药品注册申请号：017521
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 DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1979/08/28 Approved Prior to Jan 1, 1982 Discontinued
002 DEXTROSE 40% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 DEXTROSE 30% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 DEXTROSE 20% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/03/26 Discontinued
006 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/03/26 Discontinued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
1979/08/28 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
2018/03/14 SUPPL-69（补充） Approval Labeling-Package Insert STANDARD
2016/03/23 SUPPL-72（补充） Approval Manufacturing (CMC) STANDARD
2016/01/15 SUPPL-71（补充） Approval Manufacturing (CMC) STANDARD
2015/02/03 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
2014/12/22 SUPPL-68（补充） Approval Labeling-Package Insert STANDARD
2002/11/14 SUPPL-63（补充） Approval Labeling STANDARD
2002/11/14 SUPPL-62（补充） Approval Labeling STANDARD
2001/08/14 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
2000/12/07 SUPPL-61（补充） Approval Efficacy-Labeling Change With Clinical Data STANDARD
1999/11/24 SUPPL-60（补充） Approval Manufacturing (CMC) STANDARD
1999/05/25 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
1998/06/22 SUPPL-58（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/04/29 SUPPL-57（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1995/01/05 SUPPL-50（补充） Approval Labeling
1995/01/05 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/09/30 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/02/18 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/07/13 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
1991/03/26 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/02/15 SUPPL-47（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/05/18 SUPPL-48（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/01/12 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/12/09 SUPPL-39（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/06/13 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/04/23 SUPPL-38（补充） Approval Labeling
1985/04/15 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/01/24 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/09/22 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/09/21 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/08/24 SUPPL-33（补充） Approval Labeling
1984/03/16 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/28 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/03 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/04/16 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/03/26 SUPPL-15（补充） Approval Labeling
1982/03/26 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/16 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/12/21 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/20 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/11/09 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/08/26 SUPPL-17（补充） Approval Labeling
1981/06/29 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/04/16 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/21 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/09 SUPPL-10（补充） Approval Labeling
1980/09/09 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/08/06 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/31 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/18 SUPPL-2（补充） Approval Labeling
1980/07/18 SUPPL-1（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/18 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/30 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/02/11 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
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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
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