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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
EMEND | 021549 | 001 | NDA | APREPITANT | CAPSULE;ORAL | 80MG | Yes | No | 2003/03/26 | 2003/03/26 | MERCK | Prescription |
EMEND | 021549 | 002 | NDA | APREPITANT | CAPSULE;ORAL | 125MG | Yes | Yes | 2003/03/26 | 2003/03/26 | MERCK | Prescription |
EMEND | 021549 | 003 | NDA | APREPITANT | CAPSULE;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2003/03/26 | 2006/06/30 | MERCK | Discontinued |
EMEND | 022023 | 001 | NDA | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/01/25 | 2008/01/25 | MERCK AND CO INC | Discontinued |
EMEND | 022023 | 002 | NDA | FOSAPREPITANT DIMEGLUMINE | POWDER;INTRAVENOUS | EQ 150MG BASE/VIAL | Yes | Yes | 2008/01/25 | 2010/11/12 | MERCK AND CO INC | Prescription |
EMEND | 207865 | 001 | NDA | APREPITANT | FOR SUSPENSION;ORAL | 125MG/KIT | Yes | Yes | 2015/12/17 | 2015/12/17 | MSD MERCK CO | Prescription |