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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DURACLON | 020615 | 001 | NDA | CLONIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/10ML (0.1MG/ML) | Yes | No | 1996/10/02 | 1996/10/02 | MYLAN INSTITUTIONAL | Prescription |
DURACLON | 020615 | 002 | NDA | CLONIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/10/02 | 1999/04/27 | MYLAN INSTITUTIONAL | Discontinued |