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 |
|---|
| 2022/04/04 |
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:BRIMONIDINE TARTRATE; TIMOLOL MALEATE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.2%;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 |
|---|
| 021398 |
001 |
NDA |
COMBIGAN |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
Yes |
Yes |
AB |
2007/10/30
|
ABBVIE |
| 091087 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/04/04
|
SANDOZ |
| 091442 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/04/20
|
APOTEX |
| 201949 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/10/04
|
FLORIDA |
| 091086 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/10/31
|
SENTISS |
| 215598 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2022/12/12
|
UPSHER SMITH LABS |
| 215230 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2023/08/25
|
ALEMBIC |
| 214987 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2024/05/16
|
GLENMARK PHARMS LTD |
| 216114 |
001 |
ANDA |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
0.2%;EQ 0.5% BASE |
Prescription |
No |
No |
AB |
2024/09/10
|
SOMERSET |
