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 |
|---|
| 2024/02/07 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/23 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/04/04 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:VALACYCLOVIR HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 500MG BASE 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 |
|---|
| 020487 |
001 |
NDA |
VALTREX |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
Yes |
No |
AB |
1995/06/23
|
GLAXOSMITHKLINE |
| 076588 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2007/01/31
|
SUN PHARM INDS LTD |
| 077135 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Discontinued |
No |
No |
AB |
2010/05/24
|
CIPLA |
| 077478 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Discontinued |
No |
No |
AB |
2010/05/24
|
SANDOZ |
| 078518 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
MYLAN PHARMS INC |
| 079012 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
GRAVITI PHARMS |
| 090682 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
AUROBINDO PHARMA |
| 090216 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
CHARTWELL RX |
| 201506 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2012/04/03
|
JUBILANT GENERICS |
| 090500 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2014/04/04
|
APOTEX |
| 203047 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2015/04/08
|
HETERO LABS LTD V |
| 079137 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2017/12/29
|
ZYDUS LIFESCIENCES |
| 209553 |
001 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 500MG BASE |
Prescription |
No |
No |
AB |
2020/03/18
|
YILING |
活性成分:VALACYCLOVIR HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 1GM BASE 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 |
|---|
| 020487 |
002 |
NDA |
VALTREX |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
Yes |
Yes |
AB |
1995/06/23
|
GLAXOSMITHKLINE |
| 076588 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2007/01/31
|
SUN PHARM INDS LTD |
| 077135 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Discontinued |
No |
No |
AB |
2010/05/24
|
CIPLA |
| 077478 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Discontinued |
No |
No |
AB |
2010/05/24
|
SANDOZ |
| 078518 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
MYLAN PHARMS INC |
| 079012 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
GRAVITI PHARMS |
| 090682 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
AUROBINDO PHARMA |
| 090216 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2010/05/24
|
CHARTWELL RX |
| 201506 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2012/04/03
|
JUBILANT GENERICS |
| 090500 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2014/04/04
|
APOTEX |
| 203047 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2015/04/08
|
HETERO LABS LTD V |
| 079137 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2017/12/29
|
ZYDUS LIFESCIENCES |
| 209553 |
002 |
ANDA |
VALACYCLOVIR HYDROCHLORIDE |
VALACYCLOVIR HYDROCHLORIDE |
TABLET;ORAL |
EQ 1GM BASE |
Prescription |
No |
No |
AB |
2020/03/18
|
YILING |