药品注册申请号：016733
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 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Yes Yes AT 1970/08/12 Approved Prior to Jan 1, 1982 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
1970/08/12 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
2015/03/30 SUPPL-54（补充） Approval Manufacturing (CMC) STANDARD
2014/05/23 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
2013/05/08 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
2013/04/19 SUPPL-53（补充） Approval Manufacturing (CMC) STANDARD
2006/10/20 SUPPL-49（补充） Approval Labeling STANDARD
2002/07/08 SUPPL-47（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/04/03 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/04/12 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/03/25 SUPPL-44（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/09/11 SUPPL-43（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1988/04/19 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/03/05 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/10 SUPPL-39（补充） Approval Labeling
1985/05/24 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/17 SUPPL-35（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/04/15 SUPPL-38（补充） Approval Labeling
1985/04/03 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/03/12 SUPPL-30（补充） Approval Labeling
1981/11/06 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1981/10/27 SUPPL-27（补充） Approval Labeling
1981/10/27 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/09/28 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/09/24 SUPPL-32（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1981/03/18 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/07/16 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/02/15 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/01/04 SUPPL-20（补充） Approval Labeling
1979/09/25 SUPPL-23（补充） Approval Labeling
1979/09/24 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/08/06 SUPPL-21（补充） Approval Labeling
1979/04/26 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/12/27 SUPPL-15（补充） Approval Labeling
1978/12/27 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/10/27 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/10/27 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/04 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/05/26 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/03/30 SUPPL-11（补充） Approval Labeling
1978/03/15 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1978/02/14 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/06/28 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/02/04 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/10/20 SUPPL-7（补充） Approval Labeling
1976/04/02 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/04/02 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/04/02 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1974/08/30 SUPPL-3（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:SODIUM CHLORIDE; 剂型/给药途径:SOLUTION;IRRIGATION; 规格:900MG/100ML; 治疗等效代码:AT<<<
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
016733 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription Yes Yes AT Approved Prior to Jan 1, 1982 B BRAUN
017427 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription No No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
017514 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription Yes No AT Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL
017867 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription No No AT Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018314 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription No No AT Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL
213688 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE SOLUTION;IRRIGATION 900MG/100ML Prescription No No AT 2024/06/24 FRESENIUS KABI USA
更多信息
药品NDC数据与药品包装、标签说明书
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