药品注册申请号:078870
申请类型:ANDA (仿制药申请)
申请人:APOZEAL PHARMS
申请人全名:APOZEAL PHARMACEUTICALS INC
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 CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML No No AA 2009/04/27 2009/04/27 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
2023/04/19 SUPPL-6(补充) Approval Labeling STANDARD
2016/11/08 SUPPL-4(补充) Approval Labeling STANDARD
2009/04/27 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
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
与本品治疗等效的药品
活性成分:CETIRIZINE HYDROCHLORIDE 剂型/给药途径:SOLUTION;ORAL 规格:5MG/5ML 治疗等效代码:AA
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
077279 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Discontinued No No AA 2008/05/27 TEVA PHARMS
078398 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No Yes AA 2008/06/17 PADAGIS US
078412 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2008/06/18 PHARM ASSOC
076601 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2008/06/20 TARO
078488 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Discontinued No No AA 2008/10/06 BIONPHARMA
078870 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2009/04/27 APOZEAL PHARMS
090766 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2009/10/07 AMNEAL PHARMS
090191 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2009/11/12 BAJAJ
078876 001 ANDA CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML Prescription No No AA 2012/05/11 CHARTWELL MOLECULAR
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药品NDC数据与药品包装、标签说明书
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