| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | 202825 | 003 | ANDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No | 2014/11/07 | 2014/11/07 | ACCORD HLTHCARE | Prescription |
| TRALEMENT | 209376 | 001 | NDA | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | Yes | Yes | 2020/07/02 | 2020/07/02 | AM REGENT | Prescription |
| TRALEMENT | 209376 | 002 | NDA | CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | Yes | Yes | 2020/07/02 | 2020/12/02 | AM REGENT | Prescription |
| SERTRALINE HYDROCHLORIDE | 214790 | 001 | ANDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No | 2021/05/03 | 2021/05/03 | ASCENT PHARMS INC | Prescription |
| SERTRALINE HYDROCHLORIDE | 214790 | 002 | ANDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No | 2021/05/03 | 2021/05/03 | ASCENT PHARMS INC | Prescription |
| SERTRALINE HYDROCHLORIDE | 214790 | 003 | ANDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No | 2021/05/03 | 2021/05/03 | ASCENT PHARMS INC | Prescription |
| SERTRALINE HYDROCHLORIDE | 215133 | 001 | NDA | SERTRALINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | Yes | Yes | 2021/10/04 | 2021/10/04 | ALMATICA | Prescription |
| SERTRALINE HYDROCHLORIDE | 215133 | 001 | NDA | SERTRALINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | Yes | Yes | 2021/10/04 | 2021/10/04 | ALMATICA | Prescription |
| SERTRALINE HYDROCHLORIDE | 215133 | 002 | NDA | SERTRALINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | No | 2021/10/04 | 2021/10/04 | ALMATICA | Prescription |
| SERTRALINE HYDROCHLORIDE | 215133 | 002 | NDA | SERTRALINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | No | 2021/10/04 | 2021/10/04 | ALMATICA | Prescription |