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 ADVIL | 019833 | 002 | NDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 1989/09/19 | 1989/09/19 | HALEON US HOLDINGS | Discontinued |
CHILDREN'S ADVIL | 020589 | 001 | NDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 1996/06/27 | 1996/06/27 | HALEON US HOLDINGS | Over-the-counter |
CHILDREN'S ADVIL-FLAVORED | 020589 | 002 | NDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 1996/06/27 | 1997/11/07 | HALEON US HOLDINGS | Over-the-counter |
CHILDREN'S ADVIL | 020944 | 001 | NDA | IBUPROFEN | TABLET, CHEWABLE;ORAL | 50MG | No | No | 1998/12/18 | 1998/12/18 | HALEON US HOLDINGS | Over-the-counter |
CHILDREN'S ADVIL COLD | 021373 | 001 | NDA | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | SUSPENSION;ORAL | 100MG/5ML;15MG/5ML | No | No | 2002/04/18 | 2002/04/18 | HALEON US HOLDINGS | Over-the-counter |
CHILDREN'S ADVIL ALLERGY SINUS | 021587 | 001 | NDA | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | SUSPENSION;ORAL | 1MG/5ML;100MG/5ML;15MG/5ML | Yes | Yes | 2004/02/24 | 2004/02/24 | HALEON US HOLDINGS | Over-the-counter |