药品注册申请号:018314
申请类型:NDA (新药申请)
申请人:ICU MEDICAL INC
申请人全名:ICU 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 No No AT 1980/02/22 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
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
2011/02/07 SUPPL-62(补充) Approval Labeling
2004/08/06 SUPPL-53(补充) Approval Labeling
1997/08/21 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1997/03/28 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1996/10/22 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1996/08/27 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1995/08/14 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1991/09/10 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1991/08/30 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1990/02/22 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1989/02/06 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1986/11/26 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1986/08/08 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1986/02/25 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1986/02/22 SUPPL-28(补充) Approval Labeling
1986/02/22 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1985/10/29 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1985/09/26 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1984/10/17 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1984/09/22 SUPPL-15(补充) Approval Labeling
1984/09/22 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1984/03/21 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1984/03/01 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1984/02/17 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1984/02/01 SUPPL-20(补充) Approval Labeling
1982/08/31 SUPPL-7(补充) Approval Labeling
1982/07/26 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1982/06/09 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1982/02/01 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1982/01/08 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1981/09/16 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1980/09/15 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1980/07/03 SUPPL-2(补充) Approval Labeling
1980/07/03 SUPPL-1(补充) Approval Labeling
1980/06/10 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1980/06/06 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1980/05/28 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/02/22 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;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 ICU MEDICAL INC
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 ICU MEDICAL INC
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
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