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 |
|---|
| 2023/04/18 |
ORIG-1（原始申请） |
Approval |
|
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:ACETAMINOPHEN 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:1GM/100ML (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 |
|---|
| 204052 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
Yes |
AP |
2016/03/22
|
SANDOZ |
| 202605 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2016/06/13
|
HIKMA |
| 213255 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2020/08/07
|
MYLAN |
| 210969 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2020/10/21
|
EUGIA PHARMA |
| 214331 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2021/09/17
|
BAXTER HLTHCARE CORP |
| 216617 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2022/07/27
|
ASPIRO |
| 216467 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Discontinued |
No |
No |
AP |
2022/10/25
|
ZYDUS PHARMS |
| 205746 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/04/18
|
WOCKHARDT BIO AG |
| 215403 |
001 |
ANDA |
ACETAMINOPHEN |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/05/03
|
INFORLIFE |