药品注册申请号:017510
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% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML No No None 1978/02/08 Approved Prior to Jan 1, 1982 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 25 Approval Manufacturing (CMC) STANDARD
1986/02/18 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1985/11/22 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1985/06/25 SUPPL 23 Approval Labeling STANDARD
1985/05/17 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1985/04/15 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1983/01/24 SUPPL 14 Approval Labeling STANDARD
1981/10/26 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1980/10/24 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1980/09/26 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1980/08/06 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1980/07/16 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1980/02/12 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1979/10/16 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1979/10/09 SUPPL 8 Approval Labeling STANDARD
1979/06/08 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1979/01/04 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1978/09/29 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1978/09/29 SUPPL 2 Approval Labeling STANDARD
1978/09/26 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1978/03/23 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1978/02/08 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)
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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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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