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 |
|---|
| 2020/04/02 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/09/22 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/03/11 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/09/07 |
SUPPL-6（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2010/08/31 |
SUPPL-1（补充） |
Approval |
Efficacy |
UNKNOWN
|
|
|
| 2006/09/21 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
活性成分:TRAVOPROST 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.004% 治疗等效代码:AT
| 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 |
|---|
| 021994 |
001 |
NDA |
TRAVATAN Z |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
Yes |
Yes |
AT |
2006/09/21
|
SANDOZ |
| 203431 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
No |
No |
AT |
2015/07/10
|
APOTEX |
| 205050 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
No |
No |
AT |
2017/07/07
|
MYLAN |
| 203767 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
No |
No |
AT |
2021/03/19
|
MICRO LABS |
| 207040 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Discontinued |
No |
No |
AT |
2024/05/03
|
LUPIN LTD |
| 218159 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
No |
No |
AT |
2024/07/12
|
GLAND PHARMA LTD |
| 217228 |
001 |
ANDA |
TRAVOPROST |
TRAVOPROST |
SOLUTION/DROPS;OPHTHALMIC |
0.004% |
Prescription |
No |
No |
AT |
2024/09/23
|
SOMERSET THERAPS LLC |
