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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
LAROTID | 050460 | 006 | NDA | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1974/01/18 | Approved Prior to Jan 1, 1982 | GLAXOSMITHKLINE | Discontinued |
LAROTID | 062226 | 003 | ANDA | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No | 1979/11/27 | Approved Prior to Jan 1, 1982 | US ANTIBIOTICS | Prescription |
LAROTID | 062226 | 004 | ANDA | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | No | 1979/11/27 | Approved Prior to Jan 1, 1982 | US ANTIBIOTICS | Prescription |