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 |
2020/02/26 |
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
|
TRUPHARMA |
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 |
215100 |
001 |
ANDA |
AMINOCAPROIC ACID |
AMINOCAPROIC ACID |
SOLUTION;ORAL |
0.25GM/ML |
Prescription |
No |
No |
AA |
2024/09/26
|
MSN |