药品注册申请号:018897
申请类型:NDA (新药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 14.6% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/07/20 1984/07/20 Discontinued
002 SODIUM CHLORIDE 14.6% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 100MEQ/40ML (2.5MEQ/ML) Yes Yes AP 1984/07/20 Prescription
003 SODIUM CHLORIDE 23.4% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) Yes Yes AP 2020/06/18 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
2020/06/18 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2014/06/12 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2014/02/12 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
2002/03/14 SUPPL-16(补充) Approval Labeling STANDARD
2001/06/07 SUPPL-11(补充) Approval Labeling STANDARD
2001/02/16 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2000/02/09 SUPPL-13(补充) Approval Labeling STANDARD
1999/08/31 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1999/01/13 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1997/01/17 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1992/04/08 SUPPL-7(补充) Approval Labeling
1988/10/21 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1987/12/11 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1986/09/04 SUPPL-3(补充) Approval Labeling
1986/09/04 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1986/07/25 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/07/20 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
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:SOLUTION;INTRAVENOUS 规格:100MEQ/40ML (2.5MEQ/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
018897 002 NDA SODIUM CHLORIDE 14.6% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 100MEQ/40ML (2.5MEQ/ML) Prescription Yes Yes AP 1984/07/20 HOSPIRA
212070 002 ANDA SODIUM CHLORIDE 14.6% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 100MEQ/40ML (2.5MEQ/ML) Prescription No No AP 2021/04/28 FRESENIUS KABI USA
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:400MEQ/100ML (4MEQ/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
018897 003 NDA SODIUM CHLORIDE 23.4% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) Prescription Yes Yes AP 2020/06/18 HOSPIRA
212070 003 ANDA SODIUM CHLORIDE 23.4% SODIUM CHLORIDE SOLUTION;INTRAVENOUS 400MEQ/100ML (4MEQ/ML) Prescription No No AP 2022/02/14 FRESENIUS KABI USA
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