| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TRANEXAMIC ACID | 212360 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2019/07/17 | 2019/07/17 | CAPLIN | Prescription |
| TRANEXAMIC ACID | 212676 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2019/07/17 | 2019/07/17 | PROVEPHARM SAS | Prescription |
| TRANEXAMIC ACID | 209860 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2020/01/14 | 2020/01/14 | APOTEX | Prescription |
| TRANEXAMIC ACID | 217155 | 001 | ANDA | TRANEXAMIC ACID | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | No | 2023/10/16 | 2023/10/16 | AMNEAL | Prescription |
| TRANEXAMIC ACID | 216877 | 001 | ANDA | TRANEXAMIC ACID | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | No | 2024/04/16 | 2024/04/16 | NEXUS | Prescription |
| TRANEXAMIC ACID | 218599 | 001 | ANDA | TRANEXAMIC ACID | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | No | 2024/04/16 | 2024/04/16 | GLAND PHARMA LTD | Prescription |
| TRANEXAMIC ACID | 218320 | 001 | ANDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | No | No | 2024/06/11 | 2024/06/11 | RUBICON | Prescription |
| TRANEXAMIC ACID | 218242 | 001 | ANDA | TRANEXAMIC ACID | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | No | No | 2024/08/15 | 2024/08/15 | FRESENIUS KABI USA | Prescription |