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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2022/09/07 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/12/17 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
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:FINGOLIMOD HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 0.5MG 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 |
|---|
| 022527 |
001 |
NDA |
GILENYA |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
Yes |
Yes |
AB |
2010/09/21
|
NOVARTIS |
| 207979 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2019/12/04
|
BIOCON LTD |
| 208014 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Discontinued |
No |
No |
AB |
2019/12/04
|
SUN PHARM |
| 207933 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/05/18
|
HETERO LABS LTD V |
| 207985 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/06/18
|
GLENMARK PHARMS LTD |
| 208008 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/07/02
|
TEVA PHARMS USA |
| 207994 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/10/14
|
ZYDUS PHARMS |
| 207991 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/10/28
|
ACCORD HLTHCARE |
| 207993 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/12/18
|
APOTEX |
| 208004 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/12/30
|
ALKEM LABS LTD |
| 208005 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Discontinued |
No |
No |
AB |
2021/01/19
|
MYLAN |
| 208000 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2021/03/05
|
DR REDDYS |
| 207939 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2021/11/10
|
HEC PHARM CO LTD |
| 208003 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2022/09/07
|
PRINSTON INC |
| 210252 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/05/24
|
BIONPHARMA |
| 207945 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/12/06
|
EZRA VENTURES |
| 207983 |
001 |
ANDA |
FINGOLIMOD HYDROCHLORIDE |
FINGOLIMOD HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/02/28
|
AUROBINDO PHARMA LTD |
