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 ACETATE | 018893 | 001 | NDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 40MEQ/20ML (2MEQ/ML) | Yes | Yes | 1983/05/04 | 1983/05/04 | HOSPIRA | Prescription |
SODIUM ACETATE | 018893 | 002 | NDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 100MEQ/50ML (2MEQ/ML) | Yes | Yes | 1983/05/04 | 2014/09/02 | HOSPIRA | Prescription |
SODIUM ACETATE | 018893 | 003 | NDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | Yes | Yes | 1983/05/04 | 2014/09/02 | HOSPIRA | Prescription |
SODIUM ACETATE | 206687 | 001 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | No | Yes | 2017/10/30 | 2017/10/30 | FRESENIUS KABI USA | Prescription |
SODIUM ACETATE | 214805 | 001 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 100MEQ/50ML (2MEQ/ML) | No | No | 2021/05/04 | 2021/05/04 | MILLA PHARMS | Prescription |
SODIUM ACETATE | 214805 | 002 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | No | No | 2021/05/04 | 2023/08/25 | MILLA PHARMS | Prescription |
SODIUM ACETATE | 214805 | 003 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | No | No | 2021/05/04 | 2021/05/04 | MILLA PHARMS | Prescription |
SODIUM ACETATE | 214805 | 004 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 40MEQ/20ML (2MEQ/ML) | No | No | 2021/05/04 | 2024/01/22 | MILLA PHARMS | Prescription |
SODIUM ACETATE | 216920 | 001 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 40MEQ/20ML (2MEQ/ML) | No | No | 2024/03/15 | 2024/03/15 | HIKMA | Prescription |
SODIUM ACETATE | 216920 | 002 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 100MEQ/50ML (2MEQ/ML) | No | No | 2024/03/15 | 2024/03/15 | HIKMA | Prescription |
SODIUM ACETATE | 216920 | 003 | ANDA | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | No | No | 2024/03/15 | 2024/03/15 | HIKMA | Prescription |