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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2002/04/05 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
2000/05/03 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1998/02/09 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1995/10/26 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1995/09/13 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1991/11/05 SUPPL-24(补充) Approval Labeling
1990/09/11 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1988/04/19 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1988/01/13 SUPPL-21(补充) Approval Labeling
1987/07/09 SUPPL-19(补充) Approval Labeling
1987/03/05 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1986/10/10 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-10(补充) Approval Labeling
1986/01/31 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1986/01/29 SUPPL-14(补充) Approval Labeling
1986/01/29 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1985/05/24 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1985/05/17 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1984/09/08 SUPPL-5(补充) Approval Labeling
1983/11/02 SUPPL-7(补充) Approval Labeling
1983/11/02 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1983/02/16 SUPPL-4(补充) Approval Labeling
1983/02/16 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1982/05/26 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1982/01/25 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1981/10/29 ORIG-1(原始申请) 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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