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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
AUGMENTIN '125' | 050575 | 001 | NDA | AMOXICILLIN; CLAVULANATE POTASSIUM | FOR SUSPENSION;ORAL | 125MG/5ML;EQ 31.25MG BASE/5ML | Yes | No | 1984/08/06 | 1984/08/06 | US ANTIBIOTICS | Prescription |
AUGMENTIN '125' | 050597 | 001 | NDA | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET, CHEWABLE;ORAL | 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1985/07/22 | 1985/07/22 | US ANTIBIOTICS | Discontinued |