药品注册申请号：011459
申请类型：NDA (新药申请)
申请人：PFIZER
申请人全名：PFIZER LABORATORIES DIV PFIZER 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
002 VISTARIL HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Yes No AB 1968/11/15 Approved Prior to Jan 1, 1982 Prescription
004 VISTARIL HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Yes No AB Approved Prior to Jan 1, 1982 Prescription
006 VISTARIL HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
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-51（补充） Approval Labeling 901 REQUIRED
2016/02/18 SUPPL-50（补充） Approval Labeling 901 REQUIRED
2014/06/03 SUPPL-48（补充） Approval Labeling STANDARD
2004/12/24 SUPPL-39（补充） Approval Labeling STANDARD
2001/03/21 SUPPL-36（补充） Approval Labeling STANDARD
2000/08/30 SUPPL-35（补充） Approval Labeling STANDARD
2000/06/13 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2000/03/27 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1994/11/28 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1979/05/21 SUPPL-23（补充） Approval Labeling
1974/12/02 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1968/11/15 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient STANDARD
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 PAMOATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG HYDROCHLORIDE 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
011459 002 NDA VISTARIL HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
087479 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Prescription No No AB Approved Prior to Jan 1, 1982 SANDOZ
088496 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Prescription No No AB 1984/06/15 BARR
040156 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Prescription No No AB 1996/07/15 IMPAX LABS INC
201507 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 25MG HYDROCHLORIDE Prescription No No AB 2013/06/03 HERITAGE PHARMA
活性成分:HYDROXYZINE PAMOATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG HYDROCHLORIDE 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
011459 004 NDA VISTARIL HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
086183 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Prescription No Yes AB Approved Prior to Jan 1, 1982 SANDOZ
088487 001 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Prescription No No AB 1984/06/15 BARR
040156 002 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Prescription No No AB 1996/07/15 IMPAX LABS INC
201507 002 ANDA HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE;ORAL EQ 50MG HYDROCHLORIDE Prescription No No AB 2013/06/03 HERITAGE PHARMA
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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