | INJECTABLE;INTRAVENOUS | 125MG/125ML (1MG/ML) | Yes | Yes | 2011/05/09 | 2011/05/09 | SANDOZ | Prescription |
| ARGATROBAN IN SODIUM CHLORIDE | 022434 | 001 | NDA | ARGATROBAN | INJECTABLE;INTRAVENOUS | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2011/06/29 | 2011/06/29 | CIPLA | Discontinued |
| ARGATROBAN IN SODIUM CHLORIDE | 205570 | 001 | ANDA | ARGATROBAN | INJECTABLE;INTRAVENOUS | 125MG/125ML (1MG/ML) | No | No | 2017/05/22 | 2017/05/22 | GLAND PHARMA LTD | Prescription |
| ARGATROBAN IN SODIUM CHLORIDE | 209552 | 001 | NDA | ARGATROBAN | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No | 2018/11/27 | 2018/11/27 | EUGIA PHARMA SPECLTS | Prescription |
| ARGATROBAN IN SODIUM CHLORIDE | 212035 | 001 | NDA | ARGATROBAN | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | Yes | Yes | 2021/06/07 | 2021/06/07 | ACCORD HLTHCARE | Prescription |