药品注册申请号:018460
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 DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE SOLUTION;INTRAPERITONEAL 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML No No None 1981/10/29 Approved Prior to Jan 1, 1982 Discontinued
002 DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE SOLUTION;INTRAPERITONEAL 29MG/100ML;4.25GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;4.25GM/100ML;15MG/100ML;560MG/100ML;390MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
005 DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML No No None 1983/11/02 Discontinued
006 DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE SOLUTION;INTRAPERITONEAL 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG/100ML;560MG/100ML No No None 1986/01/29 Discontinued
007 DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML No No None 1986/01/29 Discontinued
008 DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;5GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML No No None 1986/01/29 Discontinued
009 DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE SOLUTION;INTRAPERITONEAL 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG/100ML;450MG/100ML No No None 1986/01/29 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
2002/04/05 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2000/05/03 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1998/02/09 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1995/10/26 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1995/09/13 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1991/11/05 SUPPL 24 Approval Labeling
1990/09/11 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1988/04/19 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1988/01/13 SUPPL 21 Approval Labeling
1987/07/09 SUPPL 19 Approval Labeling
1987/03/05 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1986/10/10 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 10 Approval Labeling
1986/01/31 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1986/01/29 SUPPL 14 Approval Labeling
1986/01/29 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1985/05/24 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1985/05/17 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1984/09/08 SUPPL 5 Approval Labeling
1983/11/02 SUPPL 7 Approval Labeling
1983/11/02 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1983/02/16 SUPPL 4 Approval Labeling
1983/02/16 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1982/05/26 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1982/01/25 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1981/10/29 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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