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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2017/05/24 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2019/08/07 |
SUPPL-3（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
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:DOXERCALCIFEROL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:2MCG/ML (2MCG/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 |
|---|
| 021027 |
002 |
NDA |
HECTOROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
2MCG/ML (2MCG/ML) |
Prescription |
Yes |
No |
AP |
2000/04/06
|
SANOFI |
| 203929 |
002 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
2MCG/ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2016/03/28
|
EPIC PHARMA LLC |
| 208974 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
2MCG/ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2017/05/24
|
AMNEAL |
| 213717 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
2MCG/ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2022/01/24
|
EUGIA PHARMA |
>>>活性成分:DOXERCALCIFEROL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:4MCG/2ML (2MCG/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 |
|---|
| 021027 |
001 |
NDA |
HECTOROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
Yes |
Yes |
AP |
2000/04/06
|
SANOFI |
| 091101 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2013/08/30
|
HIKMA |
| 200926 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2014/02/04
|
SANDOZ |
| 091333 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2014/05/05
|
SANDOZ |
| 203929 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2015/05/07
|
EPIC PHARMA LLC |
| 208974 |
002 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2017/05/24
|
AMNEAL |
| 208975 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2017/05/24
|
AMNEAL |
| 208614 |
001 |
NDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Discontinued |
Yes |
No |
AP |
2018/07/24
|
HOSPIRA |
| 210801 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Discontinued |
No |
No |
AP |
2018/11/01
|
LUPIN LTD |
| 210452 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2019/09/26
|
GLAND |
| 211670 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2020/02/07
|
MEITHEAL |
| 213717 |
002 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2022/01/24
|
EUGIA PHARMA |
| 215810 |
001 |
ANDA |
DOXERCALCIFEROL |
DOXERCALCIFEROL |
INJECTABLE;INJECTION |
4MCG/2ML (2MCG/ML) |
Prescription |
No |
No |
AP |
2023/06/15
|
ALEMBIC |