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 |
|---|
| 2019/08/23 |
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:AMINOCAPROIC ACID 剂型/给药途径:SOLUTION;ORAL 规格:0.25GM/ML 治疗等效代码:AA
| 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 |
|---|
| 015230 |
002 |
NDA |
AMICAR |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Discontinued |
Yes |
No |
AA |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 212780 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2019/08/23
|
AMNEAL |
| 212814 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Discontinued |
No |
No |
AA |
2020/02/26
|
VISTAPHARM LLC |
| 212494 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
Yes |
AA |
2020/08/11
|
TULEX PHARMS INC |
| 214140 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2021/01/26
|
CARNEGIE |
| 213825 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2021/04/08
|
BELCHER |
| 215510 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2022/03/23
|
FLORIDA |
| 216804 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2022/09/26
|
AUROBINDO PHARMA |
| 216464 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2022/11/04
|
ANNORA PHARMA |
| 214458 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2023/03/24
|
TARO |
| 213213 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2023/12/27
|
SUNNY |
