药品注册申请号：018233
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 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Yes Yes AP 1980/02/18 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
1980/02/18 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-80（补充） Approval Manufacturing (CMC) STANDARD
2007/11/02 SUPPL-68（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2005/01/19 SUPPL-63（补充） Approval Labeling STANDARD
2003/01/24 SUPPL-62（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/10/15 SUPPL-61（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
2000/06/14 SUPPL-57（补充） Approval Labeling STANDARD
1999/06/04 SUPPL-60（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/10/29 SUPPL-59（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/06/11 SUPPL-58（补充） Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/27 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/08/06 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/03/04 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/08/14 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/01/28 SUPPL-48（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/09/10 SUPPL-47（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/08/30 SUPPL-49（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/02/22 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1990/01/11 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1987/07/30 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/11/26 SUPPL-40（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/08 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/01/31 SUPPL-36（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/11/29 SUPPL-26（补充） Approval Labeling
1985/11/29 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/10/29 SUPPL-24（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/10/26 SUPPL-34（补充） Approval Labeling
1985/10/26 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/09/26 SUPPL-28（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/06/10 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/03 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/22 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/17 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/10/10 SUPPL-18（补充） Approval Labeling
1984/10/10 SUPPL-17（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/04/09 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/21 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/03/01 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/12/08 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/11/07 SUPPL-22（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1983/02/15 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1982/07/26 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/07/08 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/06/09 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/03/12 SUPPL-8（补充） Approval Labeling
1982/01/08 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/10/07 SUPPL-10（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/03/02 SUPPL-9（补充） Approval Labeling
1981/03/02 SUPPL-7（补充） Approval Labeling
1981/03/02 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/07 SUPPL-5（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/15 SUPPL-4（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/28 SUPPL-3（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/23 SUPPL-2（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/05/14 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
>>>活性成分:STERILE WATER FOR INJECTION; 剂型/给药途径:LIQUID;N/A; 规格:100%; 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
018233 001 NDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 OTSUKA ICU MEDCL
018632 001 NDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP 1982/06/30 BAXTER HLTHCARE
018802 001 NDA BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP 1982/10/27 HOSPIRA
088400 001 ANDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription No No AP 1984/01/16 FRESENIUS KABI USA
019633 001 NDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP 1988/02/29 B BRAUN
018632 002 NDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP 1988/04/19 BAXTER HLTHCARE
019869 001 NDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription Yes Yes AP 1989/12/26 OTSUKA ICU MEDCL
077393 001 ANDA STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION LIQUID;N/A 100% Discontinued No No AP 2006/08/11 TARO
209689 001 ANDA STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription No No AP 2017/11/24 FRESENIUS KABI USA
212735 001 ANDA STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION LIQUID;N/A 100% Prescription No No AP 2023/01/31 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
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