| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREZISTA | 021976 | 001 | NDA | DARUNAVIR | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2006/06/23 | 2006/06/23 | JANSSEN PRODS | Discontinued |
| PREZISTA | 021976 | 002 | NDA | DARUNAVIR | TABLET;ORAL | 600MG | Yes | No | 2006/06/23 | 2008/02/25 | JANSSEN PRODS | Prescription |
| PREZISTA | 021976 | 003 | NDA | DARUNAVIR | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2006/06/23 | 2008/10/21 | JANSSEN PRODS | Discontinued |
| PREZISTA | 021976 | 004 | NDA | DARUNAVIR | TABLET;ORAL | 75MG | Yes | No | 2006/06/23 | 2008/12/18 | JANSSEN PRODS | Prescription |
| PREZISTA | 021976 | 005 | NDA | DARUNAVIR | TABLET;ORAL | 150MG | Yes | No | 2006/06/23 | 2008/12/18 | JANSSEN PRODS | Prescription |
| PREZISTA | 021976 | 006 | NDA | DARUNAVIR | TABLET;ORAL | 800MG | Yes | Yes | 2006/06/23 | 2012/11/09 | JANSSEN PRODS | Prescription |
| PREZISTA | 202895 | 001 | NDA | DARUNAVIR | SUSPENSION;ORAL | 100MG/ML | Yes | Yes | 2011/12/16 | 2011/12/16 | JANSSEN PRODS | Prescription |