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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CYLERT | 016832 | 001 | NDA | PEMOLINE | TABLET;ORAL | 18.75MG | No | No | 1975/01/27 | Approved Prior to Jan 1, 1982 | ABBOTT | Discontinued |
CYLERT | 016832 | 002 | NDA | PEMOLINE | TABLET;ORAL | 37.5MG | No | No | 1975/01/27 | Approved Prior to Jan 1, 1982 | ABBOTT | Discontinued |
CYLERT | 016832 | 003 | NDA | PEMOLINE | TABLET;ORAL | 75MG | No | No | 1975/01/27 | Approved Prior to Jan 1, 1982 | ABBOTT | Discontinued |
CYLERT | 017703 | 001 | NDA | PEMOLINE | TABLET, CHEWABLE;ORAL | 37.5MG | No | No | 1976/01/30 | Approved Prior to Jan 1, 1982 | ABBOTT | Discontinued |