| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OXALIPLATIN | 022160 | 001 | NDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | Yes | Yes | 2009/08/07 | 2009/08/07 | TEVA PHARMS | Prescription |
| OXALIPLATIN | 022160 | 002 | NDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | Yes | Yes | 2009/08/07 | 2009/08/07 | TEVA PHARMS | Prescription |
| OXALIPLATIN | 078810 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL | No | No | 2009/08/07 | 2009/08/07 | FRESENIUS KABI ONCOL | Discontinued |
| OXALIPLATIN | 078810 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL | No | No | 2009/08/07 | 2009/08/07 | FRESENIUS KABI ONCOL | Discontinued |
| OXALIPLATIN | 078812 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No | 2009/08/07 | 2009/08/07 | SANDOZ | Discontinued |
| OXALIPLATIN | 078812 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No | 2009/08/07 | 2009/08/07 | SANDOZ | Discontinued |
| OXALIPLATIN | 078813 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No | 2009/08/07 | 2009/08/07 | HOSPIRA WORLDWIDE | Prescription |
| OXALIPLATIN | 078813 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No | 2009/08/07 | 2009/08/07 | HOSPIRA WORLDWIDE | Prescription |
| OXALIPLATIN | 078816 | 001 | ANDA | OXALIPLATIN | INJECTABLE; INJECTION | 5MG/ML | No | No | 2009/08/07 (TA) | -- | MUSTAFA NEVSAT IIAC SANAYII A.S. | None (Tentative Approval) |
| OXALIPLATIN | 078818 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL | No | No | 2009/08/07 | 2009/08/07 | SUN PHARM | Discontinued |
| OXALIPLATIN | 078818 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL | No | No | 2009/08/07 | 2009/08/07 | SUN PHARM | Discontinued |
| OXALIPLATIN | 078815 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL | No | No | 2009/09/30 | 2009/09/30 | HOSPIRA INC | Discontinued |
| OXALIPLATIN | 078815 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL | No | No | 2009/09/30 | 2009/09/30 | HOSPIRA INC | Discontinued |
| OXALIPLATIN | 078943 | 001 | ANDA | OXALIPLATIN | INJECTABLE; INJECTION | 5MG/ML | No | No | 2010/01/14 (TA) | -- | PLIVA LACHEMA | None (Tentative Approval) |
| OXALIPLATIN | 078819 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/VIAL | No | No | 2010/06/02 | 2010/06/02 | FRESENIUS KABI USA | Prescription |
| OXALIPLATIN | 078819 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/VIAL | No | No | 2010/06/02 | 2010/06/02 | FRESENIUS KABI USA | Prescription |
| OXALIPLATIN | 078811 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No | 2010/06/10 | 2010/06/10 | FRESENIUS KABI USA | Prescription |
| OXALIPLATIN | 078811 | 002 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No | 2010/06/10 | 2010/06/10 | FRESENIUS KABI USA | Prescription |
| OXALIPLATIN | 078817 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No | 2011/01/24 | 2011/01/24 | SANDOZ | Prescription |
| OXALIPLATIN | 078817 | 001 | ANDA | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No | 2011/01/24 (TA) | 2011/01/24 | SANDOZ | Prescription |