| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LANOXIN | 009330 | 002 | NDA | DIGOXIN | INJECTABLE;INJECTION | 0.25MG/ML | Yes | Yes | 1954/11/16 | Approved Prior to Jan 1, 1982 | COVIS | Prescription |
| LANOXIN PEDIATRIC | 009330 | 004 | NDA | DIGOXIN | INJECTABLE;INJECTION | 0.1MG/ML | Yes | Yes | 1954/11/16 | Approved Prior to Jan 1, 1982 | COVIS | Prescription |
| LANOXIN | 020405 | 001 | NDA | DIGOXIN | TABLET;ORAL | 0.0625MG | Yes | No | 1997/09/30 | 1997/09/30 | CONCORDIA | Prescription |
| LANOXIN | 020405 | 002 | NDA | DIGOXIN | TABLET;ORAL | 0.125MG | Yes | No | 1997/09/30 | 1997/09/30 | CONCORDIA | Prescription |
| LANOXIN | 020405 | 003 | NDA | DIGOXIN | TABLET;ORAL | 0.1875MG | Yes | No | 1997/09/30 | 1997/09/30 | CONCORDIA | Discontinued |
| LANOXIN | 020405 | 004 | NDA | DIGOXIN | TABLET;ORAL | 0.25MG | Yes | Yes | 1997/09/30 | 1997/09/30 | CONCORDIA | Prescription |
| LANOXIN | 020405 | 005 | NDA | DIGOXIN | TABLET;ORAL | 0.375MG | No | No | 1997/09/30 | 1997/09/30 | CONCORDIA | Discontinued |
| LANOXIN | 020405 | 006 | NDA | DIGOXIN | TABLET;ORAL | 0.5MG | No | No | 1997/09/30 | 1997/09/30 | CONCORDIA | Discontinued |