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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SODIUM IODIDE I 123 | 017630 | 001 | NDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | No | No | 1976/03/24 | Approved Prior to Jan 1, 1982 | GE HEALTHCARE | Discontinued |
SODIUM IODIDE I 123 | 017630 | 002 | NDA | SODIUM IODIDE I-123 | SOLUTION;ORAL | 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 1976/03/24 | Approved Prior to Jan 1, 1982 | GE HEALTHCARE | Discontinued |
SODIUM IODIDE I 123 | 017630 | 003 | NDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | No | No | 1976/03/24 | 1993/01/08 | GE HEALTHCARE | Discontinued |
SODIUM IODIDE I 123 | 018671 | 001 | NDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | Yes | Yes | 1982/05/27 | 1982/05/27 | CARDINAL HEALTH 418 | Prescription |
SODIUM IODIDE I 123 | 018671 | 002 | NDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | Yes | Yes | 1982/05/27 | 1982/05/27 | CARDINAL HEALTH 418 | Prescription |
SODIUM IODIDE I 123 | 018671 | 003 | NDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 400uCi | No | No | 1982/05/27 | 1982/05/27 | CARDINAL HEALTH 418 | Discontinued |
SODIUM IODIDE I 123 | 071909 | 001 | ANDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | No | No | 1989/02/28 | 1989/02/28 | CURIUM | Prescription |
SODIUM IODIDE I 123 | 071910 | 001 | ANDA | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | No | No | 1989/02/28 | 1989/02/28 | CURIUM | Prescription |