药品注册申请号：021621
申请类型：NDA (新药申请)
申请人：KENVUE BRANDS
申请人全名：KENVUE BRANDS LLC
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
003 CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2004/03/16 2007/11/16 Discontinued
004 CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 10MG Yes No None 2007/11/16 Over-the-counter
005 CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2007/11/16 Discontinued
006 CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2007/11/16 Discontinued
007 CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE;ORAL 2.5MG Yes No None 2020/11/30 Over-the-counter
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
2004/03/16 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>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
2024/08/15 SUPPL-17（补充） Approval Labeling-Container/Carton Labels STANDARD
2021/12/14 SUPPL-12（补充） Approval Labeling-Container/Carton Labels,Labeling-Proprietary Name Change STANDARD
2020/11/30 SUPPL-10（补充） Approval STANDARD
2007/11/16 SUPPL-5（补充） Approval Efficacy-Rx To OTC Switch UNKNOWN
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
003 6455533 2018/07/02 Y U-295 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6455533 2018/07/02 Y U-295 PDF格式**本条是由Drugfuture回溯的历史信息**
005 6455533 2018/07/02 Y U-295 PDF格式**本条是由Drugfuture回溯的历史信息**
006 6455533 2018/07/02 Y U-295 PDF格式**本条是由Drugfuture回溯的历史信息**
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
本品无治疗等效药品
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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