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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) 018336 | 001 | TIS-U-SOL IN PLASTIC CONTAINER | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 硫酸镁;氯化钾;磷酸二氢钾;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | BAXTER HLTHCARE | 1982-01-01 | No | No | RX | AT |
(NDA) 018508 | 001 | TIS-U-SOL | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 硫酸镁;氯化钾;磷酸二氢钾;氯化钠;磷酸钠 | SOLUTION;IRRIGATION | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | BAXTER HLTHCARE | 1982-02-19 | No | No | RX | AT |
(ANDA) 211965 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | BAXTER HLTHCARE CORP | 2020-08-11 | No | No | RX | AP |
(ANDA) 206486 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | FRESENIUS KABI USA | 2016-03-07 | No | No | RX | AP |
(NDA) 020488 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | HOSPIRA | 1995-07-11 | Yes | Yes | RX | AP |
(ANDA) 211966 | 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | BAXTER HLTHCARE CORP | 2020-06-01 | No | No | RX | AP |
(ANDA) 207349 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | HQ SPCLT PHARMA | 2016-03-02 | No | No | RX | AP |
(ANDA) 209932 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | NORVIUM BIOSCIENCE | 2018-09-10 | No | No | RX | AP |
(ANDA) 216597 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | AMNEAL | 2023-02-15 | No | No | RX | AP |
(ANDA) 216597 | 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | AMNEAL | 2023-02-15 | No | No | RX | AP |
(ANDA) 207966 | 001 | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 1GM/100ML | B BRAUN MEDICAL | 2020-10-27 | No | No | RX | AP |
(ANDA) 207967 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
(ANDA) 211966 | 003 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | BAXTER HLTHCARE CORP | 2020-06-01 | No | No | RX | AP |
(ANDA) 206485 | 002 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/50ML (80MG/ML) | FRESENIUS KABI USA | 2016-03-15 | No | No | RX | AP |
(ANDA) 206485 | 005 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 40GM/1000ML (40MG/ML) | FRESENIUS KABI USA | 2016-03-15 | No | No | RX | AP |
(ANDA) 213917 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | GLAND | 2020-07-10 | No | No | RX | AP |
(ANDA) 206485 | 004 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 20GM/500ML (40MG/ML) | FRESENIUS KABI USA | 2016-03-15 | No | No | RX | AP |
(ANDA) 207967 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
(ANDA) 207967 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 4GM/100ML (40MG/ML) | B BRAUN MEDICAL | 2021-04-26 | No | No | RX | AP |
(ANDA) 211966 | 001 | MAGNESIUM SULFATE IN PLASTIC CONTAINER | MAGNESIUM SULFATE | 硫酸镁 | INJECTABLE;INJECTION | 2GM/50ML (40MG/ML) | BAXTER HLTHCARE CORP | 2020-06-01 | No | No | RX | AP |