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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) 019386 | 003 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | BAXTER HLTHCARE | 1988-08-15 | No | No | DISCN | |
(NDA) 019386 | 006 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | BAXTER HLTHCARE | 2003-02-25 | Yes | Yes | RX | AP |
(NDA) 019386 | 007 | BREVIBLOC | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 20MG/ML | BAXTER HLTHCARE | 2003-05-28 | No | No | DISCN | |
(NDA) 019386 | 005 | BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 2GM/100ML | BAXTER HLTHCARE | 2003-01-27 | Yes | Yes | RX | AP |
(NDA) 019386 | 004 | BREVIBLOC IN PLASTIC CONTAINER | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | BAXTER HLTHCARE | 2001-02-16 | Yes | Yes | RX | AP |
(ANDA) 076323 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | HIKMA | 2004-08-10 | No | No | RX | AP |
(ANDA) 214172 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | HQ SPCLT PHARMA | 2022-12-02 | No | No | RX | AP |
(ANDA) 214172 | 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 2GM/100ML | HQ SPCLT PHARMA | 2022-12-02 | No | No | RX | AP |
(ANDA) 076474 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | MYLAN INSTITUTIONAL | 2005-05-02 | No | No | RX | AP |
(ANDA) 206608 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | MYLAN LABS LTD | 2018-06-08 | No | No | RX | AP |
(ANDA) 206608 | 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 2GM/100ML | MYLAN LABS LTD | 2018-06-08 | No | No | RX | AP |
(ANDA) 208538 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | GLAND | 2019-08-14 | No | No | RX | AP |
(ANDA) 076573 | 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 20MG/ML | FRESENIUS KABI USA | 2023-08-23 | No | No | DISCN | |
(ANDA) 076573 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | FRESENIUS KABI USA | 2005-05-02 | No | No | DISCN | |
(ANDA) 205520 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 10MG/ML | EUGIA PHARMA | 2015-07-23 | No | No | RX | AP |
(ANDA) 216244 | 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 2GM/100ML | EUGIA PHARMA | 2022-03-21 | No | No | RX | AP |
(ANDA) 216244 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | EUGIA PHARMA | 2022-03-21 | No | No | RX | AP |
(ANDA) 216603 | 002 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 2GM/100ML | AMNEAL | 2022-12-13 | No | No | RX | AP |
(ANDA) 216603 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | AMNEAL | 2022-12-13 | No | No | RX | AP |
(ANDA) 207107 | 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 盐酸艾司洛尔 | INJECTABLE;INJECTION | 1GM/100ML | SAGENT PHARMS INC | 2018-06-08 | No | No | RX | AP |