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 |
|---|
| 2023/03/03 |
SUPPL-16（补充） |
Approval |
Efficacy |
STANDARD
|
|
|
| 2020/02/21 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/01/17 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/07/31 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/11/22 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/06/04 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2015/04/27 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/12 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
| 2014/03/11 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/03/06 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/01/31 |
SUPPL-4（补充） |
Approval |
Efficacy |
STANDARD
|
|
|
| 2014/01/31 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/08/30 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
PRIORITY
;Orphan
|
|
|
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:SILDENAFIL CITRATE 剂型/给药途径:FOR SUSPENSION;ORAL 规格:EQ 10MG 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 |
|---|
| 203109 |
001 |
NDA |
REVATIO |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
Yes |
Yes |
AB |
2012/08/30
|
VIATRIS |
| 212260 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2019/05/31
|
NOVITIUM PHARMA |
| 212440 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2019/11/27
|
ALKEM LABS LTD |
| 212883 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2019/11/27
|
AJANTA PHARMA LTD |
| 211092 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2019/11/27
|
AMNEAL PHARMS |
| 211534 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2020/05/29
|
TEVA PHARMS USA |
| 213041 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2020/08/06
|
INVAGEN PHARMS |
| 213814 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2021/04/29
|
SOMERSET THERAPS LLC |
| 213014 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2021/05/11
|
HETERO LABS LTD V |
| 215522 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2021/11/16
|
TARO |
| 214641 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2022/02/08
|
MSN |
| 211638 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2022/03/23
|
LUPIN LTD |
| 215708 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2022/09/29
|
ZYDUS LIFESCIENCES |
| 214773 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Prescription |
No |
No |
AB |
2022/12/23
|
AUROBINDO PHARMA LTD |
| 214556 |
001 |
ANDA |
SILDENAFIL CITRATE |
SILDENAFIL CITRATE |
FOR SUSPENSION;ORAL |
EQ 10MG BASE/ML |
Discontinued |
No |
No |
AB |
2023/12/01
|
GRANULES |
