药品注册申请号:216533
申请类型:ANDA (仿制药申请)
申请人:INGENUS PHARMS LLC
申请人全名:INGENUS PHARMACEUTICALS LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE No No AT3 2022/09/13 2022/09/13 Prescription
002 TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE No No AT3 2022/09/13 Prescription
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
2022/09/13 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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:AT3
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RLDRSTE Code产品号批准日期申请人
019463 001 NDA TIMOPTIC IN OCUDOSE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription Yes Yes AT3 1986/11/05 BAUSCH AND LOMB INC
212592 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT3 2021/12/13 AMRING PHARMS
216533 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT3 2022/09/13 INGENUS PHARMS LLC
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:AT3
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RLDRSTE Code产品号批准日期申请人
019463 002 NDA TIMOPTIC IN OCUDOSE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription Yes Yes AT3 1986/11/05 BAUSCH AND LOMB INC
212291 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT3 2020/09/11 EPIC PHARMA LLC
212592 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT3 2021/12/13 AMRING PHARMS
216596 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT3 2022/09/07 MICRO LABS
216533 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT3 2022/09/13 INGENUS PHARMS LLC
217195 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT3 2023/05/08 SENTISS PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database