| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE PLAIN | 008381 | 003 | NDA | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1952/04/11 | Approved Prior to Jan 1, 1982 | ANI PHARMS | Discontinued |
| PROMETHAZINE HYDROCHLORIDE PLAIN | 008381 | 004 | NDA | PROMETHAZINE HYDROCHLORIDE | SYRUP;ORAL | 6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1952/04/11 | 1984/04/18 | ANI PHARMS | Discontinued |