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 |
|---|
| 1983/11/10 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2017/07/14 |
SUPPL-44（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/05/10 |
SUPPL-42（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2011/01/26 |
SUPPL-40（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2009/05/04 |
SUPPL-39（补充） |
Approval |
Labeling |
|
|
|
| 2007/03/28 |
SUPPL-38（补充） |
Approval |
Labeling |
|
|
|
| 2002/09/20 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 2002/05/23 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2002/04/29 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 2002/04/29 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2002/04/29 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC)-Manufacturing Process |
|
|
|
| 2001/08/30 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2001/08/30 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/09/10 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/04/22 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 1996/08/28 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/06/23 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1992/08/28 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 1991/08/05 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/08/05 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/03/28 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/12/04 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1990/02/23 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/12/28 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1989/05/01 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1988/11/14 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/11/14 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/03/29 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/03/14 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/02/03 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/02/03 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/02/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/10/09 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/10/01 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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 |
与本品治疗等效的药品
>>>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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 018487 |
001 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
20MG |
Discontinued |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
PHARMOBEDIENT |
| 018569 |
002 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
EPIC PHARMA LLC |
| 016273 |
002 |
NDA |
LASIX |
FUROSEMIDE |
TABLET;ORAL |
20MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALIDUS PHARMS |
| 018415 |
001 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
1982/07/27
|
ESJAY PHARMA |
| 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 |
| 218831 |
001 |
ANDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
20MG |
Prescription |
No |
No |
AB |
2025/07/17
|
AUROBINDO PHARMA LTD |
>>>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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 018487 |
002 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
40MG |
Discontinued |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
PHARMOBEDIENT |
| 018569 |
001 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
EPIC PHARMA LLC |
| 016273 |
001 |
NDA |
LASIX |
FUROSEMIDE |
TABLET;ORAL |
40MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
VALIDUS PHARMS |
| 018415 |
002 |
NDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
1982/07/27
|
ESJAY PHARMA |
| 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 |
| 218831 |
002 |
ANDA |
FUROSEMIDE |
FUROSEMIDE |
TABLET;ORAL |
40MG |
Prescription |
No |
No |
AB |
2025/07/17
|
AUROBINDO PHARMA LTD |
