| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | 213645 | 002 | NDA | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 350MG/50ML (7MG/ML) | Yes | Yes | 2022/01/25 | 2023/02/27 | BAXTER HLTHCARE CORP | Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | 213645 | 003 | NDA | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | Yes | Yes | 2022/01/25 | 2023/02/27 | BAXTER HLTHCARE CORP | Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | 213645 | 004 | NDA | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 700MG/100ML (7MG/ML) | Yes | Yes | 2022/01/25 | 2023/02/27 | BAXTER HLTHCARE CORP | Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | 213645 | 005 | NDA | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | Yes | Yes | 2022/01/25 | 2023/02/27 | BAXTER HLTHCARE CORP | Prescription |