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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NOXAFIL | 022003 | 001 | NDA | POSACONAZOLE | SUSPENSION;ORAL | 40MG/ML | Yes | Yes | 2006/09/15 | 2006/09/15 | SCHERING | Prescription |
NOXAFIL | 022027 | 001 | NDA | POSACONAZOLE | SUSPENSION; ORAL | 40MG/ML | No | No | 2006/10/20 | -- | SCHERING | Prescription |
NOXAFIL | 205053 | 001 | NDA | POSACONAZOLE | TABLET, DELAYED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2013/11/25 | 2013/11/25 | MERCK SHARP DOHME | Discontinued |
NOXAFIL | 205596 | 001 | NDA | POSACONAZOLE | SOLUTION;INTRAVENOUS | 300MG/16.7ML (18MG/ML) | Yes | Yes | 2014/03/13 | 2014/03/13 | MERCK SHARP DOHME | Prescription |
NOXAFIL POWDERMIX KIT | 214770 | 001 | NDA | POSACONAZOLE | FOR SUSPENSION, DELAYED RELEASE;ORAL | 300MG | Yes | Yes | 2021/05/31 | 2021/05/31 | MSD MERCK CO | Prescription |