| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMICAR | 015197 | 001 | NDA | AMINOCAPROIC ACID | TABLET;ORAL | 500MG | Yes | No | 1964/06/03 | Approved Prior to Jan 1, 1982 | HIKMA | Prescription |
| AMICAR | 015197 | 002 | NDA | AMINOCAPROIC ACID | TABLET;ORAL | 1GM | Yes | No | 1964/06/03 | 2004/06/24 | HIKMA | Prescription |
| AMICAR | 015230 | 002 | NDA | AMINOCAPROIC ACID | SOLUTION;ORAL | 0.25GM/ML | Yes | No | 1964/06/04 | Approved Prior to Jan 1, 1982 | HIKMA | Prescription |
| AMICAR | 015229 | 002 | NDA | AMINOCAPROIC ACID | INJECTABLE;INJECTION | 250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1964/06/08 | Approved Prior to Jan 1, 1982 | EPIC PHARMA LLC | Discontinued |