药品注册申请号：018569
申请类型：NDA (新药申请)
申请人：EPIC PHARMA LLC
申请人全名：EPIC PHARMA 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 TABLET;ORAL 40MG No No AB 1981/10/19 Approved Prior to Jan 1, 1982 Prescription
002 FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG No No AB Approved Prior to Jan 1, 1982 Prescription
005 FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG No No AB 1984/08/14 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
2020/12/22 SUPPL-66（补充） Approval Labeling STANDARD
2016/10/07 SUPPL-63（补充） Approval Labeling STANDARD
2015/06/05 SUPPL-62（补充） Approval Manufacturing (CMC) STANDARD
2012/10/04 SUPPL-61（补充） Approval Labeling STANDARD
2007/11/28 SUPPL-58（补充） Approval Labeling
2002/12/16 SUPPL-52（补充） Approval Manufacturing (CMC) STANDARD
2002/04/19 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
2001/06/14 SUPPL-50（补充） Approval Manufacturing (CMC) STANDARD
2001/06/14 SUPPL-49（补充） Approval Manufacturing (CMC) STANDARD
2000/11/20 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
2000/02/03 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1999/05/05 SUPPL-45（补充） Approval Manufacturing (CMC) STANDARD
1997/09/15 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1996/11/08 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1995/02/08 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
1994/04/13 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
1993/03/30 SUPPL-40（补充） Approval Labeling
1992/07/24 SUPPL-39（补充） Approval Labeling
1989/10/19 SUPPL-38（补充） Approval Labeling
1989/05/17 SUPPL-37（补充） Approval Labeling
1988/12/06 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1988/12/06 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1988/12/06 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
1988/08/25 SUPPL-36（补充） Approval Labeling
1987/11/17 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1987/11/17 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1987/11/17 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1987/11/17 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1987/11/17 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1987/11/17 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1986/02/26 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1985/02/27 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1981/10/19 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
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:TABLET;ORAL 规格:40MG 治疗等效代码:AB
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
016273 001 NDA LASIX FUROSEMIDE TABLET;ORAL 40MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018487 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
018569 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB Approved Prior to Jan 1, 1982 EPIC PHARMA LLC
018823 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 1983/11/10 HIKMA
076796 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2005/11/09 LEADING
078010 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
活性成分:FUROSEMIDE 剂型/给药途径:TABLET;ORAL 规格:20MG 治疗等效代码:AB
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
016273 002 NDA LASIX FUROSEMIDE TABLET;ORAL 20MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018487 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
018569 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB Approved Prior to Jan 1, 1982 EPIC PHARMA LLC
018823 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 1983/11/10 HIKMA
076796 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2005/11/09 LEADING
078010 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
活性成分:FUROSEMIDE 剂型/给药途径:TABLET;ORAL 规格:80MG 治疗等效代码:AB
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
016273 003 NDA LASIX FUROSEMIDE TABLET;ORAL 80MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018569 005 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1984/08/14 EPIC PHARMA LLC
070086 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1986/01/24 HIKMA
070082 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1986/10/29 MYLAN
076796 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2005/11/09 LEADING
078010 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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