| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NEXTERONE | 022325 | 001 | NDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/12/24 | 2008/12/24 | BAXTER HLTHCARE | Discontinued |
| NEXTERONE | 022325 | 002 | NDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/100ML (1.5MG/ML) | Yes | Yes | 2008/12/24 | 2010/11/16 | BAXTER HLTHCARE | Prescription |
| NEXTERONE | 022325 | 003 | NDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 360MG/200ML (1.8MG/ML) | Yes | Yes | 2008/12/24 | 2010/11/16 | BAXTER HLTHCARE | Prescription |