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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 14.6% | 018897 | 001 | NDA | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1984/07/20 | 1984/07/20 | HOSPIRA | Discontinued |
SODIUM CHLORIDE 14.6% | 018897 | 002 | NDA | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 100MEQ/40ML (2.5MEQ/ML) | Yes | Yes | 1984/07/20 | 1984/07/20 | HOSPIRA | Prescription |
SODIUM CHLORIDE 14.6% | 212070 | 001 | ANDA | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 50MEQ/20ML (2.5MEQ/ML) | No | No | 2021/04/28 | 2021/04/28 | FRESENIUS KABI USA | Prescription |
SODIUM CHLORIDE 14.6% | 212070 | 002 | ANDA | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 100MEQ/40ML (2.5MEQ/ML) | No | No | 2021/04/28 | 2021/04/28 | FRESENIUS KABI USA | Prescription |