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 |
2023/01/17 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2020/07/23 |
SUPPL-33(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2019/07/24 |
SUPPL-30(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2019/05/24 |
SUPPL-31(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/12/12 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/12/12 |
SUPPL-28(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/05/11 |
SUPPL-25(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2018/02/16 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/12 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/07/23 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/11/01 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/10/21 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2013/05/29 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/01/23 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/01/23 |
SUPPL-15(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2012/09/14 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/08/10 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/11 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/01/28 |
SUPPL-10(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/04/22 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/03/05 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/10/02 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/21 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/04/20 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/11/02 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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
|
ICHNOS |
207124 |
001 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |
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
|
ICHNOS |
207124 |
002 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |
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
|
ICHNOS |
207124 |
003 |
ANDA |
DEFERASIROX |
DEFERASIROX |
TABLET, FOR SUSPENSION;ORAL |
500MG |
Discontinued |
No |
No |
AB |
2022/09/23
|
TEVA PHARMS USA |