| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FLUDARA | 020038 | 001 | NDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/04/18 | 1991/04/18 | GENZYME CORP | Discontinued |
| FLUDARABINE PHOSPHATE | 076349 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No | 2003/08/28 | 2003/08/28 | HIKMA | Prescription |
| FLUDARABINE PHOSPHATE | 076661 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | No | No | 2004/04/28 | 2004/04/28 | SAGENT PHARMS INC | Prescription |
| FLUDARABINE PHOSPHATE | 077790 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No | 2007/04/06 | 2007/04/06 | HOSPIRA | Discontinued |
| FLUDARABINE PHOSPHATE | 022137 | 001 | NDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2007/09/21 | 2007/09/21 | SANDOZ | Discontinued |
| FLUDARABINE PHOSPHATE | 078393 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Prescription |
| FLUDARABINE PHOSPHATE | 078544 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Prescription |
| FLUDARABINE PHOSPHATE | 078610 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | Yes | 2009/02/11 | 2009/02/11 | ACTAVIS TOTOWA | Prescription |
| FLUDARABINE PHOSPHATE | 090724 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | No | No | 2010/09/27 | 2010/09/27 | AREVA PHARMS | Prescription |
| FLUDARABINE PHOSPHATE | 200647 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | No | No | 2011/12/21 | 2011/12/21 | RISING | Discontinued |
| FLUDARABINE PHOSPHATE | 200648 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/VIAL | No | No | 2012/10/16 | 2012/10/16 | RISING | Discontinued |
| FLUDARABINE PHOSPHATE | 203738 | 001 | ANDA | FLUDARABINE PHOSPHATE | INJECTABLE;INJECTION | 50MG/2ML (25MG/ML) | No | No | 2017/02/28 | 2017/02/28 | ACTAVIS LLC | Discontinued |