| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TESSALON | 011210 | 001 | NDA | BENZONATATE | CAPSULE;ORAL | 100MG | Yes | No | 1958/02/10 | Approved Prior to Jan 1, 1982 | PFIZER | Prescription |
| TESSALON | 011210 | 003 | NDA | BENZONATATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1958/02/10 | 1999/06/25 | PFIZER | Discontinued |