药品注册申请号：018902
申请类型：NDA (新药申请)
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 FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML No No AP 1984/05/22 1984/05/22 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
1984/05/22 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
2024/10/01 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2023/02/23 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2022/04/12 SUPPL-33（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2016/09/19 SUPPL-28（补充） Approval Labeling-Container/Carton Labels STANDARD Label is not available.
2016/03/08 SUPPL-27（补充） Approval Labeling-Package Insert STANDARD
2015/07/01 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2012/03/27 SUPPL-24（补充） Approval Labeling-Package Insert
2001/01/02 SUPPL-16（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1999/01/11 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1997/10/15 SUPPL-14（补充） Approval Labeling
1997/08/08 SUPPL-13（补充） Approval Labeling
1997/04/22 SUPPL-12（补充） Approval Labeling
1995/08/10 SUPPL-11（补充） Approval Labeling
1995/08/10 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1995/04/18 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1990/02/16 SUPPL-8（补充） Approval Labeling
1990/01/11 SUPPL-6（补充） Approval Labeling
1988/08/10 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1986/07/16 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1985/11/05 SUPPL-1（补充） Approval Manufacturing (CMC) 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:FUROSEMIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:10MG/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
018267 001 NDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP Approved Prior to Jan 1, 1982 HIKMA
018667 001 NDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 1982/05/28 HOSPIRA
018902 001 NDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 1984/05/22 FRESENIUS KABI USA
070017 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 1986/12/15 ACCORD HLTHCARE
075241 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 1999/05/28 HOSPIRA
077941 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2007/03/22 APOTEX
202747 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No Yes AP 2014/01/27 BAXTER HLTHCARE CORP
203428 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2014/08/26 AVET LIFESCIENCES
207552 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2016/07/20 AMNEAL PHARMS CO
212174 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/05/03 EUGIA PHARMA
213902 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2020/07/01 GLAND
208435 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2020/12/18 AREVA PHARMS
214766 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2021/01/27 SAGENT
212803 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2022/01/27 MEITHEAL
216860 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2022/12/16 MANKIND PHARMA
215856 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/04/02 SABA ILAC SANAYIVE
217557 001 ANDA FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/12/13 ASPIRO
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
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