药品注册申请号:018268
申请类型:NDA (新药申请)
申请人:B BRAUN
申请人全名:B BRAUN MEDICAL INC
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 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;450MG/100ML No No None 1980/09/05 Approved Prior to Jan 1, 1982 Discontinued
002 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;450MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;450MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;200MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;200MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
006 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;200MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
009 DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;200MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
010 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;450MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
011 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;75MG/100ML;330MG/100ML No No None 1986/01/18 Discontinued
012 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;150MG/100ML;330MG/100ML No No None 1986/01/18 Discontinued
013 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;220MG/100ML;330MG/100ML No No None 1986/01/18 Discontinued
014 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;300MG/100ML;330MG/100ML No No None 1986/01/18 Discontinued
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
1990/09/11 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1986/02/18 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1986/01/18 SUPPL 14 Approval Labeling STANDARD
1986/01/18 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1985/06/28 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1985/06/27 SUPPL 16 Approval Labeling STANDARD
1985/04/03 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1984/09/19 SUPPL 12 Approval Labeling STANDARD
1981/10/29 SUPPL 2 Approval Labeling STANDARD
1981/10/26 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1981/01/02 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1980/12/30 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1980/12/12 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1980/12/10 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1980/10/29 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1980/09/05 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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