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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
METHOTREXATE SODIUM PRESERVATIVE FREE | 203407 | 002 | ANDA | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/10ML (EQ 25MG BASE/ML) | No | No | 2018/08/09 | 2018/08/09 | SAGENT PHARMS INC | Prescription |
METHOTREXATE SODIUM PRESERVATIVE FREE | 203407 | 003 | ANDA | METHOTREXATE SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | No | No | 2018/08/09 | 2018/08/09 | SAGENT PHARMS INC | Prescription |
METHOTREXATE SODIUM | 213343 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2020/01/24 | 2020/01/24 | ACCORD HLTHCARE | Prescription |
METHOTREXATE SODIUM | 210454 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2020/01/30 | 2020/01/30 | EUGIA PHARMA | Prescription |
METHOTREXATE | 214121 | 001 | NDA | METHOTREXATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | Yes | No | 2020/08/24 | 2020/08/24 | ACCORD HLTHCARE | Discontinued |
METHOTREXATE SODIUM | 209787 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2021/04/23 | 2021/04/23 | LOTUS PHARM CO LTD | Discontinued |
METHOTREXATE SODIUM | 213362 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2023/08/07 | 2023/08/07 | DAITO | Prescription |
METHOTREXATE SODIUM | 216453 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2024/05/16 | 2024/05/16 | ELITE LABS INC | Prescription |
METHOTREXATE SODIUM | 217552 | 001 | ANDA | METHOTREXATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE | No | No | 2024/06/03 | 2024/06/03 | ALEMBIC | Prescription |