| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CUPRIC SULFATE | 019350 | 001 | NDA | CUPRIC SULFATE | INJECTABLE;INJECTION | EQ 0.4MG COPPER/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1987/05/05 | 1987/05/05 | ABRAXIS PHARM | Discontinued |
| CUPRIC SULFATE | 216324 | 001 | ANDA | CUPRIC SULFATE | INJECTABLE;INJECTION | EQ 0.4MG COPPER/ML | No | Yes | 2022/12/16 | 2022/12/16 | AM REGENT | Prescription |
| CUPRIC SULFATE | 218745 | 001 | ANDA | CUPRIC SULFATE | INJECTABLE;INJECTION | EQ 0.4MG COPPER/ML | No | No | 2024/08/19 | 2024/08/19 | APOTEX CORP | Prescription |