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 |
|---|
| 2023/04/20 |
ORIG-1（原始申请） |
Approval |
|
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:ARSENIC TRIOXIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/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 |
|---|
| 208231 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
Yes |
AP |
2018/08/31
|
FRESENIUS KABI USA |
| 210802 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/11/13
|
AMRING PHARMS |
| 206228 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/11/13
|
ZYDUS PHARMS |
| 209315 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/11/15
|
INGENUS PHARMS LLC |
| 209780 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/11/15
|
NEXUS |
| 209873 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2019/05/06
|
PENN LIFE |
| 210739 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2021/01/25
|
AMNEAL |
| 215059 |
002 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/04/22
|
GLAND PHARMA LTD |
| 217413 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2023/04/20
|
ORBICULAR |
活性成分:ARSENIC TRIOXIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/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 |
|---|
| 021248 |
002 |
NDA |
TRISENOX |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
Yes |
Yes |
AP |
2017/10/13
|
CEPHALON |
| 206228 |
002 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2019/08/30
|
ZYDUS PHARMS |
| 210739 |
002 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2021/08/19
|
AMNEAL |
| 215059 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2021/10/07
|
GLAND PHARMA LTD |
| 214011 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
2021/10/15
|
EUGIA PHARMA |
| 215359 |
001 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2021/12/02
|
SANDOZ |
| 217413 |
002 |
ANDA |
ARSENIC TRIOXIDE |
ARSENIC TRIOXIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2023/04/20
|
ORBICULAR |