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 |
|---|
| 2023/11/14 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/14 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/20 |
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:DEFERASIROX 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL 规格:125MG 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 |
|---|
| 021882 |
001 |
NDA |
EXJADE |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
Yes |
No |
AB |
2005/11/02
|
NOVARTIS |
| 203560 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2016/01/26
|
ACTAVIS ELIZABETH |
| 209782 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/11/20
|
SUN PHARM |
| 209878 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/11/20
|
MSN |
| 210060 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALEMBIC |
| 210519 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALKEM LABS LTD |
| 210920 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/11/20
|
BIONPHARMA |
| 209433 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2020/01/06
|
GLENMARK SPECLT |
| 207124 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Prescription |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |
| 206585 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2024/05/17
|
NORVIUM BIOSCIENCE |
活性成分:DEFERASIROX 剂型/给药途径:TABLET, FOR SUSPENSION;ORAL 规格:250MG 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 |
|---|
| 021882 |
002 |
NDA |
EXJADE |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
Yes |
No |
AB |
2005/11/02
|
NOVARTIS |
| 203560 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2016/01/26
|
ACTAVIS ELIZABETH |
| 209782 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/11/20
|
SUN PHARM |
| 209878 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/11/20
|
MSN |
| 210060 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALEMBIC |
| 210519 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALKEM LABS LTD |
| 210920 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/11/20
|
BIONPHARMA |
| 209433 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/01/06
|
GLENMARK SPECLT |
| 207124 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Prescription |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |
| 206585 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2024/05/17
|
NORVIUM BIOSCIENCE |
活性成分:DEFERASIROX 剂型/给药途径:TABLET, FOR SUSPENSION;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 |
|---|
| 021882 |
003 |
NDA |
EXJADE |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
Yes |
Yes |
AB |
2005/11/02
|
NOVARTIS |
| 203560 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2016/01/26
|
ACTAVIS ELIZABETH |
| 209782 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2019/11/20
|
SUN PHARM |
| 209878 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2019/11/20
|
MSN |
| 210060 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALEMBIC |
| 210519 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2019/11/20
|
ALKEM LABS LTD |
| 210920 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2019/11/20
|
BIONPHARMA |
| 209433 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2020/01/06
|
GLENMARK SPECLT |
| 207124 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Prescription |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |
| 206585 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2024/05/17
|
NORVIUM BIOSCIENCE |
