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 |
|---|
| 2020/04/23 |
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:ACYCLOVIR 剂型/给药途径:SUSPENSION;ORAL 规格:200MG/5ML 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 |
|---|
| 019909 |
001 |
NDA |
ZOVIRAX |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Discontinued |
Yes |
No |
AB |
1989/12/22
|
NORVIUM BIOSCIENCE |
| 074738 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
1997/04/28
|
ACTAVIS MID ATLANTIC |
| 077026 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Discontinued |
No |
No |
AB |
2005/06/07
|
HIKMA |
| 212718 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
2020/04/23
|
CHARTWELL RX |
| 212252 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
Yes |
AB |
2020/07/10
|
NOVITIUM PHARMA |
| 216331 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
2022/03/31
|
AUROBINDO PHARMA |
| 215669 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
2022/07/01
|
HETERO LABS LTD III |
| 215724 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
2022/08/18
|
RUBICON |
| 217393 |
001 |
ANDA |
ACYCLOVIR |
ACYCLOVIR |
SUSPENSION;ORAL |
200MG/5ML |
Prescription |
No |
No |
AB |
2023/03/09
|
MSN |