| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CHILDREN'S ZYRTEC ALLERGY | 021621 | 003 | NDA | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2004/03/16 | 2007/11/16 | KENVUE BRANDS | Discontinued |
| CHILDREN'S ZYRTEC ALLERGY | 021621 | 004 | NDA | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | Yes | No | 2004/03/16 | 2007/11/16 | KENVUE BRANDS | Over-the-counter |
| CHILDREN'S ZYRTEC ALLERGY | 021621 | 007 | NDA | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG | Yes | No | 2004/03/16 | 2020/11/30 | KENVUE BRANDS | Over-the-counter |
| CHILDREN'S ZYRTEC ALLERGY | 022155 | 002 | NDA | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | Yes | Yes | 2007/11/16 | 2007/11/16 | KENVUE BRANDS | Over-the-counter |