| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CLOZARIL | 019758 | 001 | NDA | CLOZAPINE | TABLET;ORAL | 25MG | Yes | No | 1989/09/26 | 1989/09/26 | HERITAGE LIFE | Prescription |
| CLOZARIL | 019758 | 002 | NDA | CLOZAPINE | TABLET;ORAL | 100MG | Yes | Yes | 1989/09/26 | 1989/09/26 | HERITAGE LIFE | Prescription |
| CLOZARIL | 019758 | 003 | NDA | CLOZAPINE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1989/09/26 | 2019/05/20 | HERITAGE LIFE | Discontinued |
| CLOZARIL | 019758 | 004 | NDA | CLOZAPINE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1989/09/26 | 2019/05/20 | HERITAGE LIFE | Discontinued |