| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TAPENTADOL HYDROCHLORIDE | 206657 | 001 | ANDA | TAPENTADOL HYDROCHLORIDE | SOLUTION;ORAL | EQ 20MG BASE/ML | No | No | 2016/03/31 (TA) | -- | ACTAVIS LABS UT INC | None (Tentative Approval) |
| TAPENTADOL HYDROCHLORIDE | 209369 | 002 | ANDA | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No | 2017/09/14 (TA) | -- | RHODES PHARMS | None (Tentative Approval) |
| TAPENTADOL HYDROCHLORIDE | 209369 | 003 | ANDA | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2017/09/14 (TA) | -- | RHODES PHARMS | None (Tentative Approval) |
| TAPENTADOL HYDROCHLORIDE | 214378 | 002 | ANDA | TAPENTADOL HYDROCHLORIDE | TABLET; ORAL | EQ 75MG BASE | No | No | 2022/04/28 (TA) | -- | HUMANWELL PHARMACEUTICAL US INC | None (Tentative Approval) |
| TAPENTADOL HYDROCHLORIDE | 214378 | 003 | ANDA | TAPENTADOL HYDROCHLORIDE | TABLET; ORAL | EQ 100MG BASE | No | No | 2022/04/28 (TA) | -- | HUMANWELL PHARMACEUTICAL US INC | None (Tentative Approval) |