美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ACCUTANE"
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
ACCUTANE 018662 002 NDA ISOTRETINOIN CAPSULE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1982/05/07 1982/05/07 HOFFMANN LA ROCHE Discontinued
ACCUTANE 018662 003 NDA ISOTRETINOIN CAPSULE;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1982/05/07 1982/05/07 HOFFMANN LA ROCHE Discontinued
ACCUTANE 018662 004 NDA ISOTRETINOIN CAPSULE;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1982/05/07 1983/03/28 HOFFMANN LA ROCHE Discontinued
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