美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ACTONEL"
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
ACTONEL 020835 001 NDA RISEDRONATE SODIUM TABLET;ORAL 30MG Yes No 1998/03/27 1998/03/27 APIL Prescription
ACTONEL 020835 002 NDA RISEDRONATE SODIUM TABLET;ORAL 5MG Yes No 1998/03/27 2000/04/14 APIL Prescription
ACTONEL 020835 003 NDA RISEDRONATE SODIUM TABLET;ORAL 35MG Yes Yes 1998/03/27 2002/05/25 APIL Prescription
ACTONEL 020835 004 NDA RISEDRONATE SODIUM TABLET;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1998/03/27 2007/04/16 APIL Discontinued
ACTONEL 020835 005 NDA RISEDRONATE SODIUM TABLET;ORAL 150MG Yes Yes 1998/03/27 2008/04/22 APIL Prescription
ACTONEL WITH CALCIUM (COPACKAGED) 021823 001 NDA CALCIUM CARBONATE; RISEDRONATE SODIUM TABLET, TABLET;ORAL EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 2005/08/12 2005/08/12 WARNER CHILCOTT Discontinued
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