药品注册申请号：202867
申请类型：ANDA (仿制药申请)
申请人：LUPIN LTD
申请人全名：LUPIN 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 MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE No No AT1 2014/09/04 2014/09/04 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
2014/09/04 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
2021/10/28 SUPPL-8（补充） Approval Labeling-Package Insert STANDARD
2021/10/28 SUPPL-1（补充） Approval Labeling-Container/Carton Labels,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:MOXIFLOXACIN HYDROCHLORIDE; 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RLDRSTE Code产品号批准日期申请人
021598 001 NDA VIGAMOX MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription Yes Yes AT1 2003/04/15 HARROW EYE
202867 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2014/09/04 LUPIN LTD
202525 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2015/03/06 REGCON HOLDINGS
090080 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2017/06/30 APOTEX
206242 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2017/10/04 EUGIA PHARMA
202916 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 2017/11/09 EPIC PHARMA LLC
209469 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2019/02/13 ALEMBIC
206447 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 2020/03/30 PHARMOBEDIENT
208778 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2020/03/30 GLAND
212616 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2021/02/10 UPSHER SMITH LABS
209698 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2024/11/14 SOMERSET THERAPS LLC
217988 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2025/01/27 MANKIND PHARMA
219475 001 ANDA MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2025/08/04 FDC LTD
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药品NDC数据与药品包装、标签说明书
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