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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NALFON | 017604 | 002 | NDA | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1976/03/16 | Approved Prior to Jan 1, 1982 | KEY THERAP | Discontinued |
NALFON | 017604 | 003 | NDA | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 200MG BASE | Yes | No | 1976/03/16 | Approved Prior to Jan 1, 1982 | KEY THERAP | Discontinued |
NALFON | 017604 | 004 | NDA | FENOPROFEN CALCIUM | CAPSULE;ORAL | EQ 400MG BASE | Yes | No | 1976/03/16 | 2009/07/21 | KEY THERAP | Discontinued |
NALFON | 017710 | 001 | NDA | FENOPROFEN CALCIUM | TABLET;ORAL | EQ 600MG BASE | Yes | No | 1977/06/09 | Approved Prior to Jan 1, 1982 | DISTA | Discontinued |