药品注册申请号：017609
申请类型：NDA (新药申请)
申请人：OTSUKA ICU MEDCL
申请人全名：OTSUKA ICU MEDICAL 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 NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE INJECTABLE;INJECTION 5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML No No None 1975/08/13 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
1975/08/13 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
2013/09/05 SUPPL-127（补充） Approval Manufacturing (CMC) STANDARD
2000/06/20 SUPPL-107（补充） Approval Labeling STANDARD
2000/06/15 SUPPL-110（补充） Approval Labeling STANDARD
1998/10/29 SUPPL-109（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/06/11 SUPPL-108（补充） Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-103（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/27 SUPPL-102（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/06 SUPPL-106（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/03/04 SUPPL-105（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/08/18 SUPPL-104（补充） Approval Manufacturing (CMC) STANDARD
1992/01/28 SUPPL-98（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/09/10 SUPPL-97（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/08/30 SUPPL-99（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/02/22 SUPPL-94（补充） Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-95（补充） Approval Manufacturing (CMC) STANDARD
1989/06/22 SUPPL-67（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/07/30 SUPPL-91（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/11/26 SUPPL-90（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/08 SUPPL-89（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/31 SUPPL-88（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/31 SUPPL-85（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/11/29 SUPPL-71（补充） Approval Labeling
1985/11/29 SUPPL-70（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/29 SUPPL-69（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/10/26 SUPPL-82（补充） Approval Labeling
1985/10/26 SUPPL-78（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/09/26 SUPPL-73（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/06/10 SUPPL-87（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/14 SUPPL-84（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/03 SUPPL-81（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/11/28 SUPPL-68（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/11/16 SUPPL-80（补充） Approval Labeling
1984/11/16 SUPPL-79（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/11/09 SUPPL-77（补充） Approval Manufacturing (CMC) STANDARD
1984/10/22 SUPPL-74（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/17 SUPPL-64（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/10 SUPPL-59（补充） Approval Labeling
1984/10/10 SUPPL-58（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/04/09 SUPPL-66（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/21 SUPPL-63（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/01 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/17 SUPPL-60（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/12/08 SUPPL-61（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/10/25 SUPPL-65（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1983/10/17 SUPPL-62（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/02/15 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/08 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/08 SUPPL-47（补充） Approval Labeling
1982/06/18 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/09 SUPPL-50（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/02/01 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/01/08 SUPPL-51（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/10/07 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/03/02 SUPPL-48（补充） Approval Labeling
1981/03/02 SUPPL-45（补充） Approval Labeling
1981/03/02 SUPPL-44（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/07 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/10/31 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/15 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/06/10 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/04/08 SUPPL-40（补充） Approval Labeling
1980/01/22 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/12/03 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/12/03 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/11/29 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/11/27 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/10/10 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/07/17 SUPPL-33（补充） Approval Labeling
1979/03/29 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/02/06 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/02/01 SUPPL-31（补充） Approval STANDARD
1979/01/05 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/12/29 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/11/22 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/11/22 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/11/08 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/10/11 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/15 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/08/02 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/06/26 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/06/14 SUPPL-15（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1978/06/14 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/05/01 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/03/30 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/03/15 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/02/08 SUPPL-18（补充） Approval Labeling
1978/01/23 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/09/28 SUPPL-13（补充） Approval Labeling
1977/05/20 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/04/29 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1976/11/24 SUPPL-9（补充） Approval Labeling
1976/11/08 SUPPL-5（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1976/03/17 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/11/20 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/11/03 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/10/17 SUPPL-4（补充） Approval Labeling
1975/10/15 SUPPL-1（补充） Approval Manufacturing (CMC)-Control 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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database