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 |
|---|
| 2024/03/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/03/16 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2022/09/22 |
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:DEFERASIROX 剂型/给药途径:GRANULE;ORAL 规格:180MG 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 |
|---|
| 207968 |
002 |
NDA |
JADENU SPRINKLE |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
Yes |
No |
AB |
2017/05/18
|
NOVARTIS |
| 213374 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2020/07/14
|
ALKEM LABS LTD |
| 214194 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Discontinued |
No |
No |
AB |
2021/02/09
|
AMNEAL |
| 214559 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2021/03/09
|
AUCTA |
| 214650 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2021/03/17
|
MSN |
| 214180 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2021/11/19
|
TEVA PHARMS USA |
| 215026 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2022/02/23
|
CIPLA |
| 216229 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2022/09/22
|
ANNORA PHARMA |
| 213146 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2024/05/03
|
MYLAN |
活性成分:DEFERASIROX 剂型/给药途径:GRANULE;ORAL 规格:360MG 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 |
|---|
| 207968 |
003 |
NDA |
JADENU SPRINKLE |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
Yes |
Yes |
AB |
2017/05/18
|
NOVARTIS |
| 213374 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2020/07/14
|
ALKEM LABS LTD |
| 214194 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Discontinued |
No |
No |
AB |
2021/02/09
|
AMNEAL |
| 214559 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2021/03/09
|
AUCTA |
| 214650 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2021/03/17
|
MSN |
| 214180 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2021/11/19
|
TEVA PHARMS USA |
| 215026 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2022/02/23
|
CIPLA |
| 216229 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2022/09/22
|
ANNORA PHARMA |
| 213146 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
360MG |
Prescription |
No |
No |
AB |
2024/05/03
|
MYLAN |
活性成分:DEFERASIROX 剂型/给药途径:GRANULE;ORAL 规格:90MG 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 |
|---|
| 207968 |
001 |
NDA |
JADENU SPRINKLE |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
Yes |
No |
AB |
2017/05/18
|
NOVARTIS |
| 213374 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2020/07/14
|
ALKEM LABS LTD |
| 214559 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2021/03/09
|
AUCTA |
| 214180 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2021/11/19
|
TEVA PHARMS USA |
| 215026 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2022/02/23
|
CIPLA |
| 214650 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2022/04/20
|
MSN |
| 216229 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2023/03/16
|
ANNORA PHARMA |
| 213146 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
GRANULE;ORAL |
90MG |
Prescription |
No |
No |
AB |
2024/05/03
|
MYLAN |