1. 列表页商品名字段中有红色标记P代表该数据有专利信息;当使用各个专利到期时间检索条件时,“有无专利”默认为有。
2. 批准日期显示1982-01-01的,实际为1982-01-01之前。
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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) 215320 | 001 | COMBOGESIC IVP | ACETAMINOPHEN; IBUPROFEN SODIUM | 布洛芬钠;对乙酰氨基酚 | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) | HIKMA | 2023-10-17 | Yes | Yes | RX | |
(NDA) 211733 | 001 | ADVIL DUAL ACTION WITH ACETAMINOPHENP | ACETAMINOPHEN; IBUPROFEN | 对乙酰氨基酚;布洛芬 | TABLET;ORAL | 250MG;125MG | HALEON US HOLDINGS | 2020-02-28 | Yes | Yes | OTC | |
(NDA) 209471 | 001 | COMBOGESICP | ACETAMINOPHEN; IBUPROFEN | 对乙酰氨基酚;布洛芬 | TABLET;ORAL | 325MG;97.5MG | AFT PHARMS US | 2023-03-01 | Yes | Yes | RX | |
(NDA) 208653 | 001 | APADAZP | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 盐酸苯氢可酮;对乙酰氨基酚 | TABLET;ORAL | 325MG;EQ 6.12MG BASE | ZEVRA THERAP | 2018-02-23 | Yes | No | DISCN | |
(NDA) 208653 | 002 | APADAZP | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 盐酸苯氢可酮;对乙酰氨基酚 | TABLET;ORAL | 325MG;EQ 4.08MG BASE | ZEVRA THERAP | 2019-01-04 | Yes | No | DISCN | |
(NDA) 208653 | 003 | APADAZP | ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE | 盐酸苯氢可酮;对乙酰氨基酚 | TABLET;ORAL | 325MG;EQ 8.16MG BASE | ZEVRA THERAP | 2019-01-04 | Yes | No | DISCN | |
(NDA) 206968 | 001 | ACETAMINOPHEN | ACETAMINOPHEN | 对乙酰氨基酚 | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | HIKMA | 2022-06-03 | Yes | Yes | RX | |
(NDA) 206610 | 001 | ACETAMINOPHEN | ACETAMINOPHEN | 对乙酰氨基酚 | POWDER;INTRAVENOUS | 1GM/VIAL | RISING | 2021-01-15 | Yes | No | DISCN | |
(NDA) 204957 | 001 | ACETAMINOPHEN | ACETAMINOPHEN | 对乙酰氨基酚 | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | B BRAUN MEDICAL INC | 2021-02-18 | Yes | Yes | RX | |
(NDA) 204957 | 002 | ACETAMINOPHEN | ACETAMINOPHEN | 对乙酰氨基酚 | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | B BRAUN MEDICAL INC | 2021-02-18 | Yes | Yes | RX | |
(NDA) 204031 | 001 | XARTEMIS XRP | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 盐酸羟考酮;对乙酰氨基酚 | TABLET, EXTENDED RELEASE;ORAL | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | MALLINCKRODT INC | 2014-03-11 | Yes | No | DISCN | |
(ANDA) 088825 | 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 布他比妥;咖啡因;对乙酰氨基酚 | CAPSULE;ORAL | 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GILBERT LABS | 1984-12-05 | Yes | No | DISCN | |
(ANDA) 088629 | 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 磷酸可待因;对乙酰氨基酚 | TABLET;ORAL | 300MG;60MG | NOSTRUM LABS INC | 1985-03-06 | Yes | No | DISCN | |
(ANDA) 088616 | 001 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 布他比妥;咖啡因;对乙酰氨基酚 | TABLET;ORAL | 325MG;50MG;40MG | ACTAVIS LABS UT INC | 1984-11-09 | Yes | No | RX | AA |
(ANDA) 087811 | 001 | PHRENILIN | ACETAMINOPHEN; BUTALBITAL | 布他比妥;对乙酰氨基酚 | TABLET;ORAL | 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | VALEANT | 1985-06-19 | Yes | No | DISCN | |
(ANDA) 087550 | 001 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 布他比妥;对乙酰氨基酚 | TABLET;ORAL | 325MG;50MG | WATSON LABS | 1984-10-19 | Yes | No | DISCN | |
(ANDA) 087433 | 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 磷酸可待因;对乙酰氨基酚 | TABLET;ORAL | 300MG;15MG | SANDOZ | 1982-01-01 | Yes | No | DISCN | |
(ANDA) 087003 | 001 | ROXICET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 盐酸羟考酮;对乙酰氨基酚 | TABLET;ORAL | 325MG;5MG | HIKMA | 1982-01-01 | Yes | No | DISCN | |
(ANDA) 086681 | 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 磷酸可待因;对乙酰氨基酚 | TABLET;ORAL | 300MG;30MG | PUREPAC PHARM | 1982-01-01 | Yes | No | DISCN | |
(ANDA) 085917 | 001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 磷酸可待因;对乙酰氨基酚 | TABLET;ORAL | 300MG;30MG | SANDOZ | 1982-01-01 | Yes | No | DISCN |