药品注册申请号：207523
申请类型：ANDA (仿制药申请)
申请人：SOMERSET
申请人全名：SOMERSET THERAPEUTICS 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE No No AT1 2019/06/25 2019/06/25 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/06/25 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/05/14 SUPPL-5（补充） Approval Labeling-Package Insert 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
无
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
无
与本品治疗等效的药品
>>>活性成分:DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE; 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC; 规格:EQ 2% BASE;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RLDRSTE Code产品号批准日期申请人
020869 001 NDA COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription Yes Yes AT1 1998/04/07 THEA PHARMA
077847 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Discontinued No No AT1 2008/10/28 HIKMA
078749 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2008/11/06 SANDOZ
090037 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2009/07/14 BAUSCH AND LOMB
078704 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Discontinued No No AT1 2009/09/28 TEVA PHARMS
090604 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2009/11/18 SANDOZ
202054 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2014/09/03 REGCON HOLDINGS
203058 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2014/09/22 EPIC PHARMA LLC
205295 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2019/06/13 FDC LTD
207523 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2019/06/25 SOMERSET
204777 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2020/05/28 MICRO LABS
213099 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2021/05/04 ALEMBIC
207629 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2021/05/14 EUGIA PHARMA
215520 001 ANDA DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE;EQ 0.5% BASE Prescription No No AT1 2022/09/19 GLAND
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药品NDC数据与药品包装、标签说明书
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