药品注册申请号:019682
申请类型:NDA (新药申请)
申请人:HOSPIRA INC
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 AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INJECTABLE;INJECTION 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML No No None 1988/11/01 1988/11/01 Discontinued
002 AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE INJECTABLE;INJECTION 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML No No None 1988/11/01 Discontinued
003 AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE INJECTABLE;INJECTION 4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML No No None 1988/11/01 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
2003/01/31 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2002/11/08 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2002/08/21 SUPPL-18(补充) Approval Labeling STANDARD
2002/08/21 SUPPL-15(补充) Approval Labeling STANDARD
1998/12/29 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1998/10/29 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1997/05/05 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1997/03/04 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1996/03/04 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1995/08/18 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1994/07/11 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1993/12/30 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1992/09/28 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1992/08/18 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1988/11/01 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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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