药品注册申请号：017493
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 5.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 5.5%;102MG/100ML;522MG/100ML;431MG/100ML;224MG/100ML No No None 1976/03/24 Approved Prior to Jan 1, 1982 Discontinued
002 TRAVASOL 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 8.5%;102MG/100ML;522MG/100ML;594MG/100ML;154MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 TRAVASOL 3.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 TRAVASOL 5.5% W/O ELECTROLYTES AMINO ACIDS INJECTABLE;INJECTION 5.5% (5.5GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
005 TRAVASOL 8.5% W/O ELECTROLYTES AMINO ACIDS INJECTABLE;INJECTION 8.5% (8.5GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
006 TRAVASOL 10% W/O ELECTROLYTES AMINO ACIDS INJECTABLE;INJECTION 10% (10GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
007 RENAMIN W/O ELECTROLYTES AMINO ACIDS INJECTABLE;INJECTION 6.5% (6.5GM/100ML) No No None 1982/10/15 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1976/03/24 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2003/04/30 SUPPL-66（补充） Approval Labeling STANDARD
2003/01/17 SUPPL-67（补充） Approval Manufacturing (CMC)-Control STANDARD
2003/01/03 SUPPL-65（补充） Approval Labeling STANDARD
1999/04/05 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/03/31 SUPPL-64（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/30 SUPPL-52（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/09/30 SUPPL-60（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/05/19 SUPPL-61（补充） Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL-62（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/03/12 SUPPL-56（补充） Approval Labeling STANDARD
1993/03/12 SUPPL-53（补充） Approval Labeling STANDARD
1992/09/14 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/08/24 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1991/04/03 SUPPL-58（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/03/26 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/05/04 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/12/30 SUPPL-49（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/11/18 SUPPL-48（补充） Approval Labeling STANDARD
1987/07/25 SUPPL-47（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/09/20 SUPPL-46（补充） Approval Labeling STANDARD
1985/01/24 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/28 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/01/19 SUPPL-43（补充） Approval Labeling STANDARD
1983/01/19 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/10/15 SUPPL-33（补充） Approval Labeling STANDARD
1982/10/15 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/21 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
1982/04/06 SUPPL-37（补充） Approval Labeling STANDARD
1982/04/06 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/03/08 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/16 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/12/16 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/06/29 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/06/17 SUPPL-29（补充） Approval Labeling STANDARD
1981/06/17 SUPPL-28（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1980/07/31 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/03 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/11/28 SUPPL-20（补充） Approval Labeling STANDARD
1979/11/28 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/06/04 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/05/10 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/04/27 SUPPL-21（补充） Approval Labeling STANDARD
1978/08/29 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/07/28 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/07/28 SUPPL-17（补充） Approval Labeling STANDARD
1977/12/13 SUPPL-15（补充） Approval Labeling STANDARD
1977/12/07 SUPPL-6（补充） Approval Labeling STANDARD
1977/08/18 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/07/22 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1977/07/12 SUPPL-13（补充） Approval Labeling STANDARD
1977/07/12 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/04/01 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/04/01 SUPPL-7（补充） Approval Labeling STANDARD
1977/02/07 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/08 SUPPL-3（补充） Approval Labeling STANDARD
1976/08/24 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/07/19 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/06/28 SUPPL-4（补充） Approval Manufacturing (CMC)-Control 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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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