药品注册申请号:019515
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS INJECTABLE;INJECTION 5GM/100ML;53MG/100ML;100MG/100ML;100MG/100ML;180MG/100ML;280MG/100ML;16MG/100ML No No None 1986/05/08 1986/05/08 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
2013/09/05 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
2001/07/11 SUPPL-16(补充) Approval Labeling STANDARD
2000/06/20 SUPPL-14(补充) Approval Labeling STANDARD
1998/06/22 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1996/08/06 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1989/09/13 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1986/05/08 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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