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 |
|---|
| 2016/05/12 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/05/12 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2007/06/29 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2005/11/09 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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 |
|---|
| 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: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 |
|---|
| 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: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 | RLD | RS | TE 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 |