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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SUSTIVA | 020972 | 001 | NDA | EFAVIRENZ | CAPSULE;ORAL | 50MG | Yes | No | 1998/09/17 | 1998/09/17 | BRISTOL MYERS SQUIBB | Discontinued |
SUSTIVA | 020972 | 002 | NDA | EFAVIRENZ | CAPSULE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/09/17 | 1998/09/17 | BRISTOL MYERS SQUIBB | Discontinued |
SUSTIVA | 020972 | 003 | NDA | EFAVIRENZ | CAPSULE;ORAL | 200MG | Yes | No | 1998/09/17 | 1998/09/17 | BRISTOL MYERS SQUIBB | Discontinued |
SUSTIVA | 021360 | 001 | NDA | EFAVIRENZ | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2002/02/01 | 2002/02/01 | BRISTOL MYERS SQUIBB | Discontinued |
SUSTIVA | 021360 | 002 | NDA | EFAVIRENZ | TABLET;ORAL | 600MG | Yes | No | 2002/02/01 | 2002/02/01 | BRISTOL MYERS SQUIBB | Discontinued |