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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SELZENTRY | 022128 | 001 | NDA | MARAVIROC | TABLET;ORAL | 150MG | Yes | No | 2007/08/06 | 2007/08/06 | VIIV HLTHCARE | Prescription |
SELZENTRY | 022128 | 002 | NDA | MARAVIROC | TABLET;ORAL | 300MG | Yes | Yes | 2007/08/06 | 2007/08/06 | VIIV HLTHCARE | Prescription |
SELZENTRY | 022128 | 003 | NDA | MARAVIROC | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/08/06 | 2016/11/04 | VIIV HLTHCARE | Discontinued |
SELZENTRY | 022128 | 004 | NDA | MARAVIROC | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/08/06 | 2016/11/04 | VIIV HLTHCARE | Discontinued |
SELZENTRY | 208984 | 001 | NDA | MARAVIROC | SOLUTION;ORAL | 20MG/ML | Yes | Yes | 2016/11/04 | 2016/11/04 | VIIV HLTHCARE | Prescription |