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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
GLYNASE | 020051 | 001 | NDA | GLYBURIDE | TABLET;ORAL | 1.5MG | Yes | No | 1992/03/04 | 1992/03/04 | PFIZER | Prescription |
GLYNASE | 020051 | 002 | NDA | GLYBURIDE | TABLET;ORAL | 3MG | Yes | No | 1992/03/04 | 1992/03/04 | PFIZER | Prescription |
GLYNASE | 020051 | 003 | NDA | GLYBURIDE | TABLET;ORAL | 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1992/03/04 | 1993/09/24 | PFIZER | Discontinued |
GLYNASE | 020051 | 004 | NDA | GLYBURIDE | TABLET;ORAL | 6MG | Yes | Yes | 1992/03/04 | 1993/09/24 | PFIZER | Prescription |