| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CATAFLAM | 020142 | 001 | NDA | DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1993/11/24 | 1993/11/24 | NOVARTIS | Discontinued |
| CATAFLAM | 020142 | 002 | NDA | DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1993/11/24 | 1993/11/24 | NOVARTIS | Discontinued |
| CATAFLAM | 076561 | 001 | ANDA | DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG | No | No | 2004/03/18 | 2004/03/18 | AMICI PHARMA | Prescription |
| CATAFLAM | 076561 | 002 | ANDA | DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG | No | No | 2004/03/18 | 2021/07/21 | AMICI PHARMA | Prescription |