药品注册申请号:011111
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
001 VISTARIL HYDROXYZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1957/09/18 Approved Prior to Jan 1, 1982 Discontinued
002 VISTARIL HYDROXYZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2001/03/21 SUPPL-33(补充) Approval Labeling STANDARD
1985/06/20 SUPPL-24(补充) Approval Labeling
1974/08/27 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1957/09/18 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品治疗等效的药品
本品无治疗等效药品
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