药品注册申请号：019631
申请类型：NDA (新药申请)
申请人：B BRAUN
申请人全名：B BRAUN MEDICAL 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 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;110MG/100ML No No None 1988/02/24 1988/02/24 Prescription
002 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;200MG/100ML No No None 1988/02/24 Prescription
003 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;330MG/100ML No No None 1988/02/24 Prescription
004 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML No No AP 1988/02/24 Prescription
005 DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;900MG/100ML No No None 1988/02/24 Prescription
006 DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;110MG/100ML No No None 1988/02/24 Prescription
007 DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;200MG/100ML No No AP 1988/02/24 Prescription
008 DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;330MG/100ML No No AP 1988/02/24 Prescription
009 DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML No No AP 1988/02/24 Prescription
010 DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML No No AP 1988/02/24 Prescription
011 DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;110MG/100ML No No None 1988/02/24 Prescription
012 DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;200MG/100ML No No None 1988/02/24 Prescription
013 DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;330MG/100ML No No None 1988/02/24 Prescription
014 DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;450MG/100ML No No None 1988/02/24 Prescription
015 DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 10GM/100ML;900MG/100ML No No None 1988/02/24 Prescription
016 DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 3.3GM/100ML;300MG/100ML No No None 1990/01/19 Prescription
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
1988/02/24 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
2014/08/22 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
2014/01/24 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
2004/09/27 SUPPL-23（补充） Approval Labeling STANDARD
2002/07/23 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/03/08 SUPPL-20（补充） Approval Manufacturing (CMC)-Packaging STANDARD
2001/03/12 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/04/11 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/09/25 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/03/17 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/12/19 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/07/21 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/12/29 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1991/08/29 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/09/18 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/04/13 SUPPL-8（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/01/19 SUPPL-9（补充） Approval Labeling
1990/01/19 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/11/21 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/07/26 SUPPL-7（补充） Approval Manufacturing (CMC)-Control STANDARD
1989/05/05 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/12/21 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1988/08/25 SUPPL-2（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1988/03/25 SUPPL-1（补充） Approval Labeling
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
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
>>>活性成分:DEXTROSE; SODIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:2.5GM/100ML;450MG/100ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016697 001 NDA DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019631 004 NDA DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML Prescription No No AP 1988/02/24 B BRAUN
211190 001 ANDA DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 2.5GM/100ML;450MG/100ML Prescription No No AP 2019/12/20 FRESENIUS KABI USA
>>>活性成分:DEXTROSE; SODIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;200MG/100ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016689 001 NDA DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;200MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019631 007 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;200MG/100ML Prescription No No AP 1988/02/24 B BRAUN
>>>活性成分:DEXTROSE; SODIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;330MG/100ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016687 001 NDA DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;330MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
019631 008 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;330MG/100ML Prescription No No AP 1988/02/24 B BRAUN
>>>活性成分:DEXTROSE; SODIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;450MG/100ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016683 001 NDA DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017607 001 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL
019631 009 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML Prescription No No AP 1988/02/24 B BRAUN
211276 001 ANDA DEXTROSE 5% AND SODIUM CHLORIDE 0.45% DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;450MG/100ML Prescription No No AP 2020/09/15 FRESENIUS KABI USA
>>>活性成分:DEXTROSE; SODIUM CHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:5GM/100ML;900MG/100ML; 治疗等效代码:AP<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016678 001 NDA DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017585 001 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL
019631 010 NDA DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML Prescription No No AP 1988/02/24 B BRAUN
211211 001 ANDA DEXTROSE 5% AND SODIUM CHLORIDE 0.9% DEXTROSE; SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML;900MG/100ML Prescription No No AP 2020/09/14 FRESENIUS KABI USA
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