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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 211844 | 001 | NDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | Yes | Yes | 2021/03/22 | 2021/03/22 | INFORLIFE | Prescription |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 211844 | 002 | NDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | Yes | Yes | 2021/03/22 | 2021/03/22 | INFORLIFE | Prescription |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 216159 | 001 | ANDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No | 2023/04/17 | 2023/04/17 | HIKMA | Prescription |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 216159 | 002 | ANDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | No | No | 2023/04/17 | 2023/04/17 | HIKMA | Prescription |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 218993 | 001 | ANDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | No | No | 2024/08/12 | 2024/08/12 | GLAND PHARMA LTD | Prescription |
MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 218993 | 002 | ANDA | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | No | No | 2024/08/12 | 2024/08/12 | GLAND PHARMA LTD | Prescription |