美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ATARAX"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ATARAX 010392 001 NDA HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1956/04/12 Approved Prior to Jan 1, 1982 PFIZER Discontinued
ATARAX 010392 004 NDA HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1956/04/12 Approved Prior to Jan 1, 1982 PFIZER Discontinued
ATARAX 010392 005 NDA HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1956/04/12 Approved Prior to Jan 1, 1982 PFIZER Discontinued
ATARAX 010392 006 NDA HYDROXYZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1956/04/12 Approved Prior to Jan 1, 1982 PFIZER Discontinued
ATARAX 010485 001 NDA HYDROXYZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No 1956/05/31 Approved Prior to Jan 1, 1982 ROERIG Discontinued
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