| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LIORESAL | 017851 | 001 | NDA | BACLOFEN | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/11/22 | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |
| LIORESAL | 017851 | 003 | NDA | BACLOFEN | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/11/22 | 1982/01/20 | NOVARTIS | Discontinued |
| LIORESAL | 020075 | 001 | NDA | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | Yes | Yes | 1992/06/17 | 1992/06/17 | AMNEAL | Prescription |
| LIORESAL | 020075 | 002 | NDA | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | Yes | Yes | 1992/06/17 | 1992/06/17 | AMNEAL | Prescription |
| LIORESAL | 020075 | 003 | NDA | BACLOFEN | INJECTABLE;INTRATHECAL | 0.05MG/ML | Yes | Yes | 1992/06/17 | 1996/11/07 | AMNEAL | Prescription |