| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FLUOROURACIL | 203609 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No | 2016/02/17 | 2016/02/17 | SAGENT PHARMS INC | Prescription |
| FLUOROURACIL | 203608 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No | 2017/05/11 | 2017/05/11 | SAGENT PHARMS INC | Prescription |
| FLUOROURACIL | 203608 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | No | No | 2017/05/11 | 2017/05/11 | SAGENT PHARMS INC | Prescription |
| FLUOROURACIL | 210123 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No | 2017/10/27 | 2017/10/27 | GLAND PHARMA LTD | Prescription |
| FLUOROURACIL | 210123 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | No | No | 2017/10/27 | 2017/10/27 | GLAND PHARMA LTD | Prescription |
| FLUOROURACIL | 210124 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | No | No | 2017/12/26 | 2017/12/26 | GLAND PHARMA LTD | Prescription |
| FLUOROURACIL | 210124 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No | 2017/12/26 | 2017/12/26 | GLAND PHARMA LTD | Prescription |
| FLUOROURACIL | 209271 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No | 2019/12/11 | 2019/12/11 | NOVAST LABS | Discontinued |
| FLUOROURACIL | 209271 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | No | No | 2019/12/11 | 2019/12/11 | NOVAST LABS | Discontinued |
| FLUOROURACIL | 209219 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No | 2019/12/12 | 2019/12/12 | NOVAST LABS | Discontinued |
| FLUOROURACIL | 209219 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | No | No | 2019/12/12 | 2019/12/12 | NOVAST LABS | Discontinued |
| FLUOROURACIL | 214845 | 001 | ANDA | FLUOROURACIL | CREAM;TOPICAL | 5% | No | No | 2021/10/07 | 2021/10/07 | ACCORD HLTHCARE | Prescription |
| FLUOROURACIL | 217295 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | No | No | 2023/03/03 | 2023/03/03 | ALEMBIC | Prescription |
| FLUOROURACIL | 217676 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No | 2023/10/18 | 2023/10/18 | ALEMBIC | Prescription |
| FLUOROURACIL | 215612 | 001 | ANDA | FLUOROURACIL | SOLUTION;TOPICAL | 5% | No | No | 2023/11/02 | 2023/11/02 | ENCUBE | Prescription |