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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
INOMAX | 020845 | 002 | NDA | NITRIC OXIDE | GAS;INHALATION | 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/12/23 | 1999/12/23 | MALLINCKRODT HOSP | Discontinued |
INOMAX | 020845 | 003 | NDA | NITRIC OXIDE | GAS;INHALATION | 800PPM | Yes | Yes | 1999/12/23 | 1999/12/23 | MALLINCKRODT HOSP | Prescription |
INOMAX | 020845 | 004 | NDA | NITRIC OXIDE | GAS;INHALATION | 4880PPM | Yes | Yes | 1999/12/23 | 2023/01/17 | MALLINCKRODT HOSP | Prescription |