| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TIGAN | 017530 | 001 | NDA | TRIMETHOBENZAMIDE HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/ML | Yes | Yes | 1974/07/12 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Prescription |
| TIGAN | 017531 | 006 | NDA | TRIMETHOBENZAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1974/07/12 | 2001/12/13 | KING PHARMS LLC | Discontinued |