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 |
2022/04/11 |
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:SUNITINIB MALATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 12.5MG 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 |
021938 |
001 |
NDA |
SUTENT |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
Yes |
No |
AB |
2006/01/26
|
CPPI CV |
213914 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2021/08/16
|
SUN PHARM |
213803 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2021/11/30
|
TEVA PHARMS USA |
201275 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2021/12/06
|
MYLAN |
215843 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2022/04/11
|
DR REDDYS |
218012 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
NOVUGEN |
218024 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2023/10/24
|
NATCO PHARMA |
218615 |
001 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 12.5MG BASE |
Prescription |
No |
No |
AB |
2024/03/14
|
EUGIA PHARMA |
活性成分:SUNITINIB MALATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG 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 |
021938 |
002 |
NDA |
SUTENT |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
Yes |
No |
AB |
2006/01/26
|
CPPI CV |
213914 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/08/16
|
SUN PHARM |
213803 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/11/30
|
TEVA PHARMS USA |
201275 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/12/06
|
MYLAN |
215843 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2022/04/11
|
DR REDDYS |
218012 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
NOVUGEN |
218024 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2023/10/24
|
NATCO PHARMA |
218615 |
002 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2024/03/14
|
EUGIA PHARMA |
活性成分:SUNITINIB MALATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 37.5MG 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 |
021938 |
004 |
NDA |
SUTENT |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
Yes |
No |
AB |
2009/03/31
|
CPPI CV |
213914 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2021/08/16
|
SUN PHARM |
213803 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2021/11/30
|
TEVA PHARMS USA |
201275 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2021/12/06
|
MYLAN |
215843 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2022/04/11
|
DR REDDYS |
218012 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
NOVUGEN |
218024 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2023/10/24
|
NATCO PHARMA |
218615 |
003 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 37.5MG BASE |
Prescription |
No |
No |
AB |
2024/03/14
|
EUGIA PHARMA |
活性成分:SUNITINIB MALATE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG 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 |
021938 |
003 |
NDA |
SUTENT |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
Yes |
Yes |
AB |
2006/01/26
|
CPPI CV |
213914 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/08/16
|
SUN PHARM |
213803 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/11/30
|
TEVA PHARMS USA |
201275 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/12/06
|
MYLAN |
215843 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2022/04/11
|
DR REDDYS |
218012 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
NOVUGEN |
218024 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2023/10/24
|
NATCO PHARMA |
218615 |
004 |
ANDA |
SUNITINIB MALATE |
SUNITINIB MALATE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2024/03/14
|
EUGIA PHARMA |