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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
EDARAVONE | 218349 | 001 | ANDA | EDARAVONE | INJECTABLE;INJECTION | 30MG/100ML(0.3MG/ML) | No | No | 2024/03/13 (TA) | -- | ZYDUS PHARMS USA INC | None (Tentative Approval) |
EDARAVONE | 215508 | 001 | ANDA | EDARAVONE | SOLUTION;INTRAVENOUS | 30MG/100ML (0.3MG/ML) | No | No | 2024/05/06 | 2024/05/06 | HIKMA | Prescription |
EDARAVONE | 215508 | 002 | ANDA | EDARAVONE | INJECTION;SOLUTION | 60mg/100mL | No | No | 2024/05/06 | -- | HIKMA | None (Tentative Approval) |
EDARAVONE | 215917 | 001 | ANDA | EDARAVONE | SOLUTION;INTRAVENOUS | 60MG/100ML (0.6MG/ML) | No | No | 2024/05/06 | 2024/05/06 | DR REDDYS | Prescription |
EDARAVONE | 216199 | 001 | ANDA | EDARAVONE | SOLUTION;INTRAVENOUS | 30MG/100ML (0.3MG/ML) | No | No | 2024/05/06 | 2024/05/06 | GLAND PHARMA LTD | Prescription |
EDARAVONE | 216199 | 002 | ANDA | EDARAVONE | SOLUTION;INTRAVENOUS | 60MG/100ML (0.6MG/ML) | No | No | 2024/05/06 | 2024/05/06 | GLAND PHARMA LTD | Prescription |
EDARAVONE | 218354 | 001 | ANDA | EDARAVONE | SOLUTION;INTRAVENOUS | 30MG/100ML (0.3MG/ML) | No | No | 2024/05/06 | 2024/05/06 | LONG GROVE PHARMS | Prescription |