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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
AVANDIA | 021071 | 002 | NDA | ROSIGLITAZONE MALEATE | TABLET;ORAL | EQ 2MG BASE | Yes | No | 1999/05/25 | 1999/05/25 | WOODWARD | Discontinued |
AVANDIA | 021071 | 003 | NDA | ROSIGLITAZONE MALEATE | TABLET;ORAL | EQ 4MG BASE | Yes | No | 1999/05/25 | 1999/05/25 | WOODWARD | Discontinued |
AVANDIA | 021071 | 004 | NDA | ROSIGLITAZONE MALEATE | TABLET;ORAL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/05/25 | 1999/05/25 | WOODWARD | Discontinued |