| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CLARITIN HIVES RELIEF | 019658 | 003 | NDA | LORATADINE | TABLET;ORAL | 10MG | Yes | Yes | 1993/04/12 | 2003/11/19 | BAYER HEALTHCARE LLC | Over-the-counter |
| CLARITIN HIVES RELIEF | 020641 | 003 | NDA | LORATADINE | SYRUP;ORAL | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/10/10 | 2003/11/19 | BAYER HEALTHCARE LLC | Discontinued |
| CLARITIN HIVES RELIEF REDITAB | 020704 | 003 | NDA | LORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Yes | Yes | 1996/12/23 | 2003/11/19 | BAYER HEALTHCARE LLC | Over-the-counter |