药品注册申请号:019520
申请类型:NDA (新药申请)
申请人:BAXTER HLTHCARE
申请人全名:BAXTER HEALTHCARE CORP
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 TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;5GM/100ML No No None 1988/09/23 1988/09/23 Discontinued
002 TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;10GM/100ML No No None 1988/09/23 Discontinued
003 TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;15GM/100ML No No None 1988/09/23 Discontinued
004 TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;20GM/100ML No No None 1988/09/23 Discontinued
005 TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 2.75%;25GM/100ML No No None 1988/09/23 Discontinued
006 TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;5GM/100ML No No None 1988/09/23 Discontinued
007 TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;10GM/100ML No No None 1988/09/23 Discontinued
008 TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;15GM/100ML No No None 1988/09/23 Discontinued
009 TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;20GM/100ML No No None 1988/09/23 Discontinued
010 TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE INJECTABLE;INJECTION 4.25%;25GM/100ML No No None 1988/09/23 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
2001/08/14 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2000/04/12 SUPPL-18(补充) Approval Efficacy STANDARD
2000/03/24 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1999/11/24 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1999/03/31 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1997/11/18 SUPPL-16(补充) Approval Labeling STANDARD
1997/04/29 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1994/09/30 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1994/05/19 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1993/05/05 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1992/09/14 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1992/08/24 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1992/02/27 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1992/02/27 SUPPL-8(补充) Approval Labeling
1991/12/30 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1991/02/15 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1990/05/04 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1988/09/23 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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