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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ZYVOX | 021130 | 001 | NDA | LINEZOLID | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2000/04/18 | 2000/04/18 | PFIZER | Discontinued |
ZYVOX | 021130 | 002 | NDA | LINEZOLID | TABLET;ORAL | 600MG | Yes | Yes | 2000/04/18 | 2000/04/18 | PFIZER | Prescription |
ZYVOX | 021131 | 001 | NDA | LINEZOLID | SOLUTION;INTRAVENOUS | 200MG/100ML (2MG/ML) | Yes | No | 2000/04/18 | 2000/04/18 | PFIZER | Prescription |
ZYVOX | 021131 | 002 | NDA | LINEZOLID | SOLUTION;INTRAVENOUS | 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2000/04/18 | 2000/04/18 | PFIZER | Discontinued |
ZYVOX | 021131 | 003 | NDA | LINEZOLID | SOLUTION;INTRAVENOUS | 600MG/300ML (2MG/ML) | Yes | Yes | 2000/04/18 | 2000/04/18 | PFIZER | Prescription |
ZYVOX | 021132 | 001 | NDA | LINEZOLID | FOR SUSPENSION;ORAL | 100MG/5ML | Yes | Yes | 2000/04/18 | 2000/04/18 | PFIZER | Prescription |