药品注册申请号：040804
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL RX
申请人全名：CHARTWELL RX SCIENCES 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
001 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2008/06/30 2008/06/30 Prescription
002 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG No No AB 2008/06/30 Prescription
003 HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG No No AB 2008/06/30 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
2016/11/08 SUPPL-5（补充） Approval Labeling STANDARD
2016/03/30 SUPPL-4（补充） Approval Labeling STANDARD
2014/12/23 SUPPL-3（补充） Approval Labeling STANDARD
2008/06/30 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:HYDROXYZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
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
040841 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB -- NORTHSTAR HLTHCARE
087871 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1982/12/20 AUROBINDO PHARMA LTD
088617 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes Yes AB 1986/01/10 PLIVA
040604 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2004/12/28 EPIC PHARMA LLC
040580 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2005/05/27 PRINSTON INC
040786 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2007/03/20 KVK TECH
040812 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2008/03/12 INVAGEN PHARMS
040840 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/03/31 NORTHSTAR HLTHCARE
040805 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/05/29 HETERO LABS LTD III
040804 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/06/30 CHARTWELL RX
040808 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/09/24 AMNEAL PHARM
204279 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/08/20 HERITAGE PHARMA
207121 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/03/29 NUVO PHARMS INC
217652 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/08/17 GRAVITI PHARMS
活性成分:HYDROXYZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AB
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
040842 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB -- NORTHSTAR HLTHCARE
087871 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1982/12/20 AUROBINDO PHARMA LTD
088618 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes Yes AB 1986/01/10 PLIVA
040604 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2004/12/28 EPIC PHARMA LLC
040580 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2005/05/27 PRINSTON INC
040786 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2007/03/20 KVK TECH
040812 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AB 2008/03/12 INVAGEN PHARMS
040840 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/03/31 NORTHSTAR HLTHCARE
040805 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/05/29 HETERO LABS LTD III
040804 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/06/30 CHARTWELL RX
040808 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/09/24 AMNEAL PHARM
204279 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2014/08/20 HERITAGE PHARMA
207121 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2017/03/29 NUVO PHARMS INC
217652 002 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2023/08/17 GRAVITI PHARMS
活性成分:HYDROXYZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AB
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
087871 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1982/12/20 AUROBINDO PHARMA LTD
088619 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes Yes AB 1986/01/10 PLIVA
040604 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2004/12/28 EPIC PHARMA LLC
040580 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2005/05/27 PRINSTON INC
040786 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2007/03/20 KVK TECH
040812 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AB 2008/03/12 INVAGEN PHARMS
040840 001 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/03/31 NORTHSTAR HLTHCARE
040805 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/05/29 HETERO LABS LTD III
040804 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/06/30 CHARTWELL RX
040808 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/09/24 AMNEAL PHARM
204279 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2014/08/20 HERITAGE PHARMA
207121 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/03/29 NUVO PHARMS INC
217652 003 ANDA HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2023/08/17 GRAVITI PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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