| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZOLOFT | 019839 | 001 | NDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | Yes | No | 1991/12/30 | 1991/12/30 | VIATRIS | Prescription |
| ZOLOFT | 019839 | 002 | NDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Yes | Yes | 1991/12/30 | 1991/12/30 | VIATRIS | Prescription |
| ZOLOFT | 019839 | 003 | NDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/12/30 | 1991/12/30 | VIATRIS | Discontinued |
| ZOLOFT | 019839 | 004 | NDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/12/30 | 1991/12/30 | VIATRIS | Discontinued |
| ZOLOFT | 019839 | 005 | NDA | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | Yes | No | 1991/12/30 | 1996/03/06 | VIATRIS | Prescription |
| ZOLOFT | 020990 | 001 | NDA | SERTRALINE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 20MG BASE/ML | Yes | Yes | 1999/12/07 | 1999/12/07 | VIATRIS | Prescription |