| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SUDAFED 12 HOUR | 017941 | 002 | NDA | PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | -- | Approved Prior to Jan 1, 1982 | GLAXOSMITHKLINE | Discontinued |
| SUDAFED 12 HOUR | 073585 | 001 | ANDA | PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No | 1991/10/31 | 1991/10/31 | MCNEIL CONS | Discontinued |