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 |
|---|
| 2023/10/26 |
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:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/VIAL 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 |
|---|
| 040745 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
Yes |
AP |
2008/05/21
|
BAXTER HLTHCARE |
| 204555 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2014/10/31
|
HENGRUI PHARMA |
| 210046 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2018/05/25
|
AMNEAL |
| 211757 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2022/10/18
|
XGEN PHARMS |
| 214529 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2023/07/17
|
SAGENT PHARMS INC |
| 215089 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2023/10/26
|
SUNNY |
| 216958 |
001 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2023/12/18
|
HIKMA |
活性成分:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/VIAL 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 |
|---|
| 040745 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
Yes |
AP |
2008/05/21
|
BAXTER HLTHCARE |
| 204555 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2014/10/31
|
HENGRUI PHARMA |
| 210046 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2018/05/25
|
AMNEAL |
| 211757 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2022/10/18
|
XGEN PHARMS |
| 214529 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2023/07/17
|
SAGENT PHARMS INC |
| 215089 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2023/10/26
|
SUNNY |
| 216958 |
002 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
1GM/VIAL |
Prescription |
No |
No |
AP |
2023/12/18
|
HIKMA |
活性成分:CYCLOPHOSPHAMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/VIAL 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 |
|---|
| 040745 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
Yes |
AP |
2008/05/21
|
BAXTER HLTHCARE |
| 204555 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2014/10/31
|
HENGRUI PHARMA |
| 210046 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2018/05/25
|
AMNEAL |
| 211757 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2022/10/18
|
XGEN PHARMS |
| 214529 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2023/07/17
|
SAGENT PHARMS INC |
| 215089 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2023/10/26
|
SUNNY |
| 216958 |
003 |
ANDA |
CYCLOPHOSPHAMIDE |
CYCLOPHOSPHAMIDE |
INJECTABLE;INJECTION |
2GM/VIAL |
Prescription |
No |
No |
AP |
2023/12/18
|
HIKMA |