美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=NIZORAL"
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
NIZORAL 070767 001 ANDA KETOCONAZOLE SUSPENSION;ORAL 100MG/5ML No No -- 1986/11/07 JANSSEN PHARMA Discontinued
NIZORAL 018533 001 NDA KETOCONAZOLE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1981/06/12 Approved Prior to Jan 1, 1982 JANSSEN PHARMS Discontinued
NIZORAL 019084 001 NDA KETOCONAZOLE CREAM;TOPICAL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1985/12/31 1985/12/31 JANSSEN PHARMA Discontinued
NIZORAL 019927 001 NDA KETOCONAZOLE SHAMPOO;TOPICAL 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1990/08/31 1990/08/31 JANSSEN PHARMS Discontinued
NIZORAL ANTI-DANDRUFF 020310 001 NDA KETOCONAZOLE SHAMPOO;TOPICAL 1% Yes Yes 1997/10/10 1997/10/10 KRAMER Over-the-counter
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