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 |
2021/11/17 |
SUPPL-80(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/09 |
SUPPL-76(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/09/30 |
SUPPL-75(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/04/26 |
SUPPL-72(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/04/26 |
SUPPL-70(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/12/22 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/12/06 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/04/29 |
SUPPL-58(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/04/17 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/12/05 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/11/30 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/04/12 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/09/18 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/04/22 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/03/18 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/08/05 |
SUPPL-51(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/05/16 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/12/02 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/07/18 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/04/16 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/04/25 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/02/24 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/02/24 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1993/12/09 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/05/20 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1992/05/20 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1992/05/20 |
SUPPL-35(补充) |
Approval |
Labeling |
|
|
|
1990/03/19 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/01/15 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1987/08/04 |
SUPPL-33(补充) |
Approval |
Labeling |
|
|
|
1987/08/04 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1987/08/04 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1987/08/04 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1987/06/05 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/11/28 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/02/27 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
1986/02/12 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/11/29 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/06/14 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/09/07 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/06/30 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/11/03 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1981/10/27 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/10/09 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/10/09 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1981/07/15 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1981/03/31 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1980/06/20 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/05/21 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1980/05/13 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1980/02/11 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1980/01/08 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1980/01/02 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1979/12/03 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1979/07/20 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1979/04/06 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1978/08/17 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 0.25% 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 |
001 |
NDA |
TIMOPTIC |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
Yes |
No |
AT1 |
Approved Prior to Jan 1, 1982
|
BAUSCH AND LOMB INC |
074261 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
Yes |
AT1 |
1995/04/28
|
SANDOZ |
074746 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AT1 |
1997/03/25
|
PACIFIC PHARMA |
074778 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Discontinued |
No |
No |
AT1 |
1997/03/25
|
BAUSCH AND LOMB |
077259 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AT1 |
2008/04/30
|
FDC LTD |
078771 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AT1 |
2009/09/28
|
MANKIND PHARMA |
217343 |
001 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AT1 |
2023/05/26
|
MICRO LABS |
217764 |
002 |
ANDA |
TIMOLOL MALEATE |
TIMOLOL MALEATE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.25% BASE |
Prescription |
No |
No |
AT1 |
2024/07/03
|
SOMERSET |
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 |