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 |
2015/10/15 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/10/11 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/10/30 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
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: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 |