批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2024/10/31 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/10 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/04/20 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/11/25 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/11/25 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/11/20 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2012/08/10 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/08/07 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/10ML (5MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021759 |
001 |
NDA |
ELOXATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Discontinued |
Yes |
No |
AP |
2005/01/31
|
SANOFI AVENTIS US |
| 022160 |
001 |
NDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2009/08/07
|
TEVA PHARMS |
| 078813 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2009/08/07
|
HOSPIRA WORLDWIDE |
| 078811 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2010/06/10
|
FRESENIUS KABI USA |
| 078817 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2011/01/24
|
SANDOZ |
| 091358 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2012/08/07
|
MYLAN LABS LTD |
| 203869 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2014/06/18
|
HENGRUI PHARMA |
| 204368 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2016/06/07
|
QILU PHARM HAINAN |
| 090030 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/01/31
|
FRESENIUS KABI USA |
| 207325 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
Yes |
AP |
2017/02/10
|
GLAND |
| 207474 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/03/21
|
ACCORD HLTHCARE |
| 205529 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Discontinued |
No |
No |
AP |
2017/09/06
|
EUGIA PHARMA |
| 204880 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2018/03/05
|
ACTAVIS |
| 207562 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2018/10/16
|
NOVAST LABS |
| 217348 |
001 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
50MG/10ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/01/11
|
MEITHEAL |
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:100MG/20ML (5MG/ML) 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021759 |
002 |
NDA |
ELOXATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Discontinued |
Yes |
No |
AP |
2005/01/31
|
SANOFI AVENTIS US |
| 022160 |
002 |
NDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
Yes |
Yes |
AP |
2009/08/07
|
TEVA PHARMS |
| 078813 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2009/08/07
|
HOSPIRA WORLDWIDE |
| 078811 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2010/06/10
|
FRESENIUS KABI USA |
| 078817 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2011/01/24
|
SANDOZ |
| 091358 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2012/08/07
|
MYLAN LABS LTD |
| 203869 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2014/06/18
|
HENGRUI PHARMA |
| 204368 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2016/06/07
|
QILU PHARM HAINAN |
| 090030 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/01/31
|
FRESENIUS KABI USA |
| 207325 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
Yes |
AP |
2017/02/10
|
GLAND |
| 207474 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2017/03/21
|
ACCORD HLTHCARE |
| 205529 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Discontinued |
No |
No |
AP |
2017/09/06
|
EUGIA PHARMA |
| 204880 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2018/03/05
|
ACTAVIS |
| 207562 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2018/10/16
|
NOVAST LABS |
| 217348 |
002 |
ANDA |
OXALIPLATIN |
OXALIPLATIN |
INJECTABLE;INTRAVENOUS |
100MG/20ML (5MG/ML) |
Prescription |
No |
No |
AP |
2024/01/11
|
MEITHEAL |
