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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) 050558 | 002 | ZINACEF | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PAI HOLDINGS PHARM | 1983-10-19 | Yes | No | DISCN | |
(NDA) 050558 | 003 | ZINACEF | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PAI HOLDINGS PHARM | 1983-10-19 | Yes | No | DISCN | |
(ANDA) 062590 | 002 | KEFUROX IN PLASTIC CONTAINER | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | LILLY | 1986-01-10 | No | No | DISCN | |
(ANDA) 062591 | 001 | KEFUROX | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | ACS DOBFAR | 1986-01-10 | No | No | DISCN | |
(ANDA) 062590 | 001 | KEFUROX IN PLASTIC CONTAINER | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAVENOUS | EQ 750MG BASE/VIAL | LILLY | 1986-01-10 | No | No | DISCN | |
(ANDA) 062592 | 002 | KEFUROX | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | LILLY | 1986-01-10 | No | No | DISCN | |
(ANDA) 062591 | 002 | KEFUROX | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | ACS DOBFAR | 1986-01-10 | No | No | DISCN | |
(ANDA) 062592 | 001 | KEFUROX | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAVENOUS | EQ 750MG BASE/VIAL | LILLY | 1986-01-10 | No | No | DISCN | |
(NDA) 050558 | 004 | ZINACEF | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PAI HOLDINGS PHARM | 1986-10-23 | Yes | No | DISCN | |
(ANDA) 062591 | 003 | KEFUROX | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL | ACS DOBFAR | 1987-12-17 | No | No | DISCN | |
(NDA) 050643 | 001 | ZINACEF IN PLASTIC CONTAINER | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 15MG BASE/ML | PAI HOLDINGS PHARM | 1989-04-28 | No | No | DISCN | |
(NDA) 050643 | 002 | ZINACEF IN PLASTIC CONTAINER | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 30MG BASE/ML | PAI HOLDINGS PHARM | 1989-04-28 | Yes | No | DISCN | |
(ANDA) 064035 | 002 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | WATSON LABS INC | 1993-02-26 | No | No | DISCN | |
(ANDA) 064036 | 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL | WATSON LABS INC | 1993-02-26 | No | No | DISCN | |
(ANDA) 064035 | 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | WATSON LABS INC | 1993-02-26 | No | No | DISCN | |
(ANDA) 064125 | 002 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | ACS DOBFAR SPA | 1997-05-30 | No | No | RX | AP |
(ANDA) 064125 | 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | ACS DOBFAR SPA | 1997-05-30 | No | No | RX | AB |
(ANDA) 064124 | 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INJECTION | EQ 7.5GM BASE/VIAL | ACS DOBFAR SPA | 1997-05-30 | No | No | DISCN | |
(ANDA) 064192 | 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 1.5GM BASE/VIAL | TEVA PHARMS | 1998-04-16 | No | No | DISCN | |
(ANDA) 064192 | 002 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | 头孢呋辛钠 | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | TEVA PHARMS | 1998-04-16 | No | No | DISCN |