美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ROXICET"
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
ROXICET 087003 001 ANDA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Yes No 1980/02/25 Approved Prior to Jan 1, 1982 HIKMA Discontinued
ROXICET 089351 001 ANDA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SOLUTION;ORAL 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 1986/12/03 1986/12/03 HIKMA Discontinued
ROXICET 5/500 089775 001 ANDA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 500MG;5MG No No 1989/01/12 1989/01/12 ROXANE Discontinued
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