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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) 021163 | 002 | INFUVITE ADULT | ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K | 乙酸α-生育酚;维生素C;生物素;维生素D3;维生素B12;右泛醇;叶酸;烟酰胺;维生素B6;核黄素磷酸钠;盐酸硫胺;维生素A棕榈酸酯;维生素K | SOLUTION;INTRAVENOUS | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML | SANDOZ CANADA INC | 2003-06-16 | Yes | Yes | RX | |
| (NDA) 021163 | 001 | INFUVITE ADULT | ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K | 乙酸α-生育酚;维生素C;生物素;维生素D3;维生素B12;右泛醇;叶酸;烟酰胺;维生素B6;核黄素磷酸钠;盐酸硫胺;维生素A棕榈酸酯;维生素K | SOLUTION;INTRAVENOUS | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML | SANDOZ CANADA INC | 2000-05-18 | Yes | Yes | RX | |
| (NDA) 021265 | 001 | INFUVITE PEDIATRIC | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 维生素C;生物素;维生素D3;维生素B12;右泛醇;叶酸;烟酰胺;吡哆醇;维生素A;核黄素;维生素B1;维生素E醋酸酯;维生素K | INJECTABLE;INTRAVENOUS | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | SANDOZ CANADA INC | 2001-02-21 | Yes | Yes | RX | |
| (NDA) 021265 | 002 | INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K | 维生素C;生物素;维生素D3;维生素B12;右泛醇;叶酸;烟酰胺;吡哆醇;维生素A;核黄素;维生素B1;维生素E醋酸酯;维生素K | INJECTABLE;INTRAVENOUS | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | SANDOZ CANADA INC | 2004-01-29 | Yes | Yes | RX | |
| (NDA) 018920 | 001 | M.V.I. PEDIATRIC | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素K1;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E | FOR SOLUTION;INTRAVENOUS | 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL | HOSPIRA | 2000-09-21 | Yes | No | DISCN | |
| (NDA) 006071 | 003 | BEROCCA PN | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A棕榈酸酯;核黄素磷酸钠;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML | ROCHE | 1985-10-10 | No | No | DISCN | |
| (NDA) 018439 | 002 | MVC PLUS | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML | WATSON LABS | 1985-08-08 | No | No | DISCN | |
| (NDA) 008809 | 006 | M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML | HOSPIRA | 2004-09-09 | Yes | No | DISCN | |
| (NDA) 008809 | 004 | M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML | HOSPIRA | 1985-08-08 | No | No | DISCN | |
| (NDA) 018440 | 002 | M.V.C. 9+3 | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML | ABRAXIS PHARM | 1985-08-08 | No | No | DISCN | |
| (NDA) 021625 | 001 | M.V.I. ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E;维生素K | INJECTABLE;INTRAVENOUS | 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL | HOSPIRA | 2004-01-30 | Yes | No | DISCN | |
| (NDA) 021643 | 001 | M.V.I. ADULT (PHARMACY BULK PACKAGE) | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素磷酸钠;盐酸硫胺;维生素E;维生素K | INJECTABLE;INTRAVENOUS | 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG/5ML | HOSPIRA | 2004-02-18 | Yes | No | DISCN | |
| (NDA) 008809 | 005 | M.V.I.-12 ADULT | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;维生素B6;维生素A;核黄素;盐酸硫胺;维生素E | INJECTABLE;INJECTION | 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML | HOSPIRA | 2004-04-22 | No | No | DISCN | |
| (NDA) 018933 | 002 | M.V.I.-12 LYOPHILIZED | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E | 维生素C;生物素;维生素B12;右泛醇;维生素D2;叶酸;烟酰胺;吡哆醇;维生素A;核黄素磷酸钠;维生素B1;维生素E | INJECTABLE;INJECTION | 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10MG/VIAL | TELIGENT | 1985-08-08 | No | No | DISCN | |
| (NDA) 020176 | 001 | VITAPED | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E | 维生素C;生物素;维生素B12;维生素D2;叶酸;烟酰胺;泛酸;维生素K1;吡哆醇;维生素A棕榈酸酯;核黄素;维生素B1;维生素E | INJECTABLE;INJECTION | N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A | HOSPIRA | 1993-12-29 | No | No | DISCN | |
| (NDA) 006012 | 003 | FOLVRON | FERROUS SULFATE; FOLIC ACID | 硫酸亚铁;叶酸 | CAPSULE;ORAL | 182MG;0.33MG | LEDERLE | 1982-01-01 | No | No | DISCN | |
| (NDA) 005897 | 008 | FOLVITE | FOLIC ACID | 叶酸 | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS INC | 1982-01-01 | Yes | No | DISCN | |
| (ANDA) 202522 | 001 | FOLIC ACID | FOLIC ACID | 叶酸 | INJECTABLE;INJECTION | 5MG/ML | XGEN PHARMS | 2019-11-06 | No | No | RX | AP |
| (ANDA) 089202 | 001 | FOLIC ACID | FOLIC ACID | 叶酸 | INJECTABLE;INJECTION | 5MG/ML | FRESENIUS KABI USA | 1986-02-18 | No | Yes | RX | AP |
| (NDA) 005897 | 004 | FOLVITE | FOLIC ACID | 叶酸 | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | WYETH PHARMS INC | 1982-01-01 | No | No | DISCN |
