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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
KAPVAY | 022331 | 003 | NDA | CLONIDINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.1MG | Yes | No | 2009/09/29 | 2010/09/28 | CONCORDIA PHARMS INC | Discontinued |
KAPVAY | 022331 | 004 | NDA | CLONIDINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2009/09/29 | 2010/09/28 | CONCORDIA PHARMS INC | Discontinued |