药品注册申请号:088911
申请类型:ANDA (仿制药申请)
申请人:FRESENIUS KABI USA
申请人全名:FRESENIUS KABI USA LLC
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 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML No No AP 1985/02/07 1985/02/07 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
2007/05/21 SUPPL 14 Approval Manufacturing (CMC)
2001/06/20 SUPPL 9 Approval Manufacturing (CMC)
1999/01/08 SUPPL 10 Approval Manufacturing (CMC)
1993/01/13 SUPPL 11 Approval Labeling
1987/04/30 SUPPL 7 Approval Manufacturing (CMC)
1986/10/31 SUPPL 5 Approval Manufacturing (CMC)
1985/05/17 SUPPL 3 Approval Manufacturing (CMC)
1985/05/17 SUPPL 1 Approval Manufacturing (CMC)
1985/02/07 ORIG 1 Approval
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:SODIUM CHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:9MG/ML 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
018800 001 NDA BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription Yes Yes AP 1982/10/29 HOSPIRA
018803 001 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription Yes Yes AP 1982/10/29 HOSPIRA
088912 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No Yes AP 1985/01/10 FRESENIUS KABI USA
088911 001 ANDA BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No No AP 1985/02/07 FRESENIUS KABI USA
019465 002 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription Yes No AP 1985/07/15 HOSPIRA
016677 004 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription Yes Yes AP 1985/10/30 BAXTER HLTHCARE
020178 002 NDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription Yes No AP 1992/12/07 BAXTER HLTHCARE
077407 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No Yes AP 2006/08/11 TARO
201850 001 ANDA SODIUM CHLORIDE 0.9% SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No No AP 2012/01/20 WEST-WARD PHARMS INT
203352 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No No AP 2016/05/18 JUBILANT CADISTA
206171 001 ANDA SODIUM CHLORIDE 0.9% SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No No AP 2017/07/21 SPECTRA MDCL DEVICES
211968 001 ANDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE INJECTABLE;INJECTION 9MG/ML Prescription No No AP 2020/04/23 NEPHRON
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