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 |
|---|
| 2002/12/09 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/22 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2001/11/27 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/07 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/05 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/06/27 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/05/18 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/05/15 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/04/28 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/08/24 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1999/06/07 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/01/13 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1998/06/25 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1998/03/27 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/03/06 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/01/29 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/03/25 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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/DROPS;OPHTHALMIC 规格:EQ 0.5% BASE 治疗等效代码:AT1
| 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 |
|---|
| 018086 |
002 |
NDA |
TIMOPTIC |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
Yes |
No |
AT1 |
Approved Prior to Jan 1, 1982
|
BAUSCH AND LOMB INC |
| 074262 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
Yes |
AT1 |
1995/04/28
|
SANDOZ |
| 074466 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Discontinued |
No |
No |
AT1 |
1997/03/25
|
SCIEGEN PHARMS INC |
| 074516 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Discontinued |
No |
No |
AT1 |
1997/03/25
|
EPIC PHARMA LLC |
| 074747 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
1997/03/25
|
PACIFIC PHARMA |
| 074776 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Discontinued |
No |
No |
AT1 |
1997/03/25
|
BAUSCH AND LOMB |
| 075163 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Discontinued |
No |
No |
AT1 |
2002/09/10
|
HIKMA |
| 077259 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
2008/04/30
|
FDC LTD |
| 078771 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
2009/09/28
|
MANKIND PHARMA |
| 217343 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
2023/05/26
|
MICRO LABS |
| 217764 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
2024/07/03
|
SOMERSET |
| 218460 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.5% BASE |
Prescription |
No |
No |
AT1 |
2024/08/07
|
CAPLIN |