药品注册申请号:018273
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 ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;30MG/100ML;97MG/100ML;220MG/100ML;140MG/100ML No No None 1980/10/06 Approved Prior to Jan 1, 1982 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
1990/09/11 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1987/12/28 SUPPL-14(补充) Approval Labeling STANDARD
1987/07/09 SUPPL-13(补充) Approval Labeling STANDARD
1986/02/18 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1985/11/25 SUPPL-12(补充) Approval Labeling STANDARD
1985/06/28 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1985/04/03 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1984/12/10 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1983/01/17 SUPPL-8(补充) Approval Labeling STANDARD
1981/12/16 SUPPL-5(补充) Approval Labeling STANDARD
1981/10/26 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1980/12/30 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1980/12/11 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1980/12/03 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/10/06 ORIG-1(原始申请) 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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