药品注册申请号：078395
申请类型：ANDA (仿制药申请)
申请人：RUBICON RESEARCH
申请人全名：RUBICON RESEARCH LTD
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 DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE No No AT 2008/10/28 2008/10/28 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
2008/10/28 ORIG-1（原始申请） Approval
>>>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
2021/12/03 SUPPL-10（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2015/11/27 SUPPL-8（补充） Approval Labeling-Package Insert STANDARD
2011/01/28 SUPPL-4（补充） Approval Labeling-Package Insert
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; 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC; 规格:EQ 2% BASE; 治疗等效代码:AT<<<
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
077846 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Discontinued No No AT 2008/10/28 HIKMA
078395 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2008/10/28 RUBICON RESEARCH
078748 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2008/11/06 SANDOZ
078981 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2009/04/13 SANDOZ
090143 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2009/06/25 BAUSCH AND LOMB
202053 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2014/09/11 REGCON HOLDINGS
205294 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2019/01/24 FDC LTD
212639 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2019/08/09 ALEMBIC
204778 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No Yes AT 2019/11/08 MICRO LABS
215660 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2022/01/27 GLAND
215004 001 ANDA DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE Prescription No No AT 2025/02/11 SOMERSET THERAPS LLC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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