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 |
|---|
| 2022/08/22 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/08/22 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/13 |
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:VALGANCICLOVIR HYDROCHLORIDE 剂型/给药途径:FOR SOLUTION;ORAL 规格:50MG/ML 治疗等效代码:AB
| 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 |
|---|
| 022257 |
001 |
NDA |
VALCYTE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
Yes |
Yes |
AB |
2009/08/28
|
CHEPLAPHARM |
| 205220 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2016/07/18
|
ACTAVIS LABS FL INC |
| 212890 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2020/01/13
|
AJANTA PHARMA LTD |
| 213306 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2020/01/31
|
GRANULES |
| 210169 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2022/02/17
|
MSN |
| 211475 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2022/10/04
|
HETERO LABS LTD V |
| 215124 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2022/11/17
|
AUROBINDO PHARMA |
| 216317 |
001 |
ANDA |
VALGANCICLOVIR HYDROCHLORIDE |
VALGANCICLOVIR HYDROCHLORIDE |
FOR SOLUTION;ORAL |
50MG/ML |
Prescription |
No |
No |
AB |
2023/04/11
|
APPCO |