药品注册申请号:018336
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TIS-U-SOL IN PLASTIC CONTAINER MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE SOLUTION;IRRIGATION 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML No No AT 1981/10/06 Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2001/08/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1997/04/29 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1993/12/08 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1990/05/18 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1987/07/25 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1987/05/28 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1986/02/27 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1985/08/28 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1985/06/26 SUPPL 12 Approval Labeling
1985/06/13 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1985/01/24 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1984/08/24 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1982/05/17 SUPPL 3 Approval Labeling
1981/10/06 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE 剂型/给药途径:SOLUTION;IRRIGATION 规格:20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018336 001 NDA TIS-U-SOL IN PLASTIC CONTAINER MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE SOLUTION;IRRIGATION 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML Prescription No No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018508 001 NDA TIS-U-SOL MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE SOLUTION;IRRIGATION 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML Prescription No No AT 1982/02/19 BAXTER HLTHCARE
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