美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PREZISTA"
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
PREZISTA 021976 001 NDA DARUNAVIR TABLET;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/23 2006/06/23 JANSSEN PRODS Discontinued
PREZISTA 021976 002 NDA DARUNAVIR TABLET;ORAL 600MG Yes No 2006/06/23 2008/02/25 JANSSEN PRODS Prescription
PREZISTA 021976 003 NDA DARUNAVIR TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2006/06/23 2008/10/21 JANSSEN PRODS Discontinued
PREZISTA 021976 004 NDA DARUNAVIR TABLET;ORAL 75MG Yes No 2006/06/23 2008/12/18 JANSSEN PRODS Prescription
PREZISTA 021976 005 NDA DARUNAVIR TABLET;ORAL 150MG Yes No 2006/06/23 2008/12/18 JANSSEN PRODS Prescription
PREZISTA 021976 006 NDA DARUNAVIR TABLET;ORAL 800MG Yes Yes 2006/06/23 2012/11/09 JANSSEN PRODS Prescription
PREZISTA 202895 001 NDA DARUNAVIR SUSPENSION;ORAL 100MG/ML Yes Yes 2011/12/16 2011/12/16 JANSSEN PRODS Prescription
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