药品注册申请号：076407
申请类型：ANDA (仿制药申请)
申请人：SENTISS
申请人全名：SENTISS AG
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 OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% No No AT 2008/04/15 2008/04/15 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
2020/07/15 SUPPL-3（补充） Approval Labeling STANDARD
2008/04/15 ORIG-1（原始申请） Approval
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:OFLOXACIN 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.3% 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
019921 001 NDA OCUFLOX OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription Yes Yes AT 1993/07/30 ALLERGAN
076513 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2004/05/14 APOTEX INC
076615 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Discontinued No No AT 2004/05/14 EPIC PHARMA LLC
076622 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2004/05/14 BAUSCH AND LOMB
076407 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2008/04/15 SENTISS
078559 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2009/02/25 FDC LTD
202692 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2013/04/29 ALTAIRE PHARMS INC
215886 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2022/11/23 MANKIND PHARMA
211524 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2024/03/01 AMNEAL
217904 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2024/04/12 CAPLIN
213597 001 ANDA OFLOXACIN OFLOXACIN SOLUTION/DROPS;OPHTHALMIC 0.3% Prescription No No AT 2024/08/01 SOMERSET
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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