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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 219016 | 001 | EDURANT PEDP | RILPIVIRINE HYDROCHLORIDE | 利匹韦林 | TABLET, FOR SUSPENSION;ORAL | EQ 2.5MG BASE | JANSSEN PRODS | 2024-03-15 | Yes | Yes | RX | |
(ANDA) 218868 | 001 | CISPLATIN | CISPLATIN | 顺铂 | INJECTABLE;INJECTION | 1MG/ML | QILU | 2024-05-10 | No | No | RX | AP |
(NDA) 218860 | 001 | IQIRVOP | ELAFIBRANOR | 依拉雷诺 | TABLET;ORAL | 80MG | IPSEN | 2024-06-10 | Yes | Yes | RX | |
(ANDA) 218789 | 001 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 0.5MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(ANDA) 218789 | 002 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 1MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(ANDA) 218789 | 003 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 2MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(ANDA) 218789 | 004 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 5MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(ANDA) 218789 | 005 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 10MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(ANDA) 218789 | 006 | HALOPERIDOL | HALOPERIDOL | 氟哌啶醇 | TABLET;ORAL | 20MG | AUROBINDO PHARMA LTD | 2024-04-19 | No | No | RX | AB |
(NDA) 218771 | 001 | TERIPARATIDE | TERIPARATIDE | 特立帕肽 | SOLUTION;SUBCUTANEOUS | 0.6MG/2.4ML (0.25MG/ML) | ALMAJECT | 2024-06-04 | Yes | Yes | RX | |
(ANDA) 218758 | 001 | NOREPINEPHRINE BITARTRATE | NOREPINEPHRINE BITARTRATE | 重酒石酸去甲肾上腺素 | INJECTABLE;INJECTION | EQ 1MG BASE/ML | RISING | 2024-05-13 | No | No | RX | AP |
(NDA) 218709 | 001 | XOLREMDIP | MAVORIXAFOR | 马伏沙福 | CAPSULE;ORAL | 100MG | X4 PHARMS | 2024-04-26 | Yes | Yes | RX | |
(ANDA) 218673 | 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 盐酸二甲双胍 | TABLET, EXTENDED RELEASE;ORAL | 500MG | HARMAN FINOCHEM | 2024-07-05 | No | No | RX | AB1 |
(ANDA) 218673 | 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | 盐酸二甲双胍 | TABLET, EXTENDED RELEASE;ORAL | 750MG | HARMAN FINOCHEM | 2024-07-05 | No | No | RX | AB |
(NDA) 218623 | 001 | LIBERVANTP | DIAZEPAM | 地西泮 | FILM;BUCCAL | 5MG | AQUESTIVE | 2024-04-26 | Yes | No | RX | |
(NDA) 218623 | 002 | LIBERVANTP | DIAZEPAM | 地西泮 | FILM;BUCCAL | 7.5MG | AQUESTIVE | 2024-04-26 | Yes | No | RX | |
(NDA) 218623 | 003 | LIBERVANTP | DIAZEPAM | 地西泮 | FILM;BUCCAL | 10MG | AQUESTIVE | 2024-04-26 | Yes | No | RX | |
(NDA) 218623 | 004 | LIBERVANTP | DIAZEPAM | 地西泮 | FILM;BUCCAL | 12.5MG | AQUESTIVE | 2024-04-26 | Yes | No | RX | |
(NDA) 218623 | 005 | LIBERVANTP | DIAZEPAM | 地西泮 | FILM;BUCCAL | 15MG | AQUESTIVE | 2024-04-26 | Yes | Yes | RX | |
(ANDA) 218618 | 001 | CABERGOLINE | CABERGOLINE | 卡麦角林 | TABLET;ORAL | 0.5MG | SKG PHARMA | 2024-06-26 | No | No | RX | AB |