美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=SUDAFED 12 HOUR"
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
SUDAFED 12 HOUR 017941 002 NDA PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No -- Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE Discontinued
SUDAFED 12 HOUR 073585 001 ANDA PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG No Yes 1991/10/31 1991/10/31 MCNEIL CONS Over-the-counter
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