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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ACTIFED W/ CODEINE | 012575 | 003 | NDA | CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | -- | 1984/04/04 | GLAXOSMITHKLINE | Discontinued |
ACTIFED | 018996 | 001 | NDA | PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG;5MG | No | No | -- | 1985/06/17 | GLAXOSMITHKLINE | Discontinued |