| 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 | 088766 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1984/12/28 | SMITH AND NEPHEW | Discontinued |
| FLUOROURACIL | 088767 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1984/12/28 | SMITH AND NEPHEW | Discontinued |
| FLUOROURACIL | 088929 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1986/03/04 | ABIC | Discontinued |
| FLUOROURACIL | 089152 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1986/03/21 | ABRAXIS PHARM | Discontinued |
| FLUOROURACIL | 089368 | 001 | ANDA | FLUOROURACIL | Injectable; Injection | 50MG/ML | No | No | -- | -- | QUAD PHARMS | Discontinued |
| FLUOROURACIL | 089428 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1987/01/12 | ABRAXIS PHARM | Discontinued |
| FLUOROURACIL | 089434 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1987/03/26 | SMITH AND NEPHEW | Discontinued |
| FLUOROURACIL | 089455 | 001 | ANDA | FLUOROURACIL | Injectable; Injection | 50MG/ML | No | No | -- | -- | QUAD PHARMS | Discontinued |
| FLUOROURACIL | 089519 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | -- | 1987/03/12 | ABRAXIS PHARM | Discontinued |
| FLUOROURACIL | 012209 | 001 | NDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1962/04/25 | Approved Prior to Jan 1, 1982 | SPECTRUM PHARMS | Discontinued |
| FLUOROURACIL | 012209 | 002 | NDA | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1962/04/25 | 2016/07/29 | SPECTRUM PHARMS | Discontinued |
| FLUOROURACIL | 087792 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1982/10/13 | 1982/10/13 | SPECTRUM PHARMS | Discontinued |
| FLUOROURACIL | 087791 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1983/01/18 | 1983/01/18 | MARCHAR | Discontinued |
| FLUOROURACIL | 089508 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1988/01/26 | 1988/01/26 | BEDFORD | Discontinued |
| FLUOROURACIL | 040278 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 2.5GM/50ML (50MG/ML) | No | No | 1998/09/30 | 1998/09/30 | FRESENIUS KABI USA | Prescription |
| FLUOROURACIL | 040278 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 5GM/100ML (50MG/ML) | No | No | 1998/09/30 | 1998/09/30 | FRESENIUS KABI USA | Prescription |
| FLUOROURACIL | 040279 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 1GM/20ML (50MG/ML) | No | No | 1998/09/30 | 1998/09/30 | FRESENIUS KABI USA | Prescription |
| FLUOROURACIL | 040279 | 002 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No | 1998/09/30 | 1998/09/30 | FRESENIUS KABI USA | Prescription |
| FLUOROURACIL | 040291 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 50MG/ML | No | No | 1999/03/24 | 1999/03/24 | FRESENIUS KABI USA | Discontinued |
| FLUOROURACIL | 040333 | 001 | ANDA | FLUOROURACIL | INJECTABLE;INJECTION | 500MG/10ML (50MG/ML) | No | No | 2000/01/27 | 2000/01/27 | TEVA PHARMS USA | Discontinued |