| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ANTARA (MICRONIZED) | 021695 | 001 | NDA | FENOFIBRATE | CAPSULE;ORAL | 43MG | Yes | No | 2004/11/30 | 2004/11/30 | LUPIN | Prescription |
| ANTARA (MICRONIZED) | 021695 | 002 | NDA | FENOFIBRATE | CAPSULE;ORAL | 87MG | No | No | 2004/11/30 | 2004/11/30 | LUPIN | Discontinued |
| ANTARA (MICRONIZED) | 021695 | 003 | NDA | FENOFIBRATE | CAPSULE;ORAL | 130MG | Yes | Yes | 2004/11/30 | 2004/11/30 | LUPIN | Prescription |
| ANTARA (MICRONIZED) | 021695 | 004 | NDA | FENOFIBRATE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2004/11/30 | 2013/10/18 | LUPIN | Discontinued |
| ANTARA (MICRONIZED) | 021695 | 005 | NDA | FENOFIBRATE | CAPSULE;ORAL | 90MG | Yes | No | 2004/11/30 | 2013/10/18 | LUPIN | Discontinued |