| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NUBAIN | 018024 | 001 | NDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1979/05/15 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Discontinued |
| NUBAIN | 018024 | 002 | NDA | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1979/05/15 | 1982/05/27 | ENDO OPERATIONS | Discontinued |