美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=KEFLEX"
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
KEFLEX 050405 002 NDA CEPHALEXIN CAPSULE;ORAL EQ 250MG BASE Yes No 1971/01/04 Approved Prior to Jan 1, 1982 PRAGMA Prescription
KEFLEX 050405 003 NDA CEPHALEXIN CAPSULE;ORAL EQ 500MG BASE Yes No 1971/01/04 Approved Prior to Jan 1, 1982 PRAGMA Prescription
KEFLEX 050405 004 NDA CEPHALEXIN CAPSULE;ORAL EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1971/01/04 2006/05/12 PRAGMA Discontinued
KEFLEX 050405 005 NDA CEPHALEXIN CAPSULE;ORAL EQ 750MG BASE Yes Yes 1971/01/04 2006/05/12 PRAGMA Prescription
KEFLEX 050406 001 NDA CEPHALEXIN FOR SUSPENSION;ORAL EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1971/01/04 Approved Prior to Jan 1, 1982 PRAGMA Discontinued
KEFLEX 050406 002 NDA CEPHALEXIN FOR SUSPENSION;ORAL EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* Yes No 1971/01/04 Approved Prior to Jan 1, 1982 PRAGMA Discontinued
KEFLEX 050406 003 NDA CEPHALEXIN FOR SUSPENSION;ORAL EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* Yes No 1971/01/04 Approved Prior to Jan 1, 1982 PRAGMA Discontinued
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