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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
PEMETREXED DISODIUM | 214408 | 003 | NDA | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 850MG BASE/34ML (EQ 25MG BASE/ML) | Yes | Yes | 2022/07/19 | 2022/07/19 | ACCORD HLTHCARE | Prescription |
PEMETREXED DISODIUM | 214408 | 004 | NDA | PEMETREXED DISODIUM | SOLUTION;INTRAVENOUS | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | Yes | Yes | 2022/07/19 | 2022/07/19 | ACCORD HLTHCARE | Prescription |
PEMETREXED DISODIUM | 210047 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No | 2022/08/04 | 2022/08/04 | AMNEAL | Discontinued |
PEMETREXED DISODIUM | 210047 | 002 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No | 2022/08/04 | 2023/05/08 | AMNEAL | Discontinued |
PEMETREXED DISODIUM | 214436 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No | 2022/08/18 | 2022/08/18 | BAXTER HLTHCARE CORP | Prescription |
PEMETREXED DISODIUM | 214436 | 002 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No | 2022/08/18 | 2022/08/18 | BAXTER HLTHCARE CORP | Prescription |
PEMETREXED DISODIUM | 215479 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No | 2022/12/13 | 2022/12/13 | MEITHEAL | Prescription |
PEMETREXED DISODIUM | 215479 | 002 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No | 2022/12/13 | 2022/12/13 | MEITHEAL | Prescription |
PEMETREXED DISODIUM | 215479 | 003 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 750MG BASE/VIAL | No | No | 2022/12/13 | 2022/12/13 | MEITHEAL | Prescription |
PEMETREXED DISODIUM | 215479 | 004 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 1GM BASE/VIAL | No | No | 2022/12/13 | 2022/12/13 | MEITHEAL | Prescription |
PEMETREXED DISODIUM | 203628 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No | 2023/03/10 | 2023/03/10 | NORVIUM BIOSCIENCE | Discontinued |
PEMETREXED DISODIUM | 216582 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No | 2023/12/11 | 2023/12/11 | PRINSTON INC | Prescription |
PEMETREXED DISODIUM | 215460 | 001 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No | 2024/06/14 | 2024/06/14 | HETERO LABS LTD VI | Prescription |
PEMETREXED DISODIUM | 215460 | 002 | ANDA | PEMETREXED DISODIUM | POWDER;INTRAVENOUS | EQ 500MG BASE/VIAL | No | No | 2024/06/14 | 2024/06/14 | HETERO LABS LTD VI | Prescription |