药品注册申请号:019634
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% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML No No None 1988/02/24 1988/02/24 Prescription
002 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML No No None 1988/02/24 Discontinued
003 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML No No AP 1988/02/24 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2014/08/22 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2013/02/13 SUPPL 33 Approval Labeling STANDARD
2004/09/27 SUPPL 21 Approval Labeling STANDARD
2002/07/23 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2002/03/08 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2001/03/12 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2000/04/11 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1999/05/04 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1998/09/25 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1993/07/21 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1993/04/26 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1992/12/29 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1991/08/29 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1990/09/18 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1990/04/13 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1989/11/21 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1989/05/05 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1988/12/21 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1988/03/25 SUPPL 1 Approval Labeling
1988/02/24 ORIG 1 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)
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
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
活性成分:CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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
016679 001 NDA LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription No No AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017608 001 NDA DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription Yes No AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019634 003 NDA DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE INJECTABLE;INJECTION 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML Prescription No No AP 1988/02/24 B BRAUN
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