| 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 CETIRIZINE HYDROCHLORIDE ALLERGY | 206793 | 001 | ANDA | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG | No | No | 2016/03/08 | 2016/03/08 | NOVEL LABS INC | Over-the-counter |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 206793 | 002 | ANDA | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | No | No | 2016/03/08 | 2016/03/08 | NOVEL LABS INC | Over-the-counter |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 210622 | 001 | ANDA | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No | 2019/03/13 | 2019/03/13 | HETERO LABS LTD III | Over-the-counter |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 212266 | 001 | ANDA | CETIRIZINE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No | 2019/05/16 | 2019/05/16 | QUAGEN | Over-the-counter |