药品注册申请号：075928
申请类型：ANDA (仿制药申请)
申请人：RUBICON
申请人全名：RUBICON RESEARCH PRIVATE 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 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE No No AT 2004/06/09 2004/06/09 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
2011/05/25 SUPPL-15（补充） Approval Manufacturing (CMC)
2005/04/22 SUPPL-6（补充） Approval Labeling
2004/06/09 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:CIPROFLOXACIN HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:EQ 0.3% 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
019992 001 NDA CILOXAN CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription Yes Yes AT 1990/12/31 SANDOZ
075928 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription No No AT 2004/06/09 RUBICON
076754 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Discontinued No No AT 2004/06/09 THE J MOLNER
076673 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription No No AT 2005/01/21 WATSON LABS INC
077689 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription No No AT 2006/12/13 RISING
077568 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription No No AT 2008/06/30 FDC LTD
076555 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Discontinued No No AT 2008/12/11 SCIEGEN PHARMS INC
204613 001 ANDA CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.3% BASE Prescription No No AT 2018/05/03 ALTAIRE PHARMS INC
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database