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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
REBETOL | 020903 | 001 | NDA | RIBAVIRIN | CAPSULE;ORAL | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** | No | No | 1998/06/03 | 1998/06/03 | MERCK SHARP DOHME | Discontinued |
REBETOL | 020903 | 002 | NDA | RIBAVIRIN | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/06/03 | 2001/07/25 | MERCK SHARP DOHME | Discontinued |
REBETOL | 021546 | 001 | NDA | RIBAVIRIN | SOLUTION;ORAL | 40MG/ML | Yes | No | 2003/07/29 | 2003/07/29 | SCHERING | Discontinued |