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 |
|---|
| 2020/01/14 |
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 |
|---|
| 2021/11/09 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/11/09 |
SUPPL-1（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:TRANEXAMIC ACID; 剂型/给药途径:INJECTABLE;INJECTION; 规格:100MG/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 |
|---|
| 019281 |
001 |
NDA |
CYKLOKAPRON |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
Yes |
Yes |
AP |
1986/12/30
|
PFIZER |
| 201885 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2011/08/10
|
AM REGENT |
| 091657 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2011/11/03
|
MYLAN INSTITUTIONAL |
| 202373 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2011/11/17
|
EPIC PHARMA LLC |
| 091596 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Discontinued |
No |
No |
AP |
2012/03/02
|
FRESENIUS KABI USA |
| 201580 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2013/06/14
|
XGEN PHARMS |
| 202436 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2014/02/11
|
HERITAGE |
| 203521 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2014/08/12
|
AVET LIFESCIENCES |
| 205035 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2016/01/14
|
EUGIA PHARMA |
| 206634 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Discontinued |
No |
No |
AP |
2016/06/09
|
RISING |
| 207239 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2017/02/13
|
GLAND |
| 208840 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2017/02/28
|
AMNEAL PHARMS CO |
| 206713 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2017/06/27
|
MICRO LABS |
| 206594 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Discontinued |
No |
No |
AP |
2017/09/28
|
EPIC PHARMA LLC |
| 212360 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2019/07/17
|
CAPLIN |
| 212676 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2019/07/17
|
MILLA PHARMS |
| 209860 |
001 |
ANDA |
TRANEXAMIC ACID |
TRANEXAMIC ACID |
INJECTABLE;INJECTION |
100MG/ML |
Prescription |
No |
No |
AP |
2020/01/14
|
APOTEX |