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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
COTEMPLA XR-ODT | 205489 | 001 | NDA | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 8.6MG | Yes | No | 2017/06/19 | 2017/06/19 | NEOS THERAPS INC | Prescription |
COTEMPLA XR-ODT | 205489 | 002 | NDA | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 17.3MG | Yes | No | 2017/06/19 | 2017/06/19 | NEOS THERAPS INC | Prescription |
COTEMPLA XR-ODT | 205489 | 003 | NDA | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 25.9MG | Yes | Yes | 2017/06/19 | 2017/06/19 | NEOS THERAPS INC | Prescription |