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 |
|---|
| 2022/01/27 |
ORIG-1（原始申请） |
Approval |
|
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 |
|---|
| 2025/08/06 |
SUPPL-4（补充） |
Approval |
Labeling-Package Insert |
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 | RLD | RS | TE 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 |