| 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 MOTRIN | 020516 | 001 | NDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | Yes | Yes | 1995/06/16 | 1995/06/16 | KENVUE BRANDS | Over-the-counter |
| CHILDREN'S MOTRIN | 020603 | 001 | NDA | IBUPROFEN | SUSPENSION/DROPS;ORAL | 40MG/ML | Yes | Yes | 1996/06/10 | 1996/06/10 | KENVUE BRANDS | Over-the-counter |
| CHILDREN'S MOTRIN | 020601 | 001 | NDA | IBUPROFEN | TABLET, CHEWABLE;ORAL | 50MG | Yes | No | 1996/11/15 | 1996/11/15 | KENVUE BRANDS | Discontinued |
| CHILDREN'S MOTRIN COLD | 021128 | 001 | NDA | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | Yes | Yes | 2000/08/01 | 2000/08/01 | KENVUE BRANDS | Over-the-counter |