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 |
|---|
| 2020/10/21 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/21 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/10/21 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/12/11 |
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:CYANOCOBALAMIN 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 |
|---|
| 080515 |
002 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
WEST-WARD PHARMS INT |
| 080557 |
003 |
ANDA |
VIBISONE |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 080737 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
AM REGENT |
| 083022 |
001 |
ANDA |
DODEX |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
ACCORD HLTHCARE |
| 206503 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2015/12/11
|
SOMERSET THERAPS LLC |
| 204829 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2017/06/05
|
MYLAN LABS LTD |
| 209255 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/12/18
|
VITRUVIAS THERAP |
| 209429 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2018/12/18
|
SOMERSET THERAPS LLC |
| 214390 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2020/09/24
|
GLAND PHARMA LTD |
| 213874 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2020/12/08
|
EUGIA PHARMA |
| 212915 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2021/01/04
|
SANDOZ |
| 215417 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/04/15
|
SOLA PHARMS |
| 214655 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/04/15
|
ZYDUS PHARMS |
| 215107 |
001 |
ANDA |
CYANOCOBALAMIN |
CYANOCOBALAMIN |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/11/15
|
SAGENT PHARMS INC |