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 |
|---|
| 2021/12/16 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/12/16 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/12/16 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/10/31 |
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:OSELTAMIVIR PHOSPHATE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:EQ 6MG BASE/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 |
|---|
| 021246 |
002 |
NDA |
TAMIFLU |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
Yes |
Yes |
AB |
2011/03/21
|
ROCHE |
| 209113 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2017/09/14
|
ZYDUS PHARMS |
| 208823 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2017/10/31
|
ALVOGEN |
| 208347 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2018/02/20
|
LUPIN |
| 210186 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2018/02/27
|
AMNEAL PHARMS NY |
| 211125 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2019/02/27
|
TEVA PHARMS USA |
| 212784 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2020/05/27
|
AJANTA PHARMA LTD |
| 212858 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2021/08/30
|
APTAPHARMA INC |
| 213594 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2022/01/05
|
SUNSHINE |
| 211894 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2022/01/13
|
STRIDES PHARMA |
| 214949 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Discontinued |
No |
No |
AB |
2022/02/28
|
CHEMISTRY HLTH |
| 209590 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2022/03/28
|
HETERO LABS LTD V |
| 215313 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2022/05/02
|
MSN |
| 215538 |
001 |
ANDA |
OSELTAMIVIR PHOSPHATE |
OSELTAMIVIR PHOSPHATE |
FOR SUSPENSION;ORAL |
EQ 6MG BASE/ML |
Prescription |
No |
No |
AB |
2023/02/14
|
EPIC PHARMA LLC |