美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ANDROGEL"
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
ANDROGEL 021015 001 NDA TESTOSTERONE GEL;TRANSDERMAL 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/02/28 2000/02/28 BESINS HLTHCARE Discontinued
ANDROGEL 021015 002 NDA TESTOSTERONE GEL;TRANSDERMAL 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/02/28 2000/02/28 BESINS HLTHCARE Discontinued
ANDROGEL 021015 003 NDA TESTOSTERONE GEL, METERED;TRANSDERMAL 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/02/28 2003/09/26 BESINS HLTHCARE Discontinued
ANDROGEL 022309 001 NDA TESTOSTERONE GEL, METERED;TRANSDERMAL 1.62% (20.25MG/1.25GM ACTUATION) Yes Yes 2011/04/29 2011/04/29 BESINS HLTHCARE Prescription
ANDROGEL 022309 002 NDA TESTOSTERONE GEL;TRANSDERMAL 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/04/29 2012/09/07 BESINS HLTHCARE Discontinued
ANDROGEL 022309 003 NDA TESTOSTERONE GEL;TRANSDERMAL 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/04/29 2012/09/07 BESINS HLTHCARE Discontinued
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