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
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
无
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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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