| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ONFI | 202067 | 001 | NDA | CLOBAZAM | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2011/10/21 | 2011/10/21 | LUNDBECK PHARMS LLC | Discontinued |
| ONFI | 202067 | 002 | NDA | CLOBAZAM | TABLET;ORAL | 10MG | Yes | No | 2011/10/21 | 2011/10/21 | LUNDBECK PHARMS LLC | Prescription |
| ONFI | 202067 | 003 | NDA | CLOBAZAM | TABLET;ORAL | 20MG | Yes | Yes | 2011/10/21 | 2011/10/21 | LUNDBECK PHARMS LLC | Prescription |
| ONFI | 203993 | 001 | NDA | CLOBAZAM | SUSPENSION;ORAL | 2.5MG/ML | Yes | Yes | 2012/12/14 | 2012/12/14 | LUNDBECK PHARMS LLC | Prescription |