| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | 208708 | 003 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No | 2019/06/28 | 2023/11/27 | RUBICON RESEARCH | Prescription |
| TRAMADOL HYDROCHLORIDE | 208708 | 004 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No | 2019/06/28 | 2024/04/04 | RUBICON RESEARCH | Prescription |
| TRAMADOL HYDROCHLORIDE | 206706 | 001 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2019/07/02 | 2019/07/02 | PURACAP LABS BLU | Discontinued |
| TRAMADOL HYDROCHLORIDE | 211825 | 001 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2019/08/09 | 2019/08/09 | UNICHEM | Prescription |
| TRAMADOL HYDROCHLORIDE | 209404 | 001 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No | 2025/01/31 | 2025/01/31 | MACLEODS PHARMS LTD | Prescription |
| TRAMADOL HYDROCHLORIDE | 209404 | 002 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | No | No | 2025/01/31 | 2025/01/31 | MACLEODS PHARMS LTD | Prescription |
| TRAMADOL HYDROCHLORIDE | 209404 | 003 | ANDA | TRAMADOL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No | 2025/01/31 | 2025/01/31 | MACLEODS PHARMS LTD | Prescription |