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申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
---|---|---|---|---|---|---|---|---|---|---|---|---|
(NDA) 050440 | 001 | KEFLET | CEPHALEXIN | 头孢氨苄 | TABLET;ORAL | EQ 500MG BASE | LILLY | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050440 | 003 | KEFLET | CEPHALEXIN | 头孢氨苄 | TABLET;ORAL | EQ 250MG BASE | LILLY | 1987-02-26 | Yes | No | DISCN | |
(NDA) 050406 | 001 | KEFLEX | CEPHALEXIN | 头孢氨苄 | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050406 | 002 | KEFLEX | CEPHALEXIN | 头孢氨苄 | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050406 | 003 | KEFLEX | CEPHALEXIN | 头孢氨苄 | FOR SUSPENSION;ORAL | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050405 | 002 | KEFLEX | CEPHALEXIN | 头孢氨苄 | CAPSULE;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050405 | 003 | KEFLEX | CEPHALEXIN | 头孢氨苄 | CAPSULE;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 1982-01-01 | Yes | No | DISCN | |
(NDA) 050405 | 004 | KEFLEX | CEPHALEXIN | 头孢氨苄 | CAPSULE;ORAL | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 2006-05-12 | Yes | No | DISCN | |
(NDA) 050405 | 005 | KEFLEX | CEPHALEXIN | 头孢氨苄 | CAPSULE;ORAL | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | PRAGMA | 2006-05-12 | Yes | No | DISCN |