美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=NUBAIN"
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
NUBAIN 018024 001 NDA NALBUPHINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1979/05/15 Approved Prior to Jan 1, 1982 PAR PHARM INC Discontinued
NUBAIN 018024 002 NDA NALBUPHINE HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1979/05/15 1982/05/27 PAR PHARM INC Discontinued
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