| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZANAFLEX | 020397 | 001 | NDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | Yes | Yes | 1996/11/27 | 1996/11/27 | LEGACY PHARMA USA | Prescription |
| ZANAFLEX | 020397 | 002 | NDA | TIZANIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/11/27 | 2000/02/04 | LEGACY PHARMA USA | Discontinued |
| ZANAFLEX | 021447 | 001 | NDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | Yes | No | 2002/08/29 | 2002/08/29 | LEGACY PHARMA USA | Prescription |
| ZANAFLEX | 021447 | 002 | NDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | Yes | No | 2002/08/29 | 2002/08/29 | LEGACY PHARMA USA | Prescription |
| ZANAFLEX | 021447 | 003 | NDA | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | Yes | Yes | 2002/08/29 | 2002/08/29 | LEGACY PHARMA USA | Prescription |