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 |
|---|
| 2023/04/20 |
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:ICOSAPENT ETHYL 剂型/给药途径:CAPSULE;ORAL 规格:500MG 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 |
|---|
| 202057 |
002 |
NDA |
VASCEPA |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
Yes |
No |
AB |
2017/02/16
|
AMARIN PHARMS |
| 209525 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/09/11
|
TEVA PHARMS USA |
| 209457 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/03/08
|
HIKMA |
| 209499 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/03/08
|
DR REDDYS |
| 217656 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/04/20
|
ZYDUS LIFESCIENCES |
| 217844 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/09/22
|
STRIDES SOFTGELS |
| 216811 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/12/07
|
ASCENT PHARMS INC |
| 217919 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
500MG |
Prescription |
No |
No |
AB |
2023/12/22
|
HUMANWELL PURACAP |
活性成分:ICOSAPENT ETHYL 剂型/给药途径:CAPSULE;ORAL 规格:1GM 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 |
|---|
| 202057 |
001 |
NDA |
VASCEPA |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
Yes |
Yes |
AB |
2012/07/26
|
AMARIN PHARMS |
| 209457 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2020/05/21
|
HIKMA |
| 209499 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2020/08/07
|
DR REDDYS |
| 209525 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2020/09/11
|
TEVA PHARMS USA |
| 209437 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2021/06/30
|
APOTEX |
| 217656 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2023/04/20
|
ZYDUS LIFESCIENCES |
| 217844 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2023/09/22
|
STRIDES SOFTGELS |
| 217919 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2023/12/22
|
HUMANWELL PURACAP |
| 216811 |
002 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2024/02/16
|
ASCENT PHARMS INC |
| 218899 |
001 |
ANDA |
ICOSAPENT ETHYL |
ICOSAPENT ETHYL |
CAPSULE;ORAL |
1GM |
Prescription |
No |
No |
AB |
2024/11/20
|
QILU |