药品注册申请号：019635
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 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Yes No AP 1988/03/09 1988/03/09 Prescription
002 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Yes Yes AP 1988/03/09 Prescription
003 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 3GM/100ML No No AP 1988/03/09 Prescription
004 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML No No AP 1988/03/09 Prescription
005 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE SOLUTION;INJECTION 90MG/10ML (9MG/ML) Yes No None 2016/08/08 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
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
2016/04/26 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2015/09/15 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2015/07/20 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
2015/04/07 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
2014/09/08 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
2004/02/04 SUPPL-23（补充） Approval Labeling
2004/02/04 SUPPL-22（补充） Approval Labeling
2003/06/13 SUPPL-21（补充） Approval Labeling
2002/07/01 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2002/04/15 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2000/12/07 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
2000/05/15 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1998/08/21 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1993/07/21 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1993/07/07 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1993/04/26 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1992/12/29 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1991/08/29 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1990/09/18 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1990/04/13 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1989/11/21 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1989/07/26 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1989/05/05 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1988/12/21 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1988/08/25 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1988/04/04 SUPPL-1（补充） Approval Labeling
1988/03/09 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）
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:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格: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
018016 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018090 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
019635 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription Yes No AP 1988/03/09 B BRAUN
019759 001 NDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription No No AP 1988/06/08 HOSPIRA
208122 001 ANDA SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 450MG/100ML Prescription No No AP 2018/07/23 FRESENIUS KABI USA
活性成分:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格: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
016366 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ICU MEDICAL INC
017464 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 B BRAUN
019480 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription Yes Yes AP 1985/09/17 HOSPIRA
019635 002 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription Yes Yes AP 1988/03/09 B BRAUN
076316 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription No No AP 2004/10/27 HAEMONETICS
078177 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription No No AP 2007/04/12 FRESENIUS MEDCL
207956 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription No No AP 2017/05/25 LABORATORIOS GRIFOLS
207310 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 900MG/100ML Prescription No No AP 2017/09/19 FRESENIUS KABI USA
活性成分:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:3GM/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
019022 001 NDA SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 3GM/100ML Prescription Yes Yes AP 1983/11/01 BAXTER HLTHCARE
019635 003 NDA SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 3GM/100ML Prescription No No AP 1988/03/09 B BRAUN
209476 001 ANDA SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 3GM/100ML Prescription No No AP 2019/03/13 FRESENIUS KABI USA
活性成分:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:5GM/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
019022 002 NDA SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML Prescription Yes No AP 1983/11/01 BAXTER HLTHCARE
019635 004 NDA SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 5GM/100ML Prescription No No AP 1988/03/09 B BRAUN
更多信息
药品NDC数据与药品包装、标签说明书
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