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 |
|---|
| 2022/06/24 |
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:TIMOLOL MALEATE 剂型/给药途径:SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 规格:EQ 0.25% BASE 治疗等效代码:AB
| 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 |
|---|
| 020330 |
001 |
NDA |
TIMOPTIC-XE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
Yes |
No |
AB |
1993/11/04
|
BAUSCH AND LOMB INC |
| 020963 |
001 |
NDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
Yes |
Yes |
AB |
1998/10/21
|
SANDOZ |
| 212942 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
Yes |
AB |
2020/10/22
|
ALEMBIC |
| 214645 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
GLAND PHARMA LTD |
| 215733 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AB |
2022/09/22
|
DR REDDYS |
| 216343 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Discontinued |
No |
No |
AB |
2024/05/23
|
AMNEAL |
| 210640 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AB |
2024/09/16
|
SOMERSET THERAPS LLC |
活性成分:TIMOLOL MALEATE 剂型/给药途径:SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 规格:EQ 0.5% BASE 治疗等效代码:AB
| 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 |
|---|
| 020330 |
002 |
NDA |
TIMOPTIC-XE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
Yes |
No |
AB |
1993/11/04
|
BAUSCH AND LOMB INC |
| 020963 |
002 |
NDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
Yes |
Yes |
AB |
1998/10/21
|
SANDOZ |
| 212942 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
Yes |
AB |
2020/10/22
|
ALEMBIC |
| 215733 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/09/22
|
DR REDDYS |
| 214645 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2023/02/14
|
GLAND PHARMA LTD |
| 213540 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
EUGIA PHARMA |
| 216343 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Discontinued |
No |
No |
AB |
2024/05/23
|
AMNEAL |
| 210640 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2024/09/16
|
SOMERSET THERAPS LLC |